Exhibit 99.1
ZymoGenetics and Serono Establish Broad Strategic Research, Development and
Commercialization Alliance
SEATTLE & GENEVA--(BUSINESS WIRE)--Sept. 8, 2004--
Serono and ZymoGenetics to collaborate in the development of
novel protein and antibody therapeutics
ZymoGenetics, Inc. (Nasdaq:ZGEN) and Serono
(virt-x:SEO)(NYSE:SRA) today announced their intent to enter into a
broad partnership to research, develop and commercialize novel protein
and antibody therapeutics based on discoveries made by ZymoGenetics.
As part of this alliance:
-- Serono will gain access to a large portfolio of ZymoGenetics'
genes and proteins for in-house evaluation and screening, and
rights to license such proteins over the next five years.
-- Serono will also have rights over the next five years to
license up to twelve products arising from ZymoGenetics'
internal core research projects. ZymoGenetics will have an
option to co-develop and co-commercialize in the U.S. any
products selected by Serono. Until November 2006, Serono's
rights to exclusively license proteins outside the U.S. will
be subordinate to certain existing options of Novo Nordisk
under a separate agreement.
-- ZymoGenetics will license to Serono exclusive worldwide rights
to develop and commercialize products based on Fibroblast
Growth Factor 18 (FGF-18) and the Interleukin 22 Receptor
(IL-22R). In addition, the companies will co-develop
Interleukin 31 (IL-31).
Expected payments to ZymoGenetics include:
-- A payment of $20 million in exchange for the rights to license
proteins over the next five years.
-- The purchase of $50 million of ZymoGenetics' common stock.
-- An equal share of profits from the co-commercialization of
products in the U.S. for which ZymoGenetics has co-funded
development.
-- For every protein exclusively licensed or co-developed by
Serono, up-front fees as well as potential milestone payments
related to development progress, regulatory submissions and
approvals.
-- Royalty payments on product sales outside the U.S. and, to the
extent ZymoGenetics elects not to co-develop products, on
product sales in the U.S.
The terms of this agreement are subject to review by the United
States Federal Trade Commission and Department of Justice, under the
provisions of Section 7A of the Clayton Act, 15 U.S.C. ss. 18a, as
added by the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
"We are enthusiastic about building this alliance with Serono,"
said Bruce L.A. Carter, Ph.D., President and Chief Executive Officer
of ZymoGenetics. "Maximizing the value of our broad pipeline requires
the effort of a proven research, development and commercial
enterprise. Serono has not only demonstrated its strengths in these
areas, but also has proven an effective partner in our collaborative
development of TACI-Ig. The combination of our resources should work
to create value for both companies over the years ahead."
"We are very pleased to expand our fruitful collaboration with
ZymoGenetics", said Ernesto Bertarelli, Chief Executive Officer of
Serono. "By combining ZymoGenetics' strong pipeline of therapeutic
protein candidates with our research and development capabilities, we
are well positioned to bring to the market further innovative
treatments for medical conditions with significant unmet needs."
Three license agreements for FGF-18, IL-22R and IL-31 will be
entered into as part of this alliance. Serono will have worldwide
exclusive rights for FGF-18 and IL-22R, which may be useful for
repairing cartilage damaged by osteoarthritis or physical injury, and
psoriasis, respectively. ZymoGenetics will retain co-development and
co-commercialization rights in the U.S. for IL-31, which could be
useful in treating inflammatory conditions such as asthma, psoriasis
and inflammatory bowel disease. In addition to the $20 million payment
mentioned above, ZymoGenetics will receive initial license fees
totaling $11.25 million related to these three projects. Total upfront
and milestone payments under these licenses could exceed $100 million.
Serono reiterates its guidance for 2004 with an increase in total
revenues of at least 12% and an increase in net income of at least 20%
in local currencies.
ZymoGenetics will conduct a conference call/webcast in conjunction
with today's release at 8:30 A.M. ET on Wednesday, September 8, 2004.
The webcast will include a slide presentation. Members of the news
media, investors and the general public are invited to access a live
broadcast of the conference call via the ZymoGenetics website at
http://www.zymogenetics.com/ir/events.php or through www.vcall.com.
The event will be archived. The telephone replay will be available
until 11:59 PM Pacific Time on September 14, 2004. The webcast will be
available for replay until 11:59 PM Pacific Time on October 7, 2004.
Phone numbers and access codes for the conference call are as
follows:
- -0-
*T
Live Call -- Domestic: 800-370-0740 International: 973-409-9259
An operator will answer calls for the live event.
Archived Call -- Domestic 877-519-4471 International: 973-341-3080
Replay Passcodes (required for playback):
Account #: 1628
Conference ID #: 5131574
*T
About FGF-18
Fibroblast growth factor-18 (FGF-18) plays an important role
during skeletal development and appears to be a trophic factor for
chondrocytes, the cells that produce cartilage of the joint surfaces,
in mammals. ZymoGenetics has previously shown that FGF-18 and the
genes for two of its receptors are expressed by chondrocytes in adult
human articular cartilage. Addition of FGF-18 to the culture medium of
these cells increased both their proliferation and their production of
extracellular matrix. Similar changes in chondrocyte proliferation and
matrix deposition were observed at a number of sites following local
or systemic delivery of FGF-18. These data suggest that FGF-18 may be
useful for healing cartilage damaged by injury or disease.
