To mark its 10th anniversary, Drug Discovery & Development magazine invited pharmaceutical and biotechnology companies to reflect on the history and made predictions about future of the industry. Featured here are verbatim comments from this company.

BioMS Medical Corp.

Headquarters 
Edmonton, Alberta, Canada

Years in Drug Research 
10 years

Spokesperson
Kevin Giese, CEO and President

Web site 

About the company/organization
BioMS Medical Corp. is a Canadian based biotechnology company engaged in the development and commercialization of novel therapeutic technologies. The lead technology, dirucotide (MBP8298), is for the treatment of multiple sclerosis (MS) and is being evaluated in two pivotal phase III clinical trials in secondary progressive MS (SPMS) and a phase II clinical trial in relapsing-remitting MS (RRMS). The drug has demonstrated efficacy in previous trials to delay median time to disease progression for 5 years (European Journal of Neurology, 2006). To date, there is over 1000 combined years of patient treatment experience with no safety concerns and the company has 100+ patents issued in over 30 countries (8 U.S. patents issued). In December of 2007, BioMS entered an exclusive global licensing and development agreement with Eli Lilly and Company. The FDA has recently granted dirucotide fast-track designation and the U.S. Phase III trial enrollment is complete.

A 10-year perspective: Advances and roadblocks
The focus for BioMS is not so much early research but rather clinical development. For the past decade BioMS has been developing dirucotide (MBP8298). The compound is currently being evaluated in two pivotal phase III clinical trials in secondary progressive MS (SPMS) and one phase II clinical trial in relapsing-remitting MS (RRMS).

The biggest change has been in the regulatory environment; some jurisdictions which historically were open and more collaborative are now more restricted and less prone to give open helpful advice. Conversely, others have adopted programs which have improved their access.

BioMS has also seen the emergence of new jurisdictions which offer the opportunity to conduct quality clinical trials - such as Central and Eastern Europe. This new development, although it involves many new operational environments with new processes and languages, has been a positive one.

R&D Challenges in the next 10 years
The most fundamental challenge for companies developing drugs for multiple sclerosis will be trial enrollment. Companies will likely struggle to enroll enough eligible patients, on a worldwide basis, in a reasonable timeframe. This is largely a function of the increased research in the area, particularly in the early stages of MS known as Relapsing Remitting.

Business/regulatory challenges for the next 10 years
On a business level, the biggest challenges will involve getting access to capital for biotechnology in general. The industry is high risk and requires lots of capital. However, funding for non-US based companies with less mature venture capital markets tends to be lighter in volume. Investors are often hesitant to finance early stage technology.

Bold Prediction: Where will the company/organization be in 10 years?
In ten years, BioMS could be receiving significant royalties from one of the largest selling MS drugs on the market, and successfully developing a mid-stage pipeline with the delivery-focused management team assembled.

Bold Prediction: Where will the industry will be in 10 years?
The industry outside of the U.S. will have more government involvement in early stage capital support. This involvement will ensure the flow of early stage research efforts into viable technology development companies.