R & D
Compared with Orient Europharma, which focuses on market development and distribution, Orient Pharma (OP) focuses on R&D and manufacturing. Not only to develop its own drug forms and indications, but also to obtain exclusive rights to manufacture patented products from international pharmaceutical companies, and apply for drug certifications in the United States, Japan, and Europe to enhance Orient Europharma’s global presence in the global market.
Currently 3 new drug delivery technologies are being developed, including 2-stage release technology, trans-dermal patches and instant oral dissolving tablets. The multi-stages release technology focuses on the development of the central nerve system (CNS) drugs and distal gastrointestinal tracts infection extended-release capsules. Two patents derived from this technology are under application processes, one of which has already obtained the patent approval from Taiwan Intellectual Property Office. The trans-dermal patches will be utilized in the curing of CNS pains, Alzheimer’s disease, and urinary incontinence, etc. The technology for the trans-dermal patches is under international patent application. Other drug products which are currently under research and development include new-generation lipid lowering drugs, drugs for cardiovascular system, drugs for Alzheimer’s disease, and extended-release drugs for the CNS.
Orient Pharma is actively seeking collaboration with foreign pharmaceutical companies for new drug product development and production. A contract has been signed with Summit Corporation plc for collaborating research and development of a new formulation for curing sialorrhea for patients with Parkinson’s disease. Another contract was signed with C5Rx Pharmaceuticals, Inc. (C5Rx) for collaborated development of new formulation of antineoplastic drugs in oral dosage form eligible for international patent applications. Orient Pharma provides new formulation technology to C5Rx for the development of new formulation.
Products Under Development
| Indication | Drug Form | Annual ales of Same Active WW |
Advantages of New Drug Forms | Updates |
|---|---|---|---|---|
| Sialorrhoea | Oral Solution | US$200 million | A new patentable combination with unique drug actions. | Completed formulation study and pilot human PK by 2009 Q4. To produce Biobatch by 2010 Q2. To produce human pivotal PK and clinical trials by 2010 Q3. To initial clinical trials by 2011 Q3. Expect to finish clinical trials by 2012 Q3. |
| Anti-Tuberculosis | Capsules | － | New product with lower side effect (hepatotoxicity) | Under development; expect to finish development about 5 to 6 years. |
| Hyper-lipidemia | Film-coated tablets | US$35 million | A potent next-generation cholesterol-lowering drug. Oral absorption unaffected by food. | 2011 Pivotal BE Study and Clinical Trial Conduction. |
| Depression | Long-acting tablets | US$840 million | Macromolecules allow for control of release | 2012 Q4 Pivotal BE Study. |
| Migraine | Orally disintegrating tablet | US$210 million | Disintegrates quickly in the mouth to facilitate absorption. Easy-to-swallow. | 2011 Q2 Biobatch Production & BE Study. 2011 Finish Pilot BE Study. 2012 Q1 BE Study. |