ALZA'S NEW CHIEF WILL BE EX-GLAXO CEO ERNEST MARIO
• By The Tan Sheet
ALZA'S NEW CHIEF WILL BE EX-GLAXO CEO ERNEST MARIO effective Aug. 2, the Palo Alto, Calif.-based drug delivery firm announced on July 12. Mario, deputy chairman and CEO of Glaxo Holdings until this spring, will succeed Martin Gerstel as co-chairman and CEO. Alza has been looking for a new chief executive since February 1992, when Gerstel announced his intention to leave the top spot to pursue personal interests. Mario, 55, left Glaxo in March over differences with the company's board of directors on what direction Glaxo should take in the OTC area ("The Tan Sheet" March 15, p. 3). Reportedly, Mario favored a more aggressive approach to building an OTC business than did others on the board. He joined Glaxo in 1986 as president of Glaxo U.S. and quickly rose to the top spot at the company. Prior to joining Glaxo, Mario was a group VP at Squibb. Mario will share the Alza chairmanship with founder Alejandro Zaffaroni. Jane Shaw will remain as president and chief operating officer, Alza said. Gerstel, 52, will assume the new title of vice chairman "for the interim to assist Dr. Mario during the transition," Alza added. After the transition, Gerstel "will continue as a member of the company's board of directors." Gerstel has been with Alza since its founding in 1968. Mario is assuming the top spot at Alza in the midst of the company's effort to expand its in-house promotional and manufacturing capabilities. Recent and upcoming launches of Alza- developed products include the Janssen fentanyl patch Duragesic, the Marion Merrell Dow nicotine patch Nicoderm and the two Ciba- Geigy OTC medicines -- Efidac/24 once-a-day pseudoephedrine and a 24-hour chlorpheniramine allergy product ("The Tan Sheet" July 12, In Brief). Alza also has recently established a spinoff to focus on developing proprietary drugs. Mario's main challenge, however, will be to maintain Alza's royalty stream, which remains reliant on sales of Pfizer's prescription antihypertensive Procardia XL. The $ 1 bil. product is now facing its first direct competition from a once-a-day nifedipine brand, Miles' Adalat CC. A third once-a-day nifedipine, Elan/Miles' Nifelan, is pending approval. A more significant threat could be a generic equivalent to Procardia XL. Alza's delivery system is patented through 2002, but generic firms, including KV, are understood to be pursuing bioequivalent versions. During Mario's tenure at Glaxo, Alza and Glaxo collaborated on the development of the sustained-release albuterol formulation Volmax, which was approved Dec. 23 after a five-year review. The prescription asthma drug was subsequently outlicensed to Muro. Alza and Glaxo have not disclosed any other collaborative agreements.
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
Gilead and Roche reflect on their experiences with a global initiative that delivered aligned regulatory decisions through joint hybrid inspections and synchronized review of post-approval changes.
The EMA has scheduled oral explanation meetings this week for Anavex’s blarcamesine and three other products that are nearing the end of the regulatory review cycle. These meetings usually represent the final chance for sponsors to persuade the agency that their product merits approval.
In this exclusive article with Peter Crowley, Secretary and Scientific Director of the BP Commission, you’ll discover how the BP is preparing for its landmark 2026 edition while strengthening its influence as a global bridge between science, regulation, and industry.