Sorafenib

IUPAC: 4 - {4 - [ 3 - (4 -chloro-3 -trifluoromethylphenyl) ureido] -phenoxy}- pyridine-2 -carboxylic acid

L01XE05

Cytostatic

Template: Infobox chemical / molecular formula search available

Sorafenib (trade name: Nexavar ®, manufactured by Bayer AG) is a drug from the group of multi-kinase inhibitors and is applied in the form of tablets. Areas of application are the treatment of advanced kidney cancer when standard therapy has failed or is inappropriate, and the treatment of liver cancer ( hepatocellular carcinoma no longer resezierbares ( hepatocellular carcinoma, HCC) ). It works by slowing the growth of cancer cells and the blood supply that fuels the cancer cells inhibits.

Sorafenib is one of the orphan medicinal products and is approved for the above mentioned indications in the EU since 2006. The estimated sales potential will amount to approximately € 750 million, 2011 Made Bayer AG worldwide sales of 725 million with the product.

A Phase III trial for first-line treatment of advanced skin cancer was not successful and was terminated prematurely. Similarly, the phase III clinical trial ( patients with advanced lung cancer) has the primary endpoint - an extension of overall survival - not achieved.

Pharmacology

As a multi- kinase inhibitor sorafenib has several points of attack:

Side effects

The most common side effects are diarrhea, skin rash, hair loss, hand-foot syndrome, decreased number of lymphocytes ( lymphopenia ), bleeding ( hemorrhage ), high blood pressure ( hypertension ), nausea, vomiting, skin rash, itching, tiredness (fatigue ), pain and elevated amylase and lipase.

Compulsory license

The Indian Patent Office has the generic company Natco Pharma granted a compulsory license for the production of sorafenib tosylate for the next eight years - against the payment of a license fee of six percent of the sale proceeds. With a trigger for this decision is that Bayer estimates the monthly cost of this medication with approximately € 5,000. With this patent, transfer of the generic manufacturer can reduce the cost to 175 U.S. $, of which 6 percent payable to Bayer. This judgment is the world's first, forcing a manufacturer, either to lower its own prices or to leave the production to another company. Bayer, however, has appealed against compulsory licensing.

Compulsory licenses are anchored in international trade law and are listed in the Doha Declaration as a permissible exception to the TRIPS Agreement. They allow States to implement existing patents to circumvent partially in order to protect public health - for example if it is affected by high prices of patients' access to medicines.