Adrulipase alfa is a Recombinant Enzyme owned by First Wave BioPharma, and is involved in 6 clinical trials, of which 5 were completed, and 1 is planned.

Adrulipase alfa enhances the functioning of the pancreas in pancreatic exocrine insufficiency. Lipase is an enzyme that the body uses to break down fats. Bile breaks down the large fat molecule to tiny droplets which provide lipase with an enormously increased surface to work on. This action takes place in the small intestine and the lipase involved here is a part of the pancreatic secretion.

The revenue for Adrulipase alfa is expected to reach a total of $166m through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Adrulipase alfa NPV Report.

Adrulipase alfa was originated by Laboratoires Mayoly Spindler and is currently owned by First Wave BioPharma.

Adrulipase alfa Overview

Adrulipase alfa is under development for the treatment of exocrine pancreatic insufficiency (EPI) in patients with chronic pancreatitis (CP) and cystic fibrosis (CF). It is administered as a oral capsule. The therapeutic candidate is an autologous Yarrowia lipolytica recombinant lipase. It is developed based on recombinant DNA technology. It was also under development for the treatment of malabsorption syndrome.

First Wave BioPharma Overview

First Wave BioPharma, formerly AzurRx BioPharma, is a development-stage biopharmaceutical company that focuses on non-systemic biologics for the treatment of patients with gastrointestinal disorders. The company’s products under development include MS1819 a non-systemic yeast recombinant enzyme intended for the treatment of exocrine pancreatic insufficiency exocrine (EPI) in patients with cystic fibrosis (CF) and chronic pancreatitis (CP). MS1819 completed the phase IIa trial in partnership with Mayoly which is a European Pharmaceutical company. Its pre-clinical products include AZX1103 and AZX1101 which is a recombinant beta-lactamases enzyme for the prevention of nosocomial (hospital-acquired) infections and antibiotic-associated diarrhea. The company has operations in France and the US. First Wave BioPharma is headquartered in Brooklyn, New York, the US.

The operating loss of the company was US$59.1 million in FY2021, compared to an operating loss of US$26.8 million in FY2020. The net loss of the company was US$58.5 million in FY2021, compared to a net loss of US$32.7 million in FY2020.

Quick View – Adrulipase alfa

Report Segments
  • Innovator
Drug Name
  • Adrulipase alfa
Administration Pathway
  • Oral
Therapeutic Areas
  • Gastrointestinal
Key Companies
Highest Development Stage
  • Phase II

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, potential applicable patients, drug margins, company expenses, and pricing estimates. 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 rNPV, 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.