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Zealand announces that Sanofi has submitted LixiLan for regulatory review in the US, triggering a USD 20 million milestone payment

  • The regulatory submission is an important step towards potentially making LixiLan available as a new treatment option for adult Type 2 diabetes patients in the US
  • Sanofi has redeemed a Priority Review Voucher for LixiLan, which will shorten the regulatory review time from 10 months to 6 months, if the FDA accepts the submission
  • Including the USD 20 million payment from Sanofi, milestone revenue to Zealand in 2015 amounts to EUR 21 million, in accordance with the financial guidance
  • All pipeline development milestones outlined by Zealand for achievement in 2015, have now been successfully met

COPENHAGEN, Denmark, Dec. 23, 2015 (GLOBE NEWSWIRE) -- Zealand announced that today, Sanofi confirmed that it has submitted a New Drug Application (NDA) for LixiLan to the US Food and Drug Administration (FDA).

LixiLan is an investigational single-injection, fixed-ratio combination of lixisenatide and insulin glargine for the treatment of Type 2 diabetes. Insulin glargine, marketed globally by Sanofi as Lantus(r), is the world-wide most prescribed basal insulin product for the treatment of diabetes. Lixisenatide is a once-daily prandial GLP-1 receptor agonist, invented by Zealand and with global development and commercial rights out-licensed to Sanofi. Lixisenatide is marketed outside the US by Sanofi as Lyxumia(r) for the treatment of Type 2 diabetes. In the US, the FDA accepted Sanofi's NDA for lixisenatide in September 2015 with a regulatory decision expected in Q3 2016 in accordance with the standard FDA review time.

As part of the US submission of LixiLan, Sanofi has redeemed a Priority Review Voucher. This means that if the FDA accepts the NDA, the regulatory review time for the product will be shortened to 6 months from the standard 10 months. A regulatory submission of LixiLan in Europe is expected by Sanofi in Q1 2016.

Commenting on the submission of LixiLan in the US, Britt Meelby Jensen, President and CEO of Zealand, said: "This milestone represents an important step towards potentially introducing LixiLan as a promising new combination medicine for Type 2 diabetes patients in the US. Sanofi's decision to redeem a Priority Review Voucher on LixiLan is a sign to us on how valuable they consider the product to be. For Zealand, today's news brings us closer to a potential significant revenue growth based on US royalties.

"I am pleased to confirm that all the pipeline and business milestones we set out to achieve in 2015, have now been successfully met, and the USD 20 million milestone payment from Sanofi strengthens our financial position as we move into 2016. We will continue to focus on advancing our pipeline of novel proprietary medicines to accelerate value creation for patients and our shareholders, and we foresee another year with a strong activity level and substantial news flow."

The US NDA submitted for the LixiLan combination includes results from two pivotal Phase III trials; LixiLan-L and LixiLan-O, which included 1,906 patients with Type 2 diabetes. Positive top-line results from the two trials demonstrate that LixiLan significantly lowers three-month average blood sugar levels (HbA1c) compared to both insulin glargine and lixisenatide. The proprietary name for the fixed-ratio combination is under consideration. Its safety and efficacy have not been evaluated by any regulatory authority.

Financial guidance for 2015 and terms of the license agreement with Sanofi

The submission of a US NDA for LixiLan is associated with a USD 20 million (EUR 18 million) milestone payment from Sanofi to Zealand. With this payment, Zealand has realized milestone revenue from license partners of DKK 159 million (EUR 21 million) in 2015, in line with its revenue guidance. On top of milestone payments, Zealand receives royalty revenue on Sanofi's sales of Lyxumia(r) outside the US which amounted to DKK 20.6 million (EUR 2.7 million) for the first nine months of 2015.

2015 full year net operating expenses are expected to be in the high end of a range of DKK 225-235 million (EUR 30-32 million).

The global license agreement with Sanofi covers lixisenatide (Lyxumia(r)) and any combination products, which include lixisenatide. Under the terms of the agreement, Sanofi is responsible for all development and commercialization including the financing, and Zealand is eligible to receive progress-driven milestone payments and royalties on global sales. Remaining milestone payments amount to USD 140 million, while royalties correspond to tiered, low double-digit percentages of Sanofi's global sales of lixisenatide plus a fixed low double-digit percentage of the global full net sales of LixiLan.

For further information, please contact:

Britt Meelby Jensen, President and Chief Executive Officer
Tel: +45 51 67 61 28, email: bmj@zealandpharma.com

Hanne Leth Hillman, Senior Vice President, Investor Relations and Communications
Tel: +45 50 60 36 89, email: hlh@zealandpharma.com

About Zealand Pharma

Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a biotech company with leading-edge scientific expertise in turning peptides into medicines. Zealand has a growing proprietary pipeline of novel specialty drug candidates and a mature portfolio of products and projects under license collaborations with Sanofi, Helsinn Healthcare and Boehringer Ingelheim.

Zealand's first invented medicine, lixisenatide, a once-daily prandial GLP-1 analogue for the treatment of Type 2 diabetes, is marketed globally (ex-US) as Lyxumia(r) by Sanofi and under regulatory review in the US. The license agreement with Sanofi covers also LixiLan, which is a single-product combination of lixisenatide and insulin glargine (Lantus(r)). LixiLan has been submitted for regulatory review in the US and regulatory submission is expected in the EU in Q1 2016.

The proprietary pipeline includes; danegaptide for ischemic reperfusion Injuries in Phase II development; ZP1848 for Short Bowel Syndrome in Phase II development; and the stable glucagon analogue, ZP4207, in Phase II preparation both as a single-dose rescue pen for severe hypoglycemia and for multiple-dose use to treat and control mild to moderate hypoglycemia; ZP2929 for diabetes/obesity in Phase I; as well as several preclinical peptide therapeutics.

The company is based in Copenhagen (Glostrup), Denmark. For further information about Zealand's business and activities, please visit: www.zealandpharma.com or follow us on Twitter @ZealandPharma

Source: Zealand Pharma A/S