News Release
Bristol-Myers Squibb and ZymoGenetics Enter Global Collaboration on Novel Hepatitis C Compound
January 12, 2009
PEG-Interferon lambda is a Novel Type 3 Interferon in Phase Ib trials
PRINCETON, N.J. & SEATTLE--(BUSINESS WIRE)--Jan. 12, 2009--Bristol-Myers Squibb Company (NYSE:BMY) and ZymoGenetics, Inc.
(Nasdaq:ZGEN) today announced a global collaboration for PEG-Interferon
lambda, a novel type 3 interferon currently in Phase Ib development for
the treatment of Hepatitis C, and its related development program.
Under the terms of the collaboration, Bristol-Myers Squibb agreed
to pay ZymoGenetics an upfront cash payment of $85 million for the
development and commercialization rights to PEG-Interferon lambda, and
to pay an additional license fee of $20 million in 2009. ZymoGenetics
could receive additional payments of up to $430 million based on
pre-defined development and regulatory milestones for PEG-Interferon
lambda in Hepatitis C, up to $287 million in development and regulatory
milestones for other potential indications, and up to $285 million based
on pre-defined sales-based milestones.
The companies have agreed to co-develop PEG-Interferon lambda in the
United States and Europe and will share development costs. It is
anticipated that ZymoGenetics will conduct a significant portion of
continuing Phase I and certain Phase II development activities.
ZymoGenetics will have the option to co-promote in the United States and
to share profits on product sales with Bristol-Myers Squibb.
ZymoGenetics may opt out of the co-development, co-promotion and profit
sharing arrangement in the United States, in which case ZymoGenetics
will receive double-digit royalties on PEG-Interferon lambda sales
worldwide.
Outside the United States, Bristol-Myers Squibb will be responsible for
commercialization and ZymoGenetics will receive double-digit royalties
on product sales.
"We welcome the opportunity to combine ZymoGenetics' strong foundation
in discovering and developing therapeutic proteins, with our own
internal research and development expertise in working on this
innovative Hepatitis C therapy that has the potential to help patients
prevail over this serious disease," said Francis Cuss, MD, Senior Vice
President, Discovery and Exploratory Clinical Research, Bristol-Myers
Squibb. "The profile of PEG-Interferon lambda offers the possibility of
improvements in the safety and effectiveness of combination treatment
for Hepatitis C and makes it an ideal fit with our emerging portfolio of
small molecule anti-virals."
"We believe Bristol-Myers Squibb is the ideal partner for ZymoGenetics
and that we share the vision that PEG-Interferon lambda could become an
important part of treating patients with Hepatitis C," said Douglas E.
Williams, Ph.D., Chief Executive Officer of ZymoGenetics. "We look
forward to a productive partnership focused on bringing PEG-Interferon
lambda to Hepatitis C patients as rapidly as possible."
PEG-Interferon lambda (IL-29) is a novel type 3 interferon currently in
Phase Ib development for Hepatitis C. The native human protein
Interferon lambda is generated by the immune system in response to viral
infection. PEG-Interferon lambda has the potential to be uniquely
differentiated from available interferon therapy because Interferon
lambda mediates anti-viral activity through a receptor that is distinct
from that used by Interferon alpha and is present on fewer cell types
within the tissues of the body. As a result, the possibility exists for
more targeted delivery of interferon therapy and an improved therapeutic
index.
The effectiveness of the agreement is subject to antitrust clearance by
the United States Federal Trade Commission and Department of Justice,
under the provisions of the Hart-Scott-Rodino Antitrust Improvements Act
of 1976 and other customary regulatory approvals.
About Hepatitis C1
Hepatitis C is a virus that infects the liver and is transmitted through
direct contact with blood. An estimated 170 million people worldwide are
infected with Hepatitis C and, of these, 94.5 million people live in the
Asia Pacific region. One to five percent of people with chronic
infection will develop liver cancer. Although there is no vaccine to
prevent Hepatitis C, it is a curable disease.
Conference Call and Webcast Information
ZymoGenetics will conduct a conference call/webcast on Tuesday, January
13, at 8:30 a.m. Eastern Time. The call and webcast may be accessed at www.zymogenetics.com
or by dialing 877-407-0778 (International: 201-689-8565). Participants
should dial in to the call approximately 10 minutes prior to the
scheduled start time to register. A live audio webcast and slide
presentation can be accessed by going to: www.zymogenetics.com.
The webcast will be archived for 60 days. For replay, please visit www.zymogenetics.com
or use the following information:
-- U.S. callers: 877-660-6853
-- International callers: 201-612-7415
Replay passcode account #: 286
Conference ID #: 309378
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission
is to extend and enhance human life. For more information visit www.bms.com.
About ZymoGenetics
ZymoGenetics creates novel protein drugs that help patients fight
disease. ZymoGenetics developed and markets RECOTHROM(R) Thrombin, topical
(Recombinant). Other product candidates span a wide array of clinical
opportunities that include cancer, autoimmune and viral diseases.
ZymoGenetics intends to commercialize product candidates through
internal development, collaborations with partners, and out-licensing of
patents from its extensive patent portfolio. For further information,
visit www.zymogenetics.com.
ZymoGenetics Forward Looking Statements
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements are based on the current intent and
expectations of the management of ZymoGenetics. These statements
are not guarantees of future performance and involve risks and
uncertainties that are difficult to predict. ZymoGenetics' actual
results and the timing and outcome of events may differ materially from
those expressed in or implied by the forward-looking statements because
of risks associated with our unproven preclinical and clinical
development and results, strategic partnering, including efforts by and
results of collaborations, regulatory oversight and approvals, product
sales and marketing abilities, discovery strategy, intellectual property
claims and litigation and other risks detailed in the company's public
filings with the Securities and Exchange Commission, including the
company's Annual Report on Form 10-K for the year ended December 31,
2007. Except as required by law, ZymoGenetics undertakes no obligation
to update any forward-looking or other statements in this press release,
whether as a result of new information, future events or otherwise.
Bristol-Myers Squibb Forward-Looking Statements
This press release contains "forward-looking statements" as that term
is defined in the Private Securities Litigation Reform Act of 1995,
regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are
based on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change any
of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking
statement can be guaranteed. Among other risks, there can be no
guarantee that the clinical trials described in this release will
support a regulatory filing or that the product described in this
release will receive regulatory approval. There can be no
assurance that if approved, the product will be commercially successful.
Nor is there any assurance that the transaction described in this
release will receive the necessary regulatory approvals to close.
Forward-looking statements in the press release should be evaluated
together with the many uncertainties that affect Bristol-Myers Squibb's
business, particularly those identified in the cautionary factors
discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the
year ended December 31, 2007, its Quarterly Reports on Form 10-Q, and
Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no
obligation to publicly update any forward-looking statement, whether as
a result of new information, future events, or otherwise.
References
1. World Health Organization Web site. Fact sheet N°164. http://www.who.int/mediacentre/factsheets/fs164/en/.
Accessed September 23, 2008.
CONTACT: Bristol-Myers Squibb Company
Media
Jennifer Fron Mauer, 609-252-6579
jennifer.mauer@bms.com
or
Investors
John Elicker, 609-252-4611
john.elicker@bms.com
or
ZymoGenetics
Media and Investors
Susan W. Specht 206-442-6592
spechts@zymogenetics.com
or
Media and Investors
Michael Fitzpatrick 206-442-6702
fitzpatm@zymogenetics.com
Source: ZymoGenetics
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"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding ZymoGenetics Inc.'s business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report or Form 10-K for the most recently ended fiscal year.