CAMBRIDGE, Mass., Feb 26, 2002 (BW HealthWire) -- Alkermes, Inc., (NASDAQ: ALKS) today announced that it added a poster to its website entitled "Maintenance of Efficacy Without Compromising Safety When Switching from Oral Risperidone to Risperdal Consta(TM), a Long-acting Injection Formulation of Risperidone." The poster was presented today, Tuesday, February 26, 2002 at 12:30pm ET at the Winter Workshop on Schizophrenia in Davos, Switzerland. This poster demonstrates the maintenance of efficacy without compromising safety when switching from Risperdal(R) (risperidone) tablets to Risperdal Consta. The poster is available on the Alkermes website at www.alkermes.com/news.
A new drug application (NDA) for Risperdal Consta was submitted to the U.S. Food and Drug Administration on August 31, 2001 by Johnson & Johnson Pharmaceutical Research & Development, which conducted the clinical-development program. If approved by the FDA, Risperdal Consta will be marketed in the United States by Janssen Pharmaceutica Products, LP and manufactured by Alkermes. Risperdal is currently the most widely prescribed antipsychotic medication in the United States and would be the first "atypical" antipsychotic to be available in a long-acting formulation.
Risperdal Consta is a long-acting injectable formulation of Risperdal that uses Alkermes' proprietary, injectable sustained-release drug delivery technology, Medisorb(R). The technology is based on the encapsulation of drugs into small polymeric microspheres that degrade slowly and release the medication at a controlled rate following subcutaneous or intramuscular injection. Alkermes is developing Medisorb product candidates in collaboration with pharmaceutical and biotechnology companies and on its own.
Alkermes is a leader in the development of products based on sophisticated drug delivery technologies. We have several areas of focus including: (i) controlled, sustained-release of injectable drugs lasting several days to several weeks using our ProLease(R) and Medisorb technologies; and (ii) the development of pharmaceutical products based on our proprietary AIR(TM) pulmonary technology. In addition to our Cambridge, Massachusetts headquarters, research and manufacturing facilities, Alkermes operates research and manufacturing facilities in Ohio and a medical affairs office in Cambridge, England.
Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Although Alkermes believes that such statements are based on reasonable assumptions within the bounds of our knowledge of our business and operations, there can be no assurance that: (i) long-acting Risperdal will be approved by regulatory authorities in the United States or abroad on a timely basis, if at all; (ii) if approved, this formulation of Risperdal will be commercialized successfully; or (iii) anticipated growth of sales will be achieved.
Alkermes' business is subject to significant risks and there can be no assurance that actual results of its development activities and results of operations will not differ materially from its expectations. For information with respect to other factors that could cause actual results to differ from expectations, reference is made to the reports filed by Alkermes with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended.
CONTACT: Rebecca Peterson
Director, Investor Relations
Alkermes, Inc.
(617) 583-6378