MONTHLY DOSE

DECEMBER 2018

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Schrodinger, Sun Pharma arm announce research pact

Biocon’s after joint product gets approval in EU

Lupin launches generic prostatic hyperplasia treatment drug in US

Investors irked by lack of disclosures at Sun Pharma

Alkem Labs gains after closure of USFDA inspection at St. Louis facility

USFDA makes 22 observations post inspection of Lupin's Mandideep

facilities

Lupin’s Canada arm received an approval from Health Canada for Zaxine

drug

Zydus Wellness to raise Rs2,575cr through share sale to investors

Aurobindo faces US suit over carcinogenic elements in blood pressure

drug

Cipla to acquire South African drug maker Mirren for USD33mn

USFDA recommends regulatory action after Jubilant Life's Roorkee plant

inspection

Biocon's biosimilar chase gets a boost with EU approval for Ogivri

Lupin gets Establishment Inspection Report from USFDA for Pithampur

facility unit

Dr. Reddy's launches heartburn drug in US market

Aurobindo Pharma’s arm to form JV with Shandong Luoxin Pharma

US Court decision delays Dr. Reddy's Suboxone sale

Zydus Wellness gets CCI approval for acquisition of Heinz India

EU court upholds EUR13.96mn fine on Unichem Lab in Perindopril

litigation

USFDA completes Biocon's Telangana plant inspection

Glenmark Pharmaceuticals announces new data on GBR-1302

Alembic Pharma’s Panelav facility clears USFDA inspection

Lupin out-licenses novel blood cancer drug to AbbVie

Torrent Pharma recalls Losartan hypertension tablet in US

Glenmark forays into branded dermatology segment in US

Dr. Reddy's launches anti-coagulant drug in US market

DUSA Pharmaceuticals, Inc. awarded preliminary injunctive relief

prohibiting Biofrontera from using its trade secrets

Dr. Reddy's launches oral suspension drug in the US market

Suven Life gets product patents from Brazil, Eurasia

Cipla recalls 4800 bottles of anti-HIV tablets from American market

Neuland Laboratories received no observation issued by USFDA for its

manufacturing facility

Free Pharma samples come under GST lens

3.36% of about 82,600 drugs tested by drug controllers samples found to

be substandard

Delhi HC orders ban on online sale of medicines by e-pharmacists

across country

ICRA assigns stable outlook for Indian Pharma companies

Rising shipments to US help Indian Pharma exports rebound in H1FY19

Big Pharma returning to US price hikes in January after pause

Industry

Company

Global

News for the Month

Source: Media Reports and Company Press Releases

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Company API Strengths Indications Brand (Company) Mkt Size

Lupin Apixaban 2.5 and 5 mg Managing non valvular atrial

fibrillation

Eliquis (Bristol-Myers

Squibb)

USD6,366mn

Unichem Labs Tadalafil 2.5/5/10/20 mg Treatment of erectile dysfunction Cialis (Eli Lilly) USD1.9bn

Zydus Cadila Pregabalin 25/50/75/100/150/

200/225/300 mg

Used to control seizures, painful

nerve diseases and fibromyalgia

Lyrica (Pfizer) USD5bn

Lupin Tadalafil 20 mg Treatment of pulmonary arterial

hypertension (PAH)

Adcirca (Eli Lilly) USD503.8mn

Zydus Cadila Febuxostat 40/80 mg Used to treat hyper Uricemia Uloric (Takeda) -

Company API Strengths Indications Brand (Company) Mkt Size

Zydus Cadila Teriflunomide 7/14 mg Treat relapsing multiple sclerosis Aubagio (Sanofi Aventis) USD1.6bn

Sun Pharma Ganirelix Acetate

Inj.

