BBRS held the ACR conference call this morning. The analysts (Silverman and King) were most excited about both anti-TNF treatments, Remicade and Enbrel. Since both analysts follow Biotechs, they did not discuss the COX-2 inhibitors, Celebrex and Vioxx.
The gave a brief background on anti-TNF approaches (initial clinical data in 1992), and described the medications as true therapeutic breakthroughs. They thought that the compounds would drive a movement for a high tech approach for treatment and both drugs would produce a similar class effect.
They went over the clinical data and indicated that the street was initially skeptical about Remicade, but Remicade showed safety and efficacy with infusions every 8 weeks, which would cost about $6500 per year for the drug, but since it was given in a Dr's office, it would have some extra administrative costs, which would be an incentive to Dr's.
For Enbrel they mentioned how busy and impressive the booth was and they also mentioned data on three clinical trials (Juvenile RA, combining Enbrel with MTX, and treating refractory patients).
For pros and cons they indicated that both had similar safety and efficacy.
Remicade had advantages in dosing (once per 8 weeks), effective on difficult cases, reimbersable through Medicare, less costly per year, and Dr's had financial incentive since they administer the drug. Minuses included concerns about immune response to Mab and increase lymphoma incidence (which were not seen in trials), MTX requirement, smaller data base (1 study), later approval (2H 99 for RA), administored in Dr's office, and smaller sales force.
Foe Enbrel they cited pent up demand coupled with first to market, 1300 sales reps from Wyeth/Ayerst and A.H. Robbins, AHP expertise in treating RA, 2X per week at home administration, and flexible dosing (with or w/out MTX), and strong Juvenile RA data. Negatives were expense ($10-11K per year) and no Medicare reimbursement (about 1/3 of patients).
They thought that both would make money with 250,000 to 300,000 refractory patients in the US and an equal number in Europe, coupled with the fact that RA was a life long illness.
They also mentioned another Mab (D2E7) by Cambridge Antibody Technology (Knoll is their partner) that was in Phase II and administored sub-Q every two weeks.
In addition, they mentioned the column by CYPB that filtered plasma of severe patients (but saw flare-ups when withdrawn). |
