Edwards Lifesciences (NYSE:EW)
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5 Years : From May 2011 to May 2016
New data on a catheter-delivered heart valve marketed by Edwards Lifesciences Corp. (EW) will be presented at a medical meeting this week, providing key clues on the device's potential market size in the U.S.
The data will be discussed at one of hundreds of sessions at the American College of Cardiology's annual conference, which runs from Saturday to Tuesday in Chicago. Other items to watch include data on Merck & Co.'s (MRK) antiplatelet drug vorapaxar and an anticlotting drug co-marketed by Bayer AG (BAYRY, BAYN.XE) and Johnson & Johnson (JNJ).
So far, Edwards's Sapien device has been approved by the U.S. Food and Drug Administration for inoperable patients, but the Irvine, Calif., company is trying to expand the market to patients at high risk for surgery. Two-year data on those patients is key to watch at the conference as the company seeks to gain FDA approval for the group later this year.
On its most recent post-earnings conference call, Edwards said it expects 2012 world-wide sales of its catheter-delivered heart valves to increase 70% to 90% to $560 million to $630 million, assuming Sapien is approved for high-risk patients in the U.S. mid-year.
According to J.P. Morgan Chase & Co., FDA approval for the high-risk group would add 2,000 to 2,500 patients a year receiving Sapien. While an incremental step to its current market of 22,000 inoperable patients, the research firm said, failure to gain approval would call into question Edwards's ability to broaden the market for the device to healthier patients down the road, considered a more lucrative opportunity.
Sapien treats patients with severe narrowing of the aortic valve. The condition can lead to symptoms such as fatigue, dizziness and serious heart problems. About 300,000 patients in the U.S. have a sufficiently severe condition as to require an artificial valve replacement, which is done through hours-long heart surgery. Catheter-delivered heart valves, a less-invasive alternative to surgery, are considered to have multibillion-dollar market potential.
The data to be presented Monday are part of Edwards's key "Partner" study used to gather evidence for the company's Sapien valves in the U.S. The company's one-year data on high-risk patients, presented at last year's conference, showed that patients treated with catheter-delivered valves were at least as likely to survive a year as patients treated through open-heart surgery but were more likely to suffer strokes.
Mortality rates and stroke rates in patients treated with the valve compared with those receiving surgery will be key to watch. If patients receiving Sapien continue to experience higher rates of stroke, "it could raise concerns that this neurological risk compounds over time," J.P. Morgan's Michael Weinstein said.
The conference also will feature sessions on wiring problems in some of St. Jude Medical Inc.'s (STJ) implantable defibrillators, a key business for the company. The problems have involved cables no longer on the market, but there have been questions on whether they could affect other cables that St. Jude sells.
With this week's conference and a separate medical meeting in May, "we only expect the scrutiny to grow," said Raj Denhoy, analyst at Jefferies & Co.
On the pharmaceutical side, several notable studies on approaches to cardiovascular treatment will be featured at the meeting, including:
--Full results Saturday from Merck's "TRA-2P" study of an experimental antiplatelet agent, vorapaxar. Merck said last month that the drug met the study's primary efficacy goal of reducing risk of heart attacks and related events in people with a history of cardiovascular disease but significantly increased bleeding risk.
The full results will show the magnitude of the drug's efficacy and safety risks, shedding light on whether it has a chance of reaching the market. Merck and analysts have already reduced their expectations for the drug's potential because of the bleeding risk, especially those patients with a history of stroke.
--Results Monday of the "Einstein PE" study of Xarelto, an anti-clotting drug co-marketed by Bayer and Johnson & Johnson. This study compared Xarelto with another drug regimen including enoxaparin in preventing certain blood clots in patients with a condition called pulmonary embolism. Positive results could lead to expanded use of the drug, which is currently approved to reduce risk of stroke in patients with a heart-rhythm disorder called atrial fibrillation, and to prevent certain clots in knee or hip replacement surgery.
--Results Monday of a study testing an experimental cholesterol-lowering drug co-developed by Regeneron Pharmaceuticals Inc. (REGN) and Sanofi SA (SAN.FR). The drug, code-named REGN727/SAR236553, is a fully human monoclonal antibody that binds to a protein called PCSK9, and has the potential to significantly lower bad cholesterol levels. Analysts say this class of PCSK9 drugs, which includes one being developed by Amgen Inc. (AMGN), has big market potential if the drugs are successful in further clinical studies and clear regulatory hurdles.
--By Anjali Athavaley and Peter Loftus, Dow Jones Newswires; 212-416-4912; email@example.com