Holger Kunze:Accera, Axona® A medical food for feeding the brain in the fight against Alzheimer's




Episode Loading...




PharmaTelevision requires Javascript enabled and Adobe Flash Player to watch our programmes. If you do not have Flash installed, you can download it for free from the Adobe Flash homepage.

Improve your Internet experience and start watching exciting new video content.

Video title: Holger Kunze:Accera, Axona® A medical food for feeding the brain in the fight against Alzheimer's
Released on: October 22, 2012. © PharmaTelevision Ltd
Share/save this page:
Email
Bookmark
Facebook
Twitter
LinkedIn
Follow us:
RSS
Twitter
  • Summary
  • Transcript
  • Participants
  • Company
In this episode of PharmaTelevision News Review, filmed at BioPharm America in Boston Fintan Walton talks to Holger Kunze, CEO of Accera Inc
Accera 's medical food product Axona and it's relationship with Alzheimer's Disease
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at BioPharm America, in Boston in 2012. On this show I have Holger Kunze, who is the CEO of a company called Accera, welcome.
Holger Kunze:
Thank you. Thanks for inviting me.
Fintan Walton:
Pleasure. So Holger, Accera is a company that actually has a product, it's a medical food and in someways you can look at your company as a medical food company, but you have aspirations beyond that, as I understand. First of all could you describe what Axona your medical food, what it is and where does it fit in the, in relation to Alzheimer's treatment?
Holger Kunze:
Okay. Axona, is a very exciting product, because in the Alzheimer's disease the problem is that the natural utilization of glucose as energy source, which is the only energy source to brain can really use is somewhat inhibited, nobody knows why and with that it affects also the healthy brain cells of the Alzheimer's patients. Now Axona is a great product because it actually triggers the liver to produce ketone bodies which are the only alternative energy source the brain can use and with that we are able to help to feed the brain and keep the healthy cells hopefully healthy.
Fintan Walton:
So the, so to be clear this medical food is used alongside a normal diet, or is it a replacement for a diet?
Holger Kunze:
No it's not a diet product, it's used in association with any drug treatment that the patient is on.
Fintan Walton:
Okay. So again Axona is, it is works alongside a therapy, it is not the solution to Alzheimer's as a disease?
Holger Kunze:
Exactly.
Axona the medical food and it's mode of action
Fintan Walton:
It's a medical food, but how does the patient, what's the patient get do they get us a pill or what?
Holger Kunze:
Exactly, so Axona comes in a sachet and it's a powder, and you'll mix it with really any liquid either juice, or coffee, or water, it has a mild vanilla flavor to it. And the way to take it is after a meal in the morning, so after if your breakfast is your largest meal then you'll take it, you'll sip it after you have your breakfast, or if your lunch is your larger meal then you'll take it after lunch and the way it works is that then the ingredients are taken up directly by the liver and create ketone bodies which then basically gives the energy out to brain an alternative energy source to utilize.
Clinical development and commercialization of Axona
Fintan Walton:
Just talk about a little bit about medical food, because obviously you've had this experience, so most people will be obviously aware, who watch these programs with the normal way in which a drug will get to market, so with Axona how did you develop that product from a clinical point of view and to you were able to then launch it as a product that was then suitable for Alzheimer's patients?
Holger Kunze:
Well we followed actually the same path that the drug would. We went through the preclinical trials in mouse models, and dog models which is a very good model that drug is also used for Alzheimer's disease, and then we had Phase II trials where we were able to show a positive effect in the Alzheimer's patients that were utilizing Axona. And with that we decided, because we fell under the GRAS status of medical foods because the product is very safe that we would be able to launch it immediately and make it available to the healthcare professionals in treating Alzheimer's patients, because as you know unfortunately lot of drugs have failed in that category and the drugs that are on the market are only but so effective.
Fintan Walton:
So when you did the clinical, Phase II clinical trial"
Holger Kunze:
That's right.
Fintan Walton:
what effect did you see? What was the improvement that you actually saw?
Holger Kunze:
Yes, particularly in a sub group called ApoE4 negative which probably, roughly around 50% of the patients have that genotype. We saw a significant improvement in the ADAS-Cog change over 5 which is compared even to drugs what the changes are one and a half to 2 and a half is really significant. And the way our product works is that we feed the brain and in these patients where the inability of utilizing glucose as effectively as in the healthy brain we are able to get the body, the liver to create ketones which then are observed by the brain cells as energy source and work on the mitochondrial.
Axona's medical food claims
Fintan Walton:
Just, on the medical food element there is certain, obviously certain restrictions that you can have in terms of claims?
Holger Kunze:
Of course.
Fintan Walton:
So do you have any claims at all for Axona?
Holger Kunze:
Well our only claim is that we feed the brain, so we have the ability to function in that category. We do not have claims of reversing Alzheimer's disease for example or stopping the disease process and so forth like you have with the drugs. But we felt that because the product is so safe and there is nothing else out there that helps to feed the healthy cells of these Alzheimer's disease patients, our product is the only one on the market that we should be in a market and give the physician that product in the armamentarium in treating Alzheimer's disease , as you know it's a very complex and difficult disease to manage.
Fintan Walton:
But of course your product is a prescription only?
Holger Kunze:
Right, the way we positioned the product is that we promote the product to healthcare professionals, because we feel Alzheimer's disease is not a self diagnosed disease, it's something that is very serious, it needs proper healthcare professional management and care taking and we felt that healthcare professional is in their best position to determine the value of Axona in these patients.
