Business in the Burbs » Biopharmaceutical

FDA panel to review Acorda drug on Oct. 14

Jay Loomis — Tue, 25 Aug 2009 18:22:40 +0000

October 14th will be an important day for Acorda Therapeutics Inc., a Hawthorne-based biotech company.

That’s when a U.S. Food and Drug Administration panel is scheduled to conduct a critical review of Fampridine-SR, Acorda’s new multiple sclerosis drug that is designed to make walking easier for the disease’s victims. Acorda has been working on the development of the drug since the mid-1990s.

Investor optimism about the drug’s potential has helped fuel a rise of more than 800 percent in Acorda’s stock price since September 2006.

Analysts said that a final FDA decision on Fampridine-SR may slip past an earlier deadline of Oct. 22.

“It would seem nearly impossible for the FDA to approve Fampridine so quickly after the panel” conducted its review on Oct. 14, Phil Nadeau, a Cowen & Co. analyst, said in a note to clients, according to Bloomberg News. “Nonetheless, assuming a positive panel, the delay is likely to be modest (three months or so).”

Acorda recently reached agreement with another biotech company, Biogen Idec of Cambridge, Mass., to handle the marketing and regulatory approvals for the Fampridine-SR medication in foreign markets. Acorda already sells Zanaflex, a treatment for involuntary muscle movements caused by multiple sclerosis and spinal injuries.

Curemark secures $6.5 million in funding

Jay Loomis — Mon, 10 Aug 2009 17:36:17 +0000

Curemark, a Rye-based drug research and development company, said that it has secured $6.5 million of initial funding from private investors. The privately held company said that the financing will allow it to conduct clinical trials on an autism treatment at 11 sites across the country.

Drug companies seek approval to deliver new drug through pre-filled syringes

Jay Loomis — Tue, 04 Aug 2009 17:48:52 +0000

Progenics Pharmaceuticals Inc. and Wyeth Pharmaceuticals said they have submitted an application to the U.S. Food and Drug Administration and European regulators to approve the use of pre-filled syringes with their Relistor constipation drug. The medication itself has already received regulatory approval.

Progenics, an Eastview-based biotech company, partnered with Wyeth in 2005 to jointly develop and sell Relistor, an injectable drug designed to treat constipation caused by painkillers. If regulators approves the use of the pre-filled syringes, the drug could be available in that form in the United States and Europe by the first half of next year and be easier to administer to patients, according to the companies.

Cleveland Clinic offers IntegraMed program to fertility patients

Jay Loomis — Tue, 28 Jul 2009 19:16:58 +0000

IntegraMed America Inc., the Purchase-based company that runs vein clinics and fertility centers, said that the Cleveland Clinic has begun offering its Attain IVF Program to patients undergoing fertility treatment.

The program provides refunds of 70 percent to 100 percent of patient fees if the fertility treatments do not result in the family taking home a baby. IntegraMed said the program is designed to reduce the financial risk for a patient receiving such treatments. The Cleveland Clinic, one of the largest private medical centers in the world, performed more than 600 fertility treatments during the past year.

Regeneron receives $20 million after patient enrolled in study

Jay Loomis — Thu, 23 Jul 2009 21:09:25 +0000

Regeneron Pharmaceuticals Inc., a biotech company based in Eastview, said that it has received a $20 million payment after enrolling the first patient in a study that looks at the effectiveness of its its VEGF Trap-Eye as a potential treatment for central retinal vein occlusion, a leading cause of blindness.

Regeneron received the payment as part of an agreement with Bayer HealthCare AG, its partner in developing VEGF Trap-Eye as a treatment for various eye diseases. The latest testing program includes patients from multiple countries participating in two one-year studies.

Wyeth Pharmaceuticals laying off 15 workers

Jay Loomis — Wed, 15 Jul 2009 19:27:26 +0000

Wyeth Pharmaceuticals Inc. said that it is laying off 15 unionized production workers at its Pearl River plant after a slowing economy hurt demand for the plant’s vitamin products.

The affected employees work in Wyeth’s consumer health care manufacturing business that produces and packages the Centrum family of multivitamins for the U.S. market. Sales of Centrum have slowed in recent months as consumers, facing tighter budgets in a weakening eocnomy, shifted purchases to cheaper private-label vitamins.

