Real-World Study Shows Promising Efficacy, Safety of Ropeg in MPN

Time Magazine: PharmaEssentia – The Formula for Success

Milestone Magazine : A Healthy Business – Ko-Chung Lin

KO-CHUNG LIN / FOUNDER & CEO PHARMAESSENTIA

In 2003, PharmaEssentia was established with the express aim of developing effective and safe pharmaceutical products for the treatment of human diseases. Ko-Chung Lin is one of its founders and is continuing to drive the company’s expansion and success throughout the globe.

The 80s were heady days for Taiwan. Along with Korea, Hong Kong and Singapore, it was known as one of the Four Asian Dragons, emerging economies that boomed during this era. Ever since the Taiwanese government has looked to the future, and how best to establish the country as a pioneer in a diversified portfolio of industries. One potential answer was biotech, an opportunity spearheaded by Dr. Fu-Kuen Lin, the inventor of EPO at Amgen. This produced PharmaEssentia, a fully integrated global biopharmaceutical company, established to deliver efficient, safe and cost-effective therapeutic products for the treatment of human diseases. It was founded in 2003 by a group of Taiwanese-American executives and high-ranking scientists from leading U.S. biotechnology and pharmaceutical companies, including Dr. Ko-Chung Lin, who explained:

“Fu-Kuen Lin saw an opportunity in the biotech industry some 25 years ago and was invited back to Taiwan for further talks. He thought, if we could get sufficient funding and attract some of the world’s best scientists, we would be able to help not only Taiwan but push the industry forward globally.”

In 2002, after two decades working as a scientist in the U.S. with companies like Biogen, Ko-Chung returned to his native Taiwan to lobby for funding. Knowing, like his co-founder, that it would be the key ingredient to the success of their operation.

“As the focus shifted from electronics, we saw a gap in the market. The government was really behind us, as it was trying to promote biotech as a major industry rivalling electronics.”

But the government went a lot further than just promising to back the industry, it also invested in education, training and funding, supporting the entire ecosystem to create tremendous opportunities.

“Biotech is much more science-driven than electronics, involving a lot of uncertainty and the unknown,” says Ko-Chung. “The success rate is low. With this in mind, we knew that to increase the success rate of our company and reduce the risk of failure, we would have to pursue an integrated biotech company, together with government involvement.”

Landing the government on side was imperative to provide assurance to private investors and, consequently, PharmaEssentia was able to secure an additional 60 per cent of funding. Markets, such as manufacturing, usually produce a result in three to five years, but in biotech, it can take 10 to 15 years, at least, before you can expect to see any sort of return. Ko-Chung and his co-founders were certain they had the talent and ingenuity to bring PharmaEssentia to life.

The company is committed to the improvement of health and quality of life for patients suffering from diseases such as myeloproliferative neoplasms, hepatitis and the like, working from a world-class cGMP biologics facility in Taichung. It has even developed a game-changing drug candidate called Ropeginterferon alfa-2b (P1101) to treat blood cancers, such as Polycythemia Vera. Additionally, the company was also granted the rights from business partner Kinex to sell Oraxol in certain Asian countries – an oral formulation of paclitaxel, a chemotherapy agent commonly used in first-line treatment for breast cancer. PharmaEssentia has found that Oraxol dramatically reduces the side effects experienced with paclitaxel, and Ko-Chung and his team are exploring the drug in relation to breast cancer – the leading cause of cancer death in women.

Milestone Magazine https://milestonemagazine.com/a-healthy-business-ko-chung-lin/

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.

ForbesCustom https://www.forbes.com/custom/2019/07/15/taiwan-a-bright-future/#pharmaessentia-on-the-road-to-product-launch

PharmaEssentia and AOP Orphan Receive Positive CHMP Opinion For Besremi™ (Ropeginterferon alfa-2b) For Treatment Of Polycythemia Vera (PV) In EU

https://www.prnewswire.com/news-releases/pharmaessentia-and-aop-orphan-receive-positive-chmp-opinion-for-besremi-ropeginterferon-alfa-2b-for-treatment-of-polycythemia-vera-pv-in-eu-300767190.html

WALTHAM, Mass., Dec. 17, 2018 /PRNewswire/ — PharmaEssentia, a global biopharmaceutical company focused on developing and commercializing novel treatments for treatment of rare diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Besremi, intended for the treatment of polycythaemia vera without symptomatic splenomegaly. The applicant for Besremi is AOP Orphan Pharmaceuticals AG (AOP Orphan).

