Ambrilia Biopharma Inc.

Ambrilia Biopharma Inc.

August 01, 2006 08:03 ET

Ambrilia Announces Receipt of Milestone Payment from U.S. Licensing Partner for Late-Stage Oncology Specialty Generic, Octreotide

Important manufacturing Milestone Met

MONTREAL, QUEBEC--(CCNMatthews - Aug. 1, 2006) - Ambrilia Biopharma Inc.(TSX:AMB), a biopharmaceutical company developing innovative therapeutics in the fields of cancer and infectious diseases, announced today that it has received a milestone payment resulting from an agreement with its licensing partner in the United States for its late-stage oncology specialty generic, Octreotide, for the treatment of acromegaly and certain rare digestive system cancers. Ambrilia has a Product Development and License Agreement for the U.S. with an undisclosed major pharmaceutical company, which includes upfront payments, milestones and purchase of the final product, a sustained release formulation of Octreotide, via a product sale and marketing arrangement between the two companies. Ambrilia will manufacture the product at its cGMP (Good Manufacturing Practices) facility in Montreal, Canada, and supply the finished product to the partner for sale in the U.S.

The milestone payment from the partner became due upon the manufacture of sterile batches of Octreotide meeting stability requirements and cGMP compliance. To date Ambrilia has received US $2.2 million in licensing fees and milestone payments from its partner. Further milestone payments are expected over the course of the next 20 - 24 months, as part of this multimillion dollar agreement between the two companies. Ambrilia will sell the finished product to its partner at an agreed schedule and transfer price inclusive of royalties. Ambrilia is currently conducting pivotal pharmacokinetic studies to evaluate the pharmacokinetic properties (bodily absorption, distribution, metabolism and excretion) of Octreotide in comparison to Novartis's Sandostatin® LAR (long-acting release) in human subjects. Sandostatin® sales in 2005 reached approximately US $900 million.

"Octreotide's development program is continuing to advance as planned, as signified by the milestone payment just received from our U.S. licensing partner," said Hans J. Mader, President and Chief Executive Officer of Ambrilia. "Octreotide represents an important marketing opportunity for us and our partners since the need for a sustained release formulation of the drug, for treatment of acromegaly and certain rare digestive tumors, keeps growing. Furthermore, we are delighted with the relationship with our partner and its sales and marketing capabilities in the U.S. Finally, we anticipate being in a position to announce updates on our other licensing agreements outside the U.S. shortly," he added.


Acromegaly is a chronic disease resulting from the growth of an adenomatous tumor (epithelial tumor having a glandular origin and structure) on the pituitary gland, causing an excessive production of Insulin-like Growth Factor 1 (IGF-1). The latter is a hormone secreted from the liver and other tissues in response to Human Growth Hormone and accounts for the most part of the growth promoting effects of HGH. Excessive production of IGF-1 translates into uncontrolled growth of various appendages. Control of the IGF-1 levels by Sandostatin® LAR results in normalizing such excessive growth. Octreotide is Ambrilia's proprietary prolonged-release formulation of Novartis's Sandostatin® LAR.


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 novel anti-cancer therapy (TVT-Dox), two oncology specialty generics (Octreotide, Goserelin), the first of which is late-stage and value-added, and promising anti-HIV treatments (PPL-100, SPC3). 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:

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 Information