Update on Bayer's Adempas

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Bayer’s (BAYRY) HealthCare segment has been performing very well with the addition of products like Xarelto (anticoagulant), Eylea (eye drug), Stivarga (oncology), Xofigo (oncology) and Adempas (pulmonary hypertension) to its portfolio. Bayer has projected annual peak sales of €7.5 million from these drugs. The new products are expected to contribute around €2.8 billion to segmental sales in 2014. The company is also looking to expand their label beyond current indications.

Last week, Bayer initiated the phase IIIb RESPITE (Riociguat clinical Effects Studied in Patients with Insufficient Treatment response to PDE-5 inhibitors) study on Adempas (riociguat). The study is evaluating the clinical effects of Adempas in patients suffering from pulmonary arterial hypertension (PAH). These patients demonstrated an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) either as monotherapy or in combination with an endothelin receptor antagonist (ERA).

The study will evaluate patients who were previously treated with either Pfizer Inc.’s (PFE) Viagra (sildenafil) or Eli Lilly and Co.’s (LLY) Cialis (tadalafil) for a minimum of three months.

We note that Adempas is approved in the U.S. for the treatment of adults suffering from persistent/recurrent chronic thromboembolic pulmonary hypertension (:CTEPH) following surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class. The drug is also approved in the U.S. for the treatment of adults suffering from PAH to improve exercise capacity, improve WHO functional as well as delay clinical worsening.

The drug is approved in Canada for both the above-mentioned indications and in Switzerland and Japan for CTEPH. Moreover, Adempas is under review in the EU with a final decision expected by Jun 30, 2014. In January this year the European Committee for Medicinal Products for Human Use provided a positive opinion on the approval of Adempas for both the indications.

We are encouraged by the performance of Bayer’s newly launched pharmaceutical products. Label expansions of these drugs will boost segmental sales further.

Bayer presently carries a Zacks Rank #4 (Sell). Some better-ranked stocks include Alexion Pharmaceuticals, Inc. (ALXN) carrying a Zacks Rank #1 (Strong Buy).

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