Avant Gets $11.5M Payday with FDA OK of Rotarix
By Catherine Hollingsworth
Staff Writer
Avant Immunotherapeutics Inc. will see an additional $11.5 million in milestone payments for the rotavirus vaccine Rotarix, now that it has been FDA-approved.
The Needham, Mass.-based company licensed rights to Rotarix to partner GlaxoSmithKline Plc, and stands to receive $10 million upon U.S. launch, said Una Ryan, Avant CEO. The company hopes to have Rotarix launched in the U.S. in time for the fall rotavirus season, Ryan told BioWorld Today.
Another $1.5 million will come from GSK soon, Ryan said. Half of that amount, though, will have to be paid to Paul Royalty Fund, the company handling the payments, she said.
But the royalty payments sold to Paul Royalty are capped, so Avant will receive the lion's share of the remaining royalties, more than 90 percent, Ryan said.
Avant already has received $50 million in payments - $40 million of which came with the launch of Rotarix in Europe and $10 million at signing with Paul Royalty, Ryan said.
Once on the U.S. market, Rotarix, manufactured by Rixensart, Belgium-based GSK Biologicals, will compete with Merck & Co.'s Rotateq, Ryan said. The Merck vaccine requires three doses, while Rotarix requires two doses, she said.
With two doses, Rotarix would allow infants to complete the vaccination series by age 4 months, according to Avant. The Centers for Disease Control and Prevention recommends that children complete the rotavirus immunization series by age 6 months.
The FDA's Jesse Goodman, director of the agency's Center for Biologics Evaluation and Research, said in announcing the approval that Rotarix "provides another option to combat and reduce a potentially severe illness that affects so many children."
According to the FDA, Rotarix protects against four of the many different strains of rotavirus: G1, G3, G4 and G9 strains. They are the most commonly circulating rotavirus types in the U.S., Avant said.
Rotavirus infects virtually every child in the U.S. by age 5 and is the leading cause of severe gastroenteritis in infants and young children worldwide, according to Avant.
In the U.S. each year, 2.7 million children younger than 5 years suffer from rotavirus disease, thousands of which result in hospitalizations and emergency room visits.
An FDA advisory panel last month year found that Rotarix data were adequate to support the efficacy of Rotarix to prevent rotavirus gastroenteritis in infants. In addition, the panel voted in favor of GSK's data being adequate to support the safety of Rotarix.
But the FDA has requested that GSK further study its safety in a post-marketing study of Rotarix in more than 40,000 infants.
Safety problems led to the demise of Wyeth's rotavirus vaccine RotaShield, which was voluntarily pulled from the U.S. market in 1999 due to a potential increased risk of intestinal folding (intussusception). The condition can lead to potentially life-threatening intestinal blockage, according to the FDA.
GSK conducted a study that looked at the incidence of intussusception, which can occur spontaneously in children in the absence of vaccination, the FDA said.
The study of more than 63,000 infants was done to ensure that Rotarix does not increase the risk of intussusception, the agency said.
In that study, the FDA said, there was no increase in the risk of intussusception in infants who received Rotarix (31,673) compared to those who received placebo (31,552).
Increased rates of convulsion and pneumonia-related deaths were observed in the Rotarix recipients in the intussusception study.
However, the FDA said those events were not observed in other studies conducted by the manufacturer.
"Although the FDA has concluded that the available data do not establish that these events are related to the vaccine, the agency has requested the manufacturer to conduct post-marketing safety studies involving more than 40,000 infants to provide additional safety information," the FDA said in a statement.
Shares in Avant (NASDAQ:AVAND) were down $1.21, or 10.3 percent, closing at $10.58.
bioworld.com |
