Eisai drug shows ‘significant’ reduction in epileptic seizures
WOODCLIFF LAKE, N.J. — A drug under late-stage clinical development by Eisai reduced the frequency of seizures in patients with epilepsy, according to trial results the drug maker presented Tuesday at the 2011 International Epilepsy Congress.
In a 389-patient phase-3 study of the drug perampanel, patients with partial-onset seizures who took the drug in 8-mg and 12-mg doses showed statistically significant reductions in median seizure frequency compared with those who took the placebo while receiving treatment with one to three other epilepsy drugs. The study, dubbed "Study 305," was the third in a phase-3 trial program that enrolled a total of 1,480 patients worldwide.
In the study, 14.7% of patients taking the placebo showed a reduction in seizure frequency by 50% or more, compared with 33.3% of patients taking perampanel in the 8-mg strength and 33.9% of those taking the 12-mg strength. Also, while patients in the placebo group showed a reduction in median seizure frequency of 9.7%, those taking perampanel in the 8-mg strength once per day showed a reduction of 30.5%, while those taking it the 12-mg strength once daily showed a 17.6% reduction.
"This third phase-3 study demonstrated the statistical significance and clinical efficacy of perampanel for reducing partial-onset seizures among epilepsy patients," Eisai Neuroscience Product Creation Unit president Lynn Kramer said. "Eisai is committed to developing new therapies that can offer seizure control and address unmet medical needs, as part of our [human healthcare] corporate mission."
Diabetes Prevention and Control Alliance’s Not Me program makes way to Houston
HOUSTON — The Diabetes Prevention and Control Alliance has kicked off its national campaign designed to combat the growing epidemic of Type 2 diabetes.
Not Me — an employer- and community-based initiative launched by the DPCA, a coalition launched last year by the UnitedHealth Group and several other organizations — kicked off in Houston with an event at the Tellepsen Family Downtown YMCA for healthcare employer groups and healthcare providers, hosted by the Houston Wellness Association.
The event featured Ann Albright, director of the division of diabetes translation for the Centers for Disease Control and Prevention, as the keynote speaker.
"To help us change the course of diabetes in America, we need health professionals, lay workers, employers and the private sector," Albright said. "Our goal at the CDC is by 2020 for 15 million Americans to improve their long-term health through the National Diabetes Prevention Program. The Y has projected that it can reach about 6 million of these people. So, clearly, we need even more partners to come on board."
Not Me is anchored by the the diabetes prevention program, a 16-session lifestyle intervention that is part of the CDC-led National Diabetes Prevention program, and the diabetes control program, connects people with diabetes with patient care pharmacists for private, one-on-one consultations that provide education and support to help people with diabetes better control their condition, as well as reduce the risk of developing complications from diabetes.
Houston is 1-of-6 cities that are participating in the Not Me program. Houston’s Not Me program is supported by UnitedHealthcare, the YMCA of Greater Houston and supermarket retailer Kroger.
"Diabetes is taking a devastating toll on the children, families and communities of Houston, but we have a program that is proven to help prevent the disease," said David Milich, CEO of UnitedHealthcare employer and individual of South Texas. "The good news is that Type 2 diabetes is largely preventable. It is the small lifestyle decisions we make every day that make the biggest impact. The introduction of DPCA programs provides an opportunity for Houston residents to take control of their own health and tackle this disease."
Sales down, market basket up: Winn Dixie enters 2012 with confidence
JACKSONVILLE, Fla. — According to Winn-Dixie’s chief Peter Lynch, Winn-Dixie is riding a strong headwind into fiscal 2012 powered by a number of influencers, including a marketing program that better sustains margins, its loyalty program Fuelperks!, an improved stocking system and a significant focus on improving the customer experience.
And even as Florida, home to the majority of Winn-Dixie locations, remains one of the hardest-hit states in terms of a down economy, Lynch is optimistic on the coming year. However you couch the economic climate — sustained recession or slow recovery — Americans have learned how to manage their food budgets, Lynch, Winn-Dixie chairman, president and CEO, told analysts Tuesday morning. Lynch also told analysts that Winn-Dixie steadily has been improving its approach to promotions, passing along many inflationary increases to the consumer in place of heavy promotions that make sustaining margins difficult.
That should make an improved customer experience coupled with a strategic loyalty program significant points of differentiation for a grocer reclaiming its brand identity, all the while competing with the other Floridian supermarket heavyweight Publix. The company’s Fuelperks! program will expand across 80% of the chain’s store base by October, Lynch said, up from half of the company’s store base today. By the end of fiscal 2012, Winn Dixie plans to have the Fuelperks! program operative in all locations, the company has reported in the past.
Winn-Dixie pumped up its Fuelperks! program in April — giving consumers a 15-cent-per-gallon discount if a customer purchases three of any particular bonus Fuelperks! reward items. That has become a significant incentive to make Winn-Dixie a one-stop-shop as the average cost of gas remains above $3.50 per gallon.
“Many of our customers are telling us they are saving 50 to 75 cents per gallon or more by shopping at Winn-Dixie,” stated Mary Kellmanson, Winn-Dixie’s group VP marketing, at the time of the announcement.
Winn-Dixie is also well on its way to converting more locations into the "transformational format stores," that on average perform better to its older store base to the tune of 10% higher sales per week. Target sales-per-sq.-ft. range between $400 and $500, Lynch told analysts. That compares with a chain average of an approximate $300 in sales per sq. ft. The company plans to convert 17 locations to the transformational format in fiscal 2012, two of which already are completed. Eventually, Lynch wants to convert some 60% of Winn-Dixie’s store base into the better-performing format.
Winn-Dixie on Monday evening affirmed fiscal 2011 net sales of $6.9 billion, a 1.4% decline, compared with fiscal 2010. The decrease was due to the extra week in the prior0-year period and a slight decline in identical-store sales, which on a comparable 52-week basis decreased 0.1%, compared with the prior fiscal year.
Basket size for identical stores on a comparable 52-week basis increased 1.3% while transaction count decreased 1.5%, compared with the prior fiscal year.
Winn-Dixie projects adjusted EBITDA for fiscal 2012 to be in the range of $120 million to $135 million. Among other factors, the company’s adjusted EBITDA guidance is based on its current expectation that identical-store sales for fiscal 2012 will increase by 2.5% to 3.5% and gross margin rate will be slightly higher than fiscal 2011. The company also expects to pay no income taxes in fiscal 2012 due to the sufficiency of its tax loss carryforwards.
Capital expenditures for fiscal 2012 are expected to be approximately $200 million, of which approximately $125 million will be used for the company’s store remodeling program and new store development. The additional $75 million is expected to be used for retail store improvements and maintenance, IT systems, warehousing and transportation. Due to the continuing strong sales performance in the transformational format stores. In 2012, Winn-Dixie also is setting the groundwork on a new store pipeline for fiscal 2013.