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I see Bio already got the link to you.
Rocalinda posted it on 2/3.
rocalinda Friday, 02/03/17 10:32:34 PM
Re: brichnyc post# 89811
Post #
89871
of 90439 Go
Here is the link:
http://www.thedeal.com/pharma-outlook-for-2017/
Our CEO is getting noticed. Bain?
Not that I am aware of Longterm and I have read every post (except those on ignore) for the last two years.
Longterm, what is the update on the BBQ?
Manufacturing Possibility ?
Biogen plans $1 billion plant in Switzerland (Article in Boston Globe July 2015)
By Robert Weisman GLOBE STAFF JULY 01, 2015
The Cambridge biotechnology giant Biogen Inc. plans to invest $1 billion in a new manufacturing plant in northern Switzerland that would triple the company’s global capacity to produce large protein-based drugs known as biologics.
Excerpt from Biogen's website
Manufacturing capabilities
Our quality team manages compliance and supervises consistent and dependable production of our therapies, while our supply chain group makes sure that we are able to get our therapies to patients, when and where they need them. The combination of these skills and focuses enable us to manufacture and supply medicines to patients in more than 90 countries.
In the coming years we expect to substantially increase our production capabilities by focusing on innovation that allows us to scale in advance of new pipeline products. Today we can rapidly increase production of small molecules and biologics, providing flexibility and protection to our supply chain.
In addition BIIB might have excess capacity due to the recent reduction of some of their pursuits.
Dr. Missling's answer to funding.
TWST: Do you have the financing you need to get through the development of ANAVEX 2-73 at this current stage?
Dr. Missling: Yes, we believe that sufficient financing in place and also because we are working with several foundations on specific diseases like the Michael J. Fox Foundation that has supported us very strongly for exploring ANAVEX 2-73 in a pre-clinical study of Parkinson’s disease, for which positive data was recently reported on September 22nd. And we also received support from the Rettsyndrome.org foundation, which also supported exploring ANAVEX 2-73 in a pre-clinical study in Rett syndrome, a rare disease for which Anavex received FDA orphan designation this year. We might continue these collaborations if the data continues to be promising.
Filed with SEC 10/21/16 This is superb Media coverage,
The Wall Street Transcript is a completely unique resource for investors and business researchers.
Over 20,000 CEO, Equity Analyst and Money Managers
EX-99.1 2 s104371_ex99-1.htm EXHIBIT 99-1
Exhibit 99.1
Christopher U. Missling, MS, PhD, MBA, President and CEO of Anavex Life Sciences Corp.
Please read the post closely. It was Falconeer that posted that statement on his post #83059 where he took issue with Feuerstein calling posters here profoundly stupid. Please review his background and posts.
I (drv17) am not debating anyone.
Plato- Please show us how you valued this stock at less than $1.00
You posted the same message on 1/5/17 referring people to Mt(?) feuerstein's expertise.
Feuerstein tweeted that the posters on this board are profoundly stupid and has been challenged to a debate by Falconeer on post #85039 Please see if you can arrange that debate.
falconer66a Wednesday, 12/14/16 10:22:12 PM
Re: 123tom post# 84524
Post # of 85039
“@Alz_Gal Don't try to reason with the Anavex crowd. They are profoundly stupid.”
Would love to sit down with Mr. Feuerstein and have a brief discussion of the primary, secondary, and tertiary structures of enzyme proteins, and just how those get mis-folded in dysfunctional rough endoplasmic reticula, disjointed from neuron mitochondria.
Profoundly stupid, am I?
Check back in a year. Neuron cytology and biochemistry will be the same. The status of Anavex — and it’s shareholders — will not be.
“What we need is a drug that slows down the death of the neurons, slows down the dementia process” he added.
Merck CEO: Alzheimer's Tsunami Coming
I think I have heard of a company that just might do something like that.
(Thank you 'nobrainer' for the post)
Basparks regarding "Done deal" I could not agree more. I have had that impression since September's BOD actions. Here were my thoughts at that time.
drv17 Member Level Friday, 12/02/16 09:53:38 AM
Re: None
Post #
81659
of 87239 Go
Merger Possibility?
HINTS! We are all aware of Dr. Missling's series of 1000 share buys prior to 2015 CTAD. Here is a listing of Anavex's SEC 8K filings that has served as more than just hints to me.
7/5/2013 - Dr. Missling's first contract for three years through
July 5,2016
7/5/16 - First amendment to his contract to extend employment for three years and also provided a large salary raise and many options to be vested over the three year period.
7/7/16 - Clarification of options plus an addition of the following
"UPON A CHANGE OF CONTROL ALL PREVIOUSLY GRANTED BUT UNVESTED OPTIONS SHALL VEST"
7/22/16 - Further clarifications of Missling's options.
Here is the listing of the quantity and dates of options granted to the granted to the BOD on FORM 4s filed with the SEC.
...............7/16/16..........9/22/16
Bernd.........50,000.........100,000
Favus..........1,500.........100,000
Skarpelos.... 50,000......100,000
Missling........................500,000 (In addition to contract options)
Boenisch......................106,696
Steffen.........................100,000
9/28/16 MTA to Biogen filed with the SEC.
????? QUIET PERIOD ?????
Also, Dr. Missling has stated many times that there is no need for funds.
I have a feeling that the BOD has all of the information they need and I'll rely on that.
Here is an Bloomberg article about Biogen.
Biogen’s CEO Is Out After Management Changes, Stalled Sales
by Doni Bloomfield
July 21, 2016 — 7:07 AM EDT July 21, 2016 — 11:48 AM EDT
George Scangos to leave in ‘coming months’; search beginning
Adjusted earnings beat estimates; share buyback announced
George Scangos. Photographer: David Paul Morris/Bloomberg
Biogen Inc. Chief Executive Officer George Scangos, who helped build the U.S. drugmaker into a powerful player in multiple sclerosis treatments, will leave the company after a series of top managers were replaced and sales of its biggest product stalled.
Scangos, 68, will stay on until a replacement is found, Biogen said in a statement Thursday in which it also reported second-quarter earnings. In the last year, the Cambridge, Massachusetts-based company announced new heads of sales and research, and its biggest product, the multiple sclerosis pill Tecfidera, disappointed investors.
His departure wasn’t a shock, given the company’s recent performance, Michael Yee, an analyst with RBC Capital Markets Corp., said by e-mail. “This is one where people thought there could be change given all that has gone on in the past year or so. The company’s next leader will face many of the same challenges that Scangos did in recent years -- how to advance the research and development pipeline of a storied biotechnology company that has made big, risky bets in diseases like Alzheimer’s, with mixed results. They’ll also need to boost sales of current products, which have surprised investors -- for good and bad -- in the competitive multiple sclerosis market.
Biogen will likely look outside the company for a new chief, according to Geoffrey Porges, an analyst at Leerink Partners.
Swooping In
“I imagine what they’re looking for is someone who’s already running a smaller company or has a track record of leading an integrated business unit focused on the neurosciences,” he said. Biogen has said it plans to concentrate on neurological drugs, and is working to spin off its treatments for the blood-clotting disorder hemophilia as a separate public company.
(My emphasis here.)
I understand the autofill.
Maple - You stated Austria in your post a portion copied here
"Post #
86661
of 86757 Go
Plato,
You might be right but can't ignore some patients getting better, and several TV interviews in Austria should not be wrong...."
I have seen all of these from Australia since I follow AVXL very closely and read every post and know that there has not been any work done in Europe. I just have a feeling that you are new and maybe not too good of a source of information. Thank you for responding.
Maple tree Give me links to AUSTRIA TV interviews please. Since you have been in this stock for over two years you must have good information available.
I must have missed them. TIA
I am hoping we will see the NIH pitch in here for a US trial like the Aussie's National Health and Medical Research Council does.
(Page 26 ) Alfred Group annual Report 2015-16
Research through partnership
This year’s achievements included care to prevent HIV infection, hope for those suffering severe asthma and dementia and a breakthrough in fighting blood cancer. We continued to attract a high level of funding from the National Health and Medical Research Council.
Dr. Missling has stated many times that there is no need to get additional funding at this time or something to that effect. He has not lied to us yet. I'm reminded of something I heard years ago---" Some people quit talking long after they have finished what they have to say".
Funding? MacFarlane does the research at Caufield Hospital a unit of the Alfred Group in Australia. Here are some excerpts from Alfred Group's Annual Report 2015-16 published August 2016. This indicates that a great deal of funding comes from partnerships.
(Page 4 - Alfred Group annual Report 2015-16)
Chairperson and Chief Executive’s Year in Review (continued)
Discovering the next generation of care Partnerships continued to underpin significant research developments that informed clinical practice in Australia and overseas. Researchers from The Alfred answered the long-held debate over whether aspirin should be stopped before coronary artery surgery. The results of the 10-year international study showed no increased risk of surgical bleeding or need for blood transfusion associated with asprin use. Scientists from The Alfred and Monash University made a breakthrough in targeting aggressive blood cancers through combination therapy, giving hope to people suffering from Acute Myeloid Leukaemia. At our Caulfield campus, early research results from the international drug trial of Anavex 2-73, which aims to address the symptoms of dementia, were positive. Also significant was the announcement of PrEPX, a new public health research study supported by Alfred Health, the Victorian Government and the Victorian AIDS Council. This study will expand access to pre-exposure prophylaxis (‘PrEP’) medication to prevent HIV infection in people who are at high risk.
(Page 26 )
Research through partnership
This year’s achievements included care to prevent HIV infection, hope for those suffering severe asthma and dementia and a breakthrough in fighting blood cancer. We continued to attract a high level of funding from the National Health and Medical Research Council.
