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BioSpecifics Technologies Corp. (BSTC-NASDAQ) |
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October 16, 2009 Issue |
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BioSpecifics Technologies Corp. Achieves Recent Milestone As Advisory Panel For The FDA Arthritis Committee Approves XIAFLEX™ For The Treatment Of Dupuytren’s Disease With A Vote Of Twelve To Nothing |
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BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for three clinical indications: Dupuytren's disease; Peyronie's disease; and Frozen Shoulder (adhesive capsulitis).
Its strategic partner Auxilium Pharmaceuticals,
Inc. currently has a Biologics License Application under priority review
with the U.S. Food and Drug Administration to market XIAFLEX™ in the U.S.
for the treatment of Dupuytren's disease. Pfizer, Inc. is responsible for
commercialization of XIAFLEX™ for the treatment of Dupuytren's disease and
Peyronie's disease in Europe and other territories. Mr. Wegman has served as an officer at BioSpecifics for more than 15 years and has been a member of the Board of Directors since 1994. Prior to his appointment as President on October 17, 2005, he served as the Executive Vice President of the Company. He has over 30 years of experience in the biopharmaceutical industry managing company operations, drug development, licensing and registration.
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Interview conducted by: Lynn Fosse, Senior Editor, CEOCFOinterviews.com, Published - October 16, 2009
Mr. Wegman: The recent milestone for BioSpecifics Technologies was the advisory panel for the FDA arthritis committee, which was called to evaluate the submission for XIAFLEX™, an injectable collagenase for the treatment of Dupuytren’s disease. It was an extremely successful meeting. The panel voted unanimously with no exceptions, twelve to nothing in favor of the XIAFLEX approval.
CEOCFO: Is it typical for the FDA to approve unanimously? Mr. Wegman: We don’t have any data on how often unanimous approvals occur. But, most observers were very impressed with FDA’s strong support for the approval. It included not only the members of the panel, but the FDA representatives, including the head of the division who were extremely supportive of the data and the approval of the product.
CEOCFO: Would you give us a background about Dupuytren’s disease and how collagenase is used in its treatment? Mr. Wegman: Dupuytren’s disease is caused by an excessive accumulation of collagen in the palm and as the accumulation increases the fingers become progressively contracted. BioSpecifics has conducted clinical trials with injectable collagenase in a variety of indications over the years. We started looking at this a few years ago and realized that if we were able to inject the excess collagen cords with collagenase, we could potentially avoid an invasive surgery. Currently, surgery is the only proven technique for improving Dupuytren’s.
CEOCFO: How many people typically get Dupuytren’s? Mr. Wegman: If you tally all the people of the world, about 13 to 27 million suffer from Dupuytren’s disease, and that includes early cases. Our strategic partner, Auxilium Pharmaceuticals, Inc. has estimated that between the United States and Europe, there are 240,000 candidates on an annual basis that would be possible candidates for collagenase injections.
CEOCFO: What is the next step? Mr. Wegman: The next step for our XIAFLEX™, as a treatment of Dupuytren’s disease, based on the panel’s recommendation and the other data the FDA has been reviewing is for a decision on the approval of the product within the coming months. Auxilium Pharmaceuticals has said that they would make plans to launch the product within sixty days after approval. Other upcoming milestones would be the involvement of Pfizer, Inc. who is responsible for marketing the product in Europe. Auxilium Pharmaceuticals has said that Pfizer will submit for approval in Europe in 2010.
CEOCFO: What type of physicians would be using this product? Mr. Wegman: It would be primarily hand surgeons, but Auxilium Pharmaceuticals is also going to be reaching out to general surgeons and rheumatologists in their marketing efforts.
