Please read! This is the best Pink Sheet I could find. If you can find better I'd love to hear about it.
Positives:
1.) Probably the most important positive: Patent protection 
on MANF that was recently upheld in court.
2.) Almost equally as important, the company has a strong group of advisors with big pharma backgrounds and experience in bringing novel drug therapies to market. Below is a list of recently appointed advisor and what they had to say about the company's MANF program.
Dr. Joseph Rubinfeld, co-founder of Amgen, was recently appointed as an advisor to the company and had some very glowing things to say about MANF: "I believe in MANF," said Dr. Rubinfeld, "I have reviewed a great number of technologies in my 45 year career in the biopharmaceutical field, and I believe that MANF could be one of the biggest successes that I have ever seen. The fundamental scientific premise of reducing protein misfolding is basic, yet very profound. The data, while early, demonstrates very clearly at the cellular level and in animals that MANF reduces apoptosis, improves cellular function, and restores behavioural deficits in a number of disease models, including Parkinson's, Stroke, Myocardial Infarction and Traumatic Brain Injury. These are all indications with very large markets and clear unmet medical need. I believe that if we are able to further de-risk MANF with positive toxicology studies and early clinical data, the Company's new orphan drug strategy could get MANF to market rather expeditiously. MANF has the commercial potential to become a blockbuster drug."
Dr. Robert Zimmerman from Bayer (BAYZF): "I have been involved with Amarantus formally and informally for the past three years supporting the founders as they work tirelessly to advance MANF to a stage where it has real commercial potential," said Robert J. Zimmerman, SD. "While that effort has been centered on Parkinson's disease, I believe additional opportunities exist to diversify this therapeutic candidate. Ischemia/reperfusion, cardiovascular disease, stroke, traumatic brain injury, diabetes and potentially other disease conditions appear to be impacted by MANF based upon preclinical studies and the literature."
Clinton O. Allen from Bristol Myers Squibb (BMY): "I am very excited to join Amarantus at this critical time in its growth cycle," said Clinton O. Allen, newly appointed advisor to Amarantus. "The team at Amarantus has been working tremendously hard over the last few years to bring the MANF Program closer to actualizing its true potential. Now that the Company is looking at various partnering and funding opportunities to drive shareholder value, it is an opportune time to join the team in order meticulously evaluate proposals and make recommendations for future growth."
3.) The company has received two separate grants from the Michael J. Fox Foundation in 2010 and 2011 as well as a grant from the Center of Excellence in Apoptosis Research.
If AMBS is able to continue showing positive results in toxicology studies and preclinical data it is possible that larger pharmaceutical companies will seek a partnership with them. Having patent protection will certainly help them in negotiations and having a recent patent challenge upheld in courts could prove to be quite positive for them.
A Powerful Therapeutic Protein with Neuron-Protective Properties
Rationale to follow Amarantus: Currently, available treatments for degenerative neurological disorders such as Parkinson’s disease only alleviate patient symptoms, and do not function to reverse or stop disease progression. Therefore, there is a critical need for curative therapies that can impede the deterioration of the nervous system, which is the root cause of these neurological conditions. Amarantus BioSciences [OTC BB: AMBS] is pioneering the development of a novel therapeutic protein that has neuron-protective properties – termed MANF – which has the potential to serve as a first-in-class treatment for neurological disorders that stops and/or reverses their debilitating effects. Importantly, MANF is also significantly cardiac-protective, providing Amarantus the ability to employ a two pronged drug development approach – a neurological disorder platform, and a heart disease platform.
The stock has significant upside – it is trading below a penny, as the company recently reached the end of the ‘lock-up period’ following a reverse merger in July 2011, which diluted shareholder equity. The company effectively experienced a toxic convert death-spiral – which led to a flooding of shares driving the stock price down even further. These factors have driven the stock price down 96% YTD. However, the company’s diverse and robust pipeline opens the door for a series of significant catalysts in the second half of 2012. In January 2012, Amarantus was awarded a US patent on MANF, and this year announced it would begin developmental timelines for the product. If the technology works (and pre-clinical data suggests this is the case), we should expect the stock to soar following these milestones and the bottoming out post-lock-up period. Further, the company believes it can be successful in financing efforts, which can bring MANF to clinical phase sooner rather than later. As of September 21, 2012, the stock trades at a volume of 827,000.
