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Abbott, Skyepharma Part Ways On Asthma Drug Flutiform

From BioWorld Insight (August 25, 2010)

Abbott Respiratory LLC, as expected, handed back U.S. rights to Flutiform to London-based SkyePharma plc. It was no surprise that the two firms parted ways on the asthma drug candidate after the FDA in January said further clinical trials were needed to file for regulatory approval and later the Flutiform new drug application was transferred back to SkyePharma. Still, Abbott lost out on potential future milestone payments in excess of $150 million.

The biotech said it now is weighing "whether there is a viable way forward for Flutiform." And in the event that the U.S. application can be revived, SkyePharma would look for another partner to license the U.S. rights.

The drug remains under review in Europe, where it is partnered with Mundipharma International. SkyePharma’s partner in Japan, Kyorin Pharmaceutical Co. Ltd., is expected to begin Phase III studies of the drug by March 2011 .

Due to the difference in the U.S. and European regulatory pathways, "I don’t think the issues the FDA has raised read across directly," Peter Grant, SkyePharma chief financial officer, told BioWorld International.

The market in Europe for asthma combination therapy (an inhaled corticosteroid and a long-acting beta agonists, or LABA) was $3.3 billion and is projected to grow to $5 billion in 2012, he said.

Piper Jaffray analyst Sam Fazelli stated in a research note, "We expect SKP to make a decision on continued U.S. development within the next one to two months. In that event, SkyePharma would seek a new U.S. partner for ongoing development and commercialization."

Grant indicated that the financial impact thus far from the stalled U.S. Flutiform application has been fairly minimal. He noted that the company has not missed out on any milestone payments under its deal with Abbott, because payment was only due upon U.S. approval of Flutiform.

And no material payments are due by either party as a result of terminating their agreement, Grant said.

Abbott had obtained the U.S. licensing rights to Flutiform in November 2006 through its acquisition of Kos Pharmaceuticals Inc., which had paid $25 million up front to SkyePharma earlier that year for the rights, plus a pledge for future milestones under a deal potentially totaling $165 million.

Although it continues to review its options for moving the drug forward, SkyePharma had expressed doubt in June that it could meet the FDA’s expectations for approval of its long-acting inhaler.

Such inhalers ?? LABAs ?? were the subject of a warning issued earlier this year by the FDA. The agency called on drug makers to develop risk minimization plans, including new warnings, for the medications.

The new requirements were based on FDA analyses of studies that showed an increased risk of severe exacerbation of asthma symptoms, which led to hospitalizations as well as death in some patients using LABAs for asthma. The agency has not yet released its plans on potential new classwide requirements for LABA clinical trial designs.

FDA’s shifting requirements for LABAs would mean additional studies for Flutiform, including a large postapproval safety study, according to SkyePharma. But despite the FDA’s increased scrutiny of LABAs, Merck & Co. Inc.’s formoterol drug Dulera recently was U.S.-approved.

Flutiform, a fixed-dose combination of formoterol and the inhaled steroid fluticasone, is designed to treat persistent asthma in patients 12 years and older.

The fact that SkyePharma lost Abbott as a U.S. partner on Flutiform doesn’t necessarily damage the prospects for finding another partner, Grant said. Abbott had no other respiratory products when it acquired Kos, he reasoned, but the drug might have made sense for the company if it could have been launched soon.

Now that the relationship is severed, Grant said, SkyePharma is free to out-license Flutiform to a company that might be a more "natural fit" for the drug.

Posted: August 2010