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	Providing Treatments for Rare Diseases: Is the Orphan Drug Act Enough
		Drugs are often “orphaned”, or never are produced and sold on the market, even when a compound is thought to be useful for the treatment of a rare disease.
		In the United States, an “orphan drug” is defined as a drug useful for a condition that is considered to be a rare disease.
		Once a drug receives designation, it is eligible to receive: grants, tax reductions, guidance to facilitate development, accelerated procedures on new drug approval applications, a ten year period of exclusivity of the collected data from practical medical use and a ten year term for re-examination.
	www.cwru.edu /med/epidbio/mphp439/Orphan_Drug.htm (5883 words)

	orphan drug - HighBeam Encyclopedia (Site not responding. Last check: 2007-11-03)
		The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the development and manufacturing of such drugs, which otherwise might not be profitable because of the small potential market.
		Since the 1983 act went into effect, many orphan drugs have been approved, including those for the treatment of such conditions as AIDS, cystic fibrosis, blepharospasm (uncontrolled rapid blinking), and snake bite.
		AnorMED files orphan drug application with FDA for AMD-3100 in stem cell transplant in cancer patients.
	www.encyclopedia.com /doc/1E1-orphandru.html (345 words)

	[No title]
		Drug companies are also allowed to file for orphan drug status for very narrowly defined treatment groups and later add new orphan designations for different applications of the drug.
		Orphan Drug Act was amended to replace the means test with the 200,000 client population criterion.
		For many drugs, the Orphan Drug Act actually adds a new element of risk to the drug development process, as it is possible to be barred from marketing a drug with a valid patent.
	www.cptech.org /ip/health/orphan/orphan92.html (1741 words)

	Who wants to adopt an orphan?
		It was, indeed, the Orphan Drug Act that facilitated the rapid introduction of several drugs for human immunodeficiency virus (HIV) infection to the USA market.
		The EU defines an orphan drug as one that could treat a disease with a prevalence of less than five per 10,000 of the population.
		The risks associated with coming second in the race to bring a new orphan drug to the market place are more significant than with other drugs and it remains to be seen whether this will deter some manufacturers from entering the race to produce an orphan drug in the first place.
	www.pharmj.com /Hospital/Editorial/200006/articles/orphans.html (2461 words)

	Development of Orphan Vaccines: An Industry Perspective
		The United States was the first nation to propose a legal framework to overcome the disincentives to developing orphan drugs and encourage their development and availability (9,10).
		To further encourage orphan drug availability, accompanying market-oriented incentives for orphan drug development were issued by the Office of Orphan Products Development, under the auspices of FDA (11).
		Development of orphan vaccines is guided by the limited need for or market potential of the product, with the accompanying regulations, as well as the specific characteristics of the vaccine and those who need it (24).
	www.cdc.gov /ncidod/eid/vol5no6/lang.htm (3710 words)

	Cancer-Pain Remedy Wins Orphan-Drug Status
		It is designed to encourage research and testing of drugs that may be clinically useful but are not likely attract the interest of pharmaceutical companies because the costs of development and distribution may exceed anticipated revenues from sales.
		"Orphan drug status is a big step toward bringing this important drug to a population of patients in need," said Michael Roizen, M.D., professor and chairman of the department of anesthesia and critical care at the University of Chicago.
		Goldberg altered the drug slightly, so that it continued to block the effects of morphine throughout the body, preventing the nausea and constipation the morphine caused.
	www.eurekalert.org /pub_releases/1996-07/UoC-CRWO-150796.php (510 words)

	Word Spy - orphan drug
		A drug used to treat a rare disease and for which the manufacturer receives special tax credits and marketing rights as an incentive to develop the drug.
		Some drugs lag in development because they are intended to treat less common diseases and have a relatively small market potential.
		Sodium valproate for epilepsy was just such an "orphan drug" and, according to some experts, languished in the bureaucratic pipeline because neither its manufacturer nor the FDA gave it a particularly high priority.
	www.wordspy.com /words/orphandrug.asp (239 words)

