Sorafenib (Nexavar)

On February 14, 2012, KEI filed an affidavit in an India compulsory licensing case involving Bayer patents on cancer drug Sorafenib (Nexavar). The price for Nexavar in India is $47 per 200 milligram tablet. At a daily dose of 4 tablets, this comes to $5,637 per month, or more than $68 thousand per year. The per capita income in India was $1,330 in 2010.

Initial FDA approval

Date of FDA NDA application 21-923: Signed July 6, 2005. Received by FDA on July 8, 2005.
Date on FDA approval: December 20, 2005.
Period of regulatory review: 165 days from the date application was received by FDA.

Drugs@FDA Drug Details

Drug Name(s) NEXAVAR (Brand Name Drug)
FDA Application No. (NDA) 021923
Active Ingredient(s) SORAFENIB TOSYLATE
Company BAYER HLTHCARE
Original Approval or Tentative Approval Date December 20, 2005
Chemical Type 1 New molecular entity (NME)
Review Classifications P for Priority review drug, O for Orphan drug

As of Feb 12, Bayer received 4 US Orphan drug designations

Designation Date and Indication
10-08-2004 Treatment of renal cell carcinoma.
04-20-2006 Treatment of hepatocellular carcinoma
09-29-2006 Treatment of stage IIB through stage IV melanoma
12-12-2011 Treatment of medullary thyroid cancer, anaplastic thyroid cancer, and recurrent or metastatic follicular or papillary thyroid cancer

Early trials cited in NDA

  • In the NDA, Bayer made reference to four Phase 1 trials invoving 104 patients.
  • To establish saftey and efficacy, Bayer referred one Phase II trial that had 202 patients, and a Phase III trial with 384+385= 769 patients. Assuming all of the patents were different, this was a total of 1075 patients in Phase I, II and III trials.
  • Bayer also presented data that said "additional drug-related adverse events and laboratory abnormalities were reported from clinical trials of NEXAVAR in 1286 cancer patients who received NEXAVAR as monotherapy.

Early trials identified by ClincialTrials.Gov

For trials registered in ClinicalTrials.Gov on July 12, 2012, there were 53 clinical trials mentioning the term Sorafenib that were began before the date of Bayer's July 2005 FDA NDA filing. The earliest clinical trial began on February 2002, about 42 months before the NDA filing, and less than 47 months before the drug received its initial FDA approval.

Of the 53 trials, 15 were funded by Industry, 3 received mixed funding, and 35 received no industry funding. The first trial reported in the clinicaltrials.gov registration was a February 2002 trial sponsored and funded by the NIH National Cancer Institute. The next 7 trials were sponsored or cosponsored by Bayer, followed by dozens of trials funded by the NIH and other non-industry sources.

Sponsorship and Funding of Clinical Trials on Sorafenib

Prices for Sorafenib/Nexavar

US Orange Book Patents

There are three patents listed in the FDA Orange Book on July 12, 2012. All are owned by Bayer. These include:

  • USPTO Patent 7,351,834. .omega.-Carboxyaryl substituted diphenyl ureas as raf kinase inhibitors. Filed on January 12, 2000, and granted April 1, 2008.
  • USPTO Patent 7,235,576. Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors. Filed January 11, 2002, granted on June 26, 2007
  • USPTO Patent 7897623. .omega.-carboxyl aryl substituted diphenyl ureas as p38 kinase inhibitors. Filed August 27, 2007, and granted March 1, 2011.