Cohn & Wolfe wins MS account
pharmafile | August 20, 2010 | News story | Medical Communications | Cohn & Wolfe, Genzyme, MS
Cohn & Wolfe has won a global account with Genzyme to handle communications for its work with alemtuzumab in multiple sclerosis patients.
The account is led by C&W global healthcare practice leader Mike Kan and Lisa Talbot, co-director of the New York healthcare practice.
In June, the FDA fast-tracked the manufacturer’s alemtuzumab for MS development programme for patients with relapsing-remitting (RRMS) forms of the disease.
This means it is eligible for priority review and the FDA may look at parts of the marketing application before a New Drug Application is completed.
Alemtuzumab already has oncology indications, but in MS is being evaluated in two international phase III trials, both in comparison with Merck Serono’s Rebif, an injectable form of interferon beta1-a.
CARE-MS(SM) makes the comparison in early RRMS patients who have received no treatment beforehand, while CARE-MS II compares the drugs in RRMS patients who had active disease while on other MS therapies.
The company says both trials are fully enrolled and it expects data to be available next year.
Genzyme chairman Henri Termeer acknowledged the commercial significance of this work when he said: “Alemtuzumab is a potentially transformative therapy for the treatment of MS, and an important part of our future.”
It may soon become a more crowded market, with several potential new MS treatments on the horizon, including Novartis/Mitsubishi Tanabe’s FTY-720.
Abbott and Biogen Idec are also about to start a phase III trial of daclizumab, a once-monthly injection for RRMS.
And Merck Serono itself has filed oral MS treatment cladribine with the FDA, although the manufacturer suffered a setback last November after receiving a ‘refuse to file’ letter.
Alemtuzumab is already licensed in the US as Campath(R), a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
In Europe it is MabCampath(R) for B-CLL in patients who have been treated with alkylating agents and for whom fludarabine combination therapy is not appropriate.
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