rolofylline
Peter S. Kim, Ph.D., executive vice president and president, Merck Research Laboratories, told analysts that in 2009, the Company anticipates submitting three New Drug Application (NDA) filings with the U.S. Food and Drug Administration (FDA): MK-0974, telcagepant, an investigational compound for the treatment of migraines; MK-7418, rolofylline, an investigational compound for the treatment of acute heart failure; and MK-0653C, ezetimibe combined with atorvastatin, an investigational medication for the treatment of dyslipidemia being developed by the Merck-Schering Plough joint venture. [1]
“Preserving kidney function is an important goal for improving the prognosis of patients with acute heart failure,” said lead investigator Barry M. Massie, M.D., chief of cardiology, VA Hospital, San Francisco. [2]
“Heart failure is the leading cause of hospitalisation in patients over 65 years of age, and the current practice guidelines include treatment with diuretics,” Dr. Cotter said. [3]
The study is being conducted to examine whether KW-3902IV will result in greater improvement in signs and symptoms of heart failure, with less treatment failure than standard therapy, when it is added to IV loop diuretics in subjects with acute heart failure syndrome and renal impairment. [4]
At 24 hours, dyspnoea improved by 51% in the placebo group and in the rolofylline groups by 62% (10 mg), 63% (20 mg), and 66% (30 mg). [3]
WHITEHOUSE STATION, N.J. - Merck & Co., Inc. today hosted its Annual Business Briefing where it outlined its long-term prospects and announced several key improvements in how the Company develops and markets medicines and vaccines worldwide. [1]
Patients were randomized to placebo, 10 mg, 20 mg or 30 mg of rolofylline (four hour infusion, once daily for three days) administered with IV loop diuretics. [2]
MILAN, Italy — June 20, 2008 — Infusions of the adenosine A1 receptor antagonist rolofylline are safe and can provide significantly improved renal function and reduced death and rehospitalisation of patients hospitalised for acute heart failure (AHF) who require diuretics, researchers reported here at the Heart Failure 2008 Congress (HF2008). [3]
The pilot study evaluated 301 patients with acute heart failure syndrome with elevated BNP (B-type natriuretic peptide) and renal impairment as defined by estimated creatinine clearance of 20-80 ml/min. [...] It is the leading cause of hospitalization in patients over age 65, with over a million hospital discharges annually in the US. [2]
Because of the potential for adenosine A1 receptor antagonism to reduce the seizure threshold in patients already at risk for seizures, high risk patients were excluded from the study and intermediate risk patients were treated prophylactically with oral lorazepam (1 mg). [5]
Merck plans to optimize the value of its medicines and vaccines over the long term, through effective lifecycle management, and to invest in internal and external growth opportunities, such as regional business development. [1]
The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. [5]
Follow-on biologics represent a significant market opportunity due to the extensive patent expiries of leading biologics scheduled to occur through 2017. [1]
The study was designed to identify the dose and, based on post hoc analyses of the treatment results and the patient population studied, refine the inclusion criteria and endpoints for the confirmatory Phase III studies. [2]
Sources:
[1] Merck Outlines Long-Term Prospects and Progress on Strategic Plan at …
[2] Merck News Item
[3] Rolofylline Reduces Congestion and Improves Renal Function for Patients …
[4] PROTECT-2: A Study of the Selective A1 Adenosine Receptor Antagonist KW …
[5] Merck’s Investigational Rolofylline Associated With Improved Dyspnea …