AdeTherapeutics - people, partners and understanding the process

A novel and useful product is not enough to make a biotech company successful. It also takes the right people, the right partners and a clear understanding of both the regulatory process and the financial process to make a go of it.  

The co-founder and CEO of Innovation Place based AdeTherapeutics Inc. believes they have all of these elements lined up. Sanj Singh says the company’s vision is to be the worldwide leader in developing products that deal with complications related to surgery. He says the corporate slogan, Designed by surgeons for surgeons and their patients, expresses the people element that is key to the company’s success.

“Having MDs on our team gives us a better insight into what is actually happening in an operating room and what sort of problems surgeons encounter. All our MDs also have PhDs so they go from the bedside to the lab bench and then back to the bedside,” explains Singh. “They identify the need for new products that solve problems.”

The first problem being tackled is internal scarring after surgery. Post-surgical scarring is extremely common and can lead to chronic pain and other serious complications. AdeTherapeutics has developed and patented a novel therapeutic approach for the prevention and reversal of scar tissue using a liquid compound known as Evitar.

The compound was being produced under a different name and for non-pharmaceutical purposes by a German chemical company. It had FDA audited facilities, a drug master file which serves as another source document, and Good Manufacturing Practices (GMP) in place. It was a perfect fit for AdeTherapeutics who took them on as a manufacturing partner. “They are supplying us with the product on an exclusive basis for all therapeutic purposes and because they already have all the quality assurance controls in place, we’ve probably saved about five years and maybe $40 million.”  

A 12 to 15 year timeline is considered normal for the preclinical testing and clinical phases of developing a new pharmaceutical. AdeTherapeutics’ goal is to reduce that time through strategic partnerships and collaborations. That is good news for the business side of the process which is where Singh’s expertise comes into play.  “We’ve built up a team primarily of scientists, but I’m the business guy and I’m always looking at how we can make this company attractive to financiers and how to create value for our shareholder,” says Singh.

Singh says he believes many small biotechs fail because they don’t think about the capital markets and how they work. “Financiers have a formula and it doesn’t matter how good the science is, if you can’t project a rate of return that’s good enough, if you don’t have a unique place in the market and strategy on how to get there, if your science does not save money in the healthcare system, you will not attract the attention of financiers no matter how great the science.” 

So how is AdeTherapeutics attracting partners, collaborators and investors? “One of the key things we have going for us is the discovery of a novel approach to wound healing and by varying the formulation of our compound and mode of delivery we can expand across a wide field of areas. Each time the regulatory approval process will be that much faster because the safety of the product has already been established.”

AdeTherapeutics recently received Health Canada approval to begin the rigorous process of conducting clinical trials with Evitar. It’s a stage Singh anticipated since the early days of the company when he sent an email to the Center for Drug Evaluation and Research at the United States Food and Drug Administration (FDA). “I asked why there is such a high failure rate for biotechs and the woman who is now the Director responded saying it has nothing to do with the efficacy of the trials, it has all to do with how the trials are run. It’s the process,” explains Singh. 

To help with the process of running clinical trials AdeTherapeutics developed a strategic partnership with an American company, NUMODA Corporation, which specializes in providing logistical management for clinical trials.

NUMODA will help AdeTherapeutics better manage the process by providing entirely electronic data collection thereby eliminating paper and the potential for losing data. “If our clinical researcher is running a trial and jots a note on a piece of paper and then takes those notes and puts it into a case report, that little piece of paper becomes a source document that has to be kept for at least 21 years,” explains Singh. “If, during the regulatory review, someone asks to see that little piece of paper and we can’t produce it, that could be end of it and we would have to throw out all the data. Now we don’t have to worry about that, or at least the risk is minimized.”

Using NUMODA’s platforms for clinical trials also removes many of the logistical headaches associated with expanding the trials to other countries, a requirement of the final phase of clinical trials. 

In the end, the partnership with NUMODA is expected to dramatically compress the timeline for final regulatory approval and efficiently address any queries that may be posed by the regulators.

A variety of market opportunities are being explored. In mid November of last year, AdeTherapeutics announced the first of its clinical trials using Evitar to reduce the risk of scarring after ectopic pregnancies, a condition that frequently leads to future infertility. Just a few weeks later, it announced a joint agreement with a Dutch company to develop a form of Evitar for use in spinal surgery and craniotomies. Other collaborations and partnerships for different uses are also in the works. 

Singh says his team is aiming for the use of Evitar to become standard procedure in all surgeries and with an 80 percent plus success rate in their pre-clinical trials they are well on their way to achieving that goal.

“In 1927, the Annals of Surgery said adhesions, the internal scarring caused by surgery, were the biggest problem of surgery. In the 2010 Review, adhesions remain the biggest problem in surgery and if you talk to someone who had adhesions they will tell you about the chronic pain and the lack of treatment options,” says Singh. “There is such a need for this product.”

Singh says AdeTherapeutics has caught the attention of several larger pharmaceutical companies who are keeping a close eye on the clinical trials. “Think about it,” says Singh. “With 230 million surgeries performed worldwide every year, the potential for our product is… well we are hoping for bidding wars.”

In the meantime, Singh and the AdeTherapeutics team will continue to focus on their core competency – using research and innovation to develop new technologies and products to solve real world problems.

AdeTherapeutics is located in the L.F. Kristjanson Biotechnology Complex at Innovation Place in Saskatoon.

- February 2012