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Large Scale Biology Corporation Receives U.S. Food and Drug Administration's Orphan Drug Designation for Its Lysosomal Acid Lipase Product

Posted on: Monday, 1 August 2005, 09:01 CDT

VACAVILLE, Calif., Aug. 1 /PRNewswire-FirstCall/ -- Large Scale Biology Corporation today announced that it has received Orphan Drug Designation for its recombinant human Lysosomal Acid Lipase (LAL) therapeutic product from the Office of Orphan Products Development of the U.S. Food and Drug Administration. Approval of the Designation was received less than three months after the Company submitted its application, which required no revisions or amendments. Orphan Drug Designation is a necessary first step towards gaining regulatory approval for any product used to treat Orphan patient populations.

LAL is a naturally occurring human enzyme involved in the metabolism of certain lipids, including cholesteryl esters and triglycerides. Certain diseases are caused by or exacerbated by a lack of LAL in the body, leading to serious and even life-threatening accumulations of lipids in major organs. Orphan diseases are those afflicting fewer than 200,000 patients in the U.S., with similar prevalence in Europe and other world regions. Such diseases are usually underserved by traditional pharmaceutical industry programs because of their smaller markets, thus the "Orphan" designation. The U.S. Orphan Drug Act provides several incentives, including market protection, for drugs launched into these smaller markets. In addition to Orphan indications, LAL could find utility in treating arterial lipid plaque deposits, such as those that occur in atherosclerosis, without the necessity of surgery or other interventions. While the Orphan diseases are principally the result of genetic disorders in LAL synthesis or regulation, cardiovascular deposits occur in substantially larger numbers of patients and could be the result of genetics as well as environmental and lifestyle factors, such as diet.

LSBC obtained a worldwide, exclusive license to all uses of LAL from Cincinnati Children's Hospital Medical Center. Cincinnati Children's Dr. Gregory A. Grabowski, M.D., and his research group first identified and characterized LAL and have been working closely with LSBC in a program to develop the enzyme as a therapeutic for a variety of important indications. LSBC and the Cincinnati Children's group are currently in preclinical development of LSBC's LAL, which the Company manufactures efficiently using its proprietary plant-based production system. Additional information on LSBC's development events with LAL can be found in the Company's press releases of May 2, 2005 and April 29, 2005.

"This program has made rapid progress from its inception, which is testament to the quality of the participants from Cincinnati Children's, LSBC and the Company's commercial, preclinical and regulatory partners," stated Gregory Pogue, Ph.D., LSBC's Vice President, Research and Development, and director of the LAL program. "Our collective enthusiasm, clarity of purpose and dedication enabled our extended team to develop key data in support of an Orphan Drug Designation application, which was expeditiously reviewed and approved by the FDA. We are grateful to the Agency for its professionalism and its recognition of the potential value of our product," Dr. Pogue concluded.

About Large Scale Biology Corporation

Large Scale Biology Corporation is a biotechnology company developing and biomanufacturing biotherapeutics, vaccines and industrial proteins for important life science industry markets. Corporate headquarters, molecular biology and product design laboratories are located in Vacaville, California, and the Company's bioprocess development and commercial-scale biomanufacturing facilities are located in Owensboro, Kentucky. In addition to its class- leading internal capabilities, LSBC relies on a network of industry, government and academic collaborators throughout the US and Europe to achieve rapid, commercially relevant product discovery, optimization and manufacturing. For more information about Large Scale Biology Corporation, visit the Company's website at http://www.lsbc.com/.

Forward-Looking Statements

This release contains forward-looking statements about applications of LSBC's technologies and the markets for our products. These forward-looking statements involve risks, uncertainties and situations that may cause our actual results to differ materially from those implied by these statements, including our ability to produce adequate quantities of product, the ability of our collaborators to generate demand for products we make for them, the effectiveness of our and our collaborators' technologies to produce specific therapeutic products and/or in a cost-effective manner, any difficulties or delays in obtaining regulatory approval to test and market such products, and the requirement of substantial funding for us to preserve our technology base and product pipeline. We cannot guarantee future results. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this release. For a further list and description of such risks and uncertainties see the reports filed by Large Scale Biology Corporation with the Securities and Exchange Commission, including our reports on Forms 10-K and 10-Q. Except as required by law, we do not undertake to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

NOTE: LSBC is a trademark of Large Scale Biology Corporation. Contact: Large Scale Biology Corporation Daniel Tuse, Ph.D. Vice President Business Development Tel. 707-469-2316

LSBC

CONTACT: Daniel Tuse, of Large Scale Biology Corporation,+1-707-469-2316

Web site: http://www.lsbc.com/

Source: PRNewswire-FirstCall

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