GLOBAL BIOPHARMACEUTICAL INNOVATOR PHARMAESSENTIA LAUNCHES NEW TREATMENT BESREMi®️ FOR RARE BLOOD CANCER IN SINGAPORE

Mon, 09 Sep 2024 13:03:00 +0800

Singapore becomes first market in Southeast Asia to launch BESREMi®️, setting a new standard for rare disease care

Redefining Polycythaemia Vera (PV) care, BESREMi® is the only therapy approved by Singapore's Health Sciences Authority (HSA) for adults with PV, regardless of treatment history

SINGAPORE, Sept. 9, 2024 /PRNewswire/ -- PharmaEssentia Corporation (TWSE:6446), a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in haematology and oncology, proudly announces the availability of BESREMi® (ropeginterferon alfa-2b) in Singapore. The country is the first market in Southeast Asia to introduce this breakthrough therapy for Polycythaemia Vera (PV). The launch coincides with MPN (Myeloproliferative Neoplasms) Awareness Day on 12 September, highlighting PharmaEssentia's commitment to addressing unmet medical needs and advancing patient outcomes.

Advancing PV Treatment and Awareness

Polycythaemia Vera (PV) is a rare blood cancer characterised by the abnormal and uncontrolled growth of blood cells in the bone marrow. There are around 500 PV patients in Singapore and another 5,000 patients across the rest of Southeast Asia. The low level of awareness around PV complicates effective disease management, making MPN Awareness Day crucial for educating the public and healthcare professionals about PV, its impact, the importance of early detection, diagnosis and treatment.

Dr. Peggy Loh, Singapore General Manager at PharmaEssentia said: "Today is a major milestone for PV treatment in Singapore. BESREMi®️ provides an innovative solution that targets directly the source of the disease for long-term control to reduce the risk of disease progression and thrombosis. BESREMi® is the first therapy approved by HSA for adults with PV, regardless of treatment history. It is especially timely for PV patients here who are looking for an innovative treatment option to achieve their desired healthcare outcomes. We look forward to working closely with Singapore's healthcare community to advance more comprehensive treatment approaches."

BESREMi®: A Major Advancement in PV Care

BESREMi® was approved by the FDA in 2021 as the first and only interferon therapy for adults with PV, representing a significant shift in PV management and treatment. It was developed through extensive research and clinical trials. BESREMi® is now also available in the United States, Europe, United Kingdom, Israel, South Korea, Japan, Taiwan, China, Macau and Malaysia. Unlike traditional therapies that focus on symptom management, BESREMi® addresses the underlying mechanisms of PV for comprehensive disease control, improved long-term outcomes and quality of life for patients and caregivers.

"Introducing BESREMi®️ in Singapore is a pivotal moment for us. Our commitment to biomedical research and strong international partnerships, together with Singapore's status as a leading medical hub, have given us the opportunity to make a meaningful impact on this underserved condition," said Dr. Ko-Chung Lin, Founder & CEO of PharmaEssentia.

PharmaEssentia was founded in 2003 and is committed to advancing cancer care through its expertise in interferons and pegylation technology. The company collaborates closely with healthcare professionals, research teams and patient advocacy groups to provide the best treatment options for better patient outcomes, including organising the annual MPN Asia conference to provide updates on clinical trials and data.

The Importance of Early Detection 

Dr. Ng Chin Hin, Senior Consultant, Haematology, Centre for Clinical Haematology explained: "Polycythaemia Vera (PV) is a rare blood disorder caused by a specific acquired genetic mutation known as the JAK2 mutation. Its symptoms such as headaches, fatigue and blurred vision are often non-specific and can be attributed mistakenly to other conditions like migraines or stress by both patients and doctors. Therefore, it is crucial to seek medical attention early if you experience these symptoms. Early diagnosis is vital as untreated PV is associated with a high risk of stroke, heart attack and other life-threatening blood clotting complications."

Dr. Dawn Mya Hae Tha, Senior Consultant, Haematology, Parkway Cancer Centre added: "Routine annual health screenings are important for detecting conditions that might otherwise go unnoticed until they become severe. Many patients present advanced complications by the time they visit a clinic. Blood tests including a full blood count can reveal abnormalities in blood cell count, making early detection possible."

Supporting MPN Awareness 

With the MPN Awareness Day approaching on 12 September 2024, PharmaEssentia would like to encourage people living with PV, caregivers and healthcare providers to unite in raising awareness about PV. By sharing their experiences, they can enhance understanding of the condition to build greater support for patients and encourage early detection to improve the quality of life for those affected by PV in Singapore. Those interested can join the MPN Support Group SG on Telegram. For more information on MPN Awareness Day, please refer to this infographic. 

For more information, please visit PharmaEssentia's website at www.pharmaessentia.com.

About PharmaEssentia

PharmaEssentia (TWSE: 6446), headquartered in Taipei, Taiwan, is a global and rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, PharmaEssentia aims to deliver effective new biologics for challenging diseases in the areas of haematology and oncology, with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the U.S., South Korea, Japan, China and Singapore, along with a world-class biologics production facility in Taichung, Taiwan.

About Polycythaemia Vera (PV)

Polycythaemia 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. PV may result in cardiovascular complications such as thrombosis and embolism, and often transforms to secondary myelofibrosis or leukaemia. While the molecular mechanism underlying PV is still the subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2^[1].

About BESREMi® (ropeginterferon alfa-2b)

BESREMi® is an innovative monopegylated, long-acting interferon. With its unique pegylation technology, BESREMi® has a long duration of activity in the body and is aimed to be administered once every two weeks (or every four weeks with haematological stability for at least one year), allowing flexible dosing that helps meet the individual needs of patients.

BESREMi® has orphan drug designation for the treatment of Polycythaemia Vera (PV) in adults in the United States. The product was approved by the European Medicines Agency (EMA) in 2019 and by the U.S. Food and Drug Administration (FDA) in 2021. It has received approval in the United Kingdom, Israel, South Korea, Japan, Taiwan, China, Macau, Singapore and Malaysia. The drug candidate was invented by PharmaEssentia and is manufactured in the company's Taichung plant, which was cGMP certified by TFDA in 2017 and by EMA in January 2018. PharmaEssentia retains full global intellectual property rights for the product in all indications. BESREMi® was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders.

About MPN Awareness Day

MPN Awareness Day, held every September, shines a light on Myeloproliferative Neoplasms (MPNs) —a group of rare blood cancers that impact the bone marrow. This dedicated day helps educate people about MPN symptoms, diagnosis and treatment options, highlighting the need for early detection and proper care. The goal is to better the lives of people living with MPN by spreading awareness, encouraging early diagnosis and supporting research.