Vical Pandemic Influenza Vaccine Demonstrates Cross-reactivity Against California, Texas and Mexico H1N1 Strains

Vical Incorporated (Nasdaq:VICL) announced today that the company’s DNA vaccine against A/H1N1 pandemic influenza (swine flu) has demonstrated robust immune responses in 100% of vaccinated animals against virus strains isolated from recent outbreaks in three distinct geographic locations — California, Texas and Mexico.

Vical’s plasmid DNA vaccine contains the H1 hemagglutinin gene sequence provided by the U.S. Centers for Disease Control and Prevention (CDC) for the swine-origin A/California/04/09 pandemic influenza virus, and after two doses produced immune responses well above the accepted protection threshold in 100% of vaccinated mice and rabbits using HI assays against the swine-origin A/California/07/09 x-179a, A/Texas/15/09 and A/Mexico/4108/09 influenza viruses. Hemagglutination inhibition (HI) titers were well above the protection threshold of 40, ranging from 320 to 2,560 in mice, and from 640 to 2,560 in rabbits against the California strain. Results against the Texas and Mexico strains were essentially equivalent, ranging from 640 to 2,560 in both mice and rabbits. Vical’s vaccine would also be expected to provide similar robust immune responses against other swine-origin A/H1N1 influenza virus subtypes, supporting selection of a single A/H1N1 virus strain as the basis for the vaccine.

“Cross-reactivity is consistent with previous CDC reports that circulating strains of swine-origin A/H1N1 pandemic influenza have remained antigenically homogeneous,” said Vijay B. Samant, President and Chief Executive Officer of Vical, “but future viral changes are unpredictable and could be far more substantial. The inherent speed of our DNA vaccine platform both in initial development and manufacturing could be extremely important in addressing the potential shortfalls of conventional vaccine approaches.”

Vical has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Naval Medical Research Center (NMRC), a biomedical research organization within the U.S. Navy, to develop a vaccine against H1N1 influenza.

“We are working with the U.S. Navy to secure funding to advance our H1 vaccine into human clinical testing,” added Mr. Samant. “Based on the sustained threat from the ongoing H1N1 pandemic, we have initiated critical-path manufacturing activities to allow initiation of a Phase 1 trial in as little as four to six weeks after funding is secured.”

About Vical

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company’s DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about Vical’s vaccine technologies and their potential application in a vaccine against H1N1 influenza, potential human clinical testing of such a vaccine, the Vical/NMRC CRADA, potential changes in circulating strains of influenza, potential government regulatory and procurement activities, as well as the company’s focus, collaborative partners, and product candidates. Risks and uncertainties include whether the company’s technologies will be successfully applied for the development of an H1 DNA vaccine; whether such vaccine will advance to clinical testing quickly, if at all; whether funding will be secured to support a Phase 1 trial; whether Vical, NMRC or others will continue development of any influenza DNA vaccine candidates; whether Vical and/or NMRC will terminate the CRADA before achievement of its objectives; whether the company’s DNA vaccine candidate will be effective in protecting humans against H1N1 or any other strains of influenza; whether H1N1 pandemic influenza will undergo substantial strain changes; whether Vical’s pandemic influenza vaccine will advance sufficiently to be considered for licensure during future pandemics; whether results in animal testing will be predictive of results in human testing; whether any product candidates will be shown to be safe and effective; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; and additional risks set forth in the company’s filings with the Securities and Exchange Commission. These forward-looking statements represent the company’s judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

CONTACT: Vical Incorporated
         Alan R. Engbring
         (858) 646-1127
         www.vical.com

©2012 An Inconvenient Woman. All Rights Reserved.

BioSante’s vaccine adjuvant, BioVant^TM, increases the protective effect of vaccines for multiple flu strains

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today’s presentation of H1N1 vaccine results at the Immunotherapeutics & Vaccine Summit in Providence, RI. BioSante’s vaccine adjuvant, BioVant^TM, increased the protective effect of vaccines for multiple flu strains, including a potential new vaccine against H1N1 (swine flu), which resulted in 100 percent protection from symptoms of illness, including weight loss, and death in animal studies.

The BioSante presentation, “BioVant Calcium Phosphate (CaP) Nanoparticles: An Effective & Safe Adjuvant for Influenza Vaccines including H1N1 and H5N1,” showed that BioVant-adjuvant effectively enhanced the natural immune response to the swine flu, using a BioVant-adjuvanted matrix protein M1 vaccine, and to H5N1 (bird flu), using a BioVant-adjuvanted H5N1 vaccine delivered via intranasal administration.

