J&J Could File “New Gold Standard” In Anti-TNF Therapy By Late 2007
This article was originally published in The Pink Sheet Daily
Executive Summary
CNTO 148 is in Phase III for RA, ankylosing spondylitis and psoriatic arthritis.
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Johnson & Johnson is touting best-in-class dosing and comparable efficacy to the firm's Remicade (infliximab) as advantages that will help to establish CNTO 148 (golimumab) as "the future of the anti-TNF therapy." "We think this drug could become the new gold standard in anti-[tumor necrosis factor] therapy," J&J Pharmaceuticals Worldwide Chairman Joseph Scodari said during a second quarter earnings call July 18. "It has outstanding efficacy with features that no other anti-TNF offers, such as best-in-class dosing and both IV and subcutaneous dosage form." Scodari said an "ideal TNF" should have a demonstrated long-term inhibition of joint damage, sustained benefit for signs and symptoms of the disease and availability in both subcutaneous and IV form. It should also be fully human, ultimately be approved in a broad range of indications and have a convenient monthly or better dosing interval, he said. "Amongst our subcutaneously administered competitors, the best available dosing interval in the marketplace is once every two weeks," while CNTO will be administered once every four weeks, Scodari said. He said the company expects to file a BLA for CNTO 148 by early 2008, but may file as soon as late 2007 (1 (Also see "J&J Anticipates Up To 14 NME Filings In 2006/2007" - Pink Sheet, 16 Jun, 2006.)). It is currently in Phase III for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. CNTO 148 would be the "first and only" anti-TNF available in both IV and subcutaneous forms, according to Scodari. It was developed by Centocor and Schering-Plough. In Phase II trials, half the CNTO 148 patients achieved an ACR 50 score compared to 8% in patients treated with placebo, J&J said. Twenty-five percent of CNTO 148 patients met the ACR 70 endpoint, versus none in the placebo arm. "Against all the [American College of Rheumatology] measures, CNTO performed extremely well," Scodari said. Additionally, Scodari said CNTO 148 is "highly effective in relatively low doses," which "should translate into a significant advantage from a manufacturing perspective." J&J expects that smaller doses - between one-half and one-third the amount of drug - will generate a like response with CNTO 148 compared to the blockbuster TNF inhibitor Remicade, Scodari said. As J&J strives to position CNTO 148 as the successor to Remicade, the firm continues to see strong growth for infliximab. Remicade U.S. sales jumped 18% to $595 mil. versus the year-ago period, while international sales increased 33% to $182 mil. However, overall pharmaceutical sales growth was up only 2.4% in the U.S. for the second quarter. Worldwide, second quarter pharma sales were up 3.2% over the year-ago quarter to $5.8 bil. For the first half of the year, sales were essentially flat, at 0.5% higher than the first half of 2005. J&J reported significant declines for several products, including the chronic pain patch Duragesic (down 25%), hormonal contraceptives (down 21%) and Procrit (down 9%). The firm said it was adversely impacted by the entry of generic competition for the analgesic Ultracet , the antifungal Sporanox and Duragesic (2 (Also see "J&J Plans Dapoxetine Meeting With FDA, Awaits Agency Actions" - Pink Sheet, 18 Apr, 2006.)). -Daniel Fowler |