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					                                    Genexol-PM
Samyang Corporation


1. Company Overview

Samyang Corporation has operated in various industries including chemicals, food, pharmaceuticals,
industrial fibers, feed, trade and environment. The Company‟s food business is characterized by its
sugar operations, consistently ranking second within the domestic market with approximately 30%
market share. Samyang‟s sugar revenue accounted for 21.5% of total 2005 revenue. Now, Samyang
has established four main business areas-Chemicals, Foodstuffs, Pharmaceuticals and New Bus
iness-as we diversify and upgrade our corporate structure. We are also globalizing operations a
nd expect to be an important global player.
Commercialized drug delivery systems include Genexol, Rheumastop, Nicostop, Estran, Combitran
and Angiderm. All products, with the exception of Genexol, utilize transdermal delivery for maximum
                 ®
efficacy. Genexol is a paclitaxel injection, developed by Samyang Genex, a Company subsidiary.
Samyang medical devices on the market include Monosorb, Monofast, Trisorb, Surgisorb and
BioMesh. All products are biodegradable and are currently being exported to various countries around
the world.

                                                             1200
                                                                                 R   8%
                                                                             CAG
                                                             1000


                                                             8 00


                                                             6 00


                                                             400


                                                             200


                                                               0
              ®
     [Genexol Injection]                                              2003       2004     2005   2006 3 Q



                                   (Source: Company)                [Samyang Corp. Historical Revenue]

2. Company Fact Sheet

Feb. 2007- Genexol-PM won Korea New Drug Award
           Genexol-PM (next generation anti-cancer agent using paclitaxel) launched in Korea
Dec. 2007- Genexol-PM won Health industry & technology award
Aug. 2004- R&D agreement reached with Hyundai Pharmaceutical of Korea on Cetirizine
           Hydrochloride FDA
Mar. 2004- Suture monosorb-pro approved
May. 2002- Pharmaceutical research corporation established in Utah Samyang Research Corporation
Feb. 2002- Genexol-PM received US IND approval
Aug. 2000- Surgisorb and BioMesh acquired CE mark
Dec. 1999- Medical devices acquired ISO 9001 & EN 46001 certification
Aug. 1999- KGMP certification for medical device received
Dec. 1998- Genexol Injection approved and released in Korean market
Dec. 1997- Surgisorb, and absorbable suture product, approved and released in Korean market
Nov. 1996- KGMP certification for pharmaceuticals received
Sep. 1992- Pharmaceutical research center established


                                                                     Clinical
    Platform                        Compound                                              Regions
                                                                   Trial Status
PM/PNP             Paclitaxel-PM (Polymeric micelle)               Phase II       USA / Korea / China
(Parenteral        Paclitxel-PNP (Polymeric nanoparticle)          Preclinical    USA / Korea
Delivery)          Protein Delivery (IFN, G-CSF)                   Preclinical    USA / Korea
                   Itraconazole-PNP (Polymeric nanoparticle)       Preclinical    TBD
TDS                Buprenorphine                                   Preclinical    Korea
(Transdermal)      Capcisin                                        Preclinical    Korea
FDT                Cetrizine                                       Preclinical    Korea
(Oral)             Loratadine                                      Preclinical    Korea
                   Simvastatin                                     Preclinical    USA / Korea
CSDS               Diclofenac                                      Preclinical    TBD
(Oral)             Mesalazine                                      Preclinical    TBD
                   Bisacodyl + Docusate                            Preclinical    TBD

3. Executive Summary

Samyang's pharmaceutical business unit, in collaboration with its R&D center, is engaged in the
development and manufacture of novel drugs using innovative drug delivery systems, ranging from
polymer based solubilizer and delivery system, transdermal drug delivery system, and fast dissolving
tablet to colon specific delivery system
         ®
Genexol -PM (“Genexol-PM”) is a Samyang product currently undergoing clinical phase III trials in
Korea for its potential use as a chemotherapeutic agent for the treatment of refractory cancer.
Genexol-PM is a sterile, lyophilized polymeric micellar formulation of paclitaxel that employs a
colloidal carrier system to allow intravenous delivery of paclitaxel without Cremophor EL. Genexol-PM
is currently in phase IIa clinical trials in the US.
                                                         ®
Market products that utilize paclitaxel, in particular Taxol (“Taxol”), have encountered limited use due
to the toxic side effects of Cremophor EL, which is a component used in the delivery system.
Genexol-PM is specifically designed to avoid the use of Cremophor EL, successfully delivering
paclitaxel and securing effective results.



4. Business Opportunity or Investment Highlight

We intend to enter into a technology transfer or licensing transaction with respect to Genexol-PM („the
Transaction‟). Terms of the Transaction are not set, and interested parties may further discuss the
parameters should they wish to enter into an agreement.


5. Detailed Description of technology

5-1 Potential competitors

Commercialized drug delivery systems include Genexol, Rheumastop, Nicostop, Estran, Combitran
and Angiderm. All products, with the exception of Genexol, utilize transdermal delivery for maximum
efficacy. Genexol® is a paclitaxel injection.