(Page 27)
Alzheimer’s drug trial success
Early research results of Anavex 2-73, a drug which aims to address the symptoms of dementia, are positive. Trials at Caulfield Hospital are using Anavex, which, unlike current medications, is the only drug designed to both relieve symptoms and slow the disease’s progression. The first phase of the trial began in December 2014 and the next steps will involve further research with a larger group of participants in 2017.
mokew - Research "DONA" glucosamine sulfate" capsules.
It is patented in France and is prescription in Europe but is a supplement here and in Canada. Two three year studies and both showed and increase in joint cartilage. I've had great success with it for about three years now.
I am waiting hopefully to get A2-73 soon being an older person in a retirement community and watching those that depart to memory care and beyond.
Stockzoom - Has your hero accepted this challenge yet ?
falconer66a Wednesday, 12/14/16 10:22:12 PM
Re: 123tom post# 84524
Post # of 85039
“@Alz_Gal Don't try to reason with the Anavex crowd. They are profoundly stupid.”
Would love to sit down with Mr. Feuerstein and have a brief discussion of the primary, secondary, and tertiary structures of enzyme proteins, and just how those get mis-folded in dysfunctional rough endoplasmic reticula, disjointed from neuron mitochondria.
Profoundly stupid, am I?
Check back in a year. Neuron cytology and biochemistry will be the same. The status of Anavez — and it’s shareholders — will not be.
blu - regarding Australia's Anavex A2-73 trial
It was also mentioned in The Alfred Group Annual Report 2015-16 a couple of times in the report. Specifically in the Caufield Unit portion on page 27 which was a continuation of the Research report starting on page 26 (potions copied here)
26 Annual Report 2015-16
Research through partnership
Alfred Health 27
(Section excerpted here)
Alzheimer’s drug trial success
Early research results of Anavex 2-73, a drug which aims to address the symptoms of dementia, are positive. Trials at Caulfield Hospital are using Anavex, which, unlike current medications, is the only drug designed to both relieve symptoms and slow the disease’s progression. The first phase of the trial began in December 2014 and the next steps will involve further research with a larger group of participants in 2017
Anavex was mentioned a few other times in the long report for the Alfred group
Amatuer - Have you reviewed the qualifications of the financial people on the BOD for Anavex Life Sciences? As board members they have a fiduciary responsibility to the stock holders. If they are compensating their CEO improperly, they would be open to huge lawsuits. Do you think for a moment that these people would jeopardize their reputations?
Here are the resumes of the financial people that sit on our BOD for your review.
Bernd Metzner, PhD
Bernd Metzner, PhD, a director of Anavex, is currently Chief Financial Officer of the Stroeer Group. Previously, he was Chief Administration Officer and member of the Board of Management of Bayer Schering Pharma AG, the pharmaceutical division of $100+ billion market cap company Bayer AG. In this position, Dr. Metzner had worldwide financial responsibility for the Bayer Pharma Group. During his almost 10-years with Bayer AG, Dr. Metzner also held several senior international management positions in the corporate finance organization of Bayer AG, including Chief Financial Officer of Bayer S.p.A. Italy and heading the coordination of the successful spin-off of Lanxess, a specialty chemicals group. Dr. Metzner started his career at the law firm Flick Gocke Schaumburg and has a degree in business administration from the University of Siegen. After obtaining his doctorate, he became a chartered accountant.
Elliot Favus, MD
Elliot Favus, MD, a director of Anavex, is Chief Executive Officer of Favus Institutional Research, a healthcare research firm serving institutional investors. He has been a healthcare equity research analyst on Wall Street since 2006, starting at Lazard Capital Markets and subsequently at Och-Ziff Capital Management Group. Prior to working on Wall Street, Dr. Favus was an Instructor in medicine at Mount Sinai School of Medicine in New York. He attended the University of Michigan (BA, 1996), the University of Chicago Pritzker School of Medicine (MD, 2001) and the NYU-Bellevue Hospital Internal Medicine Residency Program (2004). He is board-certified in Internal Medicine (2004) and has 10 years of basic science laboratory experience working on human genetics projects at Harvard Medical School, the University of Chicago and the University of Pittsburgh.
Tom Skarpelos
Mr. Skarpelos, a director of Anavex, is a self-employed investor with 17 years of experience working with private and public companies. For the past 10 years, he has been focused on biotechnology companies involved in drug discovery and drug development projects.Mr. Skarpelos was engaged as a consultant to Anavex Life Sciences for one year effective August 2, 2010. His experience has led to relationships with researchers at academic institutes in Europe and North America. Mr. Skarpelos is a founder of Anavex Life Sciences, and is its largest shareholder.
Blu, Amateur, Kid and anyone else - Can someone explain what the BOD might know that would cause them to award a large increase in normal quarterly options in September 2016 and also alter the normal quarterly schedule ?
The following information was obtained from SEC Filings Edgar Search Results
7/5/2013 - Dr. Missling's first contract for three years through
July 5,2016
7/5/16 - First amendment to his contract to extend employment for three years and also provided a large salary raise and many options to be vested over the three year period.
7/7/16 - Clarification of options plus an addition of the following
"UPON A CHANGE OF CONTROL ALL PREVIOUSLY GRANTED BUT UNVESTED OPTIONS SHALL VEST"
7/22/16 - Further clarifications of Missling's options.
Here is the listing of the quantity and dates of options granted to the granted to the BOD on FORM 4s filed with the SEC.
.............Reg. Qtrly
..............4/18/16 &
...............7/16/16..........9/22/16
Metzner........50,000.........100,000
Favus..........1,500.........100,000
Skarpelos.... 50,000......100,000
Missling........................500,000 (In addition to contract options)
Boenisch......................106,696
Steffen.........................100,000
9/28/16 MTA to Biogen filed with the SEC.
????? QUIET PERIOD ?????
Also, Dr. Missling has stated many times that there is no need for funds.
(I have a feeling that the BOD has all of the information they need.)
Great post. I agree about external forces may be needed.
I have sent copies of your 'stickied' post along with the video to
1. My two U.S. Senators
2. My U.S. Congressman
3. Four major TV stations
4. Alzheimers organizations covering three states
5. One fairly major "Senior" news publication that is distributed to all
retirement communities in the area.
I see that a few others have been doing the same and I would hope that the rest of the 651 followers (per Powerwalker) on this message board would also spread the word.
Dr. Misssling"s interview with The Wall Street Transcripts for those that haven't seen it.
Filed with SEC 10/21/16 This is superb Media coverage,
The Wall Street Transcript is a completely unique resource for investors and business researchers.
Over 20,000 CEO, Equity Analyst and Money Managers
EX-99.1 2 s104371_ex99-1.htm EXHIBIT 99-1
Exhibit 99.1
Christopher U. Missling, MS, PhD, MBA, President and CEO of Anavex Life Sciences Corp.
Dr. Missling, President and CEO of Anavex, has over 20 years of healthcare industry experience within large pharmaceutical companies, the biotech industry and investment banking. Prior to joining Anavex, he served as the Chief Financial Officer of Curis and ImmunoGen. In addition, at Aventis (now Sanofi), Dr. Missling served as head of financial planning on all aspects of financial strategy and M&A. His career experience also includes working as an investment banker in the healthcare practice at Deutsche Bank, serving pharmaceutical, biotech, and diagnostic companies, as well as serving as the head of healthcare investment banking at Brimberg & Co. in New York. Dr. Missling has an MS and PhD from the University of Munich in Chemistry and an MBA from Northwestern University Kellogg School of Management.
TWST: Can you tell us what Avanex is?
Dr. Missling: Anavex is a precision medicine company specializing in the development of small molecule technologies for the treatment of neurodevelopmental and neurodegenerative diseases. Neurodegeneration is the largest unmet medical need and includes Alzheimer’s and Parkinson’s disease. Neurodevelopmental indications, which are caused by genetic dysfunction, include autism, autism spectrum disorder, Fragile X, Rett syndrome and epilepsy.
TWST: Before we go on to other things, can you tell about the SIGMACEPTOR Discovery Platform is? Also, is this something that you are just using internally in the company or is it something that you outlicense or seek to outlicense?
Dr. Missling: SIGMACEPTOR is a high-throughput screening for discovering small molecule drugs with different affinity for targeting the sigma-1 receptor, and yes, it indeed can be outlicensed. SIGMACEPTOR is the core of the company because this is the basis for discovering compounds that target the sigma-1 receptor, among other important targets, which are relevant and involved in restoring cellular functions and homeostasis. This might be critical to improving the lives of patients suffering from both neurodevelopmental and neurodegenerative indications.
TWST: When you call it a discovery platform, can you provide a little more insight into what the platform consists of? Is it a screening system or a particular process?
Dr. Missling: We focus on small molecules, which are orally available, versus biologics, which typically must be injected. If you can give a patient a pill or oral formulation to take, then that is easier to administer compared to an injection for which you will need a physician or a nurse. Also, some people just don't like or tolerate injections. But the focus indeed is on small molecules.
TWST: What drug candidates are the farthest along in the pipeline? Where are they and when could they potentially be commercialized?
Dr. Missling: The most of advanced compound in our pipeline is ANAVEX 2-73, which is now in a Phase 2a clinical trial in 32 mild-to-moderate Alzheimer’s patients. The next most advanced compounds are ANAVEX 3-71 and ANAVEX 1-41, which are both at the pre-IND stage. The next stage of clinical trials is in preparation for ANAVEX 2-73: a larger Phase 2/3 study as well as another Phase 2 in an orphan indication, and it could be Rett syndrome.
TWST: Is this for Alzheimer's?
Dr. Missling: We will conduct the Phase 2/3 for Alzheimer’s.
TWST: Tell us, if you could, a little bit of a science behind the Alzheimer’s candidate, as it seems there is new information on ways to intervene in this disease process. Could you tell us how it works?
