REPORTERS Notebook
Supplier News
The Food and Drug Administration has granted marketing approval for Astepro (azelastine hydrochloride) nasal spray in the 0.15% strength, Meda Pharmaceuticals has announced.
The drug is used to relieve symptoms of seasonal and perennial allergies in patients ages 12 years and older. Seasonal and perennial allergies affect some 40 million Americans.
In clinical studies, the most commonly reported adverse reactions to the drug were bitter taste, nasal discomfort, sneezing, fatigue, headache and somnolence.
The FDA’s Oncologic Drugs Advisory Committee voted 6-4 to recommend approval for Schering-Plough Corp.’s Pegintron (pegylated interferon alfa-2b) as an adjuvant treatment for stage-3 malignant melanoma. The drug, a long-acting form of the protein interferon alfa-2b, is administered weekly by self-injection and already is approved as a treatment for hepatitis C.
“Treating malignant melanoma remains a challenge given the limited treatment options that are currently available,” University of Pittsburgh School of Medicine professor and Division of Medical Oncology chief John Kirkwood stated. “Today’s positive recommendation of pegylated interferon alfa-2b by the committee represents an important step toward a potential new option in the treatment of stage-3 malignant melanoma, especially as the incidence of the disease continues to increase.”
FDA advisory committees’ recommendations do not mandate approval of a drug, but the agency weighs them when considering whether to grant final approval.
Specialty pharmaceutical company Impax Labs said that the FDA has granted tentative approval of its abbreviated new drug application for a generic version of Flomax (tamsulosin hydrochloride) 0.4-mg capsules. Boehringer Ingelheim Pharmaceuticals markets Flomax for the functional symptoms of benign prostatic hyperplasia.
According to Wolters Kluwer Health, U.S. sales of Flomax 0.4-mg capsules were approximately $1.9 billion for the 12 months ended Aug. 31.
The FDA has approved Mylan’s generic version of a drug for Parkinson’s disease. Mylan announced the approval of its carbidopa and levodopa tablets in the 10-mg/100-mg, 25-mg/100-mg and 25-mg/250-mg strengths.
The tablets are a generic version of Bristol-Myers Squibb’s Sinemet. Branded and generic versions of the drug had sales of $79 million for the 12 months ended June 30, according to IMS Health data.
The generics arm of Swiss pharmaceutical company Novartis has completed its acquisition of an Austrian company that makes injectable drugs to treat cancer. Sandoz announced that it had acquired EBEWE Pharma for $1.3 billion, adding 15 new generic drugs to its portfolio of marketed drugs and more to the pipeline.
“We are delighted to combine EBEWE Pharma’s portfolio and pipeline of high-quality injectables with our global leadership in biopharmaceuticals, anti-infectives and other innovative technologies,” Sandoz CEO Jeff George stated. “This will greatly enhance the range of affordable generic anti-cancer medicines Sandoz offers to patients worldwide.”
Drug maker Abbott will buy the pharmaceuticals business of Belgium-based Solvay for $6.6 billion, Abbott announced. The purchase will increase Abbott’s annual sales by $3 billion, mostly outside the United States, and add $500 million to its annual pharmaceutical research and development investment, the company said.
With the acquisition, Abbott will expand its portfolio of drugs at a time when many of its existing drugs face generic competition over the next decade. The HIV drug Kaletra (lopinavir and ritonavir), which had sales of $111 million for the first six months of this year, loses patent protection in 2016; the cholesterol-lowering drug TriCor (fenofibrate)—which had sales of $336 million during the same period together with successor drug TriLipix—will lose protection in 2011.
Merck KGaA has halted trials of a multiple sclerosis drug it licensed from a U.S. biotechnology company after results showed patients did worse when taking it. The German drug maker, which is separate from U.S.-based Merck & Co., had licensed the drug atacicept from Seattle-based ZymoGenetics. An independent panel of scientists found that patients in the trial experienced an increase in disease symptoms when taking the drug.
Nevertheless, trials of the drug as a treatment for rheumatoid arthritis and lupus will continue, and similar complications have not emerged in those patient groups.