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.

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.

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.

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.

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.

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.