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FDA gives orphan-drug designation to treatment for kidney transplant patients

BY Alaric DeArment

FREMONT, Calif. The Food and Drug Administration has given orphan-drug designation to an investigational preventive treatment for delayed graft function in kidney transplant patients made by Quark Pharmaceuticals, Quark announced Tuesday.

The FDA gave the designation to QPI-1002. The company, which develops therapies that switch genes on and off through a process known as RNA interference, said it had completed enrollment and dosing in a phase 1/2 study of the drug.

 

Delayed graft function, also known as DGF, is a form of kidney failure that increases the risk of rejection of transplanted kidneys and considered an unmet medical need. The FDA grants orphan-drug designation to products for treating rare diseases and conditions affecting fewer than 200,000 people in the United States. Companies that get orphan-drug designation qualify for tax credits and longer market exclusivity periods following approval of the drug.

 

“We are confident that obtaining orphan status will facilitate the rapid development of this innovative compound and hope that ultimately, we can reduce the wait time for kidney transplants with fewer failed grafts,” Quark Pharmaceuticals president and CEO Daniel Zurr said in a statement.

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Praise the Lord and pass the clinics

BY Rob Eder

“Moreover, low-cost, convenient clinics offer the best solution for improving access to care for the uninsured, individuals without primary care physicians and workers in need of routine care.” That’s how National Center for Policy Analysis senior fellow Devon Herrick concluded his recent white paper, dated Jan. 14, 2010, “Retail Clinics: Convenient and Affordable Care.”

Hallelujah—someone in Washington finally gets it.

The other NCPA—a nonprofit, nonpartisan think tank, whose self-described mission is “to provide private sector, free-market solutions to public policy problems”—counts the Roth IRA and health savings accounts among its key policy achievements.

According to Herrick’s research, of 119 million emergency-room visits each year, 55% of them are for non-emergencies. Further, a 2006 survey of California hospitals reported that 46% of ER patients thought they could have been treated by their primary physician if they could have gotten an apppointment.

Herrick also pointed to a recent analysis from Minnesota health officials, which measured providers in the state on the appropriateness and quality of care in the treatment of two of the most common ailments in children: colds and sore throats; MinuteClinic NPs outscored primary care physicians 91% to 86%.

The NCPA holds a lot of hope in the ability of retail clinics to lower costs and improve health care; among its policy positions, the group believes retail clinics should be included in HSAs.

Herrick’s white paper came out too soon to include the recent results of the Take Care Health/Gallup patient engagement study. Drug Store News is the first media outlet to publish the results. Two key takeaways from the story that starts on page 1: Take Care, according to the Gallup study, “strongly engages” 3-out-of-4 of its customers, while the typical Gallup client scores only 1-out-of-5; Take Care’s same-clinic patient counts are up 60% versus last year.

The complete Take Care/Gallup white paper will appear in its entirety in the March edition of The Drug Store News Group’s Retail Clinician magazine.

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Reporters Notebook

BY DSN STAFF

Supplier News

Unilever’s Dove brand dove into the men’s grooming segment with its new Dove Men+Care collection available at retail in December 2009. The collection includes three varieties of body and face wash:

Clean Comfort, which is a cleansing gel that easily rinses off with a mild formula;

Extra Fresh, which is a cleansing gel that easily rinses off, with a touch of menthol for a cooling sensation; and

Deep Clean, which is a deep-cleansing gel that easily rinses off with purifying grains.

There also is a body and face bar in the Extra Fresh and Deep Clean variants, and an Active Clean shower tool. The body and face wash have a suggested retail price of $4.99 each, and the body and face bars have a SRP of $3.19 (two bars) and $7.49 (six bars). The Active Clean shower tool has a SRP of $3.99.

Eucerin, a Beiersdorf brand, has unveiled its new Eucerin Daily Skin Balance skin-fortifying body lotion and hand cream. The formula promises to strengthen skin’s protective barrier and natural defenses, while providing 24-hour moisturization to help balance the skin’s natural pH level. The products will be available beginning in April.

Japan-based cosmetics company Shiseido is looking to acquire Bare Escentuals, a maker of mineral-based makeup, for about $1.7 billion in an all-cash deal. The transaction is expected to close in first quarter 2010. Bare Escentuals’ business will operate as a separate division of Shiseido, and its brands will continue to be managed by the current leadership team.

“This looks to be a good operational fit for both companies. Bare’s growth over the next few years was largely expected to come outside the United States, particularly in Japan,” stated SunTrust Robinson Humphrey analyst William Chappell in a research note. “The merger with Shiseido should help accelerate this growth.”

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