First Regulatory Approval for Chirocaine; US FDA Advisory Committee ...
- The Medical Products Agency in Sweden has approved the grant of a
license for Chirocaine and this Swedish approval, under EU Mutual
Recognition procedure, would lead to licenses in other European
countries.
- Chiroscience has been notified that the US Food and Drug
Administration will discuss the New Drug Application for
Chirocaine at the meeting of the Anesthetics and Life Support
Drugs Advisory Committee on January 12, 1999.
The approval by the Medical Products Agency in Sweden confirms Chirocaine to be safe and effective for a broad range of uses in anaesthesia and pain, including for children and chronic pain sufferers. Chirocaine will be an important addition to the range of products used in anaesthesia and pain management, since the Swedish approval allows it to be used in situations that are unavailable using existing long-acting local anaesthetics.
Following the announcement of the proposed merger between Zeneca Group PLC and Astra AB, Zeneca is in discussion with Chiroscience to ensure that any impact of the proposed merger on the commercialization of Chirocaine is resolved as soon as possible.
Having won broad approval for Chirocaine, Chiroscience now is reviewing its product commercialization strategy which may include further differentiating the labeling of Chirocaine from other competitor products, particularly with respect to cardiovascular safety. Chiroscience will commence discussions with the Swedish authorities which could lead to a variation to the license being submitted later in 1999, possibly following the completion of some additional clinical trials. Any additional clinical studies that may be undertaken, to demonstrate enhanced benefits to patients through an increased safety margin, can be accommodated within the Group's cash reserves, which stood at (pound)59 million as at the Interim Results of September 24, 1998. The results of the commercialization strategy review, including any impact of any product launch, will be announced in due course.
Dr. John Padfield, Chief Executive of Chiroscience Group plc, commented:
"We are delighted that the Swedish authorities have found Chirocaine to be safe and effective for a broad range of uses, including new applications for long-acting local anaesthetics in children and for those who suffer from chronic pain. Given the importance of the US market we are also pleased that the FDA review will occur earlier than we had expected.
Our decision to review the commercialization strategy is necessary given the changed circumstances in the market. Chiroscience has an extensive range of patents protecting Chirocaine, the earliest of which does not expire for another 15 years. Thus, while we are disappointed that Chirocaine may not be launched in Europe as quickly as we had hoped, our product is the superior one and the outcome of our review will be in the long-term best interests of Chiroscience and its shareholders."
Notes For Editors:
Chirocaine
Chirocaine is the trade name for levobupivacaine">levobupivacaine levobupivacaine /le·vo·bu·piv·a·caine/ (le?vo-bu-piv´ah-kan) the S enantiomer of bupivacaine; a local anesthetic used as the hydrochloride salt for local infiltration anesthesia, peripheral nerve block, and epidural anesthesia., 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 epidural /epi·du·ral/ (-dur´il) situated upon or outside the dura mater.
ep·i·du·ral (
p
and spinal anaesthesia; 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 clonidine /clo·ni·dine/ (klo´ni-den) a centrally acting antihypertensive agent, used as the hydrochloride salt; also used in the prophylaxis of migraine and the treatment of dysmenorrhea, menopausal symptoms, opioid withdrawal, and cancer-related pain., and with appropriate dosage requirements for use in children. Chirocaine is a new drug derived from the established anaesthetic bupivacaine bupivacaine /bu·piv·a·caine/ (bu-piv´ah-kan) a local anesthetic, used as the hydrochloride for local infiltration, peripheral nerve block, and retrobulbar, subarachnoid, sympathetic, caudal, or epidural block.
bu·piv·a·caine (by. 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, Canada, New Zealand, Denmark and The Netherlands.
In trials completed to date approximately 1,400 patients have been exposed to Chirocaine.
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 Group plc is listed on the London Stock Exchange and is based in Cambridge and Stevenage Stevenage, city (1991 pop. 74,757) and district, Hertfordshire, E central England. Stevenage was the first new town to be designated under the New Towns Act of 1946, a program to decentralize population and industry. Manufactures include cameras and photographic goods, aircraft supplies, and electronic equipment. The old town, probably of Saxon origin, was an important stop for stagecoaches; several inns remain from that era., UK, and Seattle, Washington, USA.
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.
Additional information on Chiroscience can be accessed on the company's home page: http://www.chiroscience.com.