Copenhagen, 2013-09-12 07:50 CEST (GLOBE NEWSWIRE) --
─ Sanofi’s decision is not related to safety issues or deficiencies in the NDA, and resubmission is planned for 2015
─ Lixisenatide sales continue unaffected post approvals in the EU, Japan, Mexico and Australia
─ The LixiLan product, the investigational fixed-ratio combination of lixisenatide and Lantus®, remains on schedule to enter Phase III development in H1 2014
Zealand Pharma (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) informs of Sanofi’s (EURONEXT: SAN and NYSE: SNY) decision, as announced earlier today, to withdraw the New Drug Application (NDA) for lixisenatide in the U.S. and resubmit in 2015 after completion of the ongoing ELIXA cardiovascular (CV) outcome study.
The NDA filed for lixisenatide was accepted for review by the U.S. Food and Drug Administration (FDA) in February 2013, including early interim results from the ELIXA study. The decision by Sanofi to withdraw the application follows discussions with the FDA regarding the authorities’ proposed process for the review of these interim data. It is Sanofi’s belief that potential public disclosure of interim data, even with safeguards, could potentially compromise the integrity of the entire ELIXA study of up to 6,000 patients, as it is still ongoing. The withdrawal of the NDA by Sanofi is thus not related to any safety issues or deficiencies in the NDA.
The ELIXA study continues as planned and has been fully enrolled. Sanofi expects complete study results to be available in early 2015, and based on this time frame has concluded that the most appropriate option is to supplement the FDA’s evaluation of lixisenatide based on the complete results of the ELIXA study rather than on interim data.
The investigational LixiLan combination product, the fixed-ratio combination of lixisenatide and Lantus®, is unaffected by the postponement of the U.S. NDA for lixisenatide and remains on schedule to commence Phase III development in the first half of 2014.
Sanofi are confident that existing data from the international GetGoal program, which involves more than 5,000 patients with type 2 diabetes, establish the current positive benefit-risk profile of lixisenatide.
"Sanofi's decision to withdraw the application for lixisenatide in the US and resubmit in 2015 including full results from the important ELIXA CV safety study does not affect sales of the product outside of the U.S. Zealand has a solid cash position and we foresee continued commercial roll-out of Lyxumia in 2013 and 2014 in Europe, Japan and elsewhere, where approval has been granted. We note that the decision is voluntary and not a result of any FDA action nor related to safety concerns and we support Sanofi's view that the integrity of the ongoing full ELIXA study should not be put at risk by making interim results publicly available," said David Solomon, CEO and President of Zealand, and he continued; “Highly important is also to note that the timelines and Sanofi’s commitment to start Phase III studies with the LixiLan combination product are unaffected and reconfirmed.”
Financial guidance for 2013
Zealand’s expectations to receive revenues in 2013 from royalties on sales of lixisenatide (Lyxumia®) in regions where the product has been approved, including Europe, Japan, Mexico and Australia remain unchanged. As Sanofi has given no guidance on the expected sales of Lyxumia® and the timing of potential milestone payments from collaboration partners is uncertain, no more specific revenue guidance can be provided at this point in time.
Expectations of net operating expenses in 2013 at a range of DKK 210-240 (EUR 28-32) million are unaffected of Sanofi’s withdrawal and postponement of the NDA for lixisenatide in the U.S.
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: email@example.com
About the ELIXA Study
The Evaluation of LIXisenatide in Acute coronary syndrome (ELIXA) study is an ongoing event-driven cardiovascular (CV) outcomes study in patients with high CV risk (i.e., patients who recently experienced an acute coronary event.) The global ELIXA study started in June 2010. The target enrollment was 6,000 patients and, as of August 2013, the study is fully enrolled. Complete results should be available in approximately 15 months.
Lixisenatide is approved in Europe for the treatment of adults with type 2 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. Lixisenatide is also approved in Mexico, Australia and Japan for the treatment of adults with type 2 diabetes. Lyxumia is the proprietary name approved by the European Medicines Agency and other health authorities for lixisenatide.
Lixisenatide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) invented by Zealand for the treatment of patients with type 2 diabetes mellitus. Global rights to develop and commercialize the product are licensed to Sanofi. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.
About Zealand Pharma
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 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 CV 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.
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