adjuvant

Feds ok Iomai Phase II adjuvant patch study

Wed, 16 Apr 2008 06:59:54 -0400

Health and Human Services is giving Iomai the green light to do a mid-stage dose ranging study of its adjuvant patch for bird flu vaccine. HHS provided a $128 million contract backing Iomai's effort last year, and was rewarded with dramatic Phase I/II data on its ability to boost the effectiveness of bird flu vaccine.

The U.S. government, like other governments around the world, has been stockpiling vaccine to fight a potential pandemic. Iomai's patch worked well enough to provide protection to many people after a single dose, rather than the two usually required. That would allow physicians to stretch available vaccines over a much larger population on a much quicker basis.

"The Iomai immunostimulant patch has the potential to change how we react to an influenza pandemic, and we will move ahead quickly with the development of this technology," said Iomai CEO Stanley C. Erck. "Based on the data from this new Phase II study, Iomai and HHS will evaluate whether to proceed next with a pivotal Phase III trial."

- here's the press release

ALSO: South Korea has mobilized troops to help fight the spread of H5N1 in poultry. Report

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ALSO NOTED: Visiomed, Clinical Cell Culture to merge; Genzyme wants to reopen merger vote; Vical touts adjuvant data; and much

Wed, 10 Oct 2007 06:59:50 -0400

> Visiomed Group and Clinical Cell Culture are merging into a $27 million biotech company. Release

> Bioenvision and Genzyme want to reopen the vote on a proposed merger, despite the opposition of a big shareholder. Release

> Vical announced that data from a study in mice demonstrated the potential of its patented Vaxfectin adjuvant to be used as a dose-sparing agent with a protein-based H5N1 pandemic influenza vaccine. Release

> Roche is still confident that the company's $3 billion takeover bid for Ventana will be accepted. Report

> What do you call a migraine drug that could help alcoholics quit drinking? A big-time marketing opportunity--if it weren't going off patent next year. Report

> Say the Pfizer/Sanofi-Aventis rumors are true: Would merging with the French drug maker boost Pfizer's fortunes? Not so much, say some observers. Report

And Finally... A team of Australian scientists has found an enzyme in diabetics that prevents them from producing insulin. Report

Press Release: Novartis Gains Access to Intercell's Key Technologies and Vaccines Programs

Maureen Martino — Mon, 02 Jul 2007 12:30:08 -0400

Novartis Enhances Its Vaccine Pipeline by Gaining Access to Intercell's Key Technologies and Vaccines Programs

> Comprehensive alliance broadens Novartis Vaccines portfolio by providing continuous access to more than 10 Intercell projects in preclinical and early-stage development for upfront payment of EUR 270 million, including equity investment
> Eligible candidates include IC43 for prevention of hospital-acquired pseudomonas infections and IC47 for prevention of pneumonia infections
> Alliance expands Novartis leadership in adjuvanted vaccines through exclusive rights to further develop IC31 adjuvant in influenza - designed to enhance effectiveness
> Novartis to assume responsibility for Phase III development, manufacturing and commercialization for any projects chosen after Phase II trials

BASEL, Switzerland, July 2, 2007 - Novartis and Intercell AG have formed one of the vaccines industry's most comprehensive and innovative strategic alliances, combining the research, development, manufacturing and commercialization capabilities of Novartis with Intercell's unique research skills and highly-respected pipeline.

Several unpartnered projects in the existing Intercell R&D portfolio, which currently includes more than 10 potential projects for which Novartis may choose for further development, will further strengthen the efforts of Novartis to building a broad range of vaccines to prevent life-threatening viral and bacterial diseases as well as strengthen its range of influenza vaccines.

Novartis has also secured opt-in rights to all future vaccine candidates discovered by Intercell during the long-term collaboration. The Austrian biotechnology company is focused on novel vaccines for prevention and treatment of infectious diseases with substantial unmet medical need.

"This novel alliance will further leverage the potential of various Intercell vaccine candidates with the research, development, manufacturing and commercialization expertise of Novartis," said Jörg Reinhardt, CEO of Novartis Vaccines and Diagnostics. "We are pleased to have reached this alliance with Intercell, which shares our vision of science in vaccines and is widely regarded as having one of the most innovative pipelines."

