Remicade Relabeling Is Increasing Rate Of TB Screening, J&J Says

Centocor's efforts to increase tuberculosis screening prior to Remicade therapy are working as intended, Johnson & Johnson VP-Investor Relations Helen Short told an Oct. 16 earnings call.

"Anecdotally, I've heard that about 90%" of patients are tested for latent TB infection prior to initiating therapy with the anti-TNF monoclonal antibody Remicade, Short said. "Therefore we expect to see a substantial drop in the activation of latent TB."

Centocor initiated a risk management program for Remicade in August after 70 reports of TB in Remicade patients. The program included a black box warning in labeling, a "Dear Doctor" letter and carefully tracked safety update visits to Remicade prescribers (¹ (Also see "Centocor Remicade Black Box MD Visits Will Be 85% Complete By Aug. 31" - Pink Sheet, 20 Aug, 2001.)).

The safety update does not appear to be slowing the growth of Remicade, which is approved for use in Crohn's disease and rheumatoid arthritis. Third quarter sales increased 153% in the U.S. to $202 mil.

Remicade's sharp growth during the quarter reflects "increased awareness related to direct-to-consumer advertising, clinical data reported at medical meetings and the supply constraints of a competitor's product," Short said, a reference to the tight supply of Wyeth/Immunex' Enbrel pending the approval of additional manufacturing plants.

However, CFO Robert Darretta maintained, Enbrel supply constraints are not a significant factor in Remicade's performance. "We don't think our success is driven by a competitor's manufacturing limitations. We think it is more driven by the characteristics of our product and the effectiveness of our marketing efforts."

"We're working hard to further expand our manufacturing capability because we remain very confident in the continued growth in the product," Darretta added.

Remicade (infliximab) sales worldwide increased 121% to $511 mil. through nine months. Enbrel (etanercept) sales are tracking at $750 mil. this year.

The anticonvulsant Topamax (topiramate), which was also the subject of a "Dear Doctor" letter in August, grew by 27% in the U.S. to $68 mil. during the quarter. Short said that she is not aware of any additional reports of glaucoma associated with the drug since the letter was sent. Johnson & Johnson had received 23 reports through mid-August (² (Also see "J&J Topamax Glaucoma Warning, Lennox-Gastaut Indication Added To Label" - Pink Sheet, 10 Sep, 2001.)).

The anemia agent Procrit (epoetin) had another strong quarter, with U.S. sales increasing 62% to $742 mil. The increase included $140 mil. in wholesale stocking ahead of a September price increase, J&J noted.

The wholesaler stocking also came immediately ahead of Amgen's launch of Aranesp (darbepoetin), marking the first direct competition between the two companies in the anemia market. There is "no evidence of a significant impact to date" from Aranesp on Procrit, Darretta maintained.

The strong showing by Procrit helped J&J increase domestic pharmaceutical sales by 17.7% to $2.51 bil. for the quarter. Worldwide Rx sales increased 16.1% to $3.68 bil.

The third quarter marked the end of the year-over-year impact from the commercial withdrawal of the gastrointestinal agent Propulsid (cisapride). The company reports that approximately 1,000 patients are still receiving the product under a limited access program.

The liability impact on J&J may be just beginning. In September, a jury in Mississippi awarded $10 mil. to 10 former Propulsid users. "It is our strong belief that the verdict was insupportable and that it will be reversed on post-trial motions," Darretta declared.

"If those post-trial motions don't proceed as we think they should, then it will be reversed on appeal." J&J maintains that "none of these 10 patients were injured and that there is no basis for liability."

"Unfortunately, our legal system is such that once we placed the product on a limited access program there was a great deal of publicity and a number of lawsuits."

J&J estimates that it is facing over 700 lawsuits involving about 2,800 defendants. "It will probably be some time before we hear a case in an appropriate setting." Darretta said. "But, it is our view that our current reserves...are sufficient to substantially cover any liability that we might have," assuming "awards in the future...bear any relation to damages actually done."