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European Launch Imminent After CHMP OK for Lixisenatide


By Cormac Sheridan
Staff Writer

Zealand Pharmaceuticals A/S is set to join what is still an all too select club of European biotechnology firms with a product approval under their belts.

On Friday, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended for approval its once-daily glucagon-like peptide 1 (GLP-1) agonist Lyxumia (lixisenatide, AVE0010) for treating Type II diabetes.

The drug is recommended for "treatment of adults with Type II diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control," according to the EMA's summary of the CHMP opinion.

Formal European Commission approval should follow after 67 days, paving the way for a European launch early next year. Partner Sanofi SA also is lining up an FDA filing in December, which, all going well, could lead to a U.S. market launch in late 2013.

Friday's positive news does not trigger any milestone payment from Sanofi to Copenhagen, Denmark-based Zealand, but it can still take in $215 million in development and commercial milestones, including $40 million for a depot formulation of Lyxumia. It will also earn royalties on product sales.

The product will be pitched into a growing but highly competitive market, which was further heated up by the recent $7 billion joint acquisition of Amylin Pharmaceuticals Inc., by Bristol-Myers Squibb Co. (BMS) and AstraZeneca plc. (See BioWorld Today, July 5, 2012.)

They are now pitting Amylin's GLP-1 agonists Byetta (exenatide) and its extended-release equivalent Bydureon against the top-selling GLP-1 agonist, Novo Nordisk A/S's Victoza (liraglutide), which racked up DKK6.786 billion (US$1 .2 billion) in sales during the first nine months of 2012.

Zealand and Sanofi also have Victoza in their sights. "We've done a head-to-head study against Victoza. We've shown we have better post-prandial glucose lowering," Zealand Pharma CEO David Solomon told BioWorld Today.

"There are definitely some differences between the two profiles of the drugs," Thomas Bowers, analyst at Danske Equities in Copenhagen, told BioWorld Today.

Lyxumia's optimal setting, according to Zealand, is as part of a combination with Lantus (insulin glargine), Sanofi's long-acting basal insulin product, which is used by 4 million diabetics and which attained €3.625 billion (US$4.6 billion) in sales for the nine months to Sept. 30. "We've got this unique positioning, which is a good way to begin the [marketing] effort," Solomon said.

"Sanofi will be able to get its share of the market. The question remains, how much that will end up being?"

Jefferies analyst Peter Welford offered some numbers. "We expect worldwide sales of once-daily GLP-1 [agonists] to approach $4 billion by 2018, with convenient once-weekly forms potentially catapulting the market to over $6 billion. Our bullish stance reflects encouraging Victoza launch dynamics. Assuming a 20-25 percent once-daily GLP-1 market share for Lyxumia, we forecast $900 million peak sales," he wrote in a research note.

A combination pen device, LixiLan, which delivers Lyxumia and Lantus together, is undergoing a Phase III trial, with data due around mid-2013. "That will be very important," Bowers said. "We are quite conservative on standalone [sales]."

As part of its U.S. Phase III program, Lyxumia is undergoing a cardiovascular safety study, to take account of new FDA guidelines for GLP-1 agonists. Its safety and tolerability profile appears similar to other members of its class, with transient nausea, vomiting and diarrhea among the most common side effects.

Other safety issues, according to the EMA, including hypoglycemia when Lyxumia was administered in combination with a sulphonylurea and/or basal insulin and headache. Allergic reactions were reported in 0.4 percent of patients on the drug.

Investors had long expected a positive decision, so Zealand's stock (COPENHAGEN:ZEAL) edged down slightly on Friday, to DKK103 (US$17.59), a loss of DKK1.50.

Jefferies has a 'buy' rating on the stock, with a target price of DKK140. Danske Equities also has a 'buy' recommendation.