Strategy of Saudi Bio

The Company plans to build the Facility and sell Insulin in KSA and other countries. Acertus Pharma, the technology and raw material provider, will bring on board the strategic planning and technology for the Project as well as providing future technologies to Saudi Bio, while Biopharmax, the construction partner of the Company, will bring the engineering capabilities to do all phases of work needed to complete the “turn-key” project. These two companies bring together key personnel with hands-on experience in all phases of biotechnology management from strategic planning to successful execution of projects.

Insulin

Insulin is a naturally-occurring hormone secreted by the pancreas in the human body. Insulin is needed by the cells in the body to use-up and remove the glucose from the blood. From glucose the cells produce the energy that they need to carry out their functions. Patients with the condition of diabetes mellitus have an inability to take up and use glucose from the blood, and, as a result, the glucose level in the blood rises. In type 1 diabetes, the pancreas cannot produce enough insulin.

Therefore, insulin therapy is needed. In type 2 diabetes, patients produce insulin, but cells throughout the body do not respond normally to the insulin. Nevertheless, insulin also may be used in type 2 diabetes to overcome the resistance of the cells to insulin. Processed Insulin product comes in three different forms: vials, pre-filled syringes, and cartridges. The cartridges are used in a pen-like device that simplifies injection. Vials are used to store Insulin in higher volumes than cartridges and pre-filled syringes are syringes already filled with required dosage of Insulin. 

High-Level Production Process Overview

Insulin is a hormone which looks like a white crystalline powder when produced. It is first produced in its raw form, which is then further processed into finished, consumable products. Saudi Bio has signed a contract with Acertus Pharma FZE to source its raw material i.e. human insulin crystal. Acertus Pharma will also provide the production technology of Insulin which is based on biosynthesis with a common bacterium called Escherichia coli. The preparation process undergoes many steps of biosynthesis, followed by precipitation & purification. Finally the protein is crystallized and dried. The dried product is dispensed into glass containers and stored in at -20°C. The process control takes place in biochemistry laboratory and quality control labs. Human Insulin is released for manufacturing only when it complies with the standards laid down by European Medicines Agency (EMEA).

After the release of Human insulin by quality control department, it is taken for manufacturing of the finished product. Finished insulin types usually fall into one of four categories based on their commonly reported actions: short-acting insulin, rapid-acting analogues, intermediate-acting insulin and long-acting analogues. Doctors typically base their choice of insulin on the time course desired for the level of the illness under treatment. Factors that contribute to the choice of insulin include length of time to the onset of medication and the effective duration of medication. The Company will produce all the above mentioned four categories of Insulin.

Equipment for processing raw insulin and the production of the final product, packaging and storage of final product will be provided by Biopharmax, a leading design and construction provider for such facilities. The facility developed by Saudi Bio in conjunction with Biopharmax will be able to produce Human Insulin and other biotechnology derived products. First class European manufacturers would be used for filling and primary packing equipments. Detailed description of the equipments to be used for construction of the Facility is mentioned in section named ‘Plant construction, equipment and layout’.

With Biopharmax, Saudi Bio is confident in establishing correct conceptual design for producing insulin which is the key to success. With expertise of Biopharmax, Saudi Bio will be able to workout the technological problems, ensure effective design especially with respect to process optimization, easier scalability and defined production concept.

Third Party Manufacturing

Although the Company will focus on production of insulin in the initial stages, manufacturing insulin products for third parties on contract basis is part of its medium to long term strategy.

Biotechnology companies, which have almost doubled in number during the past five years, contribute to the need for third party manufacturing as they seek ways of bringing their products to market without making capital investments in their own manufacturing facilities. Several biopharmaceuticals are presently in the late developmental stage and their imminent approval could see a wave of new products entering the market. These bio pharmaceuticals include sterile injectables and oncology products, which are the largest product segments among biopharmaceuticals. As biopharmaceutical companies are looking to narrow their focus to research and development, there is likely to be an increased demand for higher manufacturing capacity in sterile vials and syringes.

Manufacturing plants across regional boundaries as well as complying with differing regulatory environments and requirements are encouraging the outsourcing of manufacturing and related processes among pharmaceutical and biopharmaceutical companies.

"While North America is the market leader in terms of revenue share, followed by Europe, it is Asia and the Middle East that is expected to show strong growth due to the huge manufacturing capacity available in the region," says the analyst. (Frost & Sullivan; August 17, 2005) Given that development and manufacturing of biopharmaceutical products requires both a significant capital investment and potentially high operating costs, many pharmaceutical and biotechnology companies, both large and small, have begun to rely on third party contract manufacturers to produce their products. Companies such as Merck & Co., Pfizer, and Roche are significantly decreasing their manufacturing footprints and outsourcing more of their active pharmaceutical ingredient (API) needs. Outsourcing strategies range from the use of third party contractors, who manufacture the product and perform the related activities from pre-clinical development to commercial manufacturing to selective use of contractors to manufacture material for specific phases of clinical development or commercial sale.

Biotechnology companies without the capital to build manufacturing facilities can use contract manufacturers to produce their product and still maintain control over the regulatory process. This along with recent changes in post-approval for drugs that have been simplified now allow manufacturing processes to change as technology improves. These changes in the regulation of biologics opened the door to the use of contract manufacturing for biologic products not only for clinical trial material but for commercial material as well.

Saudi Bio will benefit from this trend as large pharmaceutical companies will need to have their products manufactured locally to cut down on costs. Saudi Bio has several years before its Facility is operational. There will be time available to secure accounts for the utilization of the Facility for third party manufacturing and there are many organizations that are looking for these CMOs. The waiting time in existing CMOs are long and take over 6 months to complete a job. Once established, Saudi Bio will be ahead of the rest in the GCC countries and be able to provide such services from the Facility.