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Braintree Laboratories, Inc. In-Licenses Global Rights To Oncology Drug Platform

3/9/2006 11:12:30 AM

BRAINTREE, Mass., March 9 /PRNewswire/ -- Braintree Laboratories, Inc. today announced that it has in-licensed the global rights to develop and commercialize BLI-600, a patent protected compound that has shown significant promise as a chemoprevention agent, from INRA Transfert (IT), a subsidiary of National Institute for Agricultural Research (INRA), Paris, France. Under the terms of the agreement, Braintree Laboratories is responsible for the clinical development and worldwide registration of the compound for chemoprevention and/or treatment of colorectal cancer.

The Foods & Cancer team of the joint research group ENVT-INRA Xenobiotics managed by Pr Denis Corpet, leader in the field of food and colon carcinogenesis, has tested BLI-600 in several in-vivo animal models and has demonstrated a strong signal for both eliminating and preventing adenomas and their precursor lesions. Braintree intends to pursue the development of this compound for the prevention and/or treatment of colonic adenomas based on this licensing partnership.

Harry Keegan, III, CEO, said of today's news, "We are all very pleased with the addition of this development program to our R&D pipeline. We are hopeful that this compound truly has the potential to improve the way the medical community treats those at risk for colon cancer."

Braintree intends to file its IND for BLI-600 in the first quarter of 2006. Dr. Mark Cleveland, Vice President of New Product Development, described this technology as, "A development platform that may also allow for unique treatments beyond the scope of adenomatous polyps. We are excited about the opportunity to evaluate this compound in the field of colorectal cancer and then any follow-on indications as they arise." Clinical trials of the compound are slated to begin in the first quarter of 2006.

About Braintree Laboratories

Braintree Laboratories, Inc. is a privately held pharmaceutical company that was founded in 1982 in Braintree, Massachusetts. Braintree has five product lines in the US market in three therapeutic categories -- gastrointestinal lavages, prescription laxatives and GERD. Braintree Laboratories pioneered the first gastrointestinal lavage in 1984 with the introduction of GoLYTELY(R) (PEG-3350 and electrolytes for oral solution), which was soon adopted as a standard prepping procedure prior to colonoscopy. In 1990 Braintree received approval for PhosLo(R)(1) (Calcium Acetate) which was a dietary phosphate binder for end stage renal disease patients. Braintree then improved on GoLYTELY with the approval of NuLYTELY(R) (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) which is a modified formulation of GoLYTELY that provides improved taste and has 52% less sodium than GoLYTELY. NuLYTELY was introduced in 1991. In 1999, Braintree received approval for MiraLAX(R) (PEG-3350, NF powder for solution), the first new prescription laxative in 23 years. Additionally, in 2004, Braintree introduced the first low volume GI Lavage, HalfLytely(R) and Bisacodyl Tablets Bowel Preparation Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablets). Braintree's most recent acquisition is Axid(R) (nizatidine) Oral Solution (from Reliant Pharmaceuticals). Axid(R) Oral Solution is a bubblegum-flavored, alcohol-free formulation of nizatidine indicated for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to gastroesophageal reflux disease (GERD). Braintree began promotional activities for Axid(R) Oral Solution in September of 2005.

(1) PhosLo is a registered trademark of Nabi Biopharmaceuticals, Boca Raton, FL. About INRA

Founded in 1946, the National Institute for Agricultural Research (INRA) is a mission-oriented public research institution under the joint authority of the Ministry of Higher Education and Research and the Ministry of Agriculture and Fisheries. The research conducted at INRA concerns agriculture, food, nutrition and food safety, environment and land management, with particular emphasis on sustainable development, life sciences, material sciences and social sciences, open to Europe and the world.

INRA has a clearly identified mission-oriented vocation to serve society.

Its principal goals: producing and disseminating scientific knowledge, developing innovations and know-how for the benefit of society, through its expertise, informing decision-making by public and private sector players, promoting scientific and technical culture and participating in the science/society debate and training in and through research.

INRA has an active partnership policy with the international scientific community in numerous countries in Europe, America, Asia and Africa

Key figures: 8,850 staff members, 14 research departments, 21 regional centers, strong scientific partnerships and a budget of euro 614.5 million.

About ENVT

ENVT (Ecole Nationale Veterinaire de Toulouse, France), the National Veterinary College of Toulouse is a teaching and research establishment founded in 1793. It is also a working veterinary hospital which is open to the public. More than 100 full-time professors and research scientists, and 600 veterinary students work in the College. Most ENVT labs are devoted to infectious diseases and to animal physiology, but the INRA/ENVT joint research group Xenobiotics shelters the "Foods and Cancer" team. Led by Professor Denis E. Corpet, it discovered the effect of BLI-600 on experimental colon cancer in 1999.

INRA Transfert (IT)

INRA Transfert was created by INRA in 2001 as part of its effort to exploit research results and innovative technologies and develop them into concrete business opportunities. INRA Transfert is a fully-owned INRA subsidiary. INRA Transfert's team is involved in the commercial development of technological innovations and inventions coming from public research organizations. It is specialized in the fields of food industry, nutrition and food safety, environment, biotechnologies, animal health, production and genetic improvement of animal and vegetal species, and agricultural processes.

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Braintree Laboratories, Inc.

CONTACT: Donald R. Murphy, Account Supervisor, Fleishman-Hillard, NY,+1-212-453-2462, fax, +1-212-453-2072,, for BraintreeLaboratories, Inc.

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