GSK announces results of late-stage clinical trial for albiglutide
LONDON — GlaxoSmithKline announced the results from the first of eight phase-3 clinical trials that examined the efficacy of albiglutide in the treatment of Type 2 diabetes.
The Harmony 7 trial was a 32-week, head-to-head, open-label, noninferiority study that compared albiglutide, an investigational once weekly glucagon-like peptide-1 agonist, with once-daily liraglutide. According to the results, patients administered GSK’s drug saw a 0.78% reduction in HbA1C, while patients administered liraglutide saw a 0.99% reduction in HbA1C.
“While the prespecified margin of noninferiority was not met, these topline data support continued progression towards registration of albiglutide as a possible future once weekly treatment for Type 2 diabetes,” GSK chairman of research and development Moncef Slaoui said. “This is the first of eight phase-3 studies to conclude and we continue to look forward to receiving the results of the remaining studies which will provide a more complete assessment of the profile of albiglutide in Type 2 diabetes,” he added.
GSK said that initial results from the remaining seven phase-3 studies will become available over the course of the next several months.
Need for more convenient therapies, competition from generics, biosimilars spurs RA drug development
MOUNTAIN VIEW, Calif. — The increase in the number of people with rheumatoid arthritis, and the challenges posed to drug makers by generics, is encouraging the development of new drugs for the disease, according to a new report by Frost & Sullivan.
The report, released Thursday, found that the incidence of the disease was set to go from 2010’s 2.4 million to 2.6 million in 2017. But the lack of a convenient and safe treatment option without adverse side effects has set the stage for a wave of drug launches in the near future, and many of those drugs could become blockbusters. Many of the injectable biotech drugs currently available for RA come with serious side effects, particularly tumor necrosis factor blockers, which work by blocking the immune-system protein that cause RA, but also can lead to dangerous and potentially fatal side effects like infections and cancer.
Drugs for RA had sales of $5.78 billion in 2010, expected to increase to $8.34 billion in 2017, the report found.
"With the number of biologics on the market and in development for RA, the RA treatment market is becoming crowded," Frost & Sullivan industry manager Jennifer Brice said. "Biologics entering this market must be able to show efficacy and safety data that is comparable, if not superior, to TNF blockers to gain any market share."
Some drugs for treating RA will soon lose patent protection and face competition from biosimilars, such as Pfizer’s and Amgen’s Enbrel (etanercept), whose patent expires next year. While this could increase treatment access, it also will dampen revenues for the companies that developed the treatments, meaning newer drugs are needed. Drugs under development include Pfizer’s CP-690550 (tasocitinib) and Rigel Pharmaceuticals’ R788 (fostamatinib), both oral medications.
SXC buys HealthTrans for $250 million
LISLE, Ill. — Pharmacy benefit manager SXC Health Solutions is buying PBM service company HealthTrans for $250 million, SXC said Thursday.
Based in Colorado with additional offices in Illinois, Florida and Georgia, HealthTrans provides PBM and healthcare information technology services to about 260 clients, and its PBM business includes a suite of PBM offerings, such as nationwide retail network, formulary and rebate management, Medicare Part D services and mail order.
"The acquisition of HealthTrans is a great fit with our strategy to acquire mid-market PBM customers that already utilize our HCIT services," SXC chairman and CEO Mark Thierer said. "HealthTrans is one of the largest privately held PBMs in the country. It has a diverse customer base and a track record of strong cash flow."