Ambrilia Biopharma Inc.

Ambrilia Biopharma Inc.

December 05, 2006 08:02 ET

Ambrilia Announces Further Distribution Partnerships for Europe for its Lead Oncology Product, Octreotide

Octreotide's licensees are Archimedes Pharma for the U.K., Gerolymatos for Greece, Turkey and other export countries, Pharmis for Portugal and Brazil and Kwidza Pharma for Austria

MONTREAL, QUEBEC--(CCNMatthews - Dec. 5, 2006) - Ambrilia Biopharma Inc. (TSX:AMB), a biopharmaceutical company developing innovative therapeutics in the fields of oncology and infectious diseases, announced today further distribution partnerships for the sales and marketing in Europe of its improved sustained-release formulation of Octreotide for the treatment of acromegaly. No financial terms are released.

Archimedes Pharma Ltd., a European specialty pharmaceutical company with a growing specialist-focused commercial presence, will distribute Octreotide in the United Kingdom. The pharmaceutical division of the international Health and Beauty Company, Gerolymatos Group of Companies, is Octreotide's licensee for Greece, Turkey and other export countries. Portugal's leading specialty marketing and distribution company, Pharmis, is Octreotide's licensee for both the Portuguese and Brazilian markets and finally, one of Austria's leading privately owned pharmaceutical manufacturing company, Kwidza Pharma GmbH, has the distribution rights for Octreotide in Austria.

These agreements comprise 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 partners for sale in Europe. Discussions are currently ongoing to conclude distribution agreements for the rest of Western and Eastern Europe. On November 15th, Ambrilia announced that TEVA is Octreotide's licensee for France, Germany, Benelux, Spain and Scandinavia.

"We are delighted to count on such strong European partners for the distribution of our improved patented formulation of Octreotide," said Hans J. Mader, President and Chief Executive Officer of Ambrilia. "Their commercialization strengths in each of their respective markets will be without a doubt instrumental in Octreotide's European commercial success," he concluded.

As previously announced, Ambrilia is currently setting up small clinical studies of its formulation in acromegalics, as scheduled in the development plan of the product. Completion of these studies is expected during the second half of 2007. Ambrilia expects to file for European approval shortly thereafter.


Ambrilia's lead oncology product is a prolonged release formulation of Octreotide. The original product is commercialized as Sandostatin®LAR T(octreotide acetate for injectable suspension, a registered trademark of Novartis Pharmaceuticals Corporation)T 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.


Ambrilia Biopharma Inc. (TSX:AMB) 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, promising anti-HIV treatments (PPL-100, HIV Integrase Inhibitor Program), other anti-virals and immunomodulators. 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:

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.

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