In conversation with Bruce Brydon

In conversation with Bruce Brydon

March 23, 2010 by leonardzehr · Leave a Comment

As the CEO of closely held Trimel BioPharma Inc., Bruce Brydon has been down this road before. For one thing, he ran Biovail for nearly eight years during its glory days from 1994 until mid-2002 for major shareholder, Eugene Melnyk. When Mr. Melnyk asked his former CEO to come out of retirement a couple of years ago and head up his proxy fight to implement a new business plan and strategy for Biovail, Mr. Brydon didn’t need a lot of convincing. After all, the pair had known each other since the late 1980s when Mr. Brydon worked for Biovail’s predecessor company. Though they failed to rally enough votes to win the proxy fight and install a new Board at Biovail, their plan to recreate at Trimel the success they achieved at Biovail is taking root. In this exclusive interview with BioTuesday.ca, Mr. Brydon for the first time provides a substantive overview of Trimel’s novel technology platforms, product pipeline and strategy going forward.

Tell me about the formation of Trimel?

When it became obvious that we were not going to prevail in the proxy fight, Eugene convinced me that we couldn’t walk away from the concept he had for Trimel. First of all, we had a lot of good ideas and, secondly, we wanted to prove to a lot of people we could again create a very successful pharmaceutical company. We started working on Trimel in the summer of 2008 after the proxy fight, and it was officially incorporated in October of that year.

What did Trimel have going for it at the beginning?

We had an idea that we could utilize our skills, knowledge and contacts in the area of drug delivery technology. But considering that drug delivery was becoming old hat and that it was going to be problematic as it related to premium pricing in the future, especially in America, we knew we had to mutate drug delivery into a different animal. We first determined that alternatives to oral dosage drug delivery technologies, the more traditional form, had not been fully explored. We then migrated to the concept of localized dosing technologies, or LDTs, which is a form of drug delivery but not in the typical, oral systemic dosage format.

Trimel is also working with known compounds, so we know they work. They are not new chemical entities per se, but we are doing the work as though they were because of the route of the administration.

What are LDTs?

They’re technologies we’ve acquired or developed that provide Trimel with an ability to dose, or deliver, a prescription drug to a patient that previously couldn’t be dosed or delivered in an efficacious or safe or convenient manner. Typically, the reasons why these medications couldn’t achieve success in the marketplace were that they either couldn’t be delivered orally or they had a large number of negative acute and long-term side effects.

What are your existing technology platforms?

One is an intra-nasal gel, which we have worldwide rights to, excluding Russia and Brazil. The other two, we obtained in the acquisition of Direct Haler of Denmark last fall. The intra-nasal gel technology allows us to put a drug that is difficult to deliver orally into a gel. A small amount of the gel is then deposited into each nasal cavity. The drug is then absorbed by the patient quickly and delivered without the typical adverse side effects that are common with drugs delivered orally or topically.

The Direct Haler technology, which won the European Drug Delivery Devices Product Differentiation Innovation of the Year Award from Frost & Sullivan in 2009, gave us a pulmonary inhalation delivery technology as well as a nasal dispersion delivery system. Both of these technologies improve the distribution of medications in three ways. First, each powder-form dosage is visible to patients so that they can see that their required dose has been administered. Second, the device is disposable so there is no risk of re-infection. This is particularly important as many multi-dose nasal devices are believed to contribute to re-infecting the patient with the condition they are actually trying to treat. And third, the dose is deposited at the site of action, which can greatly improve efficacy.

The site of delivery for all of these technologies is a key advantage. The delivery site(s) for our current three delivery technology platforms, the lung and/or the nasal cavity, in many cases will allow a drug to be delivered to the localized area, or area where the medical benefit or need is highest – the nasal cavity itself, or in many cases, the brain. We have seen brain activity achieved with our technology within minutes of dosing versus oral medications, which in many cases either can’t achieve sufficient brain-level activity or may take a very high level of drug to be administered orally for only a small amount of drug to reach the target.

What else did Direct Haler provide besides the technology?