250 mcg/0.5 mL Treatment of infertility Ganirelix (Organon) USD67mn

Alembic Pharma Glycopyrrolate 1/2 mg Used as adjunctive therapy in

treatment of peptic ulcer

Robinul & Robinul Forte

(Casper Pharma LLC)

USD15mn

Alembic Pharma Candesartan

Cilexetil

4/8/16 mg Treatment of hypertension Atacand (ANI Pharma) USD22mn

Cipla Montelukast Sodium 4/5mg Treatment of asthma Singulair (Merck) USD90-100mn

Alembic Pharma Olopatadine HCL

ophthalmic solution

0.1% Treat allergic conjunctivitis Patanol (Novartis) USD61mn

Cadila Ranitidine injection 25 mg/mL, 2 mL single dose vials

& 6 mL

multi-dose vials

Treat stomach and duodenal ulcers Zantac (Glaxo) USD412.4mn

Strides Pharma,

Cadila

Albendazole 200 mg Treat infections caused

by tapeworm

Albenza (Amneal

Pharma)

USD100mn

Glenmark Hydrocortisone

Valerate Ointment

0.2% Used to treat skin conditions Westcort (Sun Pharma

Inc.)

USD11.1mn

Lupin Clobazam 10/20 mg Treatment of seizures associated

with Lennox-Gastaut syndrome

Onfi (Lundbeck Pharma) USD601.2mn

Glenmark Fluocinolone

Acetonide Oil

0.01% Treat eczema of the ear DermOtic1 Oil

(Hill Derma)

USD18.1mn

Aurobindo Potassium Chloride 8mEq(600 mg)

&10mEq(750 mg)

Treatment of hypokalemia Klor-Con (Upsher-Smith) USD60mn

Unichem Labs Pramipexole

Dihydrochloride tabs

0.125/0.25/0.5/

0.75/1/1.5 mg

Treat Parkinson's disease & Restless

Legs Syndrome

Mirapex (Boehringer

Ingelheim Pharma)

-

Zydus Cadila Doxycycline Hyclate 75/100/150 mg Treat bacterial infections Vibramycin (Pfizer) USD300mn

Strides Pharma Polyethylene Glycol 3350 & Electrolytes

for Oral Solution

236 /2.97gms,6.74/5.86gms &

22.74gms/4Liter

Laxative GoLYTELY (Braintree

Laboratories)

US400mn

(combined size)

Aurobindo Vecuronium

Bromide Injection

10/20mg Used as part of general anesthesia Norcuron Inj. (Organon) USD11mn

Dr. Reddy Sevalamer

Carbonate

0.8/2.4kg Lower high blood phosphorus

(phosphate) levels

Renvela (Genzyme

Corporation)

USD101mn

Cadila Clindamycin Phosphate and

Benzoyl Peroxide

Gel

1.2%, 5% Treat certain type of acne

(inflammatory acne vulgaris)

Duac (GSK) USD130mn

Tentative ANDA Approvals:

Final ANDA Approvals:

Source: Media Reports and Company Press Releases

Source: Media Reports and Company Press Releases

BSE Health Care Index Price Performance

Companies

Price

Chg (%)

