Kaplan, Jo Ann (AGO)

From: Kaplan, Jo Ann (AGO) Sent: Wednesday, February 11, 2015 1:57 PM To: 'Hollman, Steven P.' Cc: Kenneth.Parsigian@lw.com; 'Steven.Pacini@lw.com'; Cook, Susan M.; Gold, Eric (AGO),

Kobick, Julia (AGO); McLaughlin, Anne (AGO) Subject: RE: Zogenix v. Patrick/Supplemental Submission on Regulatory Developments

It's not my conclusion, Steven; it's the FDA's conclusion. Unless and until the FDA authorizes Zogenix to include claims related to abuse-deterrence on the label, FDA has approved the drug to be marketed only as a non-abuse-deterrent drug. Because the FDA has approved Hysingla to be marketed with claims related to abuse-deterrence, Hysingla is most certainly not a similarly situated drug.

What Judge Zobel called for was a mutual submission simply notifying the court of the facts and addressing any issue of mootness, not supplemental briefing on the motion to dismiss. Your prior post-argument submission, and our opposition thereto, informed Judge Zobel of the facts regarding the anticipated FDA approval and addressed the mootness issue. If you wish to make a joint submission that simply informs the court that the FDA has now approved the sNDA and has not approved the inclusion on the label of any claims related to abuse deterrence, we have no objection to joining in such a limited submission. If that is how you wish to proceed, please supply a draft for our review. To the extent you intend, however, to seek leave to file a brief that argues the purported relevance of this FDA action, please indicate that we do not consent to your motion.

Jo Ann

From: Hollman, Steven P. rmailto:steven.hollman(a)hoqanlovells.corn1 Sent; Wednesday, February 11, 2015 12:45 PM To: Kaplan, Jo Ann (AGO) Cc: Kenneth.Parsiqian@lw.com: 'Steven.Pacini@lw.com'; Cook, Susan M.; Gold, Eric (AGO); Kobick, Julia (AGO); McLaughlin, Anne (AGO) Subject: Zogenix v. Patrick/Supplemental Submission on Regulatory Developments

Jo Ann,

Your unilateral conclusion that this is "another non-abuse-deterrent version of Zohydro" is without foundation. Moreover, the Commonwealth's decision to treat the new formulation of Zohydro ER differently than a similarly situated drug, Hysingla, is unconstitutional. Like the new formulation of Zohydro, Hysingla contains polyethylene oxide and is not currently labeled as abuse deterrent.

Judge Zobel specifically asked us to let her know when the new formulation was approved. Our doing so has been delayed a week by your various questions and ipse dixit pronouncements that the approval bears no relevance to the pending motion. We plan to file something shortly; we will state that you oppose.

Steve

Steven Hollman Partner

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Kaplan, Jo Ann (AGO)

From: Kaplan, Jo Ann (AGO) Sent: Monday, February 09, 2015 12:13 PM To: Flollman, Steven P. Cc: Kenneth.Parsigian@lw.com; 'Steven.Pacini@lw.com,; Cook, Susan M.; Gold, Eric (AGO);

Kobick, Julia (AGO); McLaughlin, Anne (AGO) Subject: RE: Zogenix v. Patrick

Stephen: I immediately responded to your inquiry with my questions, which remained unanswered until today. The commonwealth does not needarw/ information from your client, and I never suggested to the contrary. I was asking, while simultaneously inquiring of my clients about this matter, whether Zogenix had any additional information it might want\.o supply us; your response appears to be no. Since your client therefore relies exclusively on the mere fact of the FDA sNDA approval, and since that sNDA approval entails no determination that the new version is any more abuse-deterrent than the original version, the state regulations obviously apply to the new version of Zohydro.

You still have not indicated what you perceive to be the relevance, for purposes of our pending motion, of this FDA approval of another non-abuse-deterrent version of Zohydro. In the absence of a response to that inquiry, you have not engaged in any meaningful consultation with us about your proposed supplemental filing and we do not consent to any request to file a supplemental brief. We are certainly aware of no possible relevance to this sNDA approval,

Jo Ann

From: Hollman, Steven P. [steven.hollman@hoganiovells.com] Sent: Monday, February 09, 2015 10:48 AM To: Kaplan, Jo Ann (AGO) Cc: Kenneth.Parsigian(a)lw.com; 'Steven.Pacini@lw.com'; Cook, Susan M.; Gold, Eric (AGO); Kobick, Julia (AGO); McLaughlin, Anne (AGO) Subject: FW: Zogenix v. Patrick

Jo Ann,

We asked for your position on the new formulation last Wednesday. The additional materials I supplied over the weekend are publicly available and frankly should be irrelevant to your analysis. If the Commonwealth needs access to confidential information regarding either the new formulation and/or communications with FDA, that fact alone makes clear that its conduct interferes with the federal drug approval process and is preempted.

We have held off our notification of the court for almost a week now so you could consider our request. We intend to notify the court of the approval as soon as it reopens. We will indicate that you have not responded to our request for your position on the motion for leave to file unless you advise us before then that you either consent or oppose.

