Shire attempts to block generic Intuniv
DUBLIN — Drug maker Shire has filed a patent infringement suit against Watson Pharmaceuticals and Impax Labs in response to their attempt to win approval from the Food and Drug Administration for a generic version of a Shire drug.
Shire announced that it had filed the suit in the U.S. District Court for the Northern District of California following the two generic drug makers’ filing of an approval application for guanfacine hydrochloride, a version of Shire’s Intuniv, used to treat hypertension.
Shire alleged that the filing infringes on three patents covering Intuniv, the last of which expires in July 2022, according to the FDA. Intuniv’s regulatory exclusivity period runs through September 2012.
Genzyme (again) turns down Sanofi-Aventis
CAMBRIDGE, Mass. — Biotech company Genzyme still is saying “no thanks” to French drug maker Sanofi-Aventis’ tender offer of $18.5 billion, or $69 per share, to acquire it, saying the offer “substantially undervalues” the company.
The offer has been extended until Jan. 11, Genzyme said.
Sanofi has sought to buy Genzyme since August. Genzyme, based in Cambridge, Mass., specializes in treatments for rare genetic disorders, such as Fabry disease and Gaucher disease.
Walgreens unveils benefits of Dimensions project
DEERFIELD, Ill. — Pharmacists who intervene with diabetes patients are having a clear and positive impact on clinical outcomes, a new study from Walgreens has found.
In a presentation this week, for the first time in public, two Walgreens healthcare leaders unveiled the results of a groundbreaking pilot project on pharmacy-based diabetic care. Walgreens launched the project, called Dimensions, at its worksite pharmacies in 2008. Its results were successful enough to spawn another long-term health initiative for the broader community, launched in January of this year and called Walgreens Optimal Wellness.
The two executives, Walgreens chief medical officer Cheryl Pegus, and director of health outcomes and analytics Michael Taitel, unveiled the findings of the Dimensions pilot at the World Research Group’s Diabetes Prevention and Management Forum for Health Plans and Employers. The study, they said, established that diabetes patients, who participated in a disease management program, leveraging face-to-face interactions with a pharmacist, demonstrated high levels of patient engagement [more than 90%] and significantly improved clinical outcomes.
“Chronic [diseases are] arguably the most pressing areas of concern for health care in the United States, and diabetes is one of the most difficult and most costly chronic conditions to manage,” Pegus told the gathering. “Walgreens recognized that with its unrivaled ability to reach patients where they both work and live, [its] diverse team of 70,000 healthcare-service providers and [its] understanding of the power of face-to-face interactions on health outcomes, we had a unique opportunity to help patients learn how to live healthier and better lives.”
Dimensions centered on Walgreens working with employers at its worksite pharmacies. To that end, specially trained Walgreens pharmacists provided patients and employees diabetes education at the sites, including initial one-on-one consultations and monthly follow-ups.
The results of the program “showed significant patient improvement,” Walgreens reported, “as the percent of participants with combined HbA1C, blood pressure and cholesterol values at clinical guideline goals increased from 11.8% to 21.8%.” That marked an 85% improvement, Pegus noted.
Equally striking was the retention rate. At 18 months, more than 90% of patients stayed engaged in the program, according to Pegus and Taitel. Patients also had “exceptionally positive” reactions to the pharmacist interventions, the Walgreens execs said, reporting 100% overall satisfaction with the pilot. Indeed, they noted, several patients called the program “life altering.”
The positive results of Dimensions led directly to the launch of the community-focused Walgreens Optimal Wellness program, the executives told forum attendees. That effort was launched in January in four markets, and since has been expanded to five more markets as a self-care educational program for people with Type 2 diabetes. The program builds on Dimensions, Pegus said, by emphasizing patient engagement and a personalized approach to adherence and self-management with a personal health coach at multiple Walgreens locations through a “hub and spoke” model.
In April of this year, Walgreens took the concept further, partnering with UnitedHealth Group and the YMCA of the USA to launch the Diabetes Prevention and Control Alliance. Walgreens called that effort a comprehensive collaboration to treat and manage diabetes.
”The success we have seen so far with Optimal Wellness underscores the type of pharmacy, health and wellness initiative that Walgreens is increasingly exploring as we look for innovative ways to help address areas of unmet patient need,” Pegus said. “We are excited to expand this program to additional communities and disease states and build on this momentum to continue leveraging our broad offerings.”