Among the various Intercell projects eligible to Novartis are the IC43 vaccine candidate for use in patients with hospital-acquired pseudomonas infections, which is now in Phase II trials and will expand the range of nosocomial vaccines in the Novartis pipeline, and the pre-clinical vaccine IC47 against pneumonia infections in the elderly and infants.
Pseudomonas is a life-threatening infection considered the fourth most common nosocomial pathogen and accounts for at least 10% percent of all hospital-acquired infections - particularly in burn victims, according to the US Centers for Disease Control and Prevention (CDC). IC47 is a next-generation vaccine in development for the prevention of diseases related to streptococcus pneumoniae, such as pneumonia or otitis media (ear infection).

This new collaboration with Intercell comes after Novartis signed in 2006 a marketing and distribution agreement with Intercell for IC51, a new vaccine currently in Phase III trials for use in preventing infections from the Japanese Encephalitis virus.

The alliance will specifically focus on the development of vaccines derived from Intercell's Antigen Identification Program (AIP), including IC31 adjuvant technology in selected areas. Intercell's AIP approach is complementary to the Reverse Vaccinology system used by Novartis, which selects vaccine candidates based on highly conserved antigen sequences.

Intercell has responsibility for all costs through the end of Phase II clinical trials, while Novartis will assume responsibilities for Phase III development, manufacturing and commercialization for any projects chosen during the collaboration.

Novartis has also gained exclusive rights to further develop the next-generation IC31 adjuvant for use in enhancing the effectiveness of influenza vaccines. An influenza vaccine formulated with this adjuvant began Phase I trials in June 2007. Rights have also been gained to develop IC31 in other disease areas.

The development of IC31 in influenza vaccines will further strengthen the leadership of Novartis in adjuvant technology. Novartis has the proprietary adjuvant MF59, which has been shown in influenza vaccines to boost the body's immune system and enhance protection with a lower dose of a viral antigen than other vaccines.

The complementary research approaches of both companies will also allow for the combination of various research efforts to leverage existing assets in key areas, including efforts to develop therapeutic vaccines for patients infected with the Hepatitis C virus.

Financial terms of the agreement
Novartis will make an upfront payment of EUR 270 million to Intercell for exclusive opt-in rights for any existing unpartnered vaccine project or any future projects following the completion of Phase II clinical trials. This upfront payment includes the purchase of 4.8 million new Intercell shares at a premium to the market price, which will increase the equity stake in Intercell to 16.1% from the current 6.1% acquired at the time of the IC51 vaccine agreement in 2006. The agreement is subject to customary regulatory approvals, including in the United States.

About Novartis
Novartis Vaccines and Diagnostics is a division of Novartis focused on the development of preventive treatments and tools. The division has two activities: Novartis Vaccines and Chiron. Novartis Vaccines is the world's fifth-largest manufacturer and second-largest supplier of influenza vaccines in the US. The division's products include influenza, meningococcal, pediatric and travel vaccines. Chiron, the blood testing and molecular diagnostics business, is dedicated to preventing the spread of infectious diseases through the development of novel blood-screening tools. For more information, please visit http://www.novartisvaccines.com

Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative-products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world.

For more information, please visit http://www.novartis.com

Disclaimer
This release contains certain forward-looking statements, relating to the Novartis Group's business, which can be identified by the use of forward-looking terminology such as "will pay," "will increase," "will allow," "prevent," "leverage," or similar expressions, or by express or implied discussions regarding potential development, marketing approvals, commercialization or indications or future sales of IC31, IC43 and IC47. Such forward-looking statements reflect the current views of Novartis regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with IC31, IC43, IC47 and other potential vaccine development candidates from Intercell to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that IC31, IC43, IC47 or any other potential vaccine candidates will be approved for any indications in any market or that these vaccines will reach any particular sales levels. In particular, management's expectations regarding these vaccines and/or the proprietary cell culture technology of Novartiscould be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including additional analysis of existing clinical data and new clinical data; competition in general; the ability of Novartis to obtain or maintain patent or other proprietary intellectual property protection; increased government, industry, and general public pricing pressures; and other risks and factors referred to in the Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

Press Release: GlaxoSmithKline initiates head-to-head study of cervical cancer vaccines

Maureen Martino — Thu, 18 Jan 2007 13:54:50 -0500

GlaxoSmithKline initiates head-to-head study of cervical cancer vaccines

Study to compare immunogencity of GSK’s cervical cancer candidate vaccine, CERVARIX® , to Merck’s Gardasil®

London, UK & Philadelphia, PA - GlaxoSmithKline announced today the initiation of the first study of its kind designed to compare the immunogenicity of its cervical cancer candidate vaccine