Just a fortnight after completing its $6.5 billion acquisition of ImClone Systems, Eli Lilly is cutting around 30 out of 70 in-house sales rep posts at the US biotechnology firm.

The news was revealed by the Pharmalot.com blog, which cites a spokeswoman who confirmed the cuts and noted that “this takes the overall size of the sales force back to a mid-2007 sales model that proved very effective for ImClone in maximising the sales of Erbitux (cetuximab)”. The head and neck cancer drug is marketed in North America with Bristol-Myers Squibb which lost out to Lilly in its bid to buy the New York-headquartered group.

The spokeswoman went on to say that ImClone is confident “the B-MS field sales force focused on supporting Erbitux will continue to contribute to the success of this valuable targeted agent”. She added that “we will continue to look to streamline efforts and create synergies across the Lilly and ImClone field sales organisations”.

Erbitux filed for NSCLC
The sales force cut news came as ImClone submitted an application to the US Food and Drug Administration to broaden the use of Erbitux to include first-line treatment of patients with advanced non-small cell lung cancer in combination with platinum-based chemotherapy (cisplatin/vinorelbine).

The submission is based primarily on data from the FLEX 1,100-patient Phase III study conducted by Merck KGaA (ImClone's partner outside North America) which demonstrated that the addition of Erbitux to cisplatin/vinorelbine significantly increased overall survival in the first-line treatment of patients with advanced NSCLC when compared with chemotherapy alone.

Delay for Byetta monotherapy application
Staying with Lilly, the company and partner Amylin Pharmaceuticals face a delay in getting approval for Byetta (exenatide) as a monotherapy for patients with type 2 diabetes. The FDA says it is continuing with its review of the application which may extend into 2009.

Orville Kolterman, senior vice president of R&D at Amylin, said “we remain confident in the strength of our regulatory submission," noting that “importantly, we have not received any request for additional studies”. Lilly and Amylin recently suffered a setback in their bid to gain approval for a long-acting version of the drug, Byetta LAR, when the FDA rejected data from studies meant to show that batches of the drug made by partner Alkermes were comparable to batches made at Amylin's Ohio facility.