Latest From AtheroGenics Inc.
Not before time last week, the SEC fired a shot across the bows of pharmaceutical and biotechnology companies that have been failing to accurately portray their dealings with the FDA. At the Annual Pharmaceutical Compliance Congress, SEC enforcement director Andrew Ceresney reportedly scolded biopharma companies over lapses in the accuracy of disclosures on their dealings with the FDA. Perhaps his words indicate that, after years of only scratching the surface of the problem, the SEC intends to get serious about addressing selective and misleading disclosure of material events, including biotech firms’ interactions with the FDA.
The Private Securities Litigation Reform Act of 1995, or Forward-Looking Statement Safe Harbor disclaimer as it is better known, advises investors that under such a disclaimer, companies can make financial projections and statements on clinical trial success or approval for their drugs, without fear of repercussion if those statements fail to be true. Additionally, having promised the moon, companies are under no obligation to update investors if they fail to deliver whatever promises were previously made under the Safe Harbor disclaimer.
Cerenis Therapeutics (France/US), a privately held pharmaceutical company developing novel HDL therapies to treat cardiovascular and other metabolic diseases, has made the following appointments: Tom Brya joins as senior vice-president of business development, having previously served as vice-president and general manager for a biologic CMO start-up at Cardinal Health (now part of Catalent Pharma Services); Christopher Prue, who has 30 years' pharmaceutical industry experience, having held roles at AtheroGenics, Purdue Pharma, Incara Pharmaceuticals, Glaxo Wellcome and The Upjohn Company, becomes vice-president of regulatory affairs; and Dr Cynthia Sundell joins as vice-president of drug development; she formerly led discovery efforts at AtheroGenics.
Infinity's "Big Brother" deal with the privately held affiliates Purdue and Mundipharma comes closest of any recent deal to replicating the structure of the Genentech/Roche relationship -- swapping the majority of a biotech's pipeline to a well-heeled partner in return for independence from the capital markets and enough commercial upside to deliver a long-term return for investors. But the idiosyncrasies of the Purdue/Mundipharma ownership and structure, and the recent stormy history that opened minds to the possibility of such a deal, show why further iterations of the model will remain a rarity.
- Therapeutic Areas
- North America
- Parent & Subsidiaries
- AtheroGenics Inc.
- Senior Management
Russell M Medford, MD, PhD, Pres. & CEO
Mark P Colonnese, EVP, Commercial Oper. & CFO
- Contact Info
Phone: (678) 336-2500
8995 Westside Pkwy.
Alpharetta, GA 30004