- GENERIUM granted exclusive rights to ProMetic’s Plasma Protein Purification System (“PPPSTM) derived biopharmaceuticals for Russia and Commonwealth of Independent States (“CIS”)
- US $17 million license and milestone fees, of which US $6 million is payable upfront
- GENERIUM to pay ProMetic mid-single digit royalties on sales of biopharmaceuticals in Russia and CIS
- GENERIUM to build and operate a PPPSTM based plasma purification facility to process up to 600,000 liters of plasma annually, in Russia, to manufacture therapeutics for the Russian and CIS markets
- GENERIUM to fund and conduct all required clinical trials in Russia
- GENERIUM and ProMetic create global partnership for the co-development and commercialization of two coagulation factors
LAVAL, QUEBEC, CANADA, – December 22, 2014 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX:PFSCF)
(“ProMetic” or the “Corporation”) announced today that it has entered into definitive agreements with GENERIUM Pharmaceuticals (“GENERIUM”) for several plasma-derived biopharmaceuticals to be manufactured and commercialized in Russia and CIS, as well as for the co-development and global commercialization of two plasma-derived coagulating factors.
The strategic alliance includes the granting of manufacturing rights by ProMetic to GENERIUM for several plasma-derived biopharmaceuticals using ProMetic’s proprietary PPPSTM technology. In addition, ProMetic will provide training and technical support to manufacture said plasma-derived biopharmaceuticals in a facility to be built and operated by GENERIUM, in Russia. The design of the GENERIUM plasma purification facility will be based on ProMetic’s own Laval facility and will have a plasma processing capacity of up to 600,000 litres per year. Construction of said facility has already commenced and is expected to be completed by 2017. GENERIUM will fully fund the construction and operating costs of its new cGMP PPPSTM facility.
“We are very pleased to be working with GENERIUM to capitalize on the large and rapidly growing Russian and CIS markets. GENERIUM possesses world-class development and manufacturing of biologics expertise and an unmatched Russian and CIS market access capabilities. GENERIUM represents the perfect partner to establish a leading presence of PPPSTM based therapeutic products in Russia / CIS”, stated Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic.
According to Dr Alexander Shuster, Chairman of the Board of GENERIUM Pharmaceuticals, “The competitive advantage provided by ProMetic’s state of the art and proprietary manufacturing platform will allow us to further consolidate our position as Russia’s leading biopharmaceutical company. Moreover, our strategic alliance shall leverage our core competencies in haemophilia, both in terms of product development and commercial activities”.
Of the US $17 million license and milestone fees to be paid by GENERIUM, US $6 million is to be paid up front, followed by US $11 million of staged payments to ProMetic in relation to defined development milestones. Approximately US $4 million of these milestone payments are expected to be received in 2015. In addition, GENERIUM will be funding and conducting clinical trials in Russia / CIS for the plasma-derived biopharmaceuticals providing ProMetic with exclusive rights to valuable, usable clinical data on several products outside of Russia/CIS.
Once GENERIUM’s plasma purification facility becomes operational, both GENERIUM’s and ProMetic’s facilities may complement each other as contract manufacturing organizations (“CMO”) on specific biopharmaceutical products. ProMetic will also supply the required affinity resins for the PPPSTM based Russian facility and mid-single digit royalties will be paid by GENERIUM to ProMetic on sales of the biopharmaceutical products in the Russian / CIS markets. The strategic alliance also includes two (2) coagulation factors that will be co-developed and commercialized globally with both parties equally sharing net profits from said sales.
Strategic Alliance with GENERIUM Conference Call Information
ProMetic will host a conference call at 11:00am (ET) on Monday, December 22, 2014. The telephone numbers to access the conference call are (647) 788-4922 (International) and 1-877-223-4471 (Toll-free). A replay of the call will be available from December 22, 2014 at 2:00 p.m. until December 28, 2014. The numbers to access the replay are 1-416-621-4642 (passcode: 57924797) and 1-800-585-8367 (passcode: 57924797). A live audio webcast of the conference call will be available through the following: http://www.gowebcasting.com/6182
More about GENERIUM
GENERIUM is a Russian innovative vertically integrated biotechnological company focused on science-driven drug development, production and commercialization. GENERIUM runs its own R&D center and full-cycle manufacturing unit. The company is providing patients with affordable drugs and diagnostics for treatment of diseases with high medical need, including orphan and hereditary diseases, such as hemophilia and growth hormone deficit, oncological, infectious, cardiovascular diseases and multiple sclerosis.
More about PPPSTM
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 ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (prometic.com) is a long established biopharmaceutical company with globally recognized expertise in bioseparations, plasma-derived therapeutics and small-molecule drug development. ProMetic offers its state of the art technologies for large-scale purification of biologics, drug development, proteomics and the elimination of pathogens to a growing base of industry leaders and uses its own affinity technology that provides for highly efficient extraction and purification of therapeutic proteins from human plasma in order to develop best-in-class therapeutics and orphan drugs. ProMetic is also active in developing its own novel small-molecule therapeutic products targeting unmet medical needs in the field of fibrosis, anemia, neutropenia, cancer and autoimmune diseases/inflammation as well as certain nephropathies. 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 and Asia.
Forward Looking Statements
This press release contains forward-looking statements about ProMetic’s objectives, strategies and usinesses 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 in ProMetic’s Annual Information Form for the year ended December 31, 2013, 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.