Market opportunity: Over 1.5 million people suffer from Parkinson’s disease in the United States, Western Europe, and Japan alone. The NIH estimates at least 500,000 people in the United States suffer from PD, and the total cost to the nation exceeds $6B annually. The company has stated the incidence of PD is likely to double in the next 20 years due to increase in average lifespan, coupled with a larger population approaching retirement. In 2009, the PD market generated $2.2B across the seven major markets. Between 2005 and 2009, the dopamine agonist class dominated the market, accounting for nearly half of PD market sales. Additionally, newer catechol-O-methyltransferase inhibitor and monoamine oxidase inhibitor classes have continued to penetrate the market. It is predicted that generic incursion in these classes will limit the market share, and a continued unimpressive late-stage pipeline with unproven benefits and differentiation will open the door for a new first-in-class opportunity.
Background: Amarantus has actualized two leading-edge technologies that enable the discovery of therapeutic proteins with the potential to treat high-need medical conditions: the PhenoGuard Cell Line Library; and the PhenoGaurd Protein Discovery Engine. The PhenoGaurd Cell Line Library is the company’s proprietary stock of different mammalian cell types that maintain the properties of the original tissue from which they were derived. These cell lines are not genetically engineered in any way and can be maintained indefinitely in the lab, providing Amarantus with an invaluable biological substratum to study the normal and disease states of the body. The company’s PhenoGaurd Protein Discovery Engine applies disease-specific stress conditions to their cell lines, and then studies different therapeutic candidates that save the cells from damage.
Amarantus has developed over 80 PhenoGaurd cell lines to date, and has utilized their PhenoGaurd Protein Discovery Engine to identify MANF as a potential breakthrough therapy for neurological disorders and cardiac disease.
MANF (AMRS001) was discovered studying Amarantus’ first established cell line of neurons. It was found to have a striking ability to save neurons from cell death when disease conditions were presented. This was a remarkable finding in regard to therapeutic potential, as neuron cell death is the underlying cause of neurologic conditions such as Parkinson’s disease. Animal and human studies confirm that MANF is a biological protein that is produced in the body to establish and maintain the nervous system. Furthermore, studies have shown that MANF is also highly produced during times of cardiac stress, indicating that this protein plays a crucial role in heart health.
Amarantus Biosciences
OTCBB: AMBS
52 wk: $0.01-0.13 September 21: $0.01 Mkt Cap: ~$1MM
Cash: $6K
Debt: $4.5MM
Shares Outstd: 108.24MM
Founded: 2008
Gerald E. Commissiong, President & CEO
Board of Directors:
Robert L. Harris, Independent Director
Gerald E. Commissiong, John W. Commissiong, M.D.
For more information, see this company’s profile on OMP global database .
OneMedSentinel: The State of CNS Companies in the Public Market
NOTE: This summary was produced by OneMedPlace (OMP). Research based on information provided by the company and other sources.
KEY POINTS:
MANF can stop the cell death of neurons, therefore arresting the progression of Parkinson’s disease in pre-clinical studies. Building on the finding that broad MANF production in the body is important for stabilization of the nervous system, studies have been performed to determine if MANF can stop neuron death in animal models of Parkinson’s disease (PD). Results of these studies showed that MANF has potent therapeutic properties, arresting the progression of the disease. Treatment with MANF prior to inducing PD-like conditions in animals protected the subjects from the onset of neuron degeneration. Even more impressively, in animals where Parkinson’s was already present, treatment with MANF provided restorative benefits that included regaining motor function, as well as the maintenance and increase in function of the neurons that were still present. Cumulatively, these studies provide strong evidence that MANF has the potential to serve as a first-in-class curative treatment for degenerative neurological disorders that include PD. Amarantus is currently in the design and development stages to move MANF into clinical trials.
