Published: July 2010 BioForum · BioForum – July 2010 | 2 Majors make a comeback The Life...

BioForumEdition 32

Published: July 2010

Quarter 3 FY10 January – March 2010

What would you like to change?

Has the life sciences sector discovered a formula for growth?

BioForum – July 2010 | 2

Majors make a comeback The Life Sciences Index made a solid recovery during the third quarter, finishing up 9.1 per cent as major stocks made a comeback. Positive growth among the majors – notably CSL, which gained 12.1 per cent – enabled the index to outperform the broader All Ordinaries. This mirrored the situation in the US, where the Nasdaq Biotech Index (up 11.3 per cent) outperformed the broader Nasdaq market (up 5.7 per cent). In contrast, the Life Sciences Index ex-majors posted its first quarter of negative growth in over a year with a decline of 1.1 per cent. This was in line with the broader ASX, which was flat for the quarter (up 0.2 per cent).

The Life Sciences Index’s year-on-year growth of 23.6 per cent was an improvement on the previous quarter’s yearly growth of 11.5 per cent but well below the All Ordinaries’ growth of 38.5 per cent. The ex-majors, on the other hand, maintained strong annual growth of 83 per cent.

Med devices outperform The Medical Devices Index ex-majors continued to outperform its pharma/biotech counterpart, posting a 9.7 per cent gain. While the overall Pharma/Biotech Index was up 7.9 per cent, the index ex-majors fell 5.1 per cent. The 15 per cent spread between the two ex-majors indices was the result of poor performances from a number of mid-cap pharma/biotech stocks, including Chemgenex, Probiotic and Scigen.

Little support for IPOs, secondary financingCBio was the only company to launch an IPO in the March quarter. It raised just $7 million, half the amount sought, and the stock entered the market at more than 50 per cent below issue price. In comparison, four IPOs in the US pharma/biotech sector raised a total of $373 million, a slight increase on the previous quarter, when $294 million was raised.

Secondary financing in Australia fell sharply as market support waned. While $93 million was raised during the third quarter, Heartware’s raising made up $70 million of this total, whereas $201 million was raised in Q2FY10. Activity in this area started to ramp up towards the end of 2009 but at the start of 2010, with many companies having conducted secondary raisings last year, the remaining raisings have been at the smaller end and have not received the expected level of support from the market.

The US secondary financing market also headed south, raising only $1.2 billion compared to $4.1 billion the previous quarter.

Poor performers punishedIn the past 12 months there has been a lot of heat in the market, with investors anticipating a rise in valuations, and on the back of this many capital raisings took place. There was continuing support for these valuations during the third quarter, with little profit-taking.

But it is anticipated that the market will continue to monitor companies closely, and both small and mid-caps alike need to meet expectations in order to maintain current valuations. It appears that there are more cases of poor performance being punished (eg Chemgenex) than of good performance being immediately rewarded (eg Acrux). This is because good news stories have already been factored into current pricing after a few optimistic quarters.

Feature articlesThis edition features an article on the expected impact on the life sciences sector of legislation passed recently in the US, the Health Care and Education Affordability Reconciliation Act of 2010. A second article provides background on a recent PwC report, Global pharma looks to India, which highlights that India now has a growing and increasingly sophisticated pharmaceutical industry of its own.

Craig Lawn PricewaterhouseCoopers

Tony Gellert PricewaterhouseCoopers

Manoj Santiago PricewaterhouseCoopers


PricewaterhouseCoopers Australia Life Sciences and Innovation Practice contactsAustralian Industry Leaders – Life SciencesCraig Lawn Phone: +617 3257 5672 Email: [email protected]

Manoj Santiago Phone: +612 8266 4494 Email: [email protected]

Sydney

Private Clients – Assurance

Manoj Santiago Phone: +612 8266 4494 Email: [email protected]

Private Clients – Transactions

Kate Julius Phone: +612 8266 5835 Email: [email protected]

Private Clients – Advisory

Tony Gellert Phone: +612 8266 5776 Email: [email protected]

Corporate Finance

Adrian Bunter Phone: +612 8266 5099 Email: [email protected]

Private Clients – Tax & Accounting

Craig McIlveen Phone: +612 8266 2261 Email: [email protected]

Private Clients – Tax

Stephanie Fabian Phone: +612 4925 1278 Email: [email protected]

Pharmaceutical Industry Leader

John Cannings Phone: +612 8266 6410 Email: [email protected]

Financial Assurance

Michelle Chiang Phone: +612 8266 7575 Email: [email protected]

R&D Tax

Sandra Mason Phone: +612 8266 0470 Email: [email protected]

Financial Assurance

Ian Benham Phone: +612 8266 2409 Email: [email protected]

Licensing and Forensic Accounting

Cassandra Michie Phone: +612 8266 2774 Email: [email protected]

Legal – Commercialisation & IP

Megan Dyball Phone: +612 8266 6333 Email: [email protected]

Brisbane Melbourne

Craig Lawn Phone: +617 3257 5672 Email: [email protected]

Nadia Carlin Phone: +613 8603 6616 Email: [email protected]

Troy Morgan Phone: +617 3257 8934 Email: [email protected]

Sam Lobley Phone: +613 8603 3689 Email: [email protected]


Contents01 Quarterly key findings 1

02 Feature articles 3

03 Market performance 13

Performance overview 14

Quarterly financing 17

Yearly financing 19

Top 10 performers 21

Bottom 10 performers 22

04 Announcements – Australia 23

Partnerships 24

Mergers, acquisitions and divestments 25

Clinical trials 26

Regulatory 27

Other news 28

05 Announcements – US 31

Partnerships 32

Mergers, acquisitions and divestments 32

Clinical trials 33

Regulatory 35

06 Appendix 39

Companies in the PwC Life Sciences Index 40

07 Methodology 43

08 Acknowledgements 45


01Quarterlykey findings


Market performance Page

Total market cap of the life sciences industry at end of quarter A$37,211m 14

Quarterly change in the life sciences industry 9.1% 14

Total market cap of the pharma/biotech sector at end of quarter A$25,790m 16

Quarterly change in the pharma/biotech sector 7.9% 16

Total market cap of the medical device sector at end of quarter A$11,421m 16

Quarterly change in the medical device sector 12.0% 16

Individual company performance

Top individual performer Holista Colltech Limited 21

Change in market cap over the last 4 quarters 1,456%

Bottom individual performer Nusep Limited 22

Change in market cap over the last 4 quarters -81%

Financing

Number of Australian life sciences companies that IPO’ed 1 17

Total market cap injected into the Australian life sciences index through IPOs A$7m 17

Number of US life sciences companies that IPO’ed 4 17

Total capital raised in US life sciences IPOs A$373m 17

Number of Australian life sciences companies that had secondary raisings 22 18

Total capital raised in Australian life sciences in secondary raisings A$93m 18

Number of US life sciences companies that had secondary raisings 60 18

Total capital raised in US life sciences in secondary raisings A$1,241m 18

Announcements – Australia

Total number of partnerships formed this quarter 17 24

Total number of mergers and acquisitions 20 25

Total announcements for clinical trials 13 26

Pre-clinical 0 26

Phase I 6 26

Phase II 3 26

Phase III 2 26

Total number of regulatory announcements 14 27

Announcements – US

Total number of partnerships formed this quarter 12 32

Total number of mergers and acquisitions 5 32

Total announcements for clinical trials 44 33

Pre-clinical 2 33

Phase I 4 33

Phase II 12 33

Phase III 18 33

Total number of regulatory announcements 64 35


02Feature Articles


Healthcare reform sector implications:

Year Percentage paid by enrollee

2011 – 2012 50.0%

2013 – 2014 47.5%

2015 – 2016 45.0%

2017 30.0%

2018 35.0%

2019 30.0%

2020 and beyond 25.0%

Figure 1: Medicare recipient reduction in beneficiary obligation inbrand drugs

At a glanceOverall, pharmaceutical and life sciences companies may benefit from increased revenues from more insured patients through coverage expansions.

The legislation will reduce net pharmaceutical revenues through higher discounts, rebates, taxes and fees.

The Act authorizes the establishment of a pathway for biosimilar competitors to enter the market.

Pharmaceutical and life sciences

Overall, pharmaceutical and life sciences companies may benefit from increased revenues from more insured patients through coverage expansions. On the other hand, the legislation will reduce net pharmaceutical revenues through higher discounts, rebates, taxes and fees.

On March 30, 2010, President Obama signed the “Health Care and Education Affordability Reconciliation Act of 2010,” P.L. 111-152,“2010 Reconciliation Act” that amends the comprehensive healthcare reform legislation enacted March 23 (the “Patient Protection and Affordable Care Act,” P.L. 111-148,“PPACA”).

This report focuses on aspects of the final healthcare reform and reconciliation legislation that are expected to be most significant to pharmaceutical and life sciences companies. For purposes of this report, except as stated otherwise, the term “the Act” refers to PPACA as modified by the 2010 Reconciliation Act.

Overall, pharmaceutical and life sciences companies may benefit from increased revenues from more insured patients through coverage expansions. On the other hand, the legislation will reduce net pharmaceutical revenues through higher discounts, rebates, taxes and fees. On the research side, the Act authorizes the establishment of a pathway for biosimilar competitors to enter the market for biologic drugs that are up to 20 times more expensive than the biosimilar alternative. At the same time, the Act promotes investment by granting data exclusivity for biotech drugs for 12 years.

Increased revenues from expanded coverage, but higher fees, rebates

The Act requires everyone to have healthcare insurance coverage beginning on Jan. 1, 2014. Individuals who cannot afford health insurance are eligible for either tax subsidies or Medicaid, depending on their income levels. Employers would be subject to penalties if they do not provide sufficient coverage for their full-time employees.According to the Congressional Budget Office (CBO), the Act reduces the number of uninsured by 32 million people by 2019.

The Act also expands coverage for people who are currently insured. It prohibits lifetime and annual limits on coverage, and eliminates pre-existing condition exclusions. Health insurance companies must offer coverage for children of covered individuals up to age 26, if they can’t get coverage themselves. Many of these changes begin for the first plan year within six months of enactment.

According to the CBO, nearly half the newly insured will be enrolled in Medicaid and their spending will be subject to Medicaid rebates (and formulary or drug schedules). Thus, a large group of newly insured people will be shifted from the self-pay category, on which no rebates are paid, to Medicaid programs where rebates discount prices by 17% to 23%. Medicare beneficiaries, who are enrolled in Medicare prescription drug plans (PDPs), will have major gains in coverage in 2014 and beyond.

Observation: The pharmaceutical industry is expected to sell more prescriptions because more people will have insurance coverage and existing insurance coverage will have minimum benefit requirements. However, manufacturers will be required to pay higher rebates to Medicaid programs, thus reducing the prices they receive for their products.


Closing the Medicare

Part D doughnut hole Pharmaceutical companies often lose sales when beneficiaries’ drug spending puts them in the “doughnut hole,” where they must pay totally out of pocket for their drugs. Some seniors simply stop taking the drug when they’re in that gap (between $2,830 and $6,440 of drug spending.) The Act makes several changes that are designed to help seniors move through the doughnut hole more quickly so Medicare will start paying for their drugs again. Effective immediately, the federal government will pay a $250 rebate to Medicare beneficiaries who reach the doughnut hole in 2010. Then, in 2011, pharmaceutical manufacturers will be required to discount all branded prescriptions by 50% when they’re filled in the doughnut hole. Lastly, the coinsurance rate in the Medicare Part D coverage gap will be gradually reduced in phases to 25% by 2020. (See Figure 1.) Finally, beginning in 2011, the federal government will also provide subsidies of 7% of generic drug cost filled within the doughnut hole. Each year, an additional portion of cost will be picked up until 2020, when 75% of generic drug costs will be covered by the federal government.

