Related Experiment Videos
Everolimus. Novartis
1Merck Research Laboratories, Department of Immunology & Rheumatology, 126 East Lincoln Avenue, PO Box 2000, Rahway, NJ 07065, USA. francis_dumont@merck.com
Abstract:
Everolimus (RAD-001, SDZ RAD, Certican), an analog of sirolimus, is an oral immunosuppressant that inhibits growth factor-induced cell proliferation, under development by Novartis as a potential treatment for transplant rejection. Phase III trials were initiated by the end of 1998 [319337] and were ongoing in February 2001 [400448]. At the end of 2000, Novartis was hoping to file for approval of the compound in 2001 [392881], with a possible launch in mild-2002 [392881], [401979]. Completion of phase III trials in heart transplant patients is expected this year and lung and liver transplants by 2003. In 1999, American Home Products (AHP) initiated an action for infringement of the patent EP-00401747, which covers the use of sirolimus in transplantation in the UK, the Netherlands and Germany, seeking to restrain the clinical trial program for everolimus. Novartis subsequently filed a counterclaim for invalidity. In December 1999, the UK High Court of Justice ruled that everolimus infringes the British counterpart of EP-00401747 [349637]. In contrast, in April 2000, the District Court of The Hague ruled that everolimus does not infringe patent rights licensed to AHP [362823] and in July 2000, The Court of Appeal in the UK came to the same conclusion [376559]. In February 2001, the Opposition Board at the European Patent Office upheld Novartis' European patent for everolimus, which the Board held to be 'inventive' [400448]. In July 2000, Vontobel estimated sales of SFr 80 million in 2002, rising to SFr 800 million in 2004 [378871]. In February 2001, Merrill Lynch predicted sales of SFr 125 million rising to SFr 661 million in 2005 [411704].
Insights
Everolimus, an oral immunosuppressant for transplant rejection, faced patent challenges but received a favorable ruling from the European Patent Office. Financial forecasts predict significant sales growth for this novel therapeutic.
Area of Science:
- Pharmacology and Immunology
- Drug Development and Intellectual Property Law
Background:
- Everolimus (RAD-001), an analog of sirolimus, is an oral immunosuppressant developed by Novartis.
- It inhibits growth factor-induced cell proliferation and is under investigation for preventing transplant rejection.
Purpose of the Study:
- To report on the development status, clinical trial progress, and patent litigation surrounding everolimus.
- To provide sales forecasts for everolimus in the context of its therapeutic potential.
Main Methods:
- Review of clinical trial initiation and progression for everolimus in transplant patients.
- Analysis of patent infringement lawsuits and legal rulings concerning everolimus and its active ingredient.
- Compilation of financial market analyst predictions for everolimus sales.
Main Results:
- Phase III trials for everolimus were ongoing as of February 2001, with anticipated completion dates for different transplant types.
- Patent litigation involved infringement claims and counterclaims, with mixed rulings in UK and Dutch courts, but a favorable decision on patent validity from the European Patent Office.
- Financial analysts projected substantial sales growth for everolimus, with estimates ranging from SFr 80 million in 2002 to SFr 800 million by 2004.
Conclusions:
- Everolimus demonstrated promising development progress and market potential, despite facing and overcoming patent disputes.
- The European Patent Office's decision supported the inventiveness of Novartis's patent for everolimus.
- Market forecasts indicate significant commercial success anticipated for everolimus in the immunosuppression market.