UPDATE 1-Crucell starts work on RSV vaccine

AMSTERDAM, June 24 (Reuters) – Dutch biotech Crucell (CRCL.AS) (CRXL.O) said on Thursday it would start the development of a universal respiratory syncytial virus (RSV) vaccine as part of its collaboration with Johnson & Johnson.

Crucell sold an 18 percent stake to U.S. diversified health care company J&J (JNJ.N) for 302 million euros last September as part of a flu vaccine development deal and in February said it will boost R&D funding by more than a third.

On Thursday, the company said it would start a discovery programme aimed at the development of an RSV vaccine to prevent severe infections with the most common RSV strains in infants and the elderly.

“We expect that an RSV vaccine will be the next frontier in children’s vaccines for inclusion in the routine immunisation of newborns,” Chief Executive Ronald Brus said in a statement.

While the partnership with J&J focuses on the development of and commercialisation of a universal influenza vaccine, it also included innovation programmes directed against three other disease targets.

The universal RSV vaccine has now been selected as one of the innovation programmes, while selection of the other two targets is ongoing, Crucell said.

Crucell said RSV is the most important cause of viral lower respiratory illness in infants and children and that RSV-induced disease is the last of the major paediatric diseases for which no preventive vaccine is available. (Reporting by Aaron Gray-Block; Editing by David Cowell)

Progress made toward universal flu vaccine

Washington, May 20 (ANI): Scientists have come up with a novel influenza vaccine that could represent the next step towards a universal influenza vaccine eliminating the need for seasonal immunizations.

“Current influenza vaccines are effective against only a narrow range of influenza virus strains. It is for this reason that new vaccines must be generated and administered each year. We now report progress toward the goal of an influenza virus vaccine which would protect against multiple strains,” said study’s author Peter Palese, from Mt. Sinai School of Medicine.

The main reason the current seasonal vaccine is so strain-specific is that the antibodies it induces are targeted at the globular head of the hemaglutinin (HA) molecule on the surface of the influenza virus.

This globular head is highly variable and constantly changing from strain to strain.

In this study, the researchers constructed a vaccine using HA without its globular head. Mice immunized with the headless HA vaccine showed a broader, more robust immune response than mice immunized with full-length HA, and that immune response was enough to protect them against a lethal viral challenge.

“Our results suggest that the response induced by headless HA vaccines is sufficiently potent to warrant their further development toward a universal influenza virus vaccine. Through further development and testing, we predict that a single immunization with a headless HA vaccine will offer effective protection through several influenza epidemics,” said Palese.

The findings have been reported in the inaugural issue of mBio, the first online, open-access journal published by the American Society for Microbiology. (ANI)

WA reviews flu vaccine program

The West Australian Government is reviewing the state’s handling of the flu vaccine program.

Last month WA was the first state to suspend its influenza vaccine program for children under five after hundreds of cases of adverse reactions, including fever, vomiting and convulsions.

The program was suspended nationally the next day after children in other states and territories reported severe side-effects.

The WA Health Minister Kim Hames says the review will recommend ways the department can improve its reporting systems to pick up public health risks earlier.

“What the enquires looks at is the response time of the West Australian health department,” he said.

“Did we do a good job or not? Did we do everything we could have?”.

At the weekend health consumers demanded answers from health authorities to restore confidence in vaccination.

The Therapeutic Goods Administration has tested batches of vaccine from WA and found there was nothing abnormal about them.

Maxine Drake from the WA Health Consumers Council said the lack of information could permanently deter some parents from vaccinating their children.

Now, painless vaccines!

it surely was too much pain, for a lot of good. Now, the trade-off is unlikely to stay current.

In what would make childhood immunisation easier and pain-free, scientists have developed a patch — the size of a postage stamp — which they claim could be used to deliver cheap, needle-free vaccines.

A new study, led by the University of Queensland, has found that a vaccine delivered by ‘Nanopatch’ induces a similarly protective immune response as a vaccine delivered by needle and syringe, but uses 100 times less vaccine.

According to the scientists, the patch could be used in developing countries where clean needles and refrigeration are scarce.

“The Nanopatch targeted specific antigen presenting cells found in a narrow layer just beneath the skin surface and as a result we used less than one hundredth of dose used by a needle while stimulating a comparable immune response.

“Our result is ten times better than the best results achieved by other delivery methods and does not require the use of other immune stimulants, called adjuvants, or multiple vaccinations.

“Because the Nanopatch requires neither a trained practitioner to administer it nor refrigeration, it has enormous potential cheaply deliver vaccines in developing nations,” lead scientist Professor Mark Kendall said.