Steve

Steven Holfman Partner

Hogan Loveils US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004

Tel; +1 202 637 5600

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Direct: +1 202 637 5672 Fax: +1 202 637 5910 Email: Steven.hollman@hoganiovells,com

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From: Kaplan, JoAnn (AGO) rmailto:ioann.kaplan(a)state.ma.us1 Sent: Monday, February 09, 2015 9:34 AM To: Hollman, Steven P. Cc: Kenneth.Parsiaian(a)lw.com: 'Steven.Pacini(g)lw.com'; Cook, Susan M.; Gold, Eric (AGO); Koblck, Julia (AGO); McLaughlin, Anne M (AGO) Subject: RE: Zogenix v. Patrick

Thanks, Steven. As you may be aware, state offices are closed today, as is the court. I have accessed this email remotely, but cannot remotely forward the attachments to my client contacts (who are presumably not in the office today anyway) and have no ability to get a decision for you on anything today. As far as I can tell, the attachments indicate that FDA formed no conclusions of any kind relative to any abuse-deterrent properties. If you disagree, please let me know. And either way, I still await your responses to my additional questions in my email below. Could you also clarify what you consider to be the relevance of FDA's approval of the sNDA for purposes of our pending motion?

Thank you.

Jo Ann

From: Hollman, Steven P. [steven.hollman@hoganlovells.com] Sent: Sunday, February 08, 2015 11:46 PM To: Kaplan, Jo Ann (AGO) Cc: Kenneth.Parsiaian@lw.coni: 'Steven.Pacini@lw.com'; Cook, Susan M.; Gold, Eric (AGO); Kobick, Julia (AGO); McLaughlin, Anne (AGO) Subject: Zogenix v. Patrick

Jo Ann,

Thank you for your email. Attached, in case you have not pulled them down yet, are FDA's publicly-available approval letter for the new formulation, together with the revised labeling. Please let us know the Commonwealth's position on whether the new formulation is deemed by Massachusetts to be exempt from the regulation. Regardless, we plan to notify the court of the FDA approval by filing a motion for leave to file a supplemental brief. Please let us know by noon on Monday whether you consent.

Steve

Steven Hollman Partner

Hogan Loveiis US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004

Tel: +1 202 537 5600 Direct: +1 202 637 5672 Fax: +1 202 637 5910

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Email; steven,hollman@hoganloveite.com www.hoganloveils.com

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From; Kaplan, JoAnn (AGO) [mailto:ioann.kaplan(5)state.ma.us'l Sent: Wednesday, February 04, 2015 1:44 PM To: Hollman, Steven P. Cc: Kenneth.Parslglan(5)lw.com; 'Steven.Pacini@lw.com'; Cook, Susan M.; Gold, Eric (AGO); Kobick, Julia (AGO); McLaughlin, Anne M (AGO) Subject: RE: Zogenix v, Patrick

Hi Steven. I do not know whether I can have an answer for you that quickly, but I will try. There does not appear to be any information available to us on the FDA website relative to the new formulation/FDA approval except (as you recently indicated would be the case) that the approval does not permit any claims of abuse-deterrent properties on the label. Did the FDA form any conclusion at ail at this stage regarding abuse-deterrence? If so, would you be able to supply that documentation to us? If not, was information submitted to the FDA that could potentially demonstrate to our satisfaction (assuming you were willing to provide it to us) that the reformulated drug is, in fact, abuse-deterrent?

Also, I note that the company's press release indicates (as the company has indicated in the past) that it plans to replace the current formulation with the new formulation in Q2. I had understood you to say at one point, however, that the original formulation will remain on the market and continue to be used by some patients. Is that still the case?

Thank you.

Jo Ann

Jo Ann Shotwell Kaplan Assistant Attorney General Office of the Attorney General Government Bureau/Administrative Law Division One Ashburton Place, 20th Floor Boston, Massachusetts 02108 (617)963-2085 Fax: (617) 727-5785 JoAnn.Kaplan(5)5tate.ma.us

From: Hollman, Steven P. [mailto:steven.hollman(5)hoganlovells.com1 Sent; Wednesday, February 04, 2015 1:07 PM To: Kaplan, Jo Ann (AGO) Cc; Kenneth.ParsigianPlw.com: 'Steven.Pacini@lw.com'; Cook, Susan M.; Gold, Eric (AGO); Kobick, Julia (AGO); McLaughlin, Anne (AGO) Subject: Zogenix v. Patrick

Jo Ann,

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As you may know, FDA recently approved a new formulation of Zohydro ER that contains BeadTek, which is designed to provide abuse-deterrent properties. Please let us know promptly whether Massachusetts takes the position that the challenged BORIP, BOROPA, and BORIM regulations apply to this new formulation.

We intend to advise the court of the recent regulatory approval as promptly as possible. Accordingly, we would like to hear back from you on this issue by the close of business tomorrow.

Regards,

Steven Hollman Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004 Tel; +1 202 637 5600 Direct: +1202 637 5672 Fax: +1 202 637 5910 Email; Steven.hollman(5)hoeanlovells.com

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