The Big Biopharma firm reported a downcast third quarter yesterday, with total revenue dropping 16% on the same period 2013 to $4.9bn (€3.9bn) and net profit taking a 41% hit to $707m. Lilly attributed the decline to the effect of recent patent expirations but said its clinical pipeline would drive future growth.
One product it hopes will make a dent in the glargine insulin market is its biosimilar of the blockbuster product Lantus which last year contributed $5.8bn to Sanofi's topline. The product, known as Abasria in Europe and Basaglar in the US, is a treatment for Type 1 and Type 2 diabetes patients and has been co-developed with Boehringer Ingelheim.
In Q3, Abasria became the first insulin biosimilar to receive the green light from the EU’s Committee for Medicinal Products for Human Use (CHMP) after it found it to “have a comparable quality, safety and proficiency profile to Lantus,” while stateside the US Food and Drug Administration (FDA) granted the product tentative approval, subject to the result of litigation filed by Sanofi, which is claiming patent infringement.
Discussing opportunities in a conference call yesterday (transcript here), President of Lilly Diabetes Enrique Conterno said “there is a very significant opportunity” but Lilly would be competing against both Sanofi and other companies, such as Novo Nordisk, looking for a share in the a long-acting (basal) insulin market.
“We clearly are not the only one that are coming [but] we are maybe the first that will be entering the marketplace,” he told investors.
“Clearly for us, we like our chances because we do have the commercial footprint, the expertise in diabetes and the very extensive manufacturing capacity and devices to make sure that we can provide an excellent customer experience and go toe-to-toe with Sanofi.”
Launch and network investments
As for the launch date, CEO John Lechleiter said “Lilly and Boehringer Ingelheim will launch [their] insulin glargine product based on dates that do not infringe valid and enforceable patents,” adding that in the US the “FDA may not give final approval until mid-2016 unless the court determines the patent is not infringed or is invalid or unenforceable prior to that time.”
Abasria/ Basaglar would compete against both Lantus and Novo Nordisk’s Levemir and Tresiba, while Merck & Co is also developing a “Lantus look-alike” – as Timothy Anderson from Sanford Bernstein & Co described it on the call – with its product MK-1293.
Lilly has invested heavily in its insulin manufacturing network since 2012 when the firm announced it was looking to double capacity without adding new plants or increasing its reliance on contract manufacturing organisations (CMOs) by 2017. Last year, the company pledged over $700m to sites in France, US, Puerto Rico and China. The evolution of Lilly’s pipeline to insulin and biologics is also behind the decision to shut a Puerto Rican plant, as announced last week.