Observation: Pharmaceutical companies currently provide discounts on brand prescriptions filled in the Medicare Part D coverage gap. It is unclear as to whether companies will have to provide the same level of discounts they currently provide.

Increased medicaid rebate rate

Currently, pharmaceutical manufacturers are required to rebate to the federal and state governments a portion of their revenues from sales to Medicaid patients. Under the Act, the rebate percentage for brand name drugs will increase from 15.1% to 23.1% (except for clotting factors and drugs approved exclusively for pediatric use, which increase to 17.1%); non-innovator, multiple source drugs will increase from 11% to 13% of average manufacturer price. Additionally, the rebate will extend to prescription drug spending under Medicaid managed care plans. Both of these changes take effect immediately.

Observation: The impact of an increase in the Medicaid rebate rate may be less extensive than believed as rebates currently in place already exceed this rate.

Expansion of 340(b) discounts

The 340(b) drug pricing program, passed into law by the Veterans Health Care Act of 1992, was designed to limit the cost of covered outpatient drugs to federal grantees, federally-qualified health center look-alikes as well as qualified disproportionate share hospitals. Effective immediately, the Act extends discounts to providers serving low-income and chronically sick patient populations; specifically, children’s hospitals, rural referral centers and sole community hospitals with disproportionate (DSH) payments equal to or greater than 8%. Those hospitals entitled to 340(b) pricing/discounts will receive them retroactive to Jan. 1, 2010. 340(b) hospitals will have to determine how to calculate and collect these retroactive price adjustments and pharmaceutical companies will have to estimate and accrue for the impact.

Observation: The impact of the discount expansion on the pharmaceutical industry is likely to be small.

Change in tax treatment of retiree drug subsidy, high-value plans

Current law provides a tax-free federal subsidy to companies that provide retirees with drug coverage that is at least actuarially equivalent to Medicare Part D. The Act would tax that subsidy, effective in tax years beginning after Dec. 31, 2012. Employers may react to this change by increasing costsharing with retirees, reducing the amount they spend on drug coverage, or dropping their drug benefits for retirees. Retirees who lose employer-sponsored retiree coverage would then have to enroll in a Medicare Part D plan. If an employer chooses to drop their retiree drug plan and assist retirees by offering a premium for the retiree to enroll in Medicare PDPs, pharmaceutical companies may see an increase in the number of individuals with spending in the coverage gap. Pharmaceutical companies would in turn see an increase in the number of participants enrolled who are eligible for the coverage gap discount.

The pharmaceutical industry is expected to sell more prescriptions because more people will have insurance coverage and existing insurance coverage will have minimum benefit requirements.


The taxation of this subsidy will cause pharmaceutical companies to immediately write down their deferred tax assets established for this liability, which will impact net income for affected companies. Another provision, which will be implemented in 2018, has the potential to reduce drug spending by active workers in high-value plans. Specifically, the Act imposes a 40% excise tax on plans with actuarial values in excess of specified thresholds ($27,500 for a family plan and to $10,200 for a single plan). Health insurance companies will owe the tax on amounts exceeding the thresholds, and are expected to pass that tax on to members. As a result, many plan sponsors are expected to reduce the level of benefits rather than pay the excise.

Observation: The decision by employers whether to drop their current prescription drug plans is affected, not only by the tax treatment of the retiree drug subsidy (RDS) but also by the level of discounts in the coverage gap. In the past, employers may have been reluctant to drop their plans because of the coverage gap in the standard Medicare PDPs. With that gap being gradually closed, more employers may take advantage of the larger government subsidies in PDPs. Furthermore in 2018, tax on high-value plans may encourage employers to reduce coverage, which could reduce drug spending.

Pathway for biosimilar biological products, extended patent protection, therapeutic discovery tax credit

Under the Act, the Food and Drug Administration is authorized to approve biosimilar versions of biologic drugs. Effective immediately, biologics manufacturers will be granted 12 years of exclusive data use before a “follow-on” or biosimilar can be approved using the same data that formed the basis of the regulatory approval. Although biologic drugs represent only a small portion of industry sales, they are the fastest-growing segment of the pharmaceutical market and many future “blockbusters” are expected to fall into this category.

The Act allocates $1 billion for a two-year temporary tax credit to encourage new therapies for acute and chronic diseases. Under section 9023 of the Act, “Qualifying Therapeutic Discovery Project Credit,” certain 2009 and 2010 investments made by companies with no more than 250 employees may be eligible for a 50% credit. This provision is expected to provide relief to small undercapitalized biotechnology research companies, helping them continue their innovative research on therapies to treat patients living with chronic and acute diseases. The therapeutic tax credit provision is effective immediately. Within 60 days of the Act’s passage, the Secretary of the U.S. Department of Healthcare and Human Services (HHS) will establish a program to consider and award certifications for qualified investments.

Observation: The Act’s 12 years of data exclusivity is higher than several of the major alternative proposals that would have limited exclusivity to eight years or fewer. Supporters of the longer protection believe it is necessary based on the cost, time and uncertainty involved in bringing such products to the market. Others question such a long market protection time, asserting that it slows down the ability for more affordable biosimilar forms of the drugs to come to market.

The Act’s 12 years of data exclusivity is higher than several of the major alternative proposals that would have limited exclusivity to eight years or fewer.


Pharmaceutical industry fees

Pharmaceutical manufacturers andimporters of branded prescription drugs are expected to pay $28 billion over the next 10 years in new fees. (See Figure 2). The fees will be assessed proportionately based on each organization’s share of total brand sales to government programs (e.g. Medicare Parts B & D, Medicaid, Veterans Affairs and Defense programs) during the previous year. Sales of “orphan” drugs for rare diseases and conditions would be excluded from a company’s market share calculation. Companies with sales in excess of $5 million will contribute to the fee based on a proportion of their annual net sales to government programs and companies with sales less than $5 million will not be included in the fee calculation.

Not more than $5 million net sales 0% of sales taken into account

$5 million to $125 million net sales—10% of sales taken into account $125 million to $225 million net sales—40% of sales taken into account

$225 million to $400 million net sales—75% of sales taken into account

More than $400 million—100% of sales taken into account

For example, if a company had $300 million in total brand sales, the Secretary of Treasury (the “Secretary”) would determine the fee for the company based on 0% for the first $5 million of branded sales, 10% for sales between $5 million and $125 million, 40% for sales between $125 million and $225 million, and 75% of sales between $225 million and $300 million. In this case, the fee would be calculated using $108.25 million in brand sales. This fee is not deductible for income tax purposes.

Medical device excise tax

The legislation includes a 2.3% excise tax on the sale of certain medical devices by a manufacturer, producer, or importer of such devices. The new medical device excise tax will be deductible in the same manner as other excise taxes.

The new excise tax would apply to certain medical devices sold by a manufacturer, producer, or importer that are intended for human use, as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act. The new excise tax on medical devices will apply to sales after Dec. 31, 2012. The excise tax will not apply to the following:

Eyeglasses, contacts lenses,hearing aids, and any other medical device determined by the Secretary to be a type of device that is generally purchased by the general public at retail for individual use.

Additional specific devices as determined by the Secretary to be sold at retail establishments (including over the Internet) to individuals for personal use.

These exceptions to the excise tax are not limited by device class as defined by section 513 of the Federal Food, Drug, and Cosmetic Act. It is anticipated that the Secretary will publish a list of medical device classifications that are of a type generally purchased by the general public at retail for individual use.

A present-law excise tax exemption for further manufacture and for export would apply to the new excise tax on sales of medical devices, but this present-law exemption would not apply to sales for use on vessels or aircraft. This exemption also would not apply for sales to state and local governments, nonprofit educational organizations, and qualified blood collector organizations.

Other direct and indirect effects

The Act contains dozens of provisions that are intended to increase efficiency and reduce costs in the provision of healthcare services. Many of the new directions do not mandate major changes or devote large federal outlays to implementing them. However, the legislation attempts to implement reforms in the areas of comparative effectiveness studies, pay-forperformance, wellness and disease management programs, new incentives for patients and providers to make better decisions, and insurance industry regulation.

For example, the Act creates a new non-profit Patient-Centered Outcomes Research Institute that is tasked with identifying research priorities and comparing the clinical effectiveness of medical treatments. However, the findings of the research cannot be used to make cost or coverage decisions.

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Calendar year Applicable amount

2011 $2.5 billion

2012 $2.8 billion

2013 $2.8 billion

2014 $3.0 billion

2015 $3.0 billion

2016 $3.0 billion

2017 $4.0 billion

2018 $4.1 billion

2019 and beyond $2.8 billion

Observation: Given the fixed dollar amount, over time the impact diminishes relative to pharmaceutical sales

Observation: Uncertainty remains as to which devices will be considered taxable under the new legislation. Also, manufacturers will need to make a decision if they will raise prices on devices to either completely or partially offset the tax.


Health plans will be required to provide minimum coverage without cost sharing for certain preventative services recommended by a preventative services task force, including vaccines. States providing Medicaid coverage for and removing cost-sharing for recommended preventative services and immunizations will receive a one percentage point increase in their Federal Medical Assistance Percentage.

Timeline

Effective Date Provision

2010 Eliminates lifetime and annual limits on insurance benefits

FDA can approve generic versions of biologic drugs. Biologics manufacturers have 12-year exclusivity

Patient-Centered Outcomes Research Institute for comparative effectiveness established to identify research priorities as well as conduct research that compares the clinical effectiveness of different medical treatments

2011 Eliminates cost-sharing for preventive services in Medicare; increases Medicare payments for certain preventive services. Enhance payments to states that provide preventive services and immunizations recommended by the US Preventive Services Task Force

50% discount on brand-name prescriptions and Federal subsidies for generic prescriptions filled in the Medicare Part D coverage gap begin

Pharmaceutical fees begin

2012 Equalize Part D cost-sharing for full-benefit dual eligible beneficiaries receiving home/community – care services to institutional care levels

2013 Phase in for federal subsidies of Medicare Part D brand-name prescriptions filled in the coverage gap

Financial relationship disclosure between healthcare organizations and pharmaceutical companies and suppliers

Excise tax of 2.3% begins on the sale of any taxable medical device

Elimination of tax-deduction for employers who receive Medicare Part D retiree drug subsidy payments

2014 Out-of-pocket amount that qualifies an enrollee for catastrophic coverage in Medicare Part D reduced through 2019

2018 Tax on high-value employer-provided health insurance first applies

PricewaterhouseCoopers’ Health Industries

PricewaterhouseCoopers’ Health Industries serves as a catalyst for change and as the leading adviser to organizations across the health continuum, including, payer, providers, and those involved in health sciences, biotech/medical devices, and pharmaceutical and employer practices in the public, private, and academic sectors. With a distinctive approach that is collaborative, multidisciplinary, and multi-industry, PricewaterhouseCoopers draws from the broad perspective and capabilities across and beyond thehealth industries to help solve the array of emerging complex problems health organizations face, lead cultural and clinical transformation, and create a new, sustainable model for care delivery that is quality driven, patient centered, and technology enabled.

Our clients

PricewaterhouseCoopers’ Health Industries’ clients include 40 of the top 100 hospitals in the United States and 16 of the 18 best hospitals as ranked by U.S. News & World Report; all 20 of the world’s major pharmaceutical companies; all of the top 20 commercial payers; municipal, state, and federal government agencies; and many of the world’s preeminent medical foundations and associations.

