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April 26, 2011 5:32 pm

Genzyme/Sanofi merger positions firms with two leading drugs in multiple sclerosis

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This article is provided to readers by BioPharm Insight—a news service focused on providing insight into the most price sensitive issues in the global pharmaceutical market.

Genzyme (NASDAQ:GENZ), which plans to announce pivotal results from its program evaluating Campath in multiple sclerosis later this year, is also interested in broadening its portfolio in this indication, said Dr Michael Panzara. The company remains committed to researching the drug’s effect on the autoimmune system in light of certain side-effects seen in trials, said Panzara, who is group vice president of multiple sclerosis and immune diseases at Genzyme.

Campath (alemtuzumab) is a chemotherapy drug that is currently used to treat B-cell chronic lymphocytic leukemia.

Competition in the multiple sclerosis space is intensifying, as Novartis’ (NYSE:NVS) Gilenya, the first oral therapy was both approved and entered clinics last year. Competing drug, Biogen’s (NASDAQ:BIIB) BG-12 recently reported a reduction in annualized relapses by 49% at two years, compared to the 23% reduction reported by Teva’s (NASDAQ:TEVA) laquinimod in the same period. Biogen shares spiked more than 22% on the news, and if approved, it will be positioned as a new therapy alongside its current MS franchise, Tysabri and Avonex, which also reported increased sales.

As multiple sclerosis treatment transitions towards a personalized approach and tailored therapy, Genzyme also has an active biomarker program in development to analyze predictors of safety for patients on the drug, noted Panzara. “Our company is currently evaluating when it is appropriate to switch patients. We’re constantly thinking about the most appropriate treatment algorithm,” he added.

Panzara, who oversees Genzyme’s clinical development program for Campath, was previously chief medical officer of neurology at Biogen Idec, which manufactures Tysabri, a drug currently marketed for use in multiple sclerosis. Joining Genzyme approximately 18 months ago, Panzara said he has a mandate to build out Genzyme’s multiple sclerosis franchise. He was also the product leader for Tysabri and was heavily involved with the drug’s successful re-entry into the market after it was voluntarily withdrawn in 2005 due to concerns with brain inflammation. Tysabri was successfully re-launched into the market in 2006 with a risk management program.

Campath will also need a risk management program for physicians to effectively manage the side effects with this compound, according to neurologists.

Genzyme plans to submit data from three trials for FDA approval later this year. If reviewed favorably, Campath could be approved for the treatment of relapsing-remitting MS, the most common form of this neurodegenerative disorder, as early as next year, Panzara noted. The Phase III program will demonstrate the most appropriate place for Campath in MS, and determine how the drug will ultimately be used by physicians. The drug showed a very strong effect based on data from the Phase II trial in patients with active disease, he added.

Genzyme expects to submit a complete package to the FDA that will include three studies: the Phase II trial, and the two Phase III trials: CARE-MS-1, CARE-MS-2. Results from the CARE-MS-1 trial are expected in 3Q11. CARE-MS-2 results are expected 4Q11. “From these studies, if the second study is also positive, Campath’s use may be for all patients across the MS spectrum,” Panzara said.

Campath has received mixed reviews from the neurology community despite its efficacy, as it has been shown to cause idiopathic thrombocytopenic purpura (ITP), a blood disorder, in trials. The current label for Campath contains a label warning regarding the potential for developing serious blood complications with use.

In the Phase II trials, 20% of Campath-treated patients developed thyroid disorders compared to 3% on Pfizer (NYSE:PFE) and Merck KgaA’s Rebif. However, data from a new study reported that Campath cut the risk of relapse in multiple sclerosis patients by 69% compared with Rebif after five years.

Dr Samuel Hunter, a neurologist based in Tennessee who frequently prescribes Campath off-label in MS, said the drug will most likely be used as a second-line treatment. Hunter presented a study at the American Academy of Neurology (AAN) meeting highlighting Campath’s use as rescue immunotherapy for treatment-refractory MS patients.

Aside from the Campath program, the company also has an active business development and research team in MS, said Panzara. The closest compound after Campath is a next-generation anti-CD52 compound which is in pre-clinical development. There are also small molecule compounds in development that target elements of inflammation, but the company could not discuss specifics.

Merger yields pipeline synergies

French-based pharmaceutical giant Sanofi-aventis closed its USD 20bn acquisition of Genzyme on April 8.

The merger integration with Sanofi will not stop any in-licensing and external business development plans. “If it’s the right fit, the merger will not stand in the way. It’s business as usual at Genzyme,” Panzara said.

The Sanofi merger also gives Genzyme access to its pipeline - in particular teriflunomide, an oral drug for relapsing-remitting multiple sclerosis that is currently in Phase III development. “We’re looking at how these drugs work together,” he said. The merger gives the companies combined resources, and unlocks a lot of synergy, he added.

Top-line teriflunomide data was released in late 2010 with a 31% reduction in relapse rate and a 30% reduction in disability progression for the higher 14 mg dose.

“There will be complementary synergies, and not a lot of redundancies,” he said.

As for the current misunderstandings by the public and the divide within the neurology community regarding Campath’s safety profile and use, Panzara said that the company is limited in terms of how much medical education it can offer for Campath since it has not yet received approval in MS. However, he said, investigators who have used Campath have had the chance to better understand how the drug works, and “views change once there is better knowledge about what the Phase II data means”, he noted. “Neurologists will have to understand how to manage these side effects, similar to any drug.”

Side effects have included ITP, thyroid disorders, and one case of anti-GBM, which affected the kidneys, said Panzara. The major side effects all fall under the category of autoimmune disorders, and the company is actively investigating the cause and mechanism of action behind these effects, he added.

“We are looking at new animal models, evaluating autoimmune diseases and preventative therapies including blood-based biomarkers to help patients detect potential symptoms before they occur,” he said. “We are committed to minimize those risks.”

There are currently more than 1,500 patients who have been treated with Campath in MS, Panzara said.


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