According to the scientists, the Nanopatch comprises of several thousands of densely packed projections invisible to the human eye. The influenza vaccine was dry coated onto the projections and applied to skin of mice for two minutes.

“By using far less vaccine we believe that the Nanopatch will enable the vaccination of many more people.

When compared to a needle and syringe a Nanopatch is cheap to produce and it is easy to imagine a situation in which a government might provide vaccinations for a pandemic such as swine flu to be collected from a chemist or sent in the mail.

“This is an exciting discovery and our next step s to prove the effectiveness of Nanopatches in human clinical rials,” Professor Kendall said.

Inovio Biomedical to Present at World Vaccine Congress 2010

BLUE BELL, Pa.–(Business Wire)–
Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design,
development and delivery, announced today that the company will be presenting
its DNA vaccine technology platform and the development of universal influenza
vaccine candidates at the upcoming World Vaccine Congress to be held in
Washington, DC from April 19-22.

Dr. J. Joseph Kim, Inovio President and CEO, is speaking at a panel session on
April 20th at 17:15 titled “What`s on the Horizon for DNA Vaccines?Renewing the
Promise.” The session will focus on the advancements made in translating the
potential of DNA vaccines into the clinic as well as the potential benefits of
DNA vaccines vis-à-vis other vaccine platforms in reducing vaccine development
times.

“Inovio recently announced interim data from its ongoing cervical cancer therapy
trial demonstrating the induction of strong levels of antigen-specific,
dose-related antibody and cellular immune responses. We look forward to
discussing these results at this important vaccine conference,” noted Dr. Kim.

Dr. Niranjan Y. Sardesai, Inovio Senior VP Research and Development, is speaking
in a session on April 20th called “H1N1 Federal Planning and Preparedness and
Industry Response to Federal Strategies.” His presentation, scheduled for 14:40,
is titled “Designing DNA-based Vaccines with the Capability to Provide Universal
Protection against Unmatched Influenza Virus Strains.” The presentation will
highlight the ability of Inovio`s SynCon technology to side-step current
“catch-up” strategies for providing protection against influenza by designing
and evaluating broadly cross-protective DNA vaccine candidates against multiple
influenza virus sub-types.

The World Vaccine Congress brings together thought leaders from the world`s
leading vaccine manufacturers, biotechs, governmental agencies, NGOs, research
and academic institutes. For more information on the Congress:

http://www.terrapinn.com/2010/wvcdc/index.stm

About Inovio Biomedical Corporation

Inovio Biomedical is focused on the design, development, and delivery of a new
generation of vaccines, called DNA vaccines, to prevent and treat cancers and
infectious diseases. The company`s SynCon technology enables the design of
“universal” vaccines capable of protecting against multiple – including newly
emergent, unknown – strains of pathogens such as influenza. Inovio`s proprietary
electroporation-based DNA vaccine delivery technology has been shown by initial
human data to safely and significantly increase gene expression and immune
responses. Inovio`s clinical programs include HPV/cervical cancer (therapeutic),
avian flu, and HIV vaccines. Inovio is developing its universal and avian
influenza vaccines in collaboration with scientists from the University of
Pennsylvania, the National Microbiology Laboratory of the Public Health Agency
of Canada, and the NIH`s Vaccine Research Center. Other partners and
collaborators include Merck, Tripep, University of Southampton, National Cancer
Institute, and HIV Vaccines Trial Network. More information is available at
www.inovio.com.

This press release contains, in addition to historical information,
forward-looking statements. Such statements are based on management`s current
estimates and expectations and are subject to a number of uncertainties and
risks that could cause actual results to differ materially from those described
in the forward-looking statements. Inovio is providing this information as of
the date of this press release, and expressly disclaims any duty to update
information contained in this press release.

Forward-looking statements in this press release include, without limitation,
express and implied statements relating to Inovio`s business, plans to develop
electroporation-based drug and gene delivery technologies and DNA vaccines and
pre-clinical and clinical studies. Actual events or results may differ from the
expectations set forth herein as a result of a number of risks, uncertainties
and other factors, including but not limited to: Inovio has a history of losses;
all of Inovio`s potential human products are in research and development phases;
no revenues have been generated from the sale of any such products, nor are any
such revenues expected for at least the next several years; Inovio`s product
candidates will require significant additional research and development efforts,
including extensive preclinical and clinical testing; uncertainties inherent in
clinical trials and product development programs, including but not limited to
the fact that pre-clinical and clinical results may not be indicative of results
achievable in other trials or for other indications, that results from one study
may not necessarily be reflected or supported by the results of other similar
studies, that results from an animal study may not be indicative of results
achievable in human studies, that clinical testing is expensive and can take
many years to complete, that the outcome of any clinical trial is uncertain and
failure can occur at any time during the clinical trial process, and that
Inovio`s electroporation technology and DNA vaccines may fail to show the
desired safety and efficacy traits in clinical trials; all product candidates
that Inovio advances to clinical testing will require regulatory approval prior
to commercial use, and will require significant costs for commercialization; the
availability of funding; the ability to manufacture vaccine candidates; the
availability or potential availability of alternative therapies or treatments
for the conditions targeted by Inovio or its collaborators, including
alternatives that may be more efficacious or cost-effective than any therapy or
treatment that Inovio and its collaborators hope to develop; whether Inovio`s
proprietary rights are enforceable or defensible or infringe or allegedly
infringe on rights of others or can withstand claims of invalidity; and the
impact of government healthcare proposals. Readers are also referred to Inovio`s
Annual Report on Form 10-K for the year ended December 31, 2009 filed with the
Securities and Exchange Commission which identify important risk factors that
could cause actual results to differ from those contained in the forward-looking
statements.

Investors:
Inovio Biomedical
Bernie Hertel, 858-410-3101
bhertel@inovio.com
or
Media:
Richardson & Associates
Jeff Richardson, 805-491-8313
jeff@richardsonglobalpr.com

Copyright Business Wire 2010

2009 H1N1 influenza vaccines well tolerated, induce strong immune response in adults

Washington, September 12 (ANI): Early results from various clinical trials of 2009 H1N1 influenza vaccines in healthy adults seem to be quite encouraging, say U.S. health experts.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health in the U.S., has revealed that the early data from these trials suggest that 2009 H1N1 influenza vaccines are well tolerated, and induce a strong immune response in most healthy adults, when administered in a single unadjuvanted 15-microgram dose.

It has even congratulated the companies that have carried out these trials, which it claims are an important part of the ongoing worldwide effort to develop vaccines to protect the public from 2009 H1N1 influenza.

The National Institute of Allergy and Infectious Diseases is also conducting clinical trials of 2009 H1N1 influenza vaccines, produced by Sanofi Pasteur and CSL Limited.

The trials are testing two different dosages-15 micrograms versus 30 micrograms-and evaluating the immune response to one and two doses of these vaccines.

More than 2,800 people are said to be participating in the ongoing NIAID trials of these vaccines.

The institute says that preliminary analyses of early data from its trials align with the recently announced findings, and those to be announced imminently by other companies.

Additional data from the NIAID trials are forthcoming.

“However, on the basis of these strong early data, our results are consonant with other reports that a single 15-microgram dose of unadjuvanted 2009 H1N1 influenza vaccine is well tolerated and induces a robust immune response in healthy adults between the ages of 18 and 64. For adults aged 65 and older, the immune response to 2009 H1N1 influenza vaccine is somewhat less robust, as is the case with seasonal influenza vaccines,” the institute said in a press release.

“We note that the slight discrepancies seen in our trials between the Sanofi Pasteur and CSL Limited vaccines may be due to technical differences in the preliminary measurement of the amounts of antigen in the doses used in the clinical trial lots and the relatively limited numbers of samples studied to date, as well as the fact that our data are drawn from a very early time point after immunization,” the institute added. (ANI)

Budget reduces duties on life saving drugs

New Delhi, July 6 (ANI): The basic customs duty on influenza vaccine and nine specified life saving drugs used for the treatment of breast cancer, hepatitis-B and rheumatic arthiritis, on the bulk drugs used for the manufacture of such drugs, has been reduced from 10 per cent to 5 per cent.

Announcing this while presenting the General Budget in Lok Sabha on Monday, Finance Minister Pranab Mukherjee said that they would also be totally exempt from excise duty and countervailing duty.

“The customs duty will also be reduced from 7.5 per cent to five per cent on two specified life-saving devises used in treatment of heart conditions. These devises will be fully exempt from excise duty and CVD also.”

Mukherjee has also announced the reduction of excise duty applicable to large cars / utility vehicles of engine capacity of 2000 cc and above from Rs.20,000 per vehicle to Rs.15,000 per vehicle.

“The excise duty on petrol driven trucks/lorries has been reduced from 20 per cent to 8 per cent, while on chassis of such trucks/lorries, the reduction is from ’20 per cent + Rs.10000′ to ’8 per cent + Rs.10000′,” he said.

He has further reduced the excise duty on Special Boiling Point spirits to 14 per cent and on naptha to 14 per cent. Duty paid high-speed diesel blended with up to 20 per cent bio-diesel has also been fully exempted from excise duties.

“The excise duty exemption on ‘recorded smart cards’ and ‘recorded proximity cards and tags’ has been made optional. The manufacturers will have the option to pay the applicable excise duty and avail the credit of duty paid on inputs,” he added.

