Genzyme and Bayer will seek a relapsing-remitting multiple sclerosis indication for Campath (alemtuzumab) in treatment naive-patients based on a single Phase III trial comparing the drug with Serono's Rebif (interferon beta-1a), Genzyme Oncology President Mark Enyedy said during the firm's first quarter earnings call April 23.

The two firms are in a race for the new indication for the B cell chronic lymphocytic leukemia therapy against companies including Novartis and Biogen Idec.

Genzyme and Bayer have two Phase III trials underway for the new indication but will not wait for the second one to conclude before filing the MS application. The studies are known as Comparison of Alemtuzumab With Rebif Efficacy in Multiple Sclerosis (CARE-MS) I and II.

The lead trial began enrolling in September and is designed to accrue up to 525 patients with relapsing remitting MS who have not yet started treatment (¹ Also see "Genzyme Initiates Campath Phase III Study In Multiple Sclerosis" - Pink Sheet, 26 September, 2007.). The firms expect to complete enrollment in the first half of 2009 and plan a regulatory filing in 2011.

The second CARE-MS trial involves patients who have continued to relapse while on approved disease-modifying therapies.

Enyedy pointed out the CARE-MS I trial builds on a positive Phase II study recently reported by the company. "We will recapitulate that study in a much larger patient population, and those two data sets together should be sufficient to support a label, at least in treatment-naive patients," he said.

"In parallel with that, we have this treatment-experienced study that will be fully enrolled by the time that we file for the treatment-naive patients, so I think that a combination of those development efforts will support approval," Enyedy concluded.

The firms released top-line, three-year results from the Phase II study in October (² Also see "Genzyme/Bayer Report Positive Top-Line Phase II MS Data For Campath" - Pink Sheet, 15 October, 2007.). The data show treatment with Campath twice or three times per year led to a substantial reduction in the risk of relapse (73 percent) and accumulation of disability (71 percent) versus Rebif in more than 300 patients.

After three years, the study did not show further cases of idiopathic thrombocytopenia purpura, an adverse development seen earlier in a few patients, Enyedy reported. The ITP incidence led to a clinical hold that delayed the development schedule for the MS indication.

Genzyme will discuss the Campath development program, along with its therapy for Gaucher's disease and mipomersen for cardiovascular disease, during its analyst day presentation May 7.

With sales increases across its product lines, Genzyme's first quarter revenues rose 25 percent to $1.1 billion. Net income rose 24 percent to $260.9 million.

The firm registered strong growth for its sevelamer therapies for renal disease in the first quarter; sales for Renagel and Renvela advanced 23 percent to $168.7 million. Renvela was launched in the U.S. in March.

Genzyme reiterated its forecast that sales for Myozyme (aglucosidase alpha) will reach $275 million to $285 million in 2008, down from earlier estimates, due to FDA's decision to require a new BLA for the drug made at the 2,000-liter bioreactor scale. The development delays a broad launch for the Pompe disease treatment (³ Also see "FDA To Genzyme: Another Myozyme BLA, Please" - Pink Sheet, 21 April, 2008.).

-Cathy Kelly (c.kelly@elsevier.com)

Genzyme/Bayer Hope To Fly With Single Campath Phase III Trial In MS

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