The layoffs at the 550-acre complex affect Rockland County’s largest private employer. After the layoffs, the site will have about 3,000 employees and an annual payroll of $275 million.

The latest layoffs in Pearl River follow a reduction of 13 jobs in March.

“We needed to bring our staffing in line with present production needs,” said Grace Ann Arnold, a Wyeth spokeswoman. “There has been a decrease in demand for the products produced in Pearl River.”

In January, drug maker Pfizer announced plans to buy Wyeth for $68 billion. At the time, Pfizer said that it will close factories but did not identify which ones.

Arnold said the layoffs this week are not related to the pending Pfizer acquisition. She added that the employees could be recalled to work if the plant’s production levels improve.

Acorda reaches agreement to cover foreign sales of MS drug

Jay Loomis — Wed, 01 Jul 2009 20:32:04 +0000

Acorda Therapeutics Inc., a Hawthorne-based biotech company, announced an agreement to develop, commercialize and gain regulatory clearances for its new multiple sclerosis drug in foreign markets with the assistance of another biotech company.

Biogen Idec of Cambridge, Mass., will handle the marketing and regulatory approvals for the Fampridine-SR medication in foreign markets. Acorda said that it will receive an upfront payment of $110 million and additional payments of up to $400 million from Biogen based on the sales track record of the medication, which is designed to improve the walking ability of multiple sclerosis victims.

The agreement also calls for Biogen to make royalty payments to Acorda on foreign sales of Fampridine-SR.

Another drug company, Elan, will continue to manufacture Fampridine-SR, based on an existing agreement with Acorda.

Acorda is currently seeking approval for the medication in U.S. markets from the Food and Drug Administration. The drug is also eligible for a centralized regulatory review in Europe, potentially opening up huge new markets for the medication if it receives approval.

Acorda has been working on the development of the drug since the mid-1990s.

“Biogen Idec has outstanding capabilities in commercializing neurology and oncology products and is known globally for its reputation as an innovative leader in the field of multiple sclerosis,” Ron Cohen, president and chief executive officer of Acorda, said in a written statement. “We are delighted to be working with them to make Fampridine-SR, if approved, available to people living with MS in Europe, Canada, Australia and other areas of the world.”

Regeneron reaches royalty agreements for two medications

Jay Loomis — Thu, 11 Jun 2009 18:04:15 +0000

Regeneron Pharmaceuticals Inc., a biotech company based in Tarrytown, said it has entered into two royalty agreements with Novartis Pharma AG covering two medications that the companies have been developing.

Under the first royalty agreement, Regeneron said it is entitled to receive royalties on worldwide sales of Novartis’ canakinumab, a medication currently under regulatory review to treat inflammatory diseases. Under the second royalty agreement, Novartis is entitled to receive royalties on worldwide sales of a second-generation interleukin-1 Trap, another treatment for inflammatpry diseases, if development proceeds.

Par Pharmaceutical shipping nasal spray

Jay Loomis — Tue, 09 Jun 2009 18:07:04 +0000

Par Pharmaceutical Co. Inc., a New Jersey-based drug company that has research and manufacturing operations in Chestnut Ridge, said that it has started shipping a new product. Par’s Calcitonin-salmon nasal spray is a generic version of Novartis AG’s Miacalcin brand, which booked sales of $112 million in 2008. Par earlier received regulatory approval from the U.S. Food and Drug Administration to ship the generic version of the nasal spray.

Progenics halts work on hepatitis treatment

Jay Loomis — Mon, 08 Jun 2009 21:24:16 +0000

Progenics Pharmaceuticals Inc., a Tarrytown-based biotech company, said that it has halted development of PRO 206, a treatment for the hepatitis C virus infection. The move comes at a time when Progenics said it looking to boost “operating efficiencies” and focus on its most promising drug development programs. “While our review indicated that PRO 206 did not satisfy the criteria for further development, our ongoing research and development efforts have yielded new compounds demonstrating comparable potency to PRO 206,” Chief Executive Officer Paul J. Maddon said in a written statement. The company added that it hopes to select a new drug development candidate for hepatitis in 2010.