The Minister while presenting the budget has extended the benefit of SSI exemption scheme to printed laminated rolls bearing the brand name of others by excluding this item from the purview of the brand name restriction.

“On packaged or canned software, the excise duty exemption has been provided on the portion of the value, which represents the consideration for transfer of the right to use such software, subject to specified conditions,” he said.

The Minister said that the excise duty on branded articles of jewellery has also been reduced from two per cent to NIL.

While announcing the indirect taxes in the General Budget, he reduced the basic customs duty on LCD panels from 10 per cent to 5 per cent to support the indigenous production of LCD televisions. This will be particularly beneficial in creating employment especially in the SME sector. (ANI)

China likely to manufacture new flu vaccine by July

New Delhi, May 27 (ANI): A Chinese official has revealed that the country may manufacture an A(H1N1) influenza vaccine for human use by July.

Yin Hongzhang, head of the biology production department under the State Food and Drug Administration (SFDA), says that studies on samples of a flu strain that China is likely to receive by early June may make it possible.

“The country has set up a green channel between the World Health Organization (WHO) and the Chinese drug makers. As soon as the WHO releases the vaccine strain, drug companies will be informed and will start manufacturing as soon as they can,” Xinhua quoted Yin as saying.

Given that vaccine manufacturing requires high-level safety, Yin says that China must produce one in line with WHO protocols.

WHO last week said that drug companies wouldn’t be able to make an A(H1N1) vaccine until mid-July at the earliest as the virus was growing slowly in labs, making it difficult for scientists to get the key ingredient for a vaccine.

According to the China Daily, Yin noted that WHO was not sure yet whether the A(H1N1) flu should be categorized as seasonal or pandemic, which was a problem for drug makers.

Yin also revealed that 11 drug companies in China could produce seasonal flu vaccines, but only one could make pandemic flu vaccines.

“Compared with a 1.3-billion population, our current vaccine producing ability is far from enough,” said Yin.

He further said that China would become the first country to guarantee vaccine supplies for medical staff if the A(H1N1) influenza was confirmed as pandemic.

He further said that a vaccine for A(H1N1) would produce antibodies within two weeks after being injected.

It would take another 45 days to two months to take full effect, which would normally last for more than one year, Yin added. (ANI)

Philippines bans pork imports from Mexico, US

Manila – The Philippines’ agriculture department Saturday ordered a ban on the importation of pigs and pork products from Mexico and the United States amid an outbreak of swine flu virus in the two countries. The virus is suspected to have killed 68 people in Mexico over the past three weeks, while at least eight people have been infected in the US.

Agriculture Secretary Arthur Yap said he ordered the import ban as a “precautionary measure” despite no links so far between swine farms and the outbreak.

“I ordered the Bureau of Animal Industry to strengthen the monitoring of all the ports of entry to prevent the entry of any hogs or pork from Mexico and the US,” he said.

Yap also ordered the “augmentation of existing quarantine checkpoints to further prevent the movement of sick pigs.”

While stressing that there was no outbreak of swine flu in the Philippines, Yap ordered the bureau to lift a restriction on the use of swine influenza vaccine and “encourage hog farmers to regularly vaccinate their pigs.”

The swine flu virus is typically found only in pigs or in people who have direct contact with pigs. Symptoms of the illness include very high sudden fever, headaches, red eyes, nasal flow and coughing.(dpa)

Universal influenza vaccine comes closer to reality

Washington, Apr 28 (ANI): Researchers from Saint Louis University have come a step closer to developing universal flu vaccine that would offer protection against different strains of influenza.

Currently drug companies manufacture a different flu vaccine each year to match the strains of influenza that researchers predict will circulate.

Adding a universal influenza vaccine to a seasonal vaccine would help improve protection against strains of influenza as they change each year.

Lead researcher Dr Robert Belshe, director of the Saint Louis University Centre for Vaccine Development studied a vaccine made with proteins from strains of influenza viruses A and B.”Novel vaccines, capable of inducing long-lasting, broad immunity against divergent strains,including potential pandemic viruses, are highly desirable,” said Belshe.

“This is a significant first step in developing a universal vaccine to help protect against pandemic influenza,” he added.

During the study, 377 healthy adults received three injections of a universal influenza vaccine, known as Bivalent Influenza Peptide Conjugate Vaccine (BIPCV), over a six-month period.

The researchers found that a low dose of the vaccine is well tolerated and safe.

Belshe said low dose vaccine evoked an immune response – high antibody titers – that is similar to levels associated with protecting small animals infected with influenza from serious disease and death. However, more testing is needed.

The findings were presented at the National Foundation for Infectious Disease Conference for Vaccine Research in Baltimore. (ANI)