Endo launches Fortesta
CHADDS FORD, Pa. — Endo Pharmaceuticals has launched a recently approved testosterone gel for men.
Endo announced Thursday the launch of Fortesta, approved by the Food and Drug Administration for treating low testosterone — or low T — in men, which affects about 14 million men in the United States; around 1.3 million of those men currently are receiving treatment, according to Endo.
“We are excited to bring Fortesta gel to market in the United States and are confident that once men try it, Fortesta gel will quickly become a significant treatment option for many men with low T,” Endo COO Julie McHugh said.
Merck receives CRL for MS treatment
DARMSTADT, Germany — The Food and Drug Administration declined to approve a Merck KGaA drug designed to treat relapsing-remitting multiple sclerosis.
The drug maker said it received a complete response letter from the FDA on Wednesday for cladribine tablets, Merck’s proprietary investigational oral formulation of cladribine. The regulatory agency noted in the CRL that Merck did provide substantial evidence of cladribine tablets’ effectiveness in its CLARITY1 study, but requested Merck provide an improved understanding of safety risks and the overall benefit-risk profile either through additional analyses or by additional studies.
“Our commitment to transform the way people living with MS approach their therapy options remains steadfast,” said Fereydoun Firouz, president and CEO of Merck’s U.S. subsidiary, EMD Serono. “We look forward to working with the FDA to address the safety issues in its letter and will continue to move toward identifying a potential path that provides patients and physicians the opportunity to have access to cladribine tablets in the treatment of MS.”
Cladribine tablets are approved and available under the trade name Movectro in Australia and Russia as a treatment of relapsing-remitting MS. Merck noted the tablets also are under regulatory review in other countries.
February flu benefit not as big as billed for Walgreens
DEERFIELD, Ill. — Walgreens on Thursday posted sales growth of 8.7% to $18.5 billion for its second quarter ended Feb. 28.
Comparable-store sales were up 4%, with a 4% increase across front-end same-store sales. Prescriptions filled grew by 4.5%; quarterly same-store pharmacy sales were not provided.
For the month of February, Walgreens’ pharmacy sales increased 6.4%, while comparable-pharmacy sales increased 2.7%, accounting for 64% of total sales for the month. Total front-end sales increased 10.6% in February, including 4.5 percentage points from Duane Reade stores. Comparable-store front-end sales increased 3.8% (no comparable sales figures include Duane Reade, Walgreens noted). Customer traffic in comparable stores increased 1.6%, while basket size increased 2.2%.
Sales in overall comparable stores increased 3.1%, falling just shy of projected consensus of 3.3% and well shy of Credit Suisse estimates of 4.5% released earlier this week. Credit Suisse calculated a 150 basis-point benefit from increased flu activity that would carry pharmacy comp sales higher by up to 5%. Walgreens recorded a 120 basis-point flu benefit, but only a 2.7% lift in overall pharmacy same-store sales, citing as much as a 120 basis point negative impact from fewer flu shots and the number of Midwest consumers who refilled their prescriptions earlier in January ahead of a severe February winter storm at the top of the month.
Flu shots administered season-to-date at pharmacies and Take Care Clinics totaled 6.4 million.
Overall February sales of $5.7 billion represented an increase of 7.8% from February 2010. Duane Reade stores, acquired in April 2010, contributed 2.7 percentage points to the total sales increase for the month, Walgreens reported.
Prescriptions filled at comparable stores increased 4.3% for the month of February.