The studies concluded that swine and bird flu vaccines using BioSante’s BioVant may allow for availability of a greater number of lower-dose vaccines, due to its dose sparing characteristics, and intranasal administration could provide more convenient and wider distribution during a flu pandemic.

“The results of the BioVant-influenza studies suggest that BioVant can increase the efficacy of a potential adjuvant-enhanced H1N1 vaccine,” said Michael Snabes, BioSante’s vice president of clinical development. “The exciting prospect is that BioVant also may allow use of lower doses of H1N1 swine flu vaccines in order to stretch potentially limited vaccine supplies.”

An adjuvant is a substance that, when added to a vaccine, increases the vaccine’s effectiveness by enhancing the body’s immune response. In multiple studies, BioVant has been shown to be safe and cause minimal dose-dependent inflammation at the injection site, and has been shown both to prevent the manifestation of allergic response, and, to effectively ‘switch off’ established Th2-T-cell-associated allergic reactions and potentially to be delivered via alternative routes of administration, e.g. intranasally.

About BioSante Pharmaceuticals, Inc.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. BioSante’s lead products include LibiGel^® (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin^TM (estradiol gel) developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S. Also in development are Bio-T-Gel^TM, a testosterone gel for male hypogonadism, and an oral contraceptive in Phase II clinical development using BioSante patented technology. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3 billion. The company also is developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook^TM), as a vaccine adjuvant, including for an H1N1 (swine flu) vaccine, and drug delivery.

Additional information is available online at: www.biosantepharma.com.

©2012 An Inconvenient Woman. All Rights Reserved.

Anyone who still thinks that AstraZeneca paid too much when it offered a hefty premium for MedImmune’s shares should check out a new report from Jefferies International, which estimates that the global swine flu windfall will be worth around $2.3 billion in new sales for the Maryland manufacturer in 2009 and 2010 reports FierceVaccines.

MedImmune is putting its FluMist nasal spray technology to the test against swine flu. FluMist, which got off to a shaky start in the U.S., brought in only $104 million last year, a fraction of what the big global manufacturers have been able to earn with their flu shots. But all those naysayers who scorned the terms of the MedImmune buyout in the face of such weak performance could well be silenced by the rewards available when a pandemic hits. AstraZeneca plans to make 200 million doses of swine flu vaccine by next spring.

“This puts MedImmune in a better light and helps pay back some of that $15 billion,” Jefferies analyst Jeffrey Holford told Bloomberg in an interview. “This is the first positive surprise that’s tangible.”

MedImmune has already started recruiting for human trials, saying it will test the vaccine in children aged 3 to 17 and adults aged 18 to 49. Preliminary data may be available in a matter of weeks.

- Read  more about MedImmune in this  Bloomberg feature

©2012 An Inconvenient Woman. All Rights Reserved.

Fears about swine flu have spurred more than 3,000 people so far to volunteer to take part in upcoming clinical trials of a new vaccine. That’s already more than the number scientists will need at eight different sites around the U.S.

“We don’t generally ever get a response like this,” Dr. Lisa Jackson, the principal researcher in charge of the clinical trials being readied at Seattle-based Group Health Cooperative, which fielded more than a thousand calls from people in two days.
U.S. government officials, meanwhile, say they plan to start vaccinating people in October, after researchers have a chance to review the data from trials that should wrap in September. And the Advisory Committee on Immunization Practices is reviewing how a new vaccine for A/H1N1 should be provided to people just as the fall seasonal flu vax campaign gets underway. The U.S. has placed orders for 200 million doses with MedImmune, CSL, GlaxoSmithKline, Novartis and Sanofi-Aventis. But health officials haven’t ruled out a national vaccination campaign that would require up to 600 million doses.

Altogether more than 50 governments have placed orders for a huge supply of swine flu vaccine, providing a bonanza for the big manufacturers in the field. And smaller biotech companies are benefiting as well. Early this week shares of Vical, Novavax and BioCryst Pharmaceuticals all shot up as investors scouted the industry for companies likely to get a boost from the pandemic.

New research has highlighted the need to provide vaccinations to pregnant women first, who are among the most vulnerable to the swine flu. Pregnant women are also being advised to take an antiviral like Tamiflu now if they come down with the flu. A new study in the Lancet concludes that while it’s still unknown just how the drugs could affect the fetus, the likely benefits outweigh the risks.

- check out the report from MSNBC
- read the story from the Guardian
- read the story from Reuters

©2012 An Inconvenient Woman. All Rights Reserved.

