Exhibit 99.1
ZymoGenetics Licenses Recombinant Factor XIII to Novo Nordisk
SEATTLE--(BUSINESS WIRE)--Oct. 5, 2004--
- Retains significant economic interest while creating opportunity
to invest in novel genomics-derived proteins -
- Conference call to be held Tuesday, October 5, 2004 at 8:45 AM
Eastern Time -
ZymoGenetics, Inc. (Nasdaq:ZGEN) today signed a license agreement granting
Novo Nordisk A/S (NYSE:NVO) exclusive worldwide rights to its recombinant Factor
XIII portfolio, including all related intellectual property. This transaction
transfers recombinant Factor XIII (rFactor XIII) to a company with the
infrastructure and expertise needed to capture and maximize the market value of
this product candidate. In turn, ZymoGenetics gains the opportunity to better
focus resources on developing its genomics-derived candidates TACI-Ig and IL-21,
which are in early clinical trials, and recombinant human Thrombin (rhThrombin),
which is already in Phase 2 trials. This agreement also releases resources that
will enable ZymoGenetics to pursue potential line extensions for rhThrombin,
additional indications for its genomic product candidates, and to bring other
novel drug candidates to the clinic.
"This transaction represents an important strategic move for our company,"
said Bruce L.A. Carter, Ph.D., President and Chief Executive Officer of
ZymoGenetics. "This license enables ZymoGenetics to retain a significant share
of the recombinant Factor XIII program's future economic rewards, while freeing
up resources to build even greater value elsewhere. Novo Nordisk's expertise in
the field of bleeding should lead to even greater potential for the product.
Within ZymoGenetics, we will invest more resources in the development of
rhThrombin and TACI-Ig. We believe TACI-Ig has potential in many serious
autoimmune diseases, as well as several B-cell cancers. In addition, our
demonstration of synergy between IL-21 and Rituximab in the treatment of tumors
in animals greatly expands the clinical potential of this candidate. We will
also explore the potential of future genomics-derived protein development
candidates such as IL-29 and IL-31."
Under the agreement, Novo Nordisk will gain the right to develop and
commercialize rFactor XIII on a worldwide basis. Novo Nordisk will pay
ZymoGenetics $15 million upon signing, and up to $62 million in additional
milestone payments. Novo Nordisk will also pay a royalty to ZymoGenetics on any
products containing recombinant Factor XIII, including combinations with Factor
VIIa, marketed by Novo Nordisk as NovoSeven(R). Further financial details were
not disclosed.
Factor XIII is a protein that stabilizes and strengthens blood clots.
ZymoGenetics has been developing recombinant Factor XIII for the treatment of
bleeding complications associated with congenital and acquired Factor XIII
deficiencies. The FDA recently informed ZymoGenetics that the company could
proceed with rFactor XIII clinical trials. From its work with Factor VIIa,
another protein involved in the blood-clotting cascade, Novo Nordisk has built
significant expertise in the field of bleeding and coagulation that can be
applied to the development of rFactor XIII. Scientific evidence suggests there
may be expanded potential for Factor XIII and Factor VIIa to work
synergistically in certain bleeding conditions.
ZymoGenetics will conduct a conference call/webcast in conjunction with
today's release at 8:45 AM Eastern Time on Tuesday, October 5, 2004. 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 October 12, 2004. The webcast will be available for replay until 11:59
PM Pacific Time on November 2, 2004.
Phone numbers and access codes for the conference call are as follows:
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 #: 5245751
About Recombinant human Factor XIII (rFactor XIII)
ZymoGenetics has been developing rFactor XIII for the prevention and
treatment of bleeding complications and abnormalities in blood clotting
associated with Factor XIII deficiencies. Factor XIII is the terminal enzyme in
the clotting cascade and is responsible for stabilizing blood clots. Its primary
function is to crosslink individual fibrin molecules into a strong fibrin mesh.
