Pfizer warns of lung cancer with inhaled insulin
By Lewis Krauskopf
Apr 9, 2008- Pfizer Inc and Nektar Therapeutics said on Wednesday clinical trials of the inhaled insulin Exubera found increased cases of lung cancer, leading Nektar to stop seeking a marketing partner for the troubled product and abandon it.
Nektar shares tumbled 25 percent, while shares of MannKind Corp, which has been developing its own inhaled insulin, plummeted 58 percent. Pfizer was down slightly at $20.90.
The lung-cancer revelation dealt a final setback to Exubera, which held the promise of letting diabetics avoid needle sticks and was once projected by Pfizer to be a $2 billion-a-year blockbuster. Instead, Exubera has been a commercial flop that has sullied the inhaled insulin field.
Over the course of the clinical trials, Pfizer said six of the 4,740 Exubera-treated patients versus one of the 4,292 patients not treated with Exubera developed lung cancer. One lung cancer case was also found after Exubera reached the market.
Pfizer said on Wednesday it updated the product's labeling to include a warning with safety information about lung cancer cases found in patients who used Exubera, which U.S. regulators approved in January 2006.
The warning states all patients who developed lung cancer had a history of cigarette smoking, and that too few cases existed to determine whether the development of lung cancer is related to Exubera use.
HIGH HOPES
Despite high hopes for Exubera, it garnered few prescriptions. The medicine was dogged by concerns about lung safety and about the inconvenience of the bulky device used to administer the product.
Pfizer said in October it would stop marketing Exubera and returned rights to Nektar. Pfizer reported $12 million in Exubera sales through the first three quarters of 2007; in October it took a pretax charge of $2.8 billion related to exiting Exubera.
Since then, Exubera has not been actively marketed but existing patients were able to get prescriptions while transitioning to an alternative therapy.
The warning in the label stemmed from an ongoing review of data from the Exubera clinical trial program and post-marketing experience by Pfizer and the U.S. Food and Drug Administration, Pfizer said.
Pfizer said it will be discussing withdrawals of marketing authorizations for Exubera with regulatory agencies.
Nektar said it will cease all spending associated with its inhaled insulin programs, including a next-generation version in early clinical testing, and will not incur charges related to the event.
"The news of an increased number of lung cancer cases is disappointing given that as recent as the year-end quarterly conference call, management reiterated the high level of interest from potential partners," Pacific Growth Equities analyst Patricia Bank said in a research note.
MOVED AWAY
Bank downgraded her rating on Nektar stock to "Neutral" from "Buy" on the news.
Nektar Chief Executive Howard Robin said in a statement the company has moved away from inhaled insulin the past year. Its experimental pipeline includes a treatment for pneumonia in the lung about to enter late-stage development, and mid-stage projects for colorectal cancer and opioid-induced constipation.
Since Pfizer's exit last year, Eli Lilly and Novo Nordisk also ended inhaled insulin development programs.
MannKind has been steadfast in its commitment to its experimental inhaled insulin, Technosphere Insulin, saying it held advantages over the other products.
But Natixis Bleichroeder analyst Jon LeCroy downgraded his rating on MannKind stock to "Sell" from "Hold" on the Exubera news.
"We view this as an absolute disaster for MannKind and do not see a believable scenario in which the FDA would approve another inhaled insulin," LeCroy said in his downgrade note.
Showing posts with label Exubera. Show all posts
Showing posts with label Exubera. Show all posts
Thursday, April 10, 2008
Friday, October 19, 2007
Citing Lack of Acceptance, Pfizer Pulls Plug on Inhaled Insulin
NEW YORK, Oct. 18 -- Pfizer has decided to end the marketing of Exubera, its inhaled insulin for type 1 diabetes, phasing it out over the next three months.
Jeff Kindler, chairman and chief executive officer of Pfizer, said "we made an important decision regarding Exubera, a product for which we initially had high expectations. Despite our best efforts, Exubera has failed to gain the acceptance of patients and physicians. We have therefore concluded that further investment in this product is unwarranted."
Kindler said the company would work with physicians to "transition Exubera patients to other treatment options in the next three months. We remain committed to investing significant resources in the development of new and innovative medicines to manage diabetes, including monitoring inhalation technologies and other innovative delivery systems for insulin and other medicines."
The announcement came in the company's third quarter report, which revealed third quarter revenues of $12 billion, a 2% decline from the third quarter of 2007.
The company's third quarter net income was $761 a decrease of 77% form the same period last year, "primarily reflecting pre-tax charges of $2.8 billion related to the decision to exit Exubera," the company said.
The inhaled insulin was approved less than two years ago, but that approval followed a long and rocky development process.
Although clinical trials had demonstrated Exubera to have efficacy similar to that of short-acting insulins, but without the needle stick, a host of concerns had cropped up, including worries about pulmonary toxicities, and questions about Exubera's ability to achieve a reduction in glycosylated hemoglobin (HbA1c) levels to below 7%, the accepted gold standard.
Over the years, the developmental challenge had been to reduce insulin to particles of just the right size to be inhaled by the lung and then absorbed into the bloodstream. Too small, and the particles would be exhaled. Too large, and the particles would be filtered out.
