Copenhagen, 2014-02-06 08:46 CET (GLOBE NEWSWIRE) -- Company Announcement
No. 3/2014
| Zealand informs that Sanofi has announced initiation of the LixiLan Phase III clinical program for the Fixed-Ratio combination of Lantus ® and Lyxumia ® |
- The Phase III program comprises two studies, LixiLan-O and LixiLan-L, and is planned to enroll a total of 1,825 Type II diabetes patients
- FDA submission of the Fixed-Ratio combination of Lantus ® and Lyxumia ® is targeted for late 2015
- Zealand also reports Lyxumia ® sales based royalty revenue for Q4 2013
Copenhagen, 6 February 2014 – Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) informs that Sanofi (EURONEXT: SAN and NYSE: SNY) in its Q4 2013 earnings released today, announced that the clinical Phase III development program for LixiLan has been started.
LixiLan is the Fixed-Ratio combination of Sanofi’s Lantus ® (insulin glargine), the world-wide most prescribed basal insulin, and Lyxumia ® (lixisenatide), administered as single daily injection via a disposable pen. The Phase III program comprises two studies; LixiLan-O, evaluating the Fixed-Ratio combination of Lantus ® and Lyxumia ® in 1,125 patients insufficiently controlled on oral antidiabetics drugs (OADs), and LixiLan-L, evaluating LixiLan in 700 patients not at target on basal insulin.
Commenting on the start of Phase III studies for LixiLan by Sanofi, David Solomon, President and Chief Executive Officer of Zealand, said: “We are extremely excited about the confirmed start of the LixiLan Phase III program for the Fixed-Ratio combination of Lyxumia ® and Lantus ® , representing a significant milestone for Zealand. With today’s news, the LixiLan development program is on track to defining the path of this potentially important diabetes medicine towards regulatory and commercial stages. In the US, regulatory submission for LixiLan is targeted for late 2015, leaving the potential for it to be the first fixed-ratio combination of basal insulin and a GLP-1 RA in one daily injection to reach the market in the U.S. We look forward to future advances in the program.”
Lyxumia ® (lixisenatide), a once-daily prandial GLP-1 receptor agonist invented by Zealand and licensed globally to Sanofi, was launched in the first markets in Europe in March 2013. Since then, Sanofi has been rolling-out the product commercially country by country, and Lyxumia ® is now available in several countries, including the UK, Germany, Spain, Japan and Mexico. Sales based royalty revenue to Zealand for Q4 2013 was DKK 3.2 (EUR 0.43) million , an increase of 40% over Q3 2013. For 2013, royalty revenue amounts to DKK 6.5 (EUR 0.85) million.
The Fixed-Ratio combination of Lantus ® and Lyxumia ® has been evaluated by Sanofi in a Phase IIb study versus Lantus ® alone for its effect on glycemic control, as measured by HbA1c (glycosylated hemoglobin) reduction over 24 weeks, in Type 2 diabetic patients treated with metformin . The study was completed in 2013 and publication of the results is expected in connection with a medical congress later in 2014.
The first study protocol for the LixiLan Phase III program was approved in January 2014, which triggered a previously announced milestone payment of USD 15 million to Zealand from Sanofi. The confirmed start of the Phase III studies is fully in line with announced expectations of a start in Q1 2014.
Financial result and outlook
Zealand will announce its Full Year results and Annual Report for 2013 on 20 March 2014. In this connection, the company will also publish its financial outlook for 2014.
Under the license agreement with Sanofi, covering lixisenatide (Lyxumia ® ) and any combination products including lixisenatide, Zealand is eligible to up to USD 160 million in remaining milestones. Further, Zealand is entitled to tiered low double-digit percentage royalties on Sanofi's global sales of Lyxumia ® and fixed low double-digit percentage royalties on global full net sales of the LixiLan combination product.
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For further information, please contact:
David H. Solomon, President and Chief Executive Officer
Tel: +45 2220 6300
Hanne Leth Hillman, Vice President and Head of IR & Corporate Communications
Tel: +45 5060 3689, email: hlh@zealandpharma.com
About Zealand
Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) is a biotechnology company based in Copenhagen, Denmark. Zealand specializes in the discovery, optimization and development of novel peptide drugs and has a broad and mature pipeline of drug candidates identified through its own drug discovery activities. The company’s focus lies in the field of cardio-metabolic diseases, diabetes and obesity in particular, and its lead drug invention is lixisenatide, a once-daily prandial GLP-1 agonist, which is licensed to Sanofi for the treatment of Type 2 diabetes. Lixisenatide (marketed by Sanofi as Lyxumia ® ) is approved in several countries, including Europe and Japan, and under regulatory review in a number of other countries globally. In the U.S., an NDA is planned to be submitted in 2015, after completion of the ELIXA Cardiovascular outcome study.
Zealand has a partnering strategy for the development and commercialization of its products and in addition to the license agreement with Sanofi in Type 2 diabetes, the company has partnerships with Boehringer Ingelheim in diabetes/obesity, Lilly in diabetes and obesity, Helsinn Healthcare in chemotherapy induced diarrhea and AbbVie in acute kidney injury.
For further information: www.zealandpharma.com
