Breakthrough Clinical Results
Biofrontera Inc. announced the acquisition of all US assets related to Ameluz® and RhodoLED®, including the NDA and associated patents, from Biofrontera AG. This acquisition, funded by an $11 million investment, significantly reduces royalty payments from 25-35% to 12-15% of net sales. The restructuring allows Biofrontera Inc. greater control over commercialization and operations in the US dermatology market, aiming for quicker profitability. The company also plans an upcoming FDA submission for the treatment of superficial basal cell carcinoma.
Key Highlights
- Acquisition of all US rights to Ameluz® and RhodoLED® from Biofrontera AG.
- $11 million investment to fund the acquisition and transition.
- Reduced royalty payments from 25-35% to 12-15% of net sales.
- Upcoming FDA submission for the treatment of superficial basal cell carcinoma.
Drug used in other indications
Clinical Trials of Ameluz® Beyond Actinic Keratosis
Based on the available information, there is no specific data about Ameluz® photodynamic therapy clinical trials for indications other than actinic keratosis.
While photodynamic therapy using aminolevulinic acid (ALA) has been studied for various conditions, the provided context does not contain explicit information about Ameluz® brand specifically being trialed for other indications.
The context does not provide details about any intervention models, treatment protocols, or study designs for Ameluz® trials beyond actinic keratosis applications.
Without specific information in the provided context about clinical trials of Ameluz® for non-AK indications, no further details can be provided regarding the queries.
Economic Burden
Economic Burden of Treating Actinic Keratosis in USA and Europe
Actinic keratosis (AK) represents one of the most commonly treated skin conditions in outpatient settings, characterized by high prevalence and an increasing incidence rate. This growing prevalence has significant economic implications in both the United States and European healthcare systems.
United States Economic Burden
In the United States, the direct cost of managing actinic keratosis was estimated at $US1.2 billion per year, with additional indirect costs totalling $US295 million (based on 2004 values). The primary drivers of cost in AK management were identified as physician office visits and their associated procedures.
European Economic Burden
Spain
A Spanish study evaluated treatment costs for patients with hyperkeratotic actinic keratosis, finding that treatment with 5-FU/SA cost €266 while cryotherapy treatment cost €285 (in 2014 euros).
Netherlands
Research from the Netherlands provided a comprehensive breakdown of total mean costs for different AK treatments over a 12-month post-treatment period: - 5-fluorouracil (5-FU): €433 - Imiquimod (IMQ): €728 - Ingenol mebutate (IM): €775 - Methyl aminolaevulinate photodynamic therapy (MAL-PDT): €1621
The Netherlands study concluded that 5-FU was a dominant cost-effective treatment compared to alternatives, being both more effective and less expensive than other treatment options.
Germany
In Germany, actinic keratosis represented 8.3% of the hundred most frequently treated dermatological outpatient diagnoses in 2011. The proportion of AK cases has shown an almost continuous rise over the past decade compared to other dermatological conditions. The estimated annual number of AK cases documented by German dermatologists is approximately 1.7 million.
Current State of Research
It's worth noting that pharmacoeconomic research in the field of actinic keratosis treatment is described as being "in its infancy." To develop more comprehensive economic analyses, research needs to focus on several key areas: - Updating epidemiological data - Evolving evidence-based standards - Delineating cost drivers in both immunocompetent and immunocompromised populations - Health outcomes assessment
These findings highlight the substantial economic impact of actinic keratosis treatment across different healthcare systems and point to the need for continued research to optimize treatment approaches from both clinical and economic perspectives.