Pfizer pulls out of Daxas collaboration
pharmafile | July 7, 2005 | News story | Sales and Marketing | Daxas, Nycomed, Pfizer
Pfizer has pulled out of an agreement with Altana Pharma to develop and market a new treatment for asthma and COPD following its mixed performance in clinical trials.
The companies came to a mutual decision to terminate their collaboration on Daxas after trials showed it significantly improved lung function but failed to reduce the frequency of exacerbations in a study of patients with chronic obstructive pulmonary disease.
Altana, whose shares dropped 16% on the news, said it intends to continue developing the product, which is currently being considered by European regulators for marketing approval.
Pfizer has also called a halt to research into capravirine, an HIV/Aids drug it had licensed from Shionogi. The drug was being examined for patients with HIV/Aids who had failed on currently available antiretroviral therapies.
In two phase IIb trials it failed to show a statistically significant difference between standard triple-drug HIV treatments and the same therapy combined with capravirine and rights to the compound will be returned to Shionogi.
John LaMattina, president of Pfizer’s global research and development, said: “The search for new and innovative medicines for the treatment of HIV/Aids, COPD and asthma remains a priority for Pfizer and we will continue to invest in other research activities in these areas to address the needs of patients and healthcare providers.”
Pfizer already co-markets another COPD treatment, Spiriva, with Boehringer Ingelheim, which made sales of E525 million last year, having launched in 2002 and in the US in 2004.
The one-year study of Daxas compared it to placebo and involved 1,513 patients with severe and very severe COPD.
The trial primary endpoint of lung function significantly improved with Daxas treatment and the improvement was sustained over the course of the trial. But in looking at the frequency of moderate and severe exacerbations, a co-primary endpoint, Daxas showed no statistically significant reduction in the rate of total exacerbations.
Altana is keeping open the option of looking for a new partner for Daxas, but has made no decisions about when this might happen or who it might be. In the meantime all ongoing Daxas studies will now be transferred from Pfizer to Altana.
Although the company would not give any details on the extra costs it might face, Altana will have to increase its R&D budget but this will not have any affect on the group’s forecast performance for 2005. There will not, however, be any forecast for 2006.
A company spokesman said: “Daxas will have a significant role in the treatment of COPD and we’re still sure it has the potential to achieve blockbuster status.”
He wouldn’t comment on why the collaboration had been terminated and said both Pfizer and Altana had agreed not to disclose the reasons that led to the decision.
Daxas is anticipated to be the first product to gain licences for asthma and COPD simultaneously.
Earlier this year Altana launched Alvesco, the first one puff, once-daily inhaled corticosteroid for asthma, in its first European market, the UK.
As with Daxas, the company said Alvesco also has the potential to become a blockbuster treatment.
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