1 M 6 M 12 M

Aarti Drugs Ltd 575 4.5% 4.7% -9.9%

Abbott India Ltd 7519 1.1% 3.8% 36.4%

Ajanta Pharma Ltd 1186 1.8% 20.4% -20.7%

Alembic Ltd 48 10.8% 20.7% -17.4%

Alembic Pharmaceuticals Ltd 598 -3.1% 18.8% 12.5%

Alkem Laboratories Ltd 1946 1.9% 3.1% -11.8%

Apollo Hospitals Enterprise Ltd 1259 -0.3% 20.3% 4.7%

AstraZeneca Pharma India 1452 3.9% 2.4% 23.0%

Aurobindo Pharma Ltd 731 -9.8% 20.5% 6.7%

Biocon Ltd 629 1.1% 1.6% 17.0%

Bliss GVS Pharma Ltd 166 9.9% -1.4% -21.9%

Cadila Healthcare Ltd 348 -4.5% -7.9% -19.7%

Caplin Point Laboratories Ltd 382 -5.1% -10.3% -39.8%

Cipla Ltd 520 -3.7% -15.4% -15.0%

Divi's Laboratories Ltd 1482 3.1% 42.7% 34.9%

Dr Reddy's Laboratories Ltd 2617 -3.6% 17.2% 8.5%

Dr. Lal PathLabs Ltd 913 7.9% -4.4% 3.2%

Eris Lifesciences Ltd 684 10.4% 0.1% -13.1%

FDC Ltd 173 -9.0% -23.3% -30.7%

Fortis Healthcare Ltd 140 -4.9% 4.2% -11.0%

GSK Pharmaceuticals Ltd 1512 11.6% -46.1% -38.5%

Glenmark Pharmaceuticals Ltd 692 5.9% 18.8% 16.2%

Granules India Ltd 90 1.3% 11.4% -34.6%

Gufic Biosciences Ltd 94 9.0% -23.9% -25.5%

HealthCare Global Enterprises Ltd 197 -10.3% -31.0% -29.1%

Hester Biosciences Ltd 1128 -8.5% -13.4% -39.0%

Hikal Ltd 156 3.4% 7.0% -34.1%

Indoco Remedies Ltd 218 4.4% 19.4% -23.4%

Indraprastha Medical Corp. Ltd 39 -0.6% -8.8% -39.2%

IOL Chemicals and Pharma Ltd 166 -2.0% 104.0% 102.6%

IPCA Laboratories Ltd 802 0.7% 15.1% 34.5%

J.B. Chemicals & Pharma Ltd 306 2.8% 18.7% -9.3%

Jubilant Life Sciences Ltd 710 -7.7% 1.6% -8.8%

Kopran Ltd 39 6.3% -26.6% -43.2%

BSE Health Care Index Price Performance

Companies

Price

Chg (%)

1 M 6 M 12 M

Laurus Labs Ltd 380 -1.0% -17.6% -29.6%

Lincoln Pharmaceuticals Ltd 225 -5.7% 7.7% -5.5%

Lupin Ltd 846 -4.4% -6.4% -4.4%

Mangalam Drugs and Organics Ltd 73 1.2% -22.3% -65.0%

Marksans Pharma Ltd 28 -5.6% 5.1% -30.3%

Medicamen Biotech Ltd 433 -5.7% -9.2% -31.6%

Merck Ltd 3084 9.3% 30.2% 133.3%

Morepen Laboratories Ltd 22 0.5% -22.4% -43.6%

Narayana Hrudayalaya Ltd 196 -11.6% -16.6% -34.9%

Natco Pharma Ltd 681 -4.8% -15.3% -31.1%

Nectar Lifesciences Ltd 21 -2.4% -6.6% -48.6%

Neuland Laboratories Ltd 459 -4.2% -28.5% -48.2%

Novartis India Ltd 720 3.9% 7.9% 10.3%

Opto Circuits India Ltd 9 5.2% -38.6% -11.5%

Panacea Biotec Ltd 160 9.2% -29.6% -33.6%

Pfizer Ltd (India) 2848 4.7% 10.7% 39.2%

Piramal Enterprises Ltd 2382 8.3% -6.0% -16.3%

Poly Medicure Ltd 221 2.5% 4.8% -21.3%

RPG Life Sciences Ltd 238 1.5% -31.6% -51.0%

Sanofi India Ltd 6353 3.2% 22.5% 35.4%

Shalby Ltd 147 -6.8% -12.8% -

Shilpa Medicare Ltd 384 0.7% -3.2% -37.9%

SMS Pharmaceuticals Ltd 68 2.7% -4.5% -34.4%

Strides Shasun Ltd 461 -4.9% 17.1% -44.0%

SPARC Ltd 188 -27.8% -49.5% -62.4%

Sun Pharmaceutical Industries Ltd 431 -12.5% -23.2% -24.9%

Suven Life Sciences Ltd 227 -5.9% 9.1% 10.9%

Syngene International Ltd 561 3.8% -7.6% 2.7%

Thyrocare Technologies Ltd 527 -3.3% -8.6% -23.7%

Torrent Pharmaceuticals Ltd 1771 0.1% 26.3% 27.0%

Unichem Laboratories Ltd 191 -6.6% -18.9% -41.8%

Vimta Labs Ltd 314 21.7% 40.2% 87.7%

Vivimed Labs Ltd 37 -3.8% -37.5% -65.2%

Wockhardt Ltd 524 -3.1% -18.0% -43.4%

Source: BSE website; All prices are as on 31st December 2018

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Source: BSE website; All prices are as on 31st December 2018

