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BIO Innovation Zone Company Snapshots: CONTINUUS Pharmaceuticals

June 4, 2015
This month in Philadelphia at the BIO International Convention, BIO will be partnering with the National Science foundation (NSF) and the National Institutes of Health (NIH) to host the 2nd annual, newly-expanded BIO Innovation Zone. The Zone will feature Small Business Innovation Research (SBIR) funded early-stage biotech companies.

The SBIR/STTR program provides U.S. federal funding to small businesses engaged in research with the potential for commercialization. Each of the companies has been rigorously vetted through the SBIR/STTR review process prior to receiving the non-dilutive funding to engage in R&D that has the potential for commercialization. The NIH and NSF invest a combined $940 million annually in the programs.

Today, we spoke with Bayan Takizawa, MD, MBA, the Co-Founder and Chief Business Officer for CONTINUUS Pharmaceuticals, a Woburn, MA-based biotechnology company supported by NSF’s SBIR program.

What is your company’s lead product or technology? 

CONTINUUS’s product offering is called Integrated Continuous Manufacturing, or ICM.  This is a technology that was developed at the Novartis-MIT Center for Continuous Manufacturing, a $65M joint research endeavor that started in 2007 and was able to successfully develop the first-of-its-kind first pilot plant able to produce finished drug tablets from raw chemical ingredients through a fully automated, integrated continuous process. Through ICM, the production lead time for a marketed hypertension drug was decreased from 200 days to 2 days. Other advantages of ICM include a 90% reduction in plant footprint, projected 50% reduction in COGS, improved quality assurance, and reduced environmental impact.

CONTINUUS’s product offerings include the end-to-end manufacturing processes (ICM), as well as targeted solutions for current development and/or manufacturing challenges.  With the former, CONTINUUS will develop ICM production lines for clients. In this way, pharmaceutical companies will be able to produce their drugs more cost-effectively, while ensuring better quality than is possible with current batch manufacturing processes. With the latter product offering, CONTINUUS will offer companies the ability to utilize specific novel continuous unit operations in their development and/or manufacturing processes.  More specifically, our novel continuous unit operations encompass continuous chemistry, continuous separation and purification including crystallization, and continuous drug product formation and coating.

How has the NSF SBIR program helped your company grow?

The NSF SBIR program has been instrumental in the growth of our company. Our current SBIR project has allowed us to advance our technologies significantly, bringing them closer to commercial implementation. Through this work, we were able to engage a major global pharmaceutical company in a follow-on collaborative project. The financial support from the SBIR grant has been extremely helpful. Also, as we participated in the NSF’s Beat-the-Odds program, we were able to better understand our customers and targeted markets. As a result, we adjusted our product offerings to better address potential clients’ needs. This has helped us advance many of our ongoing discussions with pharmaceutical companies, as well as attract new ones. Finally, the prestige of being a NSF SBIR awardee has allowed us to draw interest from more potential clients.

What are the upcoming milestones and long-term priorities for your company?

Our next major milestone is to sign a contract with a pharmaceutical company for the development of an ICM process for drugs of their interest. Through this work, we hope to establish ourselves as the manufacturing partner of choice in the pharmaceutical industry.  Other short-term priorities include the sale of specific novel continuous unit operations that will help pharmaceutical companies overcome limitations of their current batch process technologies. We believe that this could be an easier entry point for many companies who will soon after request ICM lines for their drugs. In addition, the sales of these unit operations represent an important source of revenue for CONTINUUS.

What do you hope to gain out of your participation at the 2015 BIO International Convention?

Our main objectives at the 2015 BIO International Convention are to help educate other companies on the benefits of Integrated Continuous Manufacturing, and to find potential clients for whom we could provide significant value through the implementation of this novel technology platform.

Tell us something about your company that investors might not know.

In addition to our work with pharmaceutical clients, we are exploring other different opportunities. For example, we are in discussions with philanthropic organizations to determine how ICM can increase patient access to critical medications in developing countries. Specifically, we are focusing on several HIV medications, and how ICM can reduce their cost structures and improve their supply chains. This work, though, could easily be extended to other life-threatening diseases, such as malaria. We believe that our technology has benefits across the entire supply chain, and when implemented, will provide advantages beyond just reducing manufacturing costs. For example ICM will help bring drugs to market faster, enable the production of personalized medicines, and eliminate many of factors that contribute to drug shortages.