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Roche's (RHHBY) Leukemia Drug Gets Prime Status in EU

The European Medicines Agency (EMA) granted PRIME (PRIorityMEdicines) designation to Roche Holdings AG's RHHBY investigational drug polatuzumab vedotin in combination with MabThera and bendamustine. The drug will be used to treat patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL).    

EMA grants the PRIME status to drugs that havea major therapeutic advantage over existing treatments, or benefit patients without treatment options.

We note that polatuzumab vedotin, an anti-CD79b antibody drug conjugate (ADC) consisting of an anti-CD79b monoclonal antibody is linked to a potent microtubule-disrupting agent. The candidate is being developed by Roche utilizing Seattle Genetics’ SGEN ADC technology.

The PRIME designation is primarily based on results from the randomized phase II component of the GO29365 study in patients suffering from relapsed or refractory DLBCL that compared treatment with polatuzumab vedotin plus bendamustine and MabThera/Rituxan(rituximab) to bendamustine plus MabThera/Rituxan.

The successful development of the candidate will boost Roche’s hematology portfolio which at present consists of MabThera/Rituxan, Gazyva/Gazyvaro and VenclextaTM/VenclyxtoTM in collaboration with AbbVie ABBV along with a pipeline which has  a small molecule antagonist of MDM2 (idasanutlin/RG7388) apart from polatuzumab vedotin.

Roche’s share price shows that the company has underperformed the Zacks classified industry year to date. The stock has moved up 11.5% compared with the Large Cap Pharmaceuticals industry’s gain of 12.3%.

Roche has a strong presence in the oncology market. The company dominates the breast cancer space with strong demand for HER2 franchise drugs with candidates like Herceptin, Perjeta and Kadcyla.

We are also impressed by the company's efforts to develop its portfolio beyond oncology into immunology.

Zacks Rank & Key Pick

Roche currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the health care sector is VIVUS, Inc. VVUS, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 60 days. The company deliveredpositive earnings surprises in each of the trailing four quarters, with an average beat of 233.69%.

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Roche Holding AG (RHHBY): Free Stock Analysis Report
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Seattle Genetics, Inc. (SGEN): Free Stock Analysis Report
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