“This is a big step for PharmaEssentia and our effort to develop and bring ropeginterferon to patients with PV,” said Kochung Lin, PhD, Chief Executive Officer of PharmaEssentia. “In addition to the positive CHMP opinion, we are in on-going discussions with the FDA on the best path forward to make ropeginterferon alfa-2b available to patients in the US. At the same time, we are also discussing with respective authorities in China and Japan how to proceed to make Ropeg available for patients with PV in these countries as well.”

Besremi will be available as a solution for injection (250 microgram/0.5 ml and 500 microgram /0.5 ml). The active substance of Besremi is ropeginterferon alfa-2b which is manufactured in the Taichung Science Park, Taiwan under PIC/S cGMP. The site was GMP certified by EMA in January 2018.

The benefits of Besremi are its ability to achieve complete hematological responses in patients with polycythaemia vera. The most common side effects are leukopenia, thrombocytopenia, arthralgia, fatigue, flu-like illness and myalgia.

Detailed recommendations for the use of Besremi will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorization has been granted by the European Commission (EC). If approved by EC, the marketing authorization for Besremi will be granted in all European Union (EU) member states, Norway, Iceland, and Lichtenstein.

The positive CHMP opinion is based on the comprehensive data package from the PROUD-PV/CONTINUATION-PV clinical development program, which was sponsored by AOP Orphan. PharmaEssentia out-licensed the exclusive rights to develop and commercialize ropeginterferon alfa-2b to AOP Orphan in PV, other MPNs, and CML for European, Commonwealth of Independent States (CIS), and Middle Eastern markets.

 

About Ropeginterferon alfa-2b

Ropeginterferon alfa-2b is a novel, long-acting, predominately (>98%) single isomer mono-pegylated proline interferon (ATC L03AB15) with improved pharmacokinetic properties and demonstrated tolerability and convenience. It is administered once every 2 weeks, or once every 4 weeks during long-term maintenance, and is expected to be the first interferon approved for PV worldwide.

Ropeginterferon alfa-2b was discovered and is manufactured by PharmaEssentia in a Taichung plant, which was cGMP certified by EMA in January 2018.

Ropeginterferon alfa-2b has Orphan Drug designation for treatment of PV in the European Union, Switzerland, and the United States of America.

 

About Polycythemia Vera

Polycythemia Vera (PV) is a cancer originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells, and platelets. This condition may result in cardiovascular complications such as thrombosis and embolism, as well as transformation to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2.

 

About PharmaEssentia

PharmaEssentia Corporation (Taipei Exchange:6446) is a global biopharmaceutical company delivering efficacious, safe and cost-effective therapeutic products for the treatment of human diseases while aiming to bring long lasting value to stakeholders. PharmaEssentia was founded in 2003 by a group of Taiwanese-American executives and high-ranking scientists from leading U.S. biotechnology and pharmaceutical companies in order to develop treatments for myeloproliferative neoplasms, hepatitis and other diseases. The company is committed to the improvement of health and quality of life for patients suffering from these diseases. The Company’s world-class cGMP biologics facility in Taichung was certified by the EMA in January 2018 and by the Taiwan Food and Drug Administration (TFDA) in December 2017. The Taichung plant is also designed and operated to be compliant with all US FDA requirements.

 

Contact

PharmaEssentia Corporation
13F, No.3, YuanQu St., NanKang Dist.,Taipei 115, Taiwan
Shan Chi Ku, Director of Business Development and Investor Relations
e-mail: ShanChi_Ku@pharmaessentia.com
Telephone: +886-2-2655-7688 #7836