	[No title] (Site not responding. Last check: 2007-11-03)
		Drug sponsors - whether drug companies or clinical researchers at academic centers - get 50 percent tax credits for monies spent on research, and from $150,000 to $300,000 in research grants.
		NORD's task force, a broad coalition of representatives from patient organizations and manufacturers of rare drugs, is lobbying to get Medicare to exempt all orphan drugs from their current classification, thereby making them eligible for the same special payment status as the current four.
		Payments for such orphan drugs typically are cobbled together by Medicare, subsidies from the manufacturers and sometimes, private insurers.
	www.mult-sclerosis.org /news/Dec2003/OrphanDrugs.html (1251 words)

	PHCentral - PAH: The Complete Resource: Action Central
		Orphan drugs and biologicals are therapies for diseases that affect 200,000 or fewer individuals in the
		The NORD proposal identifies two groups of orphan drugs and biologicals based upon the annual Medicare hospital outpatient claims volume: (1) orphan drugs and biologicals with 30,000 or fewer claims ("low volume orphan drugs") and (2) orphan drugs and biologicals with more than 30,000 claims-per year ("high volume orphan drugs").
		Orphan drugs and biologicals with annual Medicare hospital outpatient claims volume of 30,000 or fewer would be excluded from HOPPS without requiring administrative review of specific indications.
	www.phcentral.org /action/orphandrugproposal.htm (2379 words)

	Health Care Renewal: The Exorbitant Costs of Orphan Drugs (Site not responding. Last check: 2007-11-03)
		Furthermore, it is harder for generic drug companies to gain approval to market generic versions of former orphan drugs than of drugs that go off patent.
		But the price of the drug, dosed by weight, can run as high as $600,000 a year for adults on the higher of the two recommended doses." The Journal documented how this drug was first developed at the US National Institutes of Health (NIH), and a contract to manufacture the drug was given to Genzyme.
		The high cost of orphan drugs can be devastating for small businesses who can see their total health insurance bills soar when a single employee starts requiring one of these drugs.
	hcrenewal.blogspot.com /2005/11/exorbitant-costs-of-orphan-drugs.html (1106 words)

	Issues related to the Orphan Drug Act
		The Orphan Drug Act is used to privatize something that is in the public domain, such an invention paid for by tax dollars, or a patent that has expired.
		For example, Amgen used its Orphan Drug status to build a wall of manufacturing patents around EPO, which was in the public domain, and Bristol-Myers Squibb used Orphan Status to keep a competitor from submitting its own clinical research on the use of Paclitaxel for Kaposi's sarcoma.
		It is not surprising that many new drugs are "orphan drugs" under current statutory definitions, particularly given deep federal subsidies, such as the 50 percent tax credit for expenditures on clinical trials.
	www.cptech.org /ip/health/orphan (1071 words)

	The Orphan Drug Act (as amended)
		A request for designation of a drug shall be made before the submission of an application under section 505(b) for the drug, the submission of an application for certification of the drug under section 507, or the submission of an application for licensing of the drug under section 351 of the Public Health Service Act.
		A request for a designation of a drug under this subsection shall contain the consent of the applicant to notice being given by the Secretary under subsection (b) respecting the designation of the drug.
		Determinations under the preceding sentence with respect to any drug shall be made on the basis of the facts and circumstances as of the date the request for designation of the drug under this subsection is made.
	www.fda.gov /orphan/oda.htm (1519 words)

	BIO \| Orphan Drug Tax Credit Clarification Needed
		Recognizing this dilemma, the Congress enacted the Orphan Drug Tax Credit in 1983 in order to encourage biotechnology and pharmaceutical companies to develop therapies for rare diseases and conditions that affect 200,000 or fewer patients.
		Many companies, especially small biotech firms, must wait for orphan drug designation before initiating their clinical trials in order to obtain the full benefit of the credit and minimize the effective cost of developing the product.
		Proposal: Clarify that the Orphan Drug Tax Credit applies to qualified clinical trial expenses for a designated orphan drug, regardless of whether such expenses were incurred before or after the product received such designation, provided that such designation has been received.
	www.bio.org /tax/orphan/20030411.asp (518 words)