Dr. Missling: The underlying pathology of Alzheimer’s is not fully understood. The most studied hypothesis is the over-expression of beta amyloid. However, the disease is likely more complex, there are also other pathological manifestations like tau overexpression, but also inflammation, mitochondrial dysfunction and calcium imbalance in parallel. Irrespective of that, we are focusing on restoring cellular homeostasis, by activating the sigma-1 receptor, a protein that we all have in our body that is not utilized unless cells are not functioning well or out of balance, i.e. out of homeostasis. If and when cells are impaired, the sigma-1 receptor activation might help those cells to regain functionality through restoring homeostasis. We believe Alzheimer’s is a chronic neurodegenerative disease directly correlating with age, and it is similar in that way to Parkinson’s and other chronic dementia diseases. On the other hand when you have a genetic predisposition where the cells are constantly stressed or proteins are misfolded, or out of homeostasis, the body’s own repair system is probably over-challenged, overburdened, but with small molecules, you can increase the expression of the sigma-1 receptor, potentially restoring homeostasis and potentially reducing those dysfunctions. The difference would be the positive features mentioned before; we are seeing a reduction in amyloid beta but also in tau and inflammation. Calcium balance is restored and oxidative stress and mitochondrial dysfunction are improved. So our approach is not one hypothesis-dependent approach. It is utilizing a more comprehensive approach. It is more macro-management of disease rather than a micro-management approach to the disease stage. So, we are basically in sync with any hypothesis because the sigma-1 receptor is reacting independently to whatever form of dysfunction is caused by the disease. Possibly, an analogy is immuno-stimulation in oncology, where you similarly harness the body’s own existing armoire of defense by activating the body’s own immune system to help to fight the disease, and we are essentially utilizing a similar approach by activating the sigma-1 receptor, which restores cellular homeostasis.
TWST: Is ANAVEX 2-73 potentially a drug that somebody could take and an early stage when they are pre-symptomatic in order to arrest the disease? I know many of these medications ideally should be taken pre-symptomatically if and when we can get the appropriate diagnostic tools.
Dr. Missling: Yes.
TWST: But can you elaborate on the stage that this could be taken?
Dr. Missling: We presented preclinical data that ANAVEX 2-73 could halt the disease and it could improve cognitive function. It was also published that ANAVEX 2-73 might be able to prevent the symptoms of Alzheimer’s in a pre-clinical animal model. So the answer to the question is, it could be both; it could be possibly utilized for either situations or time points.
TWST: Forgive me if I'm overstepping my bounds here, but it almost sounds like something that, if it had a clean safety profile, you could even take as a prophylactic or a vaccination because you just alluded to the fact that it improved cognitive function in people. Is this at all possible do you think?
Dr. Missling: We would have to prove that in clinical trials before claiming that.
TWST: Right, you're saying it's not out of the question at this stage?
Dr. Missling: It is not out of the question, but we cannot claim that at this point.
TWST: If all goes well, when might be the earliest timeframe ANAVEX 2-73 could be on the market? I'm assuming, given the disease it's targeting, that the FDA would want to expedite approval.
Dr. Missling: It's too early for us to give a time point for that because we are really thinking step by step to establish safety first, and the current study is running for 52 weeks. But today, it's really hard to tell because it depends on the data.
TWST: Do you have the financing you need to get through the development of ANAVEX 2-73 at this current stage?
Dr. Missling: Yes, we believe that sufficient financing in place and also because we are working with several foundations on specific diseases like the Michael J. Fox Foundation that has supported us very strongly for exploring ANAVEX 2-73 in a pre-clinical study of Parkinson’s disease, for which positive data was recently reported on September 22nd. And we also received support from the Rettsyndrome.org foundation, which also supported exploring ANAVEX 2-73 in a pre-clinical study in Rett syndrome, a rare disease for which Anavex received FDA orphan designation this year. We might continue these collaborations if the data continues to be promising.
TWST: Do you have any other agreements in place that you wanted to mention to the investor community? Also, are you seeking any agreements in order to move the company forward? And, if so, can you elaborate on what you might be seeking at this time?
Dr. Missling: We announced on September 28th that Biogen has signed a material transfer agreement with Anavex to explore ANAVEX 2-73 for a completely different indication, multiple sclerosis, which is the main focus of Biogen’s portfolio. We obviously are excited to work with Biogen to explore the potential of ANAVEX 2-73 in multiple sclerosis. On October 5th, we announced a collaboration with Ariana Pharma under which we’ll use Ariana’s proprietary KEM® (Knowledge, Extraction, Management) patient stratification technology to potentially accelerate ANAVEX 2-73’s Phase 2/3 Alzheimer’s clinical development timelines. KEM® is a comprehensive and FDA-tested clinical data analysis system that enables full exploitation of complex datasets of smaller numbers of patients.
TWST: Regarding Biogen, can you elaborate a little bit on the agreement terms as to which party does what?
Dr. Missling: It is a material transfer agreement in which Biogen will explore ANAVEX 2-73 in an in-house remyelination experiment of multiple sclerosis at its own costs. We are just providing the compound. After that, the evaluation will take place depending on what the findings are, and then discussions are expected to continue from that point on.
TWST: Does Anavex own most of its IP, or are you sharing it with others?
Dr. Missling: Yes, the company owns it.
TWST: I know you are knee-deep in some very important work, but if, let us say all goes well, where do you see the company going in the future? Do you want to stay in the neurology area? Do you see increased partnerships in the future? Can you elaborate on any kind of longer-term vision?
Dr. Missling: Yes, we are focusing on the central nervous system. And I mentioned specifically indications like Alzheimer’s and Parkinson’s disease, and then also for the neurodevelopmental orphan designations or rare diseases like Rett syndrome, infantile spasm and Fragile X, which is a special form of autism. Then, we also work on improving pain management. So we have a balanced pipeline, but the main focus is indeed on the central nervous system.
TWST: Did you want to say anything further on partnerships?
Dr. Missling: For larger markets like Alzheimer’s disease, partnerships for commercialization are very common. This is something that no small company can market by itself and, for that reason, at some point in time, there will be certainly discussions in that direction.
TWST: When might that be happening? Perhaps pre-Phase 3 or afterwards?
Dr. Missling: Our goal is always to create the highest possible value for shareholders. When you enter into such a collaboration or partnership for a larger indication, we will always try to aim for improving the outcome for the shareholders.
TWST: Are there any significant management or operational changes likely to take place in the next year and, if so, can you elaborate on what they might be and what they are for?
Dr. Missling: We are consistently growing in a thoughtful manner and we are adding people selectively because we are still relatively small. So this will be at an incremental and carefully considered pace. We intend to have several clinical trials up and running next year. One will likely be an orphan indication. All those trials will be double-blind placebo-controlled studies.
TWST: As a CEO, what is your chief challenge right now? And what are you doing to address it?
Dr. Missling: The chief challenge is really to keep in mind that drug development has inherent risks, and we would like to address those in order to reduce those risks to the extent possible. So we try to always do everything to the best of our knowledge and ability to minimize clinical trial risks in particular. That is the most important task for us and for me.
TWST: What do you want a potential investor in Anavex to know today?
Dr. Missling: We are a dedicated team and most of us have big pharmaceutical backgrounds. We want to help patients in indications like Alzheimer’s and Parkinson’s, but also those other devastating diseases like Rett syndrome and infantile spasm for which there are no cures for people today.
TWST: Is there anything you wanted to add that we haven't touched upon?
Dr. Missling: We believe the results we have demonstrated to date with ANAVEX 2-73 and other compounds both clinically and pre-clinically are quite encouraging. We would encourage investors to visit our website at www.anavex.com to learn more.
TWST: Thank you.
Dr. Missling: Thank you.
----------------------------------------------------------------------
Filed with SEC EDGAR
Seq Description Document Type Size
1 8-K s104371_8k.htm 8-K 14803
2 EXHIBIT 99-1 s104371_ex99-1.htm EX-99.1 28066
Very good point. Spread the word to all.
Great work Power. Now I hope the rest on the board will do the same to both their Senators and Congressmen.
I am not good at composing a great letter so will use yours as a guide. This is what I needed. Thank you
ps. We can use this to send to our local media also as well as our State officials.
Mc - Suggestion to contact Senators and Representatives.
There are a couple of hundred posters on this board that could make an effective publicity campaign.
I suggested once before that a couple of posters collaborate and compose a very well documented informative piece and make it available for all of us to use so we could spread the news very widely. We could reach most of the 535 Senators and Congressmen and local State officials with solid information and stress the need to get this released as soon as possible.
Here is information on how to contact your elected officials.
How to Contact Your Elected Officials
Learn how to get in touch with your federal, state, and local elected leaders.
Contact Federal Elected Officials
President Barack Obama, Vice President Joe Biden and the White House - Contact the White House by submitting your comments or questions online or by phone or fax.
Members of the U.S. Congress
U.S. Senators - Get contact information for your senators in the U.S. Senate.
U.S. Representatives - Find the website and contact information for your representative in the U.S. House of Representatives.
Contact State Elected Officials
State Governors - Learn how to get in touch with your state governor.
State Legislators - Find the names and current activities of your state legislators.
( If you Google this the links will be effective. I don't know how to get them to you. Maybe a monitor could help . TIA)
I think the "insiders" got their's when they filed 506,696 options along with Dr. Missling's 500,000 options with the SEC on 9/22/16. This was just before the Biogen announcement and the apparent "Quiet Period" starting.
Why did Dr. Missling get 500,000 options awarded in Sept. in addition to all of the others ?
I believe it is because the BOD who has all of the solid information of what is occurring behind the scenes that no one else has at this time except maybe Biogen.
