Positive Recommendations From FDA Advisory Committee Meeting On Chirocaine.

LONDON--(BUSINESS WIRE)--Jan. 12, 1999--Chiroscience Group plc today announced that, at the meeting of the Anesthetics and Life Support Drugs Advisory Committee of the United States Food and Drugs Administration ("FDA") held today, the Committee voted unanimously in favor of recommending to the FDA that Chirocaine(R) would not need to carry a `black-boxed' warning on the label. Also, during the meeting, the FDA indicated that Chirocaine is approvable.

Chirocaine is the long acting local anaesthetic developed by Chiroscience for use in a wide range of surgical procedures and in pain management, both in adults and in children. Chirocaine received approval by the Medical Products Agency in Sweden in December 1998.

The two questions posed by the FDA to the Advisory Committee asked whether Chiroscience had adequately evaluated Chirocaine's potential for reduced cardiac toxicity in humans at the labelled doses and whether the product should carry a `black-boxed' warning relating to the use of the product in obstetrics at high doses of more than 0.75% by volume.

Chiroscience made presentations to the Committee members addressing these issues and answered questions posed by them. This was followed by a presentation by the FDA of the pre-clinical and clinical data made available by Chiroscience.

The consensus of the Committee was that Chiroscience had adequately evaluated Chirocaine in accordance with established standards, particularly in assessing the potential for cardiac toxicity, and that the safety profile of Chirocaine had been satisfactorily demonstrated. The pre-clinical data submitted by Chiroscience showed an advantageous cardiac and central nervous system toxicity profile for Chirocaine over bupivacaine. Furthermore, the clinical pharmacology data also demonstrated differences in cardiac toxicity between these two drugs.

Therefore, the Committee recommended to the FDA that Chirocaine need not carry a `black-boxed' warning once approved. The exact wording and data for use in the indications and combinations requested by Chiroscience to be included in the product label, together with appropriate warnings, will be determined in discussion with the FDA. The Committee recommended that the Company commit to certain studies which could be carried out post-approval to enable the utility of Chirocaine to be maximized.

It should be noted that the decisions of the Committee are not binding on the FDA.

Dr. John Padfield, Chief Executive of Chiroscience Group plc, commented:

"This is an excellent outcome and is a tribute to the many people in Chiroscience and in the scientific and clinical community worldwide who have developed Chirocaine. The next steps are for the FDA to consider the recommendations of the Committee and decide on the detailed wording and data which can be included in the product label. We remain hopeful that the label will allow us to demonstrate a clear advantage over the market-leader.

Meanwhile we continue to review the commercialization of the product in the light of the proposed merger of our marketing partner, Zeneca, with Astra. Today's review by the Advisory Committee supports our contention that Chirocaine is an important addition to the range of drugs used in anaesthesia and pain."

Notes For Editors:

'Black-Boxed' warning

A `black-boxed' warning is required by the FDA where a major side effect problem has been identified with a pharmaceutical product. This is a method of drawing specific problems to the attention of physicians and is designed to help them prescribe products appropriately.

Chirocaine

Chirocaine is the trade name for levobupivacaine, the long-acting local anaesthetic developed by Chiroscience for use in a wide range of surgical procedures, as well as in pain relief during childbirth and in pain management following surgery. On March 31, 1998, Chiroscience entered into an agreement to license Chirocaine to Zeneca Limited on an exclusive and worldwide basis, excluding Japan. Under the licensing agreement, Chiroscience is responsible for gaining approval of Chirocaine in EU countries and in the U.S. On September 7, 1998, Chiroscience entered into an agreement with Maruishi Pharmaceutical Co. Ltd. for the development and marketing rights to Chirocaine for Japan.

Chiroscience is seeking approval for the widespread usage of Chirocaine in local, regional, epidural and spinal anesthesia; for surgical and obstetric procedures, and as an epidural infusion for post-surgical and intractable pain. In addition, approval is sought for use alone or in combination with morphine, fentanyl or clonidine, and with appropriate dosage requirements for use in children.

Chirocaine is a new drug derived from the established anaesthetic bupivacaine. Pre-clinical studies have shown that Chirocaine is as potent as bupivacaine, but has a superior safety profile in its action on the heart and central nervous system. Its efficacy and safety profiles have been confirmed in over 25 clinical trials which have been completed in the UK, USA, Australia, New Zealand, Denmark and The Netherlands.

In trials completed to date over 1,400 patients have been exposed to Chirocaine.

Chirocaine was developed in response to the growing demand for local anesthetic procedures. The number of surgical procedures carried out using long acting local anesthetics is predicted to increase from 45 million worldwide in 1997 (with an estimated value of $250 million) to around 80 million in 10 years ($750 million - $1 billion). This increase is being driven by a growth in surgery and pain management (acute and chronic). When compared to general anesthesia, local anesthesia has the potential for improved patient outcome as it is faster, providing a less painful recovery, minimizing hospital costs by reducing hospital stays and decreasing the risk of post-operative infection.

Chiroscience Group plc

Chiroscience is an emerging pharmaceutical company which uses its diverse technology platform to discover, develop and bring to market novel medicines for improved healthcare. It has three businesses: Chiroscience R&D, Rapigene and ChiroTech.

Chiroscience R&D's focus is on innovative small molecule drugs and related diagnostics in the therapeutic areas of inflammatory disease, pain, osteoporosis, cancer and autoimmune diseases. Its technology platform allows the conception and development of receptor-based and enzyme-inhibiting small molecule drugs with high selectivity of action. Rapigene is involved in the creation and provision of genomic technologies and services to partner companies and to Chiroscience's drug discovery programs. Its DNA analysis systems comprise of DNA hybridization, DNA arrays and mass spectrometry tags. ChiroTech provides chiral technology services to pharmaceutical and related industries, including Chiroscience R&D.

Chiroscience financial highlights for the six months to August 31, 1998 (unaudited):

-- Revenues increased to (pound)11.4m (H1 1997: (pound)9.2m); net

loss for the period (pound)11.4m (H1 1997: (pound)14.4m)

-- ChiroTech contributed sales of (pound)6.8m (H1 1997:

(pound)5.9m); Chiroscience's drug discovery business contributed

revenues of (pound)4.5m (H1 1997: (pound)3.3m).

-- Investment in research and development of (pound)13.5m (1H 1997:

(pound)19.0m).

-- Current cash reserves of (pound)59m as at September 24, 1998.

Chiroscience Group plc is listed on the London Stock Exchange and is based in Cambridge and Stevenage, UK, and Seattle, Washington, USA.

Additional information on Chiroscience can be accessed on the company's home page: http://www.chiroscience.com.