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Archive for the 'Biopharmaceutical' Category

Par loses lawsuit, ordered to pay $69.96 million

February
10

Par Pharmaceutical Co. Inc., which has research and manufacturing operations in Chestnut Ridge, disclosed this morning that a federal judge in Illinois has ordered it to pay $69.96 million in connection with a lawsuit.

The company said the court entered the judgment in favor of Pentech Pharmaceuticals Inc., which alleged in 2004 that Par violated a contract with Pentech. The contract governed the supply and marketing of the generic version of Paxil, a drug for depression.

As a result of the decision, which came after a trial, Par will set aside reserves of $28 million on an after-tax basis in the fourth quarter of its fiscal 2008.

Par, which is based in Woodcliff Lake, N.J., said it received the decision yesterday and is considering an appeal.

Posted by Allan Drury on Tuesday, February 10th, 2009 at 10:08 am |
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Acorda submits drug application

February
2

Acorda Therapeutics Inc. of Hawthorne said this morning it has submitted an application to market Fampridine-SR, a treatment to help people with multiple sclerosis walk. The company said it believes that if the U.S. Food and Drug Administration accepts the application for review, the FDA could complete its review within 10 months.

The company said at least 400,000 people in the United States have multiple sclerosis and studies show at least 64 percent of those have trouble walking. Many people with the condition say that walking is the biggest challenge it poses, the company said.

Acorda said it has also discussed the drug with regulators in Europe and it plans to file an application there.

Posted by Allan Drury on Monday, February 2nd, 2009 at 10:47 am |
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XTL considers merger offers

January
28

XTL Biopharmaceuticals Ltd., a Valley Cottage-based biotech company, said that it is evaluating merger proposals from U.S. and foreign companies. XTL did not identify those potential merger partners, which operate in and outside of the health care sector.

“These discussions are preliminary in nature, and consequently, the timing of and ability to consummate such a transaction cannot be predicted at this time,” XTL said in a written statement.

The company added that it may still decide that its best option is to liquidate the company by distributing the remaining assets to the shareholders.

XTL originally announced plans in December to seek a merger partner or liquidate after the failure of a clinical trial for bicifadine, a treatment for nerve pain associated with diabetes. The company said that the study comparing the effectiveness of two doses of bicifadine against a placebo failed to meet its primary goals.

Posted by Jay Loomis on Wednesday, January 28th, 2009 at 3:30 pm |
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EpiCept reports positive study of skin cream

January
27

EpiCept Corp. announced positive results from a study of a skin cream that is under development at the Eastview-based biotech company. The cream, designed to relieve nerve pain, performed better than a placebo cream and at least as well as a generic cream, according to EpiCept. Jack Talley, president and chief executive officer, said that the favorable results may help EpiCept find a partner to help develop the cream.

Posted by Jay Loomis on Tuesday, January 27th, 2009 at 3:36 pm |
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Leukemia & Lymphoma Society to invest $3.7 million in study

January
22

The Leukemia & Lymphoma Society in White Plains will invest $3.7 million to help study a new treatment for acute myeloid leukemia that is under development by Celator Pharmaceuticals Inc. Celator, based in Princeton, N.J., expects to start patient enrollment in a study of the treatment during the first quarter in the United States and Canada. The treatment, known as CPX-351, is being studied in patients 60 to 75 years old.

Posted by Jay Loomis on Thursday, January 22nd, 2009 at 3:14 pm |
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Emisphere director Pack dies

December
16

The board of directors of Emisphere Technologies Inc. plans to name a successor to fill the seat of longtime director Howard M. Pack of Scarsdale, who died of a heart attack while seeing his doctor on Dec. 9, company spokesman Bob Madison said yesterday.
Pack, 90, had been on the board since Emisphere’s inception in 1986 and had chaired the board’s compensation committee. He had retired as executive vice president of finance in 1988. Pack’s term expires in 2010.
Emisphere is headquartered in Cedar Knolls, N.J. and has a research lab in Eastview.

