According to MannKind the Food and Drug Administration (FDA) has been unable to complete a review of operations at a French facility owned by Merck & Co’s NV Organon unit that will make the insulin used in Afrezza.
In a press statement MannKind CEO Alfred Mann said the Organon inspection must be completed before the FDA can finalise its review of the drug candidate.
“To our knowledge, all other FDA inspections of third-party suppliers and clinical trial sites are complete, as is the pre-approval inspection of MannKind’s manufacturing facility in Danbury, Connecticut.
He stressed that there are no other pending issues or points the firm must address now that it has complied with the FDA’s request that it change the name of the drug, from Afresa to Afrezza.
Despite this the California-based biotech has not yet been told when the FDA will complete its review and issue its final ruling on the Afrezza new drug application (NDA).
Partnership
MannKind has had something of a roller coaster ride with Afrezza since the drug emerged as the only real contender in the inhaled insulin market after the withdrawal of Pfizer’s Exubera and the shelving of Eli Lilly’s AIR.
Although the firm seems to have demonstrated that its drug shares none of the issues that ultimately led to the failure of Exubera, in recent times it has suffered a series of disappointments related to commercialisation plans.
In June, MannKind lost out in the race to buy Pfizer’s manufacturing plant in Frankfurt-Höchst, Germany, when French drugmaker Sanofi Aventis stepped in and exercised an existing purchase option at the last minute.
This prevented MannKind from gaining the manufacturing license that had motivated the deal in the first place. The firm did purchase $3m worth of insulin under the agreement.
More recently, MannKind’s failure to secure a partner for Afrezza before the end of 2009 took the shine off encouraging data on the drug’s lack of impact on lung function and caused the firm’s share price to fall 31 per cent.
In a filing with the US Securities and Exchange Commission (SEC) at the time MannKind explained that, although “substantial progress” has been made with a potential partner, any deal would not go through until the FDA completed its review.
The latest FDA inspection delay is therefore likely to impact on the signing of any agreement.