Ampligen is an oligonucleotide commercialized by AIM ImmunoTech, with a leading Phase III program in Chronic Fatigue Syndrome (Myalgic Encephalomyelitis). According to Globaldata, it is involved in 32 clinical trials, of which 15 were completed, 8 are ongoing, 6 are planned, and 3 were terminated. GlobalData uses proprietary data and analytics to provide a complete picture of Ampligen’s valuation in its risk-adjusted NPV model (rNPV). Buy the model here.

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The revenue for Ampligen is expected to reach an annual total of $145 mn by 2034 globally based off GlobalData’s Expiry Model. The drug’s revenue forecasts along with estimated costs are used to measure the value of an investment opportunity in that drug, otherwise known as net present value (NPV). Applying the drug’s phase transition success rate to remaining R&D costs and likelihood of approval (LoA) to sales related costs provides a risk-adjusted NPV model (rNPV). The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress.

Ampligen Overview

Ampligen is under development for the treatment of pancreatic cancer, HER positive breast cancer, metastatic triple negative breast cancer, colorectal cancer, HIV/AIDS infections, peritoneal cancer, pancreatic ductal adenocarcinoma, metastatic adenocarcinoma of the pancreas, melanoma, urothelial cancer, prostate cancer, long COVID complications such as COVId-19 induced myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS), post COVID -19 cognitive dysfunction (PCCD) and Ebola viral infections. The drug candidate is administered by intravenous, intraperitoneal and nasal routes. It is a synthetic derivative of inosinic acid with antiretroviral and immunomodulatory activities. Ampligen (poly I: poly C12U) is a synthetic specifically configured double-stranded RNA containing regularly occurring regions of mismatching. It acts by targeting toll like receptor 3. The drug candidate is developed based on proprietary technology.
It was also under development for the treatment of avian influenza (Japan, Canada), Ebola viral infections, West Nile virus infection, virus Zika infections, ovarian cancer, HIV infections, renal cell carcinoma, metastatic melanoma, severe acute respiratory syndrome and non-small cell lung cancer.

AIM ImmunoTech Overview

AIM ImmunoTech, formerly Hemispherx Biopharma, is an immuno- pharma company. The company focuses on the research and development of therapeutics for the treatment of multiple types of cancers, viruses and immune-deficiency disorders. Its flagship products include Ampligen (rintatolimod) sterile solution which is indicated for the treatment of patients with chronic fatigue syndrome; and Alferon N Injection used for the treatment of refractory or recurrent external condylomata acuminate. The company’s pipeline products are intended to treat various types of cancers, including ovarian, breast, colorectal, melanoma, renal cell carcinoma, pancreatic, bladder cancers, MERS and influenza virus. The company operates a production facility in New Brunswick, New Jersey. AIM ImmunoTech is headquartered in Ocala, Florida, the US.

For a complete picture of Ampligen’s valuation, buy the drug’s risk-adjusted NPV model (rNPV) here.

This content was updated on 24 July 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, drug margins and company expenses. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate valuation, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA) and phase transition success rate (PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.