By Peter Loftus
Johnson & Johnson (JNJ) will provide additional supply of its cancer drug Doxil for use in clinical trials, including one testing whether the combination of an experimental Endocyte Inc. (ECYT) drug with Doxil improves treatment of ovarian cancer.
Doxil has been in short supply since J&J's contract manufacturer experienced factory problems last year. Apart from affecting patients who were prescribed Doxil, the shortage also held up clinical trials of experimental drugs that were being tested with or against Doxil.
J&J said Thursday it would provide supplies of Doxil to two clinical trials. One is a late-stage study testing whether Endocyte's EC145 and Doxil improves overall survival of women with ovarian cancer, versus Doxil alone.
Endocyte said in a separate statement the additional Doxil would supplement an existing supply that was already in place to support the trial, and would allow the company to continue to enroll patients without interruption.
Endocyte in April agreed to license EC145 to Merck & Co. (MRK), which gained global rights to develop and commercialize the drug in exchange for a $120 million up-front payment and up to $880 million in additional payments if certain milestones are met. Endocyte retains the right to co-promote the drug with Merck in the U.S.
In addition, J&J will supply Doxil to be used in a clinical trial of VentiRx Pharmaceuticals' experimental cancer drug VTX-2337.
J&J said its Doxil supplier, Boehringer Ingelheim's Ben Venue Laboratories unit, is making progress toward resuming production of Doxil near the end of this year. Ben Venue suspended production late last year as it tried to fix manufacturing problems identified by drug regulators.
J&J has been allocating remaining supplies of Doxil through a rationing program. Earlier this year, the Food and Drug Administration approved the temporary importation of a replacement drug for Doxil, known as Lipodox.
J&J said it will continue to pursue a shorter-term option to begin restoring Doxil supplies before the end of the year.
Write to Peter Loftus at email@example.com
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