BioCryst Pharmaceuticals Reports Positive Results of Shionogi & Co. Sponsored Phase 3 Studies of i.v. Peramivir for Influenza
BIRMINGHAM, Ala., July 17 /PRNewswire-FirstCall/ -- BioCryst
Pharmaceuticals (NASDAQ:BCRX)
today announced positive results from two Phase 3 studies of
intravenous (i.v.) peramivir in patients with seasonal influenza.
The studies were sponsored by BioCryst's partner Shionogi &
Co., Ltd. of Osaka, Japan and conducted during the 2008-2009
influenza season. Shionogi and Green Cross Corporation, the license
holder of peramivir in Korea, co-conducted the portion of the
studies in Korea.
In patients with uncomplicated seasonal influenza, Shionogi
conducted a three-armed, multi-center, randomized, double-blind,
multi-national Phase 3 study of i.v. peramivir that compared the
efficacy and safety of a single dose of peramivir (either 300 mg or
600 mg) and treatment with oral oseltamivir phosphate 75 mg
(Tamiflu ) twice a day for five days. A total of 1,099 patients
were enrolled at 146 centers (Japan:100; Korea:25; Taiwan:21). Both
the 300 mg and 600 mg single dose peramivir groups demonstrated
non-inferiority for the primary endpoint, time to alleviation of
symptoms (TTAS), compared to the oseltamivir group. The medians for
TTAS for the peramivir 300 mg, peramivir 600 mg and oseltamivir
groups were 78.0 hours, 81.0 hours and 81.8 hours,
respectively.
Additionally, Shionogi conducted a double-blind, multi-center
Phase 3 study of i.v. peramivir with dosing over multiple days. The
study enrolled 42 influenza patients at high-risk of serious
complications due to one or more qualifying conditions: diagnosis
with poorly controlled diabetes mellitus, a chronic respiratory
disease requiring pharmacotherapy, or current treatment with any
immunosuppressive drug. Peramivir was administered at 300 mg or 600
mg per day, and the duration was adjusted (up to five days) on a
case-by-case basis, depending on the patient's temperature and
clinical condition. In this study, the median time to alleviation
of symptoms in all 37 evaluable patients treated with either 300 mg
or 600 mg peramivir daily was 68.6 hours.
i.v. peramivir 300 mg and 600 mg in both single and multiple
doses were generally safe and well-tolerated in these trials.
Further analyses of the study data, including secondary efficacy
endpoints and detailed safety is underway. Additional data will be
submitted for presentation at an upcoming medical meeting.
"The clinical outcomes of these Phase 3 studies are important,
especially during the declared influenza pandemic, as they indicate
the promise of peramivir as a treatment for influenza," commented
Dr. William P. Sheridan, Chief Medical Officer of BioCryst. "The
need for additional anti-viral treatment options for influenza
remains high. BioCryst is currently finalizing its plans for
peramivir Phase 3 studies intended to support U.S. regulatory
approval, while continuing to support the pre-emergency use
authorization review of peramivir by the U.S. Food & Drug
Administration."
"This data represents a significant milestone for BioCryst --
the first Phase 3 studies successfully conducted with a drug
candidate discovered by BioCryst," said Jon P. Stonehouse,
President and Chief Executive Officer of BioCryst. "We congratulate
Shionogi on the success of these rapidly completed studies, which
have the potential to lead to the first regulatory approval for
peramivir."
Shionogi has stated that the Company is making its best effort
to file its New Drug Application and to receive a manufacturing
approval as soon as possible in Japan.
About Peramivir
Peramivir is an anti-viral agent that inhibits the interactions
of influenza neuraminidase, an enzyme which is critical to the
spread of influenza within a host. Peramivir has demonstrated
clinical activity and safety in prior human studies. In laboratory
tests, peramivir has shown activity against various viral strains,
including the novel influenza A (H1N1) virus. In the U.S., BioCryst
is preparing plans for additional Phase 3 studies of i.v. peramivir
to support product registration. Additionally, i.v. peramivir is
currently undergoing a pre-emergency use authorization (EUA)
review.
