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Serum extends pact with Lipoxen by taking worldwide mktg rights for new molecules
Reghu Balakrishnan, Mumbai | Monday, October 3, 2005, 08:00 Hrs  [IST]

Serum Institute of India, country’s leading vaccine manufacturer, has extended its agreement with London-based Lipoxen Technologies Ltd, by increasing the number of blockbuster drugs the two companies are collaborating on, and facilitating access to the major Western markets.

“We have extended our existing partnership with Serum executed in December last year by broadening the reach of geographic cover to now include North America, Europe, and Japan for the four product candidates. We have also expanded upon our initial agreement by adding in an additional five candidates into the joint pipeline for the developing markets. The new products will now include Liposomal Carboplatin, Liposomal Cisplatin, Liposomal Doxorubicin, a Liposomal co-delivery HIV vaccine, and Liposomal Oral Tetanus Toxoid. Serum plans to run these products through to market approval in India and market through the developing world,” M. Scott Maguire, CEO, Lipoxen told Pharmabiz.

He added, “We have partnered on four blockbusters including EPO, Liposomal Pneumococcal vaccine, Liposomal Paclitaxel and an undisclosed proprietary protein candidate for the Western markets whereby Lipoxen and Serum will be running FDA and EMEA clinical trials for four product candidates. The goal is to run the clinical trials jointly to Phase III at which time we will likely seek a licensing partner in the form of a major international pharmaceutical company with significant global channel power.”

In last December, as Pharmabiz reported, Serum tied up with Lipoxen for conducting clinical studies on eight protein drugs including EPO, GCSF, Doxorubicin, flu and pneumococcal vaccines. These drugs have been developed using the patented polymer conjugation technology like PolyXen and ImuXen provided by Lipoxen.

According to the earlier agreement, Lipoxen will transfer the technology to Serum Institute, and is currently providing the technological know-how to the Serum scientists. If the trials are successful, serum will be able to market the products in India, Africa, Asia (except Japan) and Latin America. Lipoxen will control the marketing rights for Europe and the US.

By acknowledging the development, Dr. Umesh Shaligram, director, R&D, Serum Institute said that apart from adding new molecules, they have agreed to market the molecules worldwide together. “Under the new agreement, our marketing rights have been extended to other regulated markets like US and Europe. We hope to finish the trials of new molecules by 2009,” he added. Serum is expected to complete clinical trials on protein drugs like EPO, G-CSF, Doxirubicin, flu and Pneumococcal vaccines by early 2006.

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