Wednesday, January 3, 2018

The Prevacus Story, the next Taxol?









The Prevacus Story

Spun out of Florida State University, Prevacus is a development stage company focusing on a new treatment for concussions, a.k.a., mild traumatic brain injuries or mTBI. TBI touches many lives and is a major cause of disability worldwide. Particularly vulnerable are athletes, the military, the elderly and victims of motor vehicle accidents.
Currently, there are no drugs available for concussion treatment – just rehabilitation and rest. Prevacus’ founder, Jacob VanLandingham is a Ph.D. working in the Department of Biomedical Sciences for the FSU College of Medicine. He has spent many years in the laboratory analyzing the positive effects neuro-steroids have on edema – swelling of the brain. However, the sexual and clotting side effects of some neuro-steroids limit their use. The Prevacus scientific team is in the process of developing an alternate line of concussion therapies and is currently evaluating the safety and efficacy of these drugs in preparation for bringing these products to market. Further, Prevacus is in the early stages of novel drug testing in animals for other neurodegenerative disorders, including Alzheimer’s disease.




A few years after he retired, Favre was introduced to Jake VanLandingham, a neuroscientist at Florida State who created Prevacus to spearhead the development of a concussion drug. The drug, intended to be administered nasally within minutes after diagnosis of a brain injury, is a neurosteroid designed to work by stimulating three different gene promoters in brain cells that turn on cellular survival mechanisms to reduce swelling, inflammation, oxidative stress and cell death (all examples of trauma at the cellular level that are linked to both short- and long-term neurological impairment). It has shown promising results in rats, in improving short-term memory, motor function and anxiety after a brain injury, but the next step will be clinical trials to test its efficacy in humans. 



Another story of royalties is the Taxol story at Florida State University. Robert Holton came up with the semisynthesis pathway that was 80% effective and caught Bristol-Meyers Squibb (BMS) by storm. It was a quicker more effective way that could not be beaten. It was a faster, more efficient way that a company could use to be more profitable. While the molecule he could not patent, he did patent the process. This process included the mechanisms, dosage, and steps to achieve this drug at such an efficient rate. Holton’s lab and FSU had patented that process in 1992 and BMS had it in the market by January 1993, giving them approximately 20 years of patent usage rights (Stephenson, 2002). FSU’s contract was for a royalty rate of 4.2% of BMS’s worldwide Taxol sales (U.S. Government, 2003). 
With sales starting in 1994, FSU had received over $200 million in royalties with Holton receiving 40% of these from an inventor rights bylaw through the university. For Jake’s case with FSU, he gets 40% of whatever patents are made, so if there was a 10% deal, FSU would get 6% and Jake would get 4%, giving Jake and FSU revenue generated by their patent over the life of the patent no matter what company is selling it. If the patents and royalties were set up under Prevacus Inc. and not FSU, the royalty income comes back to the investors. There percentage of royalty income will be correlative to what percentage of the company they own. So for numbers, let’s say the company receives a patent royalty of 5%, and Jake owns 20% of the company, he will get 1% of the overall patent royalties, being 20% of the 5% that they got. The stockholders would get the rest based off their certain percentages that they owned. 

http://www.florida-institute.com/news/florida-institute-funds-tallahassee-based-prevacus

Prevacus Inc. is a start-up pharmaceutical company spun out of Florida State University in 2012. The focus of Prevacus is to provide a safe and effective rehabilitation for mild Traumatic Brain Injury (mTBI or Concussions). Its flagship product, Prevasol Nasal Spray, utilizes Neurosteroids to improve behavioral outcomes of brain injury (working memory, sensory perception and anxiety levels) as well as enhance pro-survival molecular mechanisms after TBI (edema, apoptosis, inflammation, anti-oxidant defense, glial-immune cell infiltration). The capability to administer this product both prophylactically and following injury gives its use and marketing ability a significant advantage.

https://med.fsu.edu/uploads/files/newsPubs/print/Neuroscientist%E2%80%99s%20spinout%20develops%20a%20nasal%20spray%20to%20reduce%20brain%20swelling%20after%20concussion.pdf

His drug development story starts nearly two decades ago, when as an undergraduate at Florida State University he experienced a fluke head injury that left him with three blood clots in his brain. He was already studying neurology and physical therapy, but after the injury, his studies took on a whole new meaning.
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Fast-forward to June 2012, when VanLandingham and his team licensed their work from Florida State University and started a company called Prevacus. The company’s drug, Prevasol, is a
neurosteroid that in animal models has reduced edema, inflammation and oxidative stress after brain trauma. VanLandingham said it works through a receptor that’s in both the neurons of the brain and also at the blood-brain barrier.



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