Please login to the form below

Not currently logged in
Email:
Password:

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

Share

PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Oxford University Press

Oxford University Press publishes over 100 prestigious, highly cited, and authoritative medical journals, many in collaboration with some of the...

Latest intelligence

#DemandDiversity: For International Women's Day, we ask... why do women often suffer from more side effects than men?
Women are largely prescribed exactly the same treatment regimens as men, with no account for the underlying differences in physiology and drug metabolism between the sexes....
Good design saves lives
Good design and creative thinking are essential if we are to improve on existing problems in new ways, which is why design and creativity within healthcare is vital. Health is...
Why you must understand the pricing of patient recruitment companies
Recruiting a diverse range of patients and engaging with them for your clinical trial isn’t an easy task, which means you might turn to patient recruitment companies, like us, who...

Infographics