Ambrilia Biopharma Inc.

Ambrilia Biopharma Inc.

September 16, 2008 08:00 ET

Ambrilia Expands its Goserelin Product Offering With a Novel One-Month Formulation

MONTREAL, QUEBEC--(Marketwire - Sept. 16, 2008) - Ambrilia Biopharma Inc. (TSX:AMB) today announced that it has succeeded in manufacturing a final 1-month formulation of goserelin intended for the treatment of prostate cancer and several gynecological indications. The Company has already developed a proprietary, novel 3-month formulation of goserelin for which a Phase I/II clinical program in prostate cancer patients was initiated in July 2008.

"With the addition of a 1-month goserelin formulation we now offer to interested acquirers a complete generic Zoladex® package which includes a potentially first-to-market 3-month generic version. This further enhances the value of our goserelin product offering focused on European market and maximizes potential deal terms," said Philippe Calais, President and CEO. He concluded, "All efforts are being made in order to conclude an agreement by the end of 2008."

The goserelin formulations are manufactured by Ambrilia at its GMP (Good Manufacturing Practice) facilities in Montreal.

About the novel formulations of goserelin

Ambrilia has developed novel formulations of the 3.8mg (1-month depot) and 10.8mg (3-month depot) versions of Zoladex® (goserelin), a Luteinizing Hormone-Releasing Hormone (LHRH) analogue indicated for hormone-sensitive prostate cancer and several gynecological indications such as fibro-myomas and endometriosis. Ambrilia's goserelin formulations are also injectable depot formulations. The original product worldwide sales(1) reached $US1.1B in 2007 (+10% year-over-year growth), mostly in Europe and Japan, with the 3-month depot formulation accounting for the vast majority of total sales generated.

Prostate cancer is one of the most common cancers worldwide and the leading cancer in men in Europe and North America. Hormonal therapy with LHRH analogues is one of the standard treatments for prostate cancer, blocking the hormones that can cause the cancer to grow. Similarly, in gynecological indications such as endometriosis or fibro-myomas, LHRH analogues can suppress the hormones responsible for abnormal tissue growth, prior to surgical removal, or just before natural menopause.

Ongoing clinical development

Ambrilia has initiated in July 2008 its first Phase I/II multicenter study designed to assess the hormonal efficacy, pharmacokinetic (PK) and safety of its 3-month depot formulation of goserelin in hormone-sensitive prostate cancer patients.


This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. There is a risk that expectations and forward looking statements will not prove to be accurate. Readers are cautioned not to place undue reliance on these forward-looking statements as they involve risks and uncertainties, which could make actual results 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. We refer you to the Risk Factors section of the Company's annual information form which contains a more exhaustive analysis of the risks and uncertainties that are generally connected to the business of the Company. 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, unless obligated to do so by applicable securities laws.


Ambrilia Biopharma Inc. (TSX:AMB) is a biotechnology company focused on the discovery and development of novel treatments for viral diseases and cancer. The Company's strategy aims to capitalize on its broad portfolio and original expertise in virology. Ambrilia's product portfolio is comprised of oncology and antiviral assets, including two new formulations of existing peptides for cancer treatment, a therapeutic peptide for prostate cancer, a targeted delivery technology for cancer, an HIV protease inhibitor program (exclusive worldwide rights granted to Merck & Co., Inc.) as well as HIV integrase and entry inhibitors, Hepatitis C inhibitors and anti-Influenza A compounds. 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:

Zoladex® is a registered trademark of AstraZeneca PLC

(1) AstraZeneca PLC Annual Report 2007

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