	Endovasc Creates Orphan Drug Trust; Financial Instrument Provides 50 Percent Tax Credit for Investors and Fast-Tracks ... (Site not responding. Last check: 2007-11-03)
		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.
		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.
		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.
	press.arrivenet.com /health/article.php/326154.html (936 words)

	MAPS Succeeds in Securing an Orphan Drug Designation for Marijuana
		The Orphan Drug program was created by Congress to facilitate development of drugs for rare diseases, defined as fewer than 200,000 patients per years.
		Congress intended Orphan Drug designation to be the starting point for scientific research that would culminate in an informed decision regarding the potential safety and efficacy of each designated drug for the treatment of the specific indication so designated.
		Orphan Drug designation is merely the first step in a very long process.
	www.maps.org /news-letters/v09n3/09319dob.html (659 words)

	Cystic Fibrosis Orphan Drug Designation (Site not responding. Last check: 2007-11-03)
		A description of the drug and a discussion of the scientific rationale for the use of the drug for the rare disease, including all data for nonclinical laboratory studies, clinical investigations, and other relevant data that are available to the sponsor.
		Where the sponsor of the drug that is otherwise the same drug as an already approved orphan drug seeks orphan drug designation for the subsequent drug for the same rare disease or condition, and explanation of why the proposed variation may be clinically superior to the first drug.
		Where a drug is under development for only a subset of persons with a particular disease or condition, a demonstration that the subset is medically plausible.
	www.emphycorp.com /ODDforCF.htm (8272 words)

	Halofuginone Receives FDA Orphan Drug Status For Scleroderma (Site not responding. Last check: 2007-11-03)
		"Orphan drug designation for halofuginone in the treatment of scleroderma affords Collgard the opportunity to help accelerate our efforts as part of our strategy to develop clinical opportunities for our products so they can be commercialized rapidly," said Dr. Neal Farber, Chief Executive Officer of Collgard Biopharmaceuticals.
		The FDA's orphan drug designation is intended to encourage research and development of new therapies for diseases that affect fewer than 200,000 U.S. residents.
		As a designated orphan drug, halofuginone is eligible for tax credits based upon its clinical development costs, as well as assistance from the FDA in guiding the drug through the regulatory approval process.
	www.pslgroup.com /dg/18dff6.htm (514 words)

	Costs of Human Use Clinical Trials: Surprising Evidence from the US Orphan Drug Act
		According to the US Internal Revenue Service (IRS), US taxpayers received Orphan Drug Tax Credits totaling $80.1 million in fy 1998, and $61.4 million in fy 1997, the most recent years for which data are available.
		While the tax credit is officially for rare diseases or conditions, it is in practice available to a significant number of new drugs, because of the liberal definition of a rare disease and the lack of a means test.
		For example, in 1998, of the 30 FDA approved new molecular entities, 7 were classified as orphans, or 23 percent of the total.
	www.cptech.org /ip/health/orphan/irsdata9798.html (650 words)

	PRESS RELEASE Callisto Pharmaceuticals Receives Second Orphan Drug Designation on Annamycin With Granting of Indication ... (Site not responding. Last check: 2007-11-03)
		Orphan drug designation for Annamycin to treat AML, in addition to the earlier granting of orphan drug designation for Annamycin to treat ALL, provides additional assurance to the company and its investors that Callisto is well protected against potential competition."
		Orphan drug designation, along with approval by the FDA for commercialization of Annamycin, entitles Callisto to seven years of market exclusivity in the United States, provided Callisto continues to meet certain conditions established by the FDA.
		Callisto's second drug, Atiprimod, is in a Phase I/IIa clinical trial in relapsed multiple myeloma patients, and is a small-molecule, orally available drug with antiproliferative and antiangiogenic activity.
	www.marketwire.com /mw/release_html_b1?release_id=89624 (667 words)

