Roche boosted by early trial success with....

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http://www.reuters.com/article/us-roche-gazyva-idUSKCN0YI0GB 

ZURICH/LONDON Roche got a big boost on Friday when a clinical trial testing its new blood cancer drug Gazyva proved successful, lifting prospects for a medicine that will be pivotal as the Swiss company fights the threat of biosimilar competition.

The win came earlier than expected. Investors had anticipated results of the study in 2017 but Roche was able to prove a clear benefit at the interim stage, implying the drug had a strong effect.

The company is holding back detailed results until an upcoming medical meeting but it said Gazyva proved significantly better than its older drug Rituxan at delaying disease progression in people with previously untreated follicular lymphoma.

Clinical trials with the new drug are important in deciding how well the Swiss drugmaker is placed to fend off cheaper competition from so-called biosimilar copies of Rituxan, which are likely to hit the market in the next couple of years.

Strong results with Gazyva mean Roche can argue that its new drug delivers better results for patients, even if it is more expensive than biosimilars.

Shares in Roche were up 4 percent by 1000 GMT at 263.2 Swiss francs, outperforming a 0.7 percent rise in the European pharma index.

"Gazyva has long been considered as superior to Rituxan," said ZKB analyst Michael Nawrath in a note. He said follicular lymphoma was a much bigger market than previously untreated chronic lymphocytic leukaemia, for which Gazyva is already approved in more than 70 countries.

"The U.S. approval of Gayzva for previously treated follicular lymphoma (in February) didn't lead to a breakthrough in sales, but the approval as a first-line treatment will," said Nawrath who has an "overweight" recommendation on Roche shares.

Vontobel analyst Stefan Schneider, who has a "buy" recommendation on the shares and raised his price target to 330 Swiss francs from 309 francs on the news, said Roche could bring forward the possible launch of the drug for the new use by a year.

"Replacing Rituxan with Gazyva protects Roche's CD20 franchise revenues from biosimilar erosion," he said.

Follicular lymphoma is considered incurable and relapse is common. It is estimated that more than 75,000 people are diagnosed with this most common form of non-Hodgkin lymphoma each year worldwide, Roche said.

Investors have long fretted that biosimilars will eventually eat into Roche's business, which is heavily biased towards biological medicines that have so far been relatively immune to copycat competition.

That competitive landscape is now changing with the arrival of biosimilars, which are approved by regulators as similar enough to do the job, even if they are not 100 percent identical due to different production processes.

Roche is also continuing to study Gazyva in other clinical studies, including a closely watched trial called GOYA, which analysts had expected to produce results ahead of the GALLIUM one that reported on Friday.