Accera's future business prospective
Fintan Walton:
So what is the future then for Accera, in terms of your overall vision for the business?
Holger Kunze:
Okay. Well as you know many start-up companies the first thing usually that they struggle with is financing and the same was true for us, that we were not able to truly commercialize Axona because we just did not have the resources to do that. So most of our activities have been very specific to small geographic areas in the United States, we can almost call it test market. Now since I've come on board one of my main focus is has been on getting proper financing behind Accera as a company and we were very fortunate that we were able to partner with Nestle Health Science [PharmaDeals ID = 47840]. So with the financing from Nestle Health Science we are now able to do two major activities which we were unable to do before. One is to continue clinical trials on hypothesis, or hypometabolism and we are getting ready to kick off a large clinical trial 500 patients, it's a pharma ideal type clinical trial, so the outcome of that will then also determine our path whether into the drug market or drug category, registered category or while we still continue of course in the medical food side. The second very important factor is that up till now we have been very limited in being able to reach out to healthcare professionals to help to educate them on this phenomenon of hypometabolism. It's something they know about, but we certainly bringing it to the forefront, and with the financing that we have now we are able to significantly expand our sales force and our commercialization of Axona.
Fintan Walton:
Okay, so if we then look at the rest of your program that's going on within your company, could you describe what other products you are developing?
Holger Kunze:
Yes we have other substrates within our portfolio that like esters which would require us actually to go to full drug route. One of the other compounds that we have called 1204 which is similar to Axona, we are actually starting a big clinical trial right now which is, could be considered a Phase III clinical trial in close to 500 patients and with the positive outcome of that clinical trial we would have the opportunity then to also take that product the drug route.
Fintan Walton:
So these are all for what particular indication?
Holger Kunze:
All of our indications at this point in time are dealing with Alzheimer's disease or diseases where it is an associated problem with hypometabolism.
Fintan Walton:
Holger Kunze, thank you very much indeed for coming on the show.
Holger Kunze:
Well thank you for inviting me, and I really appreciate the opportunity. Thanks.
Fintan Walton
Dr Fintan Walton is the Founder and CEO of PharmaVentures . After completing his doctoral research on the genetics of cell proliferation at the University of Michigan(US)and Trinity College (Dublin, Ireland), Dr Walton gained broad commercial experience in biotechnology in management positions at Bass and Celltech plc (1982-1992).
Holger Kunze
President and CEO
At the time of this PTV interview Holger Kunze serves as President and CEO of Accera, Inc.. 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 Nestle 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 Nestle Nutrition Division, leading it to one of the top Medical Nutrition companies in the region with more than $250M in sales for 2011. Under his leadership, Nestle Health Science consistently delivered annual targeted top and bottom line performance and is gaining market share in all key markets. Prior to joining Nestle, Mr. Kunze held various managerial positions within Novartis for more than 15 years. From 2004 to 2007, Mr. Kunze led and managed the Consumer Health division of the Asia Regional Novartis Medical Nutrition business unit. During his tenure, Mr. Kunze established the Asia Regional Medical Nutrition Office in Singapore, supported and coordinated the acquisition of the Mead Johnson Adult Nutrition business and lead and managed the Medical Nutrition businesses for Novartis in 17 Asian countries. 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 where he stabilized and grew the business after several years of poor performance and high employee turnover. Additionally, he established a new product registration strategy in China, continued to grow market share and launched two new products in Taiwan. He also hired and built a new management team and launched two new products and gained market share in Hong Kong. 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 Procter & Gamble Pharmaceuticals and additionally worked as a scientist for Phillip Morris USA. Mr. Kunzeholds a B.S. in Biochemistry from Virginia Commonwealth University and is complemented by his MBA coursework at the University of Colorado.
PharmaVentures
PharmaVentures is a corporate finance and transactions advisory firm that has served hundreds of clients worldwide in relation to their strategic deal making in the pharmaceutical, life science and healthcare sectors. Our key offerings include: Transactions / deal negotiations; Product / technology valuations; Deal term advice; Due diligence & expert reports; Strategy formulation; Alliance management; and Expert opinion for litigation/arbitration cases. PharmaVentures provides the global expertise to ensure our clients generate the highest possible return on investment from all their deal making activities. We have experience of all therapeutic areas and can offer advice on both product and technology commercialization.
Accera, Inc.
Accera discovers and develops breakthroughs in treating central nervous system 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. Currently our product pipeline includes therapeutic treatments for Parkinson's disease, Alzheimer's disease and other age-related memory loss disorders. These products are in advanced clinical development where they have demonstrated significant efficacy and outstanding safety compared to approved drugs in the marketplace. Through our proprietary scientific platform, Accera is developing therapies that address metabolic deficiencies and provide an alternative energy source for brain cells. Based on our proprietary platform, our first product for Alzheimer's (Axona) targets metabolic defects in brain neurons. As an industry innovator, Accera's new and novel therapeutic approaches positively impact patients with neurodegenerative disorders , who are in need of effective, well-tolerated treatments, and their families. We are committed to improving the care and quality of life of patients.