Anybody have analyst estimates for MK-0254 sales, 2010 or so?
Merck wants to raise your cholesterol
No. 2 U.S. pharmaceutical company experimenting with drug that would boost 'good' HDL, lower heart attack risk.
By Aaron Smith, CNNMoney.com staff writer
May 31, 2006: 9:05 PM EDT
NEW YORK (CNNMoney.com) - Merck is funding a large-scale study to see if an experimental drug that boosts a certain type of cholesterol can prevent heart attacks and strokes, possibly strengthening its position in the $25 billion cholesterol industry even as a key blockbuster teeters on the brink of patent expiration.
In the late-stage study, the experimental drug MK-0524A will be combined with niacin, a vitamin also known as B-3. Oxford University is coordinating the $78 million study and plans to recruit 20,000 patients from the United Kingdom, China and Scandinavia.
"This is an important cardiovascular outcome study," said Merck spokeswoman Janet Skidmore. "It's going to determine whether this compound (MK-0524A) could prevent heart attacks and strokes."
The MK-0524A-niacin combination will be tested to see how much it increases high-density lipoprotein, known as HDL or "good" cholesterol because it seems to prevent heart attacks. The purpose of the Merck-Oxford study is to provide hard clinical data on the experimental drug's ability to raise HDL and to lower the risk of heart attacks and strokes.
"We think that we should be able to increase HDL by at least 20 percent and we hope that will produce 15 to 20 percent reduction in heart attacks and strokes," said Dr. Jane Armitage, principal investigator of Oxford's Clinical Trial Service Unit. "Obviously we need to do this in a good-sized trial and that's what we're trying to do."
Armitage also hopes the Merck compound will reduce the "facial flushing" side effect from niacin, which is not harmful but is unpleasant enough to keep many patients from regularly taking the vitamin.
Barbara Ryan, analyst for Deutsche Bank North America, said that MK-0524A "can be a nice opportunity for Merck, but we're not extraordinarily bullish about it." Ryan projects annual sales of $550 million by 2009, eventually peaking at $800 million to $900 million.
Les Funtleyder, analyst for Miller Tabak, sees the drug as a potential blockbuster, projecting annual sales of between $900 million and $1 billion.
"If it can show that it raises HDL without the flushing side effect, that can be really important," said Funtleyder of Miller Tabak. "I think that the importance of raising HDL is underappreciated. The market could be potentially very large."
The fast-growing, multi-billion dollar business for cholesterol drugs is considered one of the most lucrative in the healthcare industry. Ryan of Deutsche Bank North America estimates the cholesterol industry at $25 billion. The dominating drug in this industry - and the world's top seller - is Lipitor from Pfizer, with $12.2 billion in 2005 sales.
Merck's blockbuster Zocor, which reduces LDL, also makes up a large chunk of that industry, but not for much longer. Zocor sales totaled $4.4 billion in 2005, but the drug loses patent protection June 23, and generic competition will cause sales to plunge by as much as 80 percent. Merck is trying to discover prospective blockbusters that could help fill the impending sales vacuum.
Merck (up $0.53 to $33.29, Research), the no. 2 drugmaker in America, plans to file an application for MK-0524A with the Food and Drug Administration in 2007. In addition, the Whitehouse Station, N.J.-based company is testing MK-0524B, which combines MK-0524A with Zocor. Merck also plans to file that cholesterol-cutting concoction to the FDA on 2007.
Pfizer (up $0.08 to $23.66, Research), the world's biggest drug company, is also experimenting with new drugs to try and shore up its future as the cholesterol market king. The New York-based drug giant is testing Lipitor, which lowers LDL, in conjunction with the experimental drug torcetrapib, which increases HDL. Al Rauch, analyst for A.G. Edwards, has projected that a successful Lipitor-torcetrapib combination could add $8 billion in annual sales for Pfizer.
Arterioscler Thromb Vasc Biol. 2006 Jun;26(6):1350-6. Epub 2006 Mar 30.
Effects of the cholesteryl ester transfer protein inhibitor torcetrapib on apolipoprotein B100 metabolism in humans.
Millar JS, Brousseau ME, Diffenderfer MR, Barrett PH, Welty FK, Faruqi A, Wolfe ML, Nartsupha C, Digenio AG, Mancuso JP, Dolnikowski GG, Schaefer EJ, Rader DJ.
Institute for Translational Medicine and Therapeutics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA. jsmillar@mail.med.upenn.edu
OBJECTIVE: Cholesteryl ester transfer protein (CETP) inhibition with torcetrapib not only increases high-density lipoprotein cholesterol levels but also significantly reduces plasma triglyceride, low-density lipoprotein (LDL) cholesterol, and apolipoprotein B (apoB) levels. The goal of the present study was to define the kinetic mechanism(s) by which CETP inhibition reduces levels of apoB-containing lipoproteins. METHODS AND RESULTS: Nineteen subjects, 9 of whom were pretreated with 20 mg atorvastatin, received placebo for 4 weeks, followed by 120 mg torcetrapib once daily for 4 weeks. Six subjects in the nonatorvastatin group received 120 mg torcetrapib twice daily for an additional 4 weeks. After each phase, subjects underwent a primed-constant infusion of deuterated leucine to endogenously label newly synthesized apoB to determine very low-density lipoprotein (VLDL), intermediate-density lipoprotein (IDL) and LDL apoB100 production, and fractional catabolic rates (FCRs). Once-daily 120 mg torcetrapib significantly reduced VLDL, IDL, and LDL apoB100 pool sizes by enhancing the FCR of apoB100 within each fraction. On a background of atorvastatin, 120 mg torcetrapib significantly reduced VLDL, IDL, and LDL apoB100 pool sizes. The reduction in VLDL apoB100 was associated with an enhanced apoB100 FCR, whereas the decreases in IDL and LDL apoB100 were associated with reduced apoB100 production. CONCLUSIONS: These data indicate that when used alone, torcetrapib reduces VLDL, IDL, and LDL apoB100 levels primarily by increasing the rate of apoB100 clearance. In contrast, when added to atorvastatin treatment, torcetrapib reduces apoB100 levels mainly by enhancing VLDL apoB100 clearance and reducing production of IDL and LDL apoB100. |
