Press release from Marketwire
ProMetic Signs Terms of Strategic Agreement for PBI-1402 and PBI-4419 With Allist Pharmaceuticals of China
Monday, October 18, 2010
-- Allist to fund and accelerate the development programs for PBI-1402 and PBI-4419 -- Allist secures exclusive commercial rights for the Chinese market -- ProMetic retains rights to data for other markets, representing savings of over US $10 M in future development costs; -- PBI-1402 clinical development will be further advanced for chemotherapy- induced anemia and cancer related anemia indications -- PBI-4419 will be developed for fibrotic disease indications -- Agreement includes US$ 59 M in milestone payments to ProMetic as well as royalties on sales in China
ProMetic Life Sciences Inc. (TSX:PLI) ("ProMetic") and Allist Pharmaceuticals, Inc. ("Allist") announced today that they have entered into a strategic agreement to develop and commercialize ProMetic's drug candidates PBI-1402 and PBI-4419 in China. This agreement strengthens ProMetic's development plan for these assets in other markets.
Allist will fund the development costs required for the regulatory approval in China for the two products. As part of the conditions for the rights granted, Allist undertakes to perform development activities according to standards meeting FDA requirements, which will then allow ProMetic to have full access to and use the data generated by Allist for markets outside China. This represents an investment in the programs well in excess of US$10 M. Allist will retain the rights for the Chinese market for PBI-1402 for the chemotherapy-induced anemia ("CIA") and cancer related anemia ("CRA") indications and for PBI-4419 for fibrotic diseases.
"We are very excited about this strategic relationship as it capitalizes on our respective companies' strengths," stated Dr. Jianhui Guo, Chief Executive Officer of Allist. "ProMetic's research & development program has generated very promising First-in-Class drugs to address unmet medical needs and Allist will accelerate the development of these two drug candidates. Our developmental capabilities provide for a natural, complementary and strategic fit with ProMetic."
Mr. Pierre Laurin, ProMetic's President and Chief Executive Officer commented: "This enabling agreement is perfectly aligned with ProMetic's development strategy for its Therapeutics business unit: (1) It leverages the synergies and the investment made by Allist in the development program in that we can use this critical data for other lucrative markets; (2) It enables us to accelerate the development of these valuable drug candidates on a cash neutral basis; and (3) It provides ProMetic with a solid partner for the ever-expanding Chinese market, expected to become the 4th largest domestic pharmaceutical market by 2013."
In addition to the funding commitments and the execution of the development program, Allist has agreed to pay ProMetic performance milestones totaling US$59 M and royalties on future products sales. Upon ProMetic completing a technology transfer for the two drug candidates this quarter, Allist will proceed with the scale-up of the manufacturing processes and will initiate clinical trials as well as other pivotal development activities.
"Allist is one of the few pharmaceutical companies in China focused on developing innovative therapeutics as opposed to generic drugs," stated Dr. Tom Chen, ProMetic's Vice-President Product and Asia Pacific Development. "Allist is very well funded and will soon have capacity to produce over 250 metric tons of pharmaceutical bulk active drugs. Allist is not only a solid partner to develop and commercialize the products in China, but this relationship strengthens ProMetic's position outside China with expanded manufacturing capabilities. For instance, ProMetic will have the option to access large supply manufacturing capacity for PBI-1402 and PBI-4419 for markets outside China," added Dr. Chen.
ProMetic and Allist will finalize and execute definitive documentation and relevant development work plans regarding this strategic agreement within sixty (60) days from the date hereof.
More on PBI-1402 and PBI-4419
PBI-1402 is a first-in-class, orally active, non-EPO receptor erythropoietic regulating agent ("ERA"), which offers significant advantages in the treatment of anemia in cancer patients. With proven anti-cancer activity and no risk to bring red blood cells or hemoglobin to unsafe levels, PBI-1402 offers the potential to become the safest drug to treat anemia in cancer patients. In a phase Ib/IIa clinical trial performed in patients suffering of anemia induced by chemotherapy, 93% of patients did not require blood transfusion. PBI-4419 is a first-in-class, orally active, more potent third generation analogue of PBI-1402. PBI-4419 is ProMetic's lead candidate drug in development for the treatment of various inflammatory and fibrosis conditions.
About Allist Pharmaceuticals, Inc.
Allist Pharmaceuticals, Inc. (http://www.allist.com.cn/allist_en/) is engaged in discovery, development and commercialization of novel pharmaceutical products for human health. The mission of the company is to be a leading innovator of therapeutic drugs devoted to human health and human life worldwide.
Founded in May of 2004, Allist's Research and Development Center is located in Zhangjiang Hi-tech Park, Shanghai and is focused on new chemical entities and drug delivery systems in the fields of cardiovascular diseases, acid-related diseases and cancers.
At present, taking advantage of a rapidly growing Chinese biomedical and pharmaceutical industry, Allist pushes forward with developing technology and improving human health strategies to realize its goals of becoming one of the leaders in the global pharmaceutical industry.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (www.prometic.com) is a biopharmaceutical company specialized in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic Ligand(TM) technology. This technology is used in large-scale purification of biologics and the elimination of pathogens. ProMetic is also active in therapeutic drug development with the mission to bring to market effective, innovative, lower cost, less toxic products for the treatment of hematology, cancer, inflammation and fibrosis. Its drug discovery platform is focused on replacing complex, expensive proteins with synthetic "drug-like" protein mimetics. Headquartered in Montreal (Canada), ProMetic has R&D facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK and business development activities in the U.S., Europe, Asia and in the Middle-East.
Forward Looking Statements
This press release contains forward-looking statements about ProMetic's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, ProMetic's ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of ProMetic to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations on page 24 of ProMetic's Annual Information Form for the year ended December 31, 2009, under the heading "Risk Factors". As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations. All amounts are in Canadian dollars unless stated otherwise.
FOR FURTHER INFORMATION PLEASE CONTACT:
On behalf of ProMetic: ProMetic Life Sciences Inc. Pierre Laurin, President and CEO 1-514-341-2115 firstname.lastname@example.org
ProMetic Life Sciences Inc. Anne Leduc Manager, Investor Relations & Communications 1-514-341-2115 email@example.com
On behalf of Allist: Allist Pharmaceuticals, Inc. Dr. Jianhui Guo Chief Executive Officer +86-21-5132-0230 firstname.lastname@example.org