Lannett Company (LCI) announced that the first human study evaluating insulin glargine, a long-acting insulin used to treat adults with Type 2 diabetes, as well as adults and pediatric patients with Type 1 diabetes for control of high blood sugar, produced positive results. Developed in accordance with strategic alliance partners within the HEC Group of companies (HEC), they are establishing the data and momentum to support the biosimilarity of glargine to the reference drug, Sanofi’s Lantus.®
According to one analyst firm, the market for global human insulin drugs will grow at nearly 5% from 2018 to 2023 and that already last year this market was pegged at $24 billion. Only a handful of producers control this market today, such as Eli Lilly, Sanofi and Novo Nordisk.
Diabetes is the driver for the demand of these products. It represents a growing public health concern in America and worldwide. Insulin therapy represents a cornerstone of diabetes therapy, and the use of basal insulins will increase as clinicians seek to help their patients reach glycemic goals. Study results reveal long-acting basal insulin analogs, such as glargine and detemir, exhibit pharmacokinetic and pharmacodynamic benefits over neutral protamine Hagedorn insulin, such as less variable absorption profiles, less pronounced peak in effect and longer duration of action.
This clinical trial was the first such study in humans to directly compare the Lannett/HEC insulin glargine to U.S. Lantus® as part of the effort to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for this biosimilar product. The clinical trial was a single center, single-dose, double-blind, randomized, two-period crossover study, comparing the PK/PD of the Lannett/HEC-insulin glargine to U.S. approved Lantus, after a single, subcutaneous dose in 27 healthy male adult human volunteers. The trial also assessed the safety profile of the Lannett/HEC-insulin glargine to U.S. approved Lantus after a single subcutaneous dose. According to Lannett, the sponsor, in its press release the study met all of its primary endpoints.
As announced back in the summer, the trial was conducted at a facility in South Africa and is the first clinical study to directly compare the Lannett/HEC insulin glargine to Lantus as part of the effort to file a biosimilar BLA within the FDA.
What is Glargine?
Insulin glargine is a long-acting insulin used to treat adults with Type 2 diabetes, as well as adults and pediatric patients with Type 1 diabetes, for the control of high blood sugar.
Who is China-based HEC?
Based in China, HEC is a holding company and Lannett is engaged with one of its subsidiaries or holdings called YiChang HEC ChangJiang Pharmaceutical Co. Ltd. They have developed a proprietary process for manufacturing the insulin protein and plan on building a dedicated facility for the manufacture of the insulin product for multiple markets worldwide.
In 2016, the two entered into an alliance to co-develop a generic insulin pharmaceutical product for the U.S. market. The deal established that Lannett would manage the clinical and regulatory steps needed for a BLA to market the product. The Northeast Philadelphia generic drug company possesses the exclusive U.S. marketing rights.
The Alliance—co Develop an Insulin Biosimilar
They forged ahead with five underlying collaborative projects, which back then included the development of certain undisclosed products and a distribution agreement. Recently, the two parties updated their alliance with some additional terms. They disclosed that Lannett would pay development costs for up to $32 million and would share an additional product development costs in excess of $32 million with HEC at a 50/50 split for up to the next $13 million.
Kristin Arnold, PhD, vice president of research and development for Lannett reports the case for biosimilarity of insulin glargine to the reference drug (Lantus) is gaining momentum based on an impressive and significant volume of supporting data. Ms. Arnold emphasized the safety profile with no serious adverse events or serious drug reactions associated with the dug during the study. She conveyed importantly that “In summary, the Phase I study, conducted in healthy volunteers, confirmed that biosimilar glargine matches the reference biologic in terms of pharmacokinetics (PK) and pharmacodynamics (PD).” Phase I studies are typically early stage trials accomplished for primarily safety data.
Generic insulin affords the generic producer the opportunity to tap into a multi-billion dollar market—insulin.