Tesamorelin - Biologic Drug Details

Summary for tesamorelin

Tradenames:	2
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for tesamorelin Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for tesamorelin Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for tesamorelin Derived from Patent Text Search

No patents found based on company disclosures

Tesamorelin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: Tesamorelin

Introduction

Tesamorelin, a peptide therapeutic developed by Theratechnologies, has been a significant player in the treatment of excess abdominal fat in patients with HIV and lipodystrophy. Here, we delve into the market dynamics and financial trajectory of this biologic drug, highlighting its development, regulatory milestones, and financial performance.

Development and Mechanism of Action

Tesamorelin is designed to mimic the growth hormone-releasing factor, stimulating the pituitary gland to produce and release growth hormone. This hormone facilitates lipolysis, breaking down abdominal fat, which is a common issue in patients with HIV and lipodystrophy[1].

Regulatory History

Initial Approval

Tesamorelin first received FDA approval in 2010 for the treatment of excess abdominal fat in HIV patients with lipodystrophy. This initial approval marked a significant milestone in the management of this condition[1].

Subsequent Formulations

In November 2018, the FDA approved the F4 formulation of tesamorelin, known as Egrifta SV, which is four times more concentrated than the original drug product. This formulation allowed for smaller administration volumes and has been the only FDA-approved treatment for reducing abdominal fat in HIV patients with lipodystrophy[1].

F8 Formulation

Theratechnologies has been working on an even more concentrated formulation, the F8 formulation, intended to further simplify dosing. However, the FDA issued a Complete Response Letter (CRL) in January 2024, citing issues with chemistry, manufacturing, and controls (CMC), as well as concerns about immunogenicity risk. Despite this setback, the company has resubmitted the supplemental Biologics License Application (sBLA) to address these concerns and expects a decision by the end of March 2025[1][4].

Market Impact

Patient Benefits

The F8 formulation, if approved, would offer patients a more convenient dosing regimen, reducing the frequency of injections and potentially improving adherence. This could enhance the quality of life for patients managing excess abdominal fat, a common complication in HIV treatment[4].

Competitive Landscape

Tesamorelin, particularly the Egrifta SV formulation, holds a unique position in the market as the only FDA-approved treatment for its specific indication. This exclusivity has contributed to its market presence and revenue generation for Theratechnologies[1].

Financial Performance

Revenue Trends

Theratechnologies has reported significant revenue from Egrifta SV. In the first quarter of Fiscal 2024, Egrifta SV sales were $9,586,000, although this represented a 24.6% decline from the same period in the previous year. The company's overall revenue for the first quarter of Fiscal 2024 was $16.2 million, with a net loss of $4,481,000[2].

Historical Revenue Growth

In Fiscal 2022, Theratechnologies reported a consolidated revenue of $80.1 million, representing a 15% growth from the previous year. The company has consistently aimed to achieve positive Adjusted EBITDA, with a focus on commercial growth and tighter budget controls[3].

Cost of Sales and R&D Expenses

The cost of sales for Egrifta SV has been affected by provisions related to the manufacturing of the F8 formulation, which has not yet been approved. In the first quarter of Fiscal 2024, the cost of sales included an $837,000 provision for this unapproved formulation. R&D expenses have also been significant, driven by the development of the oncology platform and other clinical trials[2][3].

Financial Guidance and Outlook

Fiscal 2024 Guidance

Theratechnologies has confirmed its revenue guidance for Fiscal 2024 between $87 and $90 million, with an Adjusted EBITDA range of $13-15 million. The company remains focused on achieving positive cash flow and value creation for shareholders through strategic commercial operations and potential acquisitions[2].

Future Prospects

The resubmission of the sBLA for the F8 formulation and the ongoing clinical trials in oncology and other areas position Theratechnologies for potential growth. The company's strategy includes expanding awareness and utilization of Egrifta SV and Trogarzo, as well as pursuing in-licensing, co-promotion, or product acquisitions to accelerate revenue growth[2][4].

Key Takeaways

• Regulatory Challenges: The F8 formulation of tesamorelin faces regulatory hurdles, but Theratechnologies is actively addressing these issues.
• Market Exclusivity: Egrifta SV remains the only FDA-approved treatment for reducing abdominal fat in HIV patients with lipodystrophy.
• Financial Performance: Revenue from Egrifta SV is significant, though affected by recent declines; the company aims for positive Adjusted EBITDA.
• Future Growth: The resubmission of the F8 formulation and ongoing clinical trials suggest potential for future revenue growth.

FAQs

What is tesamorelin and how does it work?

Tesamorelin is a peptide therapeutic that mimics the growth hormone-releasing factor, stimulating the pituitary gland to produce and release growth hormone, which facilitates lipolysis and breaks down abdominal fat.

What is the current regulatory status of the F8 formulation of tesamorelin?

The F8 formulation received a Complete Response Letter from the FDA in January 2024, citing issues with CMC and immunogenicity risk. Theratechnologies has resubmitted the sBLA to address these concerns.

How has the revenue from Egrifta SV performed in recent quarters?

In the first quarter of Fiscal 2024, Egrifta SV sales were $9,586,000, a 24.6% decline from the same period in the previous year.

What are the key financial goals for Theratechnologies in Fiscal 2024?

Theratechnologies aims for revenue between $87 and $90 million and an Adjusted EBITDA in the range of $13-15 million for Fiscal 2024.

What other products does Theratechnologies offer besides Egrifta SV?

Theratechnologies also sells Trogarzo (ibalizumab-uiyk), a long-acting injectable anti-CD4 monoclonal antibody approved for the treatment of HIV-1 in heavily pre-treated adults.

Sources

1. BioSpace: Theratechnologies Gets FDA Rejection for Concentrated Formulation of Tesamorelin.
2. Theratechnologies: Theratechnologies Reports Financial Results and Provides Business Update for First Quarter 2024.
3. BioSpace: Theratechnologies Reports Financial Results and Business Updates for the Fourth Quarter and Full Year Fiscal 2022.
4. Theratechnologies: Theratechnologies Submits Updated Tesamorelin F8 Formulation sBLA for FDA Review.