SPPH

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07.08.2011 (289 Days Ago)

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Title		SPPH
Country		United States

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Spencer Pharmaceutical Inc.

Spencer Pharmaceutical Inc. (OTC: SPPH)

Company Overview
Spencer Pharmaceuticals Inc. (Pinksheets: SPPH) is a public company specializing in the identification of new drug delivery applications. A global player in the biopharmaceutical market, Spencer has forged relationships with two highly respected laboratories located in Universities throughout the world. Their focus is on newly patented formulation of existing drugs from the incubation to the developmental stages or newly synthesized drugs able to cross the blood-brain barrier. The company's partners are experienced researchers providing years of research, now ready for the drug-development status.
Spencer is currently focusing on the development of 2 patented applications (ready for Human trial) in the treatment of Central Nervous System diseases and of Diabetes:

L’Institut National des Sciences Appliquées de Rouen (INSA Rouen) has discovered a new technology in the challenging area of drugs delivered to the Central Nervous System through an innovative approach that allows the crossing of the blood-brain barrier and dramatically reducing the side effects of drugs used for neurological diseases.
L’Universite du Québec à Montréal (UQAM) has discovered how to control the release of existing therapeutics molecules in order to increase their bio-availability and systemic efficacy.

The company's goal is to develop a portfolio of pro-drugs with the ability to outclass the current commercial drugs.

Technologies
Vectorization to the Central Nervous System
The Problem:

The delivery of drugs to central nervous system (CNS) is a challenge in the treatment of neurological disorders. Drugs may be administered directly into the CNS or administered systematically (e.g., by intravenous injection) for targeted action in the CNS. The major challenge to CNS drug delivery is the blood-brain barrier (BBB), which limits the access of drugs to the brain substance. Over the past decade, several treatments have been launched on the market for the treatment of Alzheimer”s disease (Donepezil for Aricept®, Rivastigmine for Exelon®, Galantamine for Razadyne®). However, the existing molecules have their effects depleted with time which leads to elevated doses. These elevated doses can cause serious adverse effects on peripheral organs due to the activity of these molecules which can lead to stopping the treatment.
The Solution:
INSA Rouen has been developing a platform for the treatment of Alzheimer’s disease. The scientific group has designed, synthesized and investigated by in vitro and in vivo experiments, new inhibitors free of adverse peripheral effects. Our strategy brings into play a ‘bio-oxidable prodrug”, which after having crossed the blood brain barrier protecting the brain, is converted to the parent drug in the CNS, via a redox-activation process.
The Strategy:
The past few years, the scientific team has been dedicated to prove the concept and has claimed the intellectual property through a registered patent. The therapeutic challenges being the same for all Central Nervous System (CNS) diseases, INSA has created a series of prodrugs able to cross efficiently the Blood Brain Barrier and outclass all the current commercial drugs for CNS diseases. (Alzheimer’s, depression, Schizophrenia, bipolar disorder and brain tumours).
We are now ready for Clinical trials.
The Scientific Team:
The research is currently performed at the National institute of Applied Sciences of Rouen (INSA) within the CNRS Laboratory UMR 6014 COBRA at the ECOFH (Research Team in Fine Organic and Heterocyclic Chemistry) managed by Pr. Francis Marsais, in partnership with the neuropsychoparmacology and pharmacy of the University of Rouen.
The Research team includes:

Chief Scientific officer: Pr. Francis Marsais
Scientific manager: Dr. Vincent Levacher
Chemical Coordinator : Dr. Cyril Papamicaël
Biomedical Coordinator: Dr. Pierre Bohn

The resources available are fitting for a laboratory of international stature: animal laboratory, cell culture room, radioactive marker room, radiation counters.

Controlled Drug Release

The Problem:
The most popular anti-diabetic drug for glycemia control in patients with type 2 diabetes is Metformin. As a short acting drug, metformin requires three-times-a-day dosing. Adverse events associated with metformin are often gastro-intestinal:

Anorexia
Nausea
Vomiting and occasionally diarrhoea, etc.

These discomforts are often distressing and represent an important barrier to successful treatment with this agent. The limitation / elimination of gastro-intestinal side-effects of metformin is an important clinical objective in the treatment of type 2 diabetes.

Side-effects of Metformin can be minimized by:
- rigorous dose
- dose reduction
- administration with food

using a CONTROLLED RELEASE SYSTEM

The Solution:
Université du Québec à Montréal (UQAM) has discovered and tested a system based on an«intelligent vehicle» that we believe is the best for oral delivery which can protect a small-molecule, a peptide or a protein during the passage of the gastro-intestinal tract and ensure the uptake of bioactive molecules from the gut into the bloodstream in an active form. In this case,UQUAM’s technology will make it easier and less painful and offer increased convenience, patient compliance, and reduced overall health costs.
The Technology:
The technology is based on patented natural polymers used as a vehicle to deliver active compounds at the absorption sites without compromising their stability and bio-availability . To be effective, it is necessary to prepare the polymer in order to confer specific deliver-abilities and protection of the active compound capabilies
When administered orally, this «intelligent vehicle» is able to recognize the harsh environments (i.e. gastric acid) or denaturing factors (i.e. proteolytic enzymes). Face these situations, the vehicle changes its configuration to adopt a structure more stable in order to protect the bioactive agents during gastro-intestinal transit and release them in the controlled way at absorption sites. Moreover, the vehicle can hang for a while on the intestinal walls and promote significantly the transport of the drug into the bloodstream.
We firmly believe that the simplicity and versatility of UQAM’s formulations make this novel natural matrix compatible with various drugs and highly competitive in the field of drug delivery systems.
The Scienfitic Team
Controlled release systems have been developed through a partnership from a very experienced team at UQAM with the intention of reducing or eliminating the side effects of many drugs, potentiate their biological activity as well as providing the possibility for once-a-day administration
Comparative Study:
Glucophage® XR (trade name for metformin extensed release) was chosen in this study because it is a largely used commercialized drug (the most prescribed worldwide for diabetes)

Market Analysis
CNS Diseases
The Central Nervous System disease market is one of the largest and fastest growing markets in the pharmaceutical industry. The global market for drugs treating Central Nervous System disorders has grown rapidly in recent years to reach US$ 66.1 billion in 2006. The global CNS market is forecast to expand to
US $104 billion in 2015.
The Alzheimer’s Disease (AD)
In 2006, global sales of the AD drugs were worth some US$ 1.6 billion. The Alzheimer’s drugs are relatively expensive medicines (costing around $1,700 to $2,300 per year for the patient). They can cause side effects however and these outweigh the sometimes limited benefits and lead to the end of the treatment. Thus, a new drug or strategy such as the one that INSA has developed with no side effects and good benefits would be a real advantage to the patient.
INSA’s strategy could be applied for AD but also for so many other diseases having an important part in the pharmaceutical market. (See table below)

Diabetes
More than 17 millions people in the United States have diabetes mellitus; most common is type 2 diabetes (90%). Type 2 diabetes is a condition characterized by high blood glucose levels caused by a lack of insulin or the body's inability to use insulin effectively. During the last decade, the prevalence of type 2 diabetes has significantly increased.
The most popular anti-diabetic drug for glycemia control in patients with type 2 diabetes is Metformin. In the United States, about 35 million prescriptions of genereic Metformin were issued in 2006. In 2008, metformin is one of only two oral anti-diabetics in the World Health Organization Model List of Essential Medicines.
To our knowledge, monolithic tablet formatting for Metformin is a growing demand in the pharmaceutical world.