Easyef® OintmentRecombinant Human Epidermal Growth Factor

General Information

Epidermal Growth Factor (EGF) is a single-chain polypeptide consisting of 53

amino acids with a molecular weight of about 6,200 Daltons. Six cysteine

residues in the sequence of hEGF from three disulfide bonds are required for

hEGF to be biologically active.

EGF was first isolated from the submaxillary glands of adult male mice. Human

EGF was discovered in human urine as an inhibitor of gastric acid secretion.

Today, hEGF has become one of the most attractive growth factors in life

sciences as well as biotechnological fields.

Human EGF is a potent stimulator of epithelial and endothelial cells and

fibroblast proliferation both in vitro and in vivo, which results in its potential as a

promising healing agent for the treatment of various skin and corneal wounds. In

dermatology, EGF can be used as a healing agent for skin wounds, such as

diabetic ulcers, bed sores, venous stasis ulcers, skin burns and surgical

incisions. In ophthalmology, EGF can be utilized as a healing agent for corneal

ulcers and ophthalmic surgery, such as corneal transplantation and excimer laser

keratectomy, and the prevention of corneal degeneration. It is also a good

candidate for the treatment of gastric ulcers because it inhibits gastric acid

secretion and regenerates gastric mucosal layer.

What is EGF?

Easyef® Ointment

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1. Re-epithelialization

EGF promotes epithelial cells to proliferate and move to fill wounds.

2. Promotion of granulation tissue

EGF stimulates fibroblasts in dermal tissue to facilitate dermal cells to

differentiate and proliferate.

3. Angiogenesis

EGF promotes endothelial cells to proliferate to regenerate blood vessels.

Mechanism of EGF Action

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Skin Regeneration and the Healing Effect

Easyef® Ointment

Outstanding effect of skin generationThe wound applied with Easyef® Ointment demonstrated the quickest healing ability.

Rapid wound healing abilityThe shortest healing time was achieved in the same wound area.

Skin regeneration rate (%)

Duration of treatment (Days)

C product

Easyef® Ointment

Completely healed in about 9.8 days

Completely healed

in about 7.8 days

Full-thickness wound model in the pigWound size/depth: 4 x 4 cm, 0.05 mmAdministration and period: twice a day (0.4 g applied per administration), treated for 11 daysRef) The Journal of the Korean Dermatological Association 1995

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ITTN=64

PPN=61

Placebo EGF 1 μg/g Placebo EGF 1 μg/g

Healing time (day)(mean±SD)

8.109±1.492 7.609±1.344 8.107±1.528 7.598±1.363

Healing time difference (day)

(mean±SD)median (min, max)

0.500±1.0981.000 (-1.500, 3.500)

0.508±1.1161.000 (-1.500, 3.500)

p-value 1) 0.0005 0.0007

95% confidence interval 0.500, 1.000 0.000, 1.000

1. Non-clinical study

2. Clinical study

► Indication: Wound healing (Skin graft donor site model)► Methodology: Placebo-controlled, randomized, double-blind, multi-center study ► Primary endpoint: Healing time by the direct evaluation(naked eye) of skin graft donor site► Result: The test group displayed statistically significant 1.0 day faster healing time compared to the control group (p=0.0005).

1) Wilcoxon signed- rank test

Key Benefits and Features

Wound healing ointment with a new concept, containing EGF, a

granulation ingredient (granulation tissue) in the human body, offered

first in Korea.

Safe because it contains no steroids or antibiotics.

White blood cells or macrophages themselves, which are created during the

healing process in our body, suppress bacteria, to some extent. Therefore,

this medicine does not contain a steroid or an antibiotic of which the

excessive use may make us tolerant of the antibiotic.

Proven in its safety and healing effect through a clinical studies in

Korea.

Top medical staffs from three prestigious Korean Institutions (Asan Medical

Center, Severance Hospital, and Samsung Medical Center) joined the

clinical procedures, and approved the safety and remarkable healing effect

of EGF.

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Table of Comparison with Competitors

Product name Easyef® Ointment A B C

APIEGF

(Epidermal Growth Factor)Sodium fusidate Mupirocin

Centella asiatica extract

TypeNo antibioticNo steroid

Antibiotic Antibiotic Antibiotic, steroid

Tolerance/Side effect

Same ingredient as in the human body

(no side effect)

Tolerance (antibiotic)

Tolerance (antibiotic)

Tolerance (antibiotic)

Side effect (steroid)

Efficacy/Effect

Assistive topical treatment of wound and skin ulcer

Pyoderma, acne, folliculitis, boil, and secondary infection due to a burn and

wound

Bacterial skin disease

 

Skin inflammation, infected wound

StorageStore in a refrigerator

(2~8℃)Room temperature

(1~30℃)Room temperature

(1~30℃)Room temperature

(1~30℃)

Product Information

Component

In 1 g

Recombinant human epidermal growth factor ------------------------------ 1 μg

(Host: E. coli JM101, Vector: pTE105)

Ointment base: white petrolatum (KP) ------------------------------------ 700 mg

Ointment base: Light liquid paraffin (KP) ----------------------------- 298.45 mg

Preservative: propylparaben (KP) ------------------------------------------- 1.5 mg

Appearance

Colorless or pale yellow, translucent ointment in tube

Administration/Dosage

Apply it to the infected area several times a day as needed.

Efficacy/Effect

Assistive topical treatment of wounds and skin ulcers

Storage

Store in a refrigerator (2~8℃).

Easyef® Ointment

Release Date : 2010.12.30

http://www.daewoong.com

For More Information Contact:

Chang-woo Suh

Tel: 82-2-550-8737

E-mail: cwsuh@daewoong.co.kr

163-3, Samsung-dong,

Gangnam-gu, Seoul 135-715, KOREA

Easyef® Ointment