The European Medicines Evaluation Agency approved GlaxoWellcome plc's application for 3TC on Thursday, clearing the anti-HIV drug for marketing in all 15 member states of the EuropeanUnion.
Pricing issues are settled in most of the countries, including the majorEuropean markets, so sales of 3TC, or Epivir, can begin there rightaway. Epivir is indicated in Europe for use with all approvedantiretroviral therapies, unlike the U.S., where it was approved foruse only in combination with AZT.
Specifically the product will be indicated in combination therapiesfor those 12 years of age and older who have CD4 counts of 500cells/mm3 or less. Much data showing 3TC's benefit, and newscience about viral load as a more accurate marker, have beenreleased since the European filing was made in July 1995.
"It is our belief that just as 3TC's unique mechanism of action andclear safety profile have made it the AIDS drug of choice in the U.S.,it soon will become a cornerstone of therapy in Europe, regardless ofthe label," UBS Securities analyst Tim Wilson said in a reportThursday.
The drug was discovered by BioChem Pharma Inc., of Laval,Quebec, and will be marketed by London-based Glaxo. Analystsgenerally have estimated BioChem Pharma gets royalties of 12percent on 3TC sales.
BioChem Pharma's stock (NASDAQ:BCHXF) gained $1.75Thursday to close at $33.50.
Wilson wrote that the launch in Europe should be bolsteredsignificantly by the results of the CAESAR trial released last month.That study in 1,892 patients showed a 54 percent reduction in the rateof progression to AIDS and death for patients using 3TC incombination with AZT-based regimens when compared to placebo.
That study should satisfy accelerated approval requirements that weremade when the drug gained U.S. approval in November 1995. Thestudy was stopped eight months short because the data were sostrong. The study was conducted in Canada, Australia, Europe andSouth Africa, hence the name acronym CAESAR.
Sales of 3TC were about $55 million in the second quarter,predominantly coming from the U.S. and Canada. Additionalcountries have cleared it recently so it is approved now in Australia,Mexico, New Zealand, Switzerland, South Africa and Uruguay. Salesin the first quarter this year were $39 million.
The additional approvals and clearance in Europe should boost 1996sales of 3TC to $281 million, Wilson said, with European salesaccounting for $36 million. Next year European sales of 3TC areexpected to be $122 million, Wilson said.
In Europe more than 15,000 patients already are taking 3TC incompassionate use programs, so their therapies will start to bereimbursed. n
-- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.