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news.ProMetic Life Sciences announced that it has entered into definitive agreements with GENERIUM Pharmaceuticals 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.
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The strategic alliance includes the granting of manufacturing rights by ProMetic to GENERIUM for several plasma-derived biopharmaceuticals using ProMetic’s proprietary PPPS 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 PPPS™ 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 PPPS 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 PPPS 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 coagulation factors that will be co-developed and commercialized globally with both parties equally sharing net profits from said sales.