Inspire signs development agreement with Boehringer Ingelheim for intranasal epinastine

US biopharmaceutical company Inspire Pharmaceuticals has entered into a development and license agreement with Boehringer Ingelheim International to develop and market an intranasal dosage form of epinastine in the US and Canada for the treatment or prevention of rhinitis.

Inspire will have full responsibility for the intranasal epinastine development programme and regulatory filings in North America. Boehringer Ingelheim will be responsible for supplying Inspire with active drug substance under 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 US and Canada, while Boehringer Ingelheim has retained the rights to develop and commercialise intranasal epinastine outside North America, based on any future results of Inspire's intranasal epinastine development programme.

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 US and/or Canada. Inspire will not owe any additional milestone payments under the agreement. If Boehringer Ingelheim commercializes Inspire's intranasal epinastine product elsewhere, it will pay royalties to Inspire on net sales of this product.

'The collaboration with Boehringer Ingelheim for the intranasal uses of epinastine represents an important expansion to Inspire's development pipeline,' said Dr Christy L. Shaffer, president and ceo of Inspire. 'We plan to meet with the pulmonary division of the US FDA to discuss an Investigational New Drug (IND) application for intranasal epinastine. We expect to initiate Phase II testing of intranasal epinastine in 2006, based on the work already completed by Boehringer Ingelheim.'