SECURITIES AND EXCHANGE
COMMISSION FORM 8-KCURRENT REPORT PURSUANT TO SECTION 13
0R 15(d) Date of Report (Date of earliest event reported) May 1, 2001 BIOCRYST
PHARMACEUTICALS, INC. DELAWARE |
000-23186 | 62-1413174 | ||
(Commission File Number) | (I.R.S. Employer Identification No.) |
2190 Parkway Lake
Drive; Birmingham, Alabama 35244 (205) 444-4600 NONE 1 |
Item 5. Other Events: |
On April 30, 2001, BioCryst Pharmaceuticals, Inc. announced Ortho-McNeil Pharmaceuticals, Inc. (Ortho-McNeil) and the R.W. Johnson Pharmaceutical Research Institute (RWJPRI), both Johnson & Johnson companies, gave four months prior notice of termination as required by the worldwide license agreement with BioCryst to develop and market products to treat and prevent viral influenza. The drug candidate, currently named RWJ-270201, is being tested in Phase III clinical trials in Europe, which are still blinded. Ortho-McNeil indicated that this business decision was not related to the safety or efficacy of the drug, but that other of its drug development programs were of a higher priority. The information contained in the press release dated April 30, 2001 related to the termination is incorporated herein by reference and filed as Exhibit 99.1 hereto. |
Item 7. Exhibits |
(c) | Exhibits |
Number | Description |
99.1 | Press release dated April 30, 2001, Ortho-McNeil Pharmaceutical, Inc. and the R.W. Johnson Pharmaceutical Research Institute to Terminate Worldwide Influenza Collaboration. |
SIGNATUREPursuant 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 thereunto duly authorized. |
BIOCRYST PHARMACEUTICALS, INC. | |
Date: May 1, 2001 | /s/ W. Randall Pittman |
W. Randall Pittman | |
Chief Financial Officer and Chief Accounting Officer |
2 |
INDEX TO EXHIBITS |
Exhibit Number |
Description | Sequentially Numbered Page | |||
---|---|---|---|---|---|
99.1 | Press release dated April 30, 2001, Ortho-McNeil Pharmaceutical, Inc. and the R.W. Johnson Pharmaceutical Research Institute to Terminate Worldwide Influenza Collaboration. | 4 |
3 |
EXHIBIT 99.1 Contact: FOR IMMEDIATE RELEASE
ORTHO-MCNEIL PHARMACEUTICAL, INC. AND THE R. W. JOHNSON
|
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. Forward-looking statements include, but are not limited to, BioCrysts plan to move forward with Phase III development of RWJ-270201; BioCrysts ability to obtain a corporate partner to continue development and potential commercialization on acceptable terms, if at all; progress with respect to continuing Phase III development; and developments with respect to clinical trials and the regulatory approval process. Even if BioCryst continues certain Phase III clinical trials, we do not know when, if ever, it will complete all the required Phase III clinical trials, or when, if ever, it will receive FDA or foreign regulatory agency approvals for, or when, if ever, marketing of RWJ-270201 will begin. 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, without limitation, that we cannot assure you that the Company will be able to continue Phase III or future development, license its proprietary influenza neuraminidase to a new corporate partner to facilitate final development and potential commercialization, or that the agreement will be completed or have favorable terms; that research and testing will continue and or will result in future milestone or royalty payments; and no assurance as to timing by which an agreement will be signed, products will be cleared for marketing, that the compound currently under development will be safe or efficacious, or that required regulatory clearances can be obtained from the U.S. Food and Drug Administration. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCrysts most recent Annual Report on Form 10-K, which identifies important factors that could cause the actual results to differ materially from those contained in the projections or forward-looking statements. # # # 5 |