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Cancer drug nivolumab wins PD1 inhibitor race to market

BMS and Ono’s skin cancer treatment approved in Japan under trade name Opdivo
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Ono Pharmaceutical has become the first company to win approval for a PD1 checkpoint inhibitor after getting a green light for its nivolumab drug in Japan.

The Japanese regulatory authorities licensed nivolumab - which has the trade name Opdivo and is being co-developed by Bristol-Myers Squibb (BMS) - as a treatment for patients with melanoma that is not treatable with surgery.

A condition of nivolumab's approval in Japan is that Ono conduct a series of post-marketing studies to confirm the drug's efficacy and safety as a melanoma therapy.

The licence means nivolumab has beaten rival drug pembrolizumab from Merck & Co to the melanoma market, although Merck seems to be in pole position in Europe and the US. Meanwhile, Roche is also snapping at the leader's heels with its MPDL-3280A candidate, although this drug is being developed initially as a treatment for lung cancer.

At the moment the only approved treatment for unresectable melanoma in Japan is dacarbazine, which generally has an overall response rate (ORR) of 13 per cent and confers a median overall survival (OS) ranging from 5.6 to 11.0 months.

Early studies of nivolumab in unresectable melanoma have shown that Ono and BMS' drug can achieve three-year OS rates of 41 per cent with an ORR of 32 per cent.

"Ono would like to obtain approvals for additional indications on ongoing development for other cancers to bring many patients Opdivo as soon as possible," said the Japanese pharma company's president Gyo Sagara.

Moreover, while the process of securing a reimbursement price for the PD1 inhibitor is progressing Ono says it will provide access to the drug free-of-charge "as soon as it is ready".

Nivolumab was developed via a collaboration between Ono and Medarex, which was acquired by BMS in 2009. Ono has rights to market the drug in Japan, Korea and Taiwan, while BMS has rights elsewhere.

Analysts believe its profile may give it the edge in what is likely to become a competitive market, with a recent Decision Resources analysis suggesting it will be the "sales-leading agent among immunotherapies" for cancer.

Hepatitis C approval for BMS

Meanwhile, in further good news for BMS, the Japanese regulators also gave marketing approval to its hepatitis C virus regimen based on Daklinza (daclatasvir) and Sunvepra (asunaprevir).

The dual therapy is Japan's first interferon- and ribavirin-free HCV regimen and has been approved for patients with genotype 1 chronic HCV infection, including those with compensated cirrhosis. The combination was awarded breakthrough status by the FDA in February.

8th July 2014

From: Research, Sales

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