PropThink: Sanofi Receives FDA Refusal To File for Lemtrada, Pushes Back Launch Potential
(Thomson Reuters ONE) -
Genzyme, a subsidiary of Sanofi (NYSE:SNY), announced this morning that the FDA
has returned the company's supplemental Biologics License Application (sBLA) for
Lemtrada on grounds that the presented data needs reorganization. Genzyme
submitted the drug for review in June of this year and hoped for a Priority
Review designation to allow for faster commercialization, as early as six months
from an acceptance date if granted. The FDA's Refusal to File (RTF) does not
require new testing or data for the drug, which might have been required under a
Complete Response Letter, but will delay approval and launch nonetheless. Sanofi
hopes Lemtrada (alemtuzumab) will be approved for the treatment of relapsing
multiple sclerosis (MS), for which trials showed promising results when compared
to an existing treatment. In the recent Phase III CARE-MS study, Lemtrada was
tested against Pfizer's (NYSE:PFE) Rebif MS treatment and demonstrated that
disability was significantly slowed by Lemtrada compared to Rebif. In fact,
patients treated with the Genzyme drug were twice as likely to experience a
reduction in disability. Revenue from Lemtrada is expected to reach $400-$600
million annually in six years if approved. Today's setback, however, will delay
the launch of Lemtrada. The company has been hoping for a late 2012 or early
2013 launch if the drug was granted a fast-track review process, but with time
for presentation reorganization, the launch could be delayed by months.
Investors should consider Lemtrada a late 2013 product unless the company gives
strong evidence of a priority review by the FDA, plus a quick resubmission.
Sanofi shares will be weak today given early guidance for a possible 2012
approval. Some investors may have already been factoring the approval into 2012
estimates.
Interestingly enough, Sanofi pulled the plug on another drug marketed by the
company, Campath, just last week. Lemtrada is essentially a different dosage of
Campath, which is approved as a leukemia treatment but only brought in about $75
million last year. Campath's removal began in a few European countries this year
and is expected to continue gradually until it remains in as few as 50 countries
worldwide. With glaring similarity between Campath and Lemtrada, Sanofi hopes to
avoid off-label use of Campath and increase Lemtrada's price to closer resemble
competitors like Tysabri and Gilenya, from Biogen Idec (NASDAQ:BIIB) and
Novartis (NYSE:NVS) respectively, both of which cost around $50,000 annually for
treatment. Campath, used off-label to treat MS instead of leukemia, would cost
less than $10,000.
Genzyme and Sanofi's other developmental multiple sclerosis treatment, Aubagio,
is still in testing as a pipeline candidate and the companies released positive
results in June comparing the drug to a placebo. Abagio, however, failed to beat
Rebif in previous trials, and has yet to impress analysts.
To see this article at PropThink.com, click here.
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Datum: 27.08.2012 - 15:51 Uhr
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News-ID 177869
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