PHARMACY

Pfizer posts losses, but CEO is hopeful for future

BY Allison Cerra

NEW YORK Pfizer couldn’t catch a break this third quarter.

The company, which posted its third quarter earnings Friday, reported that this year’s time period was grim. Pfizer’s 2007 third-quarter results indicated that revenues declined by 2 percent to $12 billion. Its reported net income dropped an astounding 77 percent compared to the same time last year. Pfizer said the dramatic drop was related to the company’s decision to discontinue the insulin inhalant Exubera.

“We made an important decision regarding Exubera, a product for which we initially had high expectations,” said Jeff Kindler, chairman and chief executive officer of Pfizer. “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.”

The company also said that it would be working to provide patients a transition to other treatment options.

Exubera wasn’t the only setback Pfizer experienced. The loss of market exclusivity for its drugs Norvasc and Zoloft also helped sandbag its revenues. But chief executive officer Kindler is still hopeful for the future.

“We need to deliver better results, continue to make tough decisions about allocating our capital wisely, and bring more new products to the market as quickly as possible,” Kindler said of the financial results. “Doing all of this will put Pfizer on the right course and build value for our shareholders.”

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FDA approves label changes for Accutane and its generics

BY Drew Buono

The Food and Drug Administration has approved label changes to Roche’s acne medication Accutane and its generic isotretinoin, manufactured by Barr Laboratories, Genpharm/Mylan Pharmaceuticals and Ranbaxy Laboratories.

The label changes were made to improve the management of the iPledge pregnancy risk management program. Pregnant women are not allowed to take the medication due to risk of birth defects.

Roche, who proposed the changes, said they are intended to enhance the flexibility of the iPledge program, reduce interruptions in treatment and reduce the burden on patients, prescribers and pharmacies, thereby making the program more consistent with the way prescribers function.

The changes are planned to go into effect on Dec. 2.

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FDA approves Ixempra for breast cancer

BY Drew Buono

WASHINGTON The Food and Drug Administration has approved Bristol-Myers Squibb’s Ixempra monotherapy for the treatment of patients with metastatic or locally advanced breast cancer whose tumors are resistant or refractory to anthracyclines, taxanes and capecitabine.

The FDA has also granted approval of Ixempra in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to an anthracycline and a taxane or whose cancer is taxane-resistant and for whom further anthracycline therapy is contraindicated.

BMS anticipates Ixempra will be available soon.

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