flu vaccine related Press Releases

Researchers identify key peptides that could lead to a universal vaccine for influenza

Jennifer Levin — Wed, 01 Feb 2012 15:29:35 -0500

Researchers identify key peptides that could lead to a universal vaccine for influenza

31-Jan-2012

Researchers at the University of Southampton, University of Oxford and Retroscreeen Virology Ltd have discovered a series of peptides, found on the internal structures of influenza viruses that could lead to the development of a universal vaccine for influenza, one that gives people immunity against all strains of the disease, including seasonal, avian, and swine flu.

Influenza, an acute viral infection, affects hundreds of thousands of people a year and puts an enormous strain on healthcare providers globally. The last pandemic flu outbreak in the UK - swine flu - was in 2009 when it claimed 457 lives. While previous pandemics have been more serious, there is a heightened risk of more severe pandemics in the future.

The scientific collaboration used a research method known as "Human Viral Challenge Studies", where healthy volunteers are infected with influenza virus, and their immune responses closely monitored in an isolation unit.

These were important to the research, published online in Nature Medicine, as they allowed the healthy volunteers to be held in "sterile" isolation conditions and ensured they had no existing infections. The volunteers were then "challenged" with influenza virus, with blood samples being taken at regular intervals to observe how their immune systems responded to the viral infection.

Researchers discovered that the immune systems produced various types of T-cells (part of the immune system that kills both viral particles, and cells infected with viral particles). Notably, the T-cells responded to peptides associated with the internal structures of the influenza viruses.

Unlike the external structures of influenza virus, that mutates very rapidly and creates a new strain of virus most years, the internal structures change very slowly over a long period of time. These internal structures are found in all strains of influenza virus - thus, a vaccine that targets such peptides may provide immunity against all strains of influenza, including seasonal (yearly), avian (bird), and swine flu, for many years.

A vaccine against these peptides would activate the T-cell immune response - which is able to respond much more rapidly than vaccines that activate an antibody response.

Dr Tom Wilkinson, Senior Lecturer in Respiratory Medicine at the University of Southampton, who led the study, says: "Influenza is a virus that we know has a global impact, and the threat of further pandemics is a real one. Most influenza vaccines only protect us against known influenza strains by creating antibodies in the blood but the influenza virus has the ability to rapidly change itself and new strains can emerge which rapidly spread across the globe by escaping this immunity.

"We have found that there is an important role for T-cells that recognise the flu virus, which if harnessed could protect against most or even all strains of seasonal and pandemic flu. Through this discovery we hope to improve vaccines for future strains of influenza; and potentially protect against the next pandemic. However there is more to do to translate these findings into new approaches to treatment."

"Current flu vaccines are very good at producing antibodies against flu, but not so good at generating a lasting immunity involving T-cells,' says Professor Sir Andrew McMichael, Director of the Medical Research Council (MRC) Weatherall Institute of Molecular Medicine at Oxford University. "The big question is: if we had a pandemic involving a much more severe virus than the swine flu we saw, what would we do in the six months it takes to develop an effective vaccine? This study suggests that vaccines stimulating a T-cell response might be an option, but there remains a lot to do to be certain of this approach."

Dr Rob Lambkin Williams, Chief Scientific Officer of Retroscreen, adds, "It is great to see the quality of data produced using the challenge study technique. Knowing that the volunteers were only infected with the viral strains that the research team had introduced, takes the guess work out of such research. The immune response observed in these volunteers was as a direct result of the virus to which they had been exposed. This quality of data will have the potential to rapidly speed up the rate that we are able to create a universal vaccine for influenza."

Retroscreen's Chief Executive Officer, Kym Denny said: "Retroscreen is delighted that our scientists and doctors have been able to work so closely with two leading universities. This work significantly expands our understanding of the immune response to influenza infection; this could be key in the fight against a future pandemic."

Finally, Professor John Oxford, President, Scientific Director and founder of Retroscreen and Professor of Virology at St Bartholomew's and the Royal London Hospital, Queen Mary's School of Medicine and Dentistry said: "Dedicated volunteers in our isolation unit have helped us to open a window into why some people get flu and others do not and even better to formulate a new vaccine."

The study was funded by the University of Southampton, the MRC and Retroscreen Virology Limited.

To view the paper published in Nature Medicine visit http://www.nature.com/nm/journal/vaop/ncurrent/full/nm.2612.html

Contact: Rebecca Attwood
r.attwood@soton.ac.uk
0238-059-5457
University of Southampton

VaxInnate Licenses Recombinant Flu Vaccines to CJ CheilJedang Corporation of South Korea

Mon, 19 Dec 2011 09:20:52 -0500

Agreement covers region with a population of 650 million individuals

CRANBURY, N.J.--(BUSINESS WIRE)-- VaxInnate Corporation announced today that it has granted biopharmaceutical company CJ CheilJedang Corporation an exclusive license to manufacture, develop and commercialize VaxInnate’s recombinant seasonal and pandemic flu vaccines in South Korea. The agreement also includes a non-exclusive license to market the vaccines in certain Southeast Asian countries, excluding China.

