UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): September 18, 2009
BioCryst Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 000-23186 | 62-1413174 | ||
| (State or Other Jurisdiction | (Commission | (IRS Employer | ||
| of Incorporation) | File Number) | Identification No.) |
| 2190 Parkway Lake Drive, Birmingham, Alabama | 35244 | |
| (Address of Principal Executive Offices) | (Zip Code) |
(205) 444-4600
(Registrant’s telephone number, including area code)
(Registrant’s telephone number, including area code)
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2 below):
| o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | ||
| o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | ||
| o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 210.14d-2(b)) | ||
| o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 1.01 Entry into a Material Definitive Agreement
On September 18, 2009, BioCryst Pharmaceuticals, Inc. (the “Company”) entered into a contract
modification with the U.S. Department of Health & Human Services (HHS) to advance the development
of intravenous (i.v.) peramivir. The modification increases the award under the original contract
by $77.2 million for a total of $179.9 million and extends the term of the contract by 12 months
for a total term of five years.
Item 7.01 Regulation FD Disclosure
On September 21, 2009, the Company issued a news release with respect to the modification. The
news release is furnished as Exhibit 99.1 hereto and is incorporated by reference.
The information furnished is not deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, is not subject to the liabilities of that section and is not
deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
99.1
|
Press release dated September 21, 2009 entitled “BioCryst Awarded Additional $77.2 million by the U.S. Department of Health & Human Services to Develop Peramivir for Influenza.” |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: September 23, 2009 | BioCryst Pharmaceuticals, Inc. |
|||
| By: | /s/ Alane Barnes | |||
| Alane Barnes | ||||
| General Counsel, Corporate Secretary | ||||
EXHIBIT INDEX
| Exhibit No. | Description | |
99.1
|
Press release dated September 21, 2009 entitled “BioCryst Awarded Additional $77.2 million by the U.S. Department of Health & Human Services to Develop Peramivir for Influenza.” |
Exhibit 99.1
BIOCRYST AWARDED ADDITIONAL $77.2 MILLION BY THE U.S. DEPARTMENT
OF HEALTH & HUMAN SERVICES TO DEVELOP PERAMIVIR FOR INFLUENZA
OF HEALTH & HUMAN SERVICES TO DEVELOP PERAMIVIR FOR INFLUENZA
• Contract modification extends term by one year and increases total U.S. government
award to develop peramivir to $180 million
award to develop peramivir to $180 million
Birmingham, Alabama — September 21, 2009 — BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) today
announced that it has been awarded a $77.2 million contract modification by the U.S. Department of
Health & Human Services (HHS) to complete Phase 3 development of its influenza neuraminidase
inhibitor, intravenous (i.v.) peramivir, for the treatment of
complicated influenza.
“We are very excited to continue working with the U.S. government to advance the development of
peramivir,” said Jon P. Stonehouse, President and Chief Executive Officer, BioCryst
Pharmaceuticals. “Peramivir is being developed with HHS to treat seriously ill and hospitalized
patients, with the goal of saving lives. This contract modification supports peramivir’s Phase 3
clinical development with the aim of gaining U.S. regulatory approval.”
“There are currently no anti-viral drugs approved to treat seriously ill patients with influenza
who need hospital care,” said Dr. William P. Sheridan, Chief Medical Officer at BioCryst. “BioCryst
is committed to working with the U.S. government to advance the development of peramivir to address
unmet medical needs for an intravenous treatment for influenza. We intend to initiate our Phase 3
studies as soon as possible.”
This contract modification brings the total award from HHS for the development of peramivir to
$179.9 million and extends the contract term by 12 months to five years. BioCryst was originally
awarded a $102.6 million, four-year contract from the HHS to develop peramivir for the treatment
of influenza in January 2007. Under the original contract, peramivir was advanced through Phase 2
and the initial steps of Phase 3 development.
Phase 3 Development of peramivir
BioCryst has finalized its plans for Phase 3 studies intended to support U.S. regulatory approval
of peramivir for influenza. Expenses for the Phase 3 studies are covered under the modified HHS
contract announced today. BioCryst is currently in the process of obtaining the appropriate Health
Authority and IRB/Ethics Committee approvals and is recruiting investigators for these studies in
the U.S. and abroad. BioCryst plans to initiate enrollment of these trials in the upcoming flu
season.
Further details regarding these Phase 3 studies are available on the internet at:
http://www.clinicaltrials.gov/ct2/results?term=Peramivir+HHS+Phase+3&recr=Open
http://www.clinicaltrials.gov/ct2/results?term=Peramivir+HHS+Phase+3&recr=Open
About peramivir
Peramivir is an anti-viral agent that was discovered by BioCryst which inhibits the interactions
of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host.
In laboratory tests, peramivir has shown activity against pandemic H1N1 swine flu origin viral
strains. Peramivir has been studied in patients with complicated and uncomplicated influenza.
BioCryst’s partner, Shionogi & Co., Ltd. is currently preparing to file for regulatory approval in
Japan this year.
About Influenza
Influenza (the flu) is a contagious respiratory illness caused by influenza viruses. It can cause
mild to severe illness, and at times can lead to death. According to the U.S. Centers for Disease
Control & Prevention, on average 5 to 20 percent of the population gets the flu in the U.S.; more
than 200,000 people are hospitalized from flu complications and about 36,000 people die from
flu-related causes.
More information is available at:
http://www.cdc.gov/flu/
http://www.hhs.gov/pandemicflu/plan/pdf/HHSPandemicInfluenzaPlan.pdf
http://www.cdc.gov/flu/
http://www.hhs.gov/pandemicflu/plan/pdf/HHSPandemicInfluenzaPlan.pdf
About BioCryst
BioCryst Pharmaceuticals designs, optimizes and develops novel
small-molecule
pharmaceuticals that block key enzymes involved in infectious diseases, cancer, and inflammatory
diseases. BioCryst has discovered and progressed two novel compounds into late-stage pivotal
clinical trials; peramivir, an anti-viral for influenza, and forodesine, a purine nucleoside
phosphorylase (PNP) inhibitor for cutaneous T-cell lymphoma (CTCL). Utilizing crystallography and
structure-based drug design, BioCryst continues to discover additional compounds and to progress
others through pre-clinical and early development to address the unmet medical needs of patients
and physicians. 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
Limited 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 and ex-U.S.
governments may choose not to issue a request for peramivir to treat influenza or such requests, if
any, may not result in an order or such order, if any, may not be profitable for BioCryst; 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 BioCryst or its licensees may not commence as expected
additional human clinical trials with our product candidates; that our product candidates may not
receive required regulatory clearances from the FDA; that ongoing and future pre-clinical 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 and partnerships 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 cash 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), 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.
###
BCRXW
CONTACT: Robert Bennett, BioCryst Pharmaceuticals, +1-919-859-7910