Alexion Pharmaceuticals Inc. in Cheshire says its six-figure drug developed to treat sufferers of a rare form of anemia is being distributed free to treat victims of the E coli epidemic sweeping Germany, a regulatory filing shows.
Alexion reports Tuesday in its 8-K filing to the Securities and Exchange Commission that its German subsidiary has been deluged with physician requests for eculizumab -- branded as Soliris -- to treat patients suffering from Shiga-toxin producing E. coli hemolytic uremic syndrome (STEC-HUS).
The ailment is a potentially life-threatening outcome of Enterohaemorrhagic Escherichia coli (EHEC) infections in which blood cells are infected and can cause kidney failure, Alexion said. The E coli outbreak has killed at least a dozen people and sickened hundreds more on the continent.
Alexion stressed in its filing that eculizumab is not approved for the treatment of STEC-HUS in Germany or elsewhere. Soliris, however, is cleared there to treat the rare genetic disease called paroxysmal nocturnal hemoglobinuria, or PNH.
Meantime, the drug maker said it is supplying Soliris at no charge to physicians who request it for STEC-HUS patients. Normally, Soliris costs patients and their insurers about $300,000 to $400,000 a year.
Alexion's altruistic bent could ultimately benefit the company in other ways.
Indeed, medical researchers -- some not directly tied to Alexion -- are studying the treatment potential of Soliris for patients suffering atypical hemolytic uremic syndrome, an ailment similar to STEC-HUS.
In the U.S., Europe and most Asian countries, drug makers must undergo lengthy -- and expensive -- clinical and human trials to prove their treatments are effective and safe. Emergency use of Soliris to treat Germany's E coli victims could yield data useful to drug investigators and regulators, observers say.
An Alexion spokesman declined to specify how much Soliris it expects to give away and at what cost to the company.