The acquisition came with three product candidates that are in clinical development. Two of them are for asthma and one is for allergic rhinitis. Those two markets together are worth about $10 billion (U.S.) a year in the United States alone. We’ll be starting one of the asthma drugs in a Phase 3 clinical trial before the end of this year. The second product candidate, if things go according to plan, could start a Phase 3 before mid-2011. With respect to the allergic rhinitis drug, we are currently waiting for patent evaluations to confirm that we have a clear path. Other therapeutic areas we can start to look at include pain, diabetes, arthritis and other types of allergies. The point is these are very flexible technologies and they eliminate a lot of difficult problems surrounding the administration of these drugs orally.

What are the advantages of Direct Haler’s technology?

The average dry powder inhaler for asthma delivers only about 30% of the metered dose while our technology delivers in excess of 70% of the metered dose. This means that with the Direct Haler technology patients should be able to administer less drug, achieving better efficacy and with fewer side effects.

Statistics indicate that about 500,000 people with asthma end up in hospital emergency rooms in the U.S. each year. It is known that, since certain patients can’t “see” the dose they are taking, and they can’t feel anything after taking a dose, they take another dose, which can be very problematic. Our inhaler delivery devices are single dose units and you can “see” that the drug has been administered. It’s an easy to use, tremendous technology. As a parent, this technology will be very comforting as you can send a child to school with one or two doses, depending on how many doses are required each day, as opposed to having the child walk around with an inhaler full of drugs.

We also have a nasal dispersion product. The main advantage of our system is that the act of blowing the medication into the nasal cavity closes the soft palate at the back of the throat and thereby permits the drug to be delivered only to the localized area, which is the nasal cavity. With nasal sprays on the market, the act of “snorting” to administer the medication causes a significant portion of it to pass through the nasal cavity and into the back of the throat, where it is then swallowed. The act of swallowing a significant portion of the medication is both unpleasant and results in less medication being “active” where it is needed most.

The intra-nasal allergic rhinitis product segment is worth in excess of $1 billion annually in the United States. One of the reasons it’s so big, as discussed before, is that nasal spray units on the market have the potential to re-infect patients as they reuse the drug’s multi-dose dispenser. Our nasal dispersion device avoids this as it is a single dose system. It should also allow us to offer a lower dose with higher efficacy, as our device delivers the medication in a fully localized manner.

What’s your lead drug?

Our lead drug is called Compleo – which is Latin for “bring man up to strength.” It uses our intra-nasal gel technology and is for male hypogonadism, or “low T” for male deficiencies of testosterone. This market currently has annual sales in the U.S. of $1 billion. As research shows that only about 10% of males are being treated for this condition, the fully treated market for this indication could be much higher and perhaps explains why it has a current growth rate of 20%. At age 50, it’s estimated that males have only 35% of the testosterone circulating in their body that they had when they were 25. Patients with low T could have what has become known as “grumpy old man syndrome”, bone fragility, depression, pain and lack of sexual desire. Research also reports that it can take doctors two or three visits before they realize what medical condition they are dealing with in terms of the symptoms they’re presented with.

There are a number of gels, patches and injectables on the market for low T in the United States. All of these products have inherent problems, not so much with their performance, but with the use of the products. First, the gel products have black box warnings from the FDA to avoid accidental transference between family members. Secondly, the gels are known to be flammable. Nevertheless, gels represent about 80% of the $1 billion market.

Our drug is a gel that is absorbed through the nasal cavity quickly, usually in eight-to-10 minutes. This results in the delivery, or blood-level spike, of testosterone in the morning. This increased blood-level of testosterone then reduces during the day, mimicking exactly how normal male testosterone levels appear in the average healthy male. This peak-and-trough effect with our product could reduce the concern over other chronic side effects. While the unmet medical need for low T may be low, our product should be much more efficacious, a lot safer and a lot easier to use. And we believe our product will expand the $1 billion market tremendously and, given the product’s features and benefits, take business away from other products.

What’s the clinical status of Compleo?