In its approval statement, the FDA noted that the safety and efficacy of Exubera have been studied in approximately 2,500 adult patients with type 1 and type 2 diabetes.
NEW YORK, Oct. 18 -- Pfizer has decided to end the marketing of Exubera, its inhaled insulin for type 1 diabetes, phasing it out over the next three months.
Jeff Kindler, chairman and chief executive officer of Pfizer, said "we made an important decision regarding Exubera, a product for which we initially had high expectations. Despite our best efforts, Exubera has failed to gain the acceptance of patients and physicians. We have therefore concluded that further investment in this product is unwarranted."
Kindler said the company would work with physicians to "transition Exubera patients to other treatment options in the next three months. We remain committed to investing significant resources in the development of new and innovative medicines to manage diabetes, including monitoring inhalation technologies and other innovative delivery systems for insulin and other medicines."
The announcement came in the company's third quarter report, which revealed third quarter revenues of $12 billion, a 2% decline from the third quarter of 2007.
The company's third quarter net income was $761 a decrease of 77% form the same period last year, "primarily reflecting pre-tax charges of $2.8 billion related to the decision to exit Exubera," the company said.
The inhaled insulin was approved less than two years ago, but that approval followed a long and rocky development process.
Although clinical trials had demonstrated Exubera to have efficacy similar to that of short-acting insulins, but without the needle stick, a host of concerns had cropped up, including worries about pulmonary toxicities, and questions about Exubera's ability to achieve a reduction in glycosylated hemoglobin (HbA1c) levels to below 7%, the accepted gold standard.
Over the years, the developmental challenge had been to reduce insulin to particles of just the right size to be inhaled by the lung and then absorbed into the bloodstream. Too small, and the particles would be exhaled. Too large, and the particles would be filtered out.
In its approval statement, the FDA noted that the safety and efficacy of Exubera have been studied in approximately 2,500 adult patients with type 1 and type 2 diabetes.
Tuesday, April 10, 2007
Pfizer Drug for Diabetes Is Lagging
By ALEX BERENSON
Exubera, the first and so far only commercially available inhaled-insulin diabetes treatment, is on the verge of turning into an expensive failure for its maker, Pfizer.
At one point, the company regarded the drug as a potential blockbuster. But despite six months of marketing to doctors, Exubera receives only about one of every 500 prescriptions for insulin written in the United States.
A new diabetes pill, Januvia, which is made by Merck and was approved after Exubera, is already prescribed about 40,000 times a week in the United States, 25 times as often as the Pfizer drug.
And so Wall Street analysts are cutting their sales estimates for Exubera, which has been dogged by questions about its safety, cost and convenience.
Pfizer says it has not given up on Exubera and last week started a new marketing campaign to persuade doctors to prescribe the medicine. In January the company projected that despite its slow start, Exubera would eventually achieve worldwide sales of $2 billion. But doctors and analysts are skeptical.
“I don’t think the drug can be saved,” said David Risinger, an analyst at Merrill Lynch, who last week cut his estimates for Exubera sales. Mr. Risinger now expects that Exubera will have $310 million in sales worldwide in 2012, down from his previous estimate of $800 million. Other analysts have also cut their forecasts.
Exubera’s problems add to the uncertainties facing Pfizer, whose shares have lost almost half their value since 2000.
While the company remains highly profitable, its financial health is increasingly tied to Lipitor, a best-selling cholesterol-lowering medicine that faces competition from cheaper drugs and in several years, patent expiration.
http://www.nytimes.com/2007/04/10/business/10drug.html?ex=1333857600&en=90e481b8629e7386&ei=5088&partner=rssnyt&emc=rss
Exubera, the first and so far only commercially available inhaled-insulin diabetes treatment, is on the verge of turning into an expensive failure for its maker, Pfizer.
At one point, the company regarded the drug as a potential blockbuster. But despite six months of marketing to doctors, Exubera receives only about one of every 500 prescriptions for insulin written in the United States.
A new diabetes pill, Januvia, which is made by Merck and was approved after Exubera, is already prescribed about 40,000 times a week in the United States, 25 times as often as the Pfizer drug.
And so Wall Street analysts are cutting their sales estimates for Exubera, which has been dogged by questions about its safety, cost and convenience.
Pfizer says it has not given up on Exubera and last week started a new marketing campaign to persuade doctors to prescribe the medicine. In January the company projected that despite its slow start, Exubera would eventually achieve worldwide sales of $2 billion. But doctors and analysts are skeptical.
“I don’t think the drug can be saved,” said David Risinger, an analyst at Merrill Lynch, who last week cut his estimates for Exubera sales. Mr. Risinger now expects that Exubera will have $310 million in sales worldwide in 2012, down from his previous estimate of $800 million. Other analysts have also cut their forecasts.
Exubera’s problems add to the uncertainties facing Pfizer, whose shares have lost almost half their value since 2000.
While the company remains highly profitable, its financial health is increasingly tied to Lipitor, a best-selling cholesterol-lowering medicine that faces competition from cheaper drugs and in several years, patent expiration.
http://www.nytimes.com/2007/04/10/business/10drug.html?ex=1333857600&en=90e481b8629e7386&ei=5088&partner=rssnyt&emc=rss
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