MANF is highly produced under cardiac stress and provides protective benefits against heart injury and damage. One of the main responses in the body during episodes of stress is to set off the production of biological compounds that help protect against organ damage. Specifically, the heart produces a particular set of factors to minimize injury during cardiac duress, and MANF has been shown to play a critical role in this cardiac protection. In animal studies the reduction of MANF made heart cells susceptible to chemically induced cell death. In contrast, excess amounts of MANF protected animals under ischemic heart conditions such as myocardial infarction. Taken together, these data denote the potent cardiac properties of MANF, which make it a strong translational candidate for the treatment of ischemic heart conditions.
MANAGEMENT, VISION
Amarantus stated in its 2Q2012 earnings report a philosophy to acquire in-license, discover and develop biologics with the potential to address critically important biological pathways involved in human disease. The company is focused in four specific areas: Development of MANF to treat Parkinson's disease; development of MANF to treat other apoptosis-related disorders; exploration of PhenoGuard Cell Lines for therapeutic protein discovery; evaluation of external drug candidates for potential in- licensure or acquisition. According to the company, the company will focus on gaining Investigational New Drug Status (IND) with the FDA for MANF as a therapeutic protein for Parkinson’s disease. The company will use the next two months to complete delivery localization experiments partially funded by The Michael J. Fox Foundation for Parkinson’s Research.
Amarantus co-founder Gerald Commissiong was appointed President and CEO in October 2011, a position he held from the company’s inception in 2008 until August 2009. During his first stint as President and CEO, Commissiong brought in seed capital and acquired IP rights to MANF.
Chief Scientific Officer (and co-founder) John W. Commissiong (Gerald’s father), who discovered MANF, previously held the same position with Neurotrophics Inc and Prescient Neuropharma Inc. From 1989-1997 Commissiong worked with NINDS-NIH, serving as Chief of the Neural Transplantation Unit and Head of the Neurotrophic Factors Group.
Amarantus is actively involved and engaged in supporting research and media outreach for brain injury, particularly with regard to chronic traumatic encephalopathy and the health of athletes participating in contact sports. In 2Q2012 Amarantus teamed with Brewer Sports International to launch the Coalition for Concussion Treatment to increase awareness about scientific advances in developing new concussion treatments.
MANUFACTURING AND PATENTS
In July 2010, the company received a notice of allowance for Composition of Matter patents for MANF throughout Europe. In January 2012, the company was awarded a US Patent protecting composition of matter for MANF. Amarantus has filed additional patent claims domestically and abroad: Method of use patent in US, EU, Japan, Canada, China, India, and Brazil; PCT Neurodegenerative disorders method of use patent application.
Amarantus has also entered into a series of agreements to develop both in-house technology and licensed platforms.
• In April 2012, Amarantus announced Rainbow BioSciences [RBCC] had executed a Letter of Intent to advance
Amarantus’ Parkinson’s disease program. In July, RBCC announced an extension of this Letter of Intent.
• Amarantus owns the license for Power3 Medical Products’ NuroPro Blood Test as it relates to Parkinson’s disease.
NuroPro is a diagnostic platform for the early detection of neurodegenerative diseases. The PD application of this
diagnostic has completed proof-of-concept and Phase I clinical validation studies.
• According to recent company filings, Amarantus will outsource the manufacturing of the MANF Parkinson's Disease
product to a Contract Manufacturing Organization.
CATATLYSTS 2012
• Financing deal to fund clinical development of MANF – 4Q2012
• Financing deal to fund clinical development of diagnostics platform – 4Q2012
• Advancement of collaboration with Rainbow BioSciences, in the form of funding and expertise toward the development
and marketing of Amarantus pipeline – 1Q2013
• Initiation of Phase II clinical validation study for NuroPro – 1Q2013
DISCLAIMER: WHILE THE COMPANY IS THE SOURCE OF THE FACTUAL DATA, THE ANALYSES AND INTERPRETATION OF THESE DATA REPRESENT THE WORK OF THE OMP RESEARCH
