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In a message dated 10/15/2003 3:16:30 PM Eastern Daylight Time, yankee11@... writes:

check this out..........

CTLA4

CTLA4 and Autoimmune DiseaseIn autoimmune disease the immune system mistakenly attacks self, targeting the tissues and organs of a person's own body. Autoimmune diseases such as rheumatoid arthritis, multiple sclerosis, lupus, psoriasis and Crohn's disease afflict millions of people in the United States and often require lifelong care and monitoring. Current treatment options are limited to broadly acting immunosuppressive drugs that may suppress the autoimmune attack but may also suppress the ability of the immune system to fight infection resulting in potentially serious side effects.

CTLA4 is a key regulator of the activity of the immune system. It "turns off" the immune response after it has successfully cleared a bacterial or viral infection. Animal and human studies have suggested that a soluble form of CTLA4 (CTLA4-Ig) may be useful in treating autoimmune diseases and organ transplant rejection. In some models, the specific immunosuppressive effects of CTLA4-Ig have been shown to persist after discontinuation of the drug, thus CTLA4-Ig may provide a unique and potentially safer treatment for autoimmune disease than current therapies. Our initial clinical trials of CTLA4-Ig in normal volunteers and in patients with Idiopathic Thrombocytopenic Purpura (ITP) have shown that CTLA4-Ig is well tolerated.

CTLA4-Ig for Rheumatoid ArthritisBristol-Myers Squibb (Bristol) is also developing a form of CTLA4-Ig that 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 (ACR) core set of outcome measures 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.

CTLA4-Ig Inventorship TrialRepligen is the exclusive licensee of all CTLA4-Ig patent rights owned by the University of Michigan (the University). 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 , 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. Repligen's failure to obtain ownership rights to the Bristol patents may restrict Repligen's ability to commercialize CTLA4-Ig.

The United States District Court for the Eastern District of Michigan has issued a ruling in the lawsuit that Repligen and The University of Michigan are prosecuting against Bristol-Myers Squibb for correction of inventorship of certain CTLA4 patents issued to Bristol. The Court ruled that there was insufficient evidence for the University scientist to be named as an inventor on these patents.

Repligen has filed a Notice of Appeal with the United States Court of Appeals for the Federal Circuit to the District Court ruling. 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.

CTLA4 Intellectual PropertyRepligen has received a Notice of Allowance on a patent that covers the use of CTLA4-Ig for the treatment of rheumatoid arthritis. The patent, which will remain in effect 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 ative Research and Development Agreement with the United States Navy. This allowed patent is independent of the patents on CTLA4-Ig, which are the subject of a lawsuit that Repligen and the University are prosecuting against Bristol-Myers Squibb Corporation.

Repligen also owns the rights to an issued US patent entitled "CLTA4-Cgamma4 Fusion Proteins", which covers the specific composition of the Company's CTLA4-Ig product form, CTLA4-Cgamma4. This form of CTLA4-Ig is a genetically engineered fusion protein that is comprised of natural CTLA4 fused to a portion of an immunoglobulin (Ig) to make a soluble form of CTLA4. The molecule covered by the patent, which will remain in force until 2016, has additionally been engineered to eliminate those portions of the Ig molecule that have the potential to induce certain undesirable natural biological mechanisms, including cell lysis or cellular toxicity which may cause side effects in a patient.

This site 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 on this site do not constitute guarantees of future performance. Investors are cautioned that statements on this site 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 on this site or with respect to the announcements described herein.

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ÂŽ© Copyright 2000-2002 RepliGen Corporation. All rights reserved.

check this out..........

CTLA4

CTLA4 and Autoimmune DiseaseIn autoimmune disease the immune system mistakenly attacks self, targeting the tissues and organs of a person's own body. Autoimmune diseases such as rheumatoid arthritis, multiple sclerosis, lupus, psoriasis and Crohn's disease afflict millions of people in the United States and often require lifelong care and monitoring. Current treatment options are limited to broadly acting immunosuppressive drugs that may suppress the autoimmune attack but may also suppress the ability of the immune system to fight infection resulting in potentially serious side effects.

CTLA4 is a key regulator of the activity of the immune system. It "turns off" the immune response after it has successfully cleared a bacterial or viral infection. Animal and human studies have suggested that a soluble form of CTLA4 (CTLA4-Ig) may be useful in treating autoimmune diseases and organ transplant rejection. In some models, the specific immunosuppressive effects of CTLA4-Ig have been shown to persist after discontinuation of the drug, thus CTLA4-Ig may provide a unique and potentially safer treatment for autoimmune disease than current therapies. Our initial clinical trials of CTLA4-Ig in normal volunteers and in patients with Idiopathic Thrombocytopenic Purpura (ITP) have shown that CTLA4-Ig is well tolerated.

CTLA4-Ig for Rheumatoid ArthritisBristol-Myers Squibb (Bristol) is also developing a form of CTLA4-Ig that 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 (ACR) core set of outcome measures 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.

CTLA4-Ig Inventorship TrialRepligen is the exclusive licensee of all CTLA4-Ig patent rights owned by the University of Michigan (the University). 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 , 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. Repligen's failure to obtain ownership rights to the Bristol patents may restrict Repligen's ability to commercialize CTLA4-Ig.

The United States District Court for the Eastern District of Michigan has issued a ruling in the lawsuit that Repligen and The University of Michigan are prosecuting against Bristol-Myers Squibb for correction of inventorship of certain CTLA4 patents issued to Bristol. The Court ruled that there was insufficient evidence for the University scientist to be named as an inventor on these patents.

Repligen has filed a Notice of Appeal with the United States Court of Appeals for the Federal Circuit to the District Court ruling. 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.

CTLA4 Intellectual PropertyRepligen has received a Notice of Allowance on a patent that covers the use of CTLA4-Ig for the treatment of rheumatoid arthritis. The patent, which will remain in effect 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 ative Research and Development Agreement with the United States Navy. This allowed patent is independent of the patents on CTLA4-Ig, which are the subject of a lawsuit that Repligen and the University are prosecuting against Bristol-Myers Squibb Corporation.

Repligen also owns the rights to an issued US patent entitled "CLTA4-Cgamma4 Fusion Proteins", which covers the specific composition of the Company's CTLA4-Ig product form, CTLA4-Cgamma4. This form of CTLA4-Ig is a genetically engineered fusion protein that is comprised of natural CTLA4 fused to a portion of an immunoglobulin (Ig) to make a soluble form of CTLA4. The molecule covered by the patent, which will remain in force until 2016, has additionally been engineered to eliminate those portions of the Ig molecule that have the potential to induce certain undesirable natural biological mechanisms, including cell lysis or cellular toxicity which may cause side effects in a patient.

This site 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 on this site do not constitute guarantees of future performance. Investors are cautioned that statements on this site 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 on this site or with respect to the announcements described herein.

Home Products Research Corporate News Contact Us Employment

ÂŽ© Copyright 2000-2002 RepliGen Corporation. All rights reserved.

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