GENZ
Campath in MS 2 year data consistent with 1 year data
Genzyme reported interim 2 year data from Campath for multiple sclerosis (MS),
which demonstrated a significantly lower risk of relapse and progression
compared to patients taking Rebif, and comparable safety data as at the 1 year
analysis. Additional data will be presented at the ECTRIMS medical conference
starting September 27, and a Phase 3 trial is expected to begin enrollment in
1H07. But, pricing for Campath in MS, which is used at about 1/18th the dose of
Campath for CLL, remains the biggest challenge to the commercial success in
MS. Reiterate BUY.
Campath had better efficacy than Rebif head-to-head
Interim 2-year data from the Phase 2 trial comparing Campath head-to-head with
Rebif in MS indicated that Campath patients experienced at least a 75% reduction
in the risk for relapse after at least two years of follow vs Rebif (p=0.00328). On
the co-primary endpoint, Campath patients experienced a 65% reduction of risk
for progression of disability (p=0.01194). Based on these data, we expect a Phase
3 trial to start in 1H07.
Safety consistent with 1 year data
The safety data for Campath at 2 years was consistent with the 1 year data.
Three additional patients were diagnosed with ITP since the 1 year data were
released. In the trial, a total of 6 patients have been diagnosed with ITP, with the
first case being fatal. However, ITP is very manageable if identified, so Genzyme
implemented enhanced monitoring for ITP in its risk management plan to facilitate
early identification and minimize risk of complications. All of the patients identified
with ITP since the first case, have responded well to treatment. The incidence of
serious adverse events was higher for Campath vs Rebif (8 patients vs 2
patients). But, the incidence of Grave’s disease, a complication with Campath in
CLL, was less than expected. Additional safety data will be presented at the
ECTRIMS conference.
Commercial success a challenge due to pricing
Campath for MS is used at a significantly lower dose than for CLL, resulting in a
cost per year of about $2000, compared to $15,000 to $25,000 for other MS
drugs. Even if all ~400k – 500k patients with MS WW took the drug, sales would
only reach $800 MM - $1 B. As a result, the Genzyme may be challenged to
adjust its pricing scheme to optimize profitability for the drug in both MS and CLL. |
