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Press Release Source: Genaera Corporation
Genaera and Ludwig Institute Extends Alliance on Discovery and Development of Novel Pharmaceutical Targets and Therapeutics
Monday March 8, 8:02 am ET
PLYMOUTH MEETING, Pa., March 8 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR - News) and the Ludwig Institute for Cancer Research (LICR) today announced a two-year extension of a collaborative agreement on the joint discovery and development of novel genes and proteins as pharmaceutical targets and therapeutics, including further research related to interleukin-9 (IL-9).
"The goal of this collaboration is to provide new therapeutic products for asthma, cancer, and other diseases, based on our combined efforts in genomics and biological research," said Roy C. Levitt, MD, Genaera's President and Chief Executive Officer. "We are extremely pleased to further our alliance with the world class investigators at the Ludwig Institute who originally identified IL-9 and its receptor. Their expertise in the area of biological discovery and developing new therapeutics such as monoclonal antibodies, adds further depth to our product development programs."
Genaera has developed IL-9 and IL-9 receptor intellectual property and exclusively in-licensed certain other related intellectual property from LICR including the original patents to IL-9 and its receptor. Studies by Genaera scientists identified a role for IL-9 and its receptor in the pathogenesis of asthma and potentially other respiratory disorders including chronic obstructive pulmonary disease (COPD) and cystic fibrosis. Biopsies from asthmatic patients have shown an increase in expression of IL-9 as compared to healthy individuals. Published findings, highlighting the central role of IL-9 in asthma, demonstrate its contribution to certain clinical features including bronchial hyperresponsiveness, IgE, mucus overproduction and eosinophil up-regulation in animal models and in patients. Genaera believes that a neutralizing antibody to IL-9 provides a novel approach to prophylaxis or treatment for asthma, and provides an important alternative to the non-specific therapies currently in use.
In April 2001, Genaera entered into a Collaboration and License agreement with MedImmune, Inc. to co-develop an IL-9 related product for asthma. This alliance provided Genaera with a significant upfront payment, guaranteed research and development support through April 2003, future royalties, and up to $55 million in milestone payments. MedImmune will conduct all development, manufacturing, marketing and sales for any product.
According to the National Institute of Allergy and Infectious Diseases and the American Lung Association, there are over 65 million patients suffering from diseases that may be IL-9 mediated, including 17 million asthmatics, 35 million respiratory allergy sufferers, 13 million sufferers of chronic bronchitis, and 2.4 million patients afflicted with COPD, a disease which claims the lives of over 107,000 Americans annually. Currently, there is a significant unmet medical need for safe and effective therapies for the respiratory distress caused by many chronic respiratory disorders, including moderate to severe asthma. Many of these disorders currently are treated symptomatically with non-specific anti-inflammatory drugs, antibiotics, or bronchodilators for prophylaxis or rescue use.
The Ludwig Institute for Cancer Research is the largest international academic institute dedicated to understanding and controlling cancer. With ten Branches in seven countries, and numerous Affiliates and Clinical Trial Centers in many others, the scientific network that is LICR quite literally covers the globe. The uniqueness of LICR lies not only in its size and scale, but also in its philosophy and ability to drive its results from the laboratory into the clinic. LICR has developed an impressive portfolio of reagents, knowledge, expertise, and intellectual property, and has also assembled the personnel, facilities, and practices necessary to patent, clinically evaluate, license, and thus translate, the most promising aspects of its own laboratory research into cancer therapies. The Cytokine Group of the LICR, led by Jean-Christophe Renauld and Jacques van Snick, studies the biology of IL-9, which was discovered by the group in 1989.
Genaera Corporation is a biopharmaceutical company committed to developing medicines for serious diseases from genomics and natural products. Research and development efforts are focused on anti-angiogenesis and respiratory diseases. Genaera has three products in development addressing substantial unmet medical needs in major pharmaceutical markets. These include squalamine, an anti-angiogenesis treatment for cancer and eye disease; IL-9 antibody, a respiratory treatment based on the discovery of a genetic cause of asthma; and LOMUCIN(TM), a mucoregulator to treat the overproduction of mucus and secretions involved in many forms of chronic respiratory disease.
This announcement contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties, known and unknown. Forward-looking statements reflect management's current views and are based on certain expectations and assumptions. Such statements include, among others, statements regarding the IL-9 antibody program. You may identify some of these forward looking-statements by the use of words in the statements such as "anticipate," "develop," "continuing," and "progress," or other words of similar meaning. Genaera's actual results and performance could differ materially from those currently anticipated and expressed in these and other forward-looking statements as a result of a number of risk factors, including, but not limited to, Genaera's history of operating losses since inception and its need for additional funds to operate its business; the costs, delays and uncertainties inherent in scientific research, drug development, clinical trials and the regulatory approval process; the risk that clinical trials for Genaera's product candidates may not be successful; the risk that Genaera may not obtain regulatory approval for its products, whether due to adequacy of the development program, the conduct of the clinical trials, changing regulatory requirements, different methods of evaluating and interpreting data, regulatory interpretations of clinical risk and benefit, or otherwise; Genaera's reliance on its collaborators, including MedImmune, in connection with the development and commercialization of Genaera's product candidates; market acceptance of Genaera's products, if regulatory approval is achieved; competition; general financial, economic, regulatory and political conditions affecting the biotechnology industry; and the other risks and uncertainties discussed in this announcement and in Genaera's filings with the U.S. Securities and Exchange Commission, all of which are available from the Commission in its EDGAR database at www.sec.gov as well as other sources. You are encouraged to read these reports. Given the uncertainties affecting pharmaceutical companies in the development stage, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. Genaera does not intend (and it is not obligated) to publicly update, revise or correct these forward-looking statements or the risk factors that may relate thereto.