Here is an earlier post of mine that gives me peace of mind.
drv17 Member Level Thursday, 12/01/16 09:51:20 AM
Re: None
Post #
81510
of 82343 Go
HINTS! We are all aware of Dr. Missling's series of 1000 share buys prior to 2015 CTAD. Here is a listing of Anavex's SEC 8K filings that has served as more than just hints to me.
7/5/2013 - Dr. Missling's first contact for three years
7/5/16 - First amendment to his contract to extend employment for three
years. This provided a large salary raise and many options to be
vested over the three year period.
7/7/16 - Clarification of options plus an addition of the following
"UPON A CHANGE OF CONTROL ALL PREVIOUSLY GRANTED BUT UNVESTED
OPTIONS SHALL VEST"
7/22/16 - Further clarifications of options.
Here is the listing of the quantity and dates of options granted to the granted to the BOD on FORM 4s
-------------- 7/16/16 -------- 9/22/16
Bernd --------50,000---------100,000
Favus -------- 1,500-------- 100,000
Skarpelos --- 50,000---------100,000
Missling---------------------500,000 (In addition to contract options)
Boenisch---------------------106,696
Thomas----------------------100,000
9/28/16 MTA to Biogen filed with the SEC.
????? QUIET PERIOD ?????
I have a feeling that the BOD has all of the information they need and I'll rely on that.
Trade I think the naked short sellers have gotten a glimpse of the BIG DOUBLE JAW BEAR TRAP that is all baited, set and waiting to be stepped in.
I hope you had a wonderful time at Disney World with your family.
I would have just thought that Anavex would have had someone "rubbing elbows" at AES since we appear to be ready to get into a phase 2 trial for epilepsy but I suppose everyone is busy with more imminent projects.
Epilepsy The annual AES (American Epilepsy Society) meeting is currently taking place in Houston (Dec 2-6) with nearly 5000 in attendance.
I inquired from IR if anyone from our company was going to be in attendance and here is the reply.
" Dear .....
Thank you for your email and interest in Anavex Life Sciences Corp. (Nasdaq: AVXL).
Anavex has not announced participation at the American Epilepsy Society meeting in Houston.
Events in which the company is participating / has participated are published on the website events page.
Please do not hesitate to contact our office if we can be of further assistance."
Its possible that IR was just not privy to the possibility of someone in attendance. I would hope there was since we should be nearing going into phase 2 trial for epilepsy.
I would expect that Dadofmarcmax attended the conference. Maybe we will hear from him on the board.
I googled it before but I forgot what it said. I'm in need and waiting to get some A2-73.
Blu 1 - Not true. I believe you are referring to the original study NCT02244541.
The current study NCT02756858 does not mention comparing to "add-on".
ClinicalTrials.gov
Phase 2a Dose Finding, PK/PD and 12 Month Exploratory Efficacy Study of ANAVEX2-73 in Patients With Alzheimer's Disease (ANAVEX)
This study is ongoing, but not recruiting participants.
Sponsor:
Anavex Life Sciences Corp.
Information provided by (Responsible Party):
Anavex Life Sciences Corp.
ClinicalTrials.gov Identifier:
NCT02244541
First received: August 31, 2014
Last updated: August 10, 2016
Last verified: August 2016
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
The primary objective of this Phase 2a study is to evaluate the maximal tolerated dose of ANAVEX2-73 in patients with AD in a repeated-dose administration scheme, with the secondary objectives being to explore the relationship between dosing regimen and pharmacodynamics efficacy outcomes and to evaluate the bioavailability of the oral form used and to explore the relationship of ANAVEX2-73 as add-on therapy to AD standard of care.
Condition Intervention Phase
Alzheimer's Disease
Drug: ANAVEX2-73 Oral
Drug: ANAVEX2-73 Intravenous
Phase 2
Here is the current study that indicates Anavex 2-73 oral only.
ClinicalTrials.gov
A service of the U.S. National Institutes of Health
An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
This study is enrolling participants by invitation only.
Sponsor:
Anavex Life Sciences Corp.
Information provided by (Responsible Party):
Anavex Life Sciences Corp.
ClinicalTrials.gov Identifier:
NCT02756858
First received: March 8, 2016
Last updated: April 27, 2016
Last verified: April 2016
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
This open label extension study is designed to provide continued access to ANAVEX 2-73 for eligible subjects with mild to moderate Alzheimer's Disease who have previously participated in the Anavex sponsored study ANAVEX2-73-002.
Condition Intervention Phase
Alzheimer's Disease
Drug: ANAVEX2-73
Phase 2
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
Resource links provided by NLM:
Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease
Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease
U.S. FDA Resources
Further study details as provided by Anavex Life Sciences Corp.:
Primary Outcome Measures:
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 104 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
Mini-mental state examination score (MMSE) [ Time Frame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, & 104 ] [ Designated as safety issue: No ]
Score from ADCS-ADL (Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory) [ Time Frame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, & 104 ] [ Designated as safety issue: No ]
Hamilton Psychiatric Rating Scale for Depression (HAM-D) Score [ Time Frame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, & 104 ] [ Designated as safety issue: No ]
Estimated Enrollment: 32
Study Start Date: March 2016
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ANAVEX2-73 Oral as assigned in ANAVEX2-73-002 Drug: ANAVEX2-73
Eligibility
Ages Eligible for Study: 55 Years to 85 Years (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Previous exposure to ANAVEX2-73 via participation in Phase 2a Study of ANAVEX2-73 Adaptive-Trial-Design With Repeated Doses, MTD Finding, Pharmacodynamic and Bioavailability Evaluation in Patients With Mild to Moderate Alzheimer's Disease With a 12-Month Open Label Follow-Up Period (ANAVEX2-73-002)
Exclusion Criteria:
Have not previously participated Phase 2a Study of ANAVEX2-73 Adaptive-Trial-Design With Repeated Doses, MTD Finding, Pharmacodynamic and Bioavailability Evaluation in Patients With Mild to Moderate Alzheimer's Disease With a 12-Month Open Label Follow-Up Period (ANAVEX2-73-002)
Strategic Advisory Board.
Since the board is quiet this AM, I will post the list of the most impressive personnel on the board which has the addition of the new Parkinson's disease experts.
Abraham Fisher, PhD
A member of the Scientific Advisory Board, Dr. Fisher has nearly 40 years of experience in drug design and discovery. He has taken lead compounds including AF102B (EVOXAC®, cevimeline HCl) from concept to approval. AF102B is the first muscarinic agonist approved for sale in the U.S. (2000) and in Japan (2001) to treat dry mouth in patients with Sjogren’s Syndrome. Dr. Fisher is also the inventor of AF710B (renamed ANAVEX 3-71). Dr. Fisher is co-founding Chairman and President of the Alzheimer’s and Parkinson’s Diseases Conference,is on the scientific review board of the Alzheimer’s Drug Discovery Foundation and is a reviewer of the Alzheimer’s Association. He is named on 21 patents worldwide, is the author of numerous peer-reviewed papers and academic book chapters and is associate editor of Current Alzheimer Research. He also serves on the editorial board of Neurodegenerative Diseases and was on the editorial boards of CNS Drug Reviews, Japanese Journal of Pharmacology and Drug Development Research. Currently Dr. Fisher is a visiting professor at the Department of Neurobiology at the Weizmann Institute in Israel. Previously he was senior scientist at the Israel Institute for Biological Research (IIBR) and held faculty appointments as adjunct professor in the Departments of Pharmacology and Psychiatry, Southern Illinois University and in the School of Medicine, Department of Molecular and Cellular Pharmacology, University of Miami.
Norman Relkin, MD, PhD
A member of the Scientific Advisory Board, Dr. Relkin is an internationally recognized expert on Alzheimer’s disease and related disorders. An American Board of Psychiatry and Neurology-certified neurologist, he graduated from Yale and earned MD and PhD degrees from New York’s Albert Einstein College of Medicine. Dr. Relkin is an Associate Professor of Neurology at the Weill Cornell Medical College and Founding Director of the Weill Cornell Memory Disorders Program. He has 20+ years of clinical trials experience, serving as principal investigator in over 20 therapeutic studies, including multi-center trials he designed. Over the past decade, Dr. Relkin pioneered the study of naturally occurring human antibodies for the treatment of Alzheimer’s. He led all three clinical trial phases of Intravenous Immunoglobulin as a potential Alzheimer’s treatment, including the pivotal National Institutes of Health (NIH) and Baxter co-sponsored study carried out at 45 sites (US and Canada). The author of numerous publications on neurodegenerative and traumatic disorders of the brain during the past 25 years, Dr. Relkin sits on editorial boards for three scientific journals. Additionally, he has been a reviewer for NIH and funding agencies in Europe and Australia, and has been a long-standing member of the Weill Cornell Institutional Review Board. In 2012, he was elected to the Board of Directors of The American Federation for Aging Research.
Michael Gold, MD
A member of the Scientific Advisory Board, Dr. Gold has over 20 years of experience in the clinical development of Alzheimer’s and other central nervous system (CNS) drugs, and currently serves as Vice President of the CNS practice at UCB, Inc., a global biopharmaceutical company. His background also includes leadership roles with GlaxoSmithKline (GSK), Johnson & Johnson (J&J) and Bristol-Myers Squibb (BMS). At GSK, Dr. Gold was responsible for the late-stage CNS and pain portfolio. He also led several clinical Phase II and Phase III Alzheimer’s disease-related project teams. At J&J, Dr. Gold served as the Compound Development Team Leader for Galantamine, an Alzheimer’s drug, culminating in FDA approval of Galantamine CR (Razadyne® ER). Prior to joining UCB, Dr. Gold served as the Chief Medical Officer of Allon Therapeutics, where he led a large pan-US and European clinical study for a neurodegenerative disease. Before joining the pharmaceutical industry, Dr. Gold was an Assistant Professor at the University of South Florida (USF) College of Medicine Department of Neurology and Director of the USF Memory Disorders Clinic. During this time, he was the Principal Investigator for several clinical trials for Alzheimer’s disease. He has also authored multiple publications related to Alzheimer’s and dementia. Dr. Gold also holds an academic appointment as an adjunct assistant professor in the Department of Medicine at the University of North Carolina at Chapel Hill.
