Case 1:14-cv-11689-RWZ Document 91-1 Filed 02/12/15 Page 1 of 6

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF MASSSACHUSETTS

ZOGENIX, INC.,
Plaintiff,
v.
DEVAL PATRICK, in his official capacity as
GOVERNOR OF THE COMMONWEALTH OF
MASSACHUSETTS,
and
CHERYL BARTLETT, RN,
in her official capacity as
DEPARTMENT OF PUBLIC HEALTH
COMMISSIONER,
and
CANDACE LAPIDUS SLOANE, M.D.,
KATHLEEN SULLIVAN MEYER, ESQ.,
MARIANNE E. FELICE, M.D.,
ROBIN RICHMAN, M.D.,
PAUL R. DeRENSIS, ESQ.,
MICHAEL E. HENRY, M.D., in their official
capacities as members of the MASSACHUSETTS
BOARD OF REGISTRATION IN MEDICINE,

Defendants.

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Civil Action No. 1:14-cv-11689

SECOND SUPPLEMENTAL MEMORANDUM OF PLAINTIFF ZOGENIX, INC.

REGARDING REGULATORY LANDSCAPE

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Pursuant to the Courts request at the December 3, 2014 motion hearing, Plaintiff
Zogenix, Inc. respectfully notifies the Court of the following developments relevant to the status
of this proceeding:
On January 30, 2015, the U.S. Food and Drug Administration (FDA) approved a new
formulation of Zohydro ER with BeadTek. Ex. 1 (FDA Supplement Approval). BeadTek is
a formulation technology designed to provide abuse-deterrent properties without changing the
release properties of hydrocodone when Zohydro ER is used as intended. Ex. 2 (Zogenix Press
Release). BeadTek incorporates pharmaceutical ingredients that immediately form a viscous gel
when crushed and dissolved in liquids or solvents. Id. These are the very same pharmaceutical
ingredients including polyethylene oxide contained in other abuse-deterrent opioid
formulations currently on the market, such as Hysingla, Oxycontin, Opana ER, Nucynta ER, and
Xartermis XL. FDA has approved new labeling for the new Zohydro ER formulation, which
(among other things) reflects the addition of polyethylene oxide and contains new language in
the Abuse section relating to the risks of parenteral abuse. Ex. 3 (Zohydro ER Labeling) at
11, 9.2. In addition, FDA has asked Zogenix to run the same Post-Marketing Requirement
(PMR) studies relating to excipient safety as the agency required of Purdue following approval
of its abuse-deterrent hydrocodone product, Hysingla. Zogenix intends to submit data regarding
the new formulation in the second half of 2015 in order to support an amended product label that
will include more explicit abuse-deterrent claims. Ex. 2.
As explained in briefs currently pending before the Court, the challenged regulations
apply to any hydrocodone-only extended release medication that is not in an abuse deterrent
form. 247 CMR 90.04(8); 243 CMR 2.07(25); 263 5.07(12). Massachusetts already had
crossed the line by unilaterally deeming Purdues drug Hysingla ER to be abuse deterrent even
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though not so labeled by FDA. While FDA has found that Hysingla ER has certain properties
that are expected to deter abuse, FDA has not yet found that the drug actually does deter abuse.
Ex. 4. For that reason, FDA has required Purdue to conduct studies to determine whether the
drug qualifies under FDA standards as abuse-deterrent. Ex. 5 (FDA has determined that you
are also required to conduct the following individual postmarketing studies of Hysingla ER
(hydrocodone bitartrate) extended-release tablets: 2808-2 Conduct epidemiologic
investigations to address whether the properties intended to deter misuse and abuse of Hysingla
ER (hydrocodone bitartrate extended-release tablets) actually result in a significant and
meaningful decrease in misuse and abuse, and their consequences, addiction, overdose, and
death, in the community. The post-marketing study program must allow FDA to assess the
impact, if any, that is attributable to the abuse-deterrent properties of Hysingla ER.).
Nonetheless, the Commonwealth unilaterally has decided to treat Hysingla as though it actually
is abuse-deterrent and therefore exempt from the challenged regulations.
Defendants decision to treat the new formulation of Zohydro ER differently only
underscores the arbitrary line-drawing that Defendants have engaged in when it comes to issues
of drug safety. Following FDA approval of the new formulation, Zogenix asked Defendants
whether they intended to recognize the new formulation of Zohydro ER as exempted from the
challenged regulations, just as they had done for Hysingla. Ex. 6. Defendants responded by
asking for detailed information about the drug and its approval process so that they could either
try to glean FDAs views on the extent of the drugs abuse deterrence or, even more alarmingly,
make their own determination as to whether the drug meets an unspecified Massachusetts
standard to qualify as being in adequate abuse deterrent form:
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
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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 all 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? Ex. 6.
This query and Defendants subsequent refusal to treat the new formulation as exempt
from the challenged regulations when Zogenix refused to supply the Commonwealth with
confidential information regarding its drug approval process before FDA only serves to
highlight that Defendants are engaging in preempted conduct by setting up their own separate
drug approval process in parallel to that undertaken by FDA, even going so far as making their
own unconstitutional determinations about the safety and abuse deterrence of an FDA-approved
drug. The Commonwealth cannot have it both ways: if the statute exempts drugs that contain
ingredients designed to deter abuse, the new formulation of Zohydro ER should be treated as
exempt. And if the Commonwealth intends to try to interpret FDA labeling decisions to
characterize a drug as abuse deterrent, Hysingla should not be treated as exempt.
Defendants effort to classify drugs as either abuse deterrent or not and then restrict
access to drugs accordingly even though FDA does not draw a bright line on this issue - is
preempted by federal law because it conflicts with FDAs careful regulatory scheme. Geier v.
Am. Honda Motor Co., Inc., 529 U.S. 861, 871 (2000) (state restrictionseven those that might
otherwise conceivably stand in harmony with federal lawmust fall where Congress intended
to avoid conflict, uncertainty, cost, and occasional risk to safety itself that too many different
safety-standard cooks might otherwise create.). And by steering physicians and patients away
from Zohydro ER toward a drug that more than twice the amount of hydrocodone -- even
though FDA has not determined that the new drug is abuse deterrent, let alone that it is safer than
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Zohydro ER the challenged regulations seek to supplant FDAs nuanced judgment about the
demonstrated safety and efficacy of approved drug products. The regulations therefore interfere
with FDAs safety determinations and its careful labeling scheme.
Meanwhile, the clock is ticking on Zohydro ERs three-year exclusivity period.
Zogenix respectfully requests that the Court deny the pending motion to dismiss and set a case
schedule, allowing several months for discovery followed by summary judgment briefing
deadlines.
*

