Novo Nordisk announced Jan. 20 it received approval for Victoza (liraglutide) from Japan's Ministry of Health, Labor and Welfare for type 2 diabetes and hopes to launch Japan's first glucagon-like peptide-1 agonist in the first half of 2010 - pending pricing negotiations for National Health Insurance reimbursement.

Once-daily liraglutide is used as a monotherapy or as an add-on to sulphonylurea and could soon have competition in Japan's GLP-1 agonist space.

Formal price negotiations take 60-90 days from the date of regulatory approval. The Japanese pricing system relies on two methods: the comparator method awards price premiums based on mechanism of action, efficacy and safety, and other measures of therapeutic usefulness; the cost-plus method calculates manufacturing costs, distribution costs and other administrative costs. Novo Nordisk told PharmAsia News it is currently preparing its Victoza pricing application, but has not determined which method will be used.

Eli Lilly's twice-daily GLP-1 analog Byetta (exenatide) is pending MHLW approval, and Chugai Pharmaceutical - in partnership with Teijin Pharma - announced plans last month to enter Phase III trials in 2010 for GLP-1 agonist taspoglutide, a once-weekly injection. Chugai parent company Roche released positive top-line results for taspoglutide; the study met the primary endpoint of non-inferiority to exenatide and showed a superior reduction in HbA1c levels after 24 weeks of treatment.

Liraglutide's Japanese approval must come as a relief for Novo Nordisk. Victoza's U.S. approval date remains unclear after missing its March 23, 2009 PDUFA date and receiving a split vote from an advisory committee review on whether a thyroid cancer signal in rodents should block approval; the company is expecting formal feedback within weeks (Also see "Victoza's Regulatory Limbo Could End Shortly " - Pink Sheet, 30 December, 2009.).

Currently, Byetta is the only GLP-1 agonist approved in the U.S.

Novo Nordisk received marketing authorization June 30 for Victoza in Europe, and launched in Germany, the U.K., Denmark, Ireland and Norway.

Byetta and Victoza also will likely face off in China's 13 million-patient diabetes market, where high-end product share is already dominated by Novo Nordisk and Lilly. Byetta was launched in August, and Victoza's approval is pending (Also see "Lilly Launches Byetta In China To Target World's Second Largest Diabetes Market" - Scrip, 31 August, 2009.).

Lilly is hoping to boost flat Byetta sales with approval of a once-weekly exenatide injection. The company announced Dec. 15 positive results from a head-to-head study comparing the once-weekly injection to the twice-daily version to support ex.-U.S. regulatory submissions. Patients on once-weekly exenatide experienced a statistically superior reduction in HbA1c of 1.6 percent from baseline compared to a 0.9 percent reduction for twice-daily exenatide patients.

In the third quarter, U.S. sales of Byetta declined 5 percent to $171.1 million compared to the third quarter of 2008. Worldwide sales for the third quarter of 2009 were up 2 percent to $205.7 million, buoyed slightly by ex-U.S. sales of $34.6 million.

Regardless of competition, the launch of Victoza expands the share of the diabetes market that GLP-1 takes, which will increase with more global approvals, according to Novo Nordisk.

"Not only are we catching in on Byetta, but we are actually together expanding the market toward the 3 percent level of overall diabetes care," Novo Nordisk CFO Jesper Brandgaard said during an Oct. 30 third-quarter earnings call.

On the same day as the Victoza approval, Japanese regulators also approved three Novartis drugs: Equa (vildagliptin) - marketed as Galvus in the EU - for type 2 diabetes, Exforge (valsartan/amlodipine) for high blood pressure, and Afinitor (everolimus) for advanced kidney cancer.

- Daniel Poppy (d.poppy@elsevier.com)

[Editor's note: This article appears courtesy of PharmAsiaNews.com, F-D-C Reports' new site for Asian biotech and pharmaceutical news. Register for a 30-day risk free trial.]

Novo Nordisk's Victoza Gains First Japanese GLP-1 Approval

More from Japan

More from Asia