John Harrison, PhD
A member of the Scientific Advisory Board, Dr. Harrison is an internationally acknowledged specialist for design of human clinical outcome measurement in Alzheimer’s disease and other cognitive impairments. Dr. Harrison has successfully integrated cognitive testing into drug development programs for many pharmaceutical and biotechnology companies including eight of the current ‘Fortune’ top 10 pharmaceutical companies. He is Honorary Senior Lecturer in the Department of Medicine at Imperial College in London, focusing on investigating cognitive change that may show disease progression in Alzheimer’s and other related indications. Dr. Harrison is a member of the American Psychological Association, holds Chartered Psychologist status with the British Psychological Society and Chartered Scientist status with the UK Science Council. He has authored/co-authored more than 60 books and scientific articles and has been invited as a specialist for cognitive tests at many international meetings, including the European Task Force for Alzheimer’s disease and American Alzheimer’s Association roundtable events. Dr. Harrison’s background also includes prior positions as Head of Neuropsychology at CeNeS Pharmaceuticals, Principal Consultant at CPC Pharma Services, and Principal Scientist at CogState Ltd. In addition to his current academic appointment, he is principal consultant at Metis Cognition Ltd and holds a PhD in neuroscience from the University of London.
Ottavio Arancio, MD, PhD
A member of the Scientific Advisory Board, Dr. Arancio is a cellular neurobiologist who has pioneered the field of mechanisms of synaptic dysfunction in Alzheimer’s disease. He is Associate Professor of Pathology and Cell Biology at the Columbia University Medical Center and The Taub Institute for Research on Alzheimer’s Disease and the Aging Brain, Columbia University. Over the last 10 years, Dr. Arancio has raised more than $25 million in grant funding and published more than 100 peer-reviewed scientific papers. Dr Arancio’s honors include the “G. Moruzzi Fellowship” (Georgetown University), the “Anna Villa Rusconi Foundation Prize” (Italy), the “INSERM Poste vert Fellowship” (France), the Edward N. and Della L. Thome Memorial Foundation Award (2010), the Margaret Cahn Research Award (2008), the American Health Assistance Foundation Centennial Award (2007) and the Zenith Award (2007). He also founded Citta Pharmaceuticals, a biotech company for development of small molecules to treat Alzheimer’s disease.
Tangui Nicolas Maurice, Ph.D.
A member of the Scientific Advisory Board, Dr. Maurice has spent 15 years in the field of neurosciences, including behavioral and molecular neuropharmacology, sigma receptors, neuropeptides, neurosteroids, neurotrophic factors, normal/pathological aging models for Alzheimer’s and related disorders, and behavioral phenotyping of rodent models. Dr. Maurice is a researcher at the Institut national de la sante et de la recherche medicale (INSERM) U710 at Montpellier. He has also held research positions at the Centre National de la Recherche Scientifique (CNRS), INSERM U336, the department of neuropsychopharmacology and hospital pharmacy at Meijo University (Nagoya, Japan), and Jouveinal Research Institute (Fresnes, France).
Jeffrey Cummings, MD
A clinical expert on the Anavex Scientific Advisory Board, Dr. Jeffrey Cummings is Professor of Neurotherapeutics and Drug Development in the Neurological Institute, Cleveland Clinic. He is Director of the Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, Nevada and Cleveland, Ohio. Dr. Jeffrey Cummings graduated magna cum laude from the University of Wyoming, Laramie and obtained his MD degree (with thesis) from the University of Washington, Seattle. He completed internship at Hartford Hospital in Hartford, Connecticut and did his Neurology residency at Boston University, Boston, Massachusetts. Dr. Cummings was formerly the Augustus S. Rose Professor of Neurology and Professor of Psychiatry and Biobehavioral Sciences at the David Geffen School of Medicine at UCLA, Los Angeles, California, USA. He was the Director of the Mary S. Easton Center for Alzheimer’s Disease Research at UCLA and Director of the Deane F. Johnson Center for Neurotherapeutics at UCLA. Dr. Cummings has expertise in neuropsychiatric assessment, outcomes in clinical trials, clinical trial design and analysis, and global clinical trials. He is a frequent consultant to industry. Dr. Cummings has authored more than 500 peer-reviewed papers and 30 books on Alzheimer’s disease, neuropsychiatry, and clinical trials. Dr. Cummings’ interests embrace the neuropsychiatry of neurologic disorders, biomarkers for neurodegenerative diseases, and clinical trials and drug development for neurologic diseases.
Paul Aisen, MD
A clinical expert on the Anavex Scientific Advisory Board, Dr. Aisen is a leading clinician and researcher in Alzheimer’s disease clinical trials and is founding director of the University of Southern California (USC) Alzheimer’s Therapeutic Research Institute in San Diego. Previously, he was on the faculty of the University of California, San Diego (UCSD) School of Medicine’s Department of Neurosciences. His primary research interests focus on the development of new strategies for the treatment of Alzheimer’s disease. Since 2007, Dr. Aisen has been Director of the Alzheimer’s Disease Cooperative Study, a consortium funded by the National Institute on Aging (NIA) to develop assessment instruments and conduct clinical trials. Dr. Aisen is Associate Editor of Alzheimer’s Research and Therapy, a major international peer-reviewed journal, and sits on the editorial board of BMC Medicine. He has published more than 180 peer-reviewed papers.
Corinne Lasmézas, DVM, PhD
A member of the Scientific Advisory Board, Professor at The Scripps Research Institute for the past 10 years and frequent TED Speaker, Dr. Lasmézas is an internationally recognized expert in the field of neurodegenerative diseases with a focus now on studying the mechanisms of neurodegeneration. Since her appointment at Scripps in 2005, Dr. Lasmézas has focused on how misfolded proteins lead to neuronal dysfunction and loss in diseases including Alzheimer’s, Parkinson’s and prion diseases. Additionally, Dr. Lasmézas is a reviewer for national and private funding agencies worldwide, including the US National Institutes of Health (NIH) and the UK Medical Research Council, and an advisor for the US Food and Drug Administration (FDA), the US Environmental Protection Agency (EPA) and the US Department of Agriculture (USDA). She has published more than 60 original scientific papers. Earlier in her career, Dr. Lasmézas’ research provided the first experimental evidence that the prion disease “mad cow disease” had been transmitted to humans, causing variant Creutzfeldt-Jakob disease. This fatal disease belongs to the same group of age-related neurodegenerative diseases as Alzheimer and Parkinson’s diseases, caused by aggregates of misfolded proteins. At the peak of the mad cow crisis, Dr. Lasmézas became an advisor to the World Health Organization (WHO) as well as several governmental and public health committees. Dr. Lasmézas holds a PhD in Neurosciences from the University Pierre & Marie Curie in Paris and obtained her Doctorate of Veterinary Medicine and Diploma of Aeronautic and Space Medicine from the University of Toulouse, France.
Jacqueline French, MD, FAAN
A member of the Scientific Advisory Board, professor in the Department of Neurology at New York University (NYU), Co-Director of Epilepsy Research and Clinical Trials at NYU’s Comprehensive Epilepsy Center and Director of the Epilepsy Study Consortium, Dr. French is an award-winning, internationally recognized expert on epilepsy, new therapeutic interventions and clinical trial methodology. She plays an ongoing leadership role in the area of development of new therapeutics for epilepsy, including co-directing a bi-annual symposium on trial design and its implications and holds positions on committees of the American Academy of Neurology (AAN), where she has also co-authored several AAN clinical practice guidelines. Broadly published, including numerous research articles, editorials and chapters, her writings have been featured in respected publications including The New England Journal of Medicine, Neuron, Neuro Image, Epilepsy Currents and Lancet Neurology. She has also edited two books on epilepsy and is an in-demand global speaker on antiepileptic drug therapeutics and related topics. Previously, Dr. French was Assistant Dean for Clinical Trials at the University of Pennsylvania, a recent President of the American Epilepsy Society, Secretary of the American Society of Experimental Neurotherapeutics, and worked with the US Food and Drug Administration (FDA) developing new trial designs for the approval of antiepileptic drugs. Dr. French trained in Neurology at Mount Sinai Hospital (New York), and did her fellowship training in EEG and epilepsy at Mount Sinai Hospital and Yale University. She was the recipient of the Epilepsy Foundation’s 2013 Hero of Epilepsy Award, honoring her longtime contributions to epilepsy research and clinical trials, alongside her significant impact on the epilepsy community.
