Pfizer ($PFE) hasn't given up on the experimental menopause drug Aprela despite delays in the program, and the drug giant aims to file for FDA approval of the treatment sometime this year, the company told Dow Jones Newswires' Peter Loftus.
Wyeth, which Pfizer acquired in 2009, began working on the drug--a combination of estrogen conjugates and bazedoxifene--in 1999, Loftus reports. The program has been dogged by safety concerns and development delays, putting the project about 5 years behind schedule. But Pfizer sees an opportunity to deliver menopausal women a new option to combat hot flashes and bone thinning.
"We think this is a market which is unsatisfied ... and if you can bring a hormone therapy which doesn't have the traditional side effects, we can actually lead that marketplace," said Olivier Brandicourt, Pfizer's primary-care chief, as quoted by Dow Jones.
Any commercial success of Aprela would likely been seen as a bonus to Pfizer's investors. The company's R&D group has been emphasizing new therapies for cancer and rheumatoid arthritis in its pipeline, with some recent successes in FDA approvals for the lung cancer drug Xalkori and the kidney cancer treatment Inlyta. Loftus reports that many analysts have already written off Aprela after the delays and safety concerns about hormone therapies, but it appears that the program still has some legs.
- get more in Loftus' report