About the Shionogi & Co., Ltd. Partnership
In February 2007, BioCryst & Shionogi & Co., Ltd.
entered into an exclusive license agreement under which Shionogi
obtained rights to develop and commercialize peramivir in Japan for
the treatment of seasonal and potentially life-threatening
influenza. In 2008, Shionogi's rights were extended to include
Taiwan. Under the terms of the agreement, BioCryst may receive
future clinical and commercial event milestone payments up to $116
million, as well as double digit royalty payments on product sales
of peramivir. BioCryst retains its rights to commercialize
peramivir in countries outside of Japan, Taiwan and South
Korea.
About BioCryst
BioCryst is a biopharmaceutical company that has developed a
diverse pipeline of novel therapeutics targeting major illnesses by
employing crystallography and structure-based drug design. BioCryst
is currently advancing investigational new drugs discovered
in-house in late-stage clinical trials for influenza and lymphoma.
In addition, the Company has a pre-clinical portfolio of novel
compounds, directed against infectious, cardiovascular and
autoimmune disease targets, to create long-term sustainable value.
The Company's strategic alliances with the U.S. Department of
Health and Human Services, Shionogi & Co., Ltd., Green Cross
Corporation and Mundipharma International Holdings Ltd. validate
its scientific foundation and the utility of its product
candidates. For more information, please visit the Company's Web
site at www.biocryst.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding future results, performance or
achievements. These statements involve known and unknown risks,
uncertainties and other factors which may cause our actual results,
performance or achievements to be materially different from any
future results, performances or achievements expressed or implied
by the forward-looking statements. These statements reflect our
current views with respect to future events and are based on
assumptions and subject to risks and uncertainties. Given these
uncertainties, you should not place undue reliance on these
forward-looking statements. Some of the factors that could affect
the forward-looking statements contained herein include: that
peramivir may not receive emergency use authorization; that the
U.S. government may choose not to ship peramivir to the CDC
Strategic National Stockpile; that to the extent peramivir is used
as a treatment for H1N1 flu (or other strains of flu), there can be
no assurance that it will prove effective; that HHS may further
condition, reduce or eliminate future funding of the peramivir
program; that ongoing peramivir clinical trials or our peramivir
program in general may not be successful; that we or our licensees
may not be able to enroll the required number of subjects in
planned clinical trials of our product candidates and that such
clinical trials may not be successfully completed; that BioCryst or
its licensees may not commence as expected additional human
clinical trials with our product candidates; that peramivir or our
other product candidates may not receive required regulatory
clearances from the FDA or other regulatory agencies; that ongoing
and future preclinical and clinical development may not have
positive results; that we or our licensees may not be able to
continue future development of our current and future development
programs; that our development programs may never result in future
product, license or royalty payments being received by BioCryst;
that BioCryst may not be able to retain its current pharmaceutical
and biotechnology partners for further development of its product
candidates or it may not reach favorable agreements with potential
pharmaceutical and biotechnology partners for further development
of its product candidates; that our actual burn rate may not be
consistent with our expectations; that BioCryst may not have
sufficient cash to continue funding the development, manufacturing,
marketing or distribution of its products and that additional
funding, if necessary, may not be available at all or on terms
acceptable to BioCryst. Please refer to the documents BioCryst
files periodically with the Securities and Exchange Commission,
specifically BioCryst's most recent Annual Report on Form 10-K,
most recent Registration Statement on Form S-3 (filed November 28,
2008 and subsequently amended Jan 23, 2009), Quarterly Reports on
Form 10-Q, and current reports on Form 8-K, all of which identify
important factors that could cause the actual results to differ
materially from those contained in our projections and
forward-looking statements.
Source: BioCryst Pharmaceuticals
CONTACT: Investors: Robert Bennett, BioCryst
Pharmaceuticals,
+1-919-859-7910; For Media-Related Inquiries: Catherine Collier,
Burns
McClellan, +1-212-213-0006
Web Site: http://www.biocryst.com
Posted: July 2009