Harald Hampel, MD, MA, PhD, MSc
A member of the Scientific Advisory Board and an internationally recognized expert on Alzheimer’s and related neurodegenerative diseases, Dr. Hampel is Professor and AXA Research Fund Chair at Sorbonne Universities’ Pierre and Marie Curie University (UPMC) in Paris, the leading university in science, technology and medicine in France. The AXA-UPMC Chair is hosted within the highly specialized Institute for Memory and Alzheimer’s Disease (IM2A), a reference center for Alzheimer’s and other neurodegenerative diseases, and affiliated with a leading neuroscience institution, the Brain and Spine Institute (ICM), as well as the Department of Neurology at the Pitié-Salpétrière University Hospital. He has conducted more than 50 clinical trials over the past 20 years and has developed international programs focused on Alzheimer’s therapy, diagnosis and the development of biological and imaging biomarkers, including his current work as AXA-UPMC Chair, which aims to improve early detection at the preclinical ‘silent stage’ before the onset of any clinical signs and symptoms. After a post-doctoral fellowship focused on structural and functional neuroimaging of the healthy aging and Alzheimer’s disease brain at the NIH/NIA Laboratory of Neurosciences in Bethesda, MD, Dr. Hampel became founding director of the Alzheimer Memorial Center and Professor of Psychiatry at the University of Munich. In 2006, he was appointed as a Professor and Chair of Psychiatry at Trinity College, University of Dublin, Ireland. During this time, he was a leading Principal Investigator at the Trinity College Institute of Neuroscience (TCIN). In 2010, Dr. Hampel was appointed as Professor, Chair and Head of Department of Psychiatry and Co-Director of the Brain Imaging Center (BIC) at the University of Frankfurt. Dr. Hampel has published more than 500 peer-reviewed research papers, 80 book chapters and eight books, many in world-leading scientific journals, such as the New England Journal of Medicine, JAMA, The Lancet, The Lancet Neurology, Nature Genetics, Nature Reviews Drug Discovery and Nature Reviews Neurology. He has won numerous awards for his scientific work on healthy and diseased brains as well as biomarker and therapy discovery in Alzheimer’s. Additionally, Dr. Hampel has been a reviewer for leading international scientific journals and funding agencies in the US, Canada and Europe and is Senior Associate Editor of the leading international Alzheimer’s journal Alzheimer’s & Dementia, the journal of the Alzheimer’s Association.
Tanya Simuni, MD
A member of the Scientific Advisory Board, Dr. Simuni is AC Nielsen Professor of Neurology and Director, Parkinson’s Disease and Movement Disorders Program at Northwestern University Feinberg School of Medicine in Chicago, Illinois. She earned her medical degree from Leningrad Medical School (Russia), completed a neurology residency and clinical neurophysiology fellowship at Temple University, Philadelphia, and a fellowship in movement disorders at the University of Pennsylvania, Philadelphia. She has built a multidisciplinary Parkinson’s disease center that has been designated a Center of Excellence by the National Parkinson’s Foundation. Dr. Simuni’s research interests include experimental pharmacology, early diagnosis, non-motor manifestations and surgical management of Parkinson’s disease. As principal or co-investigator of numerous NINDS, MJFF and industry-sponsored clinical trials, Dr. Simuni has done extensive research on the treatment of Parkinson’s disease focused on studying potential disease modifying strategies. Dr. Simuni is the principal investigator on the NINDS-funded, multicenter Phase III study of the potential disease modifying agent, isradipine. Dr. Simuni has received several prestigious awards and dedicates a substantial amount of her professional time to teaching and mentoring. She has also served as the neurology residency program director at Northwestern.
Daniel Weintraub, MD
A member of the Scientific Advisory Board, Dr. Weintraub is professor of psychiatry at Perelman School of Medicine at the University of Pennsylvania in Philadelphia. He is professor of psychiatry and neurology at Penn and psychiatrist at the Parkinson’s Disease Research, Education and Clinical Center (PADRECC) at the Philadelphia Veterans Affairs Medical Center. A geriatric psychiatrist, he conducts clinical research in the psychiatric and cognitive complications of Parkinson’s disease and is author of more than 100 journal articles, reviews and book chapters. Dr. Weintraub completed a NIMH Career Development Award titled “Depression Diagnosis and Treatment in Parkinson Disease” and has been PI on grants from the VA, Penn, The Michael J. Fox Foundation for Parkinson’s Research and several industry-sponsored studies. He is also the current Clinical Core Leader of the Penn Udall Center focused on cognition in Parkinson’s disease. Dr. Weintraub is Associate Editor for Movement Disorders journal, was formerly on the Executive Committee of the Parkinson Study Group (PSG), has been a member of four Movement Disorder Society (MDS) task forces to revise and make recommendations for the assessment of cognitive and psychiatric symptoms in Parkinson’s disease and was chair of the Psychiatry Subgroup of the NINDS Common Data Elements (CDE) project.
Kalpana M. Merchant, PhD
A member of the Scientific Advisory Board, Dr. Merchant is the President and Chief Scientific Officer (CSO) for TransThera Consulting Co., Adjunct Professor of Neurology at Northwestern University Feinberg School of Medicine and Adjunct Professor of Biology at Indiana University–Purdue University at Indianapolis. She has deep expertise in the neurobiology of chronic neurodegenerative and psychiatric disorders plus almost 25 years of experience in drug discovery and development with a special emphasis on translational strategies that improve the success rate of drug development. Earlier in her career, Dr. Merchant worked in the U.S. pharmaceutical industry as a scientific contributor and in strategic leadership/ management roles. She retired in March 2014 from Eli Lilly and Company where she was the CSO for Tailored Therapeutics – Neuroscience, accountable for scientific and business strategies to deliver personalized therapies and associated biomarkers for the neuroscience portfolio – from discovery through Phase III. Prior to Eli Lilly, Dr. Merchant conducted neuroscience drug discovery research at Pharmacia Corp. She received her PhD in neuropharmacology from the University of Utah. Following a postdoctoral research fellowship at University of Washington, she was appointed Assistant Professor of Psychiatry at the same institution. Dr. Merchant has been appointed a member of the National Center for Advancing Translational Sciences (NCATS) Advisory Council and the Cures Acceleration Network Review Board for the National Institutes of Health (NIH), the Executive Scientific Advisory Board for the Michael J Fox Foundation for Parkinson’s Research and The Wellcome Trust Review Board.
Board of Directors
Here is the listing of the Board of Directors for any new investors on this message board. I beg the indulgences of all that are familiar with it.
Christopher U. Missling, MS, PhD, MBA
Dr. Missling, President and CEO of Anavex™, has over 20 years of healthcare industry experience within large pharmaceutical companies, the biotech industry and investment banking. Prior to joining Anavex, he served as the Chief Financial Officer of Curis and ImmunoGen. In addition, at Aventis (now Sanofi), Dr. Missling worked as head of financial planning on all aspects of financial strategy and M&A. His career experience also includes working as an investment banker in the healthcare practice at Deutsche Bank, serving pharmaceutical, biotech, and diagnostic companies, as well as serving as the head of healthcare investment banking at Brimberg & Co. in New York. Dr. Missling has an MS and PhD from the University of Munich in Chemistry and an MBA from Northwestern University Kellogg School of Management.
Tasos Zografidis, MS, PhD
Dr. Zografidis, the Vice President Clinical Operations of Anavex, has over 25 years of experience in the pharmaceutical and healthcare industry, including 12 years at Wyeth (now Pfizer) in clinical project management and prior to joining Anavex most recently served as clinical and pharmaceutical consultant. He has been involved in more than a dozen clinical trials and has co-authored numerous publications. At Wyeth, Dr. Zografidis spearheaded population pharmacokinetics analysis and its implementation in the clinical setting and positively differentiated compounds. His work resulted in increased sales and he received several clinical awards for his accomplishments. Dr. Zografidis first joined Wyeth in 1998 as a Product Manager. During his tenure until 2010, he had increased responsibility as Medical Liaison for the transplantation, haemophilia and oncology divisions where he was instrumental in driving sales in assigned European territories.
Ulrich Elben, PhD
As Vice President of Preclinical Operations for Anavex, Dr. Elben oversees pipeline development and optimization. Dr. Elben has extensive experience in global pharmaceutical development and research. His background includes roles as VP of Strategic Development Operations at Vertex Pharmaceuticals, with responsibilities including project and portfolio management as well as the development of an oncology project. In addition, Dr. Elben served as a member of the Vertex drug development advisory board and drug product review committee. He was also Chief Development Officer at Avaant Pharmaceuticals, where he led the development of oncology projects across the USA, Europe and India. Earlier in his career, Dr. Elben was CEO of Axxima Pharmaceuticals in Munich, Germany. Dr. Elben started his career with Sanofi-Aventis (former Hoechst Marion Roussel) in Europe and the USA, where his last position was deputy head of project management overseeing also Alzheimer’s and schizophrenia products. He and his teams were successful at bringing several drugs through the international development cycle and ultimately to market. Dr. Elben was also secretary of the Sanofi-Aventis drug development review committee. Additionally, Dr. Elben has extensive, recent consulting experience with VCs, biotech companies and API manufacturing companies in the USA, Canada and Europe. He is currently a member of several organizations, including the CEO advisory board of the Florida Institute for the Commercialization of Public Research, BioFlorida and the Drug Information Association. Dr. Elben received his PhD in organic chemistry from the University of Bonn, Germany.
Kristina M. Capiak, CCRP
Ms. Capiak, the Vice President of Regulatory Affairs for Anavex, has more than 10 years of academic clinical research and healthcare industry experience within the biotech industry. Prior to joining Anavex, Ms. Capiak was the Global Regulatory Lead at Retrophin, Inc. where she implemented U.S. and EU strategy for the ongoing development programs, which received orphan drug designations as well as fast track designation. At Regeneron Pharmaceuticals Ms. Capiak was on the pharmacovigilance and risk management team where she analyzed the ongoing safety events for the pipeline of development products and for EYLEA®. Ms. Capiak’s background also includes clinical trial staffing and oversight for more than 60 clinical trials at both Columbia University Medical Center, where she co-authored several papers, and Memorial Sloan-Kettering Cancer Center, where she became a Certified Clinical Research Professional (CCRP) through the Society of Clinical Research Associates. While an undergraduate, Ms. Capiak participated in translational medical research at the University of Michigan Medical School through the Undergraduate Research Opportunity Program. She is a graduate of both the University of Michigan and New York City’s Columbia University.
