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Accera, Inc. (Privately Held) |
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April 6, 2012 Issue |
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The Most Powerful Name In Corporate News and Information |
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CURRENT ISSUE | COVER ARCHIVES | INDEX | CONTACT | FINANCIALS | SERVICES | HOME PAGE |
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Accera, Inc. is Bringing Hope to Patients Suffering from Central Nervous System (CNS) Disorders - with their First Product for Alzheimer’s Disease, Axona Showing some Patients with Cognitive Improvements Within Weeks |
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Accera discovers and develops breakthroughs in treating central nervous system (CNS) disorders, focusing on serious and difficult-to-diagnose neurodegenerative diseases for which there are no simple tests, no cures and a lack of new, innovative treatments to improve quality of life for patients and their families. The company is pioneering unique scientific approaches to treating CNS disorders, through products with novel mechanisms-of-action that target the underlying factors giving rise to symptoms.
With more than 30 years managerial experience with multinational pharmaceutical and nutrition companies, Holger Kunze, currently serves as President and CEO of Accera, Inc., a privately-held, commercial-stage, healthcare company focused on the discovery and development of innovative therapeutics to treat central nervous system disorders. Mr. Kunze previously served as the Regional Business Unit Head for Nestlé Health Science’s HealthCare Nutrition Business Unit in the Africa, Oceania and Asia (AOA) territories. While managing more than 600 employees, Mr. Kunze integrated the Novartis Medical Nutrition Business into the Nestlé Nutrition Division, leading it to one of the top Medical Nutrition companies in the region with more than $250M in sales for 2011. Prior to joining Nestlé, Mr. Kunze held various managerial positions within Novartis for more than 10 years. From 2004 to 2007, Mr. Kunze led and managed the Consumer Health division of the Asia Regional Novartis Medical Nutrition business unit. Prior to his position as Manager for Novartis Medical Nutrition, Mr. Kunze served as the Region Head for Novartis’ Consumer Health “OTC” Unit in the Greater China area for nearly three years. Among Mr. Kunze’s other positions within Novartis included Managing Director of Consumer Health “OTC and Nutrition” Business Units in India, Bangladesh and Sri Lanka, Medial Nutrition Manager of Novartis Medical Nutrition business unit in Asia and Marketing Manager of Novartis Nutrition USA. Prior to his time with Novartis, Mr. Kunze held various managerial positions within Proctor & Gamble Pharmaceuticals. |
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Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – April 6, 2012
Mr. Kunze: I have been working in the healthcare industry for more than 30 years. In the last 20 years specifically, much of my focus has been in the medical food arena, both for Novartis and then for Nestlé. What interested me about Accera was its fantastic product, Axona, which is prescribed for Alzheimer’s disease. This is an area that today has seen very few new products developed. It also interests me that Accera is still in its startup phase. Axona has been commercialized for more than two years and given my experience building Greenfield projects in Asia, in combination with my entrepreneurial spirit, I look forward to building the Accera company.
Mr. Kunze: Axona is a prescription medical food intended for the clinical dietary management of the metabolic processes associated with mild-to-moderate Alzheimer’s disease. One of the well-recognized physiological hallmarks of Alzheimer’s is the brain’s inability to optimally metabolize glucose, its normal energy source. Energy to the brain cannot be shut off for a very long time or brain cells will begin dying. In Alzheimer’s disease, we believe the disease progresses because brain cells cannot be properly fed and the only other energy source the brain will utilize are ketones. Therefore, we designed Axona to produce an increased amount of ketones, which are then metabolized by the brain as an alternative energy source. The brain can use up to 60% of energy coming from ketones to ensure cells that are still healthy remain energized and function properly.
Mr. Kunze: A medical food is defined in section 5-b of the Orphan Drug Act as a food which is formulated to be consumed or administered under the supervision of a physician. It is intended for the specific dietary management of a disease or condition of which distinctive nutritional requirements are based. Medical foods are extensively used in hospitals for tube feedings for patients that cannot ingest or digest normal food properly. This class of therapeutics has been around for years.
