- Sanofi is moving towards re-submission of lixisenatide (Lyxumia(r)) for US regulatory approval in July 2015
- LixiLan to be based on the prefilled SoloSTAR(r) pen platform, allowing for coverage of wide Lantus(r) dosing needs and clinically relevant dosing of Lyxumia(r)
COPENHAGEN, Denmark, June 9, 2015 (GLOBE NEWSWIRE) -- Zealand Pharma A/S ("Zealand") (Nasdaq Copenhagen: ZEAL) informs that Sanofi, in an IR Thematic Conference Call on Diabetes today, gave an update on its plans for Lyxumia(r) (lixisenatide) and LixiLan.
Lixisenatide is a prandial once-daily GLP-1 agonist invented by Zealand. Global development and commercial rights are out-licensed to Sanofi (SANF.PA) which is marketing the product worldwide, ex-US, as Lyxumia(r) for the treatment of Type 2 diabetes. LixiLan, the once-daily single injection combination of Lyxumia(r) and Lantus(r) (insulin glargine) is in clinical Phase III development. The enrolment of > 1,900 patients with Type 2 diabetes into two Phase III trials has been completed and the results are expected in Q3 2015.
On the call, Sanofi stated that lixisenatide is being prepared for US regulatory submission in July 2015, which is in the early part of its earlier informed timetable of Q3 2015.
Sanofi also informed that LixiLan will be based on the pre-filled SoloSTAR(r) pen platform with dosing flexibility to cover wide insulin glargine needs of up to 60 units of daily dosing and clinically relevant daily lixisenatide dosing of up to 20 mug.
Furthermore, Sanofi highlighted the results shown from the Phase IIb clinical Proof-of-Concept study of LixiLan (24 weeks, 323 patients with Type 2 diabetes): Robust reduction in blood glucose with an HbA1c reduction from 8.1% to 6.3% and 84% of patients reaching the target HbA1c of < 7%, of which 46% had no weight gain and no documented hypoglycemia.
Britt Meelby Jensen, President and CEO of Zealand, commented on the update: "We are very pleased to see the recent advances for Lyxumia(r) and LixiLan and the dedication Sanofi is putting behind these two products. We are proud to be the inventors of lixisenatide (Lyxumia(r)) and we believe that both Lyxumia(r) and LixiLan represent attractive therapies for Type 2 diabetes and revenue potential for Zealand."
For further information, please contact:
Britt Meelby Jensen, President and Chief Executive Officer
Tel: +45 51 67 61 28, email: firstname.lastname@example.org
Hanne Leth Hillman, Senior Vice President, Investor Relations & Communications
Tel: +45 50 60 36 89, email: email@example.com
About Zealand Pharma
Zealand Pharma A/S ("Zealand") (Nasdaq Copenhagen: ZEAL) is a biotechnology company based in Copenhagen, Denmark. Zealand has leading expertise in the discovery, design and development of novel peptide medicines and possesses in-house competences in clinical trial design and management with a therapeutic focus on metabolic diseases and acute care indications. The company is advancing a proprietary pipeline of novel medicines alongside a partnered product and development portfolio.
Zealand's first invented medicine, lixisenatide, a once-daily prandial GLP-1 agonist for the treatment of Type 2 diabetes, is marketed globally (ex-US) as Lyxumia(r) and in Phase III development as a single-injection combination with Lantus(r) (LixiLan), both under a global license agreement with Sanofi. US regulatory filing for Lyxumia(r) is planned for Q3 2015 and filing for LixiLan is planned for Q4 2015 in the US and Q1 2016 in Europe.
Zealand's proprietary pipeline includes danegaptide (prevention of Ischemic Reperfusion Injury) and two stable glucagon products, ZP4207 (treatment of severe hypoglycemia and of mild to moderate hypoglycemia) as well as several preclinical peptide therapeutics. Partnering represents an important component of strategy to leverage in-house expertise, share development risk in large clinical trials, provide funding and commercialize the company's products. Zealand currently has global license agreements and partnerships with Sanofi, Helsinn Healthcare and Boehringer Ingelheim.
For further information: www.zealandpharma.com Follow us on Twitter @ZealandPharma
Source: Zealand Pharma A/S