PHARMACY

Dr. Reddy’s launches Cresp

BY Alaric DeArment

HYDERABAD, India Generic drug maker Dr. Reddy’s has launched in India the world’s first follow-on version of a biotech anemia drug.

Dr. Reddy’s announced Monday the launch of Cresp (darbepoetin alfa), used to treat anemia in patients with chronic renal failure. Cresp is a biosimilar of Amgen’s Aranesp. Darbepoetin alfa is a version of epoetin alfa engineered to have a longer half life so that it lasts longer in the blood.

“Cresp will offer patients in India an improved treatment regimen at affordable pricing,” Dr. Reddy’s vice chairman and CEO G.V. Prasad said. “The launch of Cresp by Dr. Reddy’s is a significant step in redefining the treatment of anemia in India and underscores our commitment to provide affordable and innovative medicines to patients in India.”

Though Cresp will only be available in India, it marks Dr. Reddy’s as an additional player in the nascent global biosimilars market, so far dominated by Israel’s Teva Pharmaceutical Industries, Novartis subsidiary Sandoz and U.S.-based Hospira, all of which have become established manufacturers of biosimilars for the European market. Cresp is not the first biosimilar product from Dr. Reddy’s, which three years ago launched in India Reditux (rituximab), a biosimilar of Genentech’s and Biogen Idec’s cancer and autoimmune drug Rituxan and so far the only biosimilar monoclonal antibody in the world.

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Mission launches Uribel

BY Alaric DeArment

SAN ANTONIO Drug maker Mission Pharmacal has launched a treatment for urinary tract infections.

 

Mission announced the launch of Uribel (methenamine, sodium phosphate monobasic, phenyl salicylate, methylene blue and hyoscyamine sulfave) capsules, used to relieve local discomfort and inflammation associated with lower urinary tract infections, interstitial cystitis, painful bladder syndrome and urinary tract procedures.

 

 

Mission will handle distribution and marketing of Uribel for Star Pharmaceuticals, while an unnamed third party company will manufacture the drug.

 

 

“Uribel is an important expansion of our urology and women’s health product portfolio, and we’re excited to be partnering with Star Pharmaceuticals to bring this product to patients,” Mission president of commercial operations Terry Herring said. “Uribel provides three complementary ways to treat uncomfortable urinary tract conditions – an analgesic to relieve pain and burning, an antispasmodic to reduce urinary urgency and antiseptic that inhibits the growth of bacteria.”

 

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Genzyme, Isis announce study results for mipomersen

BY Alaric DeArment

CAMBRIDGE, Mass. Biotech company Genzyme and Isis Pharmaceuticals have finished late-stage clinical trials of a cholesterol-lowering drug, the two companies said.

Genzyme and Isis announced results of two phase 3 studies of the drug mipomersen in patients who have high cholesterol levels while taking high doses of cholesterol-lowering medications. The studies were conducted in North America, Europe and South Africa.

In one study of patients with severe hypercholesterolemia, mipomersen reduced “bad” LDL cholesterol by 36%, compared with 13% among those taking placebo; in the other study of patients with high cholesterol at high risk of cardiovascular disease, the drug reduced LDL cholesterol by 37%, compared with 5% among those taking placebo.

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