Inspire, Boehringer Ingelheim announce development and license agreement

By Lisa Kerner

Erie, Pa., Feb. 21 - Inspire Pharmaceuticals, Inc. said it has entered into a development and license agreement with Boehringer Ingelheim International GmbH.

Under the agreement, Inspire will acquire certain exclusive rights to develop and market an intranasal dosage form of epinastine in the United States and Canada for the treatment or prevention of rhinitis, according to a company news release.

Rhinitis primarily results from exposure to allergens. Its symptoms include nasal congestion or stuffiness, rhinorrhea (runny nose) and nasal itching.

Epinastine is a fast-acting molecule that blocks multiple sub-types of histamine receptors, stabilizes mast cells and affects pro-inflammatory mediators, the release stated.

Inspire will have responsibility for the intranasal epinastine development program and regulatory filings in the United States and Canada. The company is paying Boehringer Ingelheim an upfront license fee and single digit royalties to Boehringer Ingelheim on net sales of the product, if approved, in the United States and/or Canada.

As part of the transaction, Boehringer Ingelheim has retained the rights to develop and commercialize intranasal epinastine outside the United States and Canada, based on any future results of Inspire's intranasal epinastine development program. It will pay royalties to Inspire on intranasal epinastine product net sales outside of the United States and Canada, the company said.

Boehringer Ingelheim will supply Inspire with active drug substance, according to terms of a separate commercial supply agreement.

"The collaboration with Boehringer Ingelheim for the intranasal uses of epinastine represents an important expansion to Inspire's development pipeline," Inspire president and chief executive officer Christy L. Shaffer said in the release.

"This program will provide Inspire with the opportunity to build on our respiratory and allergy franchise, while leveraging our success in the market with the ocular form of epinastine, Elestat."

The U.S. prescription market for nasal allergies is about $2.8 billion annually, officials said.

Inspire said it plans to meet with the Pulmonary Division of the Food and Drug Administration to discuss an Investigational New Drug application for intranasal epinastine. The company expects to begin phase 2 testing of intranasal epinastine in 2006, based on the work already completed by Boehringer, Inspire officials said.

Inspire, a biopharmaceutical company located in Durham, N.C., discovers, develops and commercializes prescription pharmaceutical products in disease areas with significant commercial potential and unmet medical needs.

The Boehringer Ingelheim group, a family owned company based in Ingelheim, Germany, develops, manufactures and markets novel products for human and veterinary medicine.

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