Posted by Jerry Gleeson on Tuesday, December 16th, 2008 at 4:58 pm |
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EpiCept treatment improves leukemia survival rate

December
4

Shares of EpiCept Corp. rose 3.2 percent after the Tarrytown-based biotech company reported that trials of its Ceplene cancer treatment showed an improved survival rate in leukemia patients.

EpiCept is seeking a commercial partner to market Ceplene in Europe to adults with acute myeloid leukemia following regulatory approval to market the treatment in 27 European Union states, as well as Iceland, Liechtenstein and Norway. The company also said that it will intends to pursue regulatory approvals for Ceplene in the United States and Canada.

“Delaying and preventing relapse in (acute myeloid leukemia) patients who achieve complete remission is critical to their long-term survival,” said Jack Talley, chief executive officer of EpiCept.

Shares of the company rose 2 cents yesterday to 64 cents.

Posted by Jay Loomis on Thursday, December 4th, 2008 at 2:27 pm |
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Watson to buy rights to generic drugs

November
25

Watson Pharmaceuticals Inc. announced an agreement to buy rights to 17 generic drugs that will be divested as a result of the pending sale of Barr Pharmaceuticals Inc. to Teva Pharmaceutical Industries Ltd.

Watson said that it will make an upfront payment of $36 million to buy the products and will make additional payments to Teva when milestones are met on the development-stage products.

The medications in the deal include cyclosporine, which is used to treat rheumatoid arthritis, psoriasis and other ailments. Barr has major operations in Rockland County.

Posted by Jay Loomis on Tuesday, November 25th, 2008 at 4:57 pm |
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Barr settles patent cases

November
19

Barr Pharmaceuticals Inc., a generic drug manufacturer with major operations in Rockland County, said that it will have the rights to launch generic versions of the allergy treatments Allegra and Nasacort in settlements of patent litigation.

Sanofi-Aventis and other companies had filed the lawsuits accusing Barr with infringing patents on the medications. Sanofi-Aventis will receive royalty payments from Barr under the settlements that will end the litigation, according to Barr.

“We believe that these agreements represent a pro-consumer resolution to this ongoing litigation,” Barr Chief Executive Officer Bruce L. Downey said in a written statement.

Posted by Jay Loomis on Wednesday, November 19th, 2008 at 12:56 pm |
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XTL Biopharmaceuticals reports setback with pain treatment

November
18

XTL Biopharmaceuticals Ltd., a biotech company based in Valley Cottage, announced a setback involving Bicifadine, its treatment for nerve pain associated with diabetes.

The company said that the study comparing the effectiveness of two doses of Bicifadine against a placebo failed to meet its primary objective.

“We are all very disappointed with the results of the study,” Chief Executive Officer Ron Bentsur said in a written statement. “We will devote the next few days to further analyze the data and decide on the appropriate course of action for the Bicifadine program and for the company.”

Posted by Jay Loomis on Tuesday, November 18th, 2008 at 2:16 pm |
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Progenics drug approved in Australia

November
17

Progenics Pharmaceuticals Inc., an Eastview-based biotech company, said that its Relistor constipation drug can be sold in Australia following regulatory approval in that country.

Progenics partnered with Wyeth in 2005 to jointly develop and sell Relistor, an injectable drug designed to treat constipation caused by painkillers. It is the first commercial product for Progenics.

“Approval in Australia expands global access to this novel product which has already received approval in Canada, the U.S., European Union member states, and Iceland, Norway, Liechtenstein and Venezuela,” Chief Executive Officer Paul J. Maddon said in a written statement.

Posted by Jay Loomis on Monday, November 17th, 2008 at 2:14 pm |
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Japanese company to market Progenics drug

October
17

Progenics Pharmaceuticals Inc., a biotech company based in Eastview, said that a Japanese company has acquired the rights to sell its constipation drug Relistor in Japan.

Ono Pharmaceutical Co. Ltd. of Osaka, Japan, will be responsible for developing and commercializing Relistor in Japan, including pursuing regulatory marketing approval. Progenics will receive a $15 million upfront payment from Ono, with up to an additional $20 million payable based on development milestones, according to Progenics.