Under the terms of the agreement, CJ CheilJedang Corporation will be responsible for funding clinical development and licensure of the vaccine in South Korea and ten other Southeast Asian countries. Altogether, the agreement includes countries with a collective population of 650 million, including 49 million people in South Korea alone.

VaxInnate will transfer the technology required to develop and manufacture the vaccines. Financial terms of the agreement include an upfront fee, clinical and regulatory milestone payments, and royalties on sales.

CJ CheilJedang is a leading provider of drugs and vaccines to private and public markets in South Korea through CJ Pharma, the company’s biopharmaceutical arm. As with all new vaccines, the Korean and other governments must grant marketing approval based upon clinical evaluation before they can be used.

“Collaboration with VaxInnate will be a cornerstone for CJ’s flu vaccine business,” said Seok-Hee Kang, Senior Executive Vice President and Head of Pharmaceutical Business of CJ CheilJedang. “We believe that the TLR technology of VaxInnate is very competitive in vaccine development and it will place CJ in a superior position in the flu vaccine market.”

Meanwhile, VaxInnate plans to pursue clinical development and licensure of its seasonal and pandemic vaccines in the United States, Europe and other regions. The company has already conducted a number of successful clinical trials evaluating the potency, efficacy and safety of its vaccines.

“VaxInnate is pleased to partner with CJ Pharma to meet the flu vaccine needs of South Korea and parts of Southeast Asia,” said Thomas Hofstaetter, PhD, President and CEO of VaxInnate. “While this agreement is a significant milestone for us as a company, we continue to pursue partnerships for developing VaxInnate vaccines to meet global needs.”

VaxInnate produces highly immunogenic vaccines using a unique technology platform that effectively activates both the innate and adaptive immune systems. This technology -- based upon recombinant expression of fusion molecules that combine the vaccine antigen with a potent immune stimulator, the toll-like receptor 5 (TLR 5) agonist, flagellin -- conveys significant potency, speed, cost and capacity advantages.

In fact, VaxInnate’s technology makes it possible to produce hundreds of millions of vaccine doses in as little as three to four months. In a pandemic flu outbreak, the speed and capacity of this technology make it possible to supply all of the vaccine needed by a nation, from first to last doses, in several months. This represents a significant improvement compared to the time it takes to produce flu vaccines using either eggs or cell culture, from which only the first or early doses of vaccine can be produced in the early months of a pandemic flu.

About VaxInnate

In 2011, a contract worth up to $196 million over five years was awarded to VaxInnate by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), to fund the development of seasonal and pandemic flu vaccines using recombinant technology.

VaxInnate has already generated positive Phase I and Phase II clinical data for its flu vaccines. Prototype seasonal and pandemic flu vaccines were also demonstrated to have superior potency in elderly subjects. For more information about VaxInnate, please visit http://www.vaxinnate.com.

CONTACT:

For VaxInnate Corporation
Janet Skidmore
Office: +1 215-658-4915
Mobile: +1 215-429-2917
skidmorecomm@earthlink.net

KEYWORDS: United States North America New Jersey

INDUSTRY KEYWORDS: Health Biotechnology Infectious Diseases Pharmaceutical Other Health Professional Services Finance Research Other Science Science General Health

MEDIA:

Logo

First U.S. cell-based flu vaccine plant set for dedication

Mon, 12 Dec 2011 14:20:57 -0500

Facility’s ability to produce cell-based pandemic flu vaccine marks historic change

WASHINGTON--(BUSINESS WIRE)-- The first U.S. facility to use a faster and more flexible technology to make influenza vaccine was dedicated today, as part of an initiative that could provide vaccine supplies sooner in an influenza pandemic. The plant in Holly Springs, N.C., can create vaccine using cultured animal cells instead of the conventional process of using fertilized eggs. The facility is a public-private partnership of the U.S. Department of Health and Human Services, and Novartis Vaccines and Diagnostics, Inc. of Cambridge, Mass. This partnership will be maintained under contract for at least 25 years.

The dedication signals that in an influenza pandemic the facility can produce cell-based influenza vaccine that could be authorized by the U.S. Food and Drug Administration for use during the emergency.

“Today we’re marking the first change in influenza vaccine manufacturing in the United States in 50 years,” said Robin Robinson, Ph.D., director of the Biomedical Advanced Research and Development Authority in HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR). Robinson led the effort for HHS. “The pandemic readiness of this facility is a major milestone in national preparedness for pandemic influenza and other diseases.”

In an influenza pandemic, the new Novartis facility may be able to produce 25 percent of the vaccine needed in the United States. In addition, cell-based technology used in this facility for manufacturing seasonal and pandemic influenza vaccines may be adapted to produce vaccines for other known and unknown emerging infectious diseases in an emergency. The United States joins several European countries with the capability to manufacture cell-based influenza vaccines on a large scale.

Investing in new vaccine technology to improve the time necessary to produce pandemic vaccine and increase the nation’s surge capacity was recommended in two August 2010 reports, the Public Health Emergency Medical Countermeasures Enterprise Review released by Secretary Kathleen Sebelius and the President's Council of Advisors on Science and Technology Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza.

