With Hopes of Bolstering Sanofi’s Sagging Diabetes Sector, Announces FDA Approval of Adlyxin in U.S.

Published: Jul 28, 2016

With Hopes of Bolstering Sanofi’s Sagging Diabetes Sector, Announces FDA Approval of Adlyxin in U.S. July 28, 2016
By Mark Terry, BioSpace.com Breaking News Staff

Paris-based Sanofi , long a leader in the diabetes market, announced that the U.S. Food and Drug Administration (FDA) had approved Adlyxin (lixisenatide) for type 2 diabetes.

Adlyxin is a GLP-1 receptor agonist that is injected once a day during mealtime. It comes in a pre-filled, disposable pen with a single dose of 20 micrograms. In addition, patients are given a disposable pre-filled pen with a 10-microgram dose that they use once a day for 14 days. On the fifteenth day, they shift over to the 20 microgram dosage.

The product is approved already under the name Lyxumia in more than 60 countries, and marketed in more than 40.

“The approval of Adlyxin reaffirms our continued commitment to addressing the challenges faced by people living with diabetes when trying to reach and maintain their individual blood glucose (HbA1c) targets,” said Peter Guenter, Sanofi’s executive vice president and head of Global Diabetes & Cardiovascular Business Unit, in a statement. “We are pleased with this approval, as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled.”

This is likely good news for Sanofi, whose dominant diabetes program has been weakening in recent years. Olivier Brandicourt, the company’s chief executive officer, announced a new strategy in November 2015, which including boosting the diabetes market, pushing into other markets, such as oncology, and spinning off its animal health unit, Merial, and its European generics business.

At that time, Alistair Campbell, an analyst at Bernberg Bank in London told BloombergBusiness, “Brandicourt is being realistic. He’s inherited this business that had a problem with the diabetes franchise before it arrived. He needs to move people on from the diabetes franchise and try to focus on the other growth areas.”

Those new areas included Praluent, its cholesterol drug, another insulin project, Toujeo, as well as Aubagio and Lemtrada for multiple sclerosis (MS). It inked a deal in August 2015 with Google/Alphabet’s Life Sciences (now dubbed Verily), to develop diabetes therapies and blood glucose monitors.

It is also notably involved in a hostile takeover bid for San Francisco’s Medivation . Medivation’s bright spark is Xtandi, a prostate cancer drug that in 2015 grew 73 percent in the U.S. and 116 percent globally. Medivation also has at least two more oncology drugs in its pipeline, pidilizumab for B-cell lymphoma and other blood cancers, and talazoparib for breast cancer. Talazoparib, in particular, has the potential to be a blockbuster. And Xtandi is well on its way.

As mentioned earlier, Sanofi’s diabetes sector has suffered in recent years. Its business is combined in Diabetes and Cardiovascular, but during the first quarter of 2015 that franchise’s revenues dropped by about 3.5 percent. The diabetes franchise alone dropped by 4.5 percent, primarily the results of decreased sales of Lantus in the U.S., but offset somewhat by the launch of Toujeo in Europe. Additional products in the franchise include Amaryl, Apidra, Insuman, Lyxumia, and various blood sugar monitoring products.

And one fairly recent disaster was Sanofi’s deal with Valencia, California-based MannKind Corporation . In early 2014, the FDA approved Afrezza, an inhaled form of insulin. Despite what would seem to be a great alternative to injections, sales didn’t meet sales expectations. Some of that was related to insurance reimbursement issues. After months of rumors, Sanofi terminated the license and collaboration deal with MannKind.

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