CHMP Positive on Glaxo's Two Drugs


GlaxoSmithKline (GSK) announced that two chronic obstructive pulmonary disease (:COPD) drugs Incruse and Anoro have received a positive opinion from the European Medicines Agency’s (:EMA) Committee for Medicinal Products for Human Use (CHMP). A final decision from the European Commission should be out by the end of the next quarter.

Glaxo is looking to get Incruse approved as a once-daily maintenance treatment for symptomatic relief in adults with COPD. The positive CHMP recommendation came in on the basis of seven phase III clinical studies (n > 2,500) evaluating the use of Incruse (as a monotherapy or as combination therapy) versus placebo in COPD patients. Incruse is also under regulatory review in the U.S.

The other COPD drug, Anoro is a combination of Incruse (a long-acting muscarinic antagonist/LAMA, umeclidinium bromide/UMEC) and another COPD drug from Glaxo, Breo (a long-acting beta2 agonist/LABA, vilanterol/VI).

Anoro is already approved in the U.S. The U.S. Food and Drug Administration (:FDA) cleared the drug as a long-term maintenance therapy for airflow obstruction in patients suffering from COPD including chronic bronchitis and/or emphysema.

Glaxo has collaborated with Theravance, Inc. (THRX) for Anoro.

Our Take

We believe that the approval of Incruse (in the U.S. and EU) and Anoro (in the EU) will further strengthen Glaxo’s respiratory portfolio. Last year, Glaxo and Theravance had launched Breo. Apart from these, Glaxo’s pipeline consists of several other respiratory candidates, such as fluticasone furoate monotherapy and mepolizumab (anti-IL5 MAb).

If successfully commercialized, these drugs will compensate for the loss of revenues once Advair – one of Glaxo’s highest revenue grossers – goes generic. The product generated sales of $5.3 billion in 2013, accounting for almost 25% of the company’s Pharmaceuticals and Vaccines segment revenues.   

Glaxo carries a Zacks Rank #5 (Strong Sell). Some better-ranked stocks include Forest Laboratories (FRX) and Auxilium Pharmaceuticals Ltd. (AUXL). Both carry a Zacks Rank #1 (Strong Buy).

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