ARIAD Pharmaceuticals, Inc. (ARIA) announced that it has granted exclusive rights to privately-held pharmaceutical company Angelini Pharma to commercialize Iclusig in Central and Eastern Europe for the indications approved by the European Medicine Agency (EMA).
We note that Iclusig is approved in Europe for the treatment of adult patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
As per the terms of the agreement, Angelini Pharma will be responsible for the sales and marketing, medical affairs, regulatory and reimbursement support while ARIAD will remain the Marketing Authorization Holder of Iclusig and supply the packaged drug to the former.
Angelini Pharma will book Iclusig sales in several countries in the region. In exchange, ARIAD is entitled to an upfront payment along with milestone payments associated with commercial launches worth a total of $7.3 million. Angelini Pharma will also provide ARIAD with a substantial share of Iclusig sales in the region.
We note that ARIAD had received Marketing Authorization Approval for Iclusig from the European Medicine Agency in July 2013 and expects to begin commercial launches in the Central and Eastern European countries in 2015.
Per the EMA, approximately 8,000 people suffer from CML in these regions who may become resistant or intolerant to other approved tyrosine-kinase inhibitors. This agreement will allow the availability of Iclusig to patients with resistant and intolerant Ph+ ALL in more than 23 European countries.
Commercialization of Iclusig in additional geographies will substantially boost growth. We are encouraged by ARIAD Pharma’s efforts to commercialize Iclusig on a global basis.
Last week, ARIAD and Otsuka Pharmaceutical Co., Ltd. announced the signing of an agreement whereby Otsuka will commercialize Iclusig (ponatinib) and fund future clinical trials in Japan and nine other Asian countries. ARIAD Pharma will complete the New Drug Application (NDA) for Iclusig in Japan while Otsuka will file the NDA on behalf of both companies for regulatory approval in resistant and intolerant CML and Ph+ALL in 2015.
ARIAD currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Sucampo Pharmaceuticals (SCMP), Biodel Inc (BIOD) and ArQule, Inc. (ARQL). All three carry a Zacks Rank #1 (Strong Buy).
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