Sanofi's experimental drug Lyxumia has performed well in late-stage clinical trials in patients with diabetes, lending further weight to its case for regulatory approval.
According to late-stage data unveiled at the European Association for the Study of Diabetes (EASD) congress in Berlin this week, when given alongside other diabetes therapies Lyxumia (lixisenatide) can slow the process of gastric emptying, and thereby lower blood sugar after a meal.
In addition, results from the GetGoal Duo and GetGoal-L2 studies showed that a combination with basal insulin, plus oral antidiabetic agents (such as metformin), significantly reduced levels of HbA1c in people with type II diabetes, the firm said.
"Taken together, the results from the GetGoal Duo 1 and GetGoal-L trials, as well as lixisenatide’s significant effect on gastric emptying and post-prandial glucose, support the clinical rationale for the potential use of our investigational GLP-1 receptor agonist in combination with basal insulin to improve glycemic control,” said Pierre Chancel, senior VP of global diabetes at Sanofi.
Sanofi will no doubt be pleased with the results, given that it is due to file for the drug's approval in the US in December, while European regulators are already considering its marketing application following a submission in November last year.
Lyxumia is a once-daily GLP-1 receptor agonist discovered by the Danish firm Zealand Pharma, and Sanofi will be hoping that, if approved, the drug will help cushion the blow from the loss of patent protection for some of its key products, such as its blood thinner Plavix (clopidogrel) and cancer drug Taxotere (docetaxel).
In a research note late last year, brokers at Jefferies noted that the combo "represents a paradigm shift in type II diabetes treatment", and forecast peak sales of $1.3 billion.
Sanofi buys Colombian firm
Meanwhile, Sanofi also announced that it has signed an agreement to buy Colombian drugmaker Genfar SA, helping give it a stronger foothold in the Latin American market.
Genfar is the second largest generic company in sales and leader in units in Colombia, and the group has a commercial presence in Venezuela, Peru, Ecuador and ten other countries in Latin America.
The group generated sales of $133 million last year, with 30% coming from outside of the country - financial details of the agreement, which is due to close in the first quarter of next year, were not revealed.
