Lipocine's Partner Files New Drug Submission for TLANDO in Canada, Targeting 700,000 Annual TRT Prescriptions

Key Insights

• Verity Pharma, Lipocine's licensing partner, has filed a New Drug Submission for TLANDO in Canada, marking a key regulatory milestone for the first FDA-approved oral testosterone replacement therapy that requires no dose titration.
• The Canadian market represents a significant commercial opportunity with over 700,000 testosterone replacement therapy prescriptions written annually, approximately 50% covered by private insurance.
• Limited promotional activities for existing TRT options in Canada could provide TLANDO with an opportunity to capture substantial market share in this large and growing therapeutic area.

Lipocine Inc. announced that its licensing partner Verity Pharma has filed a New Drug Submission (NDS) for TLANDO in Canada, representing a significant regulatory milestone for the first and only oral testosterone replacement therapy approved by the US Food and Drug Administration that does not require dose titration.

The filing positions TLANDO to enter a substantial Canadian market, where over 700,000 prescriptions are written annually for testosterone replacement therapy (TRT), with approximately 50% of patients covered through private insurance. According to Mahesh Patel, CEO of Lipocine, "Canada represents an attractive market for TLANDO and the filing of the NDS by Verity Pharma represents an important next step in making the product available there."

Market Opportunity and Competitive Landscape

The Canadian TRT market presents unique advantages for TLANDO's potential market entry. Limited promotional activities surrounding currently available testosterone replacement therapies could provide an opportunity for TLANDO to capture a significant share of this large and growing market, according to the company's assessment.

Patel emphasized the commercial potential, stating, "We believe that, if approved, the introduction of this new and highly differentiated oral TRT option has the potential to drive significant market gains."

Partnership and Commercial Rights

In January 2024, Lipocine and Verity Pharma entered into an exclusive license agreement under which Verity Pharma gained the commercial rights to TLANDO in both the United States and Canada. This partnership structure allows Lipocine to leverage Verity Pharma's regulatory and commercial expertise in the Canadian market.

About TLANDO

TLANDO is approved by the US FDA as a testosterone replacement therapy in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). The therapy was developed using Lipocine's proprietary Lip'ral drug delivery technology platform.

The oral formulation represents a differentiated approach in the testosterone replacement therapy landscape, offering patients an alternative to traditional injection-based or topical treatments while eliminating the need for dose titration that characterizes other oral testosterone therapies.