Observation: Although estimates from the Congressional Budget Office and HHS do not credit the Act with huge savings from “bending the curve,” some of the initiatives may have a big impact directly or indirectly on pharmaceutical and life sciences companies. Manufacturers developing and distributing recommended vaccines may see an increase in demand.


Our people

PwC has a network of more than 4,000 professionals worldwide and 1,200 professionals in the US dedicated to the health industries. Our Health Industries professionals include a cadre of physicians, nurses, ancillary health providers, and some of the nation’s leading minds in medicine, science, information technology, operations, administration, and healthy policy. We are ranked as the number one worldwide business consulting provider and the number three US business consulting provider by IDC. Forrester named PwC a leader in its Risk Consulting Services, Q2 2007, and Security Consulting Q3 2007 Waves.

Our research

PricewaterhouseCoopers’ Health Research Institute (HRI) is an unparalleled resource for health industry expertise. By providing cutting-edge intelligence, perspective, and analysis on issues affecting the health industry, HRI assists executive decision makers and stakeholders worldwide in navigating their most pressing business challenges. PricewaterhouseCoopers is one of the only firms with a dedicated global healthcare research unit, capitalizing on fact-based research and collaborative exchange among its network of professional with day-to-day experience in the health industries.

For more information about PricewaterhouseCoopers in the health industries, visit us on the Web at www.pwc.com/healthindustries.

About PricewaterhouseCoopers

PricewaterhouseCoopers provides industry-focused assurance, tax, and advisory services to build public trust and enhance value for its clients and their stakeholders. More than 155,000 people in 153 countries across our network share their thinking, experience and solutions to develop fresh perspectives and practical advice.

“PricewaterhouseCoopers” refers to the network of member firms of PricewaterhouseCoopers International Limited, each of which is a separate and independent legal entity.

The information contained in this document is provided ‘as is’, for general guidance on matters of interest only. The application and impact of laws can vary widely based on the specific facts involved. Given the changing nature of laws, rules and regulations, there may be omissions or inaccuracies in information contained in this document. PricewaterhouseCoopers is not herein engaged in rendering legal, accounting, tax, or other professional advice and services. Before making any decision or taking any action, you should consult a competent professional adviser.

To have a deeper conversation about any of the issues in this paper, please contact:

PricewaterhouseCoopers US Contacts

Mike Swanick

(267) 330-6060 [email protected]

Todd D. Evans


Richard Manning


Jack Rodgers



Global pharma looks to India:Prospects for growth

The huge potential of the Indian pharmaceuticals market is impossible for foreign companies to ignore, given that it will be one of the top 10 sales markets by 2020, according to a recent report by PricewaterhouseCoopers.

India’s population is growing rapidly, as is its economy – creating a large middle-class able to afford western medicines, PwC finds. India’s epidemiological profile is also changing and the population is ageing, so demand is likely to increase for drugs for cardio-vascular problems, disorders of the central nervous system and other chronic diseases such as diabetes which is increasing at an alarming rate.

The total market is expected to rise to a value of approximately US$50 billion by 2020 according to PricewaterhouseCoopers.

Simon Friend, global pharmaceutical and life sciences leader at PricewaterhouseCoopers, commented:

“Global players in the pharmaceutical industry cannot afford to ignore India. The pharmaceutical industry’s main markets are under serious pressure. India could be the most populous country in the world by 2050 and is now making its mark as a growing market, potential competitor or partner in manufacturing and R&D, and as a location for clinical trials.”

The report highlights that India now has a growing and increasingly sophisticated pharmaceutical industry of its own. Indeed it is likely to become a competitor of global pharma in some key areas, and a potential partner in others. It has considerable contract manufacturing expertise; Indian companies are among the world leaders in the production of generics and vaccines. India now produces more than 20% of the world’s generics. Around $70 billion worth of drugs are expected to go off patent in the US over the next three years, and PwC thinks that India is capable of manufacturing a substantial share of the product to support the resulting generics opportunities. In manufacturing we are already seeing big pharma striking closer relationships with Indian generics to service global markets under marketing alliances such as GSK-DRL and Pfizer – Aurobindo.

PwC estimates that India’s 10 largest drug firms spent $480 million on R&D in 2008. Some of the leading local producers have now started conducting original research, but despite Indian pharma companies’ growing expertise in later stages of the R&D process, many of the drug candidates initially formulated in India are likely to be further developed by Western drug makers, because few Indian companies can currently afford the high costs and failure rates associated with pushing a drug right through the pipeline. Several Indian firms have already entered into research partnerships with multinationals; DRL and Torrent have joined forces with Novartis, for example, while Ranbaxy has formed alliances with GSK and Schwarz Pharmaceuticals.

India has the world’s second biggest pool of English speakers and a strong system of higher education, so it should be well-positioned to serve as a source for research talent, turning out roughly 115,000 scientists with Masters degrees and 12,000 with PhDs every year. India’s developing biotech industry and cost advantages should drive significant growth in local development of biosimilars for the global market. India has also made considerable progress in terms of stem cell research.

The Indian Government has made the provision of healthcare one of its key priorities. It has launched a new policy to build more hospitals, boost local access to healthcare and improve the quality of medical training, and promised to increase public expenditure on healthcare to 2-3% of GDP by 2010, up from a current low of 1%.

India could be the most populous country in the world by 2050 and is now making its mark as a growing market, potential competitor or partner in manufacturing and R&D, and as a location for clinical trials.


PwC notes a number of methods for foreign companies to explore opportunities in India.

Outsourcing. Recently there has been a move from outsourcing lower value and manufacturing activities to more research-based capabilities.

Licensing is being used to establish a common platform in order to gain rapid in-market acceptance and create a complete therapy range.

Franchising. US-based Medicine Shoppe International, for instance, has entered the market as Medicine Shoppe India and plans to expand to 1,000 stores by the end of 2010.

Joint ventures with domestic partners bring local expertise and a local network and require government approval. Pharmaceuticals are deemed a high priority area so approvals can be quick.

Some multinational companies such as Pfizer and Novartis are taking advantage of the potential in India through partially or wholly owned subsidiaries.

PwC also notes that as with any kind of new market opportunity there are additional factors to consider:

Inadequate energy and transport infrastructure has historically posed challenging for companies operating in India but the situation is definitely improving as the government deems it an investment need.

India offers some attractive tax benefits for pharma companies such as R&D credits and income tax exemptions in special economic zones (SEZs). Reductions in customs duties should also help global manufacturers compete in the price sensitive Indian market. India will introduce Goods and Services Tax (GST) in April 2011, which will have transformational implication for supply chain in domestic market.

Counterfeit drugs have been a serious issue in India but recent research suggests the prevalence of spurious drugs to have fallen to 0.046% of all medicines sold to consumers. Even so companies should remain alert to possible counterfeiting issues. Whilst intellectual property protection has improved substantially, some holes remain. Compliance will always be an issue and as the market expands regulatory compliance will require attention with robust programmes, vigilance and improved policing to ensure that patients and India’s reputation are protected.

Although urbanisation continues, around 70% of India’s population still resides in rural areas. PwC notes that this untapped potential is now the next volume driver for the industry but foreign companies looking to access rural markets face many hurdles such as communication, transport, marketing and a high penetration of spurious drugs so they will need to forge alliances and partnerships with local players.

Sharat Bansal, pharmaceutical and life sciences leader at PricewaterhouseCoopers in India, concluded:

“India has long been a formidable player in pharmaceutical manufacturing, but its socioeconomic strengths provide even greater grounds for optimism. Companies that will be most successful in doing business in India will be those that are most adept at managing and mixing a range of contractual relationships and partnership strategies to create networks of collaboration and discovery. India has huge potential and is at a stage that it can help the industry address some of the issues that it finds itself dealing with in more developed markets.”

Copies of Global pharma looks to India: Prospects for growth can be downloaded at www.pwc.com/pharma

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India has huge potential and is at a stage that it can help the industry address some of the issues that it finds itself dealing with in more developed markets.


03Market Performance


Performance overview

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15%

31-Dec 01-Jan 08-Jan 15-Jan 22-Jan 29-Jan 05-Feb 12-Feb 19-Feb 26-Feb 05-Mar 12-Mar 19-Mar 26-Mar 31-Mar

ASX All Ordinaries NASDAQ Composite NASDAQ Biotech Life Sciences Life Sciences ex majors

0.2%

5.7%

11.3%

9.1%

-1.1%-2%

0%

2%

4%

6%

8%

10%

12%

ASX All Ordinaries(Index)

NASDAQ Composite (Index)

NASDAQ Biotech (Index)

Life Sciences(Market Cap A$m)

Life Sciences ex majors (Market Cap A$m)

ASX All Ordinaries (Index)

NASDAQ Composite (Index)

NASDAQ Biotech (Index)

Life Sciences (Market Cap A$m)

Life Sciences ex majors(Market Cap A$m)

38.5%

56.9%

37.5%

23.6%

82.5%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

Table 2: Yearly movements of the Australian life sciences sector by market capitalisation compared to major indices

Value

31-Mar-09 31-Mar-10 % Change

ASX All Ordinaries (Index) 3,532 4,893 38.5%

NASDAQ Composite (Index) 1,529 2,398 56.9%

NASDAQ Biotech (Index) 683 939 37.5%

Life Sciences (Market Cap A$m) 30,115 37,211 23.6%


3,678 6,714 82.5%

Figure 1: Weekly performance over the quarter of the Australian life sciences compared to major indices

ASX All Ordinaries NASDAQ Composite NASDAQ Biotech Life Sciences Life Sciences ex majors

-60%

-40%

-20%

0%

20%

40%

60%

31-Mar-08 01-Jul-08 01-Oct-08 01-Jan-09 01-Apr-09 31-Mar-1001-Jul-09 01-Oct-09 01-Jan-10

Figure 2: Two-year comparison of the Australian life sciences sector by market capitalisation compared to major indices

Table 1: Quarterly movements of the Australian life sciences sector compared to major indices

Value

31-Dec-09 31-Mar-10 % Change

ASX All Ordinaries (Index) 4,883 4,893 0.2%

NASDAQ Composite (Index) 2,269 2,398 5.7%

NASDAQ Biotech (Index) 844 939 11.3%

Life Sciences (Market Cap A$m) 34,094 37,211 9.1%


6,786 6,714 -1.1%

Graph 1: Quarterly movements of the Australian life sciences sector compared to major indices

Graph 2: Yearly movements of the Australian life sciences sector by market capitalisation compared to major indices


-10%

-5%

0%

5%

10%

15%

20%

25%

30%

31-Dec-09 07-Jan-10 14-Jan-10 21-Jan-10 28-Jan-10 04-Feb-10 05-Feb-10 11-Feb-10 18-Feb-10 25-Feb-10 04-Mar-10 11-Mar-10 18-Mar-10 25-Mar-10 31-Mar-10

Life Sciences Pharma/Biotech Pharma/Biotech ex CSL Med Device Med Device ex COH, RMDLife Sciences ex majors

Figure 3: Quarterly performance of the Australian life sciences sector and subsectors

Performance overview (cont.)

