PHARMACY

BioMarin, La Jolla partner to progress kidney disease treatments

BY Alaric DeArment

SAN DIEGO Two California drug makers have signed an agreement to develop and commercialize a new drug for treating the kidney inflammation disease lupus nephritis in most of the world.

BioMarin Pharmaceutical and La Jolla Pharmaceutical announced Tuesday that they would partner to develop and commercialize Riquent (abetimus sodium) in all markets except the Asia Pacific region. The drug is in phase 3 clinical trials.

“We are very pleased to become La Jolla Pharmaceutical’s partner for Riquent,” BioMarin CEO Jean-Jacques Bienaime said in a statement. “The development history of Riquent has been long and challenging, but we feel the current study addresses the shortcomings of prior studies and provides the best possible opportunity to demonstrate that Riquent reduces the frequency of renal flares in lupus nephritis patients.”

Under the deal, BioMarin will have a co-exclusive license to develop and commercialize Riquent, and La Jolla will receive up to $289 million in milestones and equity purchases, including a $15 million upfront payment.

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American Idol judge teams with AHA to promote diabetes awareness

BY Michael Johnsen

PHILADELPHIA Music industry veteran and TV personality Randy Jackson (American Idol) will be teaming up with the American Heart Association for a second year to help people living with Type 2 diabetes understand the importance of properly managing their disease, and to encourage them to enroll in The Heart of Diabetes campaign on Jan. 8, the American Heart Association announced Tuesday.

Jackson, who lives with type 2 diabetes, is coming to Philadelphia to urge adults in the city with diabetes to get regular physical activity, make healthy food choices and work with their healthcare providers to develop a comprehensive treatment plan.

In addition, local chef Delilah Winder will host a free cooking demonstration to show how lifestyle changes, such as eating a healthy, well-balanced diet, can help individuals improve their management of Type 2 diabetes.

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NACDS challenges report on DME rules

BY Jim Frederick

ALEXANDRIA, Va. Hitting back against what it argues is inadequate or biased coverage of a health care issue of concern to its members, the National Association of Chain Drug Stores today took the Wall Street Journal to task for a report on federal regulations for providers of durable medical equipment and supplies for Medicare beneficiaries.

The organization swung into action via its NACDS Rapid Response program in response to a recent Wall Street Journal Health Blog post. The posted article, NACDS president and chief executive Steven Anderson asserted today, correctly cited the need to combat Medicare fraud but ignored the harmful impact the new DME regulations would have on pharmacies.

Through the Department of Health & Human Services, the Bush Administration pushed through new rules established by the Centers for Medicare & Medicaid Services, for the sale of DME in retail outlets. Under the new regulations, retailers wishing to participate in the market for durable medical equipment will be required to gain accreditation to sell home health and other health supplies, and to bid in competition with other DME providers to obtain contracts to sell those products. The so-called Competitive Acquisition Program was originally launched in 10 markets as a demonstration project, with delayed plans for a phased national rollout.

NACDS and other pharmacy groups were instrumental in securing that delay through legislation to postpone and reform Medicare’s competitive bidding program for DME. The group reports it is now “engaged with Congress and CMS to ensure that policies intended to safeguard the Medicare program are implemented in a manner that minimizes disruption of care.”

Responding to the WSJ article, Anderson called attention to the importance of preserving patient access to medical equipment and supplies, such as diabetes testing products.  The accreditation requirement and the recently issued rule requiring that pharmacy retailers be bonded to retain Medicare enrollment, said Anderson, “are unnecessary regulations imposed on state-licensed pharmacies that could limit patients’ ability to manage their diseases.

“While it is important to stop fraudulent claims and fly-by-night operations, CMS’ new regulations will make it much harder—even prohibitive—for legitimate suppliers to provide DME for patients,” added NACDS’ top executive. “Pharmacies play a crucial role in the management of diabetes and are an essential provider of diabetic supplies and Medicare Part B medications. These regulations will threaten patients’ access to the crucial supplies and equipment to manage their diseases effectively.”

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