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Genzyme, PTC: Mid-stage trial for DBMD treatment yields mixed results

BY Alaric DeArment

SOUTH PLAINFIELD, N.J. A mid-stage clinical trial of a drug for muscular dystrophy got mixed results, developers Genzyme Corp. and PTC Therapeutics announced.

The two companies recently announced results of a 174-patient phase 2b trial of ataluren, for treating nonsense mutation Duchenne/Becker muscular dystrophy, also known as DBMD, which can cause loss of walking ability as early as age 10 and life-threatening lung and heart complications by the late teens and early 20s. The disease affects around 1,900 patients in the United States. A “nonsense mutation” is a mutation of the DNA that causes incomplete manufacture of proteins.

The companies said the main goal of the study –– change the distance patients could walk within six minutes –– did not reach statistical significance, but that the drug was well-tolerated and no patients discontinued treatment due to adverse side effects. The drug also is undergoing studies as a treatment for nonsense mutation cystic fibrosis and hemophilia.

“The quality of the data from this well-conducted study and additional analyses will help to inform the clinical development of ataluren in other indications,” Genzyme SVP genetic diseases Geoffrey McDonough said. “We remain committed to the development of ataluren and will continue to collaborate with PTC to advance its development for the treatment of genetic disorders.”

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SXC Health Solutions signs PBM contract with HealthSpring

BY Allison Cerra

LISLE, Ill. A leading provider of pharmacy benefit management products and services announced that its informedRx PBM unit has been awarded a contract with HealthSpring.

The initial term of the contract is three years with provisions for two additional one-year extensions. HealthSpring, based in Nashville, Tenn., offers Medicare Advantage plans across seven states to over 193,000 members and a national stand-alone Medicare prescription drug plan to 387,000 members. SXC will provide HealthSpring with its full suite of PBM services which include:

  • Mail order pharmacy
  • Specialty pharmacy
  • Retail network management
  • Medicare compliance services
  • Patient care clinical services

HealthSpring will deploy mail and specialty pharmacy services beginning in 2010, with implementation of the full PBM services on Jan. 1, 2011.

“The flexibility of SXC’s full service PBM offering, combined with its expertise in Medicare Part D, aligns perfectly with our commitment to design competitive products and provide high quality healthcare benefits to Medicare members,” said Michael Mirt, HealthSpring president and COO. “We manage our Medicare Advantage plans locally and require customized benefits programs throughout our network, which made SXC, with its flexible PBM service model, an ideal partner to help us achieve our service and cost containment objectives.”

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Biosimilars could bring down specialty drug spending

BY Alaric DeArment

WHAT IT MEANS AND WHY IT’S IMPORTANT If Medicare Part D is to remain solvent in the future, then lawmakers may want to take a closer look at the more than 10% of spending on drugs under the program that has gone toward specialty drugs — some of the most expensive drugs on the market — and find ways to come up with cheaper alternatives.

(THE NEWS: GAO: Specialty drugs accounted for 10% of Medicare Part D spending in 2007. For the full story, click here)

The Government Accountability Office reported that of the $54.4 billion spent on prescription drugs under Medicare Part D in 2007, $5.6 billion went toward specialty drugs. Many specialty drugs — particularly those for cancer and autoimmune disorders, are biologics — which can cost thousands of dollars for a month’s supply and for which no generic alternatives are available. In addition, while Alzheimer’s disease often falls outside the traditional “specialty” realm, many treatments for it in the pipeline are biologics as well.

One way to save money to patients and the Centers for Medicaid and Medicare Services alike would be to create an abbreviated regulatory approval pathway for follow-on biologics, also known as biosimilars and biogenerics, similar to the one that has existed for generic pharmaceutical drugs since 1984.

As long as it gave innovator companies ample opportunity to recoup their investments and didn’t leave patients and payers waiting too long before biosimilars became available, such a pathway could go a long way toward bringing down the costs associated with cutting-edge treatments.

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