Inhaled-insulin drug Exubera - monitoring programme to be launched by Pfizer

Sep 10 2005

Drug company Pfizer says it is all set to launch a patient-monitoring scheme in order to assess the safety of its novel inhaled-insulin drug Exubera, if the product is approved for use.

Exubera which is being developed with Sanofi-Aventis SA and Nektar Therapeutics, is due to be reviewed by a U.S. Food and Drug Administration panel this week.

It is expected by most industry analysts that the drug will be given the green light, it has been touted as a potential $2 billion-a-year seller.

But some experts are concerned about the drug's potential adverse effects on the lungs or blood sugar levels.

According to Pfizer's development head, Declan Doogan, the company acknowledges that using Exubera might raise some safety issues and the company is therefore prepared for a credited follow-up programme among users.

Doogan says this is a new venture and safety is a major agenda item.

Exubera could revolutionise treatment for diabetics by doing away with the need for some, or all, insulin injections

However, according to documents released on Wednesday, the FDA says that the risks involved with using the product needed to be scrutinised closely.

Doogan has declined to comment on widespread speculation that Pfizer, the world's biggest drug maker, was attempting to buy its partner Sanofi out of the project, but confirms the two companies are in talks about the future and how the product will be managed.

Apparently, following the development of Sutent, an experimental pill against cancers of the kidney and stomach, cancer is also a growing field of focus for Pfizer.

The drug Sutent is a "smart bomb" drug that selectively targets receptors to several proteins, which are believed to act as a molecular switch for cancer growth.

Doogan says the drug is a major new therapy for Pfizer, and its scientists hope to find out in the coming year whether the drug also has the potential to fight other widely occurring cancers, such lung, breast and prostate cancers.

If cancer did become a priority area of research for Pfizer, the company might want to complement its in-house research with know-how and products licensed in from smaller companies.

Doogan says the company's internal portfolio is massive and they have a lot to keep them busy.

However, he agrees there will be certain gaps in the portfolio if they proceed in respect of tumour research needs.

He says they are going to be aggressive in acquiring new entities on the basis of their future potential and also to fill gaps in the portfolio.