Table 3: Quarterly summary of the Australian life sciences sector’s performance

MCap(A$m) % of total value

Companies with share price gains

Proportion of subsector up

Companies with share price losses

Proportion of subsector down

Companies with share price flat

Proportion of subsector flat

Total number of companies

Pharma/Biotech 25,790 69% 25 37% 41 60% 2 3% 68

Pharma/Biotech ex CSL 4,672 70% 24 36% 41 61% 2 3% 67

Med Device 11,421 31% 14 33% 23 55% 5 12% 42

Med Device ex COH, 2,042 30% 12 30% 23 58% 5 12% 40

Life Sciences 37,211 100% 39 35% 64 58% 7 7% 110

Life Sciences ex majors 6,714 100% 37 34% 63 59% 7 7% 107


7.9%

-5.1%

12.0%9.7%

9.1%

-1.1%

-8%

-6%-4%

-2%

0%

2%

4%

6%

8%

10%12%

14%

Pharma/Biotech Pharma/Biotechex CSL

Med Device Med Device/exCOH, RMD

Life Sciences Life Sciencesex majors

Life Sciences Pharma/Biotech Pharma/Biotech ex CSL Med Device Med Device ex COH, RMDLife Sciences ex majors

-60%

-40%

-20%

0%

20%

40%

60%

80%

100%

31-Mar-08 30-Jul-08 30-Sep-08 30-Dec-09 30-Mar-09 30-June-09 30-Sep-09 30-Dec-10 31-Mar-10

Figure 4: Two-year comparison of the Australian life sciences sector’s performance by market cap

Graph 3: Quarterly movements of the Australian life sciences sector and subsectors by market cap

Table 4: Quarterly movements of the Australian life sciences sectors

Market Capitalisation (A$m)

31-Dec-09 31-Mar-10 % Change

Pharma/Biotech 23,895 25,790 7.9%

Pharma/Biotech ex CSL 4,925 4,672 -5.1%

Med Device 10,198 11,421 12.0%

Med Device ex COH, RMD 1,861 2 ,042 9.7%

Life Sciences 34,094 37,211 9.1%

Life Sciences ex majors 6,786 6,714 -1.1%


Quarterly financing

Table 5: Number of Australian IPO listings

Biotech Med Devices ASX

Q3FY10 1 0 7

Q2FY10 0 0 27

Q1FY10 0 0 3

Q4FY09 0 0 0

Q3FY09 0 0 3

Figure 5: Quarterly comparison of IPOs in Australia

Capi

tal r

aise

d (A

$m)

Q3FY09 Q4FY09 Q1FY10 Q2FY10 Q3FY10

Biotech Medical Devices

06

1,215

75

219

0

200

400

600

800

1000

1200

1400

Med Device: $6m

372

Table 7: Number of US IPO listings

Biotech Med Devices

Q3FY10 4 0

Q2FY10 1 1

Q1FY10 2 0

Q3FY09 0 1

Q2FY09 0 0

0 0 0 0

7

0

1

2

3

4

5

6

7

8

Capi

tal r

aise

d (A

$m)*


Table 6: Total of quarterly Australian IPO listings

Company Listing date Issue priceCl. Price for qtr

Capital raised (A$m)

CBio 17/03/2010 $1 $0.32 $7 million

Figure 6: Quarterly comparison of IPOs in the US

Table 8: Total of quarterly US IPO listings

Company Capital raised (A$m)

Anthera Pharmaceuticals Inc $47 million

AVEO Pharmaceuticals Inc $90 million

CorMedix Inc $28 million

Ironwood Pharmaceuticals Inc $208 million

Total $373 million

IPO market

* Amounts shown are total market cap additions to the LS index from IPOs on first day of trading

Capi

tal r

aise

d (A

$m)



34

113

67

1215

16 101

80

22

7150

100

150

200

250

Figure 7: Quarterly comparison of secondary financing in Australia Table 9: Number of Australian secondary raisings

BiotechAvg. amount raised (A$m)

Med DevicesAvg. amount raised (A$m)

Q3FY10 18 1.2 4 17.9

Q2FY10 33 3.7 18 4.4

Q1FY10 30 2.2 11 9.2

Q4FY09 21 5.4 9 1.8

Q3FY09 22 1.5 4 1.3

Table 10: Number of US secondary raisings

Biotech Med Devices

Q3FY10 47 13

Q2FY10 29 16

Q1FY10 40 17

Q4FY09 7 3

Q3FY09 15 7



6471,276

1794

3161

835

47

67

795

970

406

0

500

1000

1500

2000

2500

3000

3500

4000

4500

Capi

tal r

aise

d (A

$m)

Biotech: $647mMed Device: $47m

Figure 8: Quarterly comparison of secondary financing in the US

Secondary finance market



Yearly financing

FY06 FY07 FY08 FY09 FY10 - YTD


1,636

4,277

325

1,662

517

1,013

219

5886

0

1,000

2,000

3,000

4,000

5,000

6,000 Med Dev $6m

Capi

tal r

aise

d (A

$m)

Table 12: Number of US IPO listings

Biotech Med Devices

FY10 – YTD 7 1

FY09 0 1

FY08 8 8

FY07 42 12

FY06 20 8

Figure 10: Annual comparison of IPOs in the US

0FY06 FY07 FY08 FY09 FY10 - YTD


Biotech $7m

22

176118

24 7

153

105

6350

100

150

200

250

300

350

Capi

tal r

aise

d (A

$m)*

Figure 9: Annual comparison of IPOs in Australia Table 11: Number of Australian IPO listings

Biotech Med Devices ASX

FY10 – YTD 1 0 37

FY09 1 0 24

FY08 4 3 79

FY07 6 7 245

FY06 3 8 172

IPO market

* Amounts shown are total market cap additions to the LS index from IPOs on first day of trading




0

5,000

10,000

1,5000

20,000

25,000

16,766

6,2025,542

15,8101,699

8,603 719

3,3305,790

2,171

Capi

tal r

aise

d (A

$m)

Table 14: Number of US secondary raisings

Biotech Med Devices

FY10 – YTD 116 46

FY09 48 24

FY08 80 29

FY07 258 59

FY06 257 123

Figure 12: Annual comparison of secondary finance in the US



297 438 274 210

236229

71

2,081

42253

0

500

1,000

1,500

2,000

2,500

Capi

tal r

aise

d (A

$m)

Table 13: Number of Australian secondary raisings

Biotech Med Devices

FY10 – YTD 81 33

FY09 87 41

FY08 99 66

FY07 98 75

FY06 56 28

FY05 63 43

Figure 11: Annual comparison of secondary finance in Australia

Secondary finance market


01HOLISTA COLLTECH LTD (HCT)

Return: 1,456% Closing price: $0.14 MCap: A$16.84m

Holista released financial results for the half year ending 31 December 2009, showing a 7.1% increase in revenue from the previous year, and completed the reverse acquisition begun in November 2008.

02BRAINZ INSTRUMENTS LTD (BZI)

Return: 1,119% Closing price: $0.20 MCap: A$14.62m

Brainz Instruments agreed to participate in one high impact gas exploration prospect in Louisiana, USA and secured the option to participate in a second follow-on exploration.

03OBJ LTD (OBJ)

Return: 700% Closing price: $0.04 MCap: A$45.98m

The company received a statement of intent from a global FMCG company in regards to a product development program using OBJ’s ETP and DP technologies.

04PRIMA BIOMED LTD (PRR)


The European Medicines Agency (EMEA) granted Prima Biomed SME enterprise status, and Prima Biomed submitted to the EMEA a product design application for CVac for the treatment of ovarian cancer.

05NEUREN PHARMACEUTICALS LTD (NEU)


Neuren Pharmaceuticals entered into a strategic master service agreement with Cato BioVentures, with CBV investing US$400k.

06ACRUX LTD (ACR)


Acrux signed an exclusive global licensing deal with pharmaceutical giant Eli Lilly for the commercialisation of Axiron.

07UNILIFE CORPORATION (UNS)


Unilife Corporation successfully listed on the NASDAQ, with trading commencing on 16 February 2010.

08PROBIOMICS LTD (PCC)


Probiomics released financial results for the half year ending 31 December 2009 which showed a profit of $212,226, a 220% increase from the previous period.

09BIOTA HOLDINGS LTD (BTA)


Biota Holdings met all the conditions for the acquisition of MaxThera assets. The co-owner of Biota Holdings, Daiichi Sankyo, has filed a new drug application in Japan for CS-8958, a neuraminidase inhibitor for treating influenza.

10PSIVIDA CORP (PVA)


pSivida Corporation released 24-month data for its phase III drug Illuvien which included additional efficacy and safety data reinforcing the positive top line results.

Top 10 Performers over past four quarters

0% 200% 400% 600% 800% 1,000% 1,200% 1,400% 1,600%

PVA

BTA

PCC

UNS

ACR

NEU

PRR

OBJ

HCT

BZI


01GIACONDA LTD (GIA)

Return: -40% Closing price: $0.04 MCap: A$3.05m

Giaconda’s finance facility was retired and the fixed and floating charge which relates to that loan was released. It agreed to sell the Myoconda intellectual property for the treatment of Crohn’s disease to Australian Medical Therapy Investment for $1.5m.

02BONE MEDICAL LTD (BNE)


Bone Medical released financial results for the half year ending 31 December 2009, reporting a 94% decrease in revenue from the previous year.

03INSTITUTE OF DRUG TECHNOLOGY AUSTRALIA (IDT)


IDT released financial results for the half year ended 31 December 2009, reporting a 121% decrease in profit from the previous year.

04ATOS WELLNESS LTD (ATW)


The securities of Atos Wellness were suspended from quotation at the company’s request, pending an announcement on negotiations for a planned restructure.

05SUNSHINE HEART INC (SHC)


Sunshine Heart released financial results for the half year ending 31 December 2009, reporting a 20% decrease in revenue from the previous year.

06MEDIC VISION LTD (MVH)


The ASX suspended trade in the securities of Medic Vision from 1 March because it failed to lodge its half year report and accounts. Medic Vision and Leading Edge Instrumentation successfully completed a due diligence process. In addition, the company acquired cBox Pty Ltd, a digital marketing and communication company.

07MEDICAL AUSTRALIA LTD (MLA)


Medical Australia appointed Thomas Joseph Hartigan as non-executive chairman to replace former director Thomas Mann. Mark Donnison appointed CEO and Greg Lewis appointed CFO.

08ACUVAX LTD (ACU)


Acuvax announced a share placement to meet its near term working capital needs by raising $100k at a placement price of 1.0 c a share.

09SAFETY MEDICAL PRODUCTS LTD (SFP)


The ASX suspended trade in the securities of Safety Medical Products from 1 March because it failed to lodge its half year report and accounts.

10NUSEP LTD (NSP)


NuSep agreed to raise up to $5m to fund the acquisition of BioInquire and complete the commercialisation of the IVF SpermSep instrument. NuSep has signed a binding sale purchase agreement to acquire BioInquire.

Bottom 10 Performers over past four quarters

-90% -80% -70% -60% -50% -40% -30% -20% -10% 0%

NSP

SFP

ACU

MLA

MVH

SHC

ATW

IDT

GIA

BNE


04AnnouncementsAustralia


PartnershipsCompany Pharma/biotech partner Application Value (A$m) Comments

Biotechnology Total 12

Acrux (ACR) Eli Lilly Testosterone replacement therapy

$380m Acrux has signed an exclusive global licensing deal with Eli Lilly for the commercialisation of Axiron, which is the largest such deal ever struck by an Australian biotech.

Antisense Therapeutics (ANP)

Teva Pharmaceuticals Antisense inhibitor targeting

Not applicable Teva Pharmaceuticals has discontinued clinical development of Antisense’s ATL1102 and ended the partners’ licence agreement.

Benitec (BLT) Commonwealth Scientific and Industrial Research Organisation (CSIRO)

Not disclosed CSIRO has accepted a 10% equity stake in Benitec in exchange for terminating capital growth and commercial agreements between the companies.

Benitec (BLT) Pfizer Toxicology study and research

Not disclosed Benitec (BLT) licensee company Tacere Therapeutics and Pfizer have agreed to work together for at least 12 months to complete regulatory toxicology studies.

