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Wednesday, April 28, 2010

Octapharma : Trial on Intravenous Immunoglobulin (IVIG) in Alzheimer's Disease at ICAD 2010 Congress

OctapharmaApril 21st, 2010 - The on-going phase II trial on Octapharma's 10% intravenous immunoglobulin octagam®10% will be a topic at the up-coming International Conference on Alzheimer's Disease (ICAD 2010) to take place in Honolulu, Hawaii from July 10 to 15. Researchers from around the globe will attend ICAD to share groundbreaking research and information on the cause, diagnosis, treatment and prevention of Alzheimer's disease and related disorders.

Octapharma's trial entitled "Prospective 24-week, double-blind, randomized, placebo-controlled, multicenter study evaluating safety and efficacy in mild to moderate Alzheimer’s disease under treatment with increasing dosages of intravenous immunoglobulin (octagam® 10%)" and... Octapharma's Press Release -

Siena Biotech : Roche exercises option on compounds from collaboration with Siena Biotech

Siena BiotechMarch 31st 2010 - New molecules could offer innovative treatment approach for Alzheimer’s Disease - Siena Biotech S.p.A., announced that Roche (SIX: RO, ROG; OTCQX: RHHBY) will exercise its option early to become the lead party for further development, manufacture and commercialization of certain selected candidate molecules for a better treatment of Alzheimer’s Disease.

Roche
Under the terms of the collaboration, Siena Biotech has received an undisclosed option exercise fee and is eligible for further success payments upon attainment of certain development and regulatory milestones. Following successful development and commercialization of any of the candidate compounds, Siena Biotech will also receive royalties on product sales: Siena Biotech has retained rights for the further research and development of commonly discovered novel compounds for Orphan indications... [PDF] Siena Biotech's Press Release -

Avid Radiopharmaceuticals, Cardinal Health : Milestone in Innovative Alzheimer's Research

Cardinal HealthMarch 25, 2010 — Currently, Alzheimer's disease cannot be definitively diagnosed until after death, when a brain autopsy is performed on a patient and evidence of beta-amyloid plaque deposits in the brain – which are a characteristic pathology of the disease – can be found. Accurate diagnosis during life can be challenging, particularly in the early stages of Alzheimer's, when symptoms are mild and non-definitive. However, Avid Radiopharmaceuticals, Inc. (Avid) and Cardinal Health are working together to change that.

Avid RadiopharmaceuticalsAvid and Cardinal Health announced that more than 100 clinical centers and more than 700 patients have now participated in a Phase III clinical trial that is testing whether Avid's molecular imaging agent Florbetapir F 18 can detect Alzheimer's disease in living patients. Florbetapir F 18 (also known as 18F AV-45 and Florbetapir) is used with positron emission tomography (PET) technology to detect beta-amyloid plaque deposits in the brain... Cardinal Health's Press Release - [PDF] Avid Radiopharmaceuticals' Press Release -

Signum Biosciences : Alzheimer’s Drug Discovery Foundation Funds Signum Biosciences to Move Novel Therapeutics Towards Clinic

Signum BiosciencesJan 2010 - Signum Biosciences has been awarded a $270K grant from the Alzheimer's Drug Discovery Foundation (ADDF) to investigate, "PP2A: A novel therapeutic target for Alzheimer's Disease". Signum Biosciences' news -
ALZHEIMER’S DRUG DISCOVERY FOUNDATION's Press Release :
MARCH 31, 2010 – The Alzheimer’s Drug Discovery Foundation (ADDF) announced today that it is providing a grant of $270,000 to Signum Biosciences, Inc. (Princeton, NJ) to evaluate small-molecule, orally delivered Protein Phosphatase 2a (PP2A)-modulatory compounds as disease-modifying therapeutics for Alzheimer’s disease.
Signum is developing lipid signal transduction modulators (STMs) for chronic neurodegenerative and inflammatory diseases. Signum’s STM technology, a promising new approach to Alzheimer’s, was licensed from the Princeton University Laboratory of Professor Jeffry Stock, a Signum cofounder and leader in signal transduction research. STMs activate PP2A, a master regulatory protein that, if compromised, can generate signaling imbalances leading to neuronal death and cognitive decline...[PDF] ALZHEIMER’S DRUG DISCOVERY FOUNDATION's Press Release -

