Ambrilia Biopharma Inc.

Ambrilia Biopharma Inc.

October 26, 2006 08:00 ET

Ambrilia Announces Positive Results of a Pivotal Human Pharmacokinetic Study of its New Prolonged Release Formulation of Octreotide

MONTREAL, QUEBEC--(CCNMatthews - Oct. 26, 2006) - Ambrilia Biopharma Inc. (TSX:AMB), a biopharmaceutical company developing innovative therapeutics in the fields of oncology and infectious diseases, announced today positive results of a pivotal pharmacokinetic (PK) study of its lead specialty generic, Octreotide, for the treatment of acromegaly.

The data generated in a controlled study in healthy volunteers performed in a FDA (U.S. Food and Drug Administration) approved clinical centre show that Ambrilia's formulation has a bioavailability which is superior to that of Sandostatin LAR® at the same dose. Sandostatin LAR®'s data sheet recommends injections of the product every four weeks. Ambrilia's product bioavailability will allow for longer time intervals between injections, which could improve patient compliance, and reduce the discomfort and costs associated with injections. In addition, the study supports the better stability and ease of use of Ambrilia's patented formulation, as compared to Sandostatin LAR®.

"We are very happy to report these positive PK results for our lead specialty generic Octreotide as this represents a significant event in its development program," said Hans J. Mader, President and Chief Executive Officer of Ambrilia. "This allows us to advance Octreotide's program as planned with the initiation of the clinical studies in acromegaly patients before year end," he concluded.

This PK study will be part of the international file designed to obtain registration of Ambrilia's Octreotide worldwide. The Company 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 sometime around mid 2007. Filing for approval in Europe and then North America by Ambrilia's licensees will follow shortly thereafter.


Ambrilia's lead specialty generic 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.


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, 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:

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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