First Joint Cortex-Servier High-Impact Ampakine Compound Moves into Phase I Clinical Studies

November 10, 2010 — Cortex Pharmaceuticals, Inc. (OTCBB (CORX)) announced that it had been notified by Les Laboratoires Servier (“Servier”), France’s largest privately held pharmaceutical company, of their intent to move forward into Phase I clinical studies with the jointly-discovered High Impact AMPAKINE® compound S47445 (CX1632).

“We are very pleased with the progress Servier has made with moving S47445 through pre-clinical efficacy, safety and toxicology studies, and into man in the near future” said Mark Varney, Ph.D., Cortex’s President and Chief Executive Officer. “The High Impact AMPAKINE technology represents a potential disease-modifying approach to treat Alzheimer’s disease and other memory and cognitive impairments associated with a range of neurodegenerative diseases because of the ability of the compounds to stimulate growth factors within the brain.”

In October 2000, Cortex entered into a Research Collaboration Agreement and a license Agreement with Servier, which was completed at the end of 2006 and permitted Servier another year to select three compounds for development. Servier selected S47445 for further development, and discontinued development of the other two compounds. Under the License Agreement, Servier can develop and distribute S47445 in Europe, Asia, the Middle East and certain South American countries as a treatment for neurodegenerative diseases and anxiety disorders. Cortex retains the rights to develop and distribute S47445 in North America, most of South America, Australia and New Zealand.

“Cortex applauds Servier for their persistence in bringing this compound forward,” said Dr. Varney. “This announcement is great news for both our companies and for the many patients who suffer from Alzheimer’s disease and other neurodegenerative diseases.”

Dr Emmanuel Canet, head of Servier R&D commented, "Discovery of new therapeutic approaches for neurodegenerative disorders such as Alzheimer disease remains a major challenge and it is by joining forces through collaborations such as the one developed with Cortex, that we will be able to move forward to the clinic with innovative drugs for these diseases. S 47445 fulfills all the criteria needed to enter clinical research and development as this High Impact AMPAKINE has demonstrated a compelling profile of activity in pre-clinical models. We now are looking forward to evaluating its clinical benefit in Alzheimer disease patients"... Cortex Pharmaceuticals's Press Release -

APR and Labtec : exclusive License Agreement with Ferrer Internacional

APR Applied Pharma Research s.a. and Labtec GmbH Enter Into Exclusive Licensing Agreement With Ferrer Internacional for the Registration and Marketing of Donepezil Oral Dispersible Film

10/01/10 - APR and its development partner Labtec have entered into an exclusive licensing agreement with the leading European pharmaceutical company Ferrer Internacional (Ferrer) for the promotion, distribution and marketing of Donepezil Oral Dispersible Film (ODF) in Spain, Portugal and Germany. Terms of the deal were not disclosed.

“It is an honor to work with a dedicated and professional company like APR. Donepezil Rapidfilm with its unique delivery system will be part of Ferrer’s CNS portfolio and is in line with our overall aim to bring new treatment alternatives for our patients,” said José Luis Fumanal, Vice President Domestic Operations Pharma of Ferrer. “As Ferrer has a successful track record in licensing collaborations, we are convinced that the current agreement with APR will be the initiation of another long-lasting partnership strengthening our supportive care line for our patients.”

“Market trends are clear,” said Paolo Galfetti, CEO of APR. “The future of many molecules to become off-patent such as Donepezil will be determined by dosage form diversification and patient compliance. ODF certainly is the oral dosage form contributing the most to compliance by ensuring drug delivery while being easy to use without any discomfort for patients and doctors. We are also very pleased that such a reputable company as Ferrer Internacional took the Donepezil ODF opportunity for such key markets in Europe. I would also like to express my appreciation for the great co-operation we had from Bioselenia, our strategic licensing partner, that helped to build the connection between APR and Ferrer Internacional on this deal.”... Labtec's Press Release - Applied Pharma Research's Press Release -

ExonHit Therapeutics : promising data on genomic biomarkers in Alzheimer’s disease clinical trials

November 8, 2010 - Aid in the selection of a homogeneous patient population to increase chances of successful study outcomes - Identification of biomarkers to predict response to treatment or monitor efficacy - ExonHit Therapeutics (Alternext: ALEHT) announced that promising data regarding the use of blood-based genomic biomarkers in Alzheimer’s disease (AD) clinical trials were disclosed in two distinct oral presentations at the Third Conference of Clinical Trials on Alzheimer’s Disease (CTAD) from November 3rd to November 5th in Toulouse, France.
The CTAD 2010 brought together current thought leaders involved in AD clinical trials to discuss in particular new results, new drug development, and methodological items (disease modifying outcomes, biomarkers, etc…).
To date, clinical trials designed to evaluate a new treatment for Alzheimer’s disease select patients based on clinical criteria, using psychometric scales, brain imaging and measurements in
cerebrospinal fluid. AD being a complex disease with multiple clinical manifestations, clinical trial results are sometimes difficult to interpret due to the heterogeneity of the patient population. Similarly, treatment response in AD is mainly assessed using psychometric scales with results that also vary according to the rater’s experience or the patient’s disposition.
“Including the use of a simple blood-based molecular biomarker such as AclarusDx™ in Alzheimer’s disease trials may facilitate the recruitment of a more homogeneous Alzheimer patient population and thus contribute to reduce random noise in trial results, hence making it easier to evaluate a drug’s potential efficacy,” stated Professor Serge Gauthier, M.D. from McGill University in Montreal. “In addition, drawing blood from patients can be done almost anywhere and is much easier than collecting cerebrospinal fluid in an aged and fragile patient population.”
“Thanks to the development of comprehensive profiling technologies such as our SpliceArray™ platform, pharmacogenomic analysis can be applied in clinical trials to develop predictive or monitoring biomarkers that can be used to identify patients who will benefit from a treatment or to follow their response to that treatment. This is what we have done with EHT 0202, our Phase II compound in Alzheimer’s disease,” added Matthew Pando, PhD, Executive Vice President, Therapeutics of ExonHit Therapeutics... [PDF] ExonHit Therapeutics' Press Release -

Mind-NRG : Series A financing from Index Ventures

27th October, 2010 - Company developing disease modifying compounds for CNS disorders – Index Ventures, a leading venture capital firm, announced the incorporation and Series A financing of Mind-NRG. The new Company, based in Switzerland, is devoted to the development of NRG-101, a peptidic neurotrophic factor with disease modifying potential that crosses the blood-brain barrier by a receptor-mediated transport to reach its target. Index Ventures has allocated up to € 10m to Mind-NRG, with € 1.5m invested at the start to generate further key data.
NRG-101 will be developed to treat neurological and psychiatric disorders such as Parkinson’s disease, Alzheimer’s disease and schizophrenia. Mind-NRG will initially focus on conducting pivotal in vitro and in vivo experiments to further explore the mechanism of action of the peptide and to assess the activity of NRG-101 in a variety of relevant disease models.
Michèle Ollier, partner at Index Ventures and Chairman of the new company commented: “The investment into Mind-NRG is based on the asset-centric model that Index Ventures has pioneered, in line with our focus on highly innovative, science driven therapeutic projects.”

ProteoSys – a Mainz, Germany based research company, focused on proteomics and system biology – has developed and validated NRG-101 over the last years and has assigned NRG-101 to Mind-NRG in exchange for equity in the newly formed company. “We are very excited to have formed such a strong team in order to exploit the potential of NRG-101” said Helmut Matthies, CEO of ProteoSys... [PDF] Mind-NRG's Press Release -