Achillion receives fast-track designation for hepatitis C drug
NEW HAVEN, Conn. — The Food and Drug Administration has granted fast-track designation to a drug currently under development by Achillion Pharmaceuticals for hepatitis C, the company said.
The agency gave the designation to ACH-1625, a once-daily protease inhibitor that the company said could offer improved safety and tolerability, compared with existing drugs, convenience, fewer adverse interactions with drugs used to treat HIV and liver transplants and broader genotypic coverage of the virus. Current treatments typically involve a combination of oral pharmaceuticals and injected interferons, a type of biotech drug.
"We are very pleased with the granting of a fast track designation for ACH-1625, which we believe highlights this protease inhibitor’s attributes which include broad genotypic coverage of HCV, once-daily administration and an improved safety, efficacy and tolerability profile over currently approved therapies for HCV," Achillion president and CEO Michael Kishbauch said. "As we work toward achieving our near-term milestones, we remain eager to initiate an interferon-free, all-oral combination clinical study evaluating our protease inhibitor plus NS5A inhibitor for the treatment of HCV during the second half of this year."
Fast-track designation gives a drug maker greater access to the FDA and allows it to submit data for a regulatory approval application on a rolling basis while also opening the possibility for priority review by the agency.
Report: N.Y. senator proposes tougher penalties for pharmacy crime
NEW YORK — A senator from New York is proposing new regulations that would protect pharmacies from robberies, according to published reports.
The Associated Press reported that Sen. Charles Schumer, D-N.Y., proposed stronger penalties and better security measures so that pharmacies could protect their drugs, following a pharmacy robbery on Long Island that resulted in the death of an off-duty federal agent.
Under the plan, the Drug Enforcement Agency would issue guidelines that would include installing silent alarms, timed safes and bulletproof glass, as well as sharing of pharmacy crime data between the DEA and local police. Theft from drug stores would be punishable by 20 years’ imprisonment.
Biogen Idec, Isis to develop spinal muscular atrophy drug
WESTON, Mass. — Biogen Idec and Isis Pharmaceuticals will work together on a drug invented by Isis for spinal muscular atrophy, the two companies said.
According to the companies, SMA is the most common genetic cause of infant mortality and causes muscle atrophy and weakness, occurring in 1-in-10,000 births. While children with the condition appear normal at birth, symptoms can develop within a few months and significantly shorten their lifespan. The drug, ISIS-SMNRx, is designed to compensate for the underlying genetic defect that causes SMA.
Under the agreement, Biogen Idec will pay Isis $29 million upfront, plus up to $45 million in milestone payments. In addition, Biogen Idec will have the option to license the drug until the completion of the first successful phase-2/3 trial, while Isis could receive up to $225 million in license fee and regulatory milestone payments, as well as royalties on potential sales.