🕐30.08.12 - 22:54 Uhr

HOPE FOR PATIENTS WITH A FATAL DISEASE: PACIFIC THERAPEUTICS DEVELOPING FIBROSIS TREATMENTS



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Hope for Patients with a Fatal Disease: Pacific Therapeutics Developing Fibrosis Treatments

Imagine learning that you have a disease that will suffocate you to death in a couple of years. With the population aging, more and more people are developing a lung disease called "idiopathic pulmonary fibrosis" (IPF) that does exactly this. IPF causes increasingly severe scarring and stiffening of the lungs, and is almost always fatal within three to five years. The only cure currently available is a total lung transplant, and there is a severe shortage of donors.

The impact of IPF is not trivial: as many as 200,000 patients currently suffer from the disease in the U.S. alone, with 30,000 new cases diagnosed every year. Worldwide, the number is close to 5 million people. According to Decision Resources, the market for IPF therapies is expected to reach $4.6 billion by 2020 in the U.S. and Europe.

Vancouvers Pacific Therapeutics Ltd. (CNX:PT) is ideally positioned to profit from the urgent demand for IPF therapies. The companys lead drug candidate, PTL-202, is a combination drug focused on treating fibrosis in conditions such as IPF, as well as cirrhosis of the liver. (According to the CDC, chronic liver disease is among the top ten disease related causes of death in the U.S. This market is estimated to be $3.0 billion.)

Currently, there arent any medications on the market in North America that can successfully treat IPF. Its been a tough nut to crack: for example, the FDA has refused to grant approval to InterMune Inc.s IPF drug Esbriet. While Esbriet may (or may not) slow the disease somewhat in its early stages, it cant actually make patients better. InterMune suffered another major setback in 2006, when a drug called Actimmune also failed to extend the lives of patients with IPF.

Its worth noting, however, that annual sales for Actimmune reached $141 million-for a drug that didnt even work-before InterMune was forced to stop promoting it for IPF. As for Esbriet, Morningstar Equity Research expects total annual sales in foreign markets to be around $30 million, with a per-patient cost of about $37,000 US per year. These stats offer a snapshot of the market potential for IPF drugs.

NEW COMBINATION SHOWS PROMISE

PTL-202 combines a drug called pentoxifylline and an extremely potent antioxidant called N-Acetyl-Cysteine (NAC). Pentoxifylline has already been approved by the FDA for treating muscle pain caused by blocked arteries. But the good news is that it has also been shown to reduce the severity of pulmonary fibrosis, and also to decrease liver cirrhosis, in animal studies. As for NAC, the second ingredient of PTL-202, antioxidants have been shown to slow the progression of pulmonary fibrosis in animal models. The technology for the original formulation of PTL-202 is protected by two U.S. patents.

MARKET STRATEGY: NEW USES FOR APPROVED DRUGS TO REDUCE R&D RISK

One of the major factors that differentiate Pacific Therapeutics from other pharma and biotech companies is Pacifics strategy of reformulating and repurposing drugs that have already received regulatory approval for other diseases. The advantage of this approach is that the drugs in the companys pipeline dont need to undergo the extensive-and expensive-preclinical and Phase I clinical trials that most new drugs face, which can take many years and cost hundreds of millions of dollars. The regulatory hurdles faced by Pacifics candidates are far simpler: essentially, theyre similar to those required for approval of generic versions of drugs that are already on the market. (In cases where a combination of drugs is used, as with PTL-202, some additional safety studies are needed to prove that there arent any adverse drug-drug interaction effects. PTL-202 will soon be undergoing drug-drug interaction studies (phase I) in India to keep costs down. This type of study takes only a few months.)

Then its on to filing a 505(b)(2) application, followed by Phase II studies. For PTL-202, the hope is that regulatory approval for the new use will be granted in the U.S., Europe, and other countries within the next two years.

ALSO IN THE PIPELINE

Pacifics other product candidate, PTL-303, also targets fibrosis, especially in the liver and adheres to Pacifics strategy of repurposing existing drugs and utilizing the 505(b)(2) accelerated approval method. As with IPF, to date there are no approved antifibrotic drugs for the management of liver fibrosis. PTL-303 combines a drug that has been approved for use in Japan with NAC. These drugs will be combined with a novel delivery mechanism to create a proprietary novel therapeutic.

MANAGEMENT

Pacifics founders and board are seasoned professionals, having built and exited companies in several industries including medical devices and therapeutics.

Founder, President, and CEO Doug Unwin, BSc, MBA, has 18 years of diverse business experience, including 16 years as an entrepreneur in life sciences, aquaculture and telecommunications. He earned his BSc in biology at the University of British Columbia, and also did a two-year internship at the Westlink Innovation Network, a non-profit centre of excellence that aims to accelerate the rate of successful commercialization of scientific inventions in Western Canada. Prior to founding Pacific Therapies, he served as CEO of Med BioGene Inc.; CEO of Computer Telephone Integrators Inc.; CEO of Coastal Telephone Inc.; President of DMA Aquaculture Ltd.; and VP Finance of Seagroup Financial VCC Ltd.

CFO Derick Sinclair, CA, has worked with US and Canadian public and private companies for over 20 years. He has worked for KPMG Peat Marwick Thorne and BC Rail, and served as CFO & VP Administration for Westel Telecommunications Ltd.