Biotron (BIT) Aclires group Hepatitis C Not applicable Biotron has signed a letter of intent to trial BIT225 with Aclires group.

Cellmid Limited (CDY) Pharmahungary Heart attack treatment Not applicable CDY has signed research, development and collaboration agreements with Pharmahungary.

Giaconda (GIA) Australian Medical Therapy Investment

Not disclosed Not applicable Giaconda agreed with Australian Medical Therapy Investment to vary the terms of deals previously announced.

Imugene (IMU) Merial Not disclosed Merial and Imugene are renegotiating their strategic alliance.

Living Cell Technologies (LCT)

CytoSolv Choroid plexus patents Not disclosed Living Cell Technology has taken a 10% stake in CytoSolv in exchange for a non-exclusive, non-transferable licence to use its broad choroid plexus patents.

Neuren Pharmaceuticals (NEU)

Cato BioVentures Not disclosed $450K Neuren Pharmaceuticals has signed a strategic master service agreement with Cato BioVentures, with CBV investing US$400k.

Phosphagenics (POH) Pulse Pharmacies Skincare products Not disclosed Phosphagenics has signed an agreement appointing Pulse Pharmacies as the exclusive Australia-wide distributor of its new Elixia skincare range.

Sirtex Medical (SRX) Bayer Healthcare Intermediate and advanced stage liver cancer

Not disclosed Sirtex Medical and Bayer Healthcare will partner to trial the effectiveness of the Nexavar SIRSpheres micro spheres combination compared to Nexavar therapy.

Medical Devices Total 5

CathRx (CXD) Pioneer Not disclosed Not disclosed CathRx has signed a strategic agreement with Pioneer.

Innovative Technologies for Life (ITD)

American Red Cross Safety devices used in blood banks

Not applicable ITD has signed a three year contract extension with the American Red Cross for supply of blood bank safety ancillary devices.

KarmelSonix (KSX) Pneumo Care Healthcare Not disclosed Not applicable KarmelSonix has appointed Pneumo Care Healthcare as its distribution partner for north, east and west India.

Medic Vision (MVH) Leading Edge Instrumentation

Not disclosed Not applicable Medic Vision and Leading Edge Instrumentation have completed due diligence for a strategic alliance.

OBJ (OBJ) A global FMCG company Product developing program

Not disclosed A global FMCG company has stated that it intends to develop products using OBJ’s ETP and DP technologies.


Mergers, acquisitions and divestmentsDominant company Target company Type of deal Value (A$m) Comments


Analytica (ALT) Change in ownership Not disclosed Analytica filed a Form 603 notifying the ASX that Warren Stephen Brooks has become a substantial holder, with 21,723,484 ordinary shares, a 5.35% stake.

BioSignal (BOS) RGM Acquisition Not disclosed BioSignal is planning to acquire the business of RGM subject to shareholder approval.

Biota Holdings (BTA) MaxThera Acquisition $1.4m Biota Holdings has met all the conditions for the acquisition of MaxThera assets.

Calzada (CZD) PolyNovo Biomaterials Acquisition Not disclosed Calzada has acquired all of Xceed Capital’s shares and CSIRO’s shares in PolyNovo Biomaterials.

Calzada (CZD) PolyNovo Biomaterials Acquisition Not disclosed Calzada has acquired all of CSIRO’s shares in PolyNovo Biomaterials, giving it 100% ownership.

Circadian Technologies (CIR)

Antisense Therapeutics Change in ownership Not disclosed Circadian technologies filed a Form 604 with respect to holdings of its subsidiary Polychip Pharmaceuticals in Antisense Therapeutics, and Syngene, an associate of Polychip.

Giaconda (GIA) Australian Medical Therapy Investment (AMTI)

Divestment $1.5m Giaconda has agreed to sell the Myoconda intellectual property for the treatment of Crohn’s disease to Australian Medical Therapy Investment.

Golden Village – a JV between Village Roadshow and Golden Harvest Group

RGM Group Acquisition Not disclosed Golden Village has acquired a cornerstone investment in RGM Group ahead of Biosignal’s proposed takeover.

Incitive (ICV) Hawkley Oil & Gas Acquisition Not disclosed Incitive has agreed to acquire all of the shares in Hawkley Oil & Gas.

NuSep (NSP) BioInquire Acquisition Not disclosed NuSep has signed a binding agreement to acquire BioInquire, and will raise up to $5m to fund the acquisition and commercialise the IVF SpermSep instrument.

Pharmaxis (PXS) Topigen Pharmaceuticals Acquisition Not disclosed Pharmaxis has signed an agreement to acquire Topigen Pharmaceutical.

Prana Biotechnology (PBT)

Change in ownership Not disclosed Prana Biotechnology notified the ASX that Morgan Stanley Australia Securities is no longer a substantial holder.

Probiotec (PBP) RedBak, Black Widow, Lady Bird and Natural Health Supplement

Acquisition $1.8m Probiotec has agreed to acquire the business assets of RedBak, Black Widow, Lady Bird and Natural Health Supplement.

Probiotec (PBP) Australian Diary Proteins Acquisition Not disclosed Probiotec has acquired 49.999% of the shares in ADP held by Dairy Farmers, giving it 100% ownership.

Sirtex Medical (SRX) Change in ownership Not disclosed Sirtex Medical filed a Form 603 outlining the details of substantial shareholder Platypus Asset Management.

Strides Arcolab Ascent Pharmahealth (APH)

Share acquisition Not applicable Strides Arcolab has made a conditional offer to acquire all the shares of Ascent Pharmahealth, increasing its 57% stake.


Eastland Medical Systems (EMS)

Alpine Medical Divestment $1.8m EMS has accepted an unconditional offer from Alpine Medical to buy Medical Industries Australia.

ImpediMed (IPD) Change in ownership Not disclosed ImpediMed filed a Form 64 with the ASX outlining the details of a change in Wilson HTM and associates’ substantial holding.

Medic Vision (MVH) cBox Acquisition $2.05m MVH has acquired cBox, a digital marketing and communication company.

Medtech Global (MDG) Change in ownership Not disclosed Medtech Global filed a Form 604 outlining the details of a change of interest of substantial holder Cereus Holdings.


Clinical trialsCompany Drug/device Application Comments

Pre-clinical Total 0

Phase I Total 6

AtCor Medical (ACG) A study has found central blood pressure a better indicator of development of left ventricular hypertrophy than brachial blood pressure.

AtCor Medical (ACG) SphygmoCor Pre-eclampsia A new study has found an important new inpatient use for SphygmoCor.


ArTiMist Malaria treatment in children After positive results, there will be further trials of the use of ArTiMist to treat malaria in children.

Sunshine Heart (SHC) C-Pulse heart assist system Advanced heart failure An implant of the C-Pulse heart assist system in a patient in the Phase I clinical trial has been successful.

Pharmaxis (PXS) PXS25 Pulmonary fibrosis The phase I trial of new drug candidate PXS25 has been completed.

Uscom (UCM) USCOM Septic shock Uscom confirmed the efficacy of its cardiac monitor for guiding fluid in treatment of septic shock.

Phase II 3

Bionomics Limited (BNO) BNC105 Asbestos related cancer Bionomics said it will begin a second phase II trial of BNC105.

Clinuvel Pharmaceuticals (CUV) CUV030 EPP Clinuvel has received FDA approval to commence a phase II clinical trial of CUV030 in EPP.

Immuron (IMC) Immunotherapy product Metabolic syndrome Phase II trials of IMC’s immunotherapy product have begun.

Phase III Total 2

Avexa (AVX) Apricitabine (ATC) HIV therapy Top line data from a phase III study showed positive clinical benefits at 24 weeks in HIV therapy.

QRxPharma (QRX) MoxDuo IR Pain management for knee replacements

QRxPharma began a second phase III study of MoxDuo IR dual-opioid for NDA submission.

Other Total 2

HeartWare International (HIN) Advance Heart transplants The company announced the conclusion of patient enrolment for its Advance clinical trial.

Sirtex Medical Limited (SRX) SIR-Spheres Bowel cancer SRX announced the start of a new trial of SIR-Spheres with Oxford university.


RegulatoryCompany Product Application Comments


Acrux Limited (ACR) Axiron Testosterone deficiency Acrux has lodged a new drug application with the FDA, seeking marketing authorisation for Axiron.

Actinogen (ACW) Biodegradable products Actinogen has lodged a provisional patent for a new class of environment-friendly biodegradable products.

Antisense Therapeutics (ANP) ATL 1101 Prostate cancer An Australian patent has been granted for the use of ATL1101 to treat prostate cancer.

Benitec (BLT) ‘Graham’ patent Gene expression Benitec announced it has been granted patents for the ‘Graham’ patent family in Japan.

BioProspect (BPO) Termilone Termite control The active ingredient of BioProspect’s Termilone termite solution, Erimophilone oil, has received regulatory approval in Australia.

Biota Holdings (BTO) New drug application for CS-8958

Influenza Biota Holdings (BTO) co-owner Daiichi Sankyo has filed a new drug application in Japan for CS-8958, a neuraminidase inhibitor for treating influenza.

Cellestis (CST) Quantiferon TB Gold In-tube Blood test for TB infection Cellestis’s Quantiferon TB Gold In-tube test has been approved for use in Taiwan.

ChemGenex (CXS) Omapro Leukaemia The FDA announced that a validated test to identify the T3151 mutation should be reviewed before approval of Omapro.

Clinuvel Pharmaceuticals (CUV) EEP Marketing Authorisation of EEP As a result of positive advice from EMA, Clinuvel will focus resources on the final development of afamelanotide for EEP, actinic keratosis and polymorphic light eruption.

HealthLinx (HTX) OvPlex Ovarian cancer diagnosis A UK ethics committee has approved HealthLinx’s OvPlex ovarian cancer diagnostic study.

Solagran (SLA) Bioeffective R and Ropren Solagran obtained approval to issue a pharmaceutical wholesale distribution licence to Biophar LLC.


CathRx (CXD) Irrigated ablation catheter Cardiac arrhythmia CXD has submitted an application for CE marking of its irrigated ablation catheter coupled with its variable deflectable stylet.

Compumedics (CMP) Grael HD PSG sleep diagnostic amplifier system

Sleep diagnostics CMP has received market clearance from the US FDA for its sleep diagnostic amplifier system.

LBT Innovations (LBT) MicroStreak LBT has been granted its patent in Europe for the agar plate streaking technology in its MicroStreak system.


Other newsCompany Product Application Comments


Acuvax (ACU) Acuvax announced a share placement to meet near term working capital needs by raising $100k.

Agenix (AGX) The company has appointed Nicholas Weston as executive chairman.

Benitec (BLT) Dr John Chiplin was appointed as a director.

Bone Medical (BNE) Lee S. Simon (MD) has been appointed as an advisor on regulatory affairs, clinical trials and investment.

HealthLinx (HTX) HTX005 Treatment of ovarian cancer A manuscript describing HTX005‘s use on ovarian cancer patients has been published in Clinical Science.

Holista CollTech (HCT) Dr Deborah Cooper will transition from her role as GM/chief scientific officer to become a member of the scientific advisory board.

Living Cells Technology (LCT) Considering issues relating to the sale of fake share certificates, the company clarifies that share certificates are only issued via the ADR program in the US in exceptional circumstances.

PharmaAust (PAA) After selling $2.7m in property, PharmaAust is debt-free.

Prana Biotechnology (PBT) Paul Marks was appointed a director of the company.

Prima Biomed (PRR) Matthew Lehman was appointed the new chief operating officer.

