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Archive for the 'Biopharmaceutical' Category

FDA panel to review Acorda drug on Oct. 14

August
25

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.

Posted by Jay Loomis on Tuesday, August 25th, 2009 at 1:22 pm |
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Curemark secures $6.5 million in funding

August
10

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.

Posted by Jay Loomis on Monday, August 10th, 2009 at 12:36 pm |
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Drug companies seek approval to deliver new drug through pre-filled syringes

August
4

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.

Posted by Jay Loomis on Tuesday, August 4th, 2009 at 12:48 pm |
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Cleveland Clinic offers IntegraMed program to fertility patients

July
28

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.

Posted by Jay Loomis on Tuesday, July 28th, 2009 at 2:16 pm |
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Regeneron receives $20 million after patient enrolled in study

July
23

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.

Posted by Jay Loomis on Thursday, July 23rd, 2009 at 4:09 pm |
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Wyeth Pharmaceuticals laying off 15 workers

July
15

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.

Posted by Jay Loomis on Wednesday, July 15th, 2009 at 2:27 pm |
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Acorda reaches agreement to cover foreign sales of MS drug

July
1

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.”

Posted by Jay Loomis on Wednesday, July 1st, 2009 at 3:32 pm |
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Regeneron reaches royalty agreements for two medications

June
11

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.

Posted by Jay Loomis on Thursday, June 11th, 2009 at 1:04 pm |
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Par Pharmaceutical shipping nasal spray

June
9

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.

Posted by Jay Loomis on Tuesday, June 9th, 2009 at 1:07 pm |
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Progenics halts work on hepatitis treatment

June
8

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.

Posted by Jay Loomis on Monday, June 8th, 2009 at 4:24 pm |
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Acorda drug eligible for coordinated review in Europe

June
8

Acorda Therapeutics Inc. said that its new multiple sclerosis drug is eligible for a centralized regulatory review in Europe, potentially opening up huge new markets for the medication if it receives approval.

The Hawthorne-based biotech company has been seeking approvals for the drug, known as Fampridine-SR, after a study showed that patients taking the medication walked faster than patients taking a placebo.

Multiple sclerosis is a chronic nervous-system disease in which the immune system attacks nerve fibers in the brain and spinal cord. If the drug is approved, the drug could one day make walking easier for the multiple sclerosis victims who deal with mobility problems.

Acorda said that European regulators have decided that the drug can be evaluated in a single, coordinated review on behalf of all European Union member countries, instead of the time consuming process of each country doing the evaluation seperately. Acorda could gain a 10-year market exclusivity for Fampridine-SR in European Union countries under the approval process.

Acorda is also seeking approval to market the drug in the United States from the U.S. Food and Drug Administration.

Posted by Jay Loomis on Monday, June 8th, 2009 at 3:55 pm |
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Acorda resubmits drug application

April
23

Acorda Therapeutics Inc. of Hawthorne has resubmitted an application to market Fampridine-SR, a drug that would help people with multiple sclerosis walk.

The company received word from the U.S. Food and Drug Administration March 30 that its first application was lacking information and could not be accepted for review. Acorda shares dropped $5.09, or 20.44 percent, to close at $19.81 that day.

The company said it resubmitted the application after discussions with the FDA and believes it has made the changes in the application that the agency wanted.

Acorda shares rose $3.78, or 20.6 percent this morning and were trading at $22.12 at 9:47 a.m.

Posted by Allan Drury on Thursday, April 23rd, 2009 at 9:05 am |
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Accorda announces vice president appointment

April
10

Acorda Therapeutics Inc., the biopharmaceutical company in Hawthorne, said this morning that Dr. Anthony Caggiano has been promoted to vice president of preclinical development.

He will continue to manage the preclinical and research and development departments, the company said. He will also oversee the company’s preclinical programs that seek to develop treatments for multiple sclerosis, spinal cord injuries and other neurological disorders.

Caggiano joined the company in September 2001 as a laboratory scientist and has held a number of positions since then.

Posted by Allan Drury on Friday, April 10th, 2009 at 10:12 am |
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Regeneron to share technology with Texas researchers

April
1

Regeneron Pharmaceuticals Inc., a biotech company in Eastview, announced an agreement to share key technology with researchers at the University of Texas Southwestern Medical Center in Dallas. Regeneron said the technology, known as VelocImmune, increases the speed of human antibody development. Under the agreement, the university’s researchers can use the technology to help develop new medications.

Posted by Jay Loomis on Wednesday, April 1st, 2009 at 1:43 pm |
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Acorda shares drop after FDA issues letter

March
31

Shares of Hawthorne-based Acorda Therapeutics fell 19 percent this morning after federal regulators refused to accept the company’s application for Fampridine-SR, a drug for people with multiple sclerosis.

