2014

The Zacks Analyst Blog Highlights: Genomic Health, Sanofi, Regeneron Pharmaceuticals, Amgen and Isis Pharmaceuticals

CHICAGO, May 16, 2013 /PRNewswire/ -- Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include Genomic Health Inc. (Nasdaq: GHDX), Sanofi (NYSE: SNY), Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN), Amgen Inc. (Nasdaq: AMGN) and Isis Pharmaceuticals, Inc. (Nasdaq: ISIS).

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Here are highlights from Wednesday's Analyst Blog:

Much-Awaited Test Launch from Genomic

Recently, Genomic Health Inc. (Nasdaq: GHDX) made available its lead pipeline candidate Oncotype DX prostate cancer test to physicians and their patients. This comes as a major boost to the company as its effort to launch the test by the second quarter of 2013 (ending Jun 30, 2013) paid off.

The launch of the prostate cancer test, developed in collaboration with University of California, San Francisco (UCSF) and Cleveland Clinic was based on the disclosure of positive clinical validation study at the 2013 American Urological Association (AUA) Annual Meeting in San Diego. Besides clinical elements such as PSA and biopsy Gleason Score, the results from the clinical validation study affirm that Genomic's test can predict the aggressiveness of the cancer in patients.

As a prognostic tool to assess prostate cancer aggressiveness, Genomic's Oncotype DX prostate cancer test estimates the level of expression of 17 genes across four biological pathways. The outcome of the tests is reported as Genomic Prostate Score (GPS), ranging from 0 to 100. In conjunction with other clinical factors, the GPS can estimate the patient's risk before the treatment intervention. Further, the outcome of the test can improve standards of care by helping patients to choose the right treatment on the basis of individual risk assessment.

Also, the Oncotype DX prostate cancer test is the most innovative multi-gene test to oversee treatment selection using the prostate needle biopsy sample taken before the prostate is removed. This helps low-risk patients erode invasive treatments like radical prostatectomy or radiation. Additionally, most patients can evade unnecessary treatment and its potential side effects and consider active surveillance treatment plan with routine check up.

Our Take

We are encouraged by the timely launch of Genomic's Oncotype DX prostate cancer test. The commercialization of the prostate cancer test will allow the company to serve a global market size of more than $1.6 billion.

Sanofi, Regeneron Commence Enrollment

Sanofi (NYSE: SNY) and partner Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) recently announced that they started enrolling patients for two phase III trials (SARIL-RA COMPARE and SARIL-RA ASCERTAIN) on their rheumatoid arthritis (RA) candidate, sarilumab.

The 24-week, multi-center, randomized, double-blind and active-calibrator SARIL-RA ASCERTAIN study (n = 200) will evaluate the safety and efficacy of sarilumab and Actemra (tocilizumab) in combination with methotrexate (MTX) in patients with RA who received inadequate treatment benefit from tumor necrosis factor alpha (TNF-alpha) inhibitors.

Meanwhile, the multi-center, randomized, double-blind and active-control SARIL-RA COMPARE trial will assess the safety and efficacy of sarilumab in combination with MTX versus Amgen Inc.'s (Nasdaq: AMGN) Enbrel (etanercept). The trial will enroll 700 patients suffering from moderate-to-severe RA who demonstrated an insufficient response to Humira (adalimumab) as first TNF-alpha inhibitor treatment.

We note that Sanofi and Regeneron are conducting a SARIL-RA phase III development program to evaluate the use of sarilumab in the RA indication. The program consists of five trials, namely, SARIL-RA MOBILITY, SARIL-RA TARGET, SARIL-RA COMPARE, SARILRA ASCERTAIN and SARIL-RA EXTEND.

SARIL-RA MOBILITY, the most advanced phase III trial in the SARIL-RA program, has enrolled 1,197 patients. The data from the trial is expected to be released in the first half of 2014.

Sanofi carries a Zacks Rank #3 (Hold). Sanofi is looking to combat the generic threat confronting most of its key drugs by signing deals and making acquisitions. We are pleased with Sanofi's efforts to develop its pipeline and believe that newly approved products in Sanofi's portfolio hold huge commercial potential.

Stocks that look better placed at present include Isis Pharmaceuticals, Inc. (Nasdaq: ISIS), which carries a Zacks Rank #2 (Buy).

 

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