Amerigen joins Bystolic patent challenge
NEW YORK — Another generic drug maker has joined efforts to challenge the patent on a drug made by Forest Labs for treating hypertension.
East Brunswick, N.J.-based Amerigen Pharmaceuticals announced that it had filed with the Food and Drug Administration for approval of a generic version of Bystolic (nebivolol). Amerigen’s announcement followed news that Forest and Johnson & Johnson subsidiary Janssen Pharmaceutica NV had sued Glenmark Generics, Hetero USA, Torrent Pharmaceuticals and Watson Labs on Tuesday over their filing for approval of their own versions. Watson also confirmed Wednesday that it had challenged Forest’s patent on Bystolic and sought to market a generic version of the drug in the 2.5 mg, 5 mg, 10 mg and 20 mg strengths.
Forest alleged that the companies named in the suit had infringed U.S. Patent No. 6,545,040, which is scheduled to expire in December 2021. Bystolic had sales of $391 million during the 12-month period ended in January, according to IMS Health.
Winn-Dixie offers free tests for colorectal cancer, launches ‘Test for Life’ campaign
JACKSONVILLE, Fla. — In line with National Colorectal Cancer Awareness Month, Winn-Dixie is offering customers the chance to pick up a free test at its pharmacies.
Through April 7, guests can pick up EZ Detect, a patented two-minute, noninvasive test that detects occult blood (blood not visible to the naked eye), which indicates bleeding in the gastrointestinal tract. The bleeding may be a symptom of colorectal disease, such as ulcers, hemorrhoids, colorectal cancer, polyps, colitis, diverticulitis or fissures, Winn-Dixie said. A list of pharmacies offering the test can be found here.
The offering is part of the chain’s "Test for Life" campaign, through which Winn-Dixie teamed up with UF & Shands Jacksonville and local news station Action News.
"Colorectal cancer screenings are recommended for men and women beginning at age 50 but it’s never too early to get tested," Winn-Dixie VP pharmacy John Fegan said. "We care about our guests’ health and want to encourage the community to take advantage of this opportunity and let friends know about these free tests. All it takes is one simple test to save a life."
New research examines cost-effectiveness of lowering HbA1C cutoff
NEW YORK — Reducing the cutoff of hemoglobin A1C to determine if a patient has prediabetes could be cost effective, according to a new study.
The American Diabetes Association recommends HbA1C testing as one basis for identifying diabetes and prediabetes and has established the HbA1C value of 6.5% as the diagnostic cutoff. Researchers — led by Xiaohui Zhuo of the Division of Diabetes Translation at the National Center for Chronic Disease Prevention and Health Promotion of the Centers for Disease Control and Prevention — sought to determine "the cost effectiveness associated with the alternative HbA1C cutoffs for identifying prediabetes." The researchers created a simulation sample from data of nondiabetic American adults, ages 18 years and older, from the National Health and Nutritional Examination Survey (1999-2006).
Lowering the HbA1C cutoff would increase the health benefits of the preventive interventions at higher costs:
For high-cost intervention, lowering the HbA1C cutoff from 6% to 5.9% and from 5.9% to 5.8% would result in $27,000 and $34,000 per quality-adjusted life-year gained, respectively;
Decreasing the cutoff from 5.8% to 5.7%, from 5.7% to 5.6% and from 5.6% to 5.5% would cost $45,000, $58,000, and $96,000 per QALY gained, respectively;
For the low-cost intervention, lowering the HbA1C cutoff from 6% to 5.9% and from 5.9% to 5.8% would result in $24,000 and $27,000 per QALY gained, respectively;
Lowering the cutoff from 5.8% to 5.7%, 5.7% to 5.6%, and 5.6% to 5.5% would cost $34,000, $43,000 and $70,000 per QALY gained, respectively.
"Establishing an HbA1C cutoff for prediabetes … has been more challenging than for diabetes because the relationship between the incidence of Type 2 diabetes and HbA1C below 6.5% is continuous, with no clearly demarcated threshold that is associated with an accelerated risk of diabetes or other morbidities," the study authors said. "It was found that lowering the HbA1C cutoff resulted in greater health benefıts, but also led to an increase in costs and, consequently, a decrease in the economic effıciency of preventive interventions. As a result, from a healthcare system perspective, determination of an optimal HbA1C cutoff ultimately depends on the level of effıciency that society can accept, or more specifıcally, the resources it is willing to make available for Type 2 diabetes prevention."