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Watson confirms generic Atelvia patent challenge

BY Allison Cerra

PARSIPPANY, N.J. — Watson Pharmaceuticals is looking to market a generic version of a postmenopausal osteoporosis treatment.

The generic drug maker said its subsidiary, Watson Lavs, has filed an abbreviated new drug application with the Food and Drug Administration for risedronate sodium delayed-release tablets in the 35-mg. strength. The drug is a generic version of Atelvia, which is manufactured and distributed by Warner Chilcott.

In response to the ANDA filing, Warner Chilcott filed suit against Watson last week in the U.S. District Court for the District of New Jersey to block Watson from commercializing generic Atelvia prior to the expiration of patent Nos. 7,645,459 and 7,645,460. The suit was filed under the Hatch-Waxman Act, Under the Hatch-Waxman Act, which puts a stay of FDA approval on Watson’s drug for 30 months, or until the companies settle the matter.

Watson, however, said it believes it may be a "first applicant" to file an ANDA for the generic version of Atelvia and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

Atelvia had total U.S. sales of about $17 million for the 12 months ended in August, according to IMS Health data.


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APhA Foundation launches cardiovascular health initiative

BY Alaric DeArment

WASHINGTON — The American Pharmacists Association Foundation announced Tuesday the launch of a cardiovascular health initiative.

The initiative, supported by the Centers for Disease Control and Prevention’s Division for Heart Disease and Stroke Prevention, will include a consortium meeting near Washington bringing in more than 20 stakeholders who will collaborate and share their perspectives on the legislative and regulatory changes needed to allow for implementation of care-delivery process improvements. The focus will specifically be on the care models pharmacists have employed to manage chronic disease states, such as hyperlipidemia, hypertension and diabetes.

"The APhA Foundation is excited to partner with the CDC’s DHDSP," APhA Foundation president of research Benjamin Bluml said. "The foundation, in collaboration with APhA, is well-equipped with knowledge, skills and leadership experience gained from our respective work in past research initiatives and policy efforts. We are excited to bring together a group of experts who are uniquely qualified to delivery critical insight from innovative care delivery practices that will inform the policy requirements surrounding implementation of these models."


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Study highlights efficacy of Oral-B oscillating-rotating power toothbrush

BY Antoinette Alexander

CINCINNATI — In a four- to 12-week period, power brushes with oscillating-rotating technology, pioneered by Oral-B, reduce plaque and gingivitis more than power brushes that move laterally from side-to-side, known as sonic, according to the Cochrane Collaboration, an independent healthcare research group.

Furthermore, the analysis reiterated that no other powered designs are consistently superior to manual toothbrushes. This finding originally was reported in the Collaboration’s 2003 “Power versus Manual” toothbrush systematic review. The most recent report also found that oscillating-rotating technology alone consistently is superior at removing plaque and reducing gum inflammation in not only the short-term, but over the long-term as well.

Oral-B, a Procter & Gamble oral care brand, led the development of oscillating-rotating technology in 1991, and has since published more than 90 clinical studies demonstrating the superior efficacy of oscillating-rotating technology.

“Oral-B continuously aims to provide consumers and professionals with products that meet their needs and deliver superior oral health benefits,” stated Leslie Winston, global director of professional and scientific relations for P&G Oral Care. “The Collaboration’s conclusions that oscillating-rotating technology reduces more plaque and gingivitis than both manual brushing and side-to-side power brush technology are a testament to the innovation and research occurring at P&G Oral Care and Oral-B.”

In 2005, the Cochrane Collaboration reported that clinical research showed that rotating-oscillating toothbrushes reduced plaque and gingivitis more than manual toothbrushes. In 2011, a separate Cochrane review reported a small but significant difference in plaque and gingivitis reduction for oscillating-rotating power toothbrushes versus side-to-side power toothbrushes. The report did not reach any conclusion about the clinical importance of these results.

Oral-B enhanced its power toothbrush functionality and efficacy further by applying its 3D action to the ProfessionalCare power brush series. It combines oscillating-rotating technology with gentle in-and-out pulsations that have been shown to remove even more plaque than oscillating-rotating technology alone.

In addition, the company’s flagship model, the ProfessionalCare SmartSeries 5000 with SmartGuide, incorporates many compliance-enhancing features that maximize brushing performance and increase compliance by tracking how long a person brushes and by guiding users through the four quadrants of the mouth as they brush.

Patients who use the ProfessionalCare SmartSeries 5000 with SmartGuide are, on average, five times more likely to adhere to the two minutes twice a day brushing recommendations, and are less likely to use excessive brushing force. Research has shown that 92% of patients significantly will improve their brushing thoroughness in 30 days with the ProfessionalCare SmartSeries 5000 with SmartGuide.

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