Forbes Asia: PharmaEssentia – On the road to product launch CHMP Recommended Granting Marketing Authorization For Ropeginterferon

Since 1984, the number of biotechnology companies listed on the Taiwan Stock Exchange has gone from precisely zero to more than 100, with a combined value of US$25 billion.

The government in Taipei can take some of the credit for this after identifying the industry as the next Big Thing to promote after its success in establishing the island as a center of excellence and innovation for the semiconductor manufacturing sector; but so too can the cohort of scientists and entrepreneurs who have provided the skill and the commercial acumen that has seen Taiwan established as an engine room for an industry that is not just making a significant contribution to the island’s economy but is also helping improve the health and the quality of life of millions of people around the world.

One of the Taiwanese diaspora to respond to Taipei’s clarion call was PharmaEssentia’s CEO Ko-Chung Lin. In 2003, he joined a team of Taiwanese-American executives and high-ranking scientists from leading U.S. biotechnology and pharmaceutical companies who decided to come back home to launch a company dedicated to the development of drugs designed to treat myeloproliferative neoplasms (MPNs), such as polycythemia vera (PV), essential thrombocythemia (ET), myeloid fibrosis (MF) and chronic myeloid leukemia (CML), as well as hepatitis and cancer.

“I chose to set up the company here rather than in the U.S. because Taiwan is probably the best place in the world in which to raise capital for a biotech company,” Ko-Chung explains. It was the right call. The company’s 2016 IPO raised more than US$100 million and immediately propelled PharmaEssentia into the top half of Taiwan’s league of biotech companies.

That could be just the beginning. Earlier this year, the European Commission (EC) announced that it had given marketing approval for Besremi® (ropeginterferon alfa-2b). Developed in conjunction with AOP Orphan Pharmaceuticals, Besremi® is indicated as monotherapy in adults for the treatment of polycythemia vera without symptomatic splenomegaly. Following the EC ruling, it is now the only such treatment available to PV sufferers across most of Europe.

For Ko-Chung, it makes all the blood, sweat and occasional tear that he and his colleagues have shed on the way worthwhile. “We have conceptualized an idea and turned it into a reality,” he beams. “I have been a scientist for 40 years and it is the dream of anybody in my profession to find themselves in this position. It is very rewarding.”

Ko-Chung is only too aware, however, that the hard work has only just begun. “The challenge for us now is to explain to our investors that even having met the milestone of gaining EC approval for Besremi®, making money from it will not happen overnight, and we still need their support to carry us through the initial marketing stages. Two other firms in this sector found themselves in a similarly great position of having an approved drug with a lot of potential recently, but their shares plunged because their cashflow did not immediately rise. I learned a lot from their experiences, and we try to give our shareholders as much precise information as possible so that they understand our plan and potential.”

The next step for PharmaEssentia is to strengthen its U.S. presence. The company already has a second-line PV reference drug (given to patients after they have been previously treated with another drug) and is looking for FDA approval to be classified as a first-line option. According to Ko-Chung, the PharmaEssentia’s product has the potential to treat 4.5 times more patients than the current drug of official choice.

With the assistance of its office in Boston, the company is going to expand indication for BESREMI® to include ET and is currently in talks with the FDA
to conduct a Phase 3 clinical trial. Ko-Chung expects development and rollout to take another three years or so, giving it access to a segment of the healthcare worth between US$5 billion and US$10 billion. It will also be marketed in Taiwan, Japan, Korea and China.

Another drug for Hepatitis B patients is also in the later stages of development and more innovations and discoveries will surely follow. “We are humble and we continue to learn. This is why our success rate in discovering new drugs is so high,” says Ko-Chung.