Inspire Pharmaceuticals Inc. has entered into a development and license agreement with Boehringer Ingelheim International GmbH. 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.

Under this agreement, Inspire will have full responsibility for the intranasal epinastine development programme and regulatory filings in the United States and Canada. It has been agreed that Boehringer Ingelheim will be responsible for supplying Inspire with active drug substance pursuant to the terms of a separate commercial supply agreement.

Upon appropriate regulatory approvals of this product candidate, Inspire would have exclusive marketing and sales responsibility for intranasal epinastine in the United States and Canada. As part of the transaction, Boehringer Ingelheim has retained the rights to develop and commercialise intranasal epinastine outside the United States and Canada, based on any future results of Inspire's intranasal epinastine development programme, states the company release.

Inspire is paying Boehringer Ingelheim an upfront license fee, will fund all development activities and pay single digit royalties to Boehringer Ingelheim on net sales of the product, if approved, in the United States and/or Canada. Inspire will not owe any additional milestone payments under the agreement. If Boehringer Ingelheim commercialises Inspire's intranasal epinastine product outside of the United States and Canada, it will pay royalties to Inspire on net sales of this product.

Christy L. Shaffer, president and CEO of Inspire said, "This programme 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. Our development and commercial organisations have substantial understanding of this compound and extensive experience in the allergy therapeutic market, which includes the large and attractive $2.8 billion annual US prescription market for nasal allergies."

"We plan to meet with the Pulmonary Division of the US Food and Drug Administration (FDA) to discuss an investigational new drug (IND) application for intranasal epinastine, which we would intend to submit after that meeting. We expect to initiate Phase 2 testing of intranasal epinastine in 2006, based on the work already completed by Boehringer Ingelheim," concluded Dr. Shaffer.

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

Inspire is a biopharmaceutical company dedicated to discovering, developing and commercialising prescription pharmaceutical products in disease areas with significant commercial potential and unmet medical needs.