U.S. approves Roche drug that targets severe form of MS (updated)

Geneuro SA

29/03/2017 14:26

* Ocrevus priced at $65k/year, less than competition 
    * First-ever drug approved for less common form of MS 
    * Biogen to get royalties for its share in drug 
 
 (Recasts story to focus on new treatment for PPMS, adds 
company, analysts and MS Society comments) 
    By John Miller 
    ZURICH, March 29 (Reuters) - Roche's  ROG.S  multiple 
sclerosis (MS) drug Ocrevus won U.S. approval, putting the 
potential blockbuster back on track after a brief delay and 
giving a lift to patients with a form of the disease that until 
now had no approved treatment. 
    The drug, also known as ocrelizumab and administered via 
infusion, becomes the first U.S. Food and Drug 
Administration-approved medicine for the primary progressive 
form of the neurological disease (PPMS).  
    Ocrevus, to have a list price of $65,000 annually, 
undercutting rival Merck's  MRK.N  Rebif by a quarter, is also 
approved to treat the most common form of MS, known as 
relapsing-remitting multiple sclerosis (RRMS).  urn:newsml:reuters.com:*:nBw6Xx1WDa 
    Until now, patients suffering from PPMS were often relegated 
to managing symptoms and working with rehabilitation specialists 
as drugs including Teva's  TEVA.TA  Copaxone, the most popular 
MS drug, failed to make a difference.  
    In trials with Ocrevus, however, doctors found no evidence 
of disease progression in 47 percent more PPMS patients compared 
with a placebo. 
    "The FDA's approval of Ocrevus is the beginning of a new era 
for the MS community and represents a significant scientific 
advance," said Sandra Horning, Roche's chief medical officer. 
    About 400,000 people have MS in the United States, according 
the MS Foundation, with the 15 percent suffering from PPMS 
largely without effective treatment options. PPMS is 
characterized by worsening neurologic function, while the 
more-common relapsing form comes and goes with attacks of new 
and increasing symptoms. 
    Among RRMS patients, Roche has said 75 percent more patients 
reached "no evidence of disease activity" status when taking 
Ocrevus compared with those using Rebif. 
    Ocrevus works by reducing the immune system's assault on the 
body's own neurons. Unlike some other MS drugs that target T 
cells, Roche's new agent tackles B cells' role in driving 
inflammation that is central to the neurological disease. 
    "This is a real game changer," said Cyndi Zagieboylo, 
president of the National MS Society. 
    Shares in Roche -- which is counting on Ocrevus to offset 
falling revenue from top-selling cancer drugs Rituxan, Avastin 
and Herceptin that face impending competition from cheaper 
biosimilar versions -- rose 0.24 percent to 253.60 francs.  
    While the FDA approval was largely expected, analysts said 
the FDA's broad support, for both forms of the disease, was a 
plus. 
    "The label is close to the best case," wrote Emmanuel 
Papadakis, a Barclays analyst, adding Ocrevus does not include 
health warnings accompanying other MS drugs including Biogen's 
 BIIB.O  Tysabri and Sanofi's  SASY.PA  Lemtrada.  
     
    COMPETITIVE POSITIONING 
    "Likewise, the U.S. list pricing point is clearly intended 
to position Ocrevus competitively against both orals and 
antibody options," Papadakis said. 
    Analysts forecast annual sales exceeding $3 billion by 2021, 
according to Reuters data. 
    U.S.-based Biogen will also benefit, with Roche to pay the 
part-owner of Ocrevus a royalty under a 2010 agreement. 
    The drug's U.S. entry had been delayed by three months when 
the FDA in December pushed back its approval deadline, citing 
manufacturing concerns.  urn:newsml:reuters.com:*:nL5N1FF1IX 
    Roche rival Novartis AG  NOVN.S  is also developing an MS 
treatment, BAF312, for secondary progressive multiple sclerosis. 
It could file for regulatory approval later this year, Novartis 
has said, although the official target remains 2019. 
 urn:newsml:reuters.com:*:nL5N1FF1IX 
    Other companies also seeking new MS drugs include GeNeuro SA 
 GNRO.PA .  
 
 (Additonal reporting by Akankshita Mukhopadhyay in Bengaluru 
and Bill Berkrot in New York; Editing by Bill Rigby/Ruth 
Pitchford) 
 ((J.Miller@thomsonreuters.com; +41 58 306 7734; Reuters 
Messaging: j.miller.thomsonreuters.com@reuters.net)) 
 
Keywords: ROCHE OCREVUS/