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Ambrilia Biopharma Inc. today announced that it has initiated the Phase I/II clinical development program of its proprietary, novel 3-month formulation of goserelin, in hormone-sensitive prostate cancer patients
MONTREAL, QUEBEC, CANADA | July 21, 2008 | Ambrilia Biopharma Inc. (TSX:AMB) today announced that it has initiated the Phase I/II clinical development program of its proprietary, novel 3-month formulation of goserelin, in hormone-sensitive prostate cancer patients.
"We announced last month that we had met a significant objective by achieving a final reproducible formulation of goserelin, and are now moving forward with the clinical development of this potentially first-to-market generic of Zoladex(R) 10.8mg, one of the top LHRH analogues in Europe", said Philippe Calais, President and CEO. "This next step should greatly enhance the valuation of our goserelin formulation. The strategic goal for this product remains to find the best acquirer and conclude an agreement by the end of 2008. The Company is advancing well in this divestment process".
Ambrilia's strategy is to capitalize on its broad product portfolio and original expertise in virology. During the course of 2008, execution of the strategy aims to monetize the non-virology assets through third parties agreements, in turn strengthening the Company's financial position to continue building its novel pipeline of antivirals.
About the novel formulation of goserelin
Ambrilia has developed a novel formulation of the 3-month release version of Zoladex(R) (goserelin) 10.8mg, 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 is an injectable depot formulation. The original product worldwide sales(1) reached $US1.1B in 2007 (+10% year-over-year growth), with the 3-month depot formulation capturing approximately 70% of this market.
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.
Clinical development and partnership strategy
Ambrilia has initiated its first Phase I multicenter study designed to assess the hormonal efficacy, pharmacokinetic (PK) and safety of its formulation of goserelin in prostate cancer patients.
The goserelin formulation is manufactured by Ambrilia at its GMP (Good Manufacturing Practice) facilities in Montreal, and as previously reported, the Company aims at divesting this product by the end of 2008.
Zoladex(R) is a registered trademark of AstraZeneca PLC
(1) AstraZeneca PLC Annual Report 2007
ABOUT AMBRILIA BIOPHARMA
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, HCV entry and polymerase 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.
SOURCE: Ambrilia Biopharma Inc. |
