THE R.W. JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE UPDATES BIOCRYST
RWJPRI notified BioCryst that they will not initiate the North American Phase III clinical trial of RWJ-270201 during the current flu season. In recent discussions, the U.S. Food and Drug Administration (FDA) has requested additional monitoring requirements that would require amending the study protocol for the North American Phase III trial. The necessary timing to accomplish this would delay the start of the trial and impact RWJPRI's ability to enroll sufficient numbers of influenza subjects during this influenza season. Therefore, RWJPRI will not move this trial forward in North America this influenza season, as planned. Meanwhile, Phase III studies in Europe are ongoing.
Founded in 1986, BioCryst Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development of pharmaceuticals for the treatment of infectious, inflammatory and cardiovascular diseases and disorders. BioCryst's most advanced drug candidate, RWJ-270201 (formerly known as BCX-1812), is a neuraminidase inhibitor designed to treat and prevent viral influenza. The Company licensed this drug candidate to RWJPRI and Ortho-McNeil Pharmaceutical, Inc., both Johnson & Johnson companies.
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, The R.W. Johnson Pharmaceutical Research Institute (RWJPRI) and Ortho-McNeil Pharmaceutical, Inc.'s progress with respect to our influenza neuraminidase inhibitors and developments with respect to clinical trials and the regulatory approval process. 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 the FDA may not agree with RWJPRI's amendments to clinical protocols, that any Phase III clinical trials may not be successful or be pivotal in nature, that an NDA might not be filed, or that our license with RWJPRI and Ortho-McNeil might be terminated. Even if RWJPRI completes the Phase III clinical trials, we do not know when, if ever, it will receive FDA or foreign regulatory agency approvals for, or when Ortho-McNeil will begin marketing of RWJ-270201.