MisslingCoverChristopher Missling, Ph.D., CEO and President of Anavex Life Sciences Corp. (OTCQB: AVXL), talks with Opportunist’s Managing Editor Leslie Stone about his company’s portfolio of drug development pipelines for the treatment of Alzheimer’s and other central nervous system diseases.

Alzheimer’s disease (AD) is the most common type of neurological disorder that causes dementia. More than 5.2 million Americans have this debilitating condition, which results in loss of intellectual capacity—memory, thinking and behavior—and impairs both social and occupational functioning. A March 2014 study ranks AD the third leading cause of death in the United States, claiming more than 100,000 lives each year. And, according to the Alzheimer’s Association, it is also the most expensive medical condition in the nation, with direct costs to society of caring for those with the disease totaling an estimated $214 billion—including $150 billion in costs to Medicare and Medicaid.

As the U.S. population ages, the number of AD sufferers will increase dramatically. The Chicago-based Rush Institute for Healthy Aging estimates that the number of Americans diagnosed with AD will have tripled by 2050—to nearly 16 million. This will place a huge burden on the medical care system and society in general.

Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company engaged in the discovery and development of therapies and new drug candidates useful for the treatment of cognitive disorders such as Alzheimer’s disease, other central nervous system (CNS) diseases and several types of cancer.

Founded in 2006, the company is based in New York City and owns a portfolio of five drug development pipelines that are active in the treatment of AD, as well as those afflicted withParkinson’s, Amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig’s disease, Huntington’s disease, epilepsy, anxiety and depression.

ANAVEX-LOGO_JPG“This is the biggest growing market in the pharmaceutical space,” says Anavex CEO Dr. Christopher Missling. “We are all getting older, medicines are improving and expanding our lives; however, the only area where there is no improvement is in Alzheimer’s. This disease is highly correlated with older age, so the older you become the greater your chances of getting Alzheimer’s.”

Dr. Missling has more than 20 years of healthcare industry experience within large pharmaceutical companies, the biotech industry and investment banking. As an investment banker in the healthcare practice at Deutsche Bank, he served pharmaceutical, biotech and diagnostic companies. More recently, he was head of healthcare investment banking at Brimberg & Co. in New York. As head of financial planning at Aventis (now Sanofi), he worked on all aspects of financial strategy and M&A. He was also previously chief financial officer of Curis (NASDAQ: CRIS) and ImmunoGen (NASDAQ: IMGN) where, during his tenure, shareholder value significantly increased. He has a master of science and a Ph.D. in Chemistry from the University of Munich and an MBA from Northwestern University Kellogg School of Management.

Opportunist: Can you explain the relation between age and the onset of Alzheimer’s as well as any known causes of the disease?

Dr. Missling: Once someone reaches age 65, their risk of getting AD increases. Only five years later, it doubles. And from 75 to 80 it doubles again.

Genetic causes are limited. It is primarily caused by environmental factors, a lot of which we know are bad for the brain and also happen to be bad for the heart, diabetes, obesity and also schizophrenia, anxiety, psychosomatic illness, depression and trauma. NFL players have a higher chance of these diseases from getting injured during these sports. Poor sleep, sleep deprivation and so many other things that we intuitively know are not healthy will eventually accumulate over many years and cause chronic stress in the brain. The brain cannot withhold or stand up against these things and this will lead to the start of Alzheimer’s symptoms.

The chronic stress of aging in brain cells causes gradual accumulation of damaged proteins causing misfolding of proteins. Our drugs are able to reduce this misfold of protein concentration.

Opportunist: Please tell us about your portfolio of products specifically for Alzheimer’s and other CNS diseases.

AnavexDr. Missling: Our current pipeline includes ANAVEX 2-73, our lead investigational oral treatment for Alzheimer’s. This drug has shown potential in preclinical studies to prevent, halt or even reverse the course of the disease. Anavex 2-73 is the most advanced and has now started a Phase 2 study in patients.

We have a second candidate, ANAVEX PLUS, which is an add-on to the ANAVEX 2-73. It combines ANAVEX 2-73 and donepezil (Aricept), the best-selling Alzheimer’s drug with annual global sales of $4 billion. There is potential with this drug to modify the reversal of memory loss and neuroprotection in several Alzheimer’s disease models.

Our ANAVEX 3-71, which is for Parkinson’s disease and AD, is similar to Anavex 2-73 in that it targets stress by increasing the protein that is released in the brain to reduce stress but under-expressed in Alzheimer’s patients. We are able to adjust the dosage to reduce the effects of accumulation of chronic stress in the brain and, therefore, address the causes of the disease. Again, we are treating not only the symptoms but addressing the cause.

We have completed advance preclinical research with candidates ANAVEX PLUS, ANAVEX 2- 73, ANAVEX 3-71. Our preclinical research is ongoing for ANAVEX 1-41.