In addition to partnering to bring cell-based flu vaccine and adjuvant technologies to the United States, HHS and Novartis are partnering with Synthetic Genomics Vaccines of Rockville, Maryland on new technologies to shorten the vaccine manufacturing timeline by optimizing vaccine virus seed strains used for flu vaccine production.

BARDA and Novartis also are working with North Carolina State University to train scientists from other countries to use cell culture based manufacturing techniques similar to what is used in the new facility. The training program is part of a World Health Organization initiative to strengthen the ability of developing countries to produce flu vaccine, potentially reducing the global threat from influenza.

HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. ASPR is an HHS leader in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.

Within ASPR, BARDA provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases.

For more information on pandemic preparedness efforts, visit www.phe.gov or www.flu.gov and to learn more about partnering with HHS ASPR’s BARDA in public health preparedness visit www.medicalcountermeasures.gov. Contract opportunities are announced at www.fbo.gov.

Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.

CONTACT:

HHS Press Office
202-690-6343

KEYWORDS: United States North America District of Columbia North Carolina

INDUSTRY KEYWORDS: Health Biotechnology Infectious Diseases Public Policy/Government Healthcare Reform Pharmaceutical Other Policy Issues Manufacturing Public Policy White House/Federal Government Other Manufacturing Research FDA Science

MEDIA:

Logo

Medicago Announces 2011 Third Quarter Financial Results

Mon, 14 Nov 2011 18:20:50 -0500

QUEBEC CITY, Nov. 14, 2011 /PRNewswire/ - Medicago Inc. (TSX: MDG), a biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles, today announced its operational and financial results for the third quarter ended September 30, 2011. The Company's financial statements and management report are available at www.sedar.com and at www.medicago.com.

"This was another quarter of progress on both the clinical and corporate front for the Company as we continue to advance our rapid and highly effective plant-based VLP vaccines. Earlier this year, we presented positive clinical results from our phase II pandemic H5N1 influenza vaccine clinical trial and our US phase I seasonal influenza trial, confirming to date that our vaccines are safe and can elicit a strong immune response in humans," said Andy Sheldon, President and Chief Executive Officer of Medicago. "We recently commenced operations at our 97,000-square-foot facility in North Carolina within a year of holding our groundbreaking ceremony. We also closed a significant offering priced above market that included a top 50 global pharmaceutical company as lead investor, Philip Morris International and other strategic healthcare-focused funds. This infusion of capital from strategic investors, in our opinion, further validates our approach and our technology and puts us in a strong position financially. This allows us to move forward with our clinical programs and initiatives, such as, the U.S. phase II study for our seasonal flu vaccine and the expansion of our product pipeline outside of influenza."

Key Developments:

Corporate

Medicago USA Inc. commenced operations at its 97,000-square-foot plant-based vaccine facility in Research Triangle Park, North Carolina, within 11 months of hosting the groundbreaking ceremony.
Medicago won the 2011 Frost & Sullivan Enabling Technology of the Year award in the vaccine market for the Company's achievements and leadership in the development of rapid and highly effective plant-based VLP vaccines.
Completed a private placement offering of $25 million in which the lead investor was a top 50 global pharmaceutical company.
Subsequent to quarter end, Philip Morris Investments B.V. announced the exercise of its pre-emptive right and the investment of an aggregate of $22.5 million in Medicago through a two tranche private placement. The first one of $11.3 million closed on October 27, 2011 and the second one is subject to shareholder approval.

Products

Successfully completed the first stage of the research collaboration agreement with a top 10 global pharmaceutical company for the development of a non-influenza VLP vaccine candidate. Medicago received the approval to proceed to the second stage of the collaboration.

Outlook

Upcoming potential milestones for the next six months may include, among others:

	-	Initiation of U.S. phase II clinical trial with trivalent seasonal influenza.
	-	Initiation of Infectious Disease Research Institutes (IDRIs) U.S. phase I clinical trial with a single dose of Medicago's H5N1 vaccine with their adjuvant
	-	Addition of new pipeline candidates
	-	Potential contracts with governments and pharmaceutical companies

Financial Results

Consolidated loss for the three-month period ended September 30, 2011 was $4,407,000 or $0.03 per basic and diluted share compared to a loss of $4,140,000 or $0.03 per basic and diluted share for the three-month period ended September 30, 2010. Since the beginning of the year, the consolidated loss was $14,341,000 or $0.09 per basic and diluted share compared to a loss of $11,881,000 or $0.10 per basic and diluted share for the same period in 2010. Increase in the loss for the three and nine-month period is explained by an increase in R&D expenses in relation with clinical development of our Influenza vaccine candidates and the DARPA project.

Cash and cash equivalents and short-term investments were of $28.1 million as at September 30, 2011.

As at November 11, 2011, there were 229,410,302 common shares issued and outstanding as well as 8,212,819 stock options outstanding. Warrants outstanding and Unit options outstanding as at November 11, 2011 represented a total of 25,719,417.

Detailed financial statements and the MD&A are available at www.medicago.com or www.sedar.com.

