Bristol-Myers Squibb partner Ono Pharmaceutical bagged a third approval in Japan for the immuno-oncology treatment Opdivo, its most important new product.
Opdivo transformed Ono's fortunes after it became the first PD-1 inhibitor to reach the market. The drug made its worldwide debut in Japan in September 2014, breathing new life into a company that had been struggling with the loss of patent protection and generic competition for its top brands.
The Ministry of Health Labor and Welfare (MHLW) approved Opdivo Friday to treat advanced renal cell carcinoma (RCC) that has spread and cannot be treated with surgery. That added to the drug's earlier approvals in malignant melanoma and non-small cell lung cancer (NSCLC).
RCC affects fewer patients than melanoma and NSCLC, but it is still a sizable market. It is the most common form of kidney cancer with a death toll of around 110,000 people worldwide every year, with a five-year survival rate of just 12%.
The new approval is a boost for Ono, still reeling from the unexpected news that Opdivo had failed a trial as a first-line NSCLC treatment. That lung cancer study was carried out by Bristol-Myers, Ono's partner for the drug outside Japan, South Korea and Taiwan.
Analysts cut peak sales forecasts for Opdivo after the data went public--and raised their predictions for Merck & Co.'s rival drug Keytruda, which met its goals in a first-line NSCLC trial reported in June. The outcome put Bristol-Myers on the back foot in the marketing tussle and could affect Ono's direct sales in Japan, as well as its royalty stream on overseas sales.
The importance of Opdivo to Ono cannot be overstated, particularly as the Japanese government continues to apply downward pressure to drug prices. The drug's sales rocketed 1,640% in the April to June quarter, accounting for 25 billion yen ($245 million) of the Japanese group's total revenues of 59 billion yen. Another 4 billion yen in Opdivo revenue came from BMS royalties.
Like BMS, Ono is banking on new indications to continue to drive Opdivo sales--and fend off competition from Keytruda and other new immuno-oncology drugs--as it tries to bring other pipeline candidates through to market. Ono has already filed for approval to market Opdivo for head and neck cancer and Hodgkin's lymphoma, and it has Phase III trials underway in gastric, small cell lung, esophageal, liver, brain and bladder cancers.
Ono President Gyo Sagara told The Nikkei that the company hopes to start selling the drug for Hodgkin's lymphoma with health insurance cover within the year.
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