MONTREAL, QUEBEC--(Marketwire - September 29, 2008) - Ambrilia Biopharma Inc. (TSX: AMB) today announced that it has elected to prioritize its divestment strategy of monetizing (selling or licensing) its clinical assets C2L and goserelin before year-end along with cost-cutting actions which result in a hold on its antiviral R&D activities, significant reduction in cash consumption and a 33% decrease in headcount. Previously announced 2008 milestones for the main development programs are unaffected.
“This was a tough decision but Ambrilia having less than 12-months of cash in a difficult market environment, immediate action was required in order to extend its cash further into 2009 while concentrating only on the monetization of the oncology assets,” said Philippe Calais, President and CEO. “At the moment, we believe the divestment strategy offers the best probability of success for the Company and more importantly, the potential to generate non-dilutive R&D funding and extend the runway to financing. When fully executed, Ambrilia will be in a position to better assess various strategic options for its antivirals portfolio.”
He concluded, “We are moving closer to reaching our strategic goal for octreotide C2L and goserelin which is to conclude an agreement with the best acquirer or licensing partner by the end of 2008.”
Ambrilia’s further commitment to its divestment strategy and cost-cutting actions impact primarily the antiviral R&D activities and the cash burn:
Monthly cash burn: target reduced from less than or equal to $1.4M to less than or equal to $1.0M
The cost-cutting actions include a 33% decrease in headcount, from 43 to 29 employees, in the basic research and preclinical team and administrative support functions. Some outsourcing and consultant expenses related to the hold on virology R&D activities were also cut. These measures are expected to decrease the Company’s monthly cash burn by approximately $0.4M.
ONCOLOGY
Divestments (selling or licensing): no change - C2L octreotide, goserelin, PCK3145, PSP: ongoing
C2L octreotide: no change - Advance clinical Phase III program: ongoing - 301 study (30mg): achieved - 302 study (30mg): achieved - 303 study (10 and 20mg): ongoing - Initiate regulatory filings (30mg): pending
Goserelin: no change - Complete goserelin 3-month formulation validation: achieved - Complete goserelin 1-month formulation: achieved - Initiate clinical Phase I/II program (3-month formulation): achieved
NGR-delivery technology: no change - Complete and validate siRNA proof-of-concept in vivo: achieved
VIROLOGY
Early-stage antiviral portfolio: hold on R&D activities - Generate at least one preclinical drug candidate by H1/2009: hold - Continue to make further progress in the HIV integrase program: hold - Initiate chemistry lead optimization for HIV and Hepatitis C inhibitors, and anti-Influenza A compounds during 2008: hold
PPL-100/MK-8122: no change On July 28, Ambrilia announced it was advised by Merck & Co. that HIV protease inhibitor PPL-100, also known as MK-8122, had been placed on a development hold pending outcome of additional basic science efforts to evaluate other precursors of the drug (prodrugs) and formulation options. Merck is also further exploring development of potential back-up compounds. Ambrilia’s partnership with Merck continues and the Company awaits their further progress on the program.
Ambrilia’s strategy is to capitalize on its broad product portfolio and original expertise in virology. The Company has elected to prioritize its divestment strategy of monetizing (selling or licensing) its oncology assets with cost-cutting actions which resulted in a hold on its antiviral R&D activities. The divestment strategy aims to generate non-dilutive R&D funding for Ambrilia, preserve its cash flow and extend the runway to financing.
AMBRILIA’S FORWARD-LOOKING STATEMENTS
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.
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, Hepatitis C virus 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: www.ambrilia.com
Contacts: Ambrilia Biopharma Inc. Julie M. Thibodeau, B.Sc., MBA Director, Communications 514-751-2003 ext 235 jthibodeau@ambrilia.com / ir@ambrilia.com www.ambrilia.com