About Medicago

Medicago is committed to provide highly effective and competitive vaccines based on proprietary Virus-Like Particle (VLP) and manufacturing technologies. Medicago is developing VLP vaccines to protect against pandemic and seasonal influenza and other indications, using a transient expression system which produces recombinant vaccine antigens in the cells of non-transgenic plants. This technology has potential to offer advantages of speed and cost over competitive technologies. It promises a vaccine for testing in about a month after the identification and reception of genetic sequences from a pandemic strain. This production time frame has the potential to allow vaccination of the population before the first wave of a pandemic strikes and to supply large volumes of vaccine antigens to the world market. Additional information about Medicago is available at www.medicago.com.

Forward Looking Statements

This news release includes certain forward-looking statements that are based upon current expectations, which involve risks and uncertainties associated with Medicago's business and the environment in which the business operates. Any statements contained herein that are not statements o historical facts may be deemed to be forward-looking, including those identified by the expressions "anticipate", "believe", "plan", "estimate", "expect", "intend", and similar expressions to the extent they relate to Medicago or its management. The forward-looking statements are not historical facts, but reflect Medicago's current expectations regarding future results or events. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations, including the matters discussed under "Risks Factors and Uncertainties" in Medicago's Annual Information Form filed on March 31, 2011 with the regulatory authorities. Medicago assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

SOURCE Medicago Inc.

Sinovac Selected by Beijing CDC to Supply Seasonal Influenza Vaccine Anflu(R) to Beijing Citizens

Thu, 13 Oct 2011 09:21:15 -0400

BEIJING, Oct. 13, 2011 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, announced today that it has been selected by the Beijing Centers for Disease Control and Prevention (Beijing CDC) as one of the four manufacturers to supply seasonal influenza vaccine to the citizens of Beijing for the fourth time.

Dr. Weidong Yin, Chairman, President and CEO of Sinovac, stated, "We are pleased to be chosen as one of the suppliers by the Beijing CDC for the seasonal flu vaccine campaign for the year of 2011. After the comprehensive evaluation of several different factors including product quality, service and price, Sinovac was selected for the fourth time, which further validates the high quality of our flu vaccine and our commitment to service as recognized by CDC customers. We look forward to working closely with the Beijing CDC to deliver our Anflu vaccine to the citizens under the vaccination campaign."

Starting in 2007, to prevent and control the seasonal flu, the Beijing CDC began purchasing the seasonal flu vaccines to immunize the elderly over 60 and the elementary and secondary school students in Beijing.

In 2011, the Beijing CDC plans to order a total of two million doses for this vaccination campaign. The total quantity to be supplied will depend on the actual demand in Beijing. In 2010, total about 269,000 doses of Anflu were inoculated to the target population for the vaccination campaign in Beijing. According to the Beijing Health Bureau's data as of November 30, 2010, approximately 1.6 million Beijing citizens were inoculated with the seasonal flu vaccines, inclusive of the target population covered by the free vaccination campaign.

About Sinovac

Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases including hepatitis A, seasonal influenza, H5N1 (bird flu) pandemic influenza and H1N1 influenza. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, PANFLU.1, and has received orders from the Chinese Central Government pursuit to the government stockpiling program. The Company is developing a number of new vaccine products, including vaccines for pneumococcal conjugate, enterovirus 71 (EV71) (against Hand, Foot & Mouth Disease), Japanese Encephalitis, animal and human rabies, HIB and epidemic meningitis, chickenpox, mumps and rubella. Its wholly owned subsidiary, Tangshan Yian, is focusing on the research, development, manufacturing and commercialization of animal vaccines, and has launched its internally developed inactivated rabies vaccine in China.

Safe Harbor Statement

This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words or phrases such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Among other things, the business outlook and quotations from management in this press release contain forward-looking statements. Statements that are not historical facts, including statements about Sinovac's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. Sinovac does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Helen Yang/Chris Lee
Sinovac Biotech Ltd.
Tel: +86-10-8279-9871/9659
Fax: +86-10-6296-6910
Email: ir@sinovac.com

Investors:
Stephanie Carrington
The Ruth Group
Tel: +1-646-536-7017
Email: scarrington@theruthgroup.com

Media
Victoria Aguiar
The Ruth Group
Tel: +1-646-536-7013
Email: vaguiar@theruthgroup.com

SOURCE Sinovac Biotech Ltd.

Fred Meyer to Offer Needle-Free Flu Vaccines for First Time

Wed, 07 Sep 2011 17:20:40 -0400

Select stores will use the Biojector® 2000 from Portland-based Bioject Medical Technologies Inc.

PORTLAND, Ore.--(BUSINESS WIRE)-- Fred Meyer customers now have a needle-free option to be immunized against the flu this fall. Most Fred Meyer stores in Alaska, Idaho, Oregon and Washington now have available traditional flu shots as well as a needle-free option that is manufactured by Portland-based Bioject Medical Technologies Inc.

Fred Meyer expects to immunize tens of thousands of customers in its stores during the 2011-2012 flu season, which can begin between October and December in the Northwest and run as late as May. According to the CDC, more than 160 million doses of flu vaccine were produced for last year’s flu season.