Mr. Kunze: We have treated approximately 30,000 patients with Axona and have an estimated 3,000 to 4,000 physicians that have prescribed the product since its launch in 2009. Axona does extremely well in patients that are carriers of a specific gene, which account for about 50% of Alzheimer patients. While some patients will take up to 90 days before experiencing cognitive improvements, we’ve received feedback from physicians and caregivers of patients on Axona that have witnessed benefits within weeks.
Mr. Kunze: It is still relatively limited to a group of very specialized physicians who we have been able to call on with our relatively small sales force. This is because of our own internal funding and limitations. As the newly-appointed CEO of the company, I plan to broaden our sales force and implement a full communications and marketing initiative behind the product. We are seeking additional financing by having a larger partner company invest in Accera. With that funding, we hope to build an organization and a communications platform to ensure physicians, patients and their caregivers are fully aware of this very safe and effective product.
Mr. Kunze: The other products in our pipeline are currently on hold because of financial restrictions. As soon as we secure additional funding, we hope to continue advancing our pipeline; however, we are primarily focused on further investing in Axona to generate more clinical data to build its credibility.
Mr. Kunze: While there are drugs on the market to treat Alzheimer’s disease, there are no products that address hypometabolism, which is one of the hallmark signs of the disease. Right now, Axona is the only approved product in the market that addresses Alzheimer’s in this way.
Mr. Kunze: It’s just the nature of the industry. Healthcare professionals require clinical evidence, which again takes time and is costly. I read our sales reps’ reports on a weekly basis where they include comments from physicians, patients and caregivers about how there has been a dramatic improvement of patients after they started using Axona. One of the reasons I came across and accepted this role is because I truly believe this product is a wonderful product. It really does what it is supposed to do and the difference in patients’ lives is incredible. For example, just the other day a physician reported to us a patient that used to paint as a hobby and unfortunately stopped for a few years due to her disease progression. She was on Axona for a few weeks and when she came in and presented the doctor with a beautiful picture, he asked where she bought it. She replied saying, “No, I’m back to painting again.” This is just one very small example of how patients’ quality of life can be changed with this product.
Mr. Kunze: It costs about $2.50-$3.00 per day, depending on which pharmacy or chain from which it’s purchased.
Mr. Kunze: It’s less than $100 a month. We had a report recently where a patient’s caregiver reported their mother had gone back to the way she was two years ago, before her disease progressed so significantly. Again, our goal is to provide patients and their caregivers a better quality of life as they manage this terrible disease. In some cases, they can get up out of bed and go to the bathroom on their own, they can dress themselves, they can eat by themselves again, or they do not tell the same story repeatedly. This is the type of feedback we receive from the market and from patients using the product. I personally think $2.50 or $3.00 a day is a very reasonable price for that.
Mr. Kunze: We are ok as far as our existing team and as an organization, but we do have financial constraints. What we are looking for is to have an infusion of money that allows us to commence a broader sales and marketing effort. We are also looking for some direct to consumer communications, which helps consumers understand there is a product available that could potentially help them.
Mr. Kunze:
First of all, there are not many solutions on the market. There are about
two or three products available that are FDA-approved, but not with great
success. There have been approximately twenty products or compounds that
have failed in Phase II in just two or three years and not much on the
horizon in terms of clinical development. Even products that are under
development are at least five or six years from being approved.
Additionally, none of these products have a mechanism of action similar to
Axona that feeds the brain. If you cannot feed the body and keep the body
healthy, it will not be able to fight back on its own. Our goal has been to
feed the brain, so at least the healthy cells unaffected by the other
metabolic causes of Alzheimer’s disease can stay healthy and still function. |
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While some patients will take up to 90 days before experiencing cognitive improvements, we’ve received feedback from physicians and caregivers of patients on Axona that have witnessed benefits within weeks. - Holger Kunze |
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