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Generic heartburn drug made by Korean company poised to win FDA approval

BY Alaric DeArment

SEOUL, South Korea — South Korean drug maker Hanmi Pharmaceutical Co. and U.S. partner Amneal Pharmaceuticals have made an agreement in federal court concerning a generic heartburn drug that they said clears a major hurdle to its launch.

The companies said a consent judgment had been entered by the U.S. District Court for the District of New Jersey in a patent litigation suit that AstraZeneca filed in February 2011, alleging that Hanmi infringed its patent on Nexium (esomeprazole-strontium) delayed-release capsules. The judgment states that Hanmi has acknowledged two patents in the case as enforceable and valid, and that Hanmi’s product does not infringe the claims of the two patents based on a December 2012 ruling by the court.

The Food and Drug Administration gave tentative approval to the generic drug at the end of April, and Hanmi and Amneal expect that it will receive final FDA approval soon. FDA approval would make Hanmi the first Korean company to enter the U.S. generic drug market.

 

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Update: USA Drug icon Stephen LaFrance passes away

BY Michael Johnsen

PINE BLUFF, Ark. — Stephen LaFrance, 71, former owner of USA Drug, passed away Wednesday morning, DSN has learned. 

Additional details were not immediately available, though the passing was unexpected. 

"From opening his first store in 1968, Steve always focused on two things: ‘Take care of your customers’ and ‘Treat your employees right,’" Joe Courtright, former USA Drug president and CEO, shared with DSN. "His motto was ‘Do the right thing.’ And those were certainly words he lived by. He was beloved by his employees."

"Steve was always an honorable man who lived up to his word in all of his engagements with employees, colleagues and vendors," added industry veteran Bob Berman.

According to an obit published by Ralph Robinson & Son Funeral Home,  LaFrance is survived by his wife of 44 years, Linda, along with his sons Stephen Jr. and Jason and daughter Amy. LaFrance has seven grandchildren. 

The funeral service will be held on Saturday, June 8, 2013 at 2 p.m. at the First United Methodist Church of Pine Bluff. There will be a visitation on Friday from 5:30 p.m. to 7:30 p.m. 

Memorial contributions may be made to the First United Methodist Church of Pine Bluff, PO Box 8003, Pine Bluff, AR 71611, Ralph Robinson reported. 

LaFrance was credited with building a multi-million dollar pharmacy enterprise from $26 in start-up cash, according to a January 2013 profile by Talk Business Arkansas

LaFrance formed the Stephen L. LaFrance Pharmacy, the predecessor to USA Drug, in February 1968. He grew that business into a thriving pharmacy with 144 locations, most notably on the home turf of Walmart. 

The original LaFrance Pharmacy in the mid-1970s became SAJ Distributors, a full-service wholesale distribution company that offered a broad selection of health, beauty and general merchandise to grocery, drug and discount stores. SAJ’s distributed more than 22,000 items to more than 1,000 customers from a four-story, 255,000-square-foot storage facility at its corporate headquarters here.

The first USA Drug store opened its doors in 1984. And two years later LaFrance entered the private-label production business with the formation of Select Brand Distributors. 

Between then and 2012, when Walgreens acquired all USA Drug banners, the Pine Bluff-based chain operated its 144 locations under the retail shingles USA Drug, Super D Drugs, May’s Drug Stores, Drug Warehouse and Med-X Drugs across Arkansas, Kansas, Oklahoma, Mississippi, Missouri and Tennessee.

LaFrance said the decision to sell the chain — which recorded sales of $825 million in 2011 — to Walgreens was "not only because it is the premier drug store company in [our] industry, but also because Walgreens will continue to provide [our] customers with the service and products they have come to expect."

USA Drug ranked No. 31 on the DSN PoweRx 50, with projected pharmacy sales of approximately $409 million in 2011.

DSN will update this news with additional details as they are made available. 

 

 

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American Association of Nurse Practitioners commends new legislation for improving healthcare access

BY Antoinette Alexander

AUSTIN, Texas — The American Association of Nurse Practitioners on Wednesday commended Gov. Brian Sandoval and Nevada lawmakers for passage of Assembly Bill 170, which provides Nevada patients with full and direct access to nurse practitioner services by right-sizing state regulations.

The Governor signed the measure into law during a late-night session on Monday.

"Enactment of Assembly Bill 170 streamlines and improves health care delivery, providing Nevada with the ability to adapt and respond to the state’s growing healthcare needs. It will also help recruit and retain more nurse practitioners,” stated Angela Golden, president of the American Association of Nurse Practitioners. "Nevada now keeps pace with 16 other states and the District of Columbia, which offer patients full and direct access to nurse practitioner services and moves into alignment with national recommendations. We urge lawmakers in other states that are considering similar legislation to follow suit and take steps toward closing the gap between the care that nurse practitioners are educated to provide and the care that dated regulations allow them to deliver."

 

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