Abraxane White Paper Distribution At ASCO Draws FDA Advertising Letter
This article was originally published in The Pink Sheet Daily
Executive Summary
Celgene says the white paper – which FDA says promotes Abaxane as effective for unapproved uses and superior to Bristol-Myers Squibb’s Taxol – was intended solely for potential business partners interested in nab technology.
You may also be interested in...
Cancer “Moonshot” Launch Team Announced: Uncomfortable Ties To Anti-Industry Headlines
The Vice President’s cancer “moonshot” is a great opportunity for biopharma companies to engage in a process that should remind policymakers and the public of the promise of biomedical innovation at a time when the industry’s pricing and financial engineering activities are under scrutiny on Capitol Hill. The selection of the “blue ribbon” panel puts those two images in stark contrast.
White Paper Is Actually Branded Promotion, FDA Tells Ipsen
Warning letter states that when only one drug (Increlex in this case) provides a therapy discussed in promotional materials, they "effectively promote" the drug even if they do not mention it by name.
Despite Celgene's Abraxane Stock, Trading Earn-Outs Is The Exception Not The Rule
Though Abraxane (paclitaxel) is now part of Celgene Corp.'s growing oncology portfolio, you don't need Celgene stock to invest in its newest product, a reformulation of the generic chemotherapy that's approved to treat metastatic breast cancer. As part of Celgene's cash-and-stock $2.9 billion acquisition of Abraxis BioScience Inc. Celgene deferred at least $650 million in potential payments to Abraxis shareholders, plus royalty payments tied to Abraxane sales. Unlike most earn-out-laden deals, however, the contingency value rights, or CVRs, for the earn-outs have been securitized and now trade under the ticker CELGZ. Despite potential advantages - tradeable CVRs let shareholders bet on the success or failure of specific assets, for instance - these investment vehicles are still a rarity in the marketplace.