Acorda Therapeutics Inc., a Hawthorne-based biotech company, said that it is pushing ahead with plans to seek regulatory approval for its most promising product, Fampridine-SR, a drug to help people with multiple sclerosis walk.
The company said that it remains on schedule to file a new drug application for the medication with the U.S. Food and Drug Administration during the first quarter. It also expects to submit applications for the medication to regulators in Europe and Canada.
“We are also beginning discussions with potential marketing partners to explore commercialization options in Europe and the rest of world excluding the U.S.,” Chief Executive Officer Ron Cohen said in a written statement. “Achieving these milestones will bring us closer to our goal of making Fampridine-SR available to the many people with MS who may benefit from it.”
Barr Pharmaceuticals Inc., a generic drug manufacturer with major operations in Rockland County, said that the U.S. Food and Drug Administration has approved a new drug application for Synthetic Conjugated Estrogens-A Vaginal Cream.
The cream is a plant-derived product used to treat of moderate to severe vaginal dryness and pain with intercourse. Barr’s subsidiary, Duramed Pharmaceuticals Inc., submitted the application for the drug to the FDA.
The cream is expected to be ready for prescription sales to women during the first quarter.
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, Regeneronâ€™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.
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 Womenâ€™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.