It's happening-Chiroscience gets Chirocaine back, along with the work that's already been done toward marketing, etc. Anticipated rollout this year! Today's Wall Street Journal article:
Dow Jones Newswires -- March 1, 1999
Chiroscience Gets Back Chirocaine, With Trimmings
By MICHAEL REID
Dow Jones Newswires
LONDON -- Ending almost three months of uncertainty about the future marketing of its key drug, Chiroscience Group PLC (U.CCC) said Monday it'll regain its license for the anesthetic Chirocaine from Zeneca PLC (ZEN).
The European Union has asked Zeneca to hand back the license to Chiroscience because of competition problems raised by Zeneca's merger with Sweden's Astra AB (A), which has two rival anesthetics of its own, Naropin and Marcaine.
Zeneca initially secured the rights to Chirocaine (levobupivacaine) in 1998, but when it unveiled merger plans with Astra in December, analysts immediately said regulators wouldn't allow AstraZeneca to keep Chirocaine in its anesthetics stable.
Chiroscience can now enter formal talks with other prospective partners.
Chiroscience Chief Executive John Padfield told Dow Jones Newswires the company has already talked informally to third parties. The company has also received an approvable letter from the Food and Drug Administration, the last stage of the U.S. regulatory process, and it is in talks with the FDA on final printed labeling.
Because of these developments, Padfield said the anesthetic is still on target for roll-out in the second half of 1999, "if we can get final labeling sorted out and if we can get a partner sorted out in
the next quarter."
That means the feared delay to Chirocaine's roll-out caused by Zeneca's merger with Astra, is now unlikely to eventuate.
That's also helped by the regulators ruling that Chiroscience can use commercial information and promotional material created by Zeneca. The regulators also insisted that Zeneca continue developing and commercializing the drug at its own cost for a transition period, to ensure Chirocaine doesn't suffer unfairly.
"Given the circumstances, we couldn't ask for anything better," Padfield said.
"They are committed to have to support this product for a transition period at their cost to make sure there is no competitive disadvantage," he said.
The news sent Chiroscience shares up 7.5 pence, or 3.3%, to 233 pence by 1320 GMT.
Chirocaine Eagerly Awaited In Anesthetic Market.
Although not a surprise, the E.U. ruling was nonetheless a relief to many observers who feared Chirocaine's introduction to the anesthetics market might be delayed by the handover of the marketing rights.
"Really what has come out is no major surprise. However there is an element of uncertainty which has been removed," said Lionel Wilson, analyst at Townsley & Co.
"Chiroscience can now formally initiate conversations with third parties," he said. "And Chiroscience will retain all the benefits of Zeneca's work on it."
Padfield wouldn't say which potential partners Chiroscience was talking to, but said there was a lot of interest in the anesthetic.
"The phone first rang the day after the Zeneca (merger) announcement in December," he said.
Padfield said once the company began discussions with the regulators and Zeneca, it became clear Chiroscience was going to get a good outcome.
He said the regulators had been sensitive to both the needs of the anesthesia marketplace in getting the novel Chirocaine to market without delay, and to the importance the drug represents to
Chiroscience.
Chirocaine is eagerly awaited in the anesthetic market. It is a novel long-acting local anesthetic that is more potent than its parent, bupivacaine. It can be used for children, women giving birth and
sufferers of chronic pain. It belongs to a group of anesthetics that relieves pain without impairing muscle function and it doesn't depress the heart rate. Analysts estimate its peak sales at about $300 million.
Chiroscience said the U.S. competition authorities are also reviewing the proposals for the return of the license, which includes the appointment of a trustee - also required by the European Commission - to monitor the commitments made by Zeneca.
Chiroscience said the final terms of the agreement will be disclosed when the Federal Trade Commission gives its final U.S. clearance.
-By Michael Reid; 44-171-832-8163; mreid@ap.org |
