Inhale receives Orphan Designation for inhaleable hereditary emphysema therapy.Aventis Behring LLC (Logical Link Control) See "LANs" under data link protocol.
LLC - Logical Link Control (King of Prussia King of Prussia, industrialized suburban area (1990 pop. 18,406), Montgomery co., SE Pa. It has glass and steel fabricating, food processing, printing and publishing, and varied manufacturing (textiles, liquified petroleum gas, water-treatment and electrical , PA; 610-878-4822), a global leader in the plasma protein plasma protein
Any of the various dissolved proteins of blood plasma, including antibodies and blood-clotting proteins, that act by holding fluid in blood vessels by osmosis. industry, and Inhale Therapeutic Systems, Inc. (San Carlos, CA; 650-631-3138), a pioneer in drug delivery technology solutions, announced that Aventis has received Orphan Medicinal Product medicinal product,
n a substance administered to humans or animals through injection, application, oral ingestion, inhalation, and so forth, whose purpose is to ultimately restore health or eliminate disease in an individual. Designation from the European Commission for the inhaleable form of Alpha1-Antitrypsin (Human), currently in clinical trials for the treatment of hereditary emphysema emphysema (ĕmfĭsē`mə), pathological or physiological enlargement or overdistention of the air sacs of the lungs. A major cause of pulmonary insufficiency in chronic cigarette smokers, emphysema is a progressive disease that commonly .
The Orphan Medicinal Product Designation from the European Commission has the potential to provide for up to ten years of market exclusivity in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the
European Community . Additionally, in January 2000, the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) granted orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the designation to this inhaleable dry powder Dry Powder
A slang term for cash reserves kept on hand to cover future obligations.
For example, if a venture capitalist expects bad times in the IPO markets you might hear him say something like, "we want to keep enough dry powder around to keep funding our formulation of Alpha1-Antitrypsin (Human). Orphan drug designation could provide United States marketing exclusivity for seven years upon approval by the FDA.
While this disease is rare, patients suffering from this inherited disorder experience reduced breathing function that drastically undermines their lifestyle and ability to function in society. Aventis Behring is pleased to be working with Inhale to develop this revolutionary, inhaleable formulation which we believe may help many patients resume a more normal life," said Gail Schulze, Chief Operating Officer Chief Operating Officer (COO)
The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. of Aventis Behring LLC. "Receiving Orphan Medicinal Product Designation for the inhaleable form of Alpha1-Antitrypsin moves us closer toward our goal of providing the Alpha-1 Community worldwide with a novel treatment option for this under-recognized disease."
"We believe that a dry powder inhaleable Alpha1-Antitrypsin could decrease the amount of drug used compared to intravenous infusion. Further, it may provide patients with more time to enjoy life through shortening dosing time and providing a more patient-friendly delivery mode," said Robert Chess, Chairman, Inhale Therapeutic Systems, Inc.
"We are pleased that regulatory authorities in Europe and the United States are recognizing the unique needs of the Alpha-1 Community," said John W. Walsh, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of the Alpha-1 Foundation. "As there is currently no cure for this hereditary disorder, Alpha-1 patients worldwide salute companies such as Aventis Behring and Inhale for their dedication to developing novel treatment formulations of Alpha1-Antitrypsin."
The inhaleable form of Alpha1-Antitrypsin was recently evaluated in a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained
phase I in the United States. The primary objective of this study was to examine the safety and tolerance of escalating doses of inhaleable Alpha1-Antitrypsin. All doses were well tolerated and a dose response was achieved.
Alpha1-Antitrypsin Deficiency affects approximately 100,000 Europeans and a similar number in the United States, according to the Alpha-1 Foundation, a not-for-profit organization dedicated to increasing the awareness and early diagnosis of this life-threatening genetic disorder. Unlike emphysema that develops as a result of smoke inhalation, emphysema caused by Alpha1-Anti-trypsin Deficiency is an inherited condition that may affect both the structure and the function of the lungs and can lead to chronic emphysema and premature death if left untreated. Current treatment involves weekly intra-venous infusions that may take up to two hours.
Under the collaboration between the two companies, Aventis Behring manufactures the active substance for treatment of Alpha1-Antitrypsin Deficiency. Inhale Therapeutic Systems produces the dry powder formulation for use with its proprietary inhalation system and processes and packages the powder for usage. Aventis Behring oversees the clinical pro-gram and will be responsible for the worldwide commercialization of any approved products result-ing from the collaboration.
Aventis Behring is a global leader in the plasma protein industry, providing a wide range of innovative, high quality therapies and unique support services to patients worldwide. Aventis Behring is dedicated to the research and development of proteins from human blood plasma and emerging technologies.
Aventis, a world leader in pharmaceuticals and agri-culture, is dedicated to improving life through the discovery and development of innovative products. In 2000, Aventis generated group sales of 22.3 billion Euros and employed around 92,500 people in its Pharma and Agriculture businesses. Aventis announced in November 2000 that it intends to focus on pharmaceuticals and plans to divest its activities in agriculture. Aventis was launched in December 1999 through the merger of Hoechst AG of Germany and Rhone-Poulenc SA of France. Corporate headquarters are in Strasbourg, France.
Inhale Therapeutic develops advanced drug delivery solutions for the biopharmaceutical industry. Inhale is focused on two main opportunities: improved delivery of macromolecules Macromolecules
A large molecule composed of thousands of atoms.
Mentioned in: Gene Therapy
macromolecules , including peptides and proteins, and improved performance of drug powders. Inhale is pioneering inhaleable delivery of macromolecules, supercritical fluids processing for powder particle production and advanced PEGylation. Inhale is collaborating with major pharmaceutical and biotech-nology companies, including Amgen, AstraZeneca, Aventis Behring, Biogen, Bristol-Myers Squibb, Glaxo-SmithKline, Lilly, Pfizer, Pharmacia, and Roche.