Amylin (and partners Eli Lilly and Alkermes) have submitted an application for a once-weekly version of its diabetes blockbuster Byetta to the regulators in the USA, a day after the company announced that it is cutting its sales force by 35%.

The filing to the US Food and Drug Administration is supported by data from the DURATION-1 trial, which demonstrated that once-weekly Byetta (exenatide) injection significantly reduced A1C levels from baseline (1.9%), compared with the twice-daily product (1.5%). Both treatments were also associated with an average weight loss of eight pounds from baseline.

Amylin. Lilly and Alkermes also noted that a meta-analysis of the Byetta database showed no increased risk of cardiovascular events associated with the drug's use. The analysis "applied principles outlined in the FDA's guidance for evaluating cardiovascular risk in type 2 diabetes agents”, the firms said.

The filing comes after Amylin said it will reduce its number of sales representatives by 35%, or 200 employees, a move which reflects "a new approach to sales within the diabetes market." The company’s existing primary care and specialty sales forces will merge, leaving a 325-strong field force "that brings a specialty approach to endocrinologists and diabetes-focused primary care physicians."

Lilly will continue its efforts within the endocrinology and larger primary-care prescriber (PCP) market to support Byetta, Amylin noted. Chief executive Daniel Bradbury said that the move is “in line with our stated goal of achieving positive operating cash flow by the end of 2010, while continuing to position the company to increase sales of Byetta and Symlin (pramlintide) and bring exenatide once-weekly to market as quickly as possible."

The job cuts should result in annual savings of about $45 million in 2010, with a partial benefit of about $20 million expected this year. The move went down well with analysts at JPMorgan who said that the announcement is “a prudent and necessary move on two levels”.

“First and foremost,” the analysts said, “we have long felt that Amylin should not have been targeting PCPs to begin with…after all, that’s what a large pharma partner is for”. Secondly, they say that Byetta has struggled for some time, especially since its use was linked to pancreatitis last summer, “and does not justify the high spend.”

The JPMorgan analysts added that although one could argue that this latest action was done at a time when Amylin’s board is under fire from shareholder and billionaire investor Carl Icahn, “we’re nevertheless encouraged by management’s commitment to reining in costs and being cash flow positive by the end of 2010”. Approval of exenatide once-weekly is vital for the firm but at least this news “should squelch any hopes for a near-term acquisition of Amylin by Lilly”.