In conversation with Dr. Erich Mohr

Dr. Erich Mohr enjoyed his time in academia as a neuropsychologist at the U.S. National Institutes of Health and University of Ottawa.  But he couldn’t resist the entrepreneurial call when it came knocking in 1996. Teaming up with a good friend, they formed CroMedia Global, a contract research organization that grew to 550 employees in 12 countries by 2002, when it merged with PRA International, the No. 7 CRO in the world.  CroMedia represented one-third of the merged firm and PRA two-thirds.  Dr. Mohr stayed with the new company through 2005 when he retired, but not for long.  His newest creation, closely held MedGenesis Therapeutix of Victoria, is making waves with a new treatment for serious neurologic diseases called convection-enhanced delivery (CED).  Backed with a GDNF (glial cell line-derived neurotrophic factor) protein licensed from Amgen (NASDAQ:AMGN) and collaboration with Biovail (TSX:BVF; NYSE:BVF), MedGenesis and Biovail are tackling Parkinson’s disease.  In this exclusive interview with biotuesdays.com, Dr. Mohr explains the potential of CED and its potential to transform the practice of neurology and the treatment of neurologic diseases.

What exactly is convection-enhanced delivery?

CED is a technique that provides for targeted, local treatment of central nervous system conditions such as Parkinson’s disease, epilepsy and brain cancer.  It introduces drugs with image-guided delivery through a minute bore hole to a pinpoint target in the brain, circumventing the blood-brain barrier.  The technology relies on pressure by displacing the fluid between the interstitial spaces.  That enhances your coverage from a couple millimetres to several centimetres.  And more importantly, it allows you to target where you want the drug to go, which offers a whole new universe of possibilities in terms of drug delivery over other diffusion-based delivery approaches.

How did you put the technology together?

Initially, we incorporated software developed by a group in Germany called BrainLAB, one of our collaboration partners.  Since the characteristics of tissue in the brain differ from tissue to tissue, the tricky part is to predict how a drug will distribute within the brain.  So, it’s basically about fluid dynamics.  What BrainLAB did was develop a piece of software that allows the neurosurgeon to simulate the placement of a catheter and the distribution of drug in the brain.  That gives us the ability to deliver drugs much more accurately.

The second piece of the puzzle came from another group that we are working with called Renishaw plc, a major British engineering firm.  They developed a catheter system, where the diameter of the catheter gets increasingly smaller in order to control reflux.  They also created a novel port system, which is implanted under the skin at the injection bore hole on the skull.  It is not visible, stays there permanently, is sterile and lets your neurologist infuse you with GDNF as needed.

The third breakthrough in the technology is one that we developed ourselves, which is to verify what the surgeon has done.  It’s a liposomal-encased imaging agent that’s injected ahead of the drug and allows us to verify that the surgeon actually did what he intended to do.  Verification is the key in CED, and it is done with an imaging agent.

How did your licensing deal come together a couple of months ago?

With the technology platform in hand, we approached Amgen, which has a lot of interest in its GDNF platform. But Amgen wasn’t going to give us this estate without significant financial backing.  We were in discussions with a number of venture capitalists, and then the world economy collapsed, and there was no more money.  So, there was no possibility of us doing this on our own.  A connection was made to Biovail, which had a new strategy in place to pursue CNS diseases.  And after some months of discussions about how to structure a relationship, we reached, in a five-way, the deal with Amgen, Biovail, Renishaw, BrainLAB and us.

[Editor’s note: Under the agreement, MedGenesis and Biovail acquired exclusive, worldwide rights to the GDNF protein from Amgen for CNS indications, with MedGenesis acquiring rights for non-CNS indications.  Amgen will receive regulatory and sales-based milestone payments and royalties, while Biovail assumes all commercial manufacturing responsibilities.]

In addition, MedGenesis granted Biovail a license to its CED intellectual property and technology, and both companies will collaborate to develop the GDNF protein in Parkinson’s disease and potentially other CNS indications.  MedGenesis has received an upfront payment from Biovail and is in line for milestone payments.  Biovail is funding the preclinical and Phase 2 development program, and the cost of a Phase 3 clinical trial will be shared by both companies, with each having an approximately 50% economic interest in the commercial product.]

What are the timelines with Biovail?

We are now working on the technology transfer and manufacturing aspects of the deal, so everything is on track, and we will be having a pre-IND meeting with the FDA in the next few weeks.  A Phase 2 clinical trial is scheduled to start next February, depending on our meeting with the FDA about the preclinical toxicology and Phase 1 data produced by Amgen.  If things go according to plan, the Phase 2 results should be available in April of 2012.

What’s the unmet medical need in Parkinson’s?

Parkinson’s is now treated symptomatically, so all we’re able to do is treat the symptoms of the disease.  The biggest issue in this context is that the therapeutic window becomes narrower over time and motor complications arise in patients.  There is no therapy that modifies the course of the disease, and our hope is that we can achieve that with GDNF.  What we’ve seen in the early research is that GDNF induces some spreading of surviving neurons and helps restore some of the function of the dopamine-producing nerve cells.  We’re incredibly excited to have the opportunity to work on one of the most promising frontiers of medicine.  It’s not very often you get a chance to do that.  So, I love coming to work each morning.

What’s the market potential?

If this works, it will transform the practice of neurology and the treatment of neurologic diseases.  Parkinson’s is just one indication, though the most promising one, but there are others.  In none of the indications do we have disease-modifying treatments available, so this would really be a game changer.  Or as my friend Bill Wells, the CEO of Biovail, likes to say, “If this works, it is a moon shot.”  Our target for regulatory approval is 2014.

What’s the status of your other programs?

Parkinson’s is our lead product and the only clinical stage program we have currently.  Our other projects are intractable epilepsy and glioblastoma multiforme (GBM) brain cancer.  They are also CED plays that involve accurate delivery of therapeutics to the disease site.  In the epilepsy platform, we’re still doing preclinical work. Intractable epilepsy, which is no longer treatable with oral agents, affects about one million Americans.  The brain cancer program is nearly finished at the preclinical stage and has been granted orphan drug status in the U.S. and Europe.

Who are the major shareholders of MedGenesis?

I financed the company personally with several million dollars at the beginning, and I control about half of the company.  Amgen has a small minority interest.  And the next largest shareholder is Andy Grove, the former chairman of Intel.

Any plans to go public?

Not at this time.  But if the Phase 2 program is successful, it would be one of our options.  The Phase 3 program requires us to raise money, because we will be responsible for one-half of the costs.

Dr. Erich Mohr Title: Chairman, Chief Executive Officer and Founder of MedGenesis Therapeutix Inc. Born: Nov. 7, 1954 Education: PhD (Neuropsychology), University of Victoria, Victoria, B.C.; MSc (Neuropsychology), University of Victoria, B.C.; BA (Psychology), BSc (Chemistry/Biology), University of the Pacific, Stockton, California.

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