Higher dose of Novartis drug Exelon® Patch approved by FDA for patients with mild to moderate Alzheimer's disease

Sept. 4, 2012 - The US Food and Drug Administration has approved a higher dose of Exelon® Patch (rivastigmine transdermal system) for the treatment of people with mild to moderate Alzheimer's disease. The new 13.3 mg/24 h dosage strength of Exelon Patch provides physicians with a new treatment option for patients who are experiencing a decline in overall function and cognition. 

"Alzheimer's disease is marked by progressive symptomatic decline, resulting in an increasingly large physical and emotional challenge for the patient and caregiver," said Jeffrey Cummings, MD, Director of the Cleveland Clinic Lou Ruvo Center for Brain Health. "Having multiple options for the treatment of mild to moderate Alzheimer's disease will help physicians better care for patients with the hope of improving function and cognition."... Novartis' Press Release -

ReproCELL launches Alzheimer’s disease model based on iPS-derived human neuronal cells

7th June 2012 - ReproCELL, Inc. (CEO: Chikafumi Yokoyama PhD) announces that the company will start commercializing human iPS-derived neurons in which an Alzheimer’s disease related gene has been incorporated.

ReproCELL’s scientists have successfully incorporated a gene related to Alzheimer’s disease using homologous recombinant genetic engineering technology into undifferentiated human iPS cells and then differentiated them into neurons. In these cells, it has been confirmed that amyloid beta 42 is accumulated at higher levels compared to normal neurons. This phenomena is similar to what is observed in neurons of Alzheimer’s patients. Accordingly, ReproCELL’s scientists believe the newly developed iPS cells can be useful for drug screening to identify new therapeutic molecules to treat Alzheimer’s disease patients.... ReproCELL's Press Release -

Axerion Therapeutics and AstraZeneca to Develop and Commercialize a Biologic Approach for the Treatment of Alzheimer’s Disease

May 1, 2012 - Axerion Therapeutics, Inc., a private Connecticut-based biotechnology company, and MedImmune the global biologics arm of AstraZeneca, announced that they have entered into a research collaboration and sublicense arrangement to develop and commercialize a biologic approach for the treatment of Alzheimer's disease.

The agreement with Axerion is the first collaboration signed within the new Neuroscience Innovative Medicines Unit that AstraZeneca announced in February 2012. Under this model, AstraZeneca and MedImmune will conduct neuroscience discovery research and early development for small and large molecules by tapping into the best available external science and sharing cost, risk and reward with other research partners active in psychiatry, neurology and pain research.

Under the terms of the agreement, Axerion has granted the AstraZeneca Neuroscience Innovative Medicines Unit an exclusive sublicense* to research, develop and commercialize a pre-clinical biologic that targets the binding of A-beta oligimers to prion proteins.

In exchange, the AstraZeneca Neuroscience Innovative Medicines Unit will provide Axerion with certain upfront and milestone payments plus research and development (R&D) funding during the time both companies are working together on the program. Additionally, Axerion will earn royalties on product sales. The financial terms of the deal have not been disclosed... Axerion Therapeutics' Press Release -

Piramal Healthcare : Encouraging Phase III Study Results Show PET Imaging with Florbetaben Reliably Detects Beta-Amyloid in the Brain

April 16, 2012 - Lead Compound in newly created subsidiary Piramal Imaging SA - Piramal Imaging SA (“Piramal”), a newly formed subsidiary of Piramal Healthcare Limited [NSE: PIRHEALTH, BSE: 500302], announced positive results from a Phase III study that showed that PET imaging with florbetaben reliably detects beta-amyloid in the brain during life with great accuracy and thus shows value as a potential tool to aid in the diagnosis and assessment of Alzheimer’s disease. The study results will be featured as part of the Emerging Science Program on April 25th at the American Academy of Neurology’s 64th Annual Meeting in New Orleans.

Historically, the only way to definitively diagnose Alzheimer’s disease has been after death – at autopsy – through analysis and identification of beta-amyloid in brain tissue. The global Phase III trial employed a unique and rigorous study design comparing in vivo brain PET imaging with florbetaben to post-mortem analysis of the brain tissue.

All study endpoints were met, and the study showed that PET imaging with florbetaben provided reliable, reproducible results. The visual assessment procedure proposed for routine clinical practice demonstrated 100% sensitivity and 92% specificity with excellent inter-reader agreement (kappa = 0.88).

