- ProMetic grants global co-exclusive rights for a plasma-derived orphan drug
- Hematech to pay ProMetic $10M for the orphan drug development program with $1M upfront
- Orphan drug to be manufactured in ProMetic’s Laval facility
- Hematech to build and operate a facility in Taiwan to manufacture plasma-derived biopharmaceuticals implementing ProMetic’s Plasma Protein Purification System (“PPPSTM“)
LAVAL, QUEBEC, CANADA AND TAIPEI, TAIWAN- May 07, 2012 – ProMetic Life Sciences Inc. (TSX:PLI) (“ProMetic” or the “Corporation”) and Hematech Biotherapeutics Inc. (“HBI“) announced today the signature of definitive agreements for the co-development and co-exclusive commercialization, on a world-wide basis (excluding China), of a plasma-derived biopharmaceutical product targeting a rare medical condition (“Orphan Drug”). The deal includes the granting of manufacturing rights by ProMetic to HBI of plasma-derived biopharmaceuticals using ProMetic’s proprietary PPPSTM.
The $10 million from HBI will fund the Orphan Drug’s development program up to regulatory approval; a $1 million upfront payment followed by $9 million staged payments to ProMetic related to defined development milestones. $5 million of the development fees are expected over the course of the next 15 to 18 months leading to the filing of an IND in the second half of 2013. Following the completion of clinical trials and regulatory approval, the Orphan Drug will be commercialized jointly by ProMetic and HBI on a global basis (excluding China), with both parties sharing profits equally. The Orphan Drug will be manufactured by ProMetic in its Laval facility and in HBI’s planned facility in Taiwan.
The deal includes a strategic alliance providing HBI rights to ProMetic’s proprietary PPPSTM as well as training and technical support to manufacture plasma-derived biopharmaceuticals in a Taiwanese facility to be built and operated by HBI. Under this strategic alliance, HBI will fully fund the construction and operating costs of the new cGMP plant dedicated to manufacture plasma-derived therapeutics for ProMetic and its licensees. The core cGMP manufacturing area of the facility in Taiwan will be based on the same design as ProMetic’s own Laval facility. Pursuant to this alliance, the two companies will synchronize the construction of this Taiwanese manufacturing facility along with the advancement of other plasma-derived therapeutics currently under development by ProMetic and its other licensees.
“This strategic relationship will provide Hematech and ProMetic with a valuable biopharmaceutical product with excellent market potential as well as a world class manufacturing facility implementing ProMetic’s proven manufacturing platform,” stated Dr Chan, M.D., Chairman of HBI. “We are pleased to see our financial resources and extensive experience in the manufacturing of biopharmaceuticals contributing to leverage the strategic fit between our two companies. The competitive advantage provided by ProMetic’s manufacturing platform will certainly create value for Hematech as it pursues its goal of marketing high-value, niche products targeting unmet medical needs”, added Dr. Chan.
“We are privileged to have access to the wealth of experience brought on board by Dr Chan and his colleagues at Hematech. Under Dr Chan’s leadership as Chairman, Adimmune Corporation in Taiwan successfully built the first commercial vaccine facility in Asia meeting European Medecines Agency (“EMA”) standards”, mentioned Dr Tom Chen, ProMetic’s Senior Vice President Product and Asia/Pacific Development. “Both parties will mutually benefit from their respective extensive industry expertise”, added Dr Chen.
“The combination of our sizeable investments to develop our manufacturing platform, our strategic decision to set up our own plasma manufacturing facility as well as the recent successful scale up of our process in China were all instrumental in securing this strategic partnership with HBI” mentioned Mr. Pierre Laurin, ProMetic’s President and Chief Executing Officer. “This transaction capitalizes on our mutual synergies and common commercial visions”, added Mr. Laurin.
About Orphan Drug
An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease. The assignment of orphan status to a disease and to any drugs developed to treat it is a matter of public policy in many countries, and has resulted in medical breakthroughs that may not have otherwise been achieved due to the economics of drug research and development. Orphan drugs generally follow the same regulatory development path as any other pharmaceutical product, in which testing focuses on pharmacokinetics and pharmacodynamics, dosing, stability, safety and efficacy. However, some statistical burdens are lessened in an effort to maintain development momentum.
About the Plasma Protein Purification System
The Plasma Protein Purification System (PPPSTM) allows for the targeting and removal of multiple high-value proteins from a single plasma sample at unprecedented activity levels using ProMetic’s Mimetic LigandTM adsorbent technology. This system also provides for the recovery of new biotherapeutics as they are discovered and identified. The effect of this process is to reduce the significant losses incurred when using the more conventional Cohn precipitation process.
About Hematech Botherapeutics Inc.
Hematech Biotherapeutics Inc. is a privately held biotechnology company with headquarters located in Taipei, Taiwan. Hematech Biotherapeutics Inc. is extensively involved in the sponsorship, development and production of therapeutic drug particularly in the area of hematology. Hematech Biotherapeutics Inc. maintains an extensive collaborative network with industrial partners and is committed to the development of safe, high-quality, and low cost therapeutics drug. Major shareholders of Hematech Biotherapeutics Inc. include a key supplier of vaccines and a medical service and logistics company in Taiwan. Both companies are publicly listed in Taiwan.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (http://prometic.com/) is a biopharmaceutical company specializing in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic LigandTM 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 and cancer. Its drug discovery platform is focused on replacing complex, expensive proteins with synthetic “drug-like” protein mimetics. Headquartered in Laval (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, 2011, under the heading “Risk and Uncertainties related to ProMetic’s business”. 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 indicated otherwise.