Thursday, August 29, 2013

Array Begins Phase III Study on MEK162 - Analyst Blog

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Array BioPharma Inc. (ARRY) recently initiated a phase III study (MILO: n=300) on MEK162 in patients suffering from low-grade serous ovarian cancer (LGSOC). Array consequently received a $5 million milestone payment from partner, Novartis (NVS), following the initiation of the study.

The multinational, randomized study will evaluate MEK162 in 300 patients suffering from recurrent or persistent LGSOC after a minimum of one platinum-based chemotherapy regimen and not more than three lines of prior chemotherapy regimens. The study will evaluate the effects of MEK162 in these patients in comparison to the physician's choice of standard chemotherapy treatments. The main objective of the study will be to evaluate progression-free survival and overall survival.

We note that in Apr 2010, Array and Novartis entered into a license agreement for MEK162 besides other specified MEK inhibitors. As per the terms of the deal, Novartis has the worldwide rights to co-develop and commercialize MEK162.

Array has already received $60 million (including the recent $5 million milestone payment) as an upfront fee and milestone payments under the deal. Array is eligible to receive further payments on achieving all the clinical, regulatory and commercial milestones stated in the agreement.

Array further stated in its press release that Novartis is gearing up to initiate phase III studies on MEK162 in both NRAS- and BRAF-mutant melanoma later this year.

Array also has ARRY-520 (refractory multiple myeloma) and ARRY-380 (breast cancer) in its oncology portfolio apart from MEK162. We are encouraged by the company's progress with its oncology candidates. However, the oncology market currently has big players such as Roche (RHHBY).

Currently, Array BioPharma carries a Zacks Rank #3 (Hold). However, biopharma stocks such as Jazz Pharmaceuticals (JAZZ! ) presently look better positioned with a Zacks Rank #1 (Strong Buy).

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