- Novartis plans to stop commercial marketing of its leukemia drug Arzerra in markets outside the U.S, reacting to changes in treatment standards brought by the entry of more potent new medicines for the blood cancer.
- "Novartis' intention to transition Arzerra to compassionate use programs in the non-US markets reflects the fact that many more drugs have become available for CLL over the last five years and that there is a low number of patients using Arzerra outside of the US market," said Jan van de Winkel, CEO of Genmab, which developed the drug.
- As a result of limiting Arzerra to compassionate use only, Novartis will pay Genmab $50 million to compensate for lost milestones and royalties owed to the Danish drugmaker under the companies' collaboration agreement.
Novartis' decision — while perhaps uncommon in the red-hot oncology space — reflects the strides made in the treatment of chronic lymphocytic leukemia (CLL) in the roughly ten years since Arzerra's approval in the U.S.
Most notably, the approval of AbbVie Inc.'s Imbruvica (ibrutinib) in 2013 has reshaped the CLL market. Clinical studies of the kinase inhibitor showed impressive improvements in both progression-free survival and overall survival versus Arzerra.
Arzerra was never a top-seller, pulling in about £75 million at its peak in 2013 for GlaxoSmithKline plc, which marketed the drug until transferring its oncology products to Novartis in return for the Swiss pharma's vaccine business.
Imbruvica, by contrast, has become a runaway success. Global sales totaled nearly $1.9 billion over the first nine months of 2017 and AbbVie is moving quickly to expand the drug's reach. The Indianapolis drugmaker is also partnered with Roche AG on Venclexta (venetoclax), a treatment aimed at certain CLL subpopulations.
With more patients receiving newer drugs, sales of Arzerra have fallen to marginal levels for Novartis. Through the first three quarters this year, sales totaled $27 million — down from $35 million in the same period the year prior. Genmab doesn't break sales out by region, but the U.S. market generally accounts for the lion's share of drug revenues.
The Danish company recognized approximately $6 million in royalty revenue on those sales by Novartis.
Outside of the U.S., Arzerra has been available in more than 60 countries as a monotherapy for CLL patients refractory to fludarabine and alemtuzumab. Indications in the U.S. also include an approval for previously untreated CLL patients in combination with chlorambucil.