Celvapan, Peramivir are among new preventive drugs against H1N1 virus

New vaccines and drug against swine flu (Infleunza A/ H1N1) causing H1N1 virus will soon hit markets as some companies including start-ups are testing speedier approaches to combat the swine flu epidemic.

With vaccine to prevent the swine flu virus still far-off, countries and governments are seeking out products from companies whose technologies promise to ward off infection and buy time for vaccine makers.

These drug makers are developing vaccines and anti-infectives that do not necessarily target H1N1 directly, but would be especially useful in an emergency like swine flu outbreak.

The Chicago-based Baxter International is currently developing Celvapan, a bird-flu vaccine that could be used if the WHO declared such a pandemic. TheWHO ha already declared a Level % alert, but has not offiically called it a pandemic by announing a Level 6 alert.   Baxter has requested a sample of the swine flu from the World Health Organization to develop a candidate vaccine through vero-cell cultures.

Vero cells use a speedier approach to creates the vaccine by growing the virus in animal cells instead of eggs. An anti- swine flu vaccine made through vero-cell technology could take only 13 to 16 weeks to provide initial doses, according to Baxter.

Celvapan has already received approval for use in Europe and is awaiting approval in the US.

Novavax is another company claiming to produce a vaccine against Influenza A/H1N1 / swine flu using technology based on recombinant virus-like particles. Novavax is developing treatments for seasonal and bird flu.

Novavax scientists need only the genetic sequence of the virus instead of the virus itself, says its CEO Rahul Singhvi, to create the vaccine. The swine flu sequence was released last week.

Novavax uses the same method used to develop Gardasil, the women’s HPV vaccine.

“It’s a proven technology with Gardasil,” Singhvi says. “Therefore it’s not a leap of faith that we could test one for swine flu.” Singhvi estimates it would cost $100 million to create a vaccine. Novavax has already offered its services to the government.

If Baxter and Novavax are into vaccines, there are other companies which focus on drugs and anti-virals to prevent or finish off the swine flu causing H1N1 virus.  

BioCryst Pharmaceuticals is developing an antiviral to treat influenza or flu. Called Peramivir, BioCryst’s drug is currently in clinical trials in Japan and the U.S. Peramivir, which would differ primarily because it would be taken orally or inhaled (like Relenza), could prevent a “broad range of strains”. BioCryst has got a $103 million research grant from the U.S. Department of Health and Human Services for developing Peramivir. 

A similar inhaled drug is also being developed by Pulmatrix. The Pulmatrix drug triggers the formation of a protective biophysical barrier that stops harmful bacterial and viruses from infecting the lungs.

“Unlike other drugs, we are not targeting the pathogen specifically… We are turning on capabilities that are in the airway to deal with any pathogen that comes in. We think it’s totally complementary to a vaccine,” said chief executive Robert Connelly.

Pulmarix drug also stimulates the body’s natural defenses against pathogens. The Pulmaris drug also may be able to treat people already infected.

Moreover, the product might also diminish the ability of infected people to spread germs by coughing or sneezing, according to Connely.

Pulmarix said in Influenza A /H1N1 – swine flu studies, it was found that the drug could prevent infection in pigs exposed to influenza, treated the symptoms of those already infected, and stopped infected pigs from spreading the flu to other pigs.

Pulmarix has raised $18 million from 5AM Ventures and Polaris Venture Partners.

Now Pulmatrix is advancing this drug for seasonal influenza, rhinovirus infection and asthma, but could also apply it to swine flu or another outbreak. Pulmarix has discussed this prospect of the drug with federal officials about this prospect, said Connelly.

Like Pulmatrix, NanoBio is also researching a spray that coats the inside of the nose and prevents infection by killing pathogens on contact. The spray has shown promise in mice studies, said CEO James R. Baker Jr.

“In an emergency, if you don’t have drugs or you don’t have antigen for the vaccine, you can use this,” Baker said. This wouldn’t provide as much protection as a vaccine, but it may be an option officials could turn to quickly. “We can produce enough of this in a week for millions of doses.”

NanoBio has taken in about $85 million through grants, contracts and equity financing from investors such as Perseus LLC. 

NanoBio, based in Ann Arbor, Mich., also uses its nanotechnology platform to create adjuvants designed to bolster the immune response. This could make traditional vaccines more effective and less costly to produce. NanoBio recently began testing a seasonal vaccine with this type of adjuvant in Phase I clinical trials.

Roche’s Tamiflu and GlaxoSmithKline’s Relenza are the only available medication against swine flu infection.

No vaccine against swine flu is available so far.  It would take until late November or January to make enough vaccine–that’s 600 million doses–to guard the entire population of the U.S, according to US health department officials.