Abraxane using human albumin as a solubilizer of paclitaxel                                             has been approved in the US with
metastatic breast cancer in 2005. Also it has been expanding                                            its indications. Other developmental
drugs, Xyotax and Tocosol were reported to have failed in                                               the phase 3 studies. Compared to
Abraxane, Genexol-PM is higher in MTD, which may lead to                                                improved efficacy and show a very
similar toxicity profile.

Cremophor EL has toxic side effects, namely hypersensitivity reactions and neuropathy. Genexol-PM
substitutes Cremophor EL with the Company‟s patented bioabsorbable polymer and has recorded
Maximum Tolerated Dose values 200% higher than Taxol (in nude mice bearing human breast cancer
xenograft MX-1), and lower toxicity in preclinical trials.



5-2 Key Technology Highlights

● Reduced Risk & Increased Efficacy

The goal of polymeric micelle technology is to enhance the solubility of water insoluble drugs to make
therapeutically more effective formulations. In conventional paclitaxel formulation, Taxol contains
Cremophor EL as a solubilizer, which is associated with patient toxicity of hypersensitivity. Replacing
Cremophor EL by Samyang's polymeric micelle enables reduction of toxicity. And reducing overall
toxicity enables higher dose of adminstration, which could improve therapeutic response with higher
efficacy. Genexol-PM (paclitaxel loaded polymeric micelle) parenteral formulation consists of spherical,
polymeric micelles, which do not aggregate or are not taken-up by reticulo-endotherial system (RES)
and thus freely circulate throughtout the vasculature.
Genexol-PM utilizes a low molecular weight, biodegradable, amphiphilic diblock copolymer to form
polymeric micelles of pacllitaxel. The micellar formulation has shown in clinical trials the potential to
improve delivery of the active component at specific tumor sites, while also avoiding vehicle-related
toxicity.
Paclitaxel is marketed in the US as Taxol®, and generically as Onxol™ (“Onxol”). Although the drug
has successfully demonstrated its anti-cancer effectiveness, it has also shown various problematic
areas: insolubility and toxicity. Paclitaxel is a highly hydrophobic drug, resulting in poor solubility in
conventional aqueous vehicles. As a result of its insolubility, Taxol and Onxol are formulated as non-
aqueous solutions. A key component of this formulation is Cremophor EL, which has shown toxic side
effects. Therefore the effective use of paclitaxel relies on the development of a delivery system devoid
of Cremophor EL.
                                                (in vivo Anti-Tumor Efficacy – Human Breast Cancer )


                                                                                                     Saline
                                                                                                     Taxol vehicle
                                                                                                     Genexol-PM vehicle
               ®
      (Genexol -PM)                                                                 10               Taxol 20 mg/kg
                                                                                                     Genexol-PM 60 mg/kg
                                                     Mean Relative Tumor Volume




                                                                                         1




                                                                                   0.1




                                                                                  0.01
                                                                                             0   4       8       12        16       20   24   28
                                                                                                         Days following treatment
                                 (Source: Company)
● Advanced Development Stage

Genexol-PM is currently undergoing phase II trials for pancreatic cancer in the US.
After displaying encouraging phase II study results, Genexol-PM obtained pre-market approval for
breast cancer and non-small cell lung cancer (NSCLC) in Korea in July 2006. Genexol-PM resultingly
entered into phase III trials for breast cancer and NSCLC in Korea in November 2006.



5-3 Patent Status

Drug delivery system employing block copolymer micelle and method for the preparation thereof was
filed before KIPO (the Korean Intellectual Property Office) on September 25, 1995 and granted (KR
180334). The KR patent was also granted in 7 other countries (AU 699988; CA 2231886; CN ZL
96197134.7; EP 0854731; JP 3634377; MX 218901 and US 6322805). Biodegradable polymeric
micelle-type drug composition and method for the preparation thereof was also granted in Germany,
Spain, France, Great Britain, Italy, Holland, Belgium, Switzerland, and Senden.

5-4 Commercial Prospect

According to the Thompson Pharma, the first cremophore free paclitaxel formulation in the market,
Abraxane reached worldwide sales of $174.9 million in 2006, up from $133.7 million in 2005.
Genexol-PM has been marketed in Korea in 2007 and started to compete with Abraxane in the
cremophore free paclitaxel market. Provided Genexol-PM showed higher MTD from clinical studies
than Abraxane, Samyang anticipates that Genexol-PM will dominate paclitaxel market over Abraxane.

Samyang also completed the IMS data analysis for the future market size of Genexol-PM. If
necessary, Samyang will share this information for the evaluation of Genexol-PM.
CEO: Mr. Yoon Kim


Established : 1924


Number of Staff/Employees :
Approx. 3,000


Industry Sector :
Chemicals, Foodsuffs, Pharmaceuticals, and New Business


Products/Services:
- Genexol Injection
- Genexol-PM
- Nicostop
- Reumastop
- Trisorb
- Monosrob etc.


Capital : U$ 837M (in 2006)


Sales Revenue : U$ 1.3B (in 2006)


Contact Information :
 Min Young Lee, Ph.D.
 mylee@samyang.com
 Tel. +82-2-740-7023
 Fax. +82-2-743-6626


Address
 263 Yeonji-dong, Chongno-gu
 Seoul, 110-725
 Korea


Web Site
 www.samyang.com

				
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posted:11/3/2011
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