“While needle-free vaccines have been used in the past in some public agencies and the military, this is the first time this option has been available to the public through their pharmacies,” said Marc Cecchini, vice president and director of Pharmacy for Fred Meyer Stores. “This provides a great alternative for customers who are wary of needles but want to protect themselves against the flu.”

“The Biojector offers patients a safe, easy and convenient alternative to the needle and syringe for their annual flu shot,” said Dr. Richard Stout, executive vice president and chief medical officer of Bioject. “We are pleased that Fred Meyer has chosen to incorporate this in its 2011-2012 flu immunization program.”

The Biojector is a unique CO2 gas powered needle-free injector which can deliver medications or vaccines up to 1.0 ml in volume, either subcutaneously or intramuscularly, from a sterile single-use syringe. The system has three components: a durable injection device, a disposable needle-free syringe, and a CO2 cartridge. The plastic syringe is the only part of the system that comes in contact with the patient's skin. After each injection, the used syringe is discarded and a new one is inserted for the next injection.

About Fred Meyer Stores

Fred Meyer Stores, based in Portland, Ore., offers one-stop shopping at its 132 multi-department stores in four western states. Nearly 30,000 Fred Meyer associates help customers fill their food, apparel, and general merchandise needs in Alaska, Idaho, Oregon and Washington. Stores range in size from 65,000 to 230,000 square feet and carry more than 200,000 products under one roof. Additionally, Fred Meyer donates more than 4 million pounds of food to food banks in its four-state market and contributes more than $4 million to communities across the Northwest each year through grants from the Fred Meyer Foundation as well as product donations, cash donations and sponsorships. Fred Meyer Stores is a division of The Kroger Co. (NYSE: KR). For more information, please visit our Web site at www.fredmeyer.com

About Bioject

Bioject Medical Technologies Inc., based in Portland, Oregon, USA, is an innovative developer and manufacturer of needle-free injection therapy systems (NFITS). NFITS provide an empowering technology and work by forcing medication at high speed through a tiny orifice held against the skin. This creates a fine stream of high-pressure fluid penetrating the skin and depositing medication in the tissue beneath. Bioject is focused on developing mutually beneficial agreements with leading pharmaceutical, biotechnology, and veterinary companies, as well as research, global health and government organizations. For more information about Bioject, visit www.bioject.com.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6853535&lang=en

CONTACT:

Bioject Medical Technologies, Inc.
President and CEO
Ralph Makar, 503-692-8001 ext. 4137
or
Executive Vice President and Chief Medical Officer
Dr. Richard Stout, 503-692-8001 ext. 4130
or
Fred Meyer Stores
Director, Public Affairs
Melinda Merrill, 503-797-3830

KEYWORDS: United States North America Oregon

INDUSTRY KEYWORDS: Health Biotechnology Medical Devices Pharmaceutical Retail Supermarket

MEDIA:

Logo

Medicago announces 2011 second quarter financial results

Fri, 12 Aug 2011 18:20:42 -0400

QUEBEC CITY, QC, Aug. 12, 2011 /PRNewswire/ - Medicago Inc. (TSX: MDG), a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced its operational and financial results for the second quarter ended June 30, 2011. The Company's financial statements and management report are available at www.sedar.com and at www.medicago.com.

"During the second quarter, we made significant progress on the clinical advancement of our product pipeline. Our positive Phase II clinical trial results for our H5N1 vaccine candidate coupled with our positive U.S. Phase I clinical trial results for our seasonal vaccine candidate continue to demonstrate that our rapid plant-based vaccine technology produces VLP vaccines that are safe and among the most effective of the industry," said Andy Sheldon, President and CEO of Medicago. "The second half of 2011 will see the opening of our 97,000 square foot U.S. grade vaccine facility, the continued development of our seasonal flu vaccine candidate with a U.S. clinical trial, as well as the expansion of our product pipeline outside of influenza and potential contracts with governments and pharmaceutical companies."

Highlights:

Corporate

Reported positive phase II results for its clinical trial with its H5N1 avian influenza vaccine. The vaccine was found to be safe, well tolerated and also induced a solid immune response which is among the most effective of the industry.
Reported positive U.S. phase I results in its clinical trial with its H1N1 / seasonal influenza vaccine candidate. All tested doses were found safe and well-tolerated. A single dose of 5 μg met the 3 CHMP immunogenicity criteria.This phase I trial is expected to lead to Medicago's U.S. phase IIa trial for its seasonal trivalent vaccine with the recommended H1N1, H3N2 and B influenza strains.
Signed research collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) for the development of a VLP vaccine candidate for the prevention of Ebola.
Signed research collaboration with a top 10 global pharmaceutical company for the development of a non-influenza vaccine candidate.

Financial

Received the third milestone payment of $5.6 million (U.S.) from DARPA. This is part of the $21-million (U.S.) DARPA grant awarded to Medicago to demonstrate the scalable manufacturing of its plant-expressed virus-like particle vaccines in the United States under a technology investment agreement. Medicago has received $16.3 million (U.S.) to date for this project.
Closed an offering of 34,117,600 units at a price of $0.51 per unit, representing gross proceeds of $17,399,976. Each Unit is comprised of one common share and one quarter of one common share purchase warrant. Each full Warrant has an exercise price of $0.75, exercisable for a period of 24 months. Philip Morris Investments BV, an insider of the Company, participated in the offering and acquired 17,058,800 units.

