Anavex Life Sciences Corp (AVXL)

[sokol]

Bio’s and Xena’s case for accelerated approval of AVXL 2-73 is compelling. I offer this in addition.

The Anavex clinical trial in Spain targets an unmet need in the treatment of PDD. If AVXL 2-73 demonstrates safety and any degree of efficacy, the approval of this drug will be accelerated in Spain and the EU. Australia, although not a member of the EU, is closely aligned with the EU in regulation of prescription drugs. If the shorter PDD trial in Spain is successful, I believe this will be a reason to support accelerated approval of AVXL 2-73 for PDD in Spain and the EU and for accelerated approval of AVXL 2-73 for AD in Australia and eventually the EU.

Accelerated approval in the EU

https://www.clinicaltherapeutics.com/article/S0149-2918(16)30455-6/fulltext

Accelerated Approval Paths: What they do Mean and What they Should Not Mean?

G. Calvo
Hospital Clinic of Barcelona and University of Barcelona School of Medicine, Barcelona, Spain
PlumX Metrics
https://doi.org/10.1016/j.clinthera.2016.07.012

Cognitive impairment in Parkinson’s disease: a report from a multidisciplinary symposium on unmet needs and future directions to maintain cognitive health
https://www.nature.com/articles/s41531-018-0055-3

Therapeutic Goods Administration in Australia is closely aligned with European Guidelines.

”EU guidelines

The TGA closely aligns its regulatory approaches to therapeutic products with those of comparable international regulatory counterparts wherever possible.

Technical data requirements for applications to register or vary the registration of prescription medicines in Australia are closely aligned with requirements set out in relevant European Union (EU) Guidelines and Guidelines issued by the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use.

Prior to adopting an EU or ICH Guideline, the TGA undertakes an extensive process of internal and external consultation to ensure the Guideline is consistent with prevailing requirements in Australia. TGA publishes a List of European Union and ICH Guidelines adopted in Australia.

The Australian legislative requirements applying to prescription medicines are contained in the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990, as well as in various legislative instruments such as Therapeutic Goods Orders, Notices and Determinations, see Legislation & legislative instruments.

While EU and ICH technical Guidelines adopted in Australia are generally not mandated in Australian legislation they provide guidance to sponsors to assist them to meet the legislative requirements and any deviation from a Guideline relevant to an application to register or vary the registration of a medicine must be justified.

Please Note: Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of prescription medicines by the TGA.”

https://www.tga.gov.au/publication/scientific-guidelines

As I posted once before:

Australia and Spain - Excellent Choices for Anavex Trials.

Spain encourages clinical trials to be conducted in country, and Spain passed new regulations on clinical trials to increase transparency and simplify procedures. See: http://www.barcelonaclinicaltrials.org/en/spain-passes-new-regulations-clinical-trials-increase-transparency-and-simplify-procedures.

It seems that recruitment of patients for clinical trials in Spain with its National Healthcare system is likely to move along more quickly than in many other countries. http://www.farmaindustria.es/web_en/documents/press-releases/2017/03/09/clinical-trials-early-stages-growing-steadily-spain-already-make-51-total/

We do know that recruitment for the PDD trial in Spain commenced. http://pddtrial.com

The Spanish healthcare system is one of the best in the world.
https://www.expatica.com/new/es/healthcare/general-healthcare/healthcare-system-101467/

Life expectancy in Spain ranks number 3 in the world
http://www.worldlifeexpectancy.com/spain-life-expectancy

Spanish have highest healthy life expectancy in Europe
https://www.theguardian.com/world/2013/mar/05/spanish-highest-life-expectancy-europe

Australia is an ideal country for Alzheimer’s clinical trials because it offers more support for the trials, including funds for our trials.

It has also launched the world-first dementia network to fast-track treatment and research.

https://www.9news.com.au/national/2018/07/02/20/06/australian-dementia-network-launched-to-track-diagnosis-and-care-of-patients

As far as locations for Anavex trials are concerned we are good to go. I am thankful Anavex chose to conduct two of its clinical trials in Australia and Spain, and I say this after much research and thought.