Pfizer Buys Full Rights To Exubera

Pfizer has agreed to pay $1.3 billion to Sanofi-Aventis for full rights to the experimental inhaled diabetes drug Exubera. The deal includes an insulin-manufacturing plant in Frankfurt, Germany, that previously was jointly owned by the companies.

Pfizer had originally partnered with Aventis in the development of Exubera. Later, however, Pfizer claimed that Sanofi-Synthélabo’s merger with Aventis in 2004 triggered a “change-in-control” clause, leading to speculation that Pfizer was interested in acquiring full control of the drug.

“This deal has been widely anticipated since late last summer,” Morgan Stanley analyst Jami Rubin wrote to clients in a research note. The analyst added that although the price seemed high because of some of the uncertainties still surrounding the commercial potential of Exubera, it did not seem unreasonable.

An FDA advisory committee recommended approving Exubera in September 2005, but a month later the agency extended by three months the deadline for its review of the drug. The agency is expected to make a final decision on whether to approve Exubera by the end of this month.

An approval for Exubera would represent a major breakthrough in the way diabetes patients control their insulin. Exubera is a dry-powdered formulation of insulin that is inhaled, rather than injected. Drug delivery company Nektar Therapeutics, which developed the inhalation technology, is unaffected by the deal. Nektar will receive a 15% royalty on sales of Exubera.