ZymoGenetics completed Phase 1 studies to evaluate the safety and
pharmacokinetics of rFactor XIII in patients with congenital Factor XIII
deficiency and to evaluate the safety and pharmacokinetics in healthy
volunteers. Clinical experience related to use of plasma-derived Factor XIII
shows significant potential for Factor XIII therapy in a variety of indications,
including congenital Factor XIII deficiency, a rare disease affecting
approximately 100 individuals in the United States. Individuals who are born
with congenital Factor XIII deficiency are usually diagnosed within hours of
birth and have a high risk of bleeding into the brain and in soft tissues.
Acquired Factor XIII deficiencies may occur in people born with normal levels of
Factor XIII following trauma, various surgical procedures (such as
cardiopulmonary bypass) or as a result of a disease process.
About TACI-Ig
ZymoGenetics is developing TACI-Ig for the treatment of autoimmune
diseases. TACI-Ig is a soluble fusion protein that links the extracellular
portion of the TACI receptor to the Fc portion of human immunoglobulin (Ig).
TACI-Ig binds to BLyS and APRIL, TNF family cytokines that promote B-cell
survival and the production of harmful autoantibodies, which cause certain
autoimmune diseases such as systemic lupus erythematosus (SLE). Preclinical data
indicate that levels of APRIL, as well as complexes containing both APRIL and
BLyS, are elevated in rheumatoid arthritis more than BLyS levels. TACI-Ig has
been shown to affect several stages of B-cell development and may inhibit the
survival of cells responsible for making antibodies. ZymoGenetics is developing
TACI-Ig in collaboration with Serono S.A. and is conducting Phase 1b studies in
patients with SLE and rheumatoid arthritis. The companies plan to start clinical
studies in patients with B-cell malignancies shortly.
About Interleukin 21 (IL-21)
ZymoGenetics is developing IL-21 for the treatment of cancer. IL-21 is a
novel member of the four helical bundle cytokine family, a protein family which
includes several proteins already approved for therapeutic use or in clinical
trials. IL-21 was identified using the company's genomics-based discovery
platform. IL-21 has potent biological activity in regulating key classes of
immune cells, including cytotoxic T cells and natural killer cells. These cell
types play key roles in eliminating malignant and infected cells from the body.
Based upon the ability of IL-21 to inhibit tumor growth in a number of animal
models and its mechanism of action involving regulation of immune cells,
metastatic melanoma and renal cell carcinoma were selected as the initial
indications for clinical studies, which are now underway. Potential follow-on
indications for IL-21 development include other solid tumors, such as lung,
colon or breast cancer. ZymoGenetics has retained the commercialization rights
for IL-21 in North America and has licensed the commercialization rights outside
of North America to Novo Nordisk A/S.
About rhThrombin
ZymoGenetics is developing rhThrombin for the control of bleeding
associated with surgical procedures. Thrombin is used in over 500,000 surgeries
per year in the United States. Currently, only thrombin derived from bovine
blood is available in the U.S. as a stand-alone thrombin product. Bovine-derived
thrombin has been associated with the development of antibodies that may
cross-react with human blood proteins. In some cases, these antibodies lead to
serious bleeding complications. Recombinant proteins, such as rhThrombin, can be
manufactured to higher levels of purity and consistency than proteins purified
from human or animal blood. Furthermore, the production of recombinant proteins
is not dependent on the availability of blood from human or animal donors and
can be scaled-up to meet market demands. For these reasons, ZymoGenetics
believes that rhThrombin represents a potential preferred alternative to the
bovine-derived product. ZymoGenetics is conducting a Phase 2 clinical study of
rhThrombin in patients undergoing lumbar spine surgery, liver resection, lower
extremity peripheral artery bypass surgery and formation of vascular access
grafts for dialysis.
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.
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.
CONTACT: ZymoGenetics, Inc.
Investor Relations
John Calhoun, MD, MBA
Director, Corporate Communications & Investor Relations
206-442-6744
or
Media Relations
Susan W. Specht, MBA
Corporate Communications Manager
206-442-6592