	News: Hana Biosciences Receives Orphan Drug Designation for Ropidoxuridine (IPdR), for the Treatment of Malignant ...
		Ropidoxuridine is a novel, orally available, thymidine analogue and prodrug for IUdR, which demonstrated a survival advantage in Phase II studies in anaplastic astrocytoma, a type of brain tumor.
		The Orphan Drugs Act provides for economic incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the United States.
		Orphan drug designation entitles Hana Biosciences to seven years of market exclusivity for Ropidoxuridine in the treatment of malignant glioma.
	www.genengnews.com /news/bnitem.aspx?name=2347891 (686 words)

	Orphan Drugs: Present and future markets - a Scrip strategic report
		According to published figures there are more than 6,000 rare (or orphan) diseases affecting patient populations in the world today.
		With the US Orphan Drug Act entering its 21st year in 2004, and the successful establishment of the EU orphan drug incentive programme, there is a wealth of opportunities offered to orphan drug developers.
		Drugs such as Amgen's Epogen and Ortho Biotech's Procrit already generate blockbuster sales, proving that this often ignored niche market can be highly profitable for innovative pharma and biotech companies.
	www.pjbpubs.com /scrip_reports/orphan_drugs.htm (279 words)

	Trophos Granted Orphan Drug Status for TRO19622 for the treatment of Amyotrophic Lateral Sclerosis in Europe - ...
		Trophos has already been granted orphan drug designation for TRO19622 for the treatment of ALS by the U.S. Food and Drug Administration in the USA.
		The only drug approved for ALS is riluzole (Sanofi-Aventis), which has been demonstrated to give some survival benefit to ALS patients.
		The granting of orphan drug designation status is intended to promote development of drugs to treat rare diseases or conditions which would otherwise be unprofitable to pursue.
	www.pipelinereview.com /joomla/content/view/6229/109 (630 words)

	ChemGenex Pharmaceuticals receives U.S. orphan drug designation for Ceflatonin
		Ceflatonin is the first of a new class of novel drugs that induces apoptosis (programmed cell death) and inhibits angiogenesis (new blood vessel formation).
		Orphan drug status is granted by the FDA to promote the development of drugs for diseases affecting less than 200,000 people in the United States.
		Orphan drug status entitles ChemGenex to seven years of market exclusivity for the use of Ceflatonin in the treatment of CML; protocol assistance by the FDA to optimize drug development in the preparation of a dossier that will meet regulatory requirements; and reduced fees associated with applying for market approval.
	www.news-medical.net /?id=16796 (460 words)

	News: Hana Biosciences Receives Orphan Drug Designation for Talotrexin (PT-523), For the Treatment of Acute ...
		Talotrexin, a novel nonpolyglutamatable antifolate drug, is currently being evaluated in a Phase I/II multicenter clinical trial in patients with relapsed or refractory ALL.
		Orphan drug designation entitles Hana Biosciences to seven years of market exclusivity for Talotrexin in the treatment of ALL.
		Antifolates, also known as folic acid analogs, are a class of cytotoxic or antineoplastic agents which inhibit or prevent the maturation and proliferation of malignant cells.
	www.genengnews.com /news/bnitem.aspx?name=1813433 (895 words)

	Orphan Drugs (Site not responding. Last check: 2007-11-03)
		The term "orphan drug" refers to a product that treats a rare disease affecting fewer than 200,000 Americans.
		The Orphan Drug Act was signed into law on January 4, 1983.
		The intent of the Orphan Drug Act is to stimulate the research, development, and approval of products that treat rare diseases.
	www.fda.gov /cder/handbook/orphan.htm (167 words)

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