PHARMACY

Rite Aid reports 2.2% decrease in comps for December

BY Alaric DeArment

CAMP HILL, Pa. — A shift in the New Year’s holiday calendar and the introduction of new generic drugs contributed to a decrease in same-store sales for the month of December at Rite Aid, the retail pharmacy chain said Thursday.

Rite Aid reported a 2.2% decrease in comps for the four-week period that ended Saturday, including a 1% decrease in front-end comps and a 2.9% decrease in pharmacy comps. The company said the calendar shift had a negative effect of 1.1% on front-end comps, while the decrease in pharmacy comps included a negative effect of 605 bps from new generic drug introductions. Same-store prescription count increased by 4.4%, including a 1.7% contribution from flu-related prescriptions and flu shots.

Guggenheim Partners analyst John Heinbockel said the results were in line with his firm’s expectations and reiterated Guggenheim’s "Buy" rating of Rite Aid’s stock, noting that the decline was driven largely by the generic wave, and the chain had continued to retain many of the scripts it won over during the Express Scripts-Walgreens dispute. Heinbockel also wrote that the decline in pharmacy comps was "modestly better" than the 4% drop he had forecasted. Rite Aid’s stock opened at $1.40 per share Thursday morning, unchanged from Wednesday’s closing price, falling to $1.38 in late Thursday afternoon trading.

Total sales for the four-week period decreased by 2.7%, to $2.054 billion, compared with $2.112 billion in December 2011.

Comps for the 43-week period that ended Saturday increased 0.1%, including a 1.4% increase in front-end comps and a 0.6% decrease in pharmacy comps, while same-store prescription count increased by 3.6%.

Total store sales for the 43-week period decreased by 0.6%, to $20.913 billion, compared with $21.030 billion during the same period in 2011.

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FDA approves 39 new drugs in 2012, a 16-year high

BY Jason Owen

NEW YORK — In 2012, the Food and Drug Administration approved 39 new drugs, 8 alone in December, marking the largest increase in 16 years. The wave of approvals poises pharmaceutical makers to see big gains after billions in losses in recent years to generic drug makers because of patent expirations.

2012’s tally compares to a total of 30 new drug approvals in 2011 and just 21 on 2010. At least 10 of the 39 drugs received fast-track status, which enabled them to be reviewed more quickly. 2012 saw the highest number since 1996, when 53 so-called new molecule entities received approval.

The pharmaceutical sector needs a pick-up in productivity after numerous patents expired over recent years, hitting a high-point in 2012, allowing generic manufacturers to take some of the market share with low cost substitutions. The rating agency Standard & Poor estimates major U.S. drug companies have lost about $21 billion in revenue, and European businesses lost about $10 billion, in 2012 from lucrative medicines coming off patent.

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First anti-diarrheal drug for HIV/AIDS patients receives FDA approval

BY Rebecca Haughey

SPRING SPRING, Md. — The U.S. Food and Drug Administration on Monday approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies.

Fulyzaq is intended to be used in HIV/AIDS patients whose diarrhea is not caused by an infection from a virus, bacteria or parasite. Patients take Fulyzaq two times a day to manage watery diarrhea due to the secretion of electrolytes and water in the gastrointestinal tract. Derived from the red sap of the Croton lechleri plant, Fulyzaq is the second botanical prescription drug approved by FDA. A botanical drug product is often a complex mixture derived from one or more plant materials with varying degrees of purification.

The safety and efficacy of Fulyzaq were established in a clinical trial of 374 HIV-positive patients on stable antiretroviral therapy with a history of diarrhea lasting one month or longer. The median number of daily watery bowel movements was 2.5 per day. Results showed that 17.6% of patients taking Fulyzaq experienced clinical response, compared with 8% taking placebo. In some patients, a persistent anti-diarrheal effect was seen for 20 weeks.

Fulyzaq is distributed by Salix Pharmaceuticals, based in Raleigh, N.C. under license from Napo Pharmaceuticals Veregen is marketed by Florham Park, N.J.-based PharmaDerm.

 

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