PharmaEssentia Corporation


President: Dr. Ching Leou Teng
Founded Date: 2000/05 
Tel: 886-2-2655-7688
Address: 13F, Building F, No. 3, Yuan Qu St., Nangang District, Taipei. Taiwan 
Website: http://www.pharmaessentia.com/


 

Company Profile: 

PharmaEssentia Corporation aims to deliver efficacious, safe and cost-effective therapeutic products for the treatment of human disease. As its mission is a never-ceasing quest for the improvement of health and quality of life. Founded in 2003 and led by a group of Taiwanese-Americans who were executives and high-ranking scientists at a number of leading biotech and big pharmaceutical companies in the US, to develop treatments for hepatitis and other infectious, hematologic and dermatologic diseases.

PharmaEssentia has developed a next generation of pegylated interferon, P1101 (PEG-P-IFN-alpha-2b, also known as AOP2014), this drug candidate is expected to be an effective treatment for MPNs (Myeloproliferative Neoplasms, including chronic myeloid leukemia (CML), essential thrombocythemia (ET), myeloid fibrosis (MF), polycythemia vera (PV)), hepatitis and cancer. In 2009, PharmaEssentia exclusively licensed P1101 to Austria's AOP Orphan Pharmaceuticals AG (AOP) for MPN treatment, with the authorized territory covering Central Europe, the Middle East and CIS. In contrast to other pegylated Interferons that require weekly administration, P1101 (AOP2014) is applied only every other week, resulting in higher convenience, potentially improved tolerability, compliance and long term treatment outcomes. The results of Phase II trial were presented by AOP at the America Society of Hematology (ASH) Annual Meeting, in Atlanta in 2012. With those encouraging results and the Orphan Drug Designation for polycythemia vera issued from the FDA and EMA in 2011, AOP has initiated a Phase III trial for PV in Europe in September 2013. Furthermore in July 2014, PharmaEssentia received IND Acknowledgement from US FDA about Phase III trial of P1101 for PV, with IND number 119047.

In addition to application in the treatment of PV, P1101 has also been under clinical study in Taiwan for the treatment of hepatitis B and hepatitis C (HCV-GT1 & HCV-GT2). Approval to begin Phase II trials for HBV and HCV have been given by the FDA and Taiwan's TFDA. A dosage of applying every week is designed for the treatment and the trial is set to proceed at 15 leading hospitals in Taiwan. Phase III trial for HCV-GT2 is planned to start in H1 2015, while the phase II trial for HBV is also expected to begin in the end of 2014.

PharmaEssentia has completed the construction of a cGMP biologics production plant in Taiwan to produce clinical trial quantities of the drug for these Phase III studies. The plant is certified by TFDA in April, 2013. It is set to be soon certified by EMA and FDA.

PharmaEssentia is a fully integrated biopharmaceutical company which creates and provides novel products to improve the quality of life for patients who are suffering from a number of debilitating diseases.

New Drug in Development:

New Drug

Indications

Stage

P1101

(Next generation of PEG-P-IFNα 2b)

Polycythemia Vera

Phase III

P1101

(Next generation of PEG-P-IFNα 2b)

Hepatitis C-genotype 1
Hepatitis C-genotype 2

Phase II

KX01

Psoriasis

Phase II

PEG-EPO

Anemia

Pre-Clinical

PEG-GCSF

Neutropenia

Pre-Clinical