The U.S. FDA Approves Soliqua(TM) 100/33 For The Treatment Of Adults With Type 2 Diabetes

Glostrup, Denmark, Nov. 22, 2016 (GLOBE NEWSWIRE) -- Company announcement - No. 46 / 2016

 

The U.S. FDA approves Soliqua(TM) 100/33 for the treatment of adults with type 2 diabetes
  • FDA approval triggers a $25 million milestone payment and double-digit percentage royalties of net sales of Soliqua(TM) to Zealand 
  • Sanofi plans to make Soliqua(TM) available in U.S. retail pharmacies in January 2017
  • Zealand management will host a teleconference on Tuesday 22 November at 4pm CET

Copenhagen, 22 November 2016 - Zealand Pharma (Zealand) announced today that Sanofi has received  U.S. Food and Drug Administration (FDA) approval for Soliqua(TM) 100/33 (insulin glargline and lixisenatide injection) 100 Units/mL and 33 mcg/mL for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide (Adlyxin TM).

Soliqua TM 100/33 will be delivered in a single pre-filled pen for once-daily dosing covering 15 to 60 Units of insulin glargine 100 Units/mL and 5 to 20 mcg of lixisenatide using SoloSTAR ® technology, the most frequently used disposable insulin injection pen platform in the world. [1] Soliqua TM 100/33 will be available in U.S. retail pharmacies in January 2017.

Britt Meelby Jensen, President and Chief Executive Officer of Zealand commented:  " I am  very excited about FDA's approval of Soliqua(TM). The fixed-ratio combination of Lantus ® and lixisenatide is a new drug, that has proven to outperform its individual components.   The U.S. approval of Soliqua(TM) comes only 10 days after CHMP recommended approval of Suliqua(TM) in the EU, making November 2016 one of the most important months in the history of Zealand. Together with  lixisenatide, which was approved in the U.S. in July this year under the brand name Adlyxin(TM), we expect substantial  revenue growth in the years to come. This gives us the financial strength to deliver on our strategy to develop our own product candidates, glepaglutide and dasiglucagon all the way to registration".

Elias Zerhouni, M.D., President, Global R&D, Sanofi commented: "Sanofi continues to be a pioneer in developing diabetes therapies and in bringing forward new treatment options for the approximately 50 percent of patients whose blood sugar levels remain uncontrolled on daily basal insulin. Soliqua 100/33 is an alternate new approach that can help adults living with type 2 diabetes uncontrolled on basal insulin or lixisenatide to reach their treatment goal. "

Soliqua TM 100/33 is the combination of Lantus ® (insulin glargine 100 Units/mL) and lixisenatide, a GLP-1 receptor agonist, in a once-daily injection, studied in a Phase 3 program of more than 1,900 patients. In an insulin intensification study, Soliqua TM 100/33 showed better HbA1c (average blood sugar over time) lowering versus Lantus ® with a majority of the 736 patients (55% vs. 30%) achieving the American Diabetes Association target of less than 7% at 30 weeks. Patients treated with Soliqua TM 100/33 experienced similar rates of documented (<70 mg/dL) hypoglycemia compared to Lantus ®-treated patients.

CHMP positive opinion recommending Suliqua TM in the EUEarlier in November, 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 the coming months. 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).

Conference call on Tuesday, 22 November 2016 at 4 pm CET / 10 am EDT Zealand's senior management will host a conference call Tuesday, 22 November at 4 pm CET to give an update on the implications for Zealand. Participating in the call will be Britt Meelby Jensen, President and Chief Executive Officer, Mats Blom, SVP and Chief Financial Officer and Adam Steensberg, SVP and Chief Medical and Development Officer. The presentation will be followed by a Q&A session.

The conference call will be conducted in English and the dial-in numbers are: