Critical Therapeutics In-Licenses Asthma Drug Program from Abbott Laboratories.

Business Editors

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 12, 2004

Critical Therapeutics, Inc., a privately held biopharmaceutical company engaged in the discovery and development of products for critical care medicine, today announced that it has in-licensed certain rights to both controlled release and intravenous formulations of zileuton.

Critical Therapeutics plans to develop a controlled-release formulation of zileuton, which would allow for less frequent dosing. Abbott Laboratories' immediate release formulation of the drug (Zyflo(R) Filmtab(R), zileuton tablets) received marketing approval from the U.S. Food and Drug Administration (FDA) in December 1996, and is used for the prevention and continuous treatment of asthma in patients 12 and older. Zyflo Filmtab is not part of this agreement.

"As a drug designed to block a key mediator of inflammation, zileuton directly complements our cytokine-focused product platform," said Paul D. Rubin, M.D., Critical Therapeutics' president and chief executive officer. "We are very excited about adding zileuton to our product pipeline."

The controlled release version incorporates an advanced oral delivery technology, Geomatrix(TM), that controls the amount, timing and location of drug release into the body. Geomatrix(TM) is licensed from SkyePharma PLC (Nasdaq: SKYE; LSE: SKP).

Under the agreement, Critical Therapeutics will assume all regulatory, manufacturing and marketing responsibility for the controlled-release and intravenous formulations of zileuton. Abbott will receive milestone and royalty payments based on product sales. The companies did not disclose financial terms of the agreement.

Zileuton belongs to a class of drugs known as 5-lipoxygenase (5-LO) inhibitors. The drug inhibits the production of molecules called leukotrienes, which contribute to conditions present in and around the airways of asthma patients. These conditions include swelling, bronchoconstriction and mucus secretion. Dr. Rubin oversaw the work on zileuton while supervising global clinical and pre-clinical development at Abbott from 1987 to 1993.

"This agreement provides us with the potential of near-term revenue from a product that has already completed a Phase III program. While an immediate-release, four times a day formulation of zileuton has been previously approved and is available on the market, our goals for controlled release zileuton are far greater," Dr. Rubin said. "Based on the clinical results demonstrated in unpublished studies on the product, we see an opportunity to broaden the use of zileuton through new indications and new formulations. From a cost-benefit perspective, our licensing agreement with Abbott is the ideal mechanism for both companies to realize an excellent return from this initiative."

Asthma affects approximately 20.3 million Americans, according to the American Academy of Asthma Allergy & Immunology. Direct health care costs for the disease exceed $8.1 billion annually, with pharmaceuticals representing the largest share of those costs.

Safety Information

Zyflo(R) Filmtab(R) (zileuton tablets) is not for use in the reversal of acute asthma attacks.

Patients with active liver disease should not take Zyflo. Liver function tests are recommended prior to and during treatment with Zyflo.

When taking Zyflo, theophylline dose should be reduced by 50% and appropriately monitored; patients taking propranolol or warfarin should be monitored and doses adjusted if necessary.

The only adverse event reported significantly more often by Zyflo patients than placebo-treated patients was upset stomach (8.2% vs. 2.9%, respectively).

Further information regarding Zyflo, including full prescribing information, is available from Abbott Medical Information by calling 800-633-9110.

Critical Therapeutics

Critical Therapeutics, Inc. is a privately held biopharmaceutical company focused on critical care medicine. CTI's mission is the discovery, development and commercialization of novel therapies for the treatment of acute trauma, cardiopulmonary disease and infectious and inflammatory illness. The Company's current research and development portfolio includes HMGB-1, a pro-inflammatory substance identified as a mediator of TNF-associated tissue damage; development of small molecule and vagal nerve stimulation approaches to treat inflammation; and CTI-01, a proprietary anti-inflammatory drug candidate currently in Phase I clinical trials. The Company is headquartered in Cambridge, Massachusetts. More information about CTI is available at www.criticaltherapeutics.com

About Geomatrix(TM)

SkyePharma's Geomatrix(TM) controlled release systems control the amount, timing and location of drug release into the body. This is achieved by constructing a tablet with two basic components: a core containing the active drug or drugs, and one or two additional barrier layers that control the drug's diffusion out of the core. Tablets with a wide range of predictable and reproducible drug release profiles can be made by combining different chemical components in the core and barrier layers, each with a different rate of swelling, gelling and erosion.