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Acusphere Receives Second U.S. Patent for the Use of Sustained Release Porous Microparticle Formulations.


Business Editors/Health/Medical Writers

WATERTOWN, Mass.--(BUSINESS WIRE)--Feb. 11, 2004

Acusphere, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: ACUS acus (a´kus) a needle or needle-like process.

acus

a needle or needle-like process.
), a specialty pharmaceutical company that develops drugs using its porous microparticle technology, announced today the issuance of U.S. Patent 6,689,390 entitled "Matrices Formed of Polymer and 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.
 Compounds for Use in Drug Delivery."

The patent relates to the use of certain porous microparticle formulations using slowly dissolving shell materials to create sustained release Sustained-release (SR), extended-release (ER, XR, or XL), time-release or timed-release, controlled-release (CR), or continuous-release (CR or Contin  formulations of a variety of drugs, particularly hydrophobic drugs, which are drugs that do not dissolve well in water. It is difficult to create sustained release formulations for many hydrophobic drugs because they release too slowly from the microparticles used to deliver the drug. Modifying the water uptake into the microparticles can speed the release, while retaining the desired sustained release profile of these drugs. Acusphere's technology modifies water uptake into microparticles by adjusting the porosity of the microparticles during manufacture and by choosing from a wide variety of materials to include in the microparticle's shell. This is Acusphere's second issued patent related to this sustained release technology; the first issued patent relates to compositions created by the technology.

"Acusphere's technology has the potential to develop sustained release formulations of hydrophobic drugs for a variety of routes of administration," commented 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. "We have clinical trial data that we believe demonstrates human proof-of-concept of the ability to administer sustained release formulations of a hydrophobic drug for inhalation inhalation /in·ha·la·tion/ (in?hah-la´shun)
1. the drawing of air or other substances into the lungs.inhala´tional

2. the drawing of an aerosolized drug into the lungs with the breath.

3.
. And, importantly, we believe there is also significant potential to create sustained release formulations for oral and injectable in·ject·a·ble
adj.
Capable of being injected. Used of a drug.

n.
A drug or medicine that can be injected.
 delivery, which are other leading methods of drug administration today. We believe that sustained release technology for hydrophobic drugs is an under-served area for which very limited options exist."

Acusphere estimates that hydrophobic drugs generated more than $100 billion in revenue in 2000 and constituted up to 40% of all drugs in development. Many hydrophobic drugs must be administered multiple times each day over a long period of time, causing patient discomfort and inconvenience, requiring medical staff attention and increasing costs. The creation of sustained release formulations of these drugs could improve patient compliance, and thereby the efficacy of these drugs.

Acusphere's porous microparticle technology has the potential to create sustained release formulations of these difficult to formulate hydrophobic drugs. Our porous microparticle formulations have tightly controlled size distributions, and have the potential to release drugs over periods ranging from days to weeks by intravenous, inhalation, subcutaneous subcutaneous /sub·cu·ta·ne·ous/ (sub?ku-ta´ne-us) beneath the skin.

sub·cu·ta·ne·ous
adj. Abbr. s.c., SQ
Located, found, or placed just beneath the skin; hypodermic.
 or oral routes of administration. Acusphere is currently using this technology to develop AI-128, a sustained release formulation of a hydrophobic asthma drug. AI-128 is designed to slowly release the drug locally into the lungs, thereby potentially reducing the multi-dosing per day regimen to a longer-lasting, once per day regimen.

About Acusphere, Inc.

Acusphere is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microparticle technology. Acusphere's three initial product candidates are in clinical development and are designed to address large unmet clinical needs within cardiology cardiology

Medical specialty dealing with heart diseases and disorders. It began with the 1749 publication by Jean Baptiste de Sénac of contemporary knowledge of the heart. Diagnostic methods improved in the 19th century, and in 1905 the electrocardiograph was invented.
, oncology and asthma. These product candidates were created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microparticles in a versatile manner that allows particles to be customized to address the delivery needs of a variety of drugs. Acusphere's lead product candidate, AI-700, is a cardiovascular drug in Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA  clinical development. AI-700 is designed to be a preferred alternative to the estimated 9.5 million procedures done each year in the U.S. to detect 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. , the leading cause of death in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . For more information about Acusphere visit the Company's web site at www.acusphere.com.

"Acusphere" is a trademark of Acusphere, Inc.

This Release contains forward-looking statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
, including statements regarding Acusphere's ability to develop improved formulations of hydrophobic drugs. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including anticipated operating losses operating loss

The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income.
, uncertainties associated with research, development, testing and related regulatory approvals, unproven markets, future capital needs and uncertainty of additional financing, competition, uncertainties associated with intellectual property, complex manufacturing, high quality requirements, dependence on third-party manufacturers, suppliers and collaborators, lack of sales and marketing experience, loss of key personnel, uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation, and other risks and challenges detailed in the Company's filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this Release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this Release or to reflect the occurrence of unanticipated events.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Feb 11, 2004
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