Sanofi (SNY) recently announced positive results from a phase II trial evaluating the efficacy of its hematology candidate, SAR302503 (selective JAK2 inhibitor) in three dose strengths (300 mg, 400 mg, and 500 mg) for the reduction of spleen volume and improvement in constitutional symptoms in intermediate-2 or high-risk primary or secondary myelofibrosis (MFGLQ) patients. The data was presented at the American Society of Hematology’s (ASH) annual meeting.
The open label, randomized dose-ranging phase II trial evaluated SAR302503 in 31 patients. The candidate met the primary endpoint of reducing spleen volume.
Currently, the phase III JAKARTA trial, evaluating the use of SAR302503 in 289 patients, is underway. Initial data from the trial should be out by the second quarter of 2013. Two dose strengths (400 mg and 500 mg) of SAR302503 are being studied in the JAKARTA trial.
We are pleased with Sanofi’s progress with its pipeline. Over the last few months, several of Sanofi’s pipeline candidates gained approval including US approval of Aubagio (teriflunomide) for relapsing forms of multiple sclerosis (:RMS) and US approval of Zaltrap (aflibercept) as a combination therapy for treatment-experienced patients suffering from metastatic colorectal cancer.
We expect Sanofi to continue to contain operating costs in order to increase earnings in the face of weakening sales of some of its biggest products. We also expect the company to pursue bolt-on acquisitions.
Currently, we have a Neutral recommendation on Sanofi. Sanofi carries a Zacks #2 Rank (Buy) in the short run.
Large-cap pharma stocks currently holding a Zacks #2 Rank include companies like Novo-Nordisk (NVO), Johnson & Johnson (JNJ) and Roche (RHHBY).
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