Will Supply rh-Insulin Manufactured at its New Facility in Malaysia to Public Sector Hospitals and Clinics through CCM Pharmaceuticals
Bengaluru, Karnataka, India, January 25, 2017
Biocon Ltd (BSE code: 532523, NSE: BIOCON), Asia's premier biopharmaceuticals company, announced today that the Ministry of Health (MoH), Malaysia, has awarded a three year contract, to its subsidiary, Biocon SDN. BHD., Malaysia, for supplying recombinant human insulin (rh-Insulin) formulations manufactured at its large scale biopharmaceutical facility in Johor, Malaysia. Biocon's rh-Insulin is Malaysia's first locally manufactured biosimilar biologic product approved by the National Pharmaceutical Regulatory Authority (NPRA), Malaysia, for commercial sales in the country. This marks the commercialization milestone of Biocon's first overseas facility in Malaysia.
Biocon SDN. BHD. has been awarded a MYR 300 million (~Rs 460 Cr^) contract to be serviced over a period of three years for supplying rh-Insulin cartridges and re-usable insulin pens under the Malaysian government's Off-Take Agreement (OTA) initiative, which seeks to encourage local manufacturing of new pharmaceutical products thus lowering the country's reliance on imports and also enhancing the exports potential. The contract is extendable for additional two years subject to approval by the Government of Malaysia.
Biocon will distribute insulins and insulin delivery devices through CCM Pharmaceuticals, a leading local pharmaceutical player which has an extensive supply chain network to service primary healthcare clinics and hospitals across Malaysia. Biocon is extremely proud to enable the government expand access to affordable insulin therapy for people with diabetes in Malaysia.
Biocon Chairperson & Managing Director Kiran Mazumdar-Shaw said: "We are pleased to support the Ministry of Health of Malaysia in providing high quality, affordable, rh-insulin for people with diabetes in Malaysia. It is a matter of pride that this is a 'Made in Malaysia' insulin product manufactured by Biocon Sdn. Bhd. at the BioXcell Biotech Park in Nusajaya, Johor. We expect our Malaysian facility to cater to the growing needs for affordable insulins across the globe."
Rapid urbanization, changing lifestyles and sub-optimal dietary habits are leading to a high incidence of diabetes in Malaysia, with over 3.3 million* people currently diagnosed with diabetes. The Malaysian government spends nearly ~USD566* per year on every diabetic and with the number of people with diabetes projected to cross over 4.5 million# by 2020, it will impact the government's healthcare expenditure significantly. Locally manufactured affordable rh-Insulin has the potential to reduce the diabetes treatment cost burden and increase the access to insulin therapy for diabetes patients in Malaysia.
Biocon's state-of-the-art facility with 800,000 sq. ft. built-up area has been set up with an investment of MYR 1.1 billion and complies with the highest standards of global regulatory requirements. Through high quality, affordable insulin and insulin analogs manufactured at this facility, Biocon will strengthen Malaysia's position as an emerging global biotechnology destination. Rh-Insulin is the first product from Biocon's Malaysian facility approved by NPRA, which certified Biocon's facility first in 2015.
Biocon is recognized as Asia's largest insulins producer and has been committed to affordable diabetes management through rh-Insulin (Insugen®), Insulin Glargine (Basalog®) and insulin delivery devices in India and several emerging markets. Biocon is the largest Indian Insulins company and has been the first company from India to introduce biosimilar Insulin Glargine in Japan in 2016. It has received regulatory approvals for rh-Insulin in over 60 emerging markets and is providing the product in many of these markets through its local partners. The Company had earlier announced the regulatory filing with the European Medicines Agency (EMA) for biosimilar Insulin Glargine validated at the Malaysian facility.
Biocon is one of the first Indian companies to join hands with the Malaysian Government to generate value for Biocon and the Malaysian biotechnology sector. The world-class integrated insulins facility, at the Bio-Xcell biotech park in Iskandar, Johor, was selected as an Entry Point Project (EPP) under Malaysia's Healthcare National Key Economic Area (NKEA) initiative. The facility draws a majority of its over 500-strong workforce from the local talent pool. It thus provides Malaysia's biotechnology graduates and scientists a unique opportunity to make a critical contribution to global healthcare. The commercialization of Biocon's facility will contribute towards Malaysia's emergence as a global biotechnology hub.
*Source: IDF 2015 #www.diabetes.org.my ^ 1MYR= INR15.37 as on Jan24, 2017
Forward Looking Statement
Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is India's largest and fully-integrated, innovation-led biopharmaceutical company. As an emerging global biopharmaceutical enterprise serving customers in over 100 countries, it is committed to reduce therapy costs of chronic diseases like autoimmune, diabetes, and cancer. Through innovative products and research services it is enabling access to affordable healthcare for patients, partners and healthcare systems across the globe. It has successfully developed and taken a range of Novel Biologics, Biosimilars, differentiated Small Molecules and affordable Recombinant Human Insulin and Analogs from 'Lab to Market'. Some of its key brands are INSUGEN®(rh-insulin), BASALOG® (Glargine), CANMAb™ (Trastuzumab), BIOMAb-EGFR™ (Nimotuzumab) and ALZUMAb™ (Itolizumab), a ‘first in class’ anti-CD6 monoclonal antibody. It has a rich pipeline of Biosimilars and Novel Biologics at various stages of development including Insulin Tregopil, a high potential oral insulin analog. For more information, Visit: www.biocon.com
Certain statements in this release concerning our future growth prospects are forward-looking statements, which are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those contemplated in such forward-looking statements. Important factors that could cause actual results to differ materially from our expectations include, amongst others general economic and business conditions in India, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither our company, our directors, nor any of our affiliates, have any obligation to update or otherwise revise any statements reflecting circumstances arising after this date or to reflect the occurrence of underlying events, even if the underlying assumptions do not come to fruition.