French pharmaceutical giant Sanofi-Aventis (SNY), which recently launched a hostile takeover bid for U.S. biotech giant Genzyme (GENZ), said Friday its multiple sclerosis candidate drug teriflunomide significantly cut relapses in patients who took the once-daily oral treatment.
The results from the two-year phase III study of teriflunomide for the treatment of relapsing multiple sclerosis showed that both doses (7mg and 14mg) significantly reduced annualized relapse rate by 31%, compared to a placebo. Further, the risk of disability progression was also significantly reduced by 30% for the 14mg dose. Both doses were well tolerated, the Paris-based drugmaker said.
"We are very pleased with the successful results of the TEMSO study, which are an important step forward in multiple sclerosis clinical research," Sanofi's head of research Marc Cluzel said in a statement.
Multiple sclerosis is a chronic, irreversible illness in which the body's own immune system attacks the central nervous system. Symptoms range from numbness to blindness and paralysis. In relapsing MS, patients experience recurrences or flare-ups of worsening neurological function, followed by periods in which the symptoms abate. MS affects over 400,000 Americans and more than 2.5 million people worldwide.
A Scramble for a $14 Billion Market
Although no cure has been found for MS, there are several strategies to treat symptoms or slow the disease's progression. Just last September, Novartis's (NVS) oral drug Gilenya was approved by the U.S. Food and Drug Administration. Analysts estimate it will quickly reach sales of $1 billion a year in a market estimated to be worth $13 to $14 billion. Also competing for a piece of the pie are Germany's Merck KGaA with its Rebif, Biogen Idec's (BIIB) Avonex, and Teva Pharmaceutical's (TEVA) Copaxone.
Meanwhile, rare disease drugmaker Genzyme also released data Thursday from a five-year phase II study on its MS drug potential alemtuzumab or Campath. The results continued to show strong efficacy with no new or worsening side effects. The relapse rate was much lower in those receiving alemtuzumab -- 11% -- compared to those on Rebif -- 35%. Similarly, 87% of patients on alemtuzumab experienced no worsening of symptoms of disability after five years, compared to 62% for those on Rebif. But while alemtuzumab demonstrated strong efficacy, there are safety concerns as patients developed other diseases.
Sanofi has said its offer of $69 per share for the Cambridge, Mass.-based company assumes median peak annual sales for the drug are $700 million. But some predict peak sales of up to $2 billion and think Campath should help Genzyme get a much better buyout price.
Henry Termeer, Genzyme's CEO, sure would like to see that, as he would be a net loser at the current offer. According to an analysis done by Dow Jones Investment Banker and Stephen O'Byrne of Shareholder Value Advisors, Termeer would break even at $71 per share.
In today's mid-day trading, Sanofi-Aventis shares are up 1.06% to $35.23, while Genzyme shares are down 0.30% to $72.21.
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