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No more nosocomial infection
PARIS—sanofi-aventis and Alopexx Pharmaceuticals announced in December that the two companies will begin a collaborative relationship to advance the development of a first-in-class human monoclonal antibody for the prevention and treatment of S. aureus, S. epidermidis, E. coli, Y. pestis (the bacterium that causes plague) and other serious infections. Currently in preclinical development, the new agreement includes an option for licensing the antibody at a later date.
Hospital-acquired, or nosocomial, infections continue to be a persistent problem in medical facilities around the globe. In 2005 alone, nearly 3 million cases of hospital-acquired infections were recorded in the United States. It is estimated that that number will continue to increase without powerful new weapons in the battle against organisms such as staphylococcus, E. coli, MRSA and others that are attributed to increasing numbers of both nosocomial and non-hospital-related infections.
Alopexx's new therapy is not an antibiotic. The therapy, known in testing as F598, is an antibody that has the potential to serve as an alternative to antibiotics in the fight against MRSA (methicillin-resistant S.aureus) and other infections. Unlike antibiotics, monoclonal antibodies are not expected to lead to the development of bacterial resistance to the therapy.
"F598 is a novel approach to treating these infections," says Dr. Daniel Vlock, CEO of Cambridge, Mass-based Alopexx. "It is a human monoclonal antibody that attaches to the surface of bacteria. F598 can target a number of bacteria, such as those known as MRSA, staph, E. coli and the plague."
Vlock adds, "We know the medical community world-wide needs an alternative approach to solve the growing problem of these nosocomial infections. So many of the infections are becoming drug-resistant. This is where our approach can gain ground."
sanofi-aventis sees the global potential in Alopexx's therapy, says Jack Cox, senior director of public affairs and media relations for sanofi-aventis in the United States.
"The emergence of antibiotic resistant infections is and remains an unmet medical need," Cox says. "The antibody Alopexx is developing, F 598, has the potential to be a first-in-class human antibody for prevention and treatment of nosocomial infections. This deal is totally in line with our objective of remaining a key player in the anti-infective arena and with our strategy of complementing our R&D pipeline with external opportunities."
The target of the antibody is a carbohydrate on the bacterial capsule known as PNAG. PNAG has been found to be a critical factor in the virulence and immune response to staphylococcal infections. S. aureus strains that cannot produce PNAG have a significantly reduced ability to cause infections. The antibody is directed against PNAG and works by inducing killing by the patient's own white blood cells.
Under this agreement, Alopexx will bring the product into Phase I clinical trials during 2010, with an option for an exclusive worldwide license for sanofi-aventis to develop and then commercialize the product through additional licensing. Alopexx will receive an upfront payment and research funding from sanofi-aventis and is eligible for development, regulatory and commercial milestone payments that could total $375 million, as well as additional royalty payments for sales of products commercialized under the license and collaboration.
Alopexx's Vlock said the time was right to find a big pharmaceutical partner to advance the work of his company.
"We've been in discussions with a number of possible partners," Vlock says. "It became increasingly obvious to us that sanofi-aventis would make a good partner at this time. sanofi is in the midst of a major effort to reach out to biotech companies such as ours; it made a good fit for both of us. A large pharmaceutical partner at a particular point in a company's development is a good idea and an important milestone. We need that collaboration with a large partner going forward and to take our next step."
sanofi's Cox agrees that the time is right for an aggressive new approach to fighting infections, as the number of nosocomial infections trends higher each year.
"It is estimated that there were approximately 2.9 million cases of hospital-acquired infections in the U.S.in 2005," Cox said. "Of that number, 1.2 million were due to gram-positive organisms, such as staphylococcus. That number is expected to increase to 1.9 million this year. Over the same time period, infections resistant to multiple anti-bacterials are expected to almost double from over 600,000 to close to 1.2 million."
Alopexx Pharmaceuticals was co-founded by Dr. Gerald Pier a professor of medicine at Brigham and Women's Hospital and Harvard Medical School, and Vlock. The company seeks to develop and explore the use of novel therapies for the treatment and prevention of MRSA and other serious infections.
Sanofi Pasteur expands global dengue vaccine program in Latin America
MEXICO CITY, Mexico—Sanofi Pasteur, the vaccines division of the sanofi-
aventis Group, announced in December the expansion of its dengue vaccine clinical program in Latin America with a new multicenter study in children and adolescent in
Mexico, Colombia, Honduras and Puerto Rico. The new multicenter study complements an earlier study in Mexico and an ongoing study in Peru.
According to Sanofi Pasteur, the studies are aimed at advancing the development of a novel vaccine for the prevention of dengue infections in Latin America. Currently, there is no specific treatment available against dengue fever, which is the most widespread tropical disease after malaria.
Sanofi Pasteur started the development of a dengue vaccine in the 1990s. Clinical studies with its most advanced tetravalent candidate vaccine started in the 2000s. Sanofi Pasteur's dengue vaccine candidate has been evaluated in Phase I and II clinical trials in adults and children from non-endemic (U.S.) and endemic countries (Mexico, Philippines). Overall, a balanced immune response against all four serotypes was observed after three doses of the vaccine. The vaccine appears to be well tolerated with a similar safety profile after each dose.
Sanofi Pasteur's dengue vaccine research program includes ongoing clinical studies with adults and children in Mexico, Colombia, Honduras, Puerto Rico, Peru, the Philippines, Vietnam, Singapore and Thailand.
"Fighting dengue is of the utmost public health importance; we must remain on epidemiological alert as dengue continues to circulate in Latin America," says Dr. Jorge Mendez, investigator at the children's hospital Federico Gomez in Mexico and co-investigator for the evaluation of a dengue vaccine in Mexico. "Clinical studies in Mexico are critical steps to advance the development of a vaccine for the prevention of dengue. We are happy that Mexico contributes to scientific research that would benefit the entire region."