Caelyx rights to revert back to Janssen
pharmafile | September 30, 2010 | News story | Sales and Marketing | Caelyx, Janssen, Merck
Marketing rights for cancer treatment Caeylx outside the US will be returned to Janssen from Merck after a licensing deal expires in December.
Janssen agreed with Schering-Plough in 1996 to transfer the rights in a deal which ends on 31 December this year. Schering-Plough merged with Merck last year, giving it control of the drug.
When the deal was done in 1996, the cancer drug was not seen as a core product to Janssen (a subsidiary of Johnson & Johnson), but the growing commercial importance of oncology makes the rights significant for the company.
Caelyx (pegylated liposomal doxorubicin hydrochloride) is approved in the European Union as monotherapy for metastatic breast cancer in patients where there is an increased cardiac risk.
The drug is also approved in the EU for the treatment of advanced ovarian cancer in women who have failed first-line, platinum-based therapy and for the treatment of AIDS-related Kaposi’s sarcoma in patients with low CD4 counts (<200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.
It has a further indication, in combination with Velcade (bortezomib), for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.
The rights are for Europe and associated countries, Canada, Latin America, Middle East and Asia-Pacific (excluding Japan). Janssen already market the product in the United States, Japan and Israel, under the trade name Doxil.
“Caelyx will become our first global product for the treatment of solid tumours. It represents an important addition to our growing portfolio and growing global presence that reflects our ongoing commitment to delivering important therapeutic options for patients with cancer,” said Jim Baker, worldwide vice president, Oncology and Supportive Care for Janssen. “Both Janssen and MSD are committed to working together on a smooth transition and ensuring an uninterrupted drug supply for patients.”
The deal mirrors a similar but more contentious licensing deal between Janssen and Schering-Plough for rheumatoid arthritis drugs Remicade and Simponi. Janssen are seeking to regain the rights to the drugs, claiming that 2009’s merger of Schering-Plough and Merck invalidates the licensing deal.
Merck and Schering-Plough engineered a ‘reverse takeover’ to circumvent the clause in the agreement, but may end in them losing the rights after all, depending on an arbitration process due to take place shortly.
Andrew McCononagie
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