Zealand Pharma Reports Sanofi Announces Soliqua(TM) 100/33 Now Available in the U.S

In the labeled clinical trial, once-daily Soliqua 100/33 demonstrated statistical superiority for the change in HbA1c from baseline to week 30 p®, the most prescribed basal insulin in the world.1,2,3. Soliqua 100/33 is delivered in a single pre-filled SoloStar pen with a dose range covering from 15 to 60 Units and two starting doses to support patients' insulin needs. Soliqua 100/33 was approved by the U.S. Food and Drug Administration (FDA) on 21 November, 2016. The Wholesale Acquisition Cost (WAC) price of Soliqua 100/33 is $127 for a 300 Unit pen, which equals $19.90 per day at the average final dose of 47 Units used in the labeled clinical trial.

Sanofi is offering Soliqua 100/33 at a $0 co-pay for eligible U.S. patients with commercial insurance and is working to secure coverage for Soliqua 100/33 on health plans nationwide. In November 2016, Sanofi received a positive opinion from the Committee for Medicinal Product for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of Suliqua(TM) (brand name in Europe). A formal decision by the European Commission is expected in this quarter and will trigger a $10 million milestone payment to Zealand.

Once approved, Sanofi will make Suliqua(TM) available in the EU in two pre-filled SoloSTAR® pens (10-40 SoloSTAR® pen and 30-60 SoloSTAR® pen). Under the terms of the license agreement between Sanofi and Zealand, which covers lixisenatide and any combination product that includes lixisenatide, Sanofi is responsible for all development and commercialization including the financing. The FDA approval of Soliqua 100/33 by the U.S.FDA triggered a milestone payment of $25 million to Zealand, which was received in December 2016 as planned.

Zealand is eligible to receive remaining milestone payments of up to $110 million as well as royalties on global sales. Royalties correspond to tiered, low double-digit percentages of Sanofi's global sales of Adlyxin(TM)/Lyxumia® plus a fixed low double-digit percentage of global net sales of Soliqua 100/33 /Suliqua(TM).