AZD-103 --- BLOCKBUSTER Alzheimers Drug
There are actually very few Blockbuster Drugs approved in The World in relation to the number of approved Drugs.
In order to obtain Blockbuster Status A drug must have sales of over $1 Billion/Year World Wide. To be pronounced to have BlockBuster potential a Drug must have the potential to acheive $1 Billion in Sales/Year. If the Potential Market for any drug is not sufficiently Large enough......well it just will not gain BlockBuster Status.
AZD-103 is Transition Therapeutics potential BlockBuster Alzheimers Drug. If it were to be approved it would begin to create the $10-15 Billion Market that many Analyst and Fund Managers and Investment Advisors have calculated will come about should any Drug that ameliorates the Disease be approved.
AZD-103 has all the hallmarks of the Gold Standard Alzheimers Therapy.
AZD-103 is taken Orally.
AZD-103 easily passes the Blood/Brain Barrier which is easier said than done and it does it with between 60-70% of AZD-103 blood levels reaching the Brain.
AZD-103 disaggregates the Beta Amyloid Fibrils and allows them to be flushed away. This action has shown to prevent the disease and has reversed the disease in animal models. This is disease Modifying and is very compelling.
AZD-103 has shown to improve Cognitive Function, a very debilitating complication arising from the disease that gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry out daily activities.
AZD-103 has an excelent Safety Profile.
AZD-103 starts being effective at 3.3 mg./kg. In Toxicity Studys animals have been dosed 900mg./kg. with no toxicity at all.
AZD-103 in an Independant Pre-Clinical Study in Boston was shown to have Duplicated the results and obtained the same compelling disease modifying results as the studies completed by the original researchers. et al McLaurin.
AZD-103 has already successfully concluded one Phasel Clinical Trial in Canada.
----Thirteen healthy volunteers were dosed in the study to evaluate the pharmacokinetics, safety and tolerability of a single ascending dose of AZD-103. The study showed that AZD-103 has a favourable pharmacokinetic profile that supports the targeted therapeutic dosing levels for AZD-103. The safety data indicated that AZD-103 was well tolerated by all subjects. No safety concerns or significant adverse events were observed in the study.
AZD-103 is currently wrapping up an FDA approved Multiple Ascending Dose (MAD)Phasel Trial being conducted at one site in the US. This Trial is testing Higher Doses.
AZD-103 FDA MDA Phasel Trial Results are due to be released very soon.
AZD-103 Phasell Trial application for Alzheimers will be submitted soon after.
AZD-103 is partnered to Elan through a World Wide Strategic Collaberation Agreement in which Transition is to receive us$200 Million of which $15 million is in two upfront payments and us$185 Million is in Milestone Payments.
The Milestones have been calculated by Elan and Transition to be sufficient to cover ALL of Transitions share of the Development Costs!
AZD-103 for Transition Milestone Payment Coming very soon.
Transition can elect to increase its share in AZD-103 from the current 30% up to 50% prior to the start of Phaselll AFTER analyzing the Phasell Results. Sweet!! Hindsight is 20/20 they always say......
On a Side Note here---
---The RBC Report will have to be updated soon because the authors put an extraordinary amount of weight in Elan continuing to the Phasell after seeing the Phasel Results. Their Target of $2.61 will have to be revised upwards.
Remember Dr. Cruz said they are already Designing the Phasell in more detail together with Elan. Nice.