About IL-22R
The IL-10 family cytokines IL-20 and IL-22 are pro-inflammatory
and each can signal via the receptor subunit IL-22R alpha.
Considerable evidence supports the inflammatory roles of IL-20 and
IL-22 in psoriasis including their elevated expression in psoriatic
lesions, transgenic mice phenotypes, genetic association data and
animal pharmacology. Expression of the receptor subunit IL-22R alpha
is also elevated in psoriatic lesions. Current work is directed
towards choosing the most suitable antagonist for evaluation in the
treatment of psoriasis. Such antagonists may also have use in other
instances of impaired epithelial barrier function, such as in
inflammatory bowel disease.
About IL-31
ZymoGenetics researchers discovered Interleukin 31 (IL-31) using
the Company's genomics-based discovery platform. Current in vitro and
in vivo data suggest that IL-31 may affect cellular infiltration and
inflammation. Analysis of IL-31 and IL-31 receptor levels in human and
murine disease tissues suggests that expression of IL-31, and/or its
receptor, is significantly increased in the settings of inflammatory
bowel disease, asthma and psoriasis. Further evidence suggests a
potential role of IL-31 in the development of atopic dermatitis. A
paper by ZymoGenetics scientists published in the July 2004 issue of
the journal Nature Immunology characterizes IL-31, illustrates the
hypothesized role of IL-31 in atopic dermatitis and respiratory
disease, and suggests directions for future investigation of this
cytokine and its role in human diseases.
About ZymoGenetics
ZymoGenetics is a biopharmaceutical company focused on the
discovery, development and commercialization of therapeutic proteins
for the prevention or treatment of human diseases. The Company is
developing a diverse pipeline of potential proprietary product
candidates that are moving into and through clinical development.
These span a wide array of clinical opportunities that include
bleeding, autoimmune diseases and cancer. ZymoGenetics intends to
commercialize these 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.
About Serono
Serono is a global biotechnology leader. The Company has eight
biotechnology products, Rebif(R), Gonal-F(R), Luveris(R),
Ovidrel(R)/Ovitrelle(R), Serostim(R), Saizen(R), Zorbtive(TM) and
Raptiva(R) (Luveris(R) is not approved in the USA). In addition to
being the world leader in reproductive health, Serono has strong
market positions in neurology, metabolism and growth and has recently
entered the psoriasis area. The Company's research programs are
focused on growing these businesses and on establishing new
therapeutic areas. Currently, there are approximately 30 ongoing
development projects.
In 2003, Serono achieved worldwide revenues of US$2,018.6 million,
and a net income of US$390.0 million, making it the third largest
biotech company in the world. Its products are sold in over 90
countries. Bearer shares of Serono S.A., the holding company, are
traded on the virt-x (SEO) and its American Depositary Shares are
traded on the New York Stock Exchange (SRA).
Background material
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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 discovery strategy,
preclinical and clinical development, regulatory oversight,
intellectual property claims and litigation and other risks detailed
in ZymoGenetics' public filings with the Securities and Exchange
Commission, including ZymoGenetics' Annual Report on Form 10-K for the
year ended December 31, 2003. 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.
Serono forward-looking statements
Some of the statements in this press release are forward looking.
Such statements are inherently subject to known and unknown risks,
uncertainties and other factors that may cause actual results,
performance or achievements of Serono S.A. and affiliates to be
materially different from those expected or anticipated in the
forward-looking statements. Forward-looking statements are based on
Serono's current expectations and assumptions, which may be affected
by a number of factors, including those discussed in this press
release and more fully described in Serono's Annual Report on Form
20-F filed with the U.S. Securities and Exchange Commission on March
25, 2004. These factors include any failure or delay in Serono's
ability to develop new products, any failure to receive anticipated
regulatory approvals, any problems in commercializing current products
as a result of competition or other factors, our ability to obtain
reimbursement coverage for our products, and government regulations
limiting our ability to sell our products. Serono has no
responsibility to update the forward-looking statements contained in
this press release to reflect events or circumstances occurring after
the date of this press release.
CONTACT: ZymoGenetics
Investor Relations:
John Calhoun, 206-442-6744
or
Media Relations:
Susan W. Specht, 206-442-6592
or
Serono
Corporate Media Relations:
+41 22 739 36 00
Fax: +41 22 739 30 85
http://www.serono.com
or
Corporate Investor Relations:
+41 22 739 36 01
Fax: +41 22 739 30 22
Reuters: SEO.VX / SRA.N
Bloomberg: SEO VX / SRA US
or
Media Relations, USA:
781-681-2486
Fax: 781-681-2935
http://www.seronousa.com
or
Investor Relations, USA:
781-681-2552
Fax: 781-681-2912