Outlook

Upcoming milestones include among others:

Operational U.S. vaccine facility
Initiation of U.S. phase II clinical trial with trivalent seasonal vaccine if authorization granted by the FDA
Potential contracts with governments and pharmaceutical companies
Addition of new pipeline candidates

Financial Results

The Compay's unaudited interim consolidated financial statements as at June 30, 2011 and for the six months then ended have been prepared in accordance with IFRS as issued by the International Accounting Standards Board. Additionally, the Company's unaudited consolidated statement of financial position as at January 1, 2010 and the comparative unaudited consolidated financial statements for 2010 have been adjusted to reflect our adoption of IFRS on a retrospective basis, effective on January 1, 2010 (the "Transition Date"). Consequently, all comparative financial information presented in this MD&A reflects the consistent, retrospective application of IFRS.

For the three and six-month period ended June 30, 2011, the Company had revenues of $38,000 that were generated by the research collaboration agreement for the development of a non-influenza vaccine candidate with a top 10 global pharmaceutical company announced earlier this year. Revenues in 2010 were generated by the successful completion of the proof of concept contract with the United States Army Research, Development and Engineering Command for $34,000.

Consolidated loss for the three and six-month period ended June 30, 2011 were $4,883,000 and $9,934,000, or $0.03 and $0.06 per basic and diluted share compared to a loss of $3,998,000 and $7,741,000, or $0.03 and $0.07 per basic and diluted share for the three and six-month period ended June 30, 2010. Increase in the loss for the six month period is mainly explained by the increase in R&D expenses in relation with the H5N1 Phase II clinical trial and the H1N1/seasonal vaccine Phase I clinical trial.

Cash and short-term investments were $16.6 million as at June 30, 2011 an increase of $8.1 Million from December 31, 2010. In April 2011, Medicago closed an offering of 34,117,600 units at a price of $0.51 per Unit, representing gross proceeds of $17,399,976.

As at August 12, 2011, there were 173,416,202 common shares issued and outstanding as well as 8,539,508 stock options outstanding. Warrants outstanding and Unit options outstanding as at August 12, 2011 represented a total of 27,277,736.

About Medicago

Medicago is committed to provide highly effective and competitive vaccines based on proprietary Virus-Like Particle (VLP) and manufacturing technologies. Medicago is developing VLP vaccines to protect against pandemic and seasonal influenza, using a transient expression system which produces recombinant vaccine antigens in the cells of non-transgenic plants. This technology has potential to offer advantages of speed and cost over competitive technologies. It promises a vaccine for testing in about a month after the identification and reception of genetic sequences from a pandemic strain. This production time frame has the potential to allow vaccination of the population before the first wave of a pandemic strikes and to supply large volumes of vaccine antigens to the world market. Additional information about Medicago is available at www.medicago.com.

Forward Looking Statements

SOURCE Medicago Inc.

Medicago reports positive Phase II final results for its avian flu pandemic vaccine

Thu, 30 Jun 2011 08:22:27 -0400

- Phase II part B confirms results obtained in Phase II part A -

- Company's results continue to be amongst the best for influenza vaccine manufacturing technologies -

QUEBEC CITY, June 30, 2011 /PRNewswire/ - Medicago Inc. (TSX: MDG) a biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today reported positive final results from a Phase II human clinical trial with its H5N1 Avian Influenza VLP vaccine candidate ("H5N1 vaccine"). The vaccine induced a solid immune response and was found to be safe and well tolerated.

"These positive Phase II clinical trial results continue to demonstrate that our rapid plant-based vaccine technology produces VLP vaccines that are safe and among the most effective of the industry," said Andy Sheldon, President and CEO of Medicago. "Our Phase II part B data confirms the solid results obtained in Phase II part A for optimal dosing. In addition, our results demonstrated similar efficacy in the older and younger volunteer age groups which is a potential differential advantage over other technologies."

"We soon expect to have the capacity to commercially produce these vaccines as our U.S. vaccine facility in North Carolina will be operational this fall. In addition, we believe these results further support the effectiveness of our rapid plant-based vaccine platform and the development of our seasonal flu vaccine candidate which we intend to proceed with a U.S. clinical trial in the second half of the year," continued Mr. Sheldon.

Study Design

The Phase II study was designed to assess the immunogenicity, safety and tolerability of the Company's H5N1 vaccine candidate. The study was conducted in two parts. Part A of the study enrolled 135 healthy volunteers who received Medicago's vaccine at varying dosage levels or the placebo to determine the optimal dose. The volunteers received two doses 21 days apart and data was analyzed 21 days after the last dose. Part B of the study enrolled 120 additional healthy volunteers who were immunized with Medicago's vaccine at the optimal dose of 20 ug (104) or the placebo (16). These volunteers similarly received two doses 21 days apart with the data analyzed 21 days after the last dose.

