MUMBAI - Pfizer has turned its attention to establishing a bigger presence in the U.S. for marketing generic drugs, terming it as an "engine of positive growth." The world's largest drug maker has signed a series of licensing agreements with India's Aurobindo Pharma to acquire rights of 39 generic solid oral dose products and 12 sterile injectable products.

These medicines cover a broad range of therapeutic areas including cardiovascular disease and central nervous system disorders, and will be commercialized in the U.S. through Pfizer's Greenstone subsidiary.

Speaking to PharmAsia News from Pfizer's New York-based headquarters, Kelvin Cooper, Senior VP, Portfolio Devolvement, Established Product Business Unit, said, "The generics non-exclusive drugs market is expected to grow from $270 billion at present to more than $500 billion by 2013. Pfizer intends to be part of that growth area."

"Pfizer will be marketing the products through its own channels and will have a much better reach while Aurobindo has greatly impressed us with their reliability of supply timelines and quality parameters," Cooper clarified.

Back in July 2008, Pfizer signed a supply pact with Aurobindo for five products, and now with the latest arrangement, the total number of products will reach 56. Of these, 20 will also be sold in different markets of Europe and 11 will be marketed in France.

Pfizer's Established Products Business Unit was launched in 2008 and focuses on commercialization of products where market exclusivity had been lost. This was part of an initiative to create smaller, more accountable business units aligned with customer needs. "Currently, Pfizer's Established Products Business Unit comprises of 300 'legacy molecules' with annual sales of $10 billion globally. We are poised for a stronger growth phase," Cooper said.

Hinting at more such alliances and an extension of the collaboration with Aurobindo Pharma, Cooper said Pfizer is looking at companies throughout the globe to establish a wide network to supplement its generic portfolio. As for raw materials or active pharmaceutical ingredients, Cooper said Pfizer sources from as many as 40 companies in India.

"Established Products has the benefit of Pfizer's strong brand recognition, a track record of proven efficacy and safety, broad and deep commercial infrastructure around the world and a powerful portfolio," Cooper said.

As for the future, Cooper said biosimilars could be the next growth area for Pfizer. Without providing details, he said Pfizer is currently preparing a lot of background work for biosmilar products.

Some of Pfizer's big pharma competitors, facing similar patent and pipeline challenges, also are looking at biosimilars as a business opportunity. In December, Merck launched a new division, Merck Bioventures, with the goal of launching six or more follow-on biologics between 2012 and 2017 (Also see "Merck Announces Major FOB Initiative With Its New Business Unit" - Pink Sheet, 9 December, 2008.).

Commenting on the alliance with Pfizer, Aurobindo Pharma Chairman P.V. Ramprasad Reddy said "It is an exciting opportunity for Aurobindo and provides for stability towards the company's earnings and accelerate its growth plans. The current agreements are targeted towards U.S. and European markets and will continue to explore ways to further extend this partnership."

Aurobindo has a large manufacturing base approved by several regulatory authorities with a strong product portfolio for the manufacture of post-exclusivity products. The partnership alliance is mutually beneficial, a statement from Aurobindo said. Aurobindo has filed 145 abbreviated new drug applications in the U.S., of which 90 are approved.

Pfizer, looking for new avenues of growth, suggests its merger with Wyeth will help gain the company gain market share in the Asia Pacific, possibly translating into $3 billion of incremental revenue by 2012 (Also see "Pfizer/Wyeth Will Produce (Incremental) Growth, Pfizer Assures Investors" - Scrip, 2 February, 2009.).

- Vikas Dandekar (v.dandekar@elsevier.com)

Pfizer Signs Big Bang Deal With Aurobindo For Larger Presence in Generics; Biosimilars Next ?

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