ZymoGenetics, Inc. (NASDAQ:ZGEN) and Bristol-Myers Squibb
Company (NYSE:BMY) announced that interim results from Phase 2a of
the EMERGE clinical trial of PEG-Interferon lambda administered
with ribavirin in treatment-naïve hepatitis C virus patients, will
be presented at the American Association for the Study of Liver
Diseases (AASLD) annual meeting in Boston, October 29 – November 2,
2010. PEG-Interferon lambda abstracts, including clinical,
pharmacokinetic and viral kinetic data along with in vitro data in
combination with direct-acting antiviral agents, were published
today and are available on the AASLD website at www.aasld.org.
AASLD 2010 PEG-Interferon lambda Poster
Presentations
Title: Pegylated Interferon Lambda
(PEG-IFN-λ) Phase 2 Dose-Ranging, Active-Controlled Study in
Combination with Ribavirin (RBV) for Treatment-Naïve HCV Patients
(Genotypes 1, 2, 3, or 4): Safety, Viral Response, and Impact of
IL-28B Host Genotype through Week 12
Abstract: 821
Presenter: A.J. Muir
Date: Sunday, October 31, 2010
Time: 8:00 AM – 5:30 PM
Title: Pharmacokinetics of
PEG-Interferon lambda (PEG-IFN-λ) Following Fixed Dosing in
Treatment-Naïve Hepatitis C Subjects (Single Dose Interim Data from
a Dose-Ranging Phase 2A Study)
Abstract: 830
Presenter: K.A. Byrnes-Blake
Date: Sunday, October 31, 2010
Time: 8:00 AM – 5:30 PM
Title: The Effect of Treatment
Group, HCV Genotype, and IL28B Genotype on Early HCV Viral Kinetics
in a Phase 2A Study of PEG-Interferon lambda (PEG-IFN-λ) in
Hepatitis C Patients
Abstract: 831
Presenter: J.A. Freeman
Date: Sunday, October 31, 2010
Time: 8:00 AM – 5:30 PM
Title: In vitro activity of the
combination of pegylated interferon lambda (PEG-IFN-λ) with
direct-acting antivirals in the HCV replicon model
Abstract: 1854
Presenter: F. McPhee
Date: Tuesday, November 2, 2010
Time: 7:00 AM - 12:00 PM
About PEG-Interferon lambda
PEG-Interferon lambda (IL-29) is a novel and first in class
interferon in development for hepatitis C. The native human
interferon lambda proteins are generated by the immune system in
response to viral infection, and signal through a different
receptor than type I interferons, such as interferon alpha. Because
this receptor is present on fewer cell types within the human body,
it is hypothesized that PEG-Interferon lambda may be able to
demonstrate an improved safety and tolerability profile compared to
alpha interferons.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information, please visit www.bms.com or follow us on Twitter at
http://twitter.com/bmsnews.
About ZymoGenetics
ZymoGenetics is a biopharmaceutical company focused on the
development and commercialization of therapeutic proteins for the
treatment of human diseases. The company developed and is marketing
RECOTHROM® Thrombin, topical (Recombinant) in the United States.
ZymoGenetics has two product candidates in Phase 2 clinical
development: PEG-Interferon lambda, being studied in collaboration
with Bristol-Myers Squibb for treatment of hepatitis C virus
infection, and IL-21, being tested as a potential treatment for
metastatic melanoma. In addition, ZymoGenetics has an anti-IL-31
monoclonal antibody in preclinical development, which it expects to
test initially as a treatment for atopic dermatitis. Several of the
product candidates previously identified through ZymoGenetics’
discovery research efforts have been licensed to and are being
developed by third parties, including Merck Serono and Novo
Nordisk. ZymoGenetics is eligible to receive milestone payments and
royalties related to these assets. For further information, visit
www.zymogenetics.com.
Bristol-Myers Squibb Forward-Looking Statements
This press release contains "forward-looking statements"
relating to the acquisition of ZymoGenetics by Bristol-Myers
Squibb. 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
acquisition will be completed, or if it is completed, that it will
close within the anticipated time period. 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, 2009, 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.
Except for the historical information presented herein, matters
discussed herein may constitute forward-looking statements that are
subject to certain risks and uncertainties that could cause actual
results to differ materially from any future results, performance
or achievements expressed or implied by such statements. Statements
that are not historical facts, including statements preceded by,
followed by, or that include the words “future”; “anticipate”;
“potential”; “believe”; or similar statements are forward-looking
statements. Risks and uncertainties include uncertainties as to the
timing of the tender offer and merger; uncertainties as to how many
of the ZymoGenetics shareholders will tender their shares in the
offer; the risk that competing offers will be made; the possibility
that various closing conditions for the transaction may not be
satisfied or waived, including that a governmental entity may
prohibit, delay or refuse to grant approval for the consummation of
the transaction; the effects of disruption from the transaction
making it more difficult to maintain relationships with employees,
licensees, other business partners or governmental entities; as
well as risks detailed from time to time in ZymoGenetics’ public
disclosure filings with the SEC, including its Annual Report on
Form 10-K for the fiscal year ended December 31, 2009, subsequent
quarterly filings on Form 10-Q and the Solicitation/Recommendation
Statement filed in connection with the tender offer. The
information contained in this release is as of September 28,
2010.
This press release is neither an offer to purchase nor a
solicitation of an offer to sell shares of ZymoGenetics.
Bristol-Myers Squibb Company and Zeus Acquisition Corporation have
filed a tender offer statement with the SEC, and have mailed an
offer to purchase, forms of letter or transmittal and related
documents to ZymoGenetics shareholders. ZymoGenetics has filed with
the SEC, and has mailed to ZymoGenetics shareholders a
solicitation/recommendation statement on Schedule 14D-9. These
documents contain important information about the tender offer and
stockholders of ZymoGenetics are urged to read them carefully when
they become available.
These documents will be available at no charge at the SEC's
website at www.sec.gov. The tender offer statement and the related
materials may be obtained for free by directing a request by mail
to Georgeson Inc., 199 Water Street, 26th Floor, New York, New York
10038 or by calling toll-free 800-491-3096. In addition, a copy of
the offer to purchase, letter or transmittal and certain other
related tender offer documents (once they become available) may
also be obtained free of charge from Bristol-Myers Squibb by
directing a request to: Public Affairs, Telephone No.:
609-252-6579; E-Mail: jennifer.mauer@bms.com.
ZymoGenetics Forward-Looking Statement
This press release contains forward-looking statements,
including statements related to conducting and analyzing the
results of clinical trials. Phrases such as “look forward” and
similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon
ZymoGenetics’ current expectations and involve risks and
uncertainties. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation, risks related to ZymoGenetics’ ability
to design and conduct clinical trials, the possibility that
clinical trial results may vary between different arms of a
clinical trial and the difficulty of using prior clinical trial
results to predict future outcomes, as well as those other risks
detailed in ZymoGenetics’ filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K for the year
ended December 31, 2009 and periodic reports on Form 10-Q and
current reports on Form 8-K. Do not place undue reliance on these
forward-looking statements, which speak only as of the date of this
press release. All forward-looking statements are qualified in
their entirety by this cautionary statement, and, except where
required by law, ZymoGenetics undertakes no obligation to revise or
update any forward-looking statements to reflect events or
circumstances after the date of this press release.
PEGASYS® (Peginterferon alfa-2a) is a registered trademark of
Hoffmann-La Roche
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