Progen Pharmaceuticals (PGL) Lee Horobin was appointed company secretary and Sue Macleman as chief executive.

Sirtex Medical (SRX) Drs David Liu and Andrew Kennedy were appointed as co-medical directors.

Stirling Products (STI) Neil Covey was appointed executive sales and marketing director and chief operating officer.

Stirling Products (STI) Not disclosed Not disclosed Stirling Products has acquired for C$3.6m, a new plant in Cape Breton, Canada, for manufacturing drugs.

Virax Holdings (VHL) Virax Holdings filed Appendix 3X with ASX notifying the above, notifying the appointment Mr. Tim Cooper as a non-executive director of the company.

PharmAust (PAA) Investment in oil and gas project

PharmAust has agreed to farm in to two contiguous offshore exploration permits G.R.15.P.U and kerkouane.


Advanced Surgical Design and Manufacture (AMT)

John O’Meara was appointed as a non-executive director.

Austofix Group (AYX) Greg Bitter was appointed as a non-executive director.

Brainz Instrument (BZI) Brainz Instrument has agreed to participate in a high impact gas exploration prospect in Louisiana, US with Pass Petroleum and secured the option to participate in a follow-on exploration.

Cochlear (COH) Tommie Bergman retired as chairman and non-executive director of Cochlear and Rick Holliday-Smith will succeed him as chairman.


EMS finalised its investigation into financial and regulatory irregularities which occurred between April 2007 and July 2009 and were subject to court proceedings.

Fermiscan Holding (FER) The administrator assessed offers to buy FER’s assets and invest in the company.

ImpediMed (IPD) ImpediMed appointed Walton A. Taylor as its first medical director.

Medic Vision (MVH) Medic Vision shares were suspended from trade on the ASX on 1 March after it failed to lodge its half year report and accounts.

Medical Australia (MLA) Medical Australia appointed Thomas Joseph Hartigan as non-executive chairman to replace former director Thomas Mann. Mark Donnison appointed CEO and Greg Lewis appointed CFO.

MediVac (MDV) The Federal Court ruled in favour of Diakyne, a MediVac subsidiary, in a case against a former director and associated entity.


Company Product Application Comments

Nanosonics (NAN) The company identified a sub-standard component in its assembly and updated the component, but states the Trophon EPR units on the market meet all safety and efficiency standards.

OptiScan (OIL) OIL’s chairman, Angus Holt, assumed the role of executive chairman after the departure of CEO Vicki Tutungi.

Safety Medical Products (SFP) The ASX halted trade in Safety Medical Products shares from 1 March after it failed to lodge its half year report and accounts.

SomnoMed (SOM) SomnoMed Brux Sleep disorders The company has launched SomnoMed Brux, a new range of products to treat sleep disorders.

Tyrian Diagnostics (TDX) Jaime Pinto resigned as CFO and assistant company secretary and Michael Vamos was appointed in his place.

Unilife Medical Solutions (UNI) The Federal Court of Australia approved the scheme of arrangement between UNI and its shareholders and option holders

Unilife Corporation (UNI) Schemes of arrangement were implemented to re-domicile UNI in the US.

Unilife Corporation (UNS) The company was admitted to the official list of the ASX and official quotation of its securities began on 18 January 2010.

Universal Biosensors (UBI) Marshall Heinberg was appointed to the board after the retirement of Charles Kiefel.

Universal Biosensors (UBI) Verio monitor Self monitoring of blood glucose

UBI partner LifeScan has launched a new product under the brand Verio which uses technology developed by UBI.

Uscom (UCM) Paul Butler resigned as CEO and director and Rob Phillips was appointed interim CEO.


05AnnouncementsUnited States of America


PartnershipsCompany Pharma/biotech partner Application Value (US$m) Comments


3S Bio Panacor Bioscience Hyperphosphatemia US$1m Collaborative agreement to develop and commercialise the drug Nephoxil.

Basilea Astellas Fungus US$500m Funding agreement for the development and phase III trials of the drug isavuconazole.

Ceragenix Pharmaceuticals

BioPro Pharmaceuticals Atopic dermatitis Not applicable Strategic distribution and supply agreement to market and sell the drug in Hong Kong and Taiwan.

Ipsen Inspiration Biopharmaceuticals

Haemophilia US$259m A partnership has been formed to create a haemophilia franchise.

Javelin Pharmaceuticals Myriad Pharmaceuticals Not disclosed Not disclosed The meeting to approve the merger with Myriad is in April 2010.

Johnson & Johnson Basilea Pharmaceutica MRSA and other skin infections

Not applicable European regulations rejected the partnership over concerns that data from tests run by J&J aren’t reliable.

NicOx SA Topigen Not disclosed Not disclosed NicOx has terminated its partnership with Topigen after being acquired by Pharmaxis.

Penwest Pharmaceuticals Otsuka Pharmaceuticals Undisclosed Otsuka compound

Not disclosed Strategic alliance for a fourth R&D agreement with Otsuka Pharmaceutical for the development of an undisclosed compound.

Tissue Genesis American Medical Systems Holdings

Pelvic health disorders US$1.1m Strategic partnership for R&D of adipose (fat)-derived regenerative cells.


AspenBio Pharma LRE Medical GmbH Not disclosed Not disclosed Strategic relationship to complete commercial development and manufacture of a reader instrument.

The Greffex UPMC and ISMETT Immune suppression Not disclosed Strategic alliance to investigate the approach framework.

Vicor Technologies VF Medical Not disclosed Not disclosed Exclusive distribution agreement in South Carolina, North Carolina, and specific cities in Georgia.

Mergers, acquisitions and divestmentsDominant company Target company Type of deal Value (US$m) Comments


Alcon Sirion Therapeutics Acquisition Not disclosed Alcon will purchase the rights for two FDA-approved topical eye care products from Sirion.

Azur Pharma Elam Pharmaceuticals Acquisition Not disclosed Azur has signed an agreement with Elam to acquire its analgesic therapy, Prialt.

Columbia Laboratories Watson Pharmaceuticals Acquisition US$92.5m Columbia has entered into a definitive agreement to sell all of its progesterone related assets and 11.2m common stock shares to Watson.

CombinatoRx Neuromed Pharmaceuticals

Merger US$67.8m CombinatoRx and Neuromed Pharmaceuticals have merged.


Volcano Corporation Lumen Biomedical Acquisition Not disclosed The company has acquired the Xtract, Thrombus Aspiration Catheter device line from Lumen Biomedical


Clinical trialsCompany Drug Application Comments

Pre-clinical Total 2

Beech Tree Labs BTL-TML001 Acute influenza virus infections

The FDA has approved the company’s drug for a phase I/IIa clinical evaluation.

Cyto Pulse Sciences HIV/DNA vaccine HIV The company has obtained approval from the Swedish Medical Product Agency to conduct a phase I clinical trial of the drug.

Phase I Total 4

Cerus Corporation Intercept Transmission of infectious diseases

The company’s phase I trial has shown positive results, meeting its primary endpoint.

Elixir Pharmaceuticals EX-527 Huntington’s disease The company’s partner, Siena Biotech SpA, has begun phase I clinical testing of the inhibitor.

Limerick BioPharma LIM-0705 Expulsion of toxic substances The company has announced positive data from a phase Ia trial of the drug.

ResearchPoint & Azaya Therapeutics

ATI-1123 Advanced solid tumours The company has enrolled its first patient in the phase I clinical study.

Phase II Total 12

Alnylam Pharmaceuticals ALN-RSV01 Respiratory syncytial virus (RSV)

The company has begun phase IIb clinical rrials of the drug in adult lung transplant patients.

Antares Pharma Contraceptive gel Contraception The company has received positive phase II trial results.

Argos Therapeutics AGS-004 HIV Argos Therapeutics presented new phase IIa data on the program’s impact on viral genetic diversity.

Cameron Health Subcutaneous implantable defibrillator

Sudden cardiac arrest The company has commenced its pivotal clinical trial to gain US approval.

Capstone Therapeutics AZX100 Trocar sites of arthroscopic shoulder surgery patients

Enrolment for the phase II clinical trial has been completed.

Capstone Therapeutics AZX100 Keloid scars The company completed a limited analysis of a subset of data for the phase IIa clinical trials.

EyeGate Pharma EGP-437 Anterior uveitis The company announced the completion of a phase II study of its lead product candidate, EGP-437, for the treatment of anterior uveitis.

Omeros Corporation Proprietary compositions Addiction The National Institute on Drug Abuse has announced support for the company’s phase II clinical study.

Penwest Pharmaceuticals A0001 A3243G mitochondrial DNA point mutation and impaired mitochondrial function

The company has initiated a phase IIa clinical trial of the drug.

Prima BioMed CVac Ovarian cancer The company has commenced its phase IIb clinical trial of the vaccine in the US.

Stem Cell Therapeutics Not disclosed Brain injury The company received a ‘no objection’ letter from Health Canada allowing it to begin a phase IIa clinical trial.

Vivus Qnexa Obstructive sleep apnoea Positive results from the phase II study were announced. Phase III development of Qnexa has been completed and a new drug application has been submitted to the FDA.

Phase III Total 18

Affymax Hematide Anaemia due to chronic renal failure

The company has completed treatment and follow-up of patients enrolled in a four-trial, phase III clinical program.

BSD Medical Corporation BSD-2000 hyperthermia system

Pancreatic cancer BSD has begun a phase III study of using the system in combination with chemotherapy.

Celsion Corp Thermodox Liver cancer A data monitoring committee recommended continuation of the phase III study.

Delcath Systems Melphalan Liver metastatic melanoma The company has announced that data analysis will begin in its phase III trial.

Depomed Serada Menopausal hot flashes The company plans to conduct an additional phase III trial of the drug.

Dynavax Technologies Heplisav Hepatitis B Health Canada has approved the company’s next phase III trials of the adult hepatitis B vaccine.


Company Drug Application Comments

Genentech Avastin Advanced stomach cancer The phase III study results of the drug plus chemotherapy did not meet its primary endpoint.

Gilead Sciences Quad HIV pill HIV The company’s pill succeeded in its mid-stage clinical trial.

Keryx Biopharmaceuticals Zerenex End-stage renal disease The company has reached an agreement with the FDA on the design of a phase III trial of its drug.

Pervasis Therapeutics Vascugel Haemodialysis The company has begun a phase III study now that the FDA has agreed upon the design of the trial.

Oncolytics Biotech Reolysin Platinum-refractory head and neck cancers

Oncolytics received UK MHRA approval to conduct a phase III trial.

Neoprobe RIGScan CR Tumour-associated colon or rectal cancer

The company has filed for a phase III clinical package with the FDA under a special assessment protocol.

Spinal Restoration Biological pain relief implant Chronic lower back pain The company’s implant will now be the subject of a phase III study, following agreement with the FDA.

Tioga Pharmaceuticals Asimadoline Diarrhoea predominant irritable bowel syndrome

The company has raised $18m equity financing to fund a phase III clinical trial.

Vical Incorporated Collategene Angiogenesis Advanced peripheral arterial disease

The company has reported FDA approval of the special protocol assessment agreement for a phase III clinical trial of the product.

Vivus Avanafil Erectile dysfunction The company has announced additional results of a phase III study, showing effects in 15 minutes

Vivus Qnexa Obstructive sleep apnoea Phase III development of the drug has been completed and a new drug application has been submitted to the FDA.

Zogenix ZX002 Patients needing round-the-clock opioid therapy for pain control

The company has started a phase III clinical trial of the drug.

Other Total 8

Abbott Architect HIV Ag/Ab Combo assay

Detection of HIV The company submitted the new HIV detection test to the FDA for expedited review.