The company said the Food and Drug Administration issued a “refuse to file” letter for the drug, which would help people with multiple sclerlosis walk. The FDA has “format issues” with the company’s electronic submission. The company said the FDA wants some of the data put into a different format and also requested some additional information.

“We are surprised by this development,” Dr. Ron Cohen, the company’s president and chief executive, said in a statement released by the company. “We plan to address the issues raised in this letter with (the) FDA expeditiously, as we believe Fampridine-SR is potentially an important, first-in-class treatment option for people suffering with MS.”

Acorda shares were trading at $20.13, down $4.77 or 19.16 percent at 10 a.m.

Posted by Mike Bieger on Tuesday, March 31st, 2009 at 9:25 am |
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Curemark to begin tests of drug in autism victims

March
25

Curemark LLC, a Rye-based drug research and development company focused on neurological diseases, said that it has received regulatory clearance to start a drug testing program.

The tests, designed to study the effectiveness of Curemark’s CM-AT medication as an autism treatment, are expected to begin the tests at multiple sites across the country during the second quarter.

“With 1 in 150 children diagnosed with autism, we have children who are suffering,” Dr. Joan Fallon, Curemark’s chief executive officer, said in a written statement. “We are very excited about the opportunity to enter a Phase III trial for this ever-growing population of children.”

Posted by Jay Loomis on Wednesday, March 25th, 2009 at 3:46 pm |
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Regeneron begins drug testing program for gout patients

March
25

Regeneron Pharmaceuticals Inc., a biotech company in Eastview, said that it has started a testing program to evaluate the effectiveness of its Arcalyst drug as a treatment for gout.

Regeneron said that it expected to release preliminary results of the tests in 2010. The testiing program will involve hundreds of patients.

“Nearly one and a half million Americans are treated for gout each year, but significant unmet medical needs persist,” Dr. George D. Yancopoulos, president of Regeneron Research Laboratories, said in a written statement.

Arcalyst, Regeneron’s only marketable drug, was approved last year for treatment of a rare auto-inflammatory condition known as CAPS.

Posted by Jay Loomis on Wednesday, March 25th, 2009 at 3:15 pm |
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Diebold, Acorda sign new leases

March
19

A global security business is consolidating three separate offices into a single site in Elmsford, and a biotechnology company has renewed its lease in Hawthorne, Mack-Cali Realty Corp. said.
Diebold Enterprise Security Inc. has signed a seven-and-a-half year lease for 32,000 feet at 3 Westchester Plaza, at the Cross Westchester Executive Park, Mack-Cali said. Diebold will move staff from three different buildings on Lafayette Street in White Plains to the new site in May.
The building is 84.9 percent leased. Diebold was represented by CB Richard Ellis’ Executive Vice President William V. Cuddy Jr. and Senior Associate Timothy C. Donohue. Mack-Cali Vice President of Leasing Jeffrey Warner and Senior Director of Leasing Carol McGuire represented the landlord.
Mack-Cali also announced that Acorda Therapeutics Inc. has signed a three-year lease renewal for 46,000 feet at 15 Skyline Drive in Hawthorne. The building is fully leased.

Posted by Jerry Gleeson on Thursday, March 19th, 2009 at 4:31 pm |
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Electro-Optical announces positive study results for melanoma device

February
13

Electro-Optical Sciences Inc. of Irvington announced positive results from a study of MelaFind, an instrument the company is developing to help doctors detect melanoma, a deadly form of skin cancer.

The study, involving 1,383 patients at seven treatment centers nationally, found that MelaFind had a 98 percent success rate in detecting melanoma. The company said that it expects to soon submit an application seeking approval of the device with the U.S. Food and Drug Administration.

“MelaFind appears to be an excellent tool to help detect melanoma at the earliest, most treatable stage,” Gary D. Monheit, associate clinical professor of dermatology at the University of Alabama in Birmingham and the lead investigator for the MelaFind trial, said in a written statement.

Posted by Jay Loomis on Friday, February 13th, 2009 at 3:34 pm |
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Progenics to move ahead with HIV treatment

February
10

Progenics Pharmaceuticals Inc., a Tarrytown-based biotech company, said that the company plans further development of an injectable treatment for HIV infection known as PRO 140. Progenics said that the decision follows positive results from a study of the treatment and positive comments from treatment advocates and people living with HIV. Progenics added that the study showed that PRO 140 perfomed better than a placebo and was well tolerated by patients.

Posted by Jay Loomis on Tuesday, February 10th, 2009 at 1:59 pm |
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Business in the Burbs is our online news blog about businesses based or operating in the Lower Hudson Valley. Visitors here will also find items of interest to consumers in the region. Most contributions are from business reporters and editors covering Westchester, Rockland and Putnam counties.

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