PHARMACY

Gilead to acquire Calistoga

BY Alaric DeArment

FOSTER CITY, Calif. — Drug maker Gilead Sciences plans to buy out a privately owned Seattle company that makes treatments for cancer and inflammatory diseases, Gilead said Tuesday.

The Foster City, Calif.-based company will buy Calistoga Pharmaceuticals for $375 million, plus additional milestone payments of up to $225 million.

Calistoga is currently developing CAL-101, which is in phase-2 studies, as a treatment for leukemia and non-Hodgkin’s lymphoma. The company specializes in drugs that target PI3K, an enzyme pathway that helps control the reproduction, survival and activity of cells.

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PHARMACY

Forest to acquire Clinical Data

BY Alaric DeArment

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.”

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Onglyza gets label update

BY Allison Cerra

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.

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