CEOCFO: How do you get surgeons to break with what they are used to and try your XIAFLEX product? Mr. Wegman: We have done a fair amount of market surveys and so has Auxilium, and we have been very pleasantly surprised by the response on behalf of the surgeons. Surgeons in general don’t like to do this type of surgery; they find it very tedious. It could take two to four hours in a difficult case. The other thing that surgeons understand is that many people who are older that have this disease are resistant to the surgery. It involves general anesthesia and Dupuytren’s itself is a disease that has an insidious onset, so you find older patients that say, ‘Look I have lived with this thing for many years, I don’t want to go for a bloody surgery that is associated with a high recurrence rate and the use of general anesthesia.’ However, something that can be delivered in the doctor’s office would be very appealing to that type of patient. So the surgeons are well aware of that preference on the part of the patient and they realize that this would actually expand their practice.
CEOCFO: Would you tell us about collagenase? Mr. Wegman: Collagenase is a molecule that our company is basically founded on. We are not a new company, actually our origins go back to the 1950’s and we developed the first collagenase therapy for wound debridement and that is a product that we sold for many years and it is still being sold today; it is very popular for management of wounds. We realized later on that perhaps by using it in an injectable form, we could remove collagen, which has a very wide therapeutic application, because just think about it, anytime you have excess scar tissue or excess accumulation of collagen, there are a variety of diseases that are associated with that condition. In fact, BioSpecifics has conducted clinical investigations in 11 different clinical indications. So the potential goes way beyond the ones that are actively being pursued today. That includes Dupuytren’s disease that we’ve mentioned, Peyronie’s disease and Dupuytren’s of the penis, which is where the penis is bent upwards to 90 degrees and that is caused by an excess accumulation of collagen. There is also Frozen Shoulder, which is due to adhesions around the shoulder capsule with very good results. So there are numerous applications for this product.
CEOCFO: How do you decide what to focus on at any given point? Mr. Wegman: In the case of Dupuytren’s it is because the clinical results are so good and the clinical endpoints were so clean and clear. We did put a lot effort into the findings in the early 2000s. We reached an agreement with Auxilium Pharmaceuticals in 2004 and they have been running with it ever since. They have been committed significant resources and we are getting very close to the finish line.
CEOCFO: What comes next? Mr. Wegman: We have a Phase IIb trial for Peyronie’s disease and Auxilium will announce the results of that trial by the 4th Quarter. So that is the next one we are looking for and based on those results, Auxilium expects to launch Phase III trials for Peyronie’s disease in 2010 and we will be looking for Pfizer’s involvement in the marketing.
CEOCFO: So you have good partners! Mr. Wegman: Yes.
CEOCFO: Will there be other application for collagenase down the line such as cosmetic areas? Mr. Wegman: After the product is approved, we can begin to look at new applications for collagenase.
CEOCFO: What does the financial picture look like for BioSpecifics? Mr. Wegman: BioSpecifics is in a good position; we have cash till the middle of 2012. We were able to raise money at a premium by doing pipes, so there is no pressing need for us to raise money at the moment. We slashed our burn rate in 2006, so we are well positioned.
CEOCFO: Is the investment community paying attention? Mr. Wegman: If you look at our share price increase there certainly has been more attention being focused on the company. I became president of BioSpecifics in late 2005 when shares were trading for .83 cents, and today our shares are trading around $31. There are those that believe that Auxilium Pharmaceuticals will be successful and therefore BioSpecifics will follow right behind them.
CEOCFO: Final thoughts; what should people remember most about BioSpecifics Technologies?
Mr. Wegman:
They should look at the vast potential of collagenase. They can see that the
latest application has been significantly derisked, after the successful
advisory panel and just a tremendous potential for the product going
forward. It is a very exciting time for our shareholders. |
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The recent milestone for BioSpecifics Technologies was the advisory panel for the FDA arthritis committee, which was called to evaluate the submission for XIAFLEX™, an injectable collagenase for the treatment of Dupuytren’s disease. It was an extremely successful meeting. The panel voted unanimously with no exceptions, twelve to nothing in favor of the XIAFLEX approval. - Thomas L. Wegman |
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