Drugmaker Merck & Co. said Monday it has bought rights to help market what would be the first anti-inflammatory pill for a chronic lung condition, just a few days after European regulators recommended approval there.
The deal gives Merck rights to jointly market Daxas, made by Swiss drugmaker Nycomed, for chronic obstructive pulmonary disease in Canada and several European countries. Merck, based in Whitehouse Station, N.J., also received an exclusive distribution deal for the United Kingdom.
If approved, Daxas would be the first drug in a new class of treatments for chronic obstructive pulmonary disease, which includes bronchitis and emphysema.
However, U.S. regulators have recommended against its approval. Final decisions in the U.S. and Europe are still pending.
Daxas, a pill taken once a day, blocks an enzyme involved in the lung disorder and in related inflammatory diseases. Patients now generally take inhaled medicines including corticosteroids, which reduce inflammation, and bronchodilators, which open up airway passages in the lungs to ease breathing.
Under the deal, privately owned Nycomed will receive an undisclosed upfront fee and could get additional payments for meeting development and sales milestones.
If Daxas is approved, Merck and Nycomed will co-promote it in France, Germany, Italy, Spain, Portugal and Canada, while Merck will sell it exclusively in the United Kingdom.
Nycomed, based in Zurich, will make and distribute the product. It sells brand-name medicines for respiratory, inflammatory and gastrointestinal diseases, osteoporosis and pain, plus some over-the-counter products.
Forest Laboratories Inc. has U.S. rights to sell Daxas, for which it paid Nycomed $100 million.
Earlier this month, a panel of Food and Drug Administration lung experts voted 10-5 against approving Daxas, known chemically as roflumilast, because of concerns about potentially dangerous side effects. In a study comparing Daxas with another drug, problems including suicide, cancer and weight loss were more common among the patients receiving Daxas.
However, the panel voted 9-6 that Daxas appeared effective. An FDA decision is expected by mid-May.
Last Friday, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Daxas for EU countries.
Merck shares rose 9 cents to $35.55 in early afternoon trading.
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