Case 1:14-cv-11689-RWZ Document 92-1 Filed 02/17/15 Page 1 of 5

Kaplan, Jo Ann (AGO)

From:
Sent:
To:
Cc:
Subject:

Kaplan, Jo Ann (AGO)

Wednesday, February 11, 2015 1:57 PM
'Hollman, Steven P.'
Kenneth.Parsigian@lw.com; 'Steven.Pacini@lw.com'; Cook, Susan M.; Gold, Eric (AGO),
Kobick, Julia (AGO); McLaughlin, Anne (AGO)
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

Case 1:14-cv-11689-RWZ Document 92-1 Filed 02/17/15 Page 2 of 5

Kaplan, Jo Ann (AGO)

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

From:
Sent:
To:
Cc:
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 abusedeterrent 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

1

Case 1:14-cv-11689-RWZ Document 92-1 Filed 02/17/15 Page 3 of 5

Direct: +1 202 637 5672
Fax:
+1 202 637 5910
Email: Steven.hollman@hoganiovells,com
www.hoganlovells.com
Please consider the environment before printing this e-mail.

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
2

Case 1:14-cv-11689-RWZ Document 92-1 Filed 02/17/15 Page 4 of 5

Email;

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

Please consider the environment before printing this e-mail.

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,

Case 1:14-cv-11689-RWZ Document 92-1 Filed 02/17/15 Page 5 of 5

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
www.hoganlovells.com
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