Pfizer has made a partnership-of-sorts with fellow inhaled insulin maker Mannkind in a bid to free itself from the last vestiges of its failed Exubera.

The two companies announced yesterday that Mannkind and Pfizer would move about 51 patients off Exubera onto Mannkind’s investigational inhaled insulin product Technosphere Insulin.

The move is not considered a “real” partnership and according to one analyst, Jon Lecroy of Natixis Bleichroeder, the move shows “Pfizer wants to get as far away from inhaled insulin as it can”.

In October last year, the drug giant decided to drop its inhaled insulin product Exubera following poor financial figures and an overwhelming negativity to the product. It had been touted as a blockbuster drug.

Since the product’s termination, Exubera patients have been transitioning to other diabetes therapies, but a small number of patients still have a medical need for inhaled insulin. Pfizer initiated discussions with Mannkind to give patients access to Technosphere Insulin.

Under the terms of the agreement, Pfizer will reimburse some of Mannkind’s costs relating to the transition of patients.

Mannkind’s Chief Scientific Officer Dr Peter Richardson said: “For some Exubera patients, continued treatment with inhaled insulin is needed. These patients generally fall into two categories: those with severe needle-phobia or a very poor response to subcutaneous insulin. This small number of patients represents a group with particularly high medical need who will benefit from using an inhaled insulin such as Technosphere Insulin.”

Is this the way forward?
On the same day as announcing that Mannkind would collaborate with Pfizer on transitioning inhaled insulin patients, the Californian company also released successful Phase III results for its Technosphere Insulin.

The study on Type 1 diabetes patients showed blood-sugar levels were regulated and in comparing patients taking inhaled insulin with injected insulin, Technosphere showed it was as effective as the injected version.

Other results showed there was better post-prandial glucose control, fewer hypoglycaemic events, and more weight loss in the patients taking the inhaled product.

Most important, however, was the result that showed there were no adverse effects on pulmonary function. This point is critical after Pfizer’s Exubera was found to be linked to a risk of lung cancer.

“These observations confirm the results of earlier studies and build on the important differentiating features of this product, including its positive effects on fasting glucose levels,” Richardson said in a statement.

The company expects to submit a New Drug Application to the US Food and Drug Administration by the end of the year.

But the question on everyone’s lips is, will the product fear any better than Exubera – in fact, will it even be approved?

According to analyst Lecroy, the general forecast for the product is that it will never come to market despite the apparent success of the Phase III trial.

Based on Exubera’s lung cancer scare, Lecroy told PharmaTimes he did not expect the FDA to approve the drug, and based on market analysis it was believed there was no demand for insulin in an inhaled form.

Already, inhaled insulin developers Eli Lilly and Novo Nordisk have terminated their experimental products after Exubera went under.

The other obstacle Mannkind will have to face is finding a partner to help bring the product to market should it be approved.

Mannkind remains positive that Technosphere Insulin will be an important additional option for diabetes patients.