MONTGOMERY, Texas, Sept. 24, 2002 (PRIMEZONE) -- Endovasc Ltd., Inc. (OTCBB:ENVC), a biotechnology company with two cardiovascular drugs approved for final FDA Phase III trials, announced today that it has established an Orphan Drug Trust to develop drugs for rare diseases under the Orphan Drug Act, as utilized by Celgene (Nasdaq:CELG) for Thalidomide, a treatment of severe recurrent aphthous stomatitis in severely immunocompromised patients, and Abgenix (Nasdaq:ABGX) for Gavilimomab, an acute graft-versus-host disease (aGVHD).
Orphan drugs are treatments developed for rare diseases and conditions that affect less than 200,000 people in the U.S. There are currently more than 5,000 of these maladies that have no FDA approved pharmacotherapies. However, these diseases cumulatively afflict more than 20 million Americans. Due to the limited market potential for each drug, too many rare diseases and patients ("orphans") have been left without effective treatment. This is why Congress passed the Orphan Drug Act (ODA) in the early 1980s. Since then, more than 200 drugs and biological products for rare diseases have been brought to market as a direct result of the ODA.
The successful acceptance of both of Endovasc's cardiovascular drugs by the FDA for Phase III clinical trials allows the company to select any number of over 5,000 rare diseases of which over 500 are already designated Orphan Drugs by the FDA.
The Orphan Drug credit is available for any indication that meets the criteria, even if the product itself is used for other indications that are not qualified. Thus, for example, BMS's (NYSE:BMY) Taxol has qualified for use for AIDS-related Kaposi's sarcoma, an indication that qualifies as a rare disease, while the largest market for Taxol is for breast cancer, a disease with a client population much greater than 200,000. This means that an Orphan Drug designation can help Endovasc take its potential blockbuster drugs Angiogenix(TM) and Liprostin(TM) through Phase III trials.
Many of the designated drugs have been abandoned by the original sponsor for various reasons which Endovasc believes may be reactivated and treated by either or both of Endovasc's approved drugs. Since all pre-clinical research and development has been completed, Endovasc expects to select at least one orphan drug indication from each drug and fund the development with proceeds from its newly created Orphan Drug Trust. Besides large tax credits to investors, the Office of Orphan Drug Development may designate grants up to $300,000 and provide the drug a 7-year exclusivity upon new drug approval.
"We have two well-characterized molecules that have passed the early phases of study, i.e., toxicology, animal studies, bioavailability, and stability," said Dr. David P. Summers, CEO of Endovasc. "We should use what we have learned so far with Liprostin(TM) to the advantage of some of these rare, though debilitating and heartbreaking diseases, such as scleroderma, Takayasu arteritis, insulin dependent diabetes, rare kidney and liver diseases and many inflammatory diseases such as lupus, Langerhans cell histiocytosis and multiple sclerosis."
"With Angiogenix(TM) (nAChr agonist), our patent identifies many other acetylcholine receptor agonists such as epibatidine and epibatidine derivatives, N-methyl carbamyl and N-methylthi-O-carbamyl esters of choline and epidoxidine of equal potency and high specificity to neuronal type nicotinic receptors. Any rare diseases that manifest as aangiogenic syndromes (e.g. dry macular degeneration) would be our first candidates. However, use of these agents and their potential ability to also recruit the body's own stem cells should cause us to look at the diseases benefiting from recruitment of stem cells, e.g., for increasing the number of immune cells, i.e., neutrophils, eosinophils, T cells, B cells, cells for connective tissue, chondrocytes, Epstein-Barr virus, HIV and others. We will be polling our clinical and scientific advisors during the next few weeks to identify the most likely candidates for success," said Summers.
The Orphan Drug Act provides various incentives for biotech and pharmaceutical companies. One of the major incentives is a 50% tax credit on any money invested in FDA Phase III human clinical trials performed for approved orphan indications. By creating an Orphan Drug Trust, Endovasc will be able to pass these benefits through to its investors.
"Our new Orphan Drug Trust will create a pass-through conduit that allows institutions and other U.S. investors to receive a 50% tax credit on their investments. For every $1 million invested in our trust, investors can receive a $500,000 tax credit, which they can apply against their ordinary income. This represents a huge return on their investment -- a powerful incentive for investors," said Dr. David P. Summers.
"In addition to the tax credit, many orphan drugs receive an expedited review because they are for serious and life-threatening diseases. This fast-track approval process can significantly shorten our time-to-market," stated Summers.
Endovasc's products include Angiogenix(TM) -- the revolutionary new treatment that has shown to recruit the body's own stem cells that help grow new heart vessels to relieve chest pain and improve heart function; Liprostin(TM), a liposomal prostaglandin-based treatment that studies suggest will prevent restenosis (re-blockage of arteries), increase circulation, and reduce leg pain due to poor blood flow; biodegradable stents, drug-delivery stents and newly discovered nutriceutical applications that may accelerate development of muscle mass and treat obesity in overweight diabetic women. Endovasc believes that its nutriceutical nicotine-based drinks, fitness bars or capsules (which, according to the company, will contain nicotine levels too low to be habituating or to cause the typical euphoria effects from smoking) combined with high protein complexes, could become blockbuster nonprescription products, producing positive cash flow even sooner than its later stage drugs because they are not subject to the FDA approval process.
Endovasc Ltd., Inc., established in 1996, is a biotechnology company focused in the area of cardiovascular disease, pioneering drug delivery technology designed to deliver and release drugs to their intended targets in an efficient and controlled manner. The Company's pipeline of products and processes include: Liprostin(TM), ANGIOGENIX(TM), PROStent(TM) stent-coating technology, and a biodegradable stent prosthesis.
The foregoing statements are made under the "Safe Harbor" Private Securities Litigation Reform Act of 1995 and may contain forward-looking statements that involve risks and uncertainties that may not be evident at the time of this release. For more information about Endovasc, please visit http://www.endovasc.com (Investor questions and requests for materials can be submitted online.)