Merck: Investigational drug did not meet endpoints
WHITEHOUSE STATION, N.J. Merck & Co. said Friday that preliminary results for the pivotal phase III study of rolofylline (MK-7418), the company’s investigational medicine for the treatment of acute heart failure, show that rolofylline did not meet the primary or secondary efficacy endpoints.
“Advances to help patients with acute heart failure, a disease that is the leading cause of hospitalization for patients over age 65 and that is associated with a high rate of mortality, have long been elusive,” said Dan Bloomfield, M.D., executive director, cardiovascular research, Merck Research Laboratories. “These results are disappointing because we had been hopeful that blocking the adenosine A1 receptor with rolofylline would prove to be a useful new approach for these patients.
The primary endpoint for the phase III study were that the drug would would improve symptoms of acute heart failure (compared with placebo). Secondary endpoints included reducing the risk of death, renal re-hospitalization 60 days after treatment and reducing the incidence of persistent kidney impairment.
Rolofylline was acquired by Merck through NovaCardia, which Merck purchased in 2007. Results from the PROTECT pilot study, presented at previous medical meetings and published in 2008, had showed an overall trend toward efficacy (more patients with improved shortness of breath, fewer patients with worsening renal function and/or worsening heart failure).
While Merck will continue to analyze the data with outside experts, the company will not file applications for regulatory approval this year. The results from this study will be presented at a medical meeting later this year.
Merck’s late-stage pipeline of investigational medicines for cardiovascular disease includes MK-524A (approved in some markets outside the U.S.), MK-524B, ezetimibe/atorvastatin, and anacetrapib (MK-0859) for atherosclerosis, and vernakalant for atrial fibrillation.
Johnson & Johnson unveils large drug development pipeline
NEW BRUNSWICK, N.J. Drug maker Johnson & Johnson boasted a large drug development pipeline in a statement preceding a meeting with investors Thursday.
The company highlighted early-stage compounds and new regulatory filings in neuroscience, cardiovascular disease, immunology, infectious diseases and cancer, as well as new uses for drugs already on the market.
The company also mentioned the launches of the arthritis and psoriasis drug Simponi (golimumab) and the painkiller Nucynta (tapentadol) and a focus on growing core products like the inflammatory disorder drug Remicade (infliximab), the antipsychotic Risperdal Consta (risperidone) and the attention deficit hyperactivity disorder drug Concerta (methylphenidate hydrochloride).
“We are very optimistic about our future in pharmaceuticals,” J&J worldwide chairwoman of pharmaceuticals Sheri McCoy said in a statement. “We are well-positioned with an industry-leading pipeline, the global reach and financial resources of Johnson & Johnson, a long, rich history in pharmaceuticals and a broad portfolio that is grounded in science and addresses serious unmet needs.”
Albertsons selects PDX to provide pharmacy technology solution
FORT WORTH, Texas Albertsons has selected PDX and affiliates Rx.com and NHIN to provide its pharmacy technology solution, replacing its current system with the new Enterprise Pharmacy System.
The chain’s pharmacies will implement the Rx.com Electronic Pharmacy Record, which facilitates chainwide DUR checking and allows patients the convenience of shopping at any Albertsons LLC pharmacy. In addition, NHIN will provide complete submissions, reconciliations and collections services for the retailer, as well as manage its day-to-day central host operations via Host Administrative Services.
The company plans to pilot EPS in pharmacies in Texas and Arizona later this year, and will roll out the technology companywide in 2010. Albertsons LLC currently operates nearly 250 stores in Arizona, Arkansas, Colorado, Florida, Louisiana, New Mexico and Texas.