PHARMACY

San Antonio-based pharmacy offers special services to personal injury victims

BY Alaric DeArment

SAN ANTONIO — A Texas pharmacy is allowing personal injury victims to obtain drugs and medical supplies immediately through their attorneys.

Hill’s Drug Store, based in San Antonio, announced Sunday that it would begin offering personal injury attorney-collection for victims of accidents or illnesses, whereby the store collects payments for supplies from victims’ attorneys rather than the victims themselves. Hill’s, which describes itself as one of the city’s most comprehensive medical supply stores, said the program allows victims who have filed personal injury claims to obtain needed supplies — including drugs, wheelchairs and others — through legally binding agreements with attorneys’ offices called letters of protection, without having to immediately pay for them out of pocket.

Normally, when a victim files a claim, he often must wait months or even years to settle the case and receive payment, Hill’s said.

 

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New England Compounding Center owners reach settlement

BY Alaric DeArment

BOSTON — The owners of the compounding pharmacy linked to a nationwide meningitis outbreak that has killed dozens and sickened hundreds have agreed to set up a fund of more than $100 million to compensate victims and creditors.

Legal firm Brown Rudnick announced that the owners of the New England Compounding Center had reached a settlement with bankruptcy trustee Paul Moore, its creditors and the victims to set up the fund, money from which will be distributed to creditors as well as victims who received injections of tainted steroids from NECC.

"We are pleased that a significant amount of funds will become available for distribution for victims and their families as compensation for the deaths, injuries and suffering they endured as a result of this tragic meningitis outbreak," Moore said.

According to the Centers for Disease Control and Prevention, more than 700 people were diagnosed with fungal meningitis linked to the NECC, and 64 people have died. Based in Framingham, Mass., the NECC was involved in sterile compounding of injected drugs. An investigation of the pharmacy in the wake of the meningitis outbreak found widespread contamination and disregard for basic sanitation protocols. Nationwide outrage led to calls for stronger federal oversight over pharmacies that do sterile compounding, and in November, President Barack Obama signed into law the Drug Quality and Security Act, which subjects large-scale sterile compounding to federal regulations, while leaving regulation of non-sterile compounding of medicines for individual patients up to state boards of pharmacy.

 

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Genzyme fails to win FDA approval for MS drug Lemtrada

BY Alaric DeArment

CAMBRIDGE, Mass. — The Food and Drug Administration has declined to approve a drug made by Genzyme Corp. for certain forms of multiple sclerosis, the company said Monday.

Genzyme, a subsidiary of French drug maker Sanofi, said it received a complete response letter from the FDA for Lemtrada (alemtuzumab) as a treatment for relapsing MS. A complete response letter means that the FDA has finished reviewing a regulatory application, but can’t approve it due to questions that remain. In Genzyme’s case, the FDA said the company had not submitted sufficient evidence demonstrating that Lemtrada’s benefits outweigh serious potential side effects, and that it needs at least one clinical trial of a different design from the ones already performed.

"We are extremely disappointed with the outcome of the review and the implications for patients in the U.s. suffering with multiple sclerosis who remain in need of alternative therapies to manage a devastating disease," Genzyme president and CEO David Meeker said. "We strongly believe that the clinical development program, which was designed to demonstrate how Lemtrada compares against an active comparator as opposed to placebo, provides robust evidence of efficacy and a favorable benefit-risk profile."

Genzyme said it "strongly disagrees" with the agency’s decision and plans to appeal it, adding that its goal of gaining U.S. approval for the drug by March 31 will not be met. Lemtrada is already approved in the European Union, Canada and Australia.

"This evidence was also the basis for the approvals of Lemtrada by other regulatory agencies around the world," Meeker said, referring to the existing clinical trials.

Sanofi’s stock fell by 0.87% to $52.34 per share Monday morning on the New York Stock Exchange, following the news.

Lemtrada was a centerpiece of Sanofi’s $20.1 billion purchase of Genzyme in 2011, with Genzyme shareholders set to receive milestone payments related to the drug. Genzyme, which had become a leader in treatments for rare diseases but had run into production problems, had been an attractive acquisition target for Sanofi, then known as Sanofi-Aventis, since 2010, and the French drug maker said it planned to make Genzyme its "global center for excellence" in rare diseases.

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