Safety Results

The H5N1 vaccine has been tested in over 200 healthy volunteers to date, none of which have experienced any serious adverse reactions. Local site reactions were mild and the incidence of systemic side effects was comparable to those caused by the placebo. As planned in the clinical design, monitoring of adverse event will continue for six months.

Immunogenicity Results

The Phase II part B confirms the immunogenicity and safety results obtained in the Phase II part A for the 20 ug dose group and there were no statistical differences between the GMTs, seroconversion and seroprotection results of these two groups. In those vaccinated in the 18 to 49 age group with the 20 microgram dose, 77% of immunized subjects developed an immune response against the H5N1 virus after the second immunization, 50% of subjects had a four-fold increase in HI titers from baseline and 50% of subjects had seroprotective antibody titers. In those vaccinated in the 50 to 60 age group with the 20 microgram dose, 76% of immunized subjects developed an immune response against the H5N1 virus after the second immunization, 50% of subjects had a four-fold increase in HI titers from baseline and 50% of subjects had seroprotective antibody titers. These data show that Medicago's H5N1 vaccine induces a robust hemagglutination inhibition (HAI) antibody response against the H5N1 vaccine strain.

About Medicago's pandemic flu vaccine candidate

Medicago's H5N1 vaccine candidate was formulated to protect against the Indonesian influenza virus. It is manufactured in Nicotiana benthamiana, a relative of the tobacco plant, using the Company's proprietary VLP technology. VLPs may have several advantages over traditional flu vaccines. They are made to look like a virus, allowing them to be recognized readily by the body's immune system, however, they lack the core genetic material making them non-infectious and unable to replicate. Medicago's technology only requires the genetic sequence of a viral strain and not the live influenza virus. This key difference allows vaccines to be manufactured within four weeks of obtaining the genetic sequence of a pandemic strain. This is in contrast with current manufacturing technologies which rely on strain adaptation and can only deliver a vaccine six to nine months after a pandemic is declared.

About Medicago

Medicago is committed to provide highly effective and competitive vaccines based on proprietary Virus-Like Particle (VLP) and manufacturing technologies. Medicago is developing VLP vaccines to protect against H5N1 pandemic influenza, using a transient expression system which produces recombinant vaccine antigens in non-transgenic plants. This technology has potential to offer advantages of speed and cost over competitive technologies. It could deliver a vaccine for testing in about a month after the identification and reception of genetic sequences from a pandemic strain. This production time frame has the potential to allow vaccination of the population before the first wave of a pandemic strikes and to supply large volumes of vaccine antigens to the world market. Additional information about Medicago is available at www.medicago.com.

Forward Looking Statements

This news release includes certain forward-looking statements that are based upon current expectations, which involve risks and uncertainties associated with Medicago's business and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions "anticipate", "believe", "plan", "estimate", "expect", "intend", and similar expressions to the extent they relate to Medicago or its management. The forward-looking statements are not historical facts, but reflect Medicago's current expectations regarding future results or events. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations, including the matters discussed under "Risks Factors and Uncertainties" in Medicago's Annual Information Form filed on March 31, 2011 with the regulatory authorities. Medicago assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

SOURCE Medicago Inc.

NanoBio® Announces First Patients Vaccinated in Phase 1b Intranasal Influenza Vaccine Study

Tue, 21 Jun 2011 11:20:34 -0400

ANN ARBOR, Mich.--(BUSINESS WIRE)-- Building upon a series of successful preclinical and clinical studies, NanoBio Corporation today announced the initiation of a second tolerability and immunogenicity study designed to test and further optimize its novel nanoemulsion-based intranasal vaccine adjuvant.

In 2009, NanoBio tested its nanoemulsion adjuvant in combination with the commercial influenza vaccine Fluzone®, in a first-in-man Phase 1a study of 199 healthy adults. The intranasal nanoemulsion vaccine was well tolerated in the study and elicited both mucosal and systemic immune responses after a single administration by dropper.

In the current Phase 1b study, the nanoemulsion adjuvant will again be combined with Fluzone®, and will be administered by both a sprayer device and a dropper to study the potential impact on immune response. The sprayer device will be tested using two different volumes of the vaccine. Mucosal, systemic humoral and cellular-mediated immune responses will be examined in all subjects.

Ali I. Fattom, Ph.D., Senior Vice President Vaccine Research and Development, commented, “We were pleased with the safety outcome and adjuvant effect of our novel NanoStat® technology observed in our previous first-in-man clinical trial. Data generated in the current study will be important for the advancement of the nanoemulsion adjuvant for NanoBio’s flu vaccine as well as vaccines we are developing for RSV, UTI and several other diseases.”

About NanoBio’s Vaccine Platform

NanoBio’s nanoemulsion-based, intranasal vaccines have elicited robust immune responses in animals vaccinated against seasonal and pandemic influenza, hepatitis B, RSV, HIV, pneumococcus, anthrax, smallpox and other diseases. The company’s NanoStat™ adjuvant platform technology has demonstrated numerous potential advantages over traditional vaccines, including: the ability to generate robust mucosal, systemic and cellular immunity; antigen-sparing qualities; cross-protection against strains not contained in the vaccine; ability to adjuvant multiple antigen types without inducing inflammation; thermally stabilizing the vaccine; and removing the need for needles.