Melbourne, Australia – 29/06/2009

CSL Limited, Australia’s leading biopharmaceutical company, will shortly be commencing a clinical trial of a candidate vaccine against Novel H1N1 ‘Swine’ Flu. The trial will be undertaken in partnership with Clinical Research Organisation CMAX and the Royal Adelaide Hospital in South Australia.

Healthy adults aged between 18 and 64 years are being sought to participate, and must be available to meet four appointments in Adelaide over a 6 month period.

The trial will involve participants receiving two injections of the vaccine, three weeks apart, and will compare a standard with an increased dosage of vaccine. Volunteers will need to submit to blood tests to check that they are generating an appropriate immune response to the virus.

“We understand flu vaccines very well from our long experience with yearly seasonal strains, as well as research into novel flu vaccines.” Global Director of Clinical Development at CSL, Dr Russell Basser said today.

“We appreciate that new influenza strains like the ‘swine flu’ can surprise us with properties that mean they might require higher dosing and two injections rather than one to provoke the desired level of immune response in humans.”

“CSL will be addressing these questions in the trial to ensure we know the optimum way for the vaccine to be given to protect against this strain of flu.”

It is anticipated that participants in the trial will commence being vaccinated in mid-July. This trial is being conducted with view to fulfilling a commitment to the Australian Department of Health and Ageing to supply up to 10 million people with a vaccine against Novel H1N1 ‘

©2012 An Inconvenient Woman. All Rights Reserved.

With the swine flu pandemic grabbing headlines and scaring countries the world over, GlaxoSmithKline says that it expects to reap up to $2.1 billion next year from the sale of a new H1N1 vaccine. And it’s already tripling its capacity to supply the antiviral Relenza as it dickers with about 50 countries over their plans to buy stockpiles of meds to fight the flu.

Glaxo projected $573 million in Relenza sales by the end of this year. And Glaxo says that the demand for flu meds should keep swelling its revenue stream for several years to come.

“In these last three months, governments have rapidly strengthened their pandemic stockpile and prevention strategies,” said GlaxoSmithKline’s chief executive, Andrew Witty. In some cases the talks are at a “very advanced stage. While we are currently seeing a heightened period of demand, it is likely that we will see a sustained level of orders for pandemic products over the next few years.”

Like other vaccine manufacturers, GlaxoSmithKline says that it’s work on a new vaccine has been slowed due to low yields of antigen. But Glaxo says that it should be able to supply governments with what they need by early 2010.

Analysts note that the pandemic couldn’t have come at a better time for Glaxo, one of the world’s largest vaccine makers. Generics have been steadily eating into the company’s margins, leaving Glaxo looking for new products to make up the shortfall.

- read the story from Forbes
- read the report from the Philadelphia Inquirer

©2012 An Inconvenient Woman. All Rights Reserved.

Faced with the first World Health Organization (WHO)  declared pandemic in four decades, health officials arou world are rushing to order huge stock-piles of the H1N1 (Swine) Fl vaccine in what is shaping up as a multibillion-dollar windfall for the world’s biggest manufacturers.

The French government has ordered 94 million doses of swine flu vaccine–enough to vaccinate three-quarters of the country’s population. The French inked contracts–which total $1.4 billion–with Sanofi-Aventis, GlaxoSmithKline and Novartis. Sanofi Pasteur is estimating that it will have the first supplies of a new swine flu vaccine ready for delivery in four to six months.

And France is far from the only country to lay the foundation for a mass vaccination campaign as soon as supplies arrive. The UK is considering hiring private contractors to help doctors in the country’s national health service to administer theH1N1 vaccine. Peter Holden, who represents the British Medical Association, says doctors and nurses need to be ready to administer vaccines to 30 to 40 people an hour.

While far more mild than originally feared, swine flu has nevertheless roiled populations around the globe, with each new death raising fresh fears. Those fears in turn have spurred government agencies to come up with new vaccination campaigns as a new flu season in the northern hemisphere looms.

- Read Full Reuters Article
- Read Full Dow Jones Article

©2012 An Inconvenient Woman. All Rights Reserved.

Using both a traditional egg-based as well as a cell-based approach in developing a new vaccine for swine (H1N1) flu, pharma giant, Novartis says it expects to launch a clinical trial of a new jab before the end of the month as it racks up huge orders from countries around the globe.

Novartis is one of five big manufacturers preparing swine flu vaccines for the U.S. market, a CDC official says. Dr. Pascale Wortley, the CDC’s pandemic-vaccine coordinator, says that by October the U.S. expects to have between 40 million and 160 million doses of vaccine ready for use.

