Ambrilia Biopharma Inc. Provides Update on PPL-100; Merck Places Development Hold on Drug
MONTREAL, QUEBEC--(MARKET WIRE)--Jul 28, 2008 -- Ambrilia Biopharma Inc. (Toronto:AMB.TO - News) today announced that it was advised by Merck & Co, Inc., that the HIV protease inhibitor PPL-100, also known as MK-8122, has been placed on a development hold pending outcome of additional basic science efforts to evaluate other PL-100 prodrugs and formulations options. Merck's decision to place a development hold on MK-8122 was made pursuant to the results of the recently completed single dose and multi dose studies in healthy volunteers. Merck is also further exploring development of potential back-up compounds. The exclusive license agreement between the companies entered into on October 12, 2006 provides for additional milestone-based cash payments and royalties on the future development and commercialization of each back-up compound and/or related compounds developed by Merck and which fall within the scope of the Ambrilia HIV protease inhibitor program.
"Ambrilia believes in the potential of PPL-100/MK-8122 and related compounds to offer advantages to HIV patients over the currently commercialized protease inhibitors," said Dr. Philippe Calais, President and CEO of Ambrilia. "Our partnership with Merck continues and we look forward to further progress on potential back-up compounds." Dr. Calais continued, "Both companies remain focused on the partnership and determined to provide the best compounds available to help people with HIV/AIDS."
Protease inhibitors are a key component to the current HIV/AIDS standard of care, the Highly Active Anti-Retroviral Treatment (HAART) consisting of a cocktail of HIV medicines.
About the Ambrilia and Merck Partnership
In October 2006, Ambrilia entered into an exclusive licensing agreement granting Merck & Co. - through an affiliate - the worldwide rights to its HIV protease inhibitor program, including lead compound PPL-100. In return, Ambrilia received an upfront payment of $US 17 million and is eligible for potential cash payments totaling $US212 million upon successful completion of development, clinical, regulatory and sales milestones, and royalties on all future product sales. The agreement also provides for additional milestone-based cash payments and royalties on the future development and commercialization of each back-up compound and/or related compounds developed by Merck and which fall within the scope of the Ambrilia HIV protease inhibitor program.
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. (Toronto:AMB.TO - News) 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.