Manufacturing problems at a Boehringer Ingelheim plant did a double whammy on Johnson & Johnson's ($JNJ) cancer drug, Doxil. It forced J&J to ration the drug to patients, current and future. It also interrupted clinical trials testing new drugs with or against J&J's ovarian cancer treatment, putting pipelines in jeopardy.
J&J now says it appears Boehringer Ingelheim will return to production by year's end, allowing it to release some supplies of Doxil for a trial by Endocyte ($ECYT) that will test an experimental drug in conjunction with Doxil, The Wall Street Journal reports. Endocyte says with what J&J will provide and what it has on hand, it can sign up patients without interruption. J&J says VentiRx Pharmaceuticals is getting a supply to test its experimental cancer drug, VTX-2337.
The shortage arose after manufacturing problems at Boehringer's Ben Venue Laboratories plant in Ohio halted production. J&J worked with the FDA to release Ben Venue's stock of Doxil, and the FDA allowed temporary imports of Sun Pharma's Lipodox, a similar drug not yet approved in the U.S.
Doxil is known to be a liposomal formulation of doxorubicin. I doubt a little bit about the efficiency of Doxil (compared to "convenient" non-liposomal doxorubicin) but here we have another strange issue – Doxil supposed to bring a lot of profits (if it were being manufactured and sold to patients). And what is the reason that the manufacturing process is halted for so long? I personally worked a lot with liposomal formulations – it is absolutely not a rocket science, the technology is well developed and used for several decades, therefore I would suggest that the manufacturing process by itself should not be blamed for the delay in the Doxil supply.
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