Orient EuroPharma To Expand Global Collaborations in Drug Delivery Technology

2018-07-24

 

Orient EuroPharma Co., Ltd. (OEP), which has been in the Taiwan, China and ASEAN markets for years, will be accelerating its product research time line. Its subsidiaries, Orient Pharma Co., Ltd. (OP), and OP Nano Co., Ltd. (OP Nano), have played a key role in research and development, with each having its own unique drug delivery technology and manufacturing capability. In addition, OEP is planning to expand its business in contract manufacturing and research collaborations. OEP has several niche new drugs that are open to licensing or in search of international partners in collaborative development and is looking for regional trade markets to help expand the global market.


 
Orient Pharma - Experienced in R&D and Clinical Trials of New Drugs

 

OP's research team possesses experience in new product development and an acumen for choosing the right project. OP has obtained USFDA approval for the diabetes drug Miglitol, the muscle relaxant Carisoprodol, and lipid-lowering agent Pitavastatin. OP has conducted three Phase II/III multinational multi-center clinical trials and has been offering related services to its partners around the world for years. Throughout this time, they have accumulated experience in passing GCP inspections by the health authorities in Taiwan and Singapore. OP owns the technical platform for several special dosage forms, such as the Multiple Phasic Release Technology (MPRT) and the Multi-day Transdermal Drug Delivery (MTDD) technology. Of the new drugs currently being developed, the ADHD drug ORADUR-MPH, has begun the TFDA's new drug application. Its new drug for the treatment of sialorrhea (an excessive flow of saliva) and tuberculosis are in Phase II and Phase III trials respectively. Meanwhile, the MTDD technology has been successfully transferred to Beijing Tide Pharmaceutical Co., Ltd. for the collaborative development of a patch for Alzheimer's Disease targeting the US and China markets. OEP was on the receiving end of the technology transfer for an anti-epileptic drug from Supernus of the US. OEP secured the distribution rights in Taiwan and South East Asia, while OP is responsible for part of the production. OP plants are PIC/S GMP compliant, with an annual production capacity of 400 million pills and 270 million capsules and hot melt capsules.

 

OP Nano Targets Nanopolymer Anti-Cancer Injection Production Market

 

OP Nano is currently developing two cancer drugs in Multikine (CS001P3) and Micelplatin (NC-6004), which are used in the treatment of oral cancer and pancreatic cancer respectively, with the latter having completed subject recruitment for the Phase III trial.  In a different study, a Phase I/II clinical trial on the combination of NC-6004 and immune checkpoint inhibitor will be conducted. Once the construction of the new plant is complete this year, OP Nano will apply for FDA inspection. The production batch size is expected to be 16,000 vials, with a maximum production capacity of up to 3 million vials for a single product. The plant will provide a stable supply for the world-leading nanopolymer injection for cancer treatment.

 

The unique nano-particle drug delivery technology enhances the pharmacokinetics of the drug to improve solubility and overcome restrictions in the duration of action. The technology forms a micellar nano-particle where the nanocarrier encapsulates the anti-cancer drug. When coming in contact with the target cancer cell, the drug is delivered to the cancer cell through endocytosis. The drug is then released in a slow and continuous manner inside the cell, mitigating toxicity issues and side effects typically caused by high drug concentrations. The result is the effective killing of tumor cells and improved treatment outcome.

 

(Editing by Jim Shih, Research Center for Biotechnology and Medicine Policy)