About NanoBio

NanoBio® Corporation is a privately-held biopharmaceutical company focused on developing and commercializing dermatological products, anti-infective treatments and intranasal vaccines derived from its patented NanoStat® technology platform. The company’s lead product candidates are treatments for herpes labialis (licensed to GSK in the U.S. and Canada), onychomycosis, acne, cystic fibrosis and a broad platform of intranasal vaccines. The company’s headquarters and laboratory facilities are located in Ann Arbor, Michigan.

Fluzone® is a registered trademark of Sanofi Pasteur, Division of the sanofi-aventis Group.

CONTACT:

NanoBio Corporation
John F. Coffey, Jr., 734-302-4000, ext. 107
Direct: 734-302-9107
Fax: 734-302-9150
www.nanobio.com
or
Schwartz Communications
Stacey Holifield/Brianne Donahue, 781-684-0770 (Media)
nanobio@schwartzcomm.com

KEYWORDS: United States North America Michigan

INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical

MEDIA:

VaxInnate Awarded Contract by the U.S. Government To Develop Recombinant Seasonal and Pandemic Flu Vaccines

Tue, 01 Mar 2011 08:20:43 -0500

Potential Value of Contract as High as $196 Million

CRANBURY, N.J.--(BUSINESS WIRE)-- VaxInnate Corporation today announced that it has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), worth up to $196 million to fund the development of recombinant seasonal and pandemic flu vaccines. VaxInnate is a biotechnology firm pioneering breakthrough technology for use in developing novel vaccines.

Next-Generation Flu Vaccines -- Dr. Alan Shaw (left) and Dr. Thomas Hofstaetter of VaxInnate discuss a federal contract the company was awarded for development of recombinant seasonal and pandemic flu vaccines. The contract is valued at up to $196 million over five years. Dr. Shaw is Chief Scientific Officer and Dr. Hofstaetter is CEO of the Cranbury, NJ-based biotech company. (Photo: Business Wire)

The contract initially provides funding of $118 million for a base period of 36 months, with an option to extend for 24 months. The contract is effective on February 24, 2011.

“We’re pleased and gratified to receive this award and look forward to working with BARDA to develop the next generation of vaccines for the prevention of seasonal and pandemic flu,” said Thomas Hofstaetter, PhD, President and CEO of VaxInnate. “The contract is an endorsement of VaxInnate’s proprietary technology, which makes it possible to produce hundreds of millions of doses of safe, effective flu vaccine rapidly and at low cost. It also demonstrates the potential of our technology to meet other critical and emerging public health threats in the future.”

Initial clinical trials will evaluate the components and combinations of what will ultimately be several different pandemic flu vaccines and a seasonal quadravalent flu vaccine, produced using VaxInnate’s proprietary technology. The technology involves genetically fusing vaccine antigens to the bacterial protein flagellin, a potent stimulator of the innate immune system.

VaxInnate has already completed a series of Phase I/II trials using VAX 125 and VAX128, prototype vaccines for both seasonal and pandemic Type A1 flu vaccines. The most recent trial assessed the safety and immunogenicity of three different forms of the VAX128 vaccine in several hundred healthy adults aged 18-49 and more than 100 community-living adults ≥ 65 years of age in the United States. VAX128 was demonstrated to be highly immunogenic at low doses (1-2.5 µg) and well tolerated up to 20-µg doses.

Further, the trial confirmed the safety and efficacy of the vaccine forms in elderly subjects, who are less responsive to flu vaccines due to the effects of aging on the immune system. People aged 65 and older, a population segment that is growing rapidly as baby-boomers age, suffer disproportionately from seasonal flu and its complications.

About VaxInnate

VaxInnate is a privately-held biotechnology company in Cranbury, NJ that is pioneering breakthrough technology for use in developing novel and proprietary vaccines. VaxInnate’s proprietary technology -- based upon recombinant fusion molecules that combine the vaccine antigen with a potent immune stimulator, the toll-like receptor 5 (TLR-5) agonist flagellin -- conveys significant speed, cost and volume advantages, making it capable of producing hundreds of millions of vaccine doses in just three months.

VaxInnate’s vaccines focus on infectious diseases, including seasonal and pandemic flu, malaria, and dengue. VaxInnate has generated positive Phase I and Phase II clinical data for its first three vaccines, a universal flu vaccine and prototype seasonal and pandemic flu vaccines, the last two of which demonstrated superior efficacy in elderly subjects. For more information about VaxInnate, please visit http://www.vaxinnate.com.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6629569&lang=en

CONTACT:

VaxInnate
Janet Skidmore, 215-658-4915
Mobile: 215-429-2917
skidmorecomm@earthlink.net

KEYWORDS: United States North America New Jersey

INDUSTRY KEYWORDS: Health Biotechnology Infectious Diseases Pharmaceutical Research Science

MEDIA:

Logo

Photo