Teva and Boston Scientific Thursday July 15 2009
BOSTON SCIENTIFIC CP(NYSE: BSX)
After Hours: 10.18 0.00 (0.00%) 4:39PM
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Market Cap: 15.34B
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EPS (ttm): -1.58
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Boston Scientific Corp. said it received European approval to introduce its Latitude remote-monitoring program for heart-failure devices and defibrillators across the continent in a move that could boost the adoption of its products there.
The remote-monitoring system is already approved for use in the U.S.
Analysts say that no single U.S. player in cardiac rhythm management has advanced far beyond the others in device function, so service aspects such as remote monitoring, sometimes called telemedicine, have the potential to help differentiate the companies.
The big U.S. players in cardiac rhythm management have been expanding, even touting, their possibly cost-saving telemedicine systems, as the federal government initiates widespread health-care changes. Boston Scientific, Medtronic Inc. and St. Jude Medical Inc. offer these programs in the U.S., although Medtronic has the lion's share of the market and offers its service for pacemakers, unlike the other two.
"This is where therapy is going," said Fred Colen, president of cardiac rhythm management for Boston Scientific. "Remote monitoring for patients, for any condition, is on the rise."
Boston Scientfic said it earned CE-mark approval, which certifies that the product meets consumer-safety and health standards in Europe, where the market for heart-failure devices and defibrillators is estimated to be around $1.5 billion.
So far, the Latitude program has been used for patients in the Netherlands and Denmark, and the company hopes to expand to 14 European Union countries in a phased approach.
Keay Nakae, an analyst with Collins Stewart LLC, said the company's recent U.S. growth hasn't been mirrored in Europe. Among the reasons is the lack of a monitoring system. The system "isn't a primary reason you'd use one device," he said. "But having it as a function and a capability is certainly a positive."
Telemedicine allows doctors to monitor their patients without in-office appointments and to intervene early if they see problems. This has the potential to reduce hospital visits and length of stays, though no company has completed clinical studies on the effect. Analyst Jan David Wald of Noble Financial said it will be helpful as the government begins to focus on medical cost efficiency.
"I think remote monitoring helps," he said. "On net, you're going to decrease the cost of health care."
The yearly cost of patient rehospitalization for congestive heart failure in the U.S. is estimated to be close to $10 billion, according to the West Wireless Health Institute, a research organization for wireless health technology.
The companies' services are included with the charge for the heart devices, and there is no monthly charge for patients. Doctors are reimbursed by insurance or Medicare for remote monitoring checkups as well.
Each company offers different amenities with its devices. For example, Medtronic's system monitors fluid levels automatically. Boston Scientific's system can monitor patients' weight and blood pressure. St. Jude plans to use its system for its pacemakers, pending Food and Drug Administration approval for the devices, and Boston Scientific plans to use it in its next generation of pacemakers, company representatives said.
Collins Stewart's Mr. Nakae thinks that telemedicine is more of a necessity than a bonus for the companies.
"I think it's something that everybody wants to have, and if you don't have it in the bigger picture, you could be at a disadvantage," he said.
Teva Pharma Plan B Approved by the FDA
Teva Pharmaceutical Industries (NasdaqGS: TEVA)
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Market Cap: 42.47B
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WASHINGTON -- The Food and Drug Administration approved labeling
that will allow 17-year-olds access to the Plan B emergency-contraceptive pill
without a prescription.The agency also approved a one-dose version of the product called Plan B One-Step that will also be available over-the-counter to women age 17 and older. Both products are sold by Duramed Pharmaceuticals, a unit of Teva
Pharmaceuticals Industries Ltd.
Duramed loses market exclusivity on the traditional Plan B pill -- which is
taken in two steps -- next month, allowing generic versions to be made available.
Teva said the Plan B One-Step would be available in pharmacies next month. In March a federal court ordered the FDA to lower the age requirement set by the Bush administration for Plan B to be sold over-the-counter from 18 to 17.
In 2006, the FDA agreed to make Plan B available without a prescription to
women over 18 and required the product to be placed behind the pharmacy counter. In 2004, the FDA rejected an application to make Plan B available without a prescription even though an advisory panel of outside medical experts voted to support the switch from prescription to non-prescription status.
Plan B was approved as a prescription "emergency" contraceptive in 1999. It is
made of the hormone progestin, and is designed to prevent pregnancy if taken
within 72 hours of unprotected sexual intercourse. The original Plan B pill is designed to be taken in two doses 12 hours apart.
The pills are similar to birth-control pills but contain higher doses of
progestin to block a potentially fertilized egg from becoming implanted in a
woman's uterus.The court ruling came in response to a lawsuit filed in 2005 by the Center for Reproductive Rights, a women's health advocacy group.