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Archive for the 'Drug development' Category

Acorda shares rise on FDA notice


Shares of Hawthorne-based drug company Acorda Therapeutics Inc. rose this morning on news that federal regulators will make it a priority to review an application to market a drug for multiple sclerosis.

Acorda shares were trading at $24.59, up $5.09, or 26.1 percent, at 10:25 a.m.

The company said the U.S. Food and Drug Administration has assigned “priority review” status to its application for Fampridine-SR, a drug that would help people with multiple sclerosis walk.
The FDA hopes to complete its review of the application by Oct. 22.

The company first submitted the application on Jan. 30. But on March 30, the FDA said there were “format issues” with the application and requested more information. The company resubmitted the application on April 22.

Acorda also said this morning it lost $18.7 million, or 50 cents a share, in the first quarter, compared to a loss of $16.4 million, or 54 cents a share, in last year’s first quarter.

Posted by Allan Drury on Wednesday, May 6th, 2009 at 9:43 am |
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EpiCept to seek approval of leukemia treatment


EpiCept Corp., a Tarrytown-based biotech company, said that it hopes to file an application seeking U.S. regulatory approval for Ceplene, a new leukemia treatment, during the second half of 2009. That followed an announcement in December that EpiCept had received permission from Canadian authorities to submit an application for approval of the drug. EpiCept said regulators are expected to make decisions on the drug applications in 2010.

Posted by Jay Loomis on Monday, February 2nd, 2009 at 1:49 pm |
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Regeneron drug shown to aid gout patients


Regeneron Pharmaceuticals Inc. said today clinical studies have shown its Arcalyst drug to be effective in reducing incidents of sudden pain in patients with gout, a form of arthritis.

In tests of 83 patients, Arcalyst reduced the number of gout flares 81 percent in patients prescribed allopurinol, a drug used to reduced the amount of excess uric acid in the blood that is known to trigger acute spasms of joint pain and inflammation, the Eastview-based biopharmaceutical company said.

None of the patients experienced any side effects from Arcalyst, an injected drug. The successful completion of the Phase 2 clinical trial opens the door for Phase 3 studies, which Regeneron expects to begin early next year, it said.

Arcalyst, Regeneron’s only marketable drug, was approved earlier this year for treatment of a rare auto-inflammatory condition known as CAPS. Shares of Regeneron rose nearly 6 percent in trading today to end at $21.80 a share, up $1.22.

Posted by David Schepp on Wednesday, September 3rd, 2008 at 4:43 pm |
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PsychoGenics names scientific adviser


PsychoGenics Inc. of Eastview named John McCall to its Scientific Advisory Board, reflecting the company’s growth in the areas of drug discovery and development. McCall has more than 30 years’ experience in the pharmaceutical industry including senior positions at Pfizer, Pharmacia and Upjohn, the company said. McCall is president of PharMac LLC, a consultancy in Boca Raton, Fla.

Posted by Jerry Gleeson on Monday, August 25th, 2008 at 4:08 pm |
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Barr confirms patent challenge


Barr Pharmaceuticals Inc. confirmed today that its Pomona-based subsidiary, Barr Laboratories Inc., has challenged four patents held by Amgen Inc. for its Sensipar drug, used by dialysis patients to treat side-effects of the treatment.

Barr said it filed an Abbreviated New Drug Application with the Food and Drug Administration on March 10, the first date the agency could accept such an application for the kidney drug.

On Monday, Amgen, along with patent partners Brigham and Women’s Hospital Inc. and NPS Pharmaceuticals Inc., filed suit against Barr and Israeli drug-maker Teva Pharmaceutical Industries Ltd. for planning to sell generic Sensipar before the expiration of patent protection.

Sensipar recorded $377 million in U.S. sales during the 12 months ending May, Barr said.

Teva, the world’s largest generic-drug maker, is buying Montvale, N.J.-based Barr for $9 billion, the companies said jointly earlier this month.

Shares of Barr were down fractionally in noontime trading to $65.81 a share.

Posted by David Schepp on Tuesday, July 29th, 2008 at 11:11 am |
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Emisphere reports upbeat results in drug tests


Emisphere Technologies Inc. said today new study results show an oral form of vitamin B12 that the company is developing reduced the amount of time it took for the body to absorb the nutrient, while increasing the amount of the nutrient that was absorbed.

Developing an effective oral form of the nutrient may save millions of Americans from painful injections, needed to ensure they get adequate levels of vitamin B12.

The study, which involved 20 men divided into four groups, showed vitamin B12 absorption was 10 times higher in those given a supplement using Emisphere’s eligen technology, according to the Cedar Knolls, N.J.-based company, which employs 60 workers in research and development at the Landmark at Eastview office complex.

Eligen, which the company has been developing in some form for years, essentially chaperons the nutrient through the digestive system, where it would otherwise be destroyed, into the bloodstream.

Data from the study hold “real promise for improving the way we approach vitamin B12 supplementation,” said Donald W. Jacobsen, professor of molecular medicine at Case Western Reserve University in Cleveland.

At least 5 million people a year in the United States receive some 40 million B-12 injections to treat a range of debilitating diseases.

Shares of the company at midday were up by nearly 7 percent to $3.29 a share.

Posted by David Schepp on Monday, July 28th, 2008 at 11:09 am |
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EpiCept stock jumps after drug review


EpiCept Corp. of Eastview saw its stock price jump after it said it obtained a key European approval for Ceplene, its treatment for a common form of adult leukemia. The Committee for Medicinal Products for Human Use issued a positive opinion regarding the marketing of Ceplene. The drug is administered in conjunction with low-dose Interleuken 2. Stock of EpiCept closed today at 81 cents, up 51 cents.