C. R. Bard Bard FLAIR endovascular stent graft

Failing dialysis grafts NEJM published trial results demonstrating that the graft is superior to balloon angioplasty for failing dialysis grafts.

Elixir Pharmaceuticals EX-527 Huntington’s disease The company was granted orphan designation by the European Medicines Agency and the FDA.

Genzyme Mipomersen Cholesterol related problems Positive results have been announced from a late-stage trial.

Guided Therapeutics LightTouch cervical scanner Cervical diseases After the FDA clinical trial of the device, it was announced that women 16-20 years of age have the same likelihood of significant cervical disease as women 21 and older.

Medical College of Georgia Stem cell research Cerebral palsy A clinical trial has begun to determine whether stem cells from umbilical cord blood can help children with cerebral palsy.

Medtronic ‘Deep brain’ device Parkinson’s disease The study failed to meet the goal of a reduction in the seizure rate over a three-month period.

Rockwell Medical Technologies

Soluble ferric pyrophosphate Chronic haemodialysis The company’s anaemia drug has failed its efficacy test.


RegulatoryCompany Product Application Comments


3SBio Feraheme (ferumoxytol) injection

Iron deficiency anaemia The company asked the Chinese State FDA for permission for a clinical trial of the injection.

Abbott Park Norvir Treatment of HIV The FDA approved the drug.

Abbott Laboratories and Roche

Norvir and Invirase HIV The companies’ partnership project is under FDA investigation due to clinical trial data suggesting potentially abnormal heart rhythms in patients.

Acorda Therapeutics Ampyra – dalfampridine Multiple sclerosis The FDA has approved Fampridine SR (now called Ampyra).

Actelion Zavesca (miglustat) Niemann-Pick type C (NP-C) disease

The FDA approved the drug.

Actelion Zavesca Rare neurological disorder An FDA panel has backed the use of the drug for a rare neurological disorder.

Actelion Zavesca Niemann-Pick type C (NP-C) disease

The FDA has rejected the supplementary new drug application, claiming the need for additional pre-clinical and clinical information.

Actelion Tracleer oral tablet Not disclosed The FDA has announced approval for NDA-021290 (the control supplement) for the drug.

AdvanDx S aureus PNA Fish and S aureus/CNS PNA Fish tests

PNA probe hybridisation The company has obtained FDA approval for its diagnostic tests.

Allon Therapeutics Davunetide Progressive supranuclear palsy (PSP)

The FDA has granted Allon’s drug orphan status.

Amylin Pharmaceuticals Byetta Diabetes The FDA has rejected the drug, seeking more information.

Amylin Pharmaceuticals Byetta Diabetes The FDA has rejected the new formula, due to questions about health risks and manufacturing.

Arena Pharmaceuticals Lorcaserin Obesity The FDA has accepted the application for the drug.

AVI BioPharma AVI-5038 Duchenne muscular dystrophy The EMEA has granted the drug orphan status.

Bavarian Nordic Imvamune Smallpox vaccine US authorities have approved Imvamune for emergency use in combating bioterrorism.

Basilea Pharmaceutica Ceftobiprole Complicated skin and soft tissue infections

A European panel has rejected the antibiotic ceftobiprole. Basilea received full drug rights from Johnson & Johnson in February.

BioSpecifics Technologies Xiaflex Dupuytren’s disease A European regulatory review of the drug has begun.

Bristol-Myers Squibb Company

Belatacept Acute rejection in de novo kidney transplant patients

An FDA advisory committee has recommended approval of the drug.

Cell Therapeutics Pixantrone Not disclosed The FDA has approved manufacture of the drug.

Cepheid Xpert(R) Flu A Panel test Identification of 2009 H1N1 influenza virus

Cepheid has been granted emergency use authorisation by the FDA for its Xpert(R) Flu A Panel test.

Clinical Data Vilazodone Depression A new drug application for Vilazodone was submitted to the FDA.

CombinatoRx Exalgo Pain requiring opioid painkillers The FDA has approved the sale of the extended release pain drug.

Dyax Corp Kalbitor (ecallantid) Sudden and possibly life-threatening swelling

The FDA approved ecallantid for the treatment of attacks in hereditary angiooedema patients.

Dr Reddy’s Laboratories Generic version of Sanofi-Aventis

Allergies The FDA approved the generic version of Sanofi-Aventis.

Formatech Not disclosed Enhanced solubility in hydrophobic compounds

A US patent was issued covering the formulation methods to enhance solubility in hydrophobics.

Gamid Cell-Teva Joint Venture

Stemex Stem cell treatment The EMA has approved specific waivers for Stemex for all subsets of the paediatric population.

Genentech Not disclosed Rheumatoid arthritis The FDA approved Genentech’s new rheumatoid arthritis treatment.

Genmab and GlaxoSmithKline

Arzerra (ofatumumab) Treatment of refractory chronic lymphocytic leukaemia (CLL)

Arzerra was conditionally approved for the treatment of leukaemia in Europe.

Genzyme Lumizyme (aglucosidase alpha)

Treatment of Pompe disease The FDA has approved a six-month review of Genzyme’s biologics licence application (BLA) for Lumizyme (aglucosidase alpha).

Genzyme Corp Myozyme Pompe disease The company is to make its third attempt at FDA approval for the drug.



Gilead Sciences Cayston Respiratory symptoms in cystic fibrosis

The FDA has granted marketing approval for Cayston.

Impax Laboratories Welchol tablets Not disclosed Impax Laboratories has challenged patents listed by Daiichi Sankyo relating to its Welchol tablets.

Impax Laboratories Generic Flomax Symptoms of benign prostatic hyperplasia

The FDA granted final approval for Generic Flomax with shipping to begin immediately.

InteGenx Wellbutrin XL Not disclosed The US Patent and Trademark Office has granted a notice of allowance for CPI-300, an active ingredient in Wellbutrin XL.

Lux Biosciences Luveniq Non-infectious uveitis involving the intermediate or posterior segments of the eye

Lux Biosciences filed for drug approval in the US and Europe.

The Medicines Angiomax Coronary angioplasty The Patent Office denied Medicines an extension for Angiomax. The company has filed new patents, which several generics firms are contesting.

Millennium Pharmaceuticals Velcade therapy Treatment of patients with multiple myeloma not eligible for stem cell transplantation

The FDA approved addition of updated survival data and hepatic dosing to the Velcade label.

Mylan Generic version of Keppra Not disclosed The FDA has granted approval for Mylan to produce a generic version of the anti-epileptic drug Keppra.

NicOx SA Naproxcinod Osteoarthritis The EMA has approved the marketing application.

Novo Nordisk Victoza Treatment of type-2 diabetes The FDA has approved Victoza for the treatment of diabetes.

Quark Pharmaceuticals QPI-1002 Treatment of phophylaxis of delayed graft function

FDA has granted orphan drug status to QPI-1002.

Recordati Carbaglu Acute hyperammonaemia Recordati announced the FDA approved Carbaglu in paediatric and adult patients.

Roche Rituxan/MabThera Previously treated CD20 – positive chronic lymphocytic leukaemia

The FDA has approved Rituxan/MabThera, fluarabine and cyclophosphamide.

SciClone Pharmaceuticals Ondansetron RapidFilm Nausea and vomiting from chemotherapy

The company has received European approval for Rapidfilm.

Soligenix LPM technology Oral delivery of drugs The company has received a Hong Kong patent for lipid polymer micelle (LPM) technology to improve oral delivery of drugs.

Somaxon Pharmaceuticals Silenor Insomnia The FDA approved the company’s insomnia drug Silenor.

Taiho Pharmaceutical Bup-4 Tablets Urinary incontinence and frequency

The company has secured approval for its Bup-4 Tablets 10 and 20 and Fine Granules 2%.

The Takeda Oncology Company

Velcade based therapy Multiple myeloma The FDA has approved a supplemental new drug application (sNDA) for Velcade in multiple myeloma patients.

Talecris Biotherapeutics Aerosol Alpha1-proteinease inhibitor

Alpha1-antitrypsin deficiency The FDA granted Talecris orphan drug status for Alpha1.

Taro Pharmaceuticals Industries

Levetiracetam Epilepsy Taro has received FDA approval for Levetiracetam.

Teva Pharmaceuticals Industries

Argatroban Blood-clotting The FDA has tentatively approved a generic version of Encysive Pharmaceuticals’ injectable drug.

Therapeutic Pixuvri (pixantrone) Treatment of refractory aggressive non-Hodgkin’s lymphoma after two or more prior lines of therapy

The FDA advisory panel had rejected the company’s request for accelerated approval of Pixuvri.

XenoPort Horizant Severe primary restless legs syndrome

Partner GlaxoSmithKline had received a complete response letter from the FDA for its application for Horizant, also known as GSK1838262.


Analytica AutoStart Burette Automatically resumes fluid flow following infused delivery of medication

FDA approval has allowed Analytica to market the AutoStart Burette in the US.



Boston Scientific Defibrillators Heart failure A FDA panel unanimously backed broader use of BSC’s cardiac resynchronisation therapy defibrillators in patients with mild-to-moderate heart failure.

Cardiovascular Systems Orbit II coronary trial Calcified coronary lesions The FDA granted conditional investigational device exemption (IDE) approval for a clinical trial.

Cytori Therapeutics PureGraft System Used to produced fat graft tissue

The FDA approved the PureGraft System.

Delcath Systems PHP System Metastatic liver cancer FDA has allowed the company to expand an access treatment program for the PHP System with Melphalan.

Diagnostic Hybrids FastPoint(TM) L-DFA(TM) RSV/MPV

Identification of respiratory syncytial virus and human metapneumovirus

The FDA cleared the identification kit.

Genzyme Not applicable Not applicable The FDA said it would take action to ensure products made at Genzyme’s troubled Allston, Massachusetts, plant meet regulations, but production will continue.

Medtronic Heart valve Heart defects The FDA has approved a Medtronic heart valve that can be implanted without open-heart surgery.

Novo Nordisk FlexPro Pre-filled growth hormone injection pen

The FDA approved the Flexpro.

Thoratec Corporation HeartMate II Advanced heart failure The FDA approved HeartMate II for destination therapy, broadening its potential patient eligibility, after trial data showed dramatic improvements in survival, durability and quality of life.

Volcano Corporation Eagle Eye Platinum digital IVUS catheter

Blockages or lesions in heart The company has received 510 (k) clearance from the FDA to market the Eagle Eye Platinum digital IVUS catheter in the US.


