Sanofi defended its experimental drug Lyxumia after some scientists questioned the medicine’s novelty at a diabetes conference.
Lyxumia isn’t “at all” an imitation of Bristol-Myers Squibb Co.’s Byetta, Pierre Chancel, who heads Sanofi Diabetes, said yesterday in Berlin, where he attended the European Association for the Study of Diabetes conference. The drug is “as effective as Byetta with one injection a day, super simple to use and super safe,” he said in an interview.
Sanofi needs to show Lyxumia helps patients who suffer from the most common form of diabetes, known as type 2, control the level of sugar in their blood with one injection a day to gain an edge over Byetta, which requires two shots, and other drugs from the same class. At the conference this week, participants questioned whether Lyxumia really requires only one shot.
“One concern is that it is not a once-daily drug and the regulators may pick on that,” Sam Fazeli, an analyst for Bloomberg Industries in London, wrote in e-mailed comments after attending the Lyxumia presentation at the meeting. Others wondered whether Lyxumia is too similar to Byetta, even beyond the question of how often it’s administered.
The drugs both belong to a class known as GLP-1 analogues, which mimick the function of a digestive hormone that stimulates the pancreas to produce insulin after meals. Diabetics lack the insulin they need to convert blood sugar into energy.
‘Vital for Sanofi’
If regulators approve Lyxumia, also known as lixisenatide, it will probably be the fourth GLP-1 to enter the market. Sanofi also makes Lantus, a best-selling insulin that could be used in combination with Lyxumia.
“Lyxumia is taking time to clearly stand out,” Eric Le Berrigaud, an analyst at Bryan Garnier & Co. in Paris, wrote in a Sept. 28 note. “It is vital for Sanofi to successfully launch Lyxumia in order to build on and around Lantus.”
Discussions with regulators about the new medicine are moving ahead, according to Chancel. The filing is “well advanced” and dosing “isn’t an issue,” he said. The treatment causes less nausea than Byetta, Chancel said.
The combination with Lantus is the most promising use of Lyxumia, according to analysts. When patients use the two together, “benefit is everywhere,” Chancel said.
In early studies, Lyxumia was tested both as a once-daily and as a twice-daily treatment, with no difference in blood-sugar reduction, Riccardo Perfetti, who heads medical affairs at Sanofi’s diabetes unit, said in Berlin.
A panel recommendation from European Union regulatory advisors is expected this quarter, according to David Solomon, chief executive officer of Zealand Pharma A/S, the Danish company from which Sanofi licensed Lyxumia. The U.S. regulatory filing is scheduled for December, he said in an interview.
Solomon said that late-stage tests of Lyxumia in combination with Lantus using a new pen device called “fix-flex” will start by the middle of next year.
Lyxumia works differently from other GLP-1s once inside the body, according to Solomon.
“Physicians figure out pretty fast which patient needs what medicine,” he said. “We like the fact that medicines are differentiated, simply because that’s how you address individual patient needs and that’s where medicine is going.”