Exploring Bile Acid Therapeutics with Roger Viney (DCAT Week)

Roger Viney, chief commercial officer at ICE Pharma, sat down with Grant Playter, associate editor, to discuss the history and current use of bile acid therapeutics.

Pharmaceutical Technology: Can you explain for our audience what exactly bile products are? What is the market like?

Roger Viney: Bile acids have been used for thousands of years in traditional Chinese medicine. It was not until the 1970’s that ursodexoycholic acid (UDCA) was prescribed in western medicine. The last 20 years have seen a huge growth of medicinal research in bile acids. As recently as 1999 the scientific community recognised that bile acids are metabolic regulators—and this opened a whole new area of research into bile acid based medicines.

UDCA represents ICE Pharma’s most important API, as this is a key active ingredient in drugs treating liver and gallbladder diseases. Our range of products also includes cholic acid, deoxycholic acid, chenodeoxycholic acid, their salts and taurine and glycine conjugates, which find diverse uses from nutraceuticals to excipients and APIs.

PharmTech: Can you talk a little bit about ICE Pharma’s recent publication with the Ferrier Research Institute concerning treatments for Parkinson Disease?

Viney: Recent research has revealed the role of bile acids as metabolic regulators and uncovered their potential to treat a variety of diseases. It was discovered in 1999 bile acids and their salts act as hormones and are essential in the homeostasis of metabolic activities. This makes bile acids an excellent class of molecules to target metabolic conditions such as type 2 diabetes, obesity, and nonalcoholic fatty liver disease.

Bile acids are now shown to act on a number of nuclear receptors and it is becoming clear that bile acid signalling properties are complex and extend beyond that of FXR and TGR5, where most of current bile acid research has been conducted. One growing area of interest for bile acids is with neurodegenerative disease where UDCA is showing promising results in current clinical studies.

One of the research papers with the Ferrier Institute, to which we contributed, relates to Parkinson’s Disease. Mitochondrial dysfunction is a well-documented mechanism in both sporadic and familial Parkinson’s Disease. UDCA has been identified as a bile acid which leads to increased mitochondrial function in multiple in vitro and in vivo models of Parkinson’s Disease. Our study indicates that modified novel bile acid molecules could lead to the development of more efficacious bile acids which increase mitochondrial function and ultimately cellular health so proving attractive potential novel therapeutics for Parkinson’s Disease.

PharmTech: Last year, ICE Pharma acquired an API manufacturing site from Mitsubishi in Japan. Can you talk a bit about the strategy behind this decision? What factors led you to acquire a site in that region specifically?

Viney: Tokyo Tanabe, who became Mitsubishi Tanabe, was the originally developer of UDCA in Japan in the 1950’s and since that time the benefit of UDCA in treating a range of diseases has been recognised worldwide. The Iwaki manufacturing unit is a high-quality facility with a long heritage of stable supply focusing on Japan. The Japanese and wider Asian demand for UDCA is large and increasing and the integration of the Iwaki facility and its employees into the ICE manufacturing network helps us strengthening the company’s position by providing it with a fourth UDCA API facility and a base in Asia.

Under the new ownership, and by taking advantage of ICE’s expertise, the new facility continued and improved delivery of our UDCA API. The acquisition of the Iwaki plant is a fantastic occasion to provide customers with further capacity and to strengthen ICE’s position as a global bile acids player.

PharmTech: Taken from a 10,000 ft. level, what is your perspective on the state of the global bio/pharma market?

Viney: The big talking point I have noticed at DCAT are the problems with pricing in the US market for the generic drug product manufacturers. The consolidation of the distribution channel to three main players in the US has led to an imbalance in the distribution of the value from the business. The drug product manufacturers have seen further price erosion recently and face additional business risks of late delivery penalties and unsold stock returns. Many companies that had previously been focused on the US and filing new ANDAs are looking at new markets particularly in Asia. These changes may not be in the long-term interests of the US patients.

PharmTech: Do you have any bold predictions on where the bio/pharma industry will be a year from now? How about ten?

Viney: In 2022 we saw Amylyx launch the first treatment for motor neuron disease based on a bile acid. I am expecting to see that the large amount of scientific research into bile acids will lead to further discoveries of their biological functions and potential to treat diseases. lCE Pharma has developed a library of over 500 novel bile acid compounds that we expect to license to partners who will bring these molecules through clinical trials and ultimately to market.

For more of our coverage on DCAT in 2023, viewers can visit this page.