ALTH Seeks Review of Folotyn Verdict - Analyst Blog

Recently Allos Therapeutics Inc. (ALTH) submitted a request to the European Medicines Agency (EMA) seeking a review of the negative opinion issued by the EMA’s Committee for Medicinal Products for Human Use (CHMP) regarding the company’s sole marketed product Folotyn (pralatrexate injection).  A final opinion on the re-examination is expected to be issued by the EMA within four to five months.

We remind investors that last month the CHMP recommended against the conditional approval of Folotyn (pralatrexate injection) in the EU. Allos is looking to get Folotyn approved in the EU for treating patients suffering from peripheral T-cell lymphoma (PTCL) whose disease progressed after at least one prior systemic therapy.

The European marketing authorisation application, under review since 2010, included data from a phase II study (PROPEL). We note that Folotyn is already available in the US for the PTCL indication. The drug received accelerated approval from the US Food and Drug Administration (FDA) in September 2009.

We believe that the request for re-examination of the CHMP’s opinion highlights the management’s confidence in the drug. If the drug manages to clear the regulatory hurdles and hit the European markets then it would highly welcome by the patients in the EU since currently there are no approved therapies for relapsed or refractory PTCL there. The company further stated that it along with partner Mundipharma will work closely with the CHMP during the re-examination.

We remind investors that Allos inked a co-development and commercialization deal with Mundipharma in May 2011 for Folotyn. Per the terms of the deal, the sole responsibility of commercializing the drug in the US and Canada lies with Allos. Mundipharma is responsible for commercializing Folotyn in the rest of the world. Mundipharma has already filed marketing applications in countries like Australia, South Korea and Switzerland.

Our Recommendation

Currently, we have a long-term recommendation of Neutral on Allos. We believe that Allos must reduce its dependence on Folotyn and develop additional products to sustain growth. We see limited upside potential until Allos is successful in expanding its product portfolio. The stock carries a Zacks #3 Rank (Hold rating) in the short-run.

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