Ipsen : Encouraging results of GuidAge®, large scale European trial conducted in the prevention of Alzheimer’s Dementia

22 June 2010 - Primary efficacy objective (to delay conversion to Alzheimer’s Dementia): - Unmet in overall study population, Met in patients treated for a duration of at least 4 years - The GuidAge® study marks a milestone for future research on Alzheimer’s Disease and for prevention strategies - Ipsen intends to transfer a unique biobank to French Academic research - Ipsen (Euronext: IPN; ADR: IPSEY) announced top line results of GuidAge®, the longest (5 years) and largest (2,854 subjects) European study in the prevention of Alzheimer’s Dementia (AD). This trial was conducted according to the most stringent international standards. The aim of this study was to assess the efficacy of a 5-year treatment with EGb 761® in the prevention of Alzheimer’s Dementia in a population of elderly aged 70 or more, with memory complaint spontaneously expressed to their family physician and who lived at home at the inclusion in the study...

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...About EGb 761®
EGb 761®, which is the active substance of Tanakan®, is a unique standardized extract of Ginkgo biloba. This compound features antioxidant and neuroprotective property as well as an action on β-amyloid protein in experimental models. Its consistent composition in pharmacologically active substances is achieved through specially designed plantations of Ginkgo biloba (dioecious tree in the Ginkgoaceae family) that are cultivated under controlled conditions and a standardised extraction and purification process. EGb 761® is indicated and registered in many countries for the treatment of cognitive disorders in the elderly as well as neurosensory disorders.

About GuidAge®
The aim of the GuidAge® study was to assess the efficacy of EGb 761® at a dose of 240 mg daily in the prevention of Alzheimer’s Dementia (AD) in a population of subjects aged 70 or more with a memory complaint spontaneously expressed to their family physician and living at home at the inclusion. GuidAge® is the longest and largest European study in this disease and has been conducted in full compliance with the most stringent international standards. GuidAge® was a 5-year double-blind randomized trial versus placebo conducted in France by a network of family physicians and memory clinics. The primary endpoint was the incidence of AD during a 5-year follow-up period. A total of 2,854 subjects were enrolled between March 2002 and November 2004. At entry, the mean age of the study population was 76.3 (±4.4), with mean MMSE (Mini Mental State Evaluation) at entry of 27.6 (± 1.9). Last patient last treatment date was November 2009.
The outcomes of the study pointed out that 134 individuals developed dementia of Alzheimer’s type, including 61 patients (4.3%) in the EGb 761® group and 73 patients (5.2%) in the placebo group; this difference was not significant (p=0.31). Global conversion rate found in the placebo group (5.2%) was 50% lower than usually reported in the general French population. In planned pre-specified analysis, results were in favour of EGb 761® in patients treated for at least 4 years (1.6% versus 3.0% in the placebo group, p=0.03) and in males (2.9% versus 7.0% in the placebo group, p=0.007).
Both the dose and indication in the GuidAge® study are not approved by regulatory authorities... [PDF] Ipsen's Press Release -

Forest and Merz : FDA Approval of NAMENDA XR for the Treatment of Moderate to Severe Dementia of the Alzheimer's Type

Jun 21, 2010 - Forest Laboratories, Inc. (NYSE: FRX) and Merz Pharmaceuticals GmbH announced that NAMENDA XR(TM) (memantine hydrochloride) was approved by the U.S. Food and Drug Administration for the treatment of moderate to severe dementia of the Alzheimer's type. NAMENDA XR is a 28 mg once-daily extended-release formulation of NAMENDA. The safety and efficacy of NAMENDA XR were established in a randomized, double-blind, placebo-controlled trial of 677 outpatients already taking a cholinesterase inhibitor. The results indicate that patients treated with NAMENDA XR experienced statistically significant benefits in cognition and clinical global status compared to placebo.


NAMENDA XR will be covered by U.S. Patent No. 5,061,703, which is listed in the Orange Book for NAMENDA and expires in April 2015. In addition, Forest owns pending patent applications related to NAMENDA XR. The companies are determining the appropriate commercialization strategy and market timing to ensure a successful franchise... Forest Laboratories' Press Release -

TauRx : collaborative R&D agreement with Bayer Schering Pharma

June 4, 2010 (New York, NY) - Paves the way for a new paradigm in the early diagnosis and management of Alzheimer’s disease – WisTa Laboratories Ltd, a wholly owned subsidiary of TauRx Pharmaceuticals, announced that they have entered a collaborative R&D agreement with Bayer Schering Pharma AG, Germany, which could redefine the way Alzheimer’s disease (AD) and related disorders are currently being diagnosed and treated.

Through this collaboration, the two companies will develop specific markers that will aid in the diagnostics and management of Tau-protein related AD using brain-imaging technology. The diagnostics they are jointly aiming to develop will have application in disease treatment and potentially disease prevention... [PDF] TauRx Pharmaceuticals' Press Release -

Ablynx and reMYND settle dispute amicably

2 June 2010 – Ablynx NV [Euronext Brussels: ABLX] and reMYND NV announced that they have reached a settlement concerning a dispute relating to a collaboration agreement to discover and commercialize new Nanobodies® which Ablynx and reMYND entered into in 2003. In 2007, Ablynx was notified by reMYND that a difference of interpretation existed in respect of Ablynx's contractual obligation to reMYND under the 2003 agreement.

Under this agreement, Ablynx had the obligation to pay reMYND 50% of any income received if certain Nanobodies from the above collaboration were licensed to a third party for development and commercialization. Ablynx has a collaboration with Boehringer Ingelheim in the area of Alzheimer’s disease with a potential deal value of $265 million plus royalties, under which, at this time, it believes, in contrast to reMYND, that no license to develop or commercialize any of the aforementioned Nanobodies has been granted... [PDF] reMYND's Press Release - Ablynx's newsroom -

LIFETREE CLINICAL RESEARCH® CEO AND CO-FOUNDER NAMED TO ALZHEIMER’S ASSOCIATION, UTAH CHAPETER BOARD OF DIRECTORS

5/27/2010 - The CEO and co-founder of Lifetree Clinical Research® and Lifetree Center for Neuroscience Research, one of the largest specialized clinical research organizations in the Western region of the United States, has been named to the board of directors for the Alzheimer’s Association, Utah Chapter. Alice Jackson will begin her three-year term of service effective May 24, 2010.
"Utah is facing a sharp increase in people with Alzheimer's," said Jack Jenks, executive director of the Alzheimer's Association, Utah Chapter. "The addition of Alice Jackson to our board of directors will ensure that our association will continue to benefit from a diversity of experience, expertise and insight, leading to a cure for this disease."... Lifetree Clinical Research's Press Release -

Senexis : NEXT-GENERATION DISEASE-MODIFYING DRUGS FOR ALZHEIMER’S ENTER PRE-CLINICAL DEVELOPMENT

25th May 2010 - Senexis Limited has identified drug candidates from different and novel chemical series that have shown potential in pre-clinical models, as disease modifying treatments for Alzheimer’s disease. Their success secures the drawdown of further tranche of funding from the Wellcome Trust to support pre-clinical development of the most promising candidates from the SEN1500 series.

Senexis were awarded £2.9 million by the Wellcome Trust, under the Seeding Drug Discovery initiative in 2008, to support selection studies to identify potential drug candidates for pre-clinical development. Successful completion of these studies now triggers the release of funds, enabling Senexis to initiate that planned development and file two further patents to protect this next generation of potentially disease modifying Alzheimer’s drugs.

Using proprietary drug screening technologies, Senexis have identified novel compounds, which target the soluble assemblies of brain proteins that are a toxic form of amyloid. These potential drugs have been selected for their ability to prevent amyloid from aggregating or “clumping together”. The effect of the compounds is to protect against amyloid toxicity, well before the formation of the tell-tale “plaques” that have been used to classify the disease, since the original discoveries of Alois Alzheimer over a century ago... Senexis' Press Release -

Merz and Acumen Partner in An Innovative Alzheimer's Approch

January 12, 2010 – Merz has licensed an innovative drug development program and related technology originated by Acumen Pharmaceuticals, Inc. The license provides Merz certain exclusive global drug development, manufacturing and marketing rights in exchange for upfront and milestone payments to Acumen as well as royalties on future product sales. The drug technology is based on Acumen’s pioneering work on the toxic ß-amyloid protein species appearing very early in dementia of the Alzheimer’s type.


As such, the technology holds great potential in the present quest for a disease-modifying Alzheimer treatment, interfering with the cause, not just the symptoms of one of the most devastating diseases. The development of such an innovative and promising approach therefore complements the successful track record established by Merz’ current anti dementia blockbuster drug, Memantine... [PDF] Acumen Pharmaceuticals' Press Release -

Martek Biosciences : Study Published in Alzheimer's & Dementia: The Journal of the Alzheimer's Association Shows Algal DHA Improved Memory and...

May 3, 2010 - The Memory Improvement with Docosahexaenoic acid (DHA) Study (MIDAS) published online this week in Alzheimer's & Dementia: The Journal of the Alzheimer's Association showed that algal DHA improved memory function in healthy aging adults, providing a benefit roughly equivalent to having the learning and memory skills of someone three years younger.

MIDAS is the first large, randomized and placebo-controlled study demonstrating the benefits of algal DHA in maintaining and improving brain health in older adults. The goal of MIDAS was to evaluate the effects of algal DHA on cognitive outcomes in healthy elderly people with a mild memory complaint. The study was funded by Martek Biosciences.

MIDAS found that healthy people with memory complaints who took 900 mg algal DHA capsules for six months had almost double the reduction in errors on a test that measures learning and memory performance versus those who took a placebo, a benefit roughly equivalent to having the learning and memory skills of someone three years younger. The DHA was well-tolerated and subjects taking the DHA also experienced a lower heart rate, providing a significant cardiovascular benefit.

The study population included 485 people 55 and older at 19 U.S. sites who were considered to have age-related cognitive decline. Age-related cognitive decline is defined as decline in cognitive functioning consequent to the aging process that is within normal limits given a person's age. For example, individuals may report problems remembering names or appointments or may experience difficulty solving complex problems.

MIDAS study participants consumed an oral dose of 900 mg per day of algal DHA or a placebo (corn/soy) over the course of six months. The primary endpoint was a cognitive test of memory and learning called the CANTAB Paired Associate Learning (PAL). CANTAB PAL is an assessment of visual memory and new learning, and is a useful tool for assessing patients with age-related memory loss... Martek Biosciences Corporation's Press Release -