That could mean that this fall,  U.S. school children  may be expected to get a seasonal flu shot as well as a double dose of swine flu vaccine.

Right now no one in the U.S. government has laid out a clear plan for handling swine flu this fall. Vaccinations may initially be planned only for health care workers and other front-line emergency workers. Ultimately, some believe that the U.S. will order up to 600 million doses for the entire population to guard against a so-called second wave in the fall that could include a more lethal version of A/H1N1.

- Read Monsters and Critics Full article
- Read Seattle Times Article with CDC Swine Flu Vaccine Report

©2012 An Inconvenient Woman. All Rights Reserved.

An additional $884 million in funding has been allocated to buy more ingredients an antigen and an adjuvant for swine flu vaccines. This is in addition to the $1 billion The Department of Health and Human Services committed to fighting the Swine Flu in May.

Novartis will get the bulk of the $884 million. The drugmaker has landed $690.1 million to produce bulk vaccine antigen as well as other ingredients. GlaxoSmithKline is being furnished with $71.4 million for bulk oil and water adjuvant, while Sanofi Pasteur will receive $61.4 million to produce ingredients.

Washington Business Journal writer, Vandana Sinha  reported that one month after (H1N1) swine flu was declared a global pandemic, MedImmune has been awarded additional $61 million contract from the U.S. Department of Health and Human Services, six weeks after it accepted a $90 million contract from the agency to manufacture ingredients for a potential vaccine for the H1N1 virus to fight the predicted Swine Flu outbreak.

MedImmune, now the Gaithersburg subsidiary of the London-based AstraZeneca PLC, is using the funding to produce and test the flu-fighting technology it uses in its seasonal FluMist product (nasal spray) as a viable treatment for the for the H1N1 virus.

The World Health Organization (WHO) has raised the H1N1 (Swine) Flu to the highest warning levels on the pandemic scale.

The follow-up awards were given to four of five pharmaceuticals that the federal government has been contracting with to produce potential vaccine materials — Sanofi Pasteur SA, GlaxoSmithKline PLC, Novartis AG, CSL Ltd. and MedImmune.

In all, the agency has spent nearly $1.9 billion to date on these contracts., MedImmune’s combined $150 million in awards have been the smallest so far of those companies.

Read Full Washington Business Journal Article
Read AP Story

©2012 An Inconvenient Woman. All Rights Reserved.

The newly emergent 2009 H1N1 influenza virus is a novel virus with pandemic potential. Consistent with the National Strategy for Pandemic Influenza, HHS is committing funds for the production of pilot lots for clinical studies, as well as a bulk supply of antigen and adjuvant for use in a potential vaccine for the 2009 H1N1 which will become a part of the national stockpile of pre-pandemic influenza vaccines.

A vaccine is made from a virus or bacteria (referred to as an antigen), which causes the human body’s immune system to develop antibodies against a specific virus or bacteria so the body can recognize and fight the virus or bacteria. Adjuvants may be added to a vaccine to help generate a stronger immune response so less vaccine is needed for the body to recognize and fight a virus or bacteria.

Vaccine Development

When the 2009 H1N1 strain was isolated and identified as a novel influenza virus, work began to prepare a virus reference strain. This is a standard practice when new influenza strains are discovered, where a clinical sample of the virus is mixed with another influenza virus that grows in eggs to develop a new virus that has some of the properties of the novel virus and the ability to grow in eggs. This work is necessary in order to create an influenza vaccine using conventional methods.

Once a virus reference strain is ready, it will be made available to influenza vaccine manufacturers in order to create a master virus seed, which prepares a virus to be used in making the vaccine.

Health and Human Services (HHS)Contracting Activities

Since 2004, HHS has contracted with manufacturers that currently hold U.S. licenses for flu vaccine as part of the National Strategy for Pandemic Influenza. In May 2009, HHS issued new orders on these contracts to produce a bulk supply of vaccine antigen and adjuvant and to produce pilot (also called investigational) lots of a 2009 H1N1 vaccine. Most will be stored in bulk, and a small amount will be prepared as vaccine for use in clinical studies to evaluate vaccine safety and the dosage required for a protective effect. This research will include studies with adjuvant to determine its safety and the effect it would have on the immune system’s response.

Orders for Bulk Supply of 2009 H1N1 Influenza Vaccine Antigen and Adjuvant

©2012 An Inconvenient Woman. All Rights Reserved.