NIFTY PHARMA COMPANIES

Company

Price

(Rs)

Mcap

(Rsmn)

Chg (%)

1 M 6 M 12 M

Aurobindo Pharma Ltd 731 428269 -9.8% 20.5% 6.7%

Biocon Ltd 629 377340 1.1% 1.6% 17.0%

Cadila Healthcare Ltd 348 355802 -4.5% -7.9% -19.7%

Cipla Ltd 520 418662 -3.7% -15.4% -15.0%

Divi's Laboratories Ltd 1482 393478 3.1% 42.7% 34.9%

Dr. Reddy's Laboratories Ltd 2617 434189 -3.6% 17.2% 8.5%

Glenmark Pharmaceuticals Ltd 692 195331 5.9% 18.8% 16.2%

Lupin Ltd 846 382281 -4.4% -6.4% -4.4%

Piramal Enterprises Ltd 2382 429385 8.3% -6.0% -16.3%

Sun Pharmaceutical Industries Ltd 431 1033269 -12.5% -23.2% -24.9%

The year 2018 had been quite eventful for the overall Pharma sector with strategic M&A deals, observations and good number of

tentative and final approvals.

Mergers & Acquisitions (M&A): Going ahead with the objective to

increase its footprints in US; Aurobindo Pharma bought the dermatology

business along with generic oral solid portfolio of Sandoz worth USD900mn

plus USD0.1bn of potential earn-outs. Further, to strengthen its presence in

Eastern Europe markets, it entered into a definitive agreement with Canadian

pharmaceutical firm Apotex to take over its commercial operations in five

European countries.

Zydus Wellness jointly with Cadila Healthcare acquired brands namely

Complan, Glucon-D energy drink and Nycil talcum powder from its owner

Heinz India for USD630mn.

Major Observations: In the year which saw most companies coming out of

regulatory trouble, Lupin got a shocker with USFDA issuing 22 observations at Mandideep, 5 observations at Pithampur and 1

observation at Tarapur facilities. With DRL being no exception, it received 8 observations at Duvvada facility with 5 of them being

repeat of 2017 including a warning letter of 2015.

Ramp up in Approvals: The year that went by saw the highest number of drug approvals of 971 drugs by USFDA as compared to

937 approvals (763 final approvals) last year. This includes 781 Final nods (763 final approvals last year) and 190 Tentative

go-aheads with Indian firms accounting for 35-40% of Global nods.

Sun Pharma Issue: On December 3, Sun Pharma shares witnessed a double-digit fall after a report of questionable corporate

governance practices and a whistle blower complaint to SEBI. Given the weightage of Sun Pharma, the market value destruction of

the company led to the dip in the overall Pharma Index.

For 2018, the sector had experienced volatility throughout, an assorted and action packed year indeed. There was all from

observations to approvals, mergers & acquisitions to the pricing pressure witnessed across the key markets. Going into 2019, we

feel the sector should be a part of investment discussions. The trend of USFDA approvals should continue for most of the key

players. Domestic formulations market would be a key to watch. Since, this is an election year we should expect focus on

healthcare by the government, leading to a further impetus to the growth in the sector. Overall, without much of external factors

affecting the growth, the sector should provide decent returns to investments.

Source: NSE website, Company Research; All prices are as on 31st December 2018

Approvals in the Industry Trends across the Approvals:

Source: USFDA Source: USFDA

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