Madeleine Pharmaceuticals is a small dedicated team of entrepreneurs and seasoned pharmaceutical veterans working together with scientists and selected clinicians to develop interceptive therapies from natural compounds that when given to patients with an understanding of our bodies and its inflictions of aging provide timely intervention just at the right time when needed to balance organ functions and prepare the patient and families for the prevention of the emotionally and financially exacerbations of the worst case scenario. Focused, Madeleine’s team has its aim on our first target and that being the accelerating global prevalence of acute heart failure in this developing world marked by increasing sedentary lifestyles and extended life expectancy reaching a century and more of life.

Madeleine Pharmaceuticals has a pipeline of natural products that target improved Quality of Life.

A bit of a mouthful, but our motto is to facilitate in principle game changing economically self-centered care provision: empowering interceptive measure to manage quality of life in aging populations. Allowing aging patients to remain active in their own care rather than fall back in to partial or total passivity. Madeleine wants to enable patients of progressive disease to grow old with their inflictions and increasingly play the central role in their own care – putting drugs into their own hands that can be self-administered and results monitored. The basis for our patient-centric strategies have a natural drug at their core – a kind of crystallization point for altering habits with age. These drugs are made by our bodies ourselves. They are inherently safe by their nature and regulators will eventually allow, like insulin, those in need to dose themselves taking their care into their own (or their families hands).

The introduction of new preventative, therapeutic and curative natural replacement modalities of care.

The Time has come for Vastiras®.

Madeleine’s team has invested time and money leveraged by millions of dollars in meritoriously sourced grants from Australia and the United States of America as well as significant contributions from two top tier corporate backers; one a leading distributor of new drugs and the other the top repeat innovator in medical technology. The focused executives and advisors at Madeleine Pty Ltd and Madeleine Inc have had their strategies vetted by no less than a dozen of the world’s leading clinical experts who are in the clinic day in and day out on the lookout for the next generation of care.

Madeleine operates with a series of natural drug candidates at the forefront of evolving care and on a global platform tackling the burden of increased life expectancy balanced by preservation of quality of life and improvement in the economics of outcome based medicine.

The time has come for Vastiras®.

Madeleine is readying itself for the final stages towards the introduction of its first drug to market. The following pages and linked site to www.Vastiras.com will provide you with insight into a ground breaking introduction of a natural product, found in your own body, and given as a replacement therapy, when your body cannot produce enough or simply needs more, and having an envisaged dynamics and penetration rate in heart failure paralleled in many ways by the fight against another major killer of habitual mankind: diabetes.

Madeleine’s lead candidate (MP3167 aka Vastiras®) was developed with co-founder Hospira Inc. now Pfizer (NASDAQ:PFE), in a (patented and patent pending) and cost efficient contemporary biological manufacturing process such that Vastiras® will be able to meet market demand on the scale of that like insulin.

Madeleine’s team members see Vastiras® as a kind of “insulin for heart failure”.

Natural small proteins, Madeleine’s candidates are akin to insulin in structure and behavior. MP3167 has been given by two routes of administration (into the vein – IV and under the skin – subcutaneously - SQ) to patients in five clinical trials (three in Australia and two in the United States) for the treatment of acute and congestive heart failure. A sixth trial is planned to begin in early 2017 under the guidance of the FDA in selected centers in the USA. Duke University, Harvard University, and the Cleveland Clinic are leading the charge on the re-introduction of Vastiras® into the USA after its initial discovery at the VA Hospital in Tampa in the late 1990s.

Vastiras® is not alone in Madeleine’s pipeline and a growing number of team members are applying their knowledge to further related drug candidates. All natural and all about the patient, Madeleine is focused on bringing drugs to the patient in a patient-centric model whereby time at home is spent in families rather than time in and around hospitals. With the formal emergence of same day access clinics and the investment by leading institutions in bricks and mortar to keep acute sufferers from entering the revolving doors of hospitalization, the Time has come for Vastiras®. The forces of managing the cost of medical care are working with the forces of nature and the introduction of Vastiras® and Madeleine’s suite of compounds is timely.

Vastiras® is almost ready to meet the challenge. Join us in our enthusiasm for this life-bettering and contemporary approach to heart failure that potentially can move the traditional standard of care to something of the past. Madeleine is embracing the time for change and call for focus on not just the heart in heart disease but the kidney that in managing blood, blood pressure and fluid balance may in acute heart failure be more at the heart of the matter than the heart, itself. Cardiorenal disease is the number one unmet need of medicine eclipsing in scope even that of cancer. One can argue that point if one dare but Madeleine challenges the community to find one member that has not had a family member or acquaintance or friend grapple with the challenges of heart failure.

The Time has come for Vastiras®.

Clinical testing will not be limited now to intervention in and the interruption of the costly emergency setting in hospital where the recruitment of patients to our trials would be less than one patient per month per site as in the former related acute heart failure trials. Rather, same day access, will allow multiples of out-patients to be seen in a week and Vastiras® given in various formulations to various patient subsets. As such, the Madeleine team will tailor this natural drug to its natural audience who need it most. Preventing congestion and the downward spiral of decompensation, Vastiras® works locally in the kidney with a wide margin of safety, like insulin, and the goal is to meet the regulatory requirements to allow self-administration of Vastiras® on an as needed basis. The medical community will be empowered in a new paradigm of care with Vastiras® to introduce a therapy in the outpatient same day setting. We endeavor to turn the focus of care back to the patients and families with whom we together can manage economically the costliest infliction of those of us over 65, the number one reason for hospitalization in the USA, and the costliest infliction that accounts for just 50% of the Medicare system outlays.

Truly ground breaking: Time has come for Vastiras®.