Relistor is being developed and commercialized in the rest of the world by Progenics and Wyeth Pharmaceuticals.

Posted by Jay Loomis on Friday, October 17th, 2008 at 10:51 am |
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EpiCept gets marketing rights in Europe

October
9

EpiCept. Corp. of Eastview said regulators in Europe have approved the company’s application to market Ceplene, a drug for adults with acute myeloid leukemia. The approval allows the company to market the drug in 27 European Union states, as well as Iceland, Liechtenstein and Norway. The company also wants to get permission to market the drug in North America.

Posted by Allan Drury on Thursday, October 9th, 2008 at 8:59 am |
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Acorda releases new data on drug

September
22

Acorda Therapeutics Inc., a biotech company in Hawthorne, said that new data shows promising results for a multiple sclerosis drug that is being tested on patients.

A clinical trial showed that patients taking the medication, known as Fampridine-SR, showed greater improvements in leg strength than those aking a placebo, according to Acorda.

Data released in June showed that nearly 43 percent of the patients taking the medication walked faster compared with 9.3 percent of the patients taking a placebo. If the drug receives regulatory approval, it could one day make walking easier for the multiple sclerosis victims who deal with mobility problems.

Posted by Jay Loomis on Monday, September 22nd, 2008 at 10:47 am |
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Regeneron announces agreement with Columbia

September
16

Regeneron Pharmaceuticals Inc., a biotech company based in Eastview, announced an agreement to provide access to company technolgy to researchers at Columbia University in New York looking to discover new medications.

Regeneron said that the technology covered under the agreement, known as VelocImmune, increases the speed of human antibody development.

Regeneron added that it hopes to develop similar agreements with other major universities and research institutes.

Posted by Jay Loomis on Tuesday, September 16th, 2008 at 10:58 am |
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Regeneron drug shown to aid gout patients

September
3

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

August
25

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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Regeneron, Bayer announce positive test results

August
19

Eastview-based Regeneron Pharmaceuticals Inc. and Bayer HealthCare AG said tests of a treatment for a condition that leads to blindness showed patients made “highly significant improvements” after 52 weeks.

The companies said the patients testing the treatment, called the Vascular Endothelial Growth Factor Trap-Eye, showed improvements in vision.

The treatment, which Regeneron and Bayer are seeking to commercialize, is for a condition known as wet age-related macular degeneration.

Posted by Allan Drury on Tuesday, August 19th, 2008 at 9:04 am |
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Higher losses reported at EpiCept

August
11

EpiCept Corp. of Eastview reported higher second-quarter losses after its successful challenge of European regulators’ negative opinion of its leukemia treatment Ceplene.
EpiCept said it had a net loss of $7.77 million, or 15 cents a share, on revenue of $42,000. For the comparable quarter a year earlier, it had a net loss of $7.04 million, or 22 cents a share, on revenue of $100,000. The weighted average of outstanding common stock rose from 32.4 million shares to 52 million shares in the period.

Posted by Jerry Gleeson on Monday, August 11th, 2008 at 3:49 pm |
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Emisphere says staff moves cut costs

August
11

Second-quarter losses at Emisphere Technologies Inc. were reduced as the company’s 2007 decision to move management from Eastview to New Jersey and to cut staff helped reduce expenses, it said.
Emisphere reported a net loss of $7.63 million, or 25 cents a share, on revenue of $14,000. For the comparable quarter a year earlier, it had a net loss of $12.1 million, or 43 cents a share, on revenue of $398,000.
A new management team last year shook up the biotech researcher. It moved its senior management from The Landmark at Eastview to new headquarters 50 miles away in Cedar Knolls, N.J., south of Parsippany.
By splitting its campus, it was able to trade laboratory space in Westchester at some $50 a square foot for office space in New Jersey at about $20 a square foot, company spokesman Bob Madison said.
Emisphere also cut staff since last year by about 40 percent, chiefly people in information technology, finance, and human resources, he said. It currently employs 71 people. The cost-cutting has saved the business about $1 million annually, he said.

Posted by Jerry Gleeson on Monday, August 11th, 2008 at 3:16 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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