Watson, Actavis divest more drugs as condition for FTC merger approval
NEW YORK – Watson Pharmaceuticals and Actavis will have to divest rights to almost two dozen drugs as a condition for U.S. regulatory approval of their $5.6 billion merger announced earlier this year, according to regulatory documents.
The Federal Trade Commission is requiring the companies to sell to Sandoz — Swiss drug maker Novartis’ generics division — generic versions of GlaxoSmithKline’s antidepressant Wellbutrin (bupropion hydrochloride) extended-release tablets; Valeant’s hypertension and angina drug Tiazac (diltiazem hydrochloride) extended-release capsules; and the anxiety drug lorazepam. The companies must also divest rights to GlaxoSmithKline’s hypertension drug Dynacirc (isradipine) capsules and Watson’s schizophrenia drug Loxitane (loxapine succinate) capsules while changing a contract between Actavis and Pfizer concerning the former’s authorized generic version of an extended-release painkiller containing morphine sulfate and naltrexone, transferring the manufacturing rights back to Pfizer and eliminating Actavis’ exclusive right to market the drug.
The rights to these drugs are being divested in addition to the 14 drugs that Watson and Actavis agreed to sell to Par Pharmaceutical Cos. last week as a condition for the merger.
Astellas bladder drug made available in U.S.
NORTHBROOK, Ill. — The U.S. subsidiary of Japanese drug maker Astellas Pharma has made a drug for overactive bladder available in U.S. pharmacies, the company said.
Astellas Pharma US announced the availability of Myrbetriq (mirabegron) extended-release tablets. The drug is used to treat OAB with symptoms of urge urinary incontinence, urgency and urinary frequency. The Food and Drug Administration approved the drug on June 28, 2012.
"The availability of Myrbetriq marks an important milestone in our ongoing commitment to urology," Astellas SVP sales and marketing Jim Robinson said. "We are pleased to now be able to provide a portfolio of treatment options for those living with overactive bladder."
Sanofi Pasteur presents influenza vaccine trial data
SWIFTWATER, Pa. — Sanofi Pasteur announced Monday the presentation of three clinical trials of an experimental influenza vaccine.
Sanofi Pasteur, French drug maker Sanofi’s vaccines division, presented an overview of phase-2 and phase-3 trials of its quadrivalent influenza vaccine at the first joint meeting of the Infectious Disease Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association and the Pediatric Infectious Diseases Society, an event called IDWeek, where the company announced that the Food and Drug Administration had accepted its regulatory approval application for its Fluzone quadrivalent vaccine. The vaccine is designed to prevent influenza A and B in patients ages 6 months and older.
"Rates of hospitalization and death from influenza B are higher than those seen with A (H1N1) and, overall, influenza B is a significant cause of absenteeism, clinic visits, hospitalizations and complications across all ages, but especially in children," Sanofi Pasteur senior director for U.S. scientific and medical affairs David Greenberg said. "Since two lineages of influenza type B circulate each season, public health officials have been challenged to predict which B virus to include in the vaccine to achieve the greatest effectiveness against circulating influenza strains. Due to increased vaccine production capacity in the U.S., we now have the ability to provide quadrivalent influenza vaccine to help protect against both lieges of B influenza and potentially provide a greater public health benefit from influenza immunization."