Glaxo, Roche Meet Swine-flu Drug Needs; Vaccine Is Months Away
Glaxo increased output of its flu remedy Relenza during the weekend, the London-based company said. Roche is also making more of its medicine Tamiflu, said Martina Rupp, a spokeswoman for the Basel, Switzerland-based drugmaker.
Swine flus spread in Mexico, the U.S. and Canada is heightening concern that the virus may spark the worlds first influenza pandemic since the 1968-1969 Hong Kong flu, according to the World Health Organization. That outbreak killed an estimated 1 million people worldwide, according to U.K. researchers. Seasonal flu shots typically take three to six months to make, not counting lab time needed to develop a version tailored to specific strains.
“The vaccine wont be available for quite some time, at least four months, and then it wont be in huge numbers,” said Othmar Engelhardt, a virologist at the U.K.s National Institute for Biological Standards and Control, in Potters Bar, England, north of London.
Sanofi-Aventis SAs vaccine unit is “ready to work” with world health authorities if they ask, said Pascal Barollier, a spokesman for the Paris-based drugmaker. Developing a swine-flu vaccine would take about four months, he said.
Baxter International Inc., which makes both seasonal and pandemic vaccines, has requested samples of the swine virus to do laboratory testing and potentially make shots, said Christopher Bona, a spokesman for the Deerfield, Illinois-based company. Baxters Vero-cell technology can produce flu vaccine in about half the time required by traditional egg-based manufacturing, which takes about 24 weeks, Bona said in a telephone interview.
Baxter Expertise
“Baxter has the expertise to develop vaccines against potential pandemic flu viruses,” Bona said. He declined to say how quickly after receipt of the swine virus the company might have a vaccine ready to enter production.
Homeland Security Secretary Janet Napolitano said 25 percent of “courses of treatments” of antiviral drugs were being released from U.S. stockpiles. In all, there are 50 million courses, she said. Among those are Tamiflu and Relenza.
“Tamiflu, made by Gilead and Roche, and Relenza, made by GlaxoSmithKline Plc, will be natural beneficiaries as stockpiles of these medicines should need replacing,” Les Funtleyder, an analyst with Miller Tabak & Co. in New York, said in a note to clients. “Flu vaccine makers Glaxo and Sanofi Aventis SA could also see some upside as we would expect vaccination rates going into the fall would be significantly higher than in years past.”
400 Million Treatments
Roche can produce 400 million treatments of Tamiflu over a 12-month period, said James Smith, the drugmakers medical leader for Tamiflu, in an interview. “Production capacity now basically outstrips demand.”
How much vaccine makers benefit from swine flu may depend on how fast they can get samples of the swine virus from public- health officials and develop an inoculation in their labs.
“We dont think that any of the existing vaccines are effective,” said Richard Besser, the acting head of the U.S. Centers for Disease and Prevention, based in Atlanta. “There are discussions ongoing about whether to make a vaccine and whether that should be undertaken. Its not an easy decision.”
Developing a flu vaccine can take weeks. Then it takes at least six months to make the vaccine in quantity, according to the CDC. Makers generally start work in January each year on the vaccines that will be used in the flu season that begins in October, the CDC said.
Mutating Virus
Fears of a lethal pandemic lie in the nature of flu germs, which mutate readily and can become virulent by exchanging genes with related influenza viruses. While the H5N1 bird flu that has killed more than 250 people hasnt gained genes to spread easily among humans, the Mexican swine flu already may have done so, said Malik Peiris, a microbiologist from the University of Hong Kong.
“The concern is that this virus has the ability to transmit from humans to humans because a number of the cases who got infection have had no direct exposure to swine,” said Peiris, who has studied the virus behind severe acute respiratory syndrome, or SARS, and avian flu. There is no vaccine for the strain, he said.
Flu Similarities