Forest to acquire Clinical Data
NEW YORK — Drug maker Forest Labs plans to acquire the developer of a recently approved antidepressant.
Forest announced that it would pay $1.2 billion, or $30 per share, to acquire Clinical Data, saying the acquisition would give it control of the drug Viibryd (vilazodone hydrochloride), a treatment for major depressive disorder in adults that won Food and Drug Administration approval last month. The agreement also includes up to $6 per share in addition for milestones related to Viibryd.
“We are pleased to enter into this agreement with Clinical Data,” Forest chairman, president and CEO Howard Solomon said. “Depression is a debilitating disease that affects the daily lives of millions of patients. We believe that we are uniquely positioned to bring Viibryd to market in light of our long and successful experience of clinical development and expertise in the antidepressant market.”
Onglyza gets label update
PRINCETON, N.J., and WILMINGTON, Del. — The makers behind a popular Type 2 diabetes treatment have included data from two clinical studies in an update to the drug’s prescribing information.
Bristol-Myers Squibb and AstraZeneca said the Food and Drug Administration approved the labeling update for Onglyza (saxagliptin), which now includes efficacy and safety information about the drug’s effects on patients with renal impairment or end-stage renal disease.
One study was a 12-week trial involving patients with severe kidney damage or end-stage kidney disease, which compared Onglyza with the patients’ current treatment plus a placebo. The results showed patients experienced greater improvements to their blood sugar levels, those the rates of side effects were the same.
In the second study, which was a 52-week trial, compared Onglyza with titrated glipizide in patients with inadequate glycemic control on metformin therapy and were dieting and exercising. The study showed that Onglyza plus metformin provided similar HbA1c reductions.
“Many people with Type 2 diabetes also experience kidney impairment, which can limit treatment options. With this update, Onglyza now includes efficacy and safety data in its label supporting its use in this important population,” said Elliott Sigal, EVP, chief scientific officer and president, research and development at Bristol-Myers Squibb. “The study comparing Onglyza to titrated glipizide provides further evidence for the use of Onglyza as an add-on therapy to metformin.”
The drug makers added that renal function should be tested prior to taking Onglyza and periodically thereafter.
Report: North Dakota pharmacy ownership bill defeated
NORTH DAKOTA — A House bill that would have paved the path for chain and big-box pharmacy retailers to set up shop in North Dakota was rejected on Tuesday, according to a local news report.
Under the current law, pharmacies must be majority-owned by a licensed pharmacist, but House Bill 1434 would have eliminated that portion of the law, the Bismarck Tribune reported. The bill was defeated 71-23.
Those in favor of the bill said the state should open up the market to competition.
However, those against the bill argued that the state’s pharmacies offered better service and cheaper prices, and the U.S. Supreme Court already has upheld the law itself, the article stated.