Bernd Metzner, PhD
Bernd Metzner, PhD, a director of Anavex, is currently Chief Financial Officer of the Doehler Group, a global producer and provider of technology-based natural ingredients for the food and beverage industry with sales activities in more than 130 countries. Previously, he was Chief Administration Officer and member of the Board of Management of Bayer Schering Pharma AG, the pharmaceutical division of $100+ billion market cap company Bayer AG. In this position, Dr. Metzner had worldwide financial responsibility for the Bayer Pharma Group. During his almost 10-years with Bayer AG, Dr. Metzner also held several senior international management positions in the corporate finance organization of Bayer AG, including Chief Financial Officer of Bayer S.p.A. Italy and heading the coordination of the successful spin-off of Lanxess, a specialty chemicals group. Dr. Metzner started his career at the law firm Flick Gocke Schaumburg and has a degree in business administration from the University of Siegen. After obtaining his doctorate, he became a chartered accountant.
Elliot Favus, MD
Elliot Favus, MD, a director of Anavex, is Chief Executive Officer of Favus Institutional Research, a healthcare research firm serving institutional investors. He has been a healthcare equity research analyst on Wall Street since 2006, starting at Lazard Capital Markets and subsequently at Och-Ziff Capital Management Group. Prior to working on Wall Street, Dr. Favus was an Instructor in medicine at Mount Sinai School of Medicine in New York. He attended the University of Michigan (BA, 1996), the University of Chicago Pritzker School of Medicine (MD, 2001) and the NYU-Bellevue Hospital Internal Medicine Residency Program (2004). He is board-certified in Internal Medicine (2004) and has 10 years of basic science laboratory experience working on human genetics projects at Harvard Medical School, the University of Chicago and the University of Pittsburgh.
Tom Skarpelos
Mr. Skarpelos, a director of Anavex, is a self-employed investor with 17 years of experience working with private and public companies. For the past 10 years, he has been focused on biotechnology companies involved in drug discovery and drug development projects.Mr. Skarpelos was engaged as a consultant to Anavex Life Sciences for one year effective August 2, 2010. His experience has led to relationships with researchers at academic institutes in Europe and North America. Mr. Skarpelos is a founder of Anavex Life Sciences, and is its largest shareholder.
Steffen Thomas, PhD
Steffen Thomas, PhD, a director of Anavex, has over 15 years of experience as a European patent attorney and is currently practicing at Epping Hermann Fischer, a major intellectual property law firm in Europe. Previously, he worked for Japan-based Takeda Pharmaceutical Company, the largest pharmaceutical company in Asia and a top firm worldwide, as an in-house patent attorney. Prior to that, he worked for Nycomed Pharma, acquired by Takeda in 2011 for approximately USD $10 billion. Dr. Thomas’ legal practice covers drafting of patent applications, prosecuting patent applications before national and international patent offices, defending and challenging patents in opposition, appeal, and nullity proceedings, enforcing patents before the infringement courts, and preparing opinions on patentability and infringement in the technical field of chemistry. Dr. Thomas has particular expertise in small molecule pharmaceuticals. He holds MS and PhD degrees in Chemistry from the University of Munich.
Dual vs Mono therapy.
I am confused. Here is the only on-going trial for Anavex 2-73 copied from clinicaltrials.gov. Maybe I don't understand the argument about dual therapy.
Previous Study | Return to List | Next Study
An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
This study is enrolling participants by invitation only.
Sponsor:
Anavex Life Sciences Corp.
Information provided by (Responsible Party):
Anavex Life Sciences Corp.
ClinicalTrials.gov Identifier:
NCT02756858
First received: March 8, 2016
Last updated: April 27, 2016
Last verified: April 2016
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
This open label extension study is designed to provide continued access to ANAVEX 2-73 for eligible subjects with mild to moderate Alzheimer's Disease who have previously participated in the Anavex sponsored study ANAVEX2-73-002.
Condition Intervention Phase
Alzheimer's Disease
Drug: ANAVEX2-73
Phase 2
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
Resource links provided by NLM:
Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease
Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease
U.S. FDA Resources
Further study details as provided by Anavex Life Sciences Corp.:
Primary Outcome Measures:
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 104 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
Mini-mental state examination score (MMSE) [ Time Frame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, & 104 ] [ Designated as safety issue: No ]
Score from ADCS-ADL (Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory) [ Time Frame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, & 104 ] [ Designated as safety issue: No ]
Hamilton Psychiatric Rating Scale for Depression (HAM-D) Score [ Time Frame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, & 104 ] [ Designated as safety issue: No ]
Estimated Enrollment: 32
Study Start Date: March 2016
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ANAVEX2-73 Oral as assigned in ANAVEX2-73-002 Drug: ANAVEX2-73
This was filed March 8,2016 and it shows Anavex 2-73 as the only drug administered.
Dr. Misssling"s interview with The Wall Street Transcripts for those that haven't seen it.
Filed with SEC 10/21/16
EX-99.1 2 s104371_ex99-1.htm EXHIBIT 99-1
Exhibit 99.1
Christopher U. Missling, MS, PhD, MBA, President and CEO of Anavex Life Sciences Corp.
Dr. Missling, President and CEO of Anavex, has over 20 years of healthcare industry experience within large pharmaceutical companies, the biotech industry and investment banking. Prior to joining Anavex, he served as the Chief Financial Officer of Curis and ImmunoGen. In addition, at Aventis (now Sanofi), Dr. Missling served as head of financial planning on all aspects of financial strategy and M&A. His career experience also includes working as an investment banker in the healthcare practice at Deutsche Bank, serving pharmaceutical, biotech, and diagnostic companies, as well as serving as the head of healthcare investment banking at Brimberg & Co. in New York. Dr. Missling has an MS and PhD from the University of Munich in Chemistry and an MBA from Northwestern University Kellogg School of Management.
TWST: Can you tell us what Avanex is?
Dr. Missling: Anavex is a precision medicine company specializing in the development of small molecule technologies for the treatment of neurodevelopmental and neurodegenerative diseases. Neurodegeneration is the largest unmet medical need and includes Alzheimer’s and Parkinson’s disease. Neurodevelopmental indications, which are caused by genetic dysfunction, include autism, autism spectrum disorder, Fragile X, Rett syndrome and epilepsy.
TWST: Before we go on to other things, can you tell about the SIGMACEPTOR Discovery Platform is? Also, is this something that you are just using internally in the company or is it something that you outlicense or seek to outlicense?
Dr. Missling: SIGMACEPTOR is a high-throughput screening for discovering small molecule drugs with different affinity for targeting the sigma-1 receptor, and yes, it indeed can be outlicensed. SIGMACEPTOR is the core of the company because this is the basis for discovering compounds that target the sigma-1 receptor, among other important targets, which are relevant and involved in restoring cellular functions and homeostasis. This might be critical to improving the lives of patients suffering from both neurodevelopmental and neurodegenerative indications.
TWST: When you call it a discovery platform, can you provide a little more insight into what the platform consists of? Is it a screening system or a particular process?
Dr. Missling: We focus on small molecules, which are orally available, versus biologics, which typically must be injected. If you can give a patient a pill or oral formulation to take, then that is easier to administer compared to an injection for which you will need a physician or a nurse. Also, some people just don't like or tolerate injections. But the focus indeed is on small molecules.
TWST: What drug candidates are the farthest along in the pipeline? Where are they and when could they potentially be commercialized?
Dr. Missling: The most of advanced compound in our pipeline is ANAVEX 2-73, which is now in a Phase 2a clinical trial in 32 mild-to-moderate Alzheimer’s patients. The next most advanced compounds are ANAVEX 3-71 and ANAVEX 1-41, which are both at the pre-IND stage. The next stage of clinical trials is in preparation for ANAVEX 2-73: a larger Phase 2/3 study as well as another Phase 2 in an orphan indication, and it could be Rett syndrome.
TWST: Is this for Alzheimer's?
Dr. Missling: We will conduct the Phase 2/3 for Alzheimer’s.
TWST: Tell us, if you could, a little bit of a science behind the Alzheimer’s candidate, as it seems there is new information on ways to intervene in this disease process. Could you tell us how it works?
Dr. Missling: The underlying pathology of Alzheimer’s is not fully understood. The most studied hypothesis is the over-expression of beta amyloid. However, the disease is likely more complex, there are also other pathological manifestations like tau overexpression, but also inflammation, mitochondrial dysfunction and calcium imbalance in parallel. Irrespective of that, we are focusing on restoring cellular homeostasis, by activating the sigma-1 receptor, a protein that we all have in our body that is not utilized unless cells are not functioning well or out of balance, i.e. out of homeostasis. If and when cells are impaired, the sigma-1 receptor activation might help those cells to regain functionality through restoring homeostasis. We believe Alzheimer’s is a chronic neurodegenerative disease directly correlating with age, and it is similar in that way to Parkinson’s and other chronic dementia diseases. On the other hand when you have a genetic predisposition where the cells are constantly stressed or proteins are misfolded, or out of homeostasis, the body’s own repair system is probably over-challenged, overburdened, but with small molecules, you can increase the expression of the sigma-1 receptor, potentially restoring homeostasis and potentially reducing those dysfunctions. The difference would be the positive features mentioned before; we are seeing a reduction in amyloid beta but also in tau and inflammation. Calcium balance is restored and oxidative stress and mitochondrial dysfunction are improved. So our approach is not one hypothesis-dependent approach. It is utilizing a more comprehensive approach. It is more macro-management of disease rather than a micro-management approach to the disease stage. So, we are basically in sync with any hypothesis because the sigma-1 receptor is reacting independently to whatever form of dysfunction is caused by the disease. Possibly, an analogy is immuno-stimulation in oncology, where you similarly harness the body’s own existing armoire of defense by activating the body’s own immune system to help to fight the disease, and we are essentially utilizing a similar approach by activating the sigma-1 receptor, which restores cellular homeostasis.
