Business Model

After successfully completing two Phase II clinical trials and demonstrating the efficacy and effectiveness of the new drug for sepsis treatment, reducing both mortality and hospital stay, Pharmamel is now in the final phase of the Phase III clinical trial, preparing for subsequent commercialization and licensing.

Regarding the data, sepsis is the leading cause of hospital death worldwide, with an annual registration of 50 million cases resulting in 12 million deaths. One in every five deaths globally is related to sepsis, and many survivors face significant long-term complications.

The incidence of sepsis is increasing, with an annual increase of 1.5%, attributed to the lack of adequate treatment and the growing resistance to antibiotics, which in turn increases mortality rates.

Pharmamel's goal is to complete the Phase III clinical trial within approximately 48 months and obtain drug approval from the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA), followed by licensing to the pharmaceutical industry.

Competitive advantage

Currently, there are no specific treatments for sepsis that control the exaggerated inflammatory response and prevent multiorgan failure, perpetuating a high mortality rate.

The primary treatment for sepsis involves the use of antibiotics to combat the infection and fluid therapy to restore blood pressure and prevent multiple organ failure. However, these measures are insufficient to address this epidemic and reduce high mortality, particularly due to the increasing antibiotic resistance.

Scalability

The economic scalability of Pharmamel's intravenous melatonin treatment presents itself as a promising solution in the battle against sepsis, standing out for its ability to reduce the need for intensive and prolonged hospital resources. This innovative approach not only directly benefits patients by improving clinical outcomes but also alleviates the economic burden associated with managing this devastating illness.

One of the most significant aspects of this therapy is its potential to decrease hospital stays, leading to a reduction in healthcare costs and the utilization of hospital resources. Furthermore, by improving clinical outcomes and potentially reducing mortality associated with sepsis, Pharmamel's intravenous melatonin treatment offers an additional benefit to the healthcare system by reducing disease burden and related expenses.

The adoption of this innovative solution not only positively impacts patients and healthcare system efficiency but also has broader economic implications. The reduction in costs associated with sepsis could translate into significant long-term savings for healthcare systems and society as a whole.

The scalability of Pharmamel's intravenous melatonin treatment presents a unique opportunity for expansion into other markets, supported by its ability to adapt to various clinical settings and healthcare systems. Approval by various regulatory bodies will not only enable its commercialization in multiple regions but also consolidate its presence internationally, offering an innovative and effective solution in the fight against sepsis.