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Pfizer buys out Exubera rights

World number one to pay $1.3bn to sanofi-aventis to market inhaled insulin potential blockbuster

Pfizer has taken full control of worldwide rights for inhaled insulin drug Exubera after agreeing to pay sanofi-aventis $1.3bn.

The agreement settles a spat over the experimental drug that has been ongoing since Sanofi Synthelabo's merger with Aventis in 2004. Pfizer had asserted that the merger triggered a change-of-control clause in their contract that allowed it to renegotiate the deal.

The new agreement was reached after Pfizer pursued the matter in US and German courts. Besides worldwide development and marketing rights, Pfizer will gain full control of the manufacturing plant for Exubera in Frankfurt that it previously joint-owned with Sanofi.

ìWe sought the sanofi-aventis rights to Exubera based on the strong addition it would represent to our portfolio of innovative medicines,î Pfizer's chief executive Hank McKinnell said in a statement.

The new agreement will not affect Pfizer's other partner in the project, biotech firm Nektar Therapeutics, which will remain entitled to royalties based on net sales of Exubera.

With the number of diabetes cases increasing, the move could prove lucrative to Pfizer. Analysts see a lot of promise in inhaled insulin technology, as it could greatly reduce the need to inject insulin. However, scientists have some concerns over pulmonary safety because the insulin is absorbed by the lungs rather than under the skin.

Some analysts have forecast annual sales of Exubera at over $2bn a year if it gets full US Food and Drug Administration (FDA) approval. In October 2005, the FDA extended the review period by three months to study more data on the drug.

Standard & Poor's analyst Herman Saftlas maintained a 'hold' opinion on Pfizer shares after the Exubera announcement.

ìDespite concern about long-term effect on lung function, we think Exubera offers key advantages over existing therapies,î he said. However, he added that Pfizer's prospects still depended heavily on other R&D drugs, including Lipitor-torcetrapib, the planned successor to the cholesterol drug Lipitor, that still faces clinical and regulatory hurdles.

Pfizer faces some challenging patent expiries on key drugs including Zoloft, Zithromax and Norvasc over the next few years, which could amount to over $14bn in lost sales.

30th September 2008

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