For the foregoing reasons, as well as those previously presented, Defendants motion to
dismiss should be denied.
Dated: February 12, 2015

Respectfully Submitted,
/s/ Steven P. Hollman
Kenneth J. Parsigian (BBO # 550770)
Steven J. Pacini (BBO # 676132)
LATHAM & WATKINS LLP
John Hancock Tower, 20th Floor
200 Clarendon Street
Boston, MA 02116
Tel: (617) 948-6000
Fax: (617) 948-6001
kenneth.parsigian@lw.com
steven.pacini@lw.com
HOGAN LOVELLS US LLP
Steven P. Hollman (pro hac vice)
Susan M. Cook (pro hac vice)
555 Thirteenth Street, N.W.
Washington, D.C. 20004
(202) 637-5672 (Telephone)
(202) 637-5910 (Fax)
steven.hollman@hoganlovells.com
susan.cook@hoganlovells.com
Attorneys for Plaintiff Zogenix, Inc.
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CERTIFICATE OF SERVICE
I certify that the foregoing Second Supplemental Memorandum of Plaintiff Zogenix,
Inc. Regarding Regulatory Landscape was filed through the ECF system on 12th day of
February and will be sent electronically to the registered participants as identified on the
Notice of Electronic Filing (NEF).
/s/ Steven P. Hollman

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