Posted by Jerry Gleeson on Friday, July 25th, 2008 at 4:29 pm |
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Par Pharma acquires rights to thin-film drug technology


Strativa Pharmaceuticals, the branded drug unit of Par Pharmaceuticals Cos., which employs some 440 workers in Rockland County, has acquired the U.S. rights to a thin-film formulation of an anti-emetic drug, known as Ondansetron, for use by cancer patients.

Anti-emetics are drugs the prevent nausea and vomiting, frequent side effects of radiation and chemotherapy. The drug, should it make it to market, would resemble breath strips, postage stamp-sized films that dissolve in the mouth.

Terms of the deal with Warren, N.J.-based MonoSol Rx, the developer of the thin-film technology, weren’t disclosed, but milestone payments to MonoSol could reach $23.5 million, the companies said.

U.S. sales of anti-emetics reached more than $1.6 billion last year, Par said.

Par, based in Woodcliff Lake, N.J., previously secured rights to Ondansetron for use as an oral spray, currently in development.

MonoSol said it is moving quickly to trials of the thin-film version with the hope of filing a new drug application with U.S. regulators within a year.

Posted by David Schepp on Tuesday, June 17th, 2008 at 4:41 pm |
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Acorda shares soar


Shares of Acorda Therapeutics Inc. soared 29 percent today after the Hawthorne-based biotech company reported a promising trial of its multiple sclerosis drug.

The results of the trial showed that nearly 43 percent of the patients taking the medication, known as Fampridine-SR, walked faster compared to 9.3 percent of the patients taking a placebo, according to Acorda.

If the drug receives regulatory approval, it could one day make walking easier for the multiple sclerosis victims who deal with mobility problems. Multiple sclerosis is a chronic nervous system disease in which the immune system attacks nerve fibers in the brain and spinal cord. More than 400,000 Americans have MS. Most are between the ages of 20 and 50.

“With the success of this trial, we have achieved a critical milestone for Fampridine-SR,” said Ron Cohen, president and chief executive officer of Acorda.

The trial included 240 patients at 39 MS centers in the United States and Canada.
Acorda has been working on the development of the drug since the mid-1990s. That was when Acorda acquired the rights to the medication from Elan, a pharmaceutical company in Ireland.

Cohen said that the company has now successfully completed two trials of the medication that demonstrated improved walking ability for MS victims. Based on those results, Cohen said that the company plans to submit an application seeking regulatory approval of the medication during the first quarter.

Shares of Acorda surged $6.20 to $27.76 in early afternoon trading on the Nasdaq Stock Market.

Posted by Jay Loomis on Monday, June 2nd, 2008 at 11:48 am |
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Progenics stock rises on drug trial news


Progenics Pharmaceuticals Inc. of Eastview and its research partner, Wyeth Pharmaceuticals, announced good and bad news concerning drug trials on its treatment for side effects of painkillers. Investors focused on the positive, and Progenics stock rose 9.79 percent today.
The companies said that a phase 2 study of an oral form of its Relistor drug for the treatment of constipation showed statistically significant improvements in patients. A phase 3 study of an intravenous form of Relistor on post-operative gastrointestinal function, however, fell short of research goals.
Progenics stock closed at $14.47, up $1.29.

Posted by Jerry Gleeson on Thursday, May 22nd, 2008 at 4:17 pm |
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White Plains firm critical of FDA’s review of drug


Two consumer-advocacy organizations are criticizing a U.S. Food and Drug Administration investigation into a generic version of a popular, once-daily dose antidepressant, calling the regulatory agency’s review “inadequate.”

White Plains-based ConsumerLab.com and The People’s Pharmacy, of Durham, N.C., faulted a affirmative determination by the FDA that a generic version of Wellbutrin XL 300, manufactured by Impax Laboratories and distributed by Teva Pharmaceuticals,  because the findings were based on information from a lower dose of the drug.

In reporting its findings this week, the FDA said the generic version, marketed as Budeprion XL 300 milligrams, was “safe and effective.” The agency also said the generic version was equivalent, and therefore interchangeable with, Wellbutrin XL 300.

Calling the FDA’s findings disappointing, ConsumerLab.com and The People’s Lab said there was no evidence that the FDA evaluated the generic drug fully.

“For the FDA to say that it has reviewed the safety and efficacy of this product is not correct,” said Dr. Tod Cooperman, president of ConsumerLab.com.

“The FDA is misleading the public by publishing a positive review which actually provides no data for the 300 milligram product – the strength about which people are complaining,” said Joe Graedon of The People’s Pharmacy (www.peoplespharmacy.com).

The agency undertook its investigation after receiving complaints that patients taking the branded product experienced a loss of effectiveness when switched to the generic pill. Further, patients reported new onset or worsening of side effects.

Posted by David Schepp on Friday, April 18th, 2008 at 4:43 pm |
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Emisphere drug proves positive in dog studies


Emisphere Technologies Inc. reported today that studies involving dogs have provided additional evidence that a technology the company is developing enhances absorption of oral vitamin B12 supplements.

The results confirm an earlier report of effectiveness in studies conducted in rats using Emisphere’s Eligen technology, which reportedly improves absorption of orally administered drugs.

About 40 million Americans undergo annual B12 injections to treat a variety of serious medical conditions. An addition 5 million people yearly consume more than 600 million B12 tablets in various strengths as nutritional supplements, Emisphere said.

Posted by David Schepp on Wednesday, April 16th, 2008 at 2:55 pm |
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