Q. What is Boston Oncology?
A. Boston Oncology is a U.S.-based biopharmaceutical company with an affiliate, Tadawy, Bio-Medical Co. based in Riyadh, Saudi Arabia. Boston Oncology is establishing manufacturing and commercial capabilities in the emerging markets throughout the Arabian Gulf, Middle East, North Africa, Latin America and Southeast Asia. We are establishing local manufacturing for the most widely used specialty small-molecule and biotechnology drugs, increasing availability and affordability for a rapidly growing patient base.
Q. Why did you choose the name “Boston Oncology”?
A. We chose this name because our company embodies the quality, reputation, and innovation that are synonymous with Boston – a city world-renowned for its medical community, especially in the areas of cancer research and care. Incidentally, Boston is where our founder and CEO, Abdullah Baaj, M.D. PharmD grew up and attended medical school.
Q. How do you compete with other pharmaceutical companies?
A. Global pharmaceutical companies’ supply chains are based on large-scale, centralized production. These operations can efficiently serve large, established customer bases like those in North America and Europe, but we believe they have insufficiently served developing markets where the institutions and populations are rapidly changing. We will compete by setting up local manufacturing centers that feature cutting-edge single-use technologies that enable high-quality, small-batch production. This flexible production technology allows Boston Oncology to more quickly adapt to changing market needs and product developments.
Q. Do you import your drugs or manufacture them?
A. Both, depending of the stage of operations and the needs of the local market. Our business model calls for us to enter a given market over two phases. In stage I, we temporarily import drugs while construction of the manufacturing centers is underway. This allows us to begin clinical trials and product registration in the local markets more quickly and introduce the quality of drugs to our valued physicians and patients. During stage II, we produce the drugs locally from the manufacturing centers. We plan to perform cGMP- and local FDA-compliant manufacturing of pharmaceuticals in market. Depending on the size of the market and the technical requirements of each product, we may perform a combination of bulk production, fill-and-finish and secondary packaging.
Q. What are your prices?
A. Prices differ depending on the drug, its life cycle, and the ease of manufacturing. Generally, generic drugs have lower prices than originator brands containing the same compound.
Q. Are you a generics company?
A. Through our joint ventures, Boston Oncology expects to manufacture generic drugs and biosimilars under license and agreements with high-quality, globally experienced pharmaceutical marketers, researchers and manufacturers.
Q. Does Boston Oncology plan to manufacture more than oncology drugs?
A. While our initial focus was oncology care products, including cytotoxic chemotherapies and biologics, our growing portfolio and pipeline includes products to treat rheumatoid arthritis, bacterial infection, diabetes other specialty conditions.
Efficacy and Safety
Q. Have your products been tested or backed by any studies?
A. Yes, the generic small-molecule drugs and several of the biologics in our portfolio have been used with confidence for many years in countries throughout Europe, Latin America and Asia. As for cutting-edge therapies not yet commercialized, they will undergo thorough clinical trials before we introduce them in local markets.
Q. How do you ensure the quality of your products?
A. Our drugs are manufactured according to the strict production standards of our globally recognized suppliers and the drug regulators in our target markets. We base our state-of-the-art manufacturing facilities on the World Health Organization’s manufacturing guidelines, and we ensure our employees receive training on the most current pharmaceutical production processes.
Q. Are any of your drugs approved by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA)? If not, what approvals are required?
A. Boston Oncology does not plan to distribute or sell products in the U.S. or Europe, so our current portfolio of products does not require approval from these governing bodies. Nonetheless, almost all of our small-molecule generic drugs have received approval from either the FDA or EMA. Our products undergo all testing required by local drug administrations in each market before commercial sales begin.
Regulatory and Legal Issues
Q. Are there any patents on the drugs you manufacture?
A. Patent laws and product-specific patent coverage differ among countries. We manufacture generic and biosimilar products in accordance with local laws and industry regulations. Our products are not branded, not patented, and are marketed locally only after we have satisfied all necessary registration to ensure compliance with outstanding local patents.
Q. Will regulatory and legal issues change as you expand and enter new countries?
A. Yes, as we expand into new markets, we will be prepared to comply with any unique laws relating to the production and distribution of pharmaceutical products. We will only enter new markets after first completing the proper regulatory due diligence and obtaining all necessary licenses and approvals.