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$89M Deal: Inspire Licenses Antihistamine Drug Candidate From Spanish Firm

Posted November 1, 2006

— Inspire Pharmaceuticals

is committing $7 million up front for the licensing rights for a potential oral antihistamine from a Spanish drug company.

Inspire (NASDAQ: ISPH) said Wednesday before the markets opened that it had agreed to pay $7 million in cash and up to $82 million in additional payments and royalties for the rights to “bilastine.” It is in Phase III of development.

The drug is being developed by FAES Farma, S.A.

The licensing deal covers commercialization rights in the U.S. and Canada.

Inspire’s deal comes after it failed to win approval of its own lead drug candidate, which is a proposed treatment for dry eye. Inspire also recently stopped a trial for an anti-clotting drug. Inspire shares slipped 7 cents, to $5.27, in midday trading.

Bilastine would treat allergic rhinitis, which affects some 40 million people in the U.S. It would be delivered orally. Additional formulations could be developed under the agreement.

“Our collaboration with FAES represents an ideal strategic opportunity for Inspire,” said Christy Shaffer, Inspire’s chief executive officer. “Bilastine expands our allergy franchise and will leverage our clinical development expertise and historical success of our commercial team.

“We have the opportunity to develop and commercialize multiple formulations of the compound for oral and ocular uses,” she added. “We expect that bilastine can generate significant near-term revenues and bridge to the commercialization of other compounds in our pipeline.”

According to Shaffer, bilastine could produce more than $200 million in annual revenues if the drug wins regulatory approval. The oral antihistamine market in the U.S. alone is worth $3 billion a year, she added.

The compound is protected by a U.S. patent through 2017. It has been tested in nearly 4,000 people, and Phase III trials in Europe had “positive outcomes,” Inspire said.

The U.S. Food and Drug Administration accepted an investigational new-drug application for bilastine from FAES in April of this year. Inspire said it planned to submit a new drug application after a meeting with the FDA to discuss bilastine and forthcoming results from a study examining cardiac safety. Inspire also said it probably would conduct “at least one additional trial” in the U.S.


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