Acusphere's Inhaled Sustained Release Asthma Formulation Begins Phase I Clinical Trials; First Product to Enter the Clinic Under Joint Venture with Elan Corporation.Business Editors & Health/Medical Writers BIOWIRE2K WATERTOWN, Mass.--(BW HealthWire)--May 9, 2002 Acusphere, Inc. announced today enrollment of the first human subjects 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 of the company's novel, dry powder Dry Powder A slang term for cash reserves kept on hand to cover future obligations. Notes: 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 , sustained release, microparticle formulation of a leading inhaled asthma drug. The product candidate is the first to enter clinical trials under a joint venture with Elan Corporation, plc (NYSE NYSE See: New York Stock Exchange : ELN Noun 1. ELN - a Marxist terrorist group formed in 1963 by Colombian intellectuals who were inspired by the Cuban Revolution; responsible for a campaign of mass kidnappings and resistance to the government's efforts to stop the drug trade; "ELN kidnappers target ), and the second Acusphere product candidate in clinical development. The joint venture with Elan was formed to develop and commercialize a portfolio of inhalation products for local delivery to the lungs and systemic delivery through the lungs. Acusphere's formulation is designed to slowly release the asthma drug locally in the lungs and thereby reduce the multi-dosing per day regimen to a long lasting, once per day regimen. The Phase I clinical trial will compare the pulmonary deposition and pharmacokinetics of the sustained release formulation to that of the current immediate release commercially available product in healthy volunteers. "We are very pleased with the progress that has been made under this joint venture and this particular program, which we began 15 months ago. The initiation of this clinical study is an important step and one that illustrates the commitment and progress with which the two companies have worked," said Larry Sternson stern·son n. Nautical A bar of metal or wood set between the keelson and the sternpost to fortify the joint. Also called stern knee. [stern2 + (keel)son.] , Ph.D., President of Elan Drug Delivery. Sherri C. Oberg, 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 Acusphere, commented, "This initial clinical trial with our joint venture partner, Elan, represents an important benchmark for Acusphere. The development of this sustained release formulation for pulmonary delivery in asthma patients underscores the versatility of our porous microparticle technology. With the initiation of this study Acusphere now has two product candidates in clinical trials." Acusphere's pulmonary drug delivery system has potential for local delivery of drugs to the lung as well as systemic delivery through the lung. Local delivery to the lung is useful for the treatment of respiratory diseases, such as asthma. In 2000, the U.S. market for asthma drugs was approximately $5 billion. Many asthma drugs must be inhaled several times per day and could benefit from a sustained release delivery system. Systemic delivery of drugs through the lung and into the bloodstream would be useful for the delivery of drugs that are currently injected into the bloodstream using a needle. Most protein and peptide drugs marketed by the biotechnology industry are currently injected. Patient compliance and the indications for these protein drugs could be expanded if these drugs could be inhaled rather than injected. About Acusphere, Inc. Acusphere is a privately-held specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary porous microparticle technology. This technology allows the size and porosity of microparticles to be engineered resulting in a versatile drug delivery system for all routes of administration. This porous microparticle technology is broadly applicable as a pulmonary drug delivery system and a hydrophobic hydrophobic /hy·dro·pho·bic/ (-fo´bik) 1. pertaining to hydrophobia (rabies). 2. not readily absorbing water, or being adversely affected by water. 3. drug delivery system (HDDS HDDS Hazards Data Distribution System HDDS High-Density Data System HDDS Hull Design Database System HDDS Hazardous Device Disposal Squad HDDS Hold Deck Deck Switch HDDS Hydro-Dynamic Device Simulator (TM)). In addition to the inhaled sustained release asthma drug candidate, Acusphere is developing two other porous microparticle product candidates, AI-700 and AI-850. AI-700 is an ultrasound contrast agent for the detection of coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. that has completed Phase II clinical trials. AI-850 is an improved formulation of the cancer drug, paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); , which is hydrophobic (i.e. poorly soluble) and has been reformulated using Acusphere's HDDS(TM), a technology for improving the dissolution of poorly soluble drugs. AI-850 is expected to enter clinical trials by the end of the second quarter. Acusphere has focused on therapeutic areas where its drug delivery technology has the potential to provide significant clinical benefits. Each of Acusphere's product candidates targets potential markets in excess of $1 billion worldwide. The company is financed by a leading group of venture capital investors including Polaris Venture Partners, Thomas Weisel Capital Partners and Bank of America
Bank of America (NYSE: BAC TYO: 8648 ) is the largest commercial bank in the United States in terms of deposits, and the largest company of its kind in the world. Ventures. For more information about Acusphere visit the company's Web Site at http://www.acusphere.com. About Elan Corporation Elan Corporation, plc is a leading worldwide, fully integrated biopharmaceutical company headquartered in Ireland, with its principal research, development, manufacturing and marketing facilities located in Ireland and the United States. Elan is focused on the marketing of therapeutic products and services in neurology, pain management, oncology, infectious disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. , dermatology and on the development and commercialization of products using its extensive range of proprietary drug delivery technologies. Elan shares trade on the New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of , London and Dublin Stock Exchanges. |
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