More MS news articles for April 2004

Repligen Product Candidate Highlighted at American Academy of Neurology

Initial Data Presented on CTLA4-Ig in Multiple Sclerosis

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109&STORY=/www/story/04-29-2004/0002163213&EDATE=

April 29, 2004
Source: Repligen Corporation
PRNewswire

Repligen Corporation announced today the presentation of initial data from a Phase 1 clinical study at the annual meeting of the American Academy of Neurology which supports the safety and novel mechanism of action of CTLA4-Ig for multiple sclerosis. The data was presented by the Principal Investigator, Dr Samia Khoury, M.D., and was conducted at Brigham and Women's Hospital, a teaching affiliate of Harvard Medical School. Dr. Khoury concluded in her presentation that a single dose of CTLA4-Ig at either 2mg/kg or 10mg/kg in patients with relapsing-remitting multiple sclerosis appeared to be safe and provides early evidence of a biologic effect of administration of the drug.

"The initial data from this clinical trial extends earlier results in a pre-clinical model of multiple sclerosis and supports a biological mechanism of action for CTLA4-Ig in humans," stated Walter C. Herlihy, Ph.D., President and Chief Executive Officer of Repligen Corporation. "We look forward to further analysis of the clinical data following completion of the study."

The objective of the ongoing Phase 1 clinical trial of CTLA4-Ig in patients with relapsing-remitting multiple sclerosis is to evaluate the general and disease specific safety of a single infusion of CTLA4-Ig and to observe the effect of CTLA4-Ig on immune function of patients with multiple sclerosis. This is an open label, dose escalation study in which patients receive a single infusion of CTLA4-Ig at one of 2mg/kg, 10mg/kg, 20mg/kg or 35mg/kg followed by clinical evaluation for 3 months. We anticipate that this study, which is supported in part through funding from the National Institutes of Health, will be completed by the end of the year.

About CTLA4-Ig for Autoimmune Disease

CTLA4 is a T-cell regulatory protein which is one of the immune system's natural "off switches." Repligen is developing a soluble form of CTLA4 (CTLA- Ig) which has potential immunosuppressive activity for use in autoimmune diseases such as rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis and organ transplantation. Previously, Repligen and its academic collaborators conducted experiments in a rodent model of multiple sclerosis called EAE, which established that CTLA4-Ig has the potential to block unwanted immune responses without compromising the immune system's ability to fight off infections.

Repligen owns the exclusive rights to U.S. patent 6,685,941 entitled "Methods of Treating Autoimmune Disease via CTLA4-Ig," issued to the University of Michigan (the University). The patent, which will remain in force until 2021, covers a method of treating rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis and scleroderma with CTLA4-Ig and the use of CTLA4-Ig in combination with other immunosuppressants. This issued patent is independent from the CTLA4-Ig patents that are the subject of a lawsuit that Repligen and the University are prosecuting against Bristol-Myers Squibb Corporation (NYSE: BMY).

Bristol-Myers Squibb (Bristol) is also developing a form of CTLA4-Ig, which is currently in Phase 3 clinical trials for treatment of rheumatoid arthritis and a Phase 2 clinical trial of CTLA4-Ig in multiple sclerosis and has announced plans to initiate a Phase 2 clinical trial in systemic lupus erythematosis. Repligen and the University believe that the University has a rightful claim to ownership of certain patents of Bristol which relate to compositions and uses of CTLA4. In September 2003, the District Court found in favor of Bristol. Repligen and the University have appealed the ruling of the District Court with the United States Court of Appeals for the Federal Circuit. Repligen's failure to obtain ownership rights to the Bristol patents may restrict Repligen's ability to commercialize CTLA4-Ig.

About Repligen Corporation

Repligen Corporation is a biopharmaceutical company committed to being the leader in the development of novel therapeutics for profound neuropsychiatric disorders and autoimmune disease with particular emphasis on applications for children. Repligen has a Specialty Pharmaceuticals business comprised of rProtein A(TM) and SecreFlo(TM), the profits from which will be used to partially support the development of our proprietary products. Repligen's corporate headquarters are located at 41 Seyon Street, Building #1, Suite 100, Waltham, MA 02453. Additional information may be requested from http://www.repligen.com.

This release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding current or future financial performance, management's strategy, plans and objectives for future operations, clinical trials and results, litigation strategy, product research, intellectual property, development and manufacturing plans and performance such as the anticipated growth in target markets, including, without limitation, the market for autoimmune disease treatment and the monoclonal antibody market and projected growth in product sales, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: the success of current and future collaborative relationships, the success of our clinical trials and our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights for our products, the risk of current and future litigation regarding our patent and other intellectual property rights, the risk of litigation with collaborative partners, our limited sales and marketing experience and capabilities, our limited manufacturing capabilities and our dependence on third-party manufacturers and value-added resellers, our ability to hire and retain skilled personnel, the market acceptance of our products, our ability to compete with larger, better financed pharmaceutical and biotechnology companies that may develop new approaches to the treatment of our targeted diseases, our history of losses and expectation of incurring continued losses, our ability to generate future revenues, our ability to raise additional capital to continue our drug development programs, our volatile stock price, the effects of our anti-takeover provisions, and other risks detailed in Repligen's filings with the Securities and Exchange Commission. Repligen assumes no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein.