By Alexander Alex, C. John Harris, Dennis A. Smith
With a spotlight on case stories of R&D courses in a number of illness parts, the e-book highlights primary productiveness matters the pharmaceutical has been dealing with and explores strength methods of enhancing examine effectiveness and efficiency.
• Takes a complete and holistic method of the issues and capability suggestions to drug compound attrition
• Tackles an issue that provides billions of greenbacks to drug improvement courses and well-being care costs
• Guides discovery and improvement scientists via R&D phases, instructing requisites and explanation why medications can fail
• Discusses capability methods ahead using new methods and possibilities to minimize attrition
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Extra info for Attrition in the pharmaceutical industry : reasons, implications, and pathways forward
In 2011, Savient Pharma obtained marketing approval for its gout treatment Krystexxa (pegloticase). Savient was reputedly for sale after marketing approval was gained from the FDA, but due to a lack of suitors, the company took the drug to market itself. Sales remained stubbornly low, and with produc tion problems, the challenge to increase sales to cover its rising debts proved too great and Savient was forced to file for bankruptcy in 2013. Too many marketed drugs fail to recoup their developments costs, but clearly the worst outcome of all is the withdrawal of a drug when it is on the market.
Vioxx, the cyclooxygenase 2 inhibitor, also approved by the FDA in 1999, was withdrawn by Merck in 2004, after concerns of increased risk of heart attack and stroke after long‐term use. It was widely used to treat rheumatoid arthritis and other diseases involving chronic pain, and it was estimated it had been used in over 50 million patients before withdrawal but also associated with between 88,000 and 140,000 cases of severe heart disease . As the safety–efficacy balance has become increasingly driven in the direction of safety, these cases will probably increase.
Allergan with arguably a more traditional belief in sustainable growth driven through R&D innovation, versus Valeant and it’s acquisition-based growth model and a focus on strong financial discipline. Throughout 2014, it was a battle fought in the boardroom, the courtroom, and in the press-room. However a final showdown was avoided, when a more welcome suitor emerged for Allergan. Activis, a company with corporate values apparently more closely aligned to Allergan’s own, came forward with an acceptable $66 billion offer.