Watson challenges Abbott patent on Niaspan
PARSIPPANY, N.J. — Watson Pharmaceuticals is challenging the patent protection on a drug made by Abbott for treating cholesterol, the company said.
Watson, through a subsidiary, filed with the Food and Drug Administration for approval of niacin extended-release tablets in the 500-mg and 1,000-mg strengths. The drug is a generic version of Abbott’s Niaspan.
Abbott filed a lawsuit against Watson Friday in the U.S. District Court for the District of Delaware to try and prevent Watson from commercializing its drug before the expiration of two of Abbott’s patents, set to take place in May 2017 and March 2018, according to the FDA. Under the Hatch-Waxman Act of 1984, the law that created an abbreviated approval pathway for generic pharmaceuticals, the lawsuit puts a stay of final FDA approval on Watson’s drug that will last for 30 months or until the two companies reach a settlement.
Niaspan had sales of about $1.2 billion during the 12-month period ended in January, according to IMS Health.
NCPA applauds local pharmacist for participation in Dispose My Meds
ALEXANDRIA, Va. — The National Community Pharmacists Association has applauded a member of its organization for participating in the organization’s drug disposal program.
Pharmacy owner and NCPA member John McDonald, who operates Marra’s Pharmacy in Cohoes, N.Y., collected $30,000 of mail-order waste as part of NCPA’s Dispose My Meds, a program launched in 2010 that includes participation from 1,400 independent community pharmacies nationwide and aims to reduce the improper disposal of unused medications. McDonald’s collection, which was highlighted in an Albany CBS 6 affiliate news report, included pills, insulin, insulin strips and more than 50 boxes of nasal spray.
The organization said McDonald’s collection reflects an example in the NCPA report “Waste Not, Want Not,” which documented the problem of medication waste associated with mail-order pharmacies.
“The wasteful healthcare spending identified by John McDonald and CBS 6 may be a shocking and extreme case, but is indicative of a problem that is all too common and real,” NCPA president and Pharmacy Providers of Oklahoma executive director and CEO Lonny Wilson said. “This case illustrates two important points. First, it is essential that health plan sponsors preserve the patients’ freedom to choose a pharmacy provider. The face-to-face, patient-pharmacist interaction in a community pharmacy improves health outcomes and prevents the waste identified in this news report that is associated with ‘auto-shipping’ mail order programs. Second, community pharmacies can help patients discard their unused or expired medication in an environmentally responsible fashion through programs such as the NCPA Dispose My Meds initiative.”
Patients taking oral cancer drugs may risk drug interactions, study finds
WASHINGTON — Pills for treating cancer have created numerous alternatives to spending hours in a clinic or at home receiving chemotherapy infusions, but risks of drug interactions remain, according to a new survey by the research arm of pharmacy benefit manager Medco Health Solutions.
The survey, released Friday by the Medco Research Institute, found that 23% to 74% of patients taking one of nine oral cancer drugs also were on a drug that had the potential to reduce the cancer drugs’ effectiveness or increase its toxicity. The drugs studied belong to a class known as oral kinase inhibitors and included Novartis’ Gleevec (imatinib) and Tarceva (erlotinib), made by Roche and Astellas Pharma.
"Oral cancer drugs represent a huge advancement in oncology treatment, but make no mistake — these are powerful drugs," Medco Oncology Therapeutic Research Center national practice leader Milayna Subar said. "These high-cost medications can have severe side effects and need to be actively monitored for proper use and adherence."
The study also found that 43% of the 4,617 patients receiving Gleevec were prescribed a drug that might diminish its efficacy, while 68% were taking a drug that could raise its level of toxicity. The other drugs were found to have their efficacy potentially impaired 23% to 57% of the time, and 24% to 74% of patients were using medicines that might raise their toxicity.
"Since these are drugs launched in the past decade for fairly small patient populations, we are learning more bout how they are used in real-world settings as compared to traditional clinical trials that test safety and efficacy in a tightly controlled environment," Medco Research Institute senior director and therapeutic area research lead and study co-author Steve Bowlin said. "Oncologists are not always aware of other medications prescribed by other doctors and vice-versa, which can pose a real hazard for their patients on oral cancer therapies."
The study was based on pharmacy claims from about 11,600 patients using one of nine oral kinase inhibitors.