Monday, April 19, 2010

Sun Pharma : USFDA tentative approval for generic Namenda® tablets

April 10, 2010: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Forest Laboratories, Inc.’s Namenda 5 mg and 10 mg tablets.
These generic Memantine tablets are equivalent to Forest Laboratories, Inc’s Namenda® tablets and includes two strengths: 5 mg and 10 mg. These strengths of Memantine have a combined annual sale of approximately $1.2 billion in the US.
Memantine tablets are indicated for the treatment of moderate to severe Alzheimer’s Disease... [PDF] Sun Pharmaceutical Industries' Press Release -

GE Healthcare : positive Phase 2 data with flutemetamol and Phase 3 program now underway

GE HealthcareApril 9, 2010 – GE Healthcare will present results from its multicenter phase 2 study of flutemetamol at the 4th annual Human Amyloid Imaging (HAI) Meeting in Toronto, Canada. Flutemetamol is a positron emission tomography (PET) imaging agent in development by GE Healthcare, in the field of brain imaging.

The purpose of the phase 2 study was to investigate the efficacy of flutemetamol in differentiating between patients with clinically probable Alzheimer’s disease (AD) and cognitively intact healthy volunteers (HVs). In the study, subjects with a high probability of amyloid (27 AD patients) and a low probability of amyloid (25 healthy subjects) underwent PET imaging with flutemetamol... GE Healthcare's Press Release -

Friday, April 9, 2010

BELLUS Health : launch of NRM8499 Phase I clinical study for the treatment of Alzheimer's disease

bellus healthApril 1, 2010 - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") announced that, on March 30, 2010, the Company initiated a Phase I clinical study for NRM8499, a prodrug of tramiprosate. NRM8499 is intended for the treatment of Alzheimer's disease. The randomized, double-blind, placebo-controlled study will investigate the safety, tolerability and pharmacokinetic profile of NRM8499 in a group of up to 84 young and elderly healthy subjects.

NRM8499 was previously identified by BELLUS Health as a compound which increases the brain exposure to tramiprosate. Preclinical studies conducted in rodents showed that NRM8499 increased plasma and brain exposure to tramiprosate by 1.5 to 3 fold. The Company believes that an increase in the exposure of tramiprosate to the brain may help improve the therapeutic effect on cognitive function and other clinical outcomes in Alzheimer's disease.

"We are very excited about the launch of the NRM8499 Phase I clinical study. The knowledge acquired through the tramiprosate development program concerning this compound, along with our enhanced understanding of Alzheimer's disease acquired through more than 15 years of preclinical and clinical research in this field, leads us to believe that the potential for NRM8499 is extremely promising,"... BELLUS Health's Press Release -

Takeda & Janssen : About Agreement Reached to Co-market R113675 (Galantamine Hydrobromide), a Treatment for Alzheimer’s Disease

JANSSEN PHARMACEUTICAL K.K.April 1, 2010 --- Takeda Pharmaceutical Company Limited (“Takeda”) announced that it has signed an agreement dated March 31, 2010 with JANSSEN PHARMACEUTICAL K.K. (Head Office: Tokyo, President: Toon Overstijns, hereinafter called “Janssen Pharma”) and Janssen Pharmaceutica N.V. (Head Office: Belgium, Managing Director: Tom Heyman) regarding co-marketing in Japan of galantamine (R113675), which is a drug for Alzheimer's Disease and chemically known as galantamine hydrobromide (hereinafter called “galantamine”).

Takeda Pharmaceutical
Following the development of galantamine by Janssen Pharmaceutica, for the treatment of Alzheimer’s Disease in Japan, Janssen Pharma submitted an application for approval to the Ministry of Health, Labor and Welfare in February 2010.

Janssen Pharmaceutica N.V.
Once approved, Takeda and Janssen Pharma will co-market galantamine under the same brand name... Takeda's Press Release - JANSSEN PHARMACEUTICAL K.K.'s Press Release [Japanese] -