Dosing in our Phase 2B clinical study is now finished and we expect to have results in the late April timeframe. We expect to meet with the FDA for a post-Phase 2B meeting and plan to start a Phase 3 clinical trial for this product before the end of the year. We also have a plan to start a small Phase 3 study in Europe shortly after we start the Phase 3 in the U.S. Given this timing, the European trial should be finished, filed and approved ahead of the completion of the U.S. program.

What’s your partnering strategy for Compleo?

The intent is for us to utilize a strategic marketing partner, with significant presence in its respective market, to commercialize all our products. Our plan is to finish the Phase 3 Compleo clinical study ourselves and manufacture the drug for the distributor. We are following 13 companies right now that we review on a monthly basis. Over the next year or so, we’ll start discussing Compleo’s features and benefits, its clinical status and its commercial opportunity with a number of them. These companies are all Specialty and Big Pharma top level companies, as opposed to bottom third companies. Over time, we’ll narrow our list down to the top two or three companies that are very keen for this product. Our management group has decades of experience in the pharmaceutical industry. As a result, we have existing relationships with most of our target list of companies. So, we anticipate favourable reactions when we do approach them to discuss the Compleo opportunity.

What’s the clinical status of your other nasal gel products?

We expect to be in a Phase 2 clinical trial next year with a gel to treat anorgasmia, or a lack of ability to achieve orgasm in women. There are no products currently approved in the U.S. to treat any form of female sexual dysfunction (FSD). Unlike the pills or gels currently under investigation for FSD that have to be taken or applied daily, we believe our product can be used on-demand – about 30 minutes before having sexual relations.

FSD is a broad disease category. Statistics reveal that 43% of women between the ages of 18 and 59 suffer from various symptoms, including decreased sexual desire and arousal, painful sexual intercourse and inability to achieve orgasm. Our projections indicate that the annual market for an “as needed” treatment for anorgasmia, instead of taking a medication every day, could exceed $5 billion. There is a significant unmet medical need for this recognized medical condition as treatment now includes sexual behavioural clinics where women are treated with Viagra, and creams and gels.

We have two additional gel products currently under development. One is for Parkinson’s disease and the other is for an anxiety agent to treat acute panic breakthrough disorder. Both are in preclinical testing now, but we expect to be in humans with Parkinson’s next year.

What do you notice most about running Trimel versus Biovail?

The major difference is that we have fewer customers at Trimel. By that, I don’t mean customers in the traditional sense. When you’re running a business, everybody that you touch in that business, whether it’s your employees, your board, or whomever it might be, is a customer, and they have needs that have to be satisfied. When you have fewer customers, you have a greater ability to act unilaterally. You can move your company forward at a much faster rate. Trimel is a completely entrepreneurial driven environment. Once a business’ head count starts measuring in the hundreds, it stops being fun.

How are you structuring yourself financially?

One of the things we believe is that we have a sufficiently strong reputation and a financially strong major shareholder to see us through. We believe our reputation would be of great assistance to us if we went to the market for funds, either through private equity, a reverse takeover or an initial public offering. We are confident we can generate additional funding internally from our existing shareholder base. We have about 55 shareholders currently and Eugene Melnyk owns about 85% of Trimel.

Are there plans to go public?

Our only plan is to keep all of our options open. There is no plan at present to become a public company. We know that, some time in this coming year, we are going to have to bring in additional capital. Seeking additional funding could come in the form of a loan from Mr. Melnyk, receiving additional capital from our existing shareholder base or partnering one of more of our product candidate assets. Fortunately, we have a lot of financing options that aren’t available to many other developmental stage companies.

DDD

Bruce D. BrydonTitle: Chief Executive Officer, Trimel BioPharma Inc. Born: January 4, 1947 Career Highlights: President and Chief Executive Officer, Biovail Corp. 1994-2002; President and Managing Director, Boehringer Mannheim, 1990-1994; Managing Director, Beirersdorf Canada; Healthcare Industry Consultant, Province of Manitoba; President, Professional Drug Systems, St. Louis.

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Disclosure: No positions