Ms Drug Prize Of $1.3 Billion Spurs Merck Kgaa, Novartis Race
Merck and Novartis plan to ask regulators this year to approve tablets to fight the incurable illness. Initial test data showed that patients who took the drugs had fewer disease flare- ups than those who received placebo or existing treatments.
A pill may mean an end to painful injections or infusions that can cost $28,000 a year to control multiple sclerosis, which can rob people of their mobility and leave them with chronic aches and depression. Merck, of Darmstadt, Germany, and Novartis, of Basel, Switzerland, are running ahead of Teva Pharmaceutical Industries Ltd., Biogen Idec Inc. and Sanofi-Aventis SA in the chase for an oral treatment. The results may shake up the $6 billion multiple sclerosis market.
“Its going to be a neck-and-neck race between Merck and Novartis,” said Markus Mayer, a Munich-based analyst for UniCredit SpA, after Merck released initial data last month.
The Teva, Biogen and Sanofi pills may not reach patients before 2012, according to Jack Scannell, an analyst for Sanford C. Bernstein Ltd. in London. Frost & Sullivan, a research company based in New York, predicts the market for drugs to treat early stages of multiple sclerosis may double by 2013.
Merck fell 73 cents, or 1.1 percent, to 67.37 euros in Frankfurt trading, while Novartis shares climbed 42 centimes, or 1 percent, to 42.51 francs in Zurich.
Cancer Cases
Merck said in January that four patients were diagnosed with cancer during the late-stage trial of its medicine, known as cladribine. An independent monitoring board didnt consider the cases a safety concern because there were too few to show a statistical significance, said Phyllis Carter, a Merck spokeswoman.
Conceived as both a leukemia and multiple sclerosis drug, cladribine was approved to treat the blood cancer more than 10 years ago and has been used by doctors in injected form to treat multiple sclerosis in so-called off-label use.
Novartis has also reported two fatal infections and seven successfully treated cases of skin cancer in patients who took its candidate, FTY720. Final test results later in the year will demonstrate how safe each of the medicines is.
If the tablets arent linked to such side effects, either could “revolutionize treatment,” Citigroup analyst Mark Dainty wrote in a note to clients in January. The products may generate a total $2.6 billion in revenue in four years time, according to the analyst.
Vulnerable
Rebif vies with two other so-called beta interferons, Betaseron by Bayer AG and Biogens Avonex, and with a fourth injected therapy, Copaxone from Sanofi and Teva. Interferons generally cut patients rate of flare-ups by about 25 to 30 percent, Scannell of Bernstein said.
To take over the market, the oral medicines first need to overcome safety concerns.
“Concerns over cancer and opportunistic infection are the real barriers to what could be substantial first-line use in a multiple sclerosis market worth around $10 billion a year,” Scannell said in a note to clients this week.
Infection Risk
Unlike interferons — genetically produced versions of natural proteins that suppress the entire immune system — cladribine and FTY720 affect only certain types of cells, said Doug Brown, research manager for the Multiple Sclerosis Society in London who doesnt have financial ties to either Merck or Novartis.
The pills work by lowering the amount of immune cells in the body, leaving patients susceptible to infections, Brown said. Long-term side effects from cladribine are unproven because leukemia patients took the drug on a shorter-term basis than multiple sclerosis sufferers would do, he said.
“We dont see anything in the study that could prevent the drug from being given to patients,” said Bruno Musch, head of global clinical development unit for neurodegenerative diseases for Merck, in an interview before the preliminary results were released last month.