PharmaEngine, Inc.


Chairman: Rong-Jin Lin
President and Chief of Executive Officer: Dr. Grace Yeh
Founded Date: 2002/08 
Tel: 886-2-2515-8228 
Fax: 886-2-2515-7558 
Address: 11F, 10 Sec. 3 Minsheng Road, Taipei, Taiwan
Website: http://www.pharmaengine.com/


 

Company Profile:

PharmaEngine, Inc. is a biopharmaceutical company established in Taipei, Taiwan in 2003, and funded by TTY Biopharm and Taiwan venture capitals. PharmaEngine adopts the business model of “no research, development only” and focuses on the development of new drugs for the treatment of cancer and Asian prevalent diseases. The company is led by Mr. Rong-Jin Lin and Dr. Grace Yeh, as well as supported by reputable advisors and consultants.

In 2003, PharmaEngine licensed the exclusive rights to develop and commercialize PEP02 in Asia from Hermes Biosciences, Inc. (South San Francisco, CA), and subsequently expanded the territory to Europe in 2005. Hermes retained the rights in North America and all other territories. Hermes BioSciences, Inc. was acquired by Merrimack in 2009. In May 2011, PharmaEngine and Merrimack execution of an agreement under which PharmaEngine grants back to Merrimack the rights to develop, manufacture, and commercialize PEP02 (known under the designation of MM-398 by Merrimack) in Asia and Europe, with the exception of Taiwan. PharmaEngine is eligible for US$10 million upfront and upto US$210 million milestone payments, as well tiered royalties. PEP02 is a novel and highly stable nanoliposomal formulation of irinotecan. PharmaEngine has tested PEP02 in several human clinical studies to date, including four phase I studies and two phase II studies in gastric and pancreatic cancers. Both phase II studies met their primary endpoints of response rate and 3-month survival. In May 2014, PharmaEngine announces MM-398 (PEP02) in combination with 5-FU/LV met the primary endpoint of overall survival in phase 3 post-gemcitabine metastatic pancreatic cancer study (NAPOLI-1). Based on PEP02 clinical data, the clinical development plan of PEP02 is to explore pancreatic, lung, colorectal, gastric, and brain cancers. The broad anti-tumor activity of PEP02 in a variety of cancer types with large potential markets (> US$ 1 billion) is commercially attractive.

In 2012, the company licensed the Asia-Pacific rights of PEP503 (crystalline hafnium oxide, aka NBTXR3) from Nanobiotix, Inc. which is in a phase I clinical trial in France. In addition, PharmaEngine and BeBetter executed a Collaboration and Research Agreement. The two companies will collaborate to design, synthesize and develop new chemical entities against predefined targets in oncology. BeBetter is responsible for discovering optimized compounds for IND-enabling studies. PharmaEngine will be responsible for development and commercialization. This collaboration opens a new chapter for partnership between Taiwan and China in searching for novel anti-cancer drugs. Currently, we are actively seeking potential new drug candidates fitted in our company strategy aiming to develop innovative products.

Currently, we are actively seeking potential new drug candidates fitted in our company strategy, aiming to develop innovative products and efforts in-license oncology projects in preclinical to phase II stages.

Pipeline:

New Drug

Indications

Core Strength

Current Phase

PEP02
(Irinotecan liposome injection)

Pancreatic Cancer

Topoisomerase I inhibitor

Pre-NDA

Colorectal Cancer

Phase 2 ongoing

Gastric Cancer

Phase 2 completed

Ewing’s sarcoma

Phase 1 ongoing

Brain Cancer

Phase 1 ongoing

PEP503
(Crystalline hafnium oxide)

Sarcoma Soft Tissue

Radiotherapy enhancer

Phase 1 completed

Solid Tumor

Phase 1 planning

PEP06
(NCE)

Solid Tumor

(Nonpublic Information)

Research