Panacea Biotec In 10-Yr Pact With Osmotica Of US

<div>Delhi-based drug firm Panacea Biotec has entered into a 10 year collaboration agreement with Osmotica Pharmaceutical, USA, for late phase development and marketing of high end generic medicines. Eighteen products from Panacea&rsquo;s research pipeline will initially be part of the pact, with a provision to add more.<br /><br />The products, which belong to the therapeutic categories that enjoy approximately $25-billion market in the US, will be developed and marketed on a 50:50 partnership basis, Rajesh Jain, joint managing director, Panacea said.<br /><br />Under the agreement, Panacea will be in charge of product identification, research, development and manufacturing while Osmotica would lead product registration, legal matters, marketing, sales and distribution in the US and key foreign markets. &ldquo;The collaboration is based on a 50:50 risk, investment and profit sharing by both companies. Panacea will receive initial research fee from Osmotica and, as the research progresses, milestone payments representing 50 per cent of the development cost&rdquo;, Jain said.<br /><br />The companies expect to file the first product in its research pipeline for regulatory approval next year. &ldquo;We expect to launch the first product developed under the collaboration in 2015&rdquo;, Forrest Waldon, CEO, Osmotica said.<br /><br />According to Jain, the partnership is unique as it is trying to develop a highly complex category of products that will require clinical trials under US law before being given marketing approval. &ldquo;It is not just vanilla generic that require only bio-equivalance studies for regulatory approval. We are working on novel drug delivery systems and nanoparticle based drug delivery platforms&rdquo;, he said.<br /><br />The research collaboration is in line with Panacea&rsquo;s long-term objective to diversify its product portfolio from predominantly vaccines to other medicines. Panacea had registered a loss last year after WHO suspended its approval towards its key product, oral polio vaccine. The vaccine is expected to be back in the WHO approved list soon.<br /><br />Panacea shares rose to a month&rsquo;s high to close at Rs 107.25 a share on Bombay Stock Exchange today after the announcement.<br /><br />Privately held Osmotica is a speciality pharmaceutical company focusing on neurology and central nervous system based drugs.<br /><br />&nbsp;</div>