At the request of the U.S. Food and Drug Administration, Pfizer Inc. has halted mid-stage clinical studies of what would have been the world’s first biologic pain reliever for back and diabetes-related discomfort.
The news about the once-heralded drug tanezumab, released Monday shortly after the stock market closed, is yet another blow for Pfizer’s new-drug pipeline as the company faces the November 2011 expiration of the patent on Lipitor, the world’s leading medicine, with sales of more than $11 billion last year. It also is disappointing news to Pfizer’s drug-development team in New London, which has been involved in setting up and analyzing tanezumab’s clinical studies.
Just last month, Pfizer had presented positive data on tanezumab, demonstrating the injectable antibody’s effect on reducing knee pain in osteoarthritis patients. A week later, New York-based Pfizer, which has its biggest worldwide research site in Groton, announced that the FDA had asked it to stop a late-stage study of tanezumab in osteoarthritis patients because some people using the experimental drug wound up needing joint replacements.
The FDA’s latest request “follows further consideration of reports of adverse events in osteoarthritis patients,” Pfizer said in a statement, citing “the agency’s concerns regarding the potential for such events in other patient populations in which the compound is being studied.”
Pfizer said it continues to study tanezumab as a pain reliever for cancer patients and in other groups with unmet medical needs.
Pfizer’s stock price was down 18 cents, or about 1.2 percent, at the end of trading Monday, finishing at $14.55 a share.
The latest drug-testing closure for Pfizer follows several years of bad luck and bad decisions regarding some of the company’s most-promising medicines.
Among the most spectacular failures have been heart medication torcetrapib, once heralded as a potential successor to Lipitor but, after an $800 million investment in research during clinical trials, found to result in excessive deaths; the inhaled insulin Exubera, which never caught on with patients and cost the company nearly $3 billion, and the Russian-born antihistamine Dimebon, which had shown excellent results in midstage trials on Alzheimer’s disease but utterly failed in clinical tests that ended earlier this year and cost Pfizer at least $300 million.
Tanezumab was one of the most promising drugs being developed by San Francisco-based Rinat Neuroscience Corp. when Pfizer bought the company four years ago for a reported $500 million. A pipeline review announced by Pfizer just last year put tanezumab as among its top drug prospects.
Earlier studies of the drug showed significant pain relief and no major health risks.
“Repeated dosing with this compound gives sustained pain relief,” Northwestern University researcher Thomas Schnitzer told the website MedPage Today last fall.
But naysayers have questioned the potential market for tanezumab, wondering if an injectable biologic pain reliever would be embraced. Biologic medicines are made with live organisms.
Pfizer indicated it has not given up on tanezumab. It said the shutdown of its latest clinical trials would have no effect on the employment of local scientists.
“Pfizer will continue to work with the FDA to reach a common understanding about the appropriate scope of continued clinical investigation of tanezumab,” the company said.
Related Websites - A big week expected for the banks as half year results are rolled out It's going to be a big week for the banks as the major banks begin to release their half year results. First today will be Barclays and HSBC, both of...
- Projecting the Right Image of Your Company Through Your Corporate Blog Few people realize how powerful a blog can be when it comes to projecting an image to the public. Words have a power all their own and the wrong ones...
- Wynn Macau Rises in Hong Kong on 32% Quarterly Growth Wynn Macau Ltd. advanced to the highest in more than six months in Hong Kong trading after reporting first-quarter revenue surged 32 percent. Wynn Macau climbed 2.8 percent to HK$12.42,...
- Nanotech Robots Developed to Fight Cancer [/caption] On Sunday, March 21, 2010, a group of United States researchers released their findings in the journal Nature. The study offers early proof that a new treatment approach of...
- The history of the epic failure of Xbox 360 Well Dean Takahashi wrote a mind-blowing article about the truth that leads to Xbox 360 hardware failure or we called it RRoD (Red Ring of Death). The story is also...
- Are You Psychic? Test Yourself Online for Free! Are You Psychic? Test yourself online for free! I found this really cool psychic self test online which requires you to choose which shape will be chosen next...it then rates...
- Disgraced HP CEO to get about $28m in cash, stock [/caption] SAN FRANCISCO – Lauded for making Hewlett-Packard Co. the world's biggest technology company, CEO Mark Hurd was in talks for a new contract worth about $100 million, according to...