Lannett Casts Regulatory Doubts For Its Insulin Glargine Product
$LCI
Biotechnology: Pharmaceutical Preparations
Health Care
- Lannett Company Inc (NYSE:LCI) is facing continued competitive pressures related to its current portfolio and evaluating options to establish a sustainable capital structure.
- The company is in discussions with some secured creditors regarding a potential recapitalization or restructuring of its capital structure. It expects to be able to reach an agreement in the near term.
- Concurrently, Lannett announced that the pivotal trial of biosimilar insulin glargine demonstrated positive results, in line with prior expectations.
- The company is co-developing this product with its strategic alliance partners within the HEC Group of Companies (HEC).
- The crossover study was designed to demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity between Lannett/HECs biosimilar insulin glargine and US-Lantus using the euglycemic clamp technique in healthy male adult volunteers.
- The study met all its primary and secondary endpoints and reported no serious adverse events.
- Lannett is moving forward expeditiously to complete the Biologics License Application, intending to apply to the FDA within the next several months.
- Significant steps are necessary for the company to receive FDA approval to commercialize this product effectively, and there is no guarantee that the company will succeed.
- Lannett continues to assess the potential impacts of recent insulin market developments, including manufacturers' announcements related to lowering the price of insulin for patients, especially list prices, and enhancing market transparency.
- Price Action: LCI shares are down 49.47% at $0.95 on the last check Tuesday.