Merck shares fall following FDA rejection of cholesterol drug
WHITEHOUSE STATION, N.J. The Food and Drug Administration yesterday sent a not approvable letter to Merck for its application for the compound MK-0524A, otherwise known as Cordaptive, according to published reports. The drug is a compound of extended-release niacin and laropiprant that can be used alone or with a statin as adjunctive therapy to diet for the treatment of elevated LDL cholesterol, low HDL cholesterol, and elevated triglyceride levels.
In the FDA’s letter, the agency rejected the proposed trade name Cordaptive for MK-0524A. The company said at the appropriate time it expects to pursue the alternative trade name Tredaptive for use in the U.S.
Merck’s executive vice president and president, research laboratories Peter Kim said that company, “plans to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A.”
The agency had accepted Merck’s application for the drug back in late August.
As a result of the “not approvable” letter, stock shares for Merck fell by 5 percent in after-hours trading after closing the day up by 1.8 percent. This is the second time this month that Merck share have fallen over the concerns of a drug. Earlier this month, stocks fell after the American College of Cardiology physicians advised doctors to prescribing the cholesterol drug Vytorin because it was not as effective as other drugs in slowing down atherosclerosis.
Anderson highlights NACDS achievements in annual speech
PALM BEACH, Fla. The National Association of Chain Drug Stores president and chief executive officer Steve Anderson addressed the attendees yesterday at the association’s annual meeting with his “State of the Association” speech.
“I think the stakes are very high and we are ready to live and to thrive in this moment,” said Anderson. “In January 2009, we are going to have a new president in the White House, and a new administration that will be serving that president. We are going to have a new congress, new governors and state legislators, and the healthcare debate is going to rage and the response to economic conditions are going to dominate.”
Anderson highlighted some of the policy victories of the association over the past year. This includes a six-month delay of the tamper-resistant paper requirement for Medicaid prescriptions, the two-year delay of California’s e-pedigree requirement, the preservation of access to retail pharmacy for military families and veterans through the TRICARE program and the temporary injunction won by NACDS and the National Community Pharmacists Association to block the Medicaid pharmacy reimbursement cuts that would have gone into effect in January 2008.
“NACDS talked about the cost when patients don’t take their medications as prescribed—by one estimate, $177 billion annually,” said Anderson. “We talked about the seven most common chronic diseases. We cited there a $1.3 trillion annual drag on the economy, not to mention the human suffering. … We talked about the ability of retail pharmacy to make a difference if we are only given the chance.”
Anderson also talked about strengthening the presence of the pharmacy in the health care system. He called for the industry to take action, at this “defining age” in health care. Anderson said, “We have a vision for the future. We are branding pharmacies as the face of neighborhood healthcare.”
“The state of your association is very strong, in large part, because our staff team is working very well together,” said Anderson, who noted that results on issues are the best indicator of strength. “… No silos, no egos—that is way this is supposed to work.”
He also made reference to the economic impact that retail stores have on the economy. “Based on our analysis, retail stores with pharmacies have a total annual economic impact of $2.2 trillion,” said Anderson. This was after he noted that the stores had annual sales of $758 billion, so therefore the effect is almost tripled by pharmacies. For every $1 spent in these stores has a ripple effect of $2.93 throughout the entire economy.
“We do all those things that drive our nation’s economy and produces millions of jobs in this country,” said Anderson. “This is what you do and I think that is pretty amazing.”
Mylan’s Digitek recalled by Actavis
WASHINGTON Actavis Totowa has notified health care professionals of a Class I nationwide recall of all strengths of Mylan Pharmaceuticals’ drug Digitek.
The drug is used to treat heart failure and abnormal heart rhythms.
The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient.