Special Report III
UK Do-i, a Korea based pharmaceutical holding company is currently in process of establishing a local manufacturing facility through its U.S. subsidiary BNCP Corporation. UK Chemipharm, another subsidiary pharmaceutical company based in Korea, had been developing Ready-to-Use UK Injection Kit (Full Kit) and Half Injection Kit (Half Kit). UK Chemipharm is the current manufacturer and distributor of their product within Korea and overseas. After establishment of its first U.S. office 10 years ago, UK Do-i came along a long and challenging journey to become the first Korean Pharmaceutical company to build an Injectable cGMP manufacturing facility in the U.S. UK Do-i believes that their kit will be the new global standard product in injectable industry.
With major investments from UK Do-i, and funding(equity finance) through BNCP Corporation, Indiana State’s bond finance and County incentive programs, UK Do-i have bought 52,400sqft building site and 12 acres of land for their pharmaceutical facilities. With budget of 30 million dollars, construction will be started in March 2015 and completed by end of that year.
It is expected to receive U.S. FDA’s full approval on facility and product within 2017. Distribution and sales of products in the U.S. and Canada are expected to start in 2018, and target regions will be expanded into EU and Latin American countries.
Within three years after product approval of U.S. FDA, sales are expected to grow over 30 million units of UK Injection Kits which will generate $180 million dollars in revenue. And within five years, it is expected to grow to reach 50 million units of UK Injection Kit and $300 million dollars in revenue. UK Do-i is aiming to reach 10 % of market share in the antibiotic injection industry after 5 years of sales activities.
UK Injection Kit has its unique strength which serves unmet need of existing device and process. Normally there are around seven burdensome steps in preparing and administering an injectable product; 1) preparation of medicine and dissolution equipment 2) unsealing medicine and dissolution equipment 3) dissolve under disinfection environment 4) labeling 5) priming 6) administer injection 7) disposal. These seven steps are widely exposed to variety of difficulties and problems including but not limited to; possibilities of contamination due to microbial, unintended mix of foreign substances, human error and other burdens including high demand on time and budget input. To decrease the risk and time, many drug manufacturers have developed numerous ready-to-use products and UK Injection kit is one of the most advanced and innovative form of ready-to-use products in the current market.
UK Chemipharm has been researching and developing since 2000 to make the most efficient IV injection kit. After four years of development, UK Chemipharm has successfully came up with its final edition of the kit with its patents in Korea, U.S., Canada,, EU, China, and Mexico, and Patent Pending under review in India, Brazil and UAE, etc. The core technology and a huge benefit of this product is that any existing vial is attachable to the ready-to-use kit. This allows much more flexibility to expand the products portfolio because the vial component of UK Injection Kit can be utilized by any standard size vial that is being sold on market. Another core technology is the connection part of between vial and solution as Saline, Dextrose and WFI, etc. It is an aseptic connection set which prevents any germs to infiltrate while mixing vial to the solution. Plastic needle on the connection part is bidirectional. Just one-touch pushing the needle from solution bag side, rubber stopper is penetrated and both side connected with bidirectional needle. With pumping the solution bag lightly, solution is transferred to the vial and mixed with the powder in vial. Then by the just same way (pumping solution bag lightly), the constituted solution is re-transferred to the solution bag and ready to IV infusion set. From 2004, UK Chemipharm has obtained marketing authorization for Cefmetazole, Vancomycin, Imipenem/Cilastatin, Cefotiam, Ceftriaxone, Cefoperazone/Sulbactam, Teicoplanin, Ceftizoxime, Cefotetan UK injection kit from KFDA and launched these products in Korea and Japan. Also, UK Chemipharm is currently working on developing FLOMOXEF Na and MEROPENEM injection kit.
These products are very popular among nurses, doctors, and pharmacist and especially have strengths in same areas where international assessment criteria also emphasizes, including minimizing infection risk, safety from needle injury, and no leakage of any solution which will reduce any allergy occurrence among the users.
UK Chemipharm’s most innovative UK Injection Kit allows any users to constitute the vials and solutions in a closed system. Any foreign substances or bacteria that have risk of contaminations are blocked by our product to provide safety and reduce the possibilities of infection. This will reduce any further treatment costs which can be generated by infection complications. It will also reduce needle injury and allow safe preparation to make solutions in short period of time which also reduces costs for inventory management and waste disposal for any unnecessary materials that were previously used for preparation.
Thus, followings can be emphasized as the benefits of this product;
1. Closed system applicable for USP chapter(797)
2. Reduce the risk of microbial contamination
3. Faster preparation time with ready to mix system
4. Reduce the needle injury and antibiotic allergy of practitioner
5. Wide range of antibiotic product portfolio
6. And more innovations & advantages
Below document was published few years ago and it shows infection and other problematic issues with injectable products:
A) Hospital-Acquired Infection is… An infection caught while hospitalized. Most nosocomial infections are due to bacteria. Since antibiotics are frequently used within hospitals, the types of bacteria and their resistance to antibiotics is different than bacteria outside of the hospital. A nosocomial infection is strictly and specifically an infection “not present or incubating prior to admittance to the hospital, but generally occurring 72 hours after admittance **U.S. Center for Disease Control and Prevention (CDC)
B) Nosocomial Infection rate of 15 general hospitals in the entire domestic area - Patients discharged from hospitals: 3.7% - Entire hospitals: 5.8% ~ 15.5% - Intensive Care Unit (ICU): 10.5% ~ 39.7% - Patients who had a surgical operation: 5.6% ~ 9.8% * Korean Society for Nosocomial Infection Control
C) Endogenous Infection (67% from total HAI): when patient’s immune ability is declined, it is occurred by bacteria that patient already have in their body Exogenous Infection (33% from total HAI): can be prevented by infection control Not possible to prevent 100% of Hospital-Acquired Infection **U.S. Center for Disease Control and Prevention (CDC)
D) In hospital ward-based preparation of IV medicines: Certain risks by nursing or medical staff: Errors in dose preparation and administration as a result of frequent interruptions, cramped working areas and lack of time. (26.9% of error rate for the preparation of IV drugs) Incompatibility or instability due to use of incorrect diluents, or inappropriate storage Potential hazards to nursing staff from needlestick injury Preparation of a single IV dose has been measured at between 3 to13 mins
E) Needlestick Injury’ - Parenteral introduction of blood or other infectious material into the body, of usually nursing, laboratory staff and physicians during the performance of his or her duties, by a hollow-bore needle, or sharp instrument, including, but not limited to, needles, lancets, scalpels and contaminated glass 12 billion injections are administered each year worldwide Over 3 million people are injured by accidental needlestick injury Hepatitis B, Hepatitis C, HIV and AIDS are the main viruses implicated in needlestick injury **World Health Organization (WHO)
F) No. of using injections: 12 billion/yr - U.S. 17%, Japan 13%, EEA 35% Ratio of using ready to mix system: 10% - U.S. 25%, Japan 15%, EEA 20%
Because this product was the solution to above problems, UK Chemipharm and its product line has been expanding its business throughout Korea and Japan. UK Chemipharm is currently distributing to over 100 general hospitals in Korea and reached $10 million revenue in 2013. Also in 2013, UK Chemipharm contracted with with Daewoong Pharmaceutical to co-promote this product. This year, it is expected to grow over $ 20 million dollar sales and by the end of next year with new product launched, it is expected to reach $40 million dollars. Current production lines are being operated two shifts a day and 6days a week due to dramatic growth in the market and construction of new manufacturing facilities are scheduled next year.
After receiving BGMP and KGMP in 2003, UK Chemipharm maintained stable net profit which led to continuous investment in research and development. They were able to provide various portfolios and launch new products consistently. UK Do-i’s long term goal of entering U.S. is now actualized, and they are in process of strategic partnership with several big antibiotic drug vial manufacturing companies.
CEO, UK Do-i Co., Ltd.
Gibum Oh is the CEO of UK Do-i and its subsidiary companies; UK Chemipharm, UK Ucera, Kacel, BNCP USA Corp., BNCP China Corp. UK Chemipharm manufactures and R&D for FDF(Finished Dosage Form) and API(Active Pharmaceutical Ingredient). UK Ucera manufactures and supply thermal protectors for electronics. Kacel manufactures and distributes tungsten carbide tools and develops PVD coating technology. BNCP USA is in charge of marketing for North and South America and Europe. BNCP China is in charge of marketing and R&D in China.