Chairman of the Board Greg Beniston, LLB, is an experienced counsel with expertise in technology, corporate/commercial, securities, corporate governance and aviation. He was previously Legal Counsel and Corporate Secretary for cancer-imaging company Xillix Technologies and was VP Legal and Corporate Secretary of MDSI Mobile Data Solutions Inc.

Dr. Wendi Rodrigueza, PhD, brings years of drug-development experience to Pacifics Board of Directors. She received her doctorate from the University of British Columbia, and did postdoctoral fellowships at Thomas Jefferson University and The Medical College of Pennsylvania. She previously served as Director, Product Development, at Espirion Therapeutics Inc., which was sold to Pfizer for $1.3 billion in 2003. Dr. Rodrigueza is currently the VP of Drug Development for ProNAi Therapeutics.

Pacifics Scientific Advisory Board and Clinical Steering Committee include thought leaders in the fields of lung disease and inflammatory disorders from the University of British Columbia, the University of Washington, UCLA, Georgetown University, and the University of Vienna in Austria.

THE BOTTOM LINE

Pacific is currently focused on developing a treatment for a debilitating, fatal disease with no cure. With over 5 million patients worldwide and no approved therapy in North America, IPF represents a huge unmet medical need. The market for IPF therapies will grow to over $4 billion by 2020 in the U.S. and Europe. As for the rest of the companys current and future pipeline, the potential market for anti-fibrotic indications overall is more than $16 billion.

Up to 80% of all new drug candidates fail during preclinical or early clinical testing. With Pacifics strategy of reformulating and repurposing approved drugs that have already undergone extensive clinical trials, the idea is to reduce the risk, time and cost of taking products to market, by avoiding the pitfalls of working with compounds whose safety and toxicity profiles are unknown. In addition, utilizing the 505(b)(2) filing procedure with the FDA will reduce potential approval to within 2 years.

The company is still tightly held with a sound share structure of just under 22 million shares (5 million shares in escrow), and is currently seeking new financing to support research activities and clinical testing. The companys current market capitalization is just over $3 million, a significant discount to its peers. The main priority, though, is to maintain shareholder value over the long term by meeting value-creating milestones. CEO Doug Unwin notes that Pacific would welcome a buyout at the Phase II stage of development of PTL-202. As one of the very few players in the potentially lucrative fibrosis sector, Pacific is at an ideal stage of growth to benefit its investors.

-Katherine Austin
The Bottom Line Report

The Bottom Line Report

The Bottom Line Report is an investor newsletter focusing on Canadian public companies in Biotech, Mining, Energy and Green market sectors. The report highlights specific CNSX, TSX and TSX Venture juniors and gives investors insight into specific corporate initiatives while shedding light on the relevance to the overall industry.

Katherine Austin

Katherine is a market analyst and journalist who has written about biotech, pharmaceuticals, and cleantech for over 20 years. Her clients have included Amgen, Sanofi Aventis, the United Nations, Howard Hughes Medical Institute, GE Healthcare, Lux Research, GigaOm Pro, and Frost & Sullivan. Katherine has been interviewed by the New York Times, Forbes, USA Today, and Business Week regarding reports she has written. She is also a member of the Gerson Lehrman Groups Council of Healthcare Advisors and of Guidepoint Globals Advisors Panel, both of which advise investment analysts and corporate executives on emerging technologies. In her previous life, Katherine was a research scientist. This background and her experience as an analyst give her an edge in spotting disruptive technologies, from nanoparticle drug delivery to thin-film solar power, and allow her to analyze their potential impact on the market.

Legal Disclaimer/Disclosure: A fee has been paid for the production and distribution of this Report. This document is not and should not be construed as an offer to sell or the solicitation of an offer to purchase or subscribe for any investment. No information in this Report should be construed as individualized investment advice. A licensed financial advisor should be consulted prior to making any investment decision. The Bottom Line Report makes no guarantee, representation or warranty and accepts no responsibility or liability as to its accuracy or completeness. Expressions of opinion are those of the Bottom Line Report only and are subject to change without notice. The Bottom Line Report assumes no warranty, liability or guarantee for the current relevance, correctness or completeness of any information provided within this Report and will not be held liable for the consequence of reliance upon any opinion or statement contained herein or any omission. Furthermore, we assume no liability for any direct or indirect loss or damage or, in particular, for lost profit, which you may incur as a result of the use and existence of the information, provided within this Report.

Pacific Therapeutics

409 Granville Street
Suite #1500
Vancouver, BC
V6C-1T2 Canada

Contact Information


as of 4:00pm EST Aug 29, 2012

Recent Press Releases
From Pacific Therapeutics:

Initiation of Clinical Trial

Pacific Therapeutics Ltd. is pleased to announce that enrollment of test subjects for its initial clinical trial has been completed and initial dosing of healthy individuals commenced on August 22, 2012 under the clinical trial protocol submitted to the Central Drugs Standard Control Organization [...]

Pacific Therapeutics Ltd. Issues Stock Options to Directors, Officers and Consultants

Pacific Therapeutics Ltd. is a development stage specialty pharmaceutical company focused on the identification and development of drug candidates to treat diseases of progressive excessive scarring (fibrosis). [...]

Pacific Therapeutics Ltd. Contracts Investor Relations Consultants

Douglas Unwin, President and CEO of the Issuer is pleased to announce that the Issuer has contracted with Sustainable Capital Corp. for investor relations services subject to regulatory approval. The term of the contract is for one month with an automatic monthly renewal for an additional month until terminated by either party. [...]

    

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