J&J’s Doxil/Caelyx shortages affect ovarian cancer trials

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Johnson & Johnson’s (NYSE:JNJ) limited supply of chemotherapy drug Doxil/Caelyx (doxorubicin) is currently impacting two Phase III ovarian cancer trials, a source close to the situation told Biopharm Insight. The supply of doxorubicin for independent pharmaceutical companies is currently on hold, a J&J company spokesperson confirmed.

Doxil is a chemotherapy drug currently approved for the treatment of ovarian cancer and multiple myeloma.

The source explained that the supply of Doxil/Caelyx was intermittent for the last few months, but has now stopped completely on Amgen’s (NASDAQ:AMGN) late-stage TRINOVA-2 study and Endocyte’s (NASDAQ:ECYT) PROCEED trial in ovarian cancer.

Requests for Doxil/Caelyx for use in clinical studies, such as investigator initiated studies (IIS) or studies by independent pharmaceutical companies are currently on hold pending full supply availability, the J&J spokesperson noted.

The supply of Doxil/Caelyx has been limited due to unplanned down time because of production equipment failures at the contract manufacturing firm Ben Venue Laboratories, the spokesperson said. Ben Venue is a unit of Germany-based Boehringer Ingelheim.

Ben Venue is the sole manufacturer of Doxil and is currently facing capacity constraints that are resulting in the shortage of this and other critical care products it manufactures, a Ben Venue spokesperson said. The Company understands the importance of Doxil, as well as the other critical care products it produces for patients around the world, and is working diligently to minimize the current shortages, the spokesperson added.

Amgen’s TRINOVA-2 Phase III trial investigates whether AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival.

An Amgen spokesperson said the TRINOVA trials are not on hold, and the company has been proactively managing the drug supply shortage situation. The TRINOVA-2 trial is currently open to recruitment, and Amgen is working closely with investigators across all trials to ensure that the shortages cause minimal disruption, the spokesperson noted.

Endocyte’s PROCEED Phase III pivotal trial compares the progression free survival advantage of patients with platinum-resistant ovarian cancer who receive combination therapy with EC145 and PLD against patients on PLD and placebo.

Endocyte did not respond to requests for comment.

J&J has communicated to investigators in both company-sponsored and investigator-initiated studies, which are being conducted outside its organization, about the Doxil/Caelyx supply shortage.

In early August, the company announced the Doxil C.A.R.E.S. physician access program in the US, an allocation program for physicians designed to allow as many patients as possible who are currently receiving Doxil an option to continue their current course of therapy, the spokesperson explained. As supply is expected to be intermittent in the months ahead, all physician requests for Doxil are made through this program in the US.

But requests for Doxil and Caelyx for clinical studies, such as IIS or studies by independent pharmaceutical companies, are on hold pending full supply availability.

UK supply

A second source said the situation in the UK is difficult and physicians may have to consider alternatives.

J&J has been closely managing the situation with regards to supply of Caelyx 20mg and 50mg vials and can confirm that the shortage is impacting the UK, a second J&J spokesperson said. The shortage is due to manufacturing issues at J&J’s third party contract manufacturer, the spokesperson said. J&J is experiencing a similar supply shortage in other countries around the world and it is working to resolve the situation as quickly as possible, he added.

Patients who have already received Caelyx, or will receive available Caelyx stock, can be reassured that this shortage in supply is not due to any concerns over the safety or quality of the product, the spokesperson said.

The limited availability of Caelyx has led the company to implement a strict patient allocation program until the shortage of supply is resolved and to minimize the impact on patients, the J&J spokesperson said. The company has asked clinicians to give priority to patients already being treated with Caelyx, where there is no alternative treatment options remaining, the spokesperson added.

J&J also advises that no new patients start Caelyx therapy, until an adequate supply becomes available, unless these patients have no other options remaining, he said.

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