06Appendix


Companies in the PwC Life Sciences IndexClosing Mcap (A$m) Quarterly return

Med Device

ACG ATCOR MEDICAL HOLDINGS LIMITED 15.06 -23%

ADO ANTEO DIAGNOSTICS LIMITED 26.91 657%

AMT ADVANCED SURGICAL DESIGN & MANUFACTURE LIMITED 17.65 -8%

AQL AQUACAROTENE LIMITED 3.46 0%

ATW ATOS WELLNESS LTD 3.43 0%

AYX AUSTOFIX GROUP LIMITED 11.39 -9%

BOD BIOMD LIMITED 6.44 19%

BRC BRAIN RESOURCE COMPANY LIMITED (THE) 23.85 -13%

BZI BRAINZ INSTRUMENTS LIMITED 14.63 413%

CBB CORDLIFE LIMITED 46.84 -21%

CGS COGSTATE LTD 18.91 -10%

CLV CLOVER CORPORATION LIMITED 42.12 4%

CMP COMPUMEDICS LIMITED 32.23 -8%

COH COCHLEAR LIMITED 4,118.62 5.5%

CXD CATHRX LTD 21.07 -77%

CYC CYCLOPHARM LIMITED 19.67 0%

ELX ELLEX MEDICAL LASERS LIMITED 14.43 -6%

EMS EASTLAND MEDICAL SYSTEMS LTD 28.60 7%

FLS FLUOROTECHNICS LIMITED 12.01 -14%

GBI GENERA BIOSYSTEMS LIMITED 45.63 -7%

HIN HEARTWARE INTERNATIONAL, INC 659.43 35%

IPD IMPEDIMED LIMITED 81.77 4%

ITD ITL LIMITED 8.43 -20%

KSX KARMELSONIX LIMITED 20.37 -21%

LBT LABTECH SYSTEMS LIMITED 9.44 -25%

MDG MEDTECH GLOBAL LIMITED 5.61 12%

MDV MEDIVAC LIMITED 7.84 -36%

MGZ MEDIGARD LIMITED 8.85 -10%

MLA MEDICAL AUSTRALIA LIMITED 5.31 -50%

MOD MEDICAL CORPORATION AUSTRALASIA LIMITED 5.73 15%

MVH MEDIC VISION LIMITED 3.71 -43%

NAN NANOSONICS LIMITED 136.22 -8%

NDL NEURODISCOVERY LIMITED 2.41 0%

OBJ OBJ LIMITED 45.99 38%

OIL OPTISCAN IMAGING LIMITED 8.56 -20%

RMD RESMED INC 5,260.51 18%

SFP SAFETY MEDICAL PRODUCTS LIMITED 2.94 -12%

SHC SUNSHINE HEART, INC. 18.33 -11%

SOM SOMNOMED LIMITED 36.08 9%

TDX TYRIAN DIAGNOSTICS LIMITED 7.48 0%

UBI UNIVERSAL BIOSENSORS, INC. 270.49 -2%

UCM USCOM LIMITED 25.92 -6%

UNS UNILIFE CORPORATION 301.69 15%


Closing Mcap (A$m) Quarterly return

Pharma and Biotech

ACR ACRUX LIMITED 375.70 7%

ACW ACTINOGEN LIMITED 1.79 -10%

ACU ACUVAX LIMITED 7.45 -29%

AGX AGENIX LIMITED 8.42 0%

ACL ALCHEMIA LIMITED 117.00 -15%

ALT ANALYTICA LIMITED 23.58 38%

ANP ANTISENSE THERAPEUTICS LIMITED 12.97 -60%

AOP APOLLO CONSOLIDATED LIMITED 3.88 -20%

APH ASCENT PHARMAHEALTH LTD 82.32 57%

AVX AVEXA LIMITED 127.15 -3%

AVH AVITA MEDICAL LTD 15.44 -12%

BLT BENITEC LIMITED 17.76 13%

BDM BIODIEM LIMITED 21.69 -20%

BNO BIONOMICS LIMITED 106.60 -11%

BPH BIOPHARMICA LIMITED 16.56 -30%

BPO BIOPROSPECT LIMITED 14.36 -31%

BOS BIOSIGNAL LIMITED 0.00 -100%

BTA BIOTA HOLDINGS LIMITED 406.28 -6%

BIT BIOTRON LIMITED 11.00 1%

BNE BONE MEDICAL LIMITED 13.54 -28%

CZD CALZADA LIMITED 11.44 14%

CST CELLESTIS LIMITED 284.61 -9%

CDY CELLMID LIMITED 9.12 -18%

CXS CHEMGENEX PHARMACEUTICALS LTD 123.21 -56%

CIR CIRCADIAN TECHNOLOGIES LIMITED 32.57 11%

CUV CLINUVEL PHARMACEUTICALS LIMITED 80.35 -2%

CTE CRYOSITE LIMITED 5.60 20%

CSL CSL LIMITED 21,118.44 12%

GEN GENESIS RESEARCH AND DEVELOPMENT CORPORATION LIMITED 1.25 0%

GTG GENETIC TECHNOLOGIES LIMITED 13.11 -17%

GIA GIACONDA LIMITED 3.06 -46%

HGN HALCYGEN PHARMACEUTICALS LIMITED 103.62 8%

HTX HEALTHLINX LIMITED 20.96 78%

HXL HEXIMA LIMITED 34.43 -10%

HCT HOLISTA COLLTECH LIMITED4 16.85 -3%

IMC IMMURON LIMITED 22.97 -2%

IMU IMUGENE LIMITED 6.61 -48%

ICV INCITIVE LIMITED 3.06 -14%

IDT INSTITUTE OF DRUG TECHNOLOGY AUSTRALIA LIMITED 35.99 -40%

LCT LIVING CELL TECHNOLOGIES LIMITED 68.14 14%

MVP MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED 10.54 6%

MSB MESOBLAST LIMITED 286.30 50%

NEU NEUREN PHARMACEUTICALS LIMITED 12.21 -11%


Closing Mcap (A$m) Quarterly return

Pharma and Biotech (cont.)

NRT NOVOGEN LIMITED 45.45 -25%

NSP NUSEP LIMITED 4.93 -25%

PAB PATRYS LIMITED 27.01 21%

PAA PHARMAUST LIMITED 12.74 25%

PXS PHARMAXIS LTD 637.67 4%

POH PHOSPHAGENICS LIMITED 85.07 69%

PYC PHYLOGICA LIMITED 21.22 -33%

PBT PRANA BIOTECHNOLOGY LIMITED 32.77 -7%

PRR PRIMA BIOMED LTD 95.23 -7%

PCC PROBIOMICS LIMITED 5.59 -14%

PBP PROBIOTEC LIMITED 89.27 -34%

PGL PROGEN PHARMACEUTICALS LIMITED. 13.59 2%

PVA PSIVIDA CORP. 77.56 -1%

QRX QRXPHARMA LIMITED 93.96 18%

SIE SCIGEN LIMITED 154.64 -71%

SLT SELECT VACCINES LIMITED 2.04 14%

SRX SIRTEX MEDICAL LIMITED 331.82 -21%

SLA SOLAGRAN LIMITED 53.49 -28%

SPL STARPHARMA HOLDINGS LIMITED 163.79 -1%

STI STIRLING PRODUCTS LIMITED 14.59 -14%

TEO TELESSO TECHNOLOGIES LIMITED 3.19 54%

TIS TISSUE THERAPIES LIMITED 30.40 38%

VLA VIRALYTICS LIMITED 22.29 46%

VHL VIRAX HOLDINGS LIMITED 14.02 45%

XCD XCEED CAPITAL LTD 2.60 -41%

Notes:

IAT Removed from index. Suspended from the ASX

CYT Removed from index. Delisted from the ASX

RBY Removed from index. Appointed liquidators

PLI Removed from index. Delisted from the ASX

UNI Name changed from Unilife Medical Solutions Llimited (UNI) to Unilife Corporation (UNS)


07Methodology


Sources

BioForum draws on historical data from the following sources:

Bloomberg

Connect 4

the ASX

company websites

PwC Global Pharma and Life Science Quarterly Newsbriefs

Market performance

The Australian life sciences sector’s market performance is tracked through two indices:

i) PwC Life Sciences Index

ii) PwC Life Sciences Index ex majors (CSL, ResMed and Cochlear)

Analysis is provided without the large-capitalisation stocks (majors) so the performance of smaller-capitalisation stocks can be observed.

The PwC Life Sciences Index is based on the performance of life sciences companies listed on the Australian Securities Exchange (ASX). It comprises two subsectors:

i) pharmaceutical/biotechnology

ii) medical devices

These sectors have been classified according to the Global Industry Classification Standard. The index includes life sciences companies primarily involved in research, development, commercialisation and manufacturing of pharmaceutical and biotechnology products and medical devices. It excludes healthcare, medical software and distribution companies. Companies included in the PwC Life Sciences Index are listed at the end of each issue of BioForum.

The PwC Life Sciences Index is based on the combined market capitalisation of the listed companies and calculates the change of their value over the quarter and change over the previous year. These changes are compared to the changes in the market performance of the following indices:

ASX All Ordinaries

NASDAQ Composite

NASDAQ Biotech

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•

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Different formulae are used to calculate the value of these indices and track their performance. These formulae use a combination of company market prices and a weighted average of market capitalisation. Because of these different methods of calculating value, the absolute value of the indices cannot be directly compared. Only their changes over time can be sensibly compared.

Top and bottom performers

Annual data on these companies is sourced from Bloomberg each quarter. Company announcements are sourced from the ASX or directly from company websites.

IPO and secondary finance markets

IPO and secondary financing data is sourced from the Connect 4 database’s health-care industry category. We include data from companies on the PwC Life Sciences Index only. Data on options, rights and bonus issues is excluded.

The US IPO and secondary financing data is sourced from our quarterly PwC Global Pharma and Life Sciences Newsbrief.

Announcements

These are from companies listed on the PwC Life Sciences Index only. They are sourced from Connect 4 using the health-care industry category. We include announcements on partnerships, mergers and acquisitions and divestments, clinical results, regulatory activity and other information. Examples of other information include management and board changes, the closing or opening of offices, and successful grant applications.

Announcements on the following are excluded:

trading halts

capital raisings

proposed (versus actual) mergers, acquisitions and partnerships

progress reports on clinical trials (results only are included)

market registration approval

The US announcement data is sourced from our quarterly PwC Global Pharma and Life Sciences Newsbrief.

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08Acknowledgements

Written and edited by:PricewaterhouseCoopers (www.pwcglobal.com), a global professional services organisation serving the life sciences sector and other industries.

External contributors:PwC Global Pharmaceutical Team

Quantitative research and analysis by the PricewaterhouseCoopers BioForum team:Tony Gellert, Manager, Principal Author Joe Adendorff, Consultant Angelique Fitzgerald, Consultant Emma Stewart, Undergraduate Consultant

PwC Life Sciences Practice contributorsCraig Lawn, Partner, National Life Science Industry Leader Manoj Santiago, Partner, Sydney Life Science Industry Leader Adrian Bunter, Director Stephanie Wood, Administration

ExternalKaren Hunt, Editor and proof reader

This material is intended for PricewaterhouseCoopers professionals, their clients and other life sciences professionals. Quotation, citation, attribution, reproduction or utilisation of any portion of this publication by any party other than PricewaterhouseCoopers is strictly prohibited without the express written permission of the Australian Leader of PricewaterhouseCoopers. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means − electronic, mechanical, photocopied, recorded or otherwise − without the prior written permission of the Asia-Pacific Leader of PricewaterhouseCoopers.

This document is provided by PricewaterhouseCoopers as general guidance only and does not constitute the provision of legal advice, tax services, investment advice or professional consulting of any kind. The information provided herein should not be used as a substitute for consultation with professional tax, accounting, legal or other competent advisers. The application and impact of laws can vary widely based on the specific facts involved. Given the changing nature of laws, rules and regulations, there may be omissions or inaccuracies in the information presented herein. Before making any decision or taking any action, you should consult a professional adviser who has been provided with all the pertinent facts relevant to your particular situation.

The information is provided “as is” with no assurance or guarantee of ompleteness, accuracy or timeliness of the information, and without warranty of any kind, express or implied, included but not limited to warranties of performance, merchantability and fitness for a particular purpose. In no event will PricewaterhouseCoopers or its professionals be liable in any way to you or to anyone else for any decision made or action taken in reliance on the information, or for any direct, indirect, consequential, special or other damages related to you or your use of information, even if advised of the possibility of such damages.

Designations used by companies to distinguish their products are often claimed as trademarks. In all instances where PricewaterhouseCoopers is aware of a claim, the product names appear in initial capital letters or all capital letters. Readers, however, should contact the appropriate companies for more complete information regarding trademarks and registration.

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