Piramal has signed an agreement to acquire worldwide rights to the molecular imaging research and development portfolio of Bayer Pharma AG through its newly created subsidiary – Piramal Imaging SA. Florbetaben is the lead compound in the portfolio... Piramal Healthcare's Press Release -

Bristol-Myers Squibb and MESO SCALE DISCOVERY : Agreement to Develop Diagnostic Assays for Alzheimer's Disease

March 28, 2012  – Bristol-Myers Squibb Company (NYSE:BMY) and Meso Scale Discovery announced they have entered an agreement to develop diagnostic assays that will measure cerebrospinal fluid biomarkers for use in Alzheimer's disease research.

Under the terms of the agreement, the companies will develop these assays based on the Meso Scale Discovery® MULTI-ARRAY technology platform. Meso Scale Discovery will commercialize the assays for Alzheimer's disease research and drug development, and plans to release the assays in the second quarter of 2012. Terms of the agreement were not disclosed.

"The collaboration with Meso Scale Discovery demonstrates Bristol-Myers Squibb's commitment to advancing the science of Alzheimer's disease research," said Jane Tiller, vice president, Global Clinical Research, Bristol-Myers Squibb. "These assays could provide the Alzheimer's disease research community with an important tool to help advance understanding of this complex and devastating disease and may lead to advances in the diagnosis and treatment of Alzheimer's disease."... Meso Scale Discovery's Press Release - Bristol-Myers Squibb's Press Releases -

PhRMA : Collaborations Between Public and Private Sector Are Critical to Advance Alzheimer’s Research

February 7, 2012 — The Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John J. Castellani responded to new efforts unveiled by the Administration to combat Alzheimer’s Disease:

“Alzheimer’s disease is one of America’s top health challenges. It ravages the minds of patients, seriously impacts entire families and currently costs the U.S. health care system $172 billion a year. According to the Alzheimer’s Association, an American will develop the disease every 33 seconds in 2050, costing the U.S. health care system $1.1 trillion. These costs are simply unsustainable.

“The outlook could change course, however, if a treatment were discovered that helps delay the onset of Alzheimer’s. Biopharmaceutical research companies, recognizing the great health and economic need to help delay or prevent the onset of Alzheimer’s, have invested heavily in this area and are currently researching and developing nearly 100 medicines to help address this public health priority.

“Discovering an Alzheimer’s treatment is by no means an easy task; and it can certainly benefit from collaborations between industry, academia and federal research institutions. In addition to their individual efforts to discover and develop novel treatments for Alzheimer’s, biopharmaceutical companies have partnered with each other and with academic and federal research institutions to help move forward the scientific understanding of this complex disease... PhRMA's Press Release -

Pfizer : Diagnosis of Alzheimer's and What You Need to Know as a Caregiver

One in eight people over 65 have Alzheimer's disease, and many more have personal experience as a family member or caregiver to someone with the disease. On The Doctors, Dr. Freda Lewis-Hall and Dr. Travis Stork discuss signs of dementia and key steps to take if you suspect someone in your life may have Alzheimer's disease. [PfizerNews on YouTube]

Medivation and Pfizer : Results from Phase 3 Concert Trial of Dimebon in Alzheimer's Disease

January 17, 2012 - Dimebon Did Not Meet Primary Efficacy Endpoints - Medivation, Inc. (NASDAQ: MDVN) and Pfizer Inc. (NYSE: PFE) announced results from the CONCERT trial, which is a Phase 3 trial that evaluated dimebon (latrepirdine) when added to ongoing treatment with donepezil HCL tablets in patients with mild-to-moderate Alzheimer's disease. Dimebon did not achieve statistically significant results for either of the two co-primary endpoints, the Alzheimer's Disease Assessment Scale — cognitive subscale (ADAS-cog), which measures cognitive ability, or the Alzheimer's Disease Cooperative Study — Activities of Daily Living (ADCS-ADL), which measures self care and daily function.

"We are disappointed in the CONCERT results and the implications for Alzheimer's disease patients and their caregivers," said David Hung, M.D., president and CEO of Medivation. "I would like to extend my sincere thanks to the patients, their physicians and study teams involved in this trial."

Dimebon was generally well tolerated in the study. A full analysis of the results from CONCERT will be conducted and submitted for presentation at an upcoming scientific congress.

