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Mannkind cuts workforce

Mannkind Corporation is cutting about 41 per cent of its workforce in the wake of the US Food and Drug Administration's refusal to approve the company's inhaled insulin for diabetes Afrezza

Mannkind Corporation is cutting about 41 per cent of its workforce in the wake of the US Food and Drug Administration's (FDA) recent refusal to approve the company's inhaled insulin for diabetes Afrezza.

After the layoffs, which are expected to be complete by mid-April, the company will be down to 257 employees. Mannkind said the restructuring will better position it to continue development of Afrezza.

In its January 19 complete response letter (CRL), the FDA asked for two new studies of the product, which is a rapid-acting drug-device combination intended to control hyperglycaemia in adults with type 1 and type 2 diabetes when used at mealtimes.

"As you can imagine, the receipt of the CRL put us into full contingency plan mode," CEO Hakan Edstrom said, during a conference call with investors and the media. "We are certainly resolved to pursue the approval of Afrezza; however, the focus right now is on a realistic and achievable plan to get from here to approval."

The CEO noted that the company is also in the process of performing a detailed internal review of projects, ongoing activities and spending priorities. "Our goal is to ensure that we can manage our existing resources to the greatest extent possible through the period of time required to conduct the additional clinical studies," he said.

Edstrom said Mannkind is awaiting guidance from the FDA about the additional clinical studies and that once that guidance is received, the company will begin to arrange meetings with potential partners. "The intent of those meetings will be to share with them the details of the CRL, our plans going forward and to get their perspective on the regular path to approval as it relates to partnership negotiation," he said.

The January CRL was the second time the FDA has declined to approve Afrezza. An initial CRL was issued in early 2010. Mannkind resubmitted the marketing application in July of last year, responding to the initial letter by providing additional clinical data.

11th February 2011

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