November 5, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Basel, Switzerland-based Roche announced its strategic plan at an investor event in London today. The company plans to have as many as seven major data releases from clinical trials between now and the end of 2017 on top of the seven readouts that occurred in 2015.
“Thanks to our diversified late-stage portfolio we are well positioned to maintain our leadership in oncology, expand further in the immunology and ophthalmology segments, and potentially offer new treatments to help improve the lives of people with multiple sclerosis and hemophilia,” said Daniel O’Day, chief operations officer of Roche’s Pharmaceuticals Division, in a statement. “And we are looking to harness the vast increase in molecular information as the next important steps in our efforts to develop even better, more personalized treatment solutions.”
Roche is arguing that its pipeline will help offset the competition it expects from biosimilar drugs. Biosimilars are compounds that behave in a similar fashion to established drugs. Unlike generic drugs, which are essentially identical to branded drugs that are marketed after the branded drugs’ patent protection ends, biosimilars can be marketed competitively against branded drugs while patent protection remains.
“I am absolutely convinced that with the strength of our portfolio, the readouts that are coming in over the next 18 months, and the opportunity to potentially launch eight or nine medicines now and the end of 2017,” O’Day said at the investors event, “we will mitigate the risk of biosimilars.”
Roche specifically cites atezolizumab for bladder and lung cancer, ocrelizumab for multiple sclerosis, and ACE-910 for hemophilia, as its most promising compounds. According to Thomson Reuters Cortellis, if approved, those drugs could bring in combined annual sales of $5 billion by 2020.
In addition, Roche provided details about Cotellic, which is currently under regulatory review in the U.S. and Europe in combination with Zelboraf for the treatment of BRAF mutation-positive unresectable metastatic melanoma, with decisions expected by the end of this year. In addition, Alectinib will have a U.S. Food and Drug Administration (FDA) decision in March 2016. The drug is an oral medication for the treatment of ALK-positive non-small cell lung cancer (NSCLC).
Roche is also focusing on treatments for blood cancers, asthma, hemophilia and age-related vision lost. Its drug Gazyva/Gazyvaro (obinutuzumab) has been approved in more than 50 countries in combination with chlorambucil for untreated chronic lymphocytic leukemia (CLL), and in October the FDA granted priority review for Roche’s Biologic License Application (BLA) for Gazyva to treat follicular lymphoma in patients who relapsed after or are refractory to a rituximab-containing regimen.
The company also reported on various partnerships and collaborations, including its development of Cotellic with Exelixis, Inc. , its collaboration with Plexxikon, a member of the Daiichi Sankyo Group on Zelboraf, and its collaboration with AbbVie on Venetoclax.
Roche has been volatile this year, although its current trend is upward. Shares traded for $288.50 on Jan. 13, 2015, dropped to $244.40 on Jan. 22, then spiked up to $277 on May 27. They then dropped down again to $256.50 on July 8, back up to $278.75 on Aug. 4, then down to $247.80 on Sept. 24. Shares are currently trading for $273.50.
