GlaxoSmithKline has linked up with Amira Pharmaceuticals in a deal that could net the San Diego-based biotechnology firm up to $425 million.

GSK has gained worldwide exclusive rights to develop, manufacture and commercialise Amira’s FLAP (5-lipoxygenase activating protein) inhibitors for the treatment of respiratory and cardiovascular disease, notably AM103. Data from a Phase I study completed in November, show that the compound has the potential as a once-daily, oral, non-steroidal asthma treatment and was also well-tolerated.

If all potential development and regulatory milestones are achieved, Amira could receive up to $425 million and will also be entitled to receive tiered royalty payments. The firms noted that despite the success of inhaled beta-agonist and corticosteroid therapy, “there is still a significant need for alternative therapies” and although other drugs target the leukotriene pathway, a FLAP inhibitor has the potential to inhibit a broad spectrum of said leukotrienes. They are also being investigated for use in other respiratory indications, including rhinitis, as well as other inflammatory and cardiovascular diseases.

Moncef Slaoui, GSK’s chairman of R&D said AM103 has the potential to offer patients a convenient and effective alternative treatment for respiratory diseases while Amira chief executive Bob Baltera was elated about the deal. He described it as a momentous day in the young life” of his firm, which was founded in 2005, adding that it “validates the abilities and expertise in Amira to expedite the delivery of novel medicines”.

EU’s positive opinion for Hycamtin
GSK also announced that the European Medicines Agency has issued a positive opinion on Hycamtin (topotecan) as a monotherapy for the treatment of relapsed small cell lung cancer in patients for whom re-treatment with the first-line regimen is not considered appropriate.

The company noted that Hycamtin is the only oral single-agent chemotherapy approved for SCLC after failure of first-line therapy and patients can be treated at home. This is a clear benefit given that Hycamtin delivered intravenously requires five consecutive days of therapy every three weeks, GSK noted.

The drug, a topoisomerase I inhibitor, received a similar approval in the USA last October.