Ambrilia Biopharma Inc. Announces European Licensing Partnership With TEVA For Its Lead Oncology Product, Octreotide
TEVA Europe, a subsidiary of the global generic pharmaceutical leader Teva Pharmaceutical Industries Ltd., is Octreotide's licensee for France, Germany, Benelux, Spain and Scandinavia. The agreement comprises of development, regulatory and sales milestones payments, product supply at fixed price as well as royalties on sales and agreed upon minimal annual sales. Ambrilia will manufacture the product at its cGMP (Good Manufacturing Practices) facility in Montreal, Canada, and supply the finished product to its partner for sale in Europe.
"We are very pleased to have TEVA as our partner for the marketing of our improved formulation of Octreotide in those important jurisdictions in Europe. We believe this partnership with the world's largest generic pharmaceutical company bodes well for the future commercial success of Octreotide in Europe," said Hans J. Mader, President and Chief Executive Officer of Ambrilia.
As previously announced, Ambrilia is currently setting up limited clinical studies of its formulation in acromegalics, as scheduled in the development plan of the product. Completion of these studies is expected in the second half of 2007. Ambrilia expects to file for European approval shortly thereafter.
ABOUT OCTREOTIDE, SANDOSTATIN®LAR AND ACROMEGALY
Ambrilia's lead oncology product is a prolonged release formulation of Octreotide. The original product is commercialized as Sandostatin®LAR (octreotide acetate for injectable suspension, a registered trademark of Novartis Pharmaceuticals Corporation) and is owned by Novartis. Octreotide is used for the treatment of a rare disease called acromegaly caused by a tumor of the pituitary gland, and for certain rare digestive tumors.
Acromegaly is a rare and serious chronic condition related to a permanent hypersecretion of growth hormone (GH) by the pituitary gland, generally of tumoral origin. This causes an excessive production of Insulin-like Growth Factor 1 (IGF-1), a hormone secreted from the liver and other tissues. Excessive production of IGF-1 and GH translates into uncontrolled growth of various organs, and debilitating symptoms. Control of the GH and IGF-1 levels by Sandostatin®LAR results in normalizing such excessive growth and symptoms. Medical treatment has an important role to play in the management of patients with acromegaly. It is a life long treatment, with few, mild side effects.
ABOUT AMBRILIA BIOPHARMA
Ambrilia Biopharma Inc. (TSX:AMB.TO - News) is a biopharmaceutical company developing innovative and proprietary early to mid-stage therapeutics in the fields of oncology and infectious diseases. Ambrilia's product portfolio includes an anti-cancer therapeutic peptide (PCK3145), a Tumor Vasculature Targeting (TVT) technology platform, an improved, prolonged release formulation of Octreotide, a new formulation of Goserelin and promising anti-HIV treatments (PPL-100, Anti-HIV Peptides, Integrase Inhibitor Program). Exclusive worldwide rights to PPL-100 and its related compounds have been granted to Merck & Co., Inc. in return for milestone payments that could total up to $US 232 million. Ambrilia's head office, research and development and manufacturing facilities are located in Montreal with a regional office in France. For more information, please visit the Company's web site: www.ambrilia.com
Ambrilia's forward-looking statements
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the Company's filings. Such statements are also based on various assumptions, including the successful and timely completion of clinical studies on Ambrilia's products demonstrating efficacy and safety for human use, their successful commercialization within the forecasted timelines and the attainment of the forecasted milestone payments and other revenues. While Ambrilia anticipates that subsequent events and developments may cause Ambrilia's views to change, Ambrilia specifically disclaims any obligation to update these forward-looking statements.
Contact: Contacts: Ambrilia Biopharma Inc. Julie M. Thibodeau Director, Communications 514-751-2003 ext 235 jthibodeau@ambrilia.com; ir@ambrilia.com http://www.ambrilia.com
Source: Ambrilia Biopharma Inc.