Bristol Boosts ImClone Funding To Accelerate Erbitux Development
This article was originally published in The Pink Sheet Daily
Executive Summary
Bristol will invest an additional “several hundred million dollars” toward Erbitux late-stage clinical trials in brain, breast, bladder, esophageal, gastric and lung cancers.
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ImClone and Bristol-Myers Squibb are repositioning to begin a "blitz" of late-stage clinical trials with the goal of rapidly expanding the oncology claims carried by Erbitux (cetuximab). Bristol and ImClone announced July 27 an amendment to the terms of their co-development and co-promotion agreement for Erbitux to fund the expansion of Phase II and Phase III clinical trials for breast, bladder, esophageal, gastric and stage 3 lung cancer. Under the new terms, Bristol would pay all development costs of the compound up to an undisclosed annual threshold. After that threshold is met, ImClone will contribute a percentage of costs, which the firms also refused to divulge "for competitive reasons." However, ImClone did say the change would mean that Bristol will invest an additional "several hundred million dollars" in Erbitux development compared with the original agreement, allowing ImClone's portion of Erbitux R&D spending in 2007 to be "$35 million to $40 million less than what we had anticipated earlier in the year," ImClone Executive Committee Chairman Alex Denner said in a July 31 conference call with investors. Erbitux has an early October user fee date for an sBLA receiving priority review for third-line metastatic colorectal cancer (1 (Also see "Erbitux Gets Priority Review For Third-Line Colorectal Cancer Claim" - Pink Sheet, 11 Jun, 2007.)). ImClone also is in discussions with FDA regarding the submission of an sBLA for Erbitux as first-line treatment of recurrent or metastatic head and neck cancer (2 (Also see "Erbitux Shows Survival Benefit With Chemo In First-Line Metastatic Head & Neck Cancer" - Pink Sheet, 4 Apr, 2007.)). The product is approved in the U.S. for treatment of irinotecan-refractory or intolerant metastatic colorectal cancer and locally or regionally advanced squamous cell carcinoma of the head and neck with radiation or as a monotherapy in patients with recurrent or metastatic squamous cell cancer when platinum-based therapy has failed. ImClone advanced the development of five early clinical antibodies during the quarter, with three that have already entered or are poised to enter Phase II or III trials. IMC-1121b, a VEGF-2 inhibitor, has moved into Phase II studies including combination with Erbitux in colorectal patients who have failed previous therapies. IMC-11F8 will move into Phase II during the next quarter for bladder cancer, and IMC-18F1, which targets VEGF-1, will enter Phase II for breast and colorectal cancer indications by year's end. During its earnings call for the second quarter ended June 30, ImClone noted that Erbitux sales were "modest," increasing to $162.1 million from $160.1 million in the first quarter. However, looking forward, the firm expects to regain positive momentum in sales. ImClone nearly doubled its sales force - adding 27 oncology sales professionals to the existing 37 - who will call on "customers that represent more than 95 percent of Erbitux's business," Senior VP, Commercial Operations, Michael Bailey told investors. JP Morgan analyst Geoffrey Meacham maintained his "neutral" rating for the company in a July 31 research note, also noting diminishing competition from Amgen's Vectibix (panitumumab) (3 (Also see "Vectibix Vs. Erbitux: The Race For A First-Line Colorectal Cancer Indication" - Pink Sheet, 26 Jan, 2007.)). -Pamela Taulbee ([email protected]) |