TWST: Is ANAVEX 2-73 potentially a drug that somebody could take and an early stage when they are pre-symptomatic in order to arrest the disease? I know many of these medications ideally should be taken pre-symptomatically if and when we can get the appropriate diagnostic tools.
Dr. Missling: Yes.
TWST: But can you elaborate on the stage that this could be taken?
Dr. Missling: We presented preclinical data that ANAVEX 2-73 could halt the disease and it could improve cognitive function. It was also published that ANAVEX 2-73 might be able to prevent the symptoms of Alzheimer’s in a pre-clinical animal model. So the answer to the question is, it could be both; it could be possibly utilized for either situations or time points.
TWST: Forgive me if I'm overstepping my bounds here, but it almost sounds like something that, if it had a clean safety profile, you could even take as a prophylactic or a vaccination because you just alluded to the fact that it improved cognitive function in people. Is this at all possible do you think?
Dr. Missling: We would have to prove that in clinical trials before claiming that.
TWST: Right, you're saying it's not out of the question at this stage?
Dr. Missling: It is not out of the question, but we cannot claim that at this point.
TWST: If all goes well, when might be the earliest timeframe ANAVEX 2-73 could be on the market? I'm assuming, given the disease it's targeting, that the FDA would want to expedite approval.
Dr. Missling: It's too early for us to give a time point for that because we are really thinking step by step to establish safety first, and the current study is running for 52 weeks. But today, it's really hard to tell because it depends on the data.
TWST: Do you have the financing you need to get through the development of ANAVEX 2-73 at this current stage?
Dr. Missling: Yes, we believe that sufficient financing in place and also because we are working with several foundations on specific diseases like the Michael J. Fox Foundation that has supported us very strongly for exploring ANAVEX 2-73 in a pre-clinical study of Parkinson’s disease, for which positive data was recently reported on September 22nd. And we also received support from the Rettsyndrome.org foundation, which also supported exploring ANAVEX 2-73 in a pre-clinical study in Rett syndrome, a rare disease for which Anavex received FDA orphan designation this year. We might continue these collaborations if the data continues to be promising.
TWST: Do you have any other agreements in place that you wanted to mention to the investor community? Also, are you seeking any agreements in order to move the company forward? And, if so, can you elaborate on what you might be seeking at this time?
Dr. Missling: We announced on September 28th that Biogen has signed a material transfer agreement with Anavex to explore ANAVEX 2-73 for a completely different indication, multiple sclerosis, which is the main focus of Biogen’s portfolio. We obviously are excited to work with Biogen to explore the potential of ANAVEX 2-73 in multiple sclerosis. On October 5th, we announced a collaboration with Ariana Pharma under which we’ll use Ariana’s proprietary KEM® (Knowledge, Extraction, Management) patient stratification technology to potentially accelerate ANAVEX 2-73’s Phase 2/3 Alzheimer’s clinical development timelines. KEM® is a comprehensive and FDA-tested clinical data analysis system that enables full exploitation of complex datasets of smaller numbers of patients.
TWST: Regarding Biogen, can you elaborate a little bit on the agreement terms as to which party does what?
Dr. Missling: It is a material transfer agreement in which Biogen will explore ANAVEX 2-73 in an in-house remyelination experiment of multiple sclerosis at its own costs. We are just providing the compound. After that, the evaluation will take place depending on what the findings are, and then discussions are expected to continue from that point on.
TWST: Does Anavex own most of its IP, or are you sharing it with others?
Dr. Missling: Yes, the company owns it.
TWST: I know you are knee-deep in some very important work, but if, let us say all goes well, where do you see the company going in the future? Do you want to stay in the neurology area? Do you see increased partnerships in the future? Can you elaborate on any kind of longer-term vision?
Dr. Missling: Yes, we are focusing on the central nervous system. And I mentioned specifically indications like Alzheimer’s and Parkinson’s disease, and then also for the neurodevelopmental orphan designations or rare diseases like Rett syndrome, infantile spasm and Fragile X, which is a special form of autism. Then, we also work on improving pain management. So we have a balanced pipeline, but the main focus is indeed on the central nervous system.
TWST: Did you want to say anything further on partnerships?
Dr. Missling: For larger markets like Alzheimer’s disease, partnerships for commercialization are very common. This is something that no small company can market by itself and, for that reason, at some point in time, there will be certainly discussions in that direction.
TWST: When might that be happening? Perhaps pre-Phase 3 or afterwards?
Dr. Missling: Our goal is always to create the highest possible value for shareholders. When you enter into such a collaboration or partnership for a larger indication, we will always try to aim for improving the outcome for the shareholders.
TWST: Are there any significant management or operational changes likely to take place in the next year and, if so, can you elaborate on what they might be and what they are for?
Dr. Missling: We are consistently growing in a thoughtful manner and we are adding people selectively because we are still relatively small. So this will be at an incremental and carefully considered pace. We intend to have several clinical trials up and running next year. One will likely be an orphan indication. All those trials will be double-blind placebo-controlled studies.
TWST: As a CEO, what is your chief challenge right now? And what are you doing to address it?
Dr. Missling: The chief challenge is really to keep in mind that drug development has inherent risks, and we would like to address those in order to reduce those risks to the extent possible. So we try to always do everything to the best of our knowledge and ability to minimize clinical trial risks in particular. That is the most important task for us and for me.
TWST: What do you want a potential investor in Anavex to know today?
Dr. Missling: We are a dedicated team and most of us have big pharmaceutical backgrounds. We want to help patients in indications like Alzheimer’s and Parkinson’s, but also those other devastating diseases like Rett syndrome and infantile spasm for which there are no cures for people today.
TWST: Is there anything you wanted to add that we haven't touched upon?
Dr. Missling: We believe the results we have demonstrated to date with ANAVEX 2-73 and other compounds both clinically and pre-clinically are quite encouraging. We would encourage investors to visit our website at www.anavex.com to learn more.
TWST: Thank you.
Dr. Missling: Thank you.
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Filed with SEC EDGAR
Seq Description Document Type Size
1 8-K s104371_8k.htm 8-K 14803
2 EXHIBIT 99-1 s104371_ex99-1.htm EX-99.1 28066
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frrol, you have mentioned a Part C to the anavex 2-73 trial.
I can't seem to find any information on it. Can you provide a link or some reference about Part C for me? TIA
That would really be great if Anavex could show some slides depicting removal of plaque.
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WOnder if the good Dr thought to do brain scans as well at the beginning?
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Despite what others might say, I pray that you will be 100% succeessfull with both investments.
All of you that are care givers need all of the prayers and support that others can give. You are all special people with a tremendous burden to carry and I feel that you would have the support of most of us monetarily invested in this company with the hopes that Anavex will succeed in finding "cures" to all of the CNS diseases.
I had a similar wish also, but in checking FDA trials for Biogen I found two trials with their aducanumab (BIIB037) drug. One trial labelled ENGAGE and the other labelled EMERGE. I could not see any difference with a quick review of the trials unless it is eligibility of participants that I didn't look at closely or possibly different placebos.
Both trials are monthly infusion of aducanumab compared to a placebo. Both trials were started in Sept. 2015 and the latest updates were November 30 2016. These are studies are double blinded.
Perhaps someone with knowledge of trials could determine if what you (and I) were hoping for is a possibility.
I thought I remembered that someone posted that Biogen's drug was very effective in removing plaque and that a trial failure was based on something else. I could not find that info in a recent search however.
A blended family is exactly what I might expect with Dr. Missling continuing to shepherd his and Skarpelos's "Division" ?
I have been trying to interpret the reason for the addition of the wording regarding Dr. Missling's options which stated
"ON A CHANGE OF CONTROL ALL PREVIOUSLY GRANTED BUT UNVESTED OPTIONS SHALL VEST"
I intended to re-post this.
Credit to Ven who originally posted the statement of Biogen's need.
drv17 Member Level Tuesday, 11/29/16 09:47:59 PM
Re: None
Post #
81313
of 81661 Go
"Biogen needs AVXL more than AVXL needs Biogen"
I forgot which poster stated this but here is a portion of an article written by Todd Campbell in The Motley Fool.
Despite outperforming expectations, year-over-year top-line growth remained tepid compared to the company's historical rates, and a decision by management to shelve development of a next-generation multiple sclerosis (MS) therapy marked a second failure of a key pipeline candidate this year.
In June, the company reported disappointing mid-stage results for anti-lingo, a therapy it hoped could restore the damage to a nerve's myelin sheath that causes MS symptoms. Then in its conference call with investors in October, Biogen announced it's abandoning MT-1303, a S1P modulator that Biogen once hoped could insulate itself against fast-approaching competition from Celgene and Novartis , two companies developing their own S1P drugs. After reviewing MT-1303's market potential, Biogen is walking away from MT-1303 only a year after securing the rights to it from Mitsubishi Tanabe .
Michael D. Ehlers, executive VP of research and development, said, "As we looked at how the landscape was evolving, both in terms of the regulatory competitive landscape, changing features there, and the corresponding fit with our strategic priorities about where we could best allocate resources based on our own expertise and competency -- we just determined that it wasn't as good of a fit as other things which we could allocate our resources toward."
Now what
Biogen is the dominant player in MS treatment, and that's not going to change overnight. However, new drugs are on the horizon that could eat away at Biogen's market share over the next few years, so investors are right to be concerned about Biogen's R&D stumbles.
Management isn't giving up on MS, but it is shifting a lot of R&D focus to other indications, including Alzheimer's disease. If that R&D pays off, then management could tap into a massive and underserved market. However, this research is still ongoing, and it could be a while before we learn how effective these "moonshots" are at curbing disease.
My emphasis- drv17