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Archive for the 'Drug testing' Category

Progenics to start tests on treatment

September
8

Progenics Pharmaceuticals Inc. of Eastview said it will start tests on an experimental treatment for prostate cancer. The therapy, prostate-specific membrane antigen antibody-drug conjugate, combines a prostate-cancer antibody with a cancer drug. The company said that unlike traditional chemotherapy, the treatment delivers the drug selectively to prostate cancer cells.

Posted by Allan Drury on Monday, September 8th, 2008 at 12:37 pm |
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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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Emisphere reports upbeat results in drug tests

July
28

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

July
25

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

June
17

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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Regeneron shares fall after analyst downgrade

June
5

Shares of Regeneron Pharmaceuticals Inc. dropped nearly 20 percent today after an analyst downgraded the stock on concerns about the outlook for an experimental cancer drug known as aflibercept.

The stock of the Eastview-based biotech company had been under pressure since Regeneron and its research partner, Sanofti-aventis of Paris, announced on May 21 that a phase 2 study of 215 women with advanced ovarian cancer showed no significant response to aflibercept.

Regeneron shares fell $3.73 to $15.35 after analysts at Credit Suisse cut the rating of the stock to neutral.

Posted by Jay Loomis on Thursday, June 5th, 2008 at 5:35 pm |
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Progenics stock rises on drug trial news

May
22

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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Regeneron stock falls on test data

May
21

Disappointing data in a clinical trial of a treatment for ovarian cancer sent stock in Regeneron Pharmaceuticals Inc. of Eastview tumbling today.
The company and its research partner, Sanofti-aventis of Paris, said that a phase 2 study of 215 women with advanced ovarian cancer showed no significant response to a drug called aflibercept. The compound is a fused protein that aims to inhibit the growth of tumors by starving them of blood.
Regeneron stock was down as much as 16 percent. It closed yesterday at $18.58, down $2.89 or 13.5 percent. It was down 23.1 percent for the year.
In a statement, the company said there are few treatment options for advanced ovarian cancer.
“We and Sanofi-aventis are continuing to evaluate the data from this trial in order to determine the next steps for aflibercept in advanced ovarian cancer,” Dr. George Yancopoulos, Regeneron’s president, said in the statement.
Sanofi is Regeneron’s largest shareholder, with 19 percent of its stock.
Joseph Pantginis, an analyst who follows the company for Canaccord Adams, said part of the selloff in the stock may have been related to the larger drop in the markets yesterday. The announcement contained some good news about other drug trial results, he said, and Regeneron and Sanofi are testing aflibercept in four phase 3 trials that combine the drug with chemotherapy.
“Overall, the profile of the drug still looks very promising for other indications,” said Pantginis, a former scientist at Regeneron. He said he holds no shares of company stock.

Posted by Jerry Gleeson on Wednesday, May 21st, 2008 at 3:43 pm |
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White Plains firm critical of FDA’s review of drug

April
18

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

April
16

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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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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