By Mark Terry, BioSpace.com Breaking News Staff
Copenhagen, Denmark-based Zealand Pharma announced today that it had submitted a New Drug Application (NDA) for its drug LixiLan to the U.S. Food and Drug Administration (FDA).
As part of a licensing deal with Paris-based Sanofi , the submission triggers a $20 million milestone payment to Zealand.
“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 $20 million (U.S.) milestone payment from Sanofi strengthens our financial position as we move into 2016,” said Meelby Jensen, president and chief executive officer of Zealand, in a statement. “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.”
LixiLan is an injectable fixed-ratio combination of lixisenatide and insulin glargine to treat Type 2 diabetes. Insulin glargine is marketed worldwide by Sanofi as Lantus. Lixisenatide is a prandial GLP-1 receptor agonist, which was developed by Zealand. Sanofi holds the commercial out-licenses for the drug.
Lixisenatide is currently marketed outside the U.S. by Sanofi as Lyxumia.
In addition to the milestone payments, Sanofi has redeemed a Priority Review Voucher with the FDA. What this means is that if the FDA accepts the NDA, the regulatory review time will be cut from a typical 10 months to six months. LixiLan is also being submitted in Europe by Sanofi in the first quarter of 2016.
On Nov. 5, 2015, Sanofi signed a licensing deal with Seoul, South Korea-based Hanmi Pharmaceutical Co., Ltd. worth $4.2 billion to develop several diabetes treatments. This deal allows Sanofi to choose worldwide rights to develop and commercialize three drugs, including efpeglenatide, a long-acting glucagon-like peptide-1 receptor agonist (GLP1-RA), a weekly insulin medication, and a fixed-dose weekly GLP-1 RA/insulin drug combination.
Analysts note that Sanofi’s diabetes business has been struggling. In October, Sanofi cut its sales forecast for diabetes drugs in the next three years. Much of this is related to a slump in Lantus sales. Bloomberg has projected that Sanofi’s diabetes sales will probably decrease from 4 to 8 percent through 2018. Lantus lost patent protection earlier this year and faces generic competition in Europe from Eli Lilly and Company (LLY).
The deal with Hanmi focuses on long-acting treatments for diabetes, an area that Eli Lilly and Novo Nordisk are very active in, as well as Biodel . Michael Novod, an analyst with Nordea, told Reuters that the Sanofi-Hanmi deal was “very bad news” for Zealand Pharma. It might also be behind Sanofi’s willingness to turn in a Priority Review Voucher, to eke out every bit of profitability it can from LixiLan before it gets battered by other products currently in its pipeline.
“This milestone represents an important step towards potentially introducing LixiLan as a promising new combination medicine for Type 2 diabetes patients in the U.S.,” said Jensen in a statement. “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 U.S. royalties.”