Medivation and Pfizer will discontinue development of dimebon for all indications and will terminate the ongoing open label extension study in Alzheimer's disease. The companies also announce that they will terminate their collaboration to co-develop and market dimebon pursuant to the terms of their Collaboration Agreement... Medivation's Press Release - Pfizer's Press Release -

Aphios® Awarded Phase II SBIR Grant From National Institute On Aging For Alzheimer's Disease Research

January 24, 2012— Aphios® Corporation has received a Phase II SBIR grant from the National Institutes of Health (NIH) amounting to $2.4 million over two years. The National Institute on Aging (NIA), part of the NIH, awarded the grant to the Aphios Corporation to develop an “Alzheimer’s Disease Therapeutic.”

Alzheimer’s Disease (AD) is the third leading cause of death in America and among the highest in the industrial world. AD is a devastating age-related neurological disorder that affects more than 4.5 million Americans and more than 10 million people worldwide. Experts estimate that 22 million people around the world and more than 8 million Americans will be afflicted with this disease by 2025.

“Aphios is developing APH-0703, a potent protein kinase C (PKC) modulator that activates the alpha-secretase pathway which can dramatically enhance the generation of soluble amyloid precursor protein (sAPP), diminishing plaques and cognitive deficits associated with Alzheimer’s Disease,” explains Dr. Trevor P. Castor, President and CEO, Aphios Corporation. “We are developing novel formulations of APH-0703 based on Aphios’ proprietary hydrophobic-based formulation and patented SFS-PNS polymer nanospheres technologies. After formulation selection, Aphios will manufacture and characterize the API and final drug product following cGMP guidelines, and conduct preclinical studies in preparation of filing an IND with the FDA to conduct human clinical trials.”... Aphios' Press Release -

Targacept : Decision by AstraZeneca to Advance AZD1446 in Alzheimer’s Disease

January 05, 2012 - Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, announced that AstraZeneca has informed the company that it plans to progress the development of Targacept’s product candidate AZD1446 as a treatment for Alzheimer’s disease.

AZD1446 is a selective modulator of the alpha4beta2 neuronal nicotinic receptor that arose out of a research collaboration conducted by Targacept and AstraZeneca. Under the terms of a 2005 collaborative research and license agreement, AstraZeneca is responsible for conducting and funding the development and potential commercialization of AZD1446. The next clinical trial of AZD1446 is expected to be a Phase 2 study as an adjunct treatment to donepezil in patients with mild to moderate Alzheimer’s disease... Targacept's Press Release -

Abbott Biotech Ventures Invests in NeuroGenetic Pharmaceuticals

January 4, 2012 - Advancing Research on Therapy for Alzheimer’s Disease -

NeuroGenetic Pharmaceuticals, Inc. (NGP), a privately held biopharmaceutical company focused on Alzheimer’s disease (AD) therapeutics, has received an investment from Abbott Biotech Ventures. The amount of the investment was not disclosed. Dr. William T. Comer, president and CEO of NGP said, “The funding will expedite the development of our lead candidate, NGP 555, for the prevention of AD, including achieving our immediate goal of initiating clinical trials.”

Earlier, NGP announced that it has been awarded a Small Business Innovation Research (SBIR) fast-track grant from the National Institutes of Health (NIH) for preclinical work on NGP 555. The first phase award is in the amount of $288,000 with future awards to approach $1 million for each subsequent phase, which can be up to three rounds of additional funding for milestone-based achievements.

About NeuroGenetic Pharmaceuticals, Inc. 

NeuroGenetic Pharmaceuticals, Inc. (NGP), a biopharmaceutical discovery and development company founded in 2009, is developing innovative drug therapies for Alzheimer’s disease. Based in San Diego, Calif., the company’s next objective is to obtain an Investigational New Drug approval for its clinical candidate, NGP 555. Future clinical trials will utilize specific amyloid biomarkers and/or brain scanning as an early diagnostic and to monitor drug efficacy in clinical trials. Combining early disease identification with a treatment capable of preventing AD-related pathology, such as NGP 555, would represent an important advance in our ability to prevent AD or hinder its progression to dementia. Clearly, the earlier AD is detected and treated, the better the likelihood of a good outcome.

NGP 555, a proprietary “first in class” molecule for the treatment/prevention of Alzheimer’s disease, is a gamma-secretase modulator targeting the γ-secretase complex, a key enzyme in the amyloid pathway. The compound has excellent brain penetration and is devoid of side-effects seen with other potential amyloid therapies such as gamma-secretase inhibitors and monoclonal antibodies. Based on the pre-clinical studies in rodents, this compound is expected to prevent the formation of Aβ42 and the deposition of amyloid plaques in the human brain, thereby precluding neuronal cell death and the dementia associated with AD... NeuroGenetic Pharmaceuticals' Press Release -