Opportunist: How does Anavex stand apart from the competition?

Dr. Missling: That’s a very good question. The key differentiating factor is that in the past there has been a very low success rate in developing Alzheimer’s drugs. This is mainly because the community targeted the most obvious and appropriate aggregation of plaques and focused on removing them from the brain. Removal was successful, but it didn’t translate into reduction of symptoms or improved quality of life. The plaques are a key element of the disease, but we are taking a different approach. Instead of directly removing the plaques, our drugs are targeting and treating the cause. Our data shows that a much more effective treatment reducing the plaques by treating the cause: stress on the brain cells. That is the differentiating factor.

Opportunist: What specific types of cancer do your drug candidates treat?

Dr. Missling: Pancreatic, prostate, ovarian and melanoma. They respond very well to the targets and drugs we have identified. Our current budget for cancer research is limited, but we suspect there will be application in other cancers in the future. We haven’t explored those yet because we don’t have the bandwidth to explore them. So we will continue as we go.

Our cancer compounds, such as ANAVEX 1037, are at various stages of pre-clinical development and may play an important role in preventing the spread—metastasis—of cancer cells throughout the body, as well as the formation of new blood vessels that enable cancer to grow and the proliferation of tumor cells. These compounds also show great promise at selectively killing human cancer cells without adversely affecting normal and healthy cells.

Opportunist: What is your primary role as CEO and president of Anavex?

Dr. Missling: Guiding the company strategically and operationally through the task of creating value for shareholders.

We have a wonderful extended network of scientists and scientific collaborators worldwide from the West to Europe. We select them based on their work, publications they have written and if we see that they are working on the areas that we feel are very strongly linked to the cause of disease. That is where we seek the collaboration.

Opportunist: Since your company’s new fiscal year just started in October, what are your goals for Anavex between now and Sept. 30, 2015?

Dr. Missling: We would like to see data on Phase 2 of our clinical trials, which we will have reviewed by then, and also show data on the preclinical experiments that are under way. We would also like to expand collaboration with other scientists and possibly license additional drugs and move forward with our existing pipeline.

Opportunist:Is there anything you would like to say to potential investors?

Dr. Missling: I would point out that Alzheimer’s disease represents an underserved multibillion dollar market opportunity. In the United States alone, this is between $13 billion to $67 billion per year. The biggest drug so far in this country was Lipitor, the cholesterol-lowering medication. From an investment point of view, the market we are targeting is even bigger.

Opportunist: What do you enjoy most about your work?

elderlywomanDr. Missling: That we are, hopefully, able to find a treatment or drug for curing this terrible disease that affects so many patients and families and caregivers. It is extremely dissatisfying to see the current treatment options. This has been my biggest driver for getting up early in the morning and working on these drugs. We have started Phase 2 trials and hope to have data by next year so that we can see how the drugs work on patients.

I have the passion to find a cure for this disease. It’s the only Holy Grail we are missing, and we have yet to find an answer on how to improve the situation. The richest person in the world cannot treat this disease today and that really shows what an enormous challenge we have ahead of us. Other indications that used to be deadly diseases, such as HIV and some cancers are now treatable and have turned into chronic diseases. There is only one deadly disease lacking an effective treatment, and that is Alzheimer’s. Being able to conquer this would be a significant reward independent of the commercial success of such an endeavor.

Opportunist: Have you been personally affected by Alzheimer’s?

Dr. Missling: My grandmother and grandfather were very late-stage affected. It’s very disheartening and sad to see people whom you love lose their personality and also their dignity as they are reduced to childlike behavior.

Opportunist: Where do you see the company five years from now?

Dr. Missling: I think if we have successfully completed and confirmed the data in Phase 2, we will move to a Phase 3 study. That could very well be an efficacy study, and if it’s successful and everything works out as expected, we will be able to apply for approval to sell the drug on the market in five years.

I want to point out that the appreciation for the mechanism is getting clearer and clearer. The targets we are addressing seem to be confirming all the evidence we are given every day. For example, last week we heard that anxiety can be a positive trigger for Alzheimer’s and that walnuts are very good for reducing stress in the brain. This is similar to what we want to achieve with our drugs. All the information in scientific publications and evidence is mounting to the role of increased chronic stress that has prolonged for many years and causes the later age to eventually break out and into Alzheimer’s symptoms.

LesphotoLeslie Stone is an award-winning writer, editor with more than two decades of experience covering business, finance, real estate and lifestyle issues for newspapers, magazines and online publications. Originally from Virginia, she currently resides between Florida and Michigan. Follow Leslie on Twitter: @lescstone.

Anavex Life Sciences Corp. - http://www.anavex.com/

Anavex has paid the writer $1,000 for services in connection with the preparation and publication of this article.