Thanks to psoriasis, the 2003 American Academy of Dermatology meeting in San Francisco is boasting some of biotechnology's biggest names and brightest products.
With Amgen Inc., Genentech Inc., Biogen Inc. and Centocor Inc. on hand to present drug data, the meeting has investors and analysts abuzz over the competition for the psoriasis market. SG Cowen Securities Corp. said in a research note the conference "has been extremely well attended" thus far and "enthusiasm for novel biologics has gained significant momentum" in the face of the coming wave of psoriasis products.
South San Francisco-based Genentech, along with partner XOMA Ltd., of Berkeley, Calif., presented preliminary Raptiva data Saturday from a continuing open-label study involving 339 patients. The data showed 41 percent of patients achieved a 75 percent or greater improvement in Psoriasis Area and Severity Index scores, and 82 percent achieved a PASI score of 50 or greater after 12 weeks of 2 mg/kg/week of Raptiva.
Patients who reached the PASI 50 score or had an Overall Lesion Severity scale score of clear, minimal or mild after 12 weeks were eligible to enter the continuous-treatment aspect of the trial.
At week 13, the weekly dose, given subcutaneously, was reduced to 1 mg/kg. From weeks 13 to 24, 77 percent of the 290 patients had a 50 percent or greater PASI improvement, and more than 51 percent had 75 percent or greater PASI improvement. More than 22 percent achieved a 90 percent or greater improvement.
Through weeks 49 to 60, more than 79 percent of patients who continued therapy had a PASI 50 score and more than 64 percent achieved a PASI 75 score. More than 31 percent achieved a 90 percent or greater improvement in their scores.
No new adverse events occurred in patients that continued on therapy, with the most common complaints in the first 12 weeks being headache, chills, pain, nausea, common colds, fever and weakness.
Raptiva is designed to block the activation of T cells. The psoriasis biologics license application for the product was filed in December. The companies also are developing Raptiva for rheumatoid arthritis and psoriatic arthritis, with both programs in Phase II studies. Genentech and XOMA on Friday presented full data from the most recent Phase III trial of the drug, and SG Cowen said the presentation highlighted quality-of-life data that could add to claims of the drug's effectiveness. (See BioWorld Today, Dec. 27, 2002.)
The data, which used the Dermatology Life Quality Index, "demonstrated a close correlation in quality-of-life improvement among patients treated with Raptiva and the PASI 50 score," suggesting that patients who didn't achieve the PASI 75 score still experienced "a meaningful improvement in their disease," the firm wrote in its report.
The Johnson & Johnson unit, Centocor, of Malvern, Pa., presented data from its Remicade IMPACT trial (Infliximab Multinational Psoriatic Arthritis Controlled Trial) on Saturday. Data from the 101-patient trial showed 39 patients who were treated with Remicade and qualified for the PASI score (meaning they had moderate to severe psoriasis) had positive results. The average reduction of the PASI was 81 percent in the Remicade group, compared to 36 percent in placebo. Sixty-seven percent of Remicade patients achieved an improvement of at least 75 percent, compared to zero in the placebo group. The results were maintained through 50 weeks.
Also, Remicade patients experienced improvement in their joints, as indicated by the ACR measurement tools. Sixty-nine percent of 51 patients in the Remicade group met the ACR 20 response criteria, compared to 8 percent for placebo. Twenty-five patients achieved ACR 50 scores, and 29 percent achieved ACR 70 scores, compared to zero for placebo.
Centocor released Remicade Phase II psoriasis data last week at the conference. SG Cowen pointed to the drug's two- to three-hour infusion time as problematic, but said "given the strong clearance rates and rapidity of onset, we believe Remicade will represent an important treatment option in the market." SG Cowen projects "modest revenues" for Remicade in 2006 in psoriasis. The product, an anti-tumor necrosis factor biologic, is approved for rheumatoid arthritis and Crohn's disease.
Little new data on Cambridge, Mass.-based Biogen's Amevive was presented at the conference, but Leerink Swann & Co. came away from the weekend feeling that Amevive "appears to have captured far greater interest by Wall Street analysts than physicians, at this point." Leerink Swann said it hosted a dinner with several dermatologists in order to assess the biologic landscape. Other analysts see it as having an early foothold in the field through early marketing efforts. Amevive is approved for psoriasis, but in February was turned down for the disease in Europe. Amevive (alefacept) is designed to selectively target the CD45RO+ subset of T cells. (See BioWorld Today, Feb. 21, 2003.)
Amgen, of Thousand Oaks, Calif., released the full dataset for Enbrel in moderate to severe psoriasis after the markets closed Monday. Top-line efficacy data were released about a month ago, and Leerink & Swann said, "Our physician consultants uniformly believe that Enbrel will emerge as the biologic of choice for the treatment of psoriasis."
Biogen's stock (NASDAQ:BGEN) fell $2.70 Monday, or 8 percent, to close at $30.73. Amgen (NASDAQ:AMGN) lost $1.22 to close at $57.34. Genentech (NYSE:DNA) lost 82 cents to close at $34.45. The Nasdaq Biotech composite fell 3.1 percent.