Replies to post #72013 on Biotech Values

[DewDiligence]

Merck KGaA Soars on Cladribine Data in MS

http://online.wsj.com/article/BT-CO-20090123-705669.html

›By Allison Connolly
JANUARY 23, 2009, 8:01 A.M. ET

FRANKFURT (Dow Jones)--Shares of Merck KGaA (MRK.XE) rose Friday after the German pharmaceutical company announced promising results for its oral multiple sclerosis treatment, which analysts say has blockbuster potential and could start generating sales and revenue for Merck by 2010. Merck's Phase III trial, involving 1,326 patients, showed the oral form of cladribine reduced the relapse rate in patients by as much as 58% compared with a placebo. Although more patients experienced lymphopenia - a reduction in immune-moderating white blood cells - while taking the drug, other minor side effects, such as headaches, remained the same.

Merck plans to apply for registration with European and U.S. regulators in mid-2009.

In doing so, analysts say cladribine now has at least a six-month lead over rival oral treatment FTY720 from Novartis AG (NVS), which is expected to wrap up Phase III trials by the end of the year.

Analysts called the cladribine data encouraging, and the market agreed, sending the shares higher. They traded up 5.8% at EUR68.07 at 1253 GMT.

UniCredit sais the results are a "positive surprise." The brokerage pointed out the drug is more effective than interferon treatments, which have a 30% relapse reduction rate, and is more convenient in pill form with a comparable safety profile. With fast-track status in the U.S., cladribine could reach the market ahead of FTY720, UniCredit said.

Equinet analysts said the drug now seems "approvable" on the back of the results.

LBBW analysts estimate cladribine has blockbuster potential with peak annual sales of EUR1.2 billion. They say it could replace Merck's earlier multiple sclerosis drug Rebif, which posted sales of EUR1.2 billion in 2007.‹

[masterlongevity]

Cladribine in RRMS + FTY are going to really hit tysabri

cladribine should be on the market by Q1 10 and FTY by Q2 10.

I think tysabri will remain as a salvage therapy. 100K pts by end 2010 is not possible.

Even 60K pts might be a stretch. I think tysabri only has 1 good yr of growth left, barring any major setbacks

[genisi]

Just to note that Teva might have a stake there due to the Ivax acquisition:

http://www.tevapharm.com/pdf/12909ACL.PDF (see p.23)

"Ivax and Serono are parties to an agreement for the development of a proprietary oral formulation of cladribine (Mylinax®) as a treatment of multiple sclerosis."