geeeeze, stubborn..........
Repligen Files Appeal to District Court Decision in CTLA4-Ig Patent Suit
Tuesday October 7, 8:30 am ET
WALTHAM, Mass., Oct. 7 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN - News) announced today that it has filed a Notice of Appeal with the United States Court of Appeals for the Federal Circuit to the ruling of the United States District Court for the Eastern District of Michigan in the lawsuit that Repligen and The University of Michigan (the "University") are prosecuting against Bristol-Myers Squibb (NYSE: BMY - News) for correction of inventorship of certain CTLA4 patents issued to Bristol-Myers Squibb ("Bristol"). The District Court ruled last month that there was insufficient evidence for the University scientist to be named as an inventor on these patents. It is anticipated that both Repligen and Bristol will file written briefs to the United States Court of Appeals for the Federal Circuit which, may be followed by oral arguments in 2004. The Federal Circuit may decide to uphold the District Court's decision, overturn the District Court's decision or remand it back to the District Court for further consideration.
"We continue to believe that a scientist from the University of Michigan made significant inventive contributions in discovering the activity of CTLA4- Ig," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen. "We will continue to aggressively assert our position on the patents that are the subject of this lawsuit. Additionally, we will protect our independent patent position which claims the use of CTLA4-Ig for treatment of rheumatoid arthritis, multiple sclerosis and systemic lupus erythematosis which is separate from the patents in suit."
CTLA4-Ig Inventorship Trial
CTLA4 is a T-cell regulatory protein which is one of the immune system's natural "off switches" and may have potential use in organ transplantation and autoimmune diseases. Repligen is the exclusive licensee of all CTLA4-Ig patent rights owned by the University of Michigan. Repligen and the University believe that the University has a rightful claim to ownership of certain patents of Bristol-Myers Squibb which relate to compositions and uses of CTLA4, arising out of the inventive contributions by one of the University's scientists. Repligen and the University filed a complaint against Bristol in the United States District Court for the Eastern District of Michigan seeking a correction of inventorship. The suit asserts that Dr. Craig Thompson, the scientist from the University, made inventive contributions as part of a collaboration with Bristol scientists and is therefore a rightful inventor on patents issued to Bristol. The District Court ruled this September that there is not sufficient evidence to name Thompson as an inventor on the patents in suit. Repligen's failure to obtain ownership rights to the Bristol patents may restrict Repligen's ability to commercialize CTLA4-Ig. The patents in suit are independent from the allowed patent covering the use of CTLA4-Ig for the treatment of rheumatoid arthritis, multiple sclerosis and systemic lupus erythematosis.
Repligen's Use Patent for CTLA4-Ig
Repligen has received a Notice of Allowance from the United States Patent and Trademark Office for a patent covering the use of CTLA4-Ig for the treatment of rheumatoid arthritis. The patent, which will remain in force until 2020, also covers a method of treating multiple sclerosis, systemic lupus erythematosis and scleroderma with CTLA4-Ig and the use of CTLA4-Ig in combination with other immunosuppressants. Repligen owns the exclusive rights to this patent through a license agreement with The University of Michigan and through a Cooperative Research and Development Agreement with the United States Navy. This allowed patent is independent from the patents on CTLA4-Ig which are the subject of the lawsuit that Repligen and the University are prosecuting against Bristol-Myers Squibb. Repligen also owns an issued United States patent which covers the composition of the CTLA4-Ig product form that it is developing.
About CTLA4-Ig for Rheumatoid Arthritis
Bristol-Myers Squibb is also developing a form of CTLA4-Ig which is currently in Phase 3 clinical trials for treatment of rheumatoid arthritis. Reports from Phase 2 clinical studies on this product candidate presented at the American College of Rheumatology meeting in December 2002 indicate that CTLA4-Ig has activity in rheumatoid arthritis patients with inadequate response to therapy with either etanercept (Enbrel®) or methotrexate. The studies evaluated the addition of CTLA4-Ig to Enbrel® or to methotrexate in patients with active rheumatoid arthritis despite treatment with either therapy alone. CTLA4-Ig was well tolerated and resulted in significant, dose dependent improvements using the American College of Rheumatology core set of outcome measures (ACR) of joint pain, tenderness and disease activity. These results suggest that CTLA4-Ig may have a unique activity profile in rheumatoid arthritis. Bristol is also conducting 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 later this year.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company committed to being the leader in the development of new drugs for pediatric developmental disorders including autism and immune and metabolic disorders. Repligen has a Specialty Pharmaceuticals business comprised of rProtein A(TM) and SecreFlo(TM), the profits from which will be used to support the development of our proprietary products. rProtein A(TM) is a consumable reagent used by the pharmaceutical industry to produce a class of drugs called monoclonal antibodies and SecreFlo(TM), secretin for injection, is marketed to gastroenterologists for pancreatic assessment and for use during a gastrointestinal procedure called ERCP. Repligen's corporate headquarters are located at 41 Seyon Street, Building #1, Suite 100, Waltham, MA 02453. Additional information may be requested from www.repligen.com.
This release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934. 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 and product development and manufacturing plans and performance such as the anticipated growth in 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 market acceptance of our products, our ability to compete with larger, better financed pharmaceutical and biotechnology companies, new approaches to the treatment of our targeted diseases, our expectation of incurring continued losses, our uncertainty of product revenues and profits, our ability to generate future revenues, our ability to raise additional capital to continue our drug development programs, the success of our clinical trials, 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 litigation regarding our intellectual property rights, our limited sales and manufacturing capabilities, our dependence on third-party manufacturers and value added resellers, our ability to hire and retain skilled personnel, our volatile stock price, 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.
CONTACT:
Walter C. Herlihy, Ph.D.
President and Chief Executive Officer
(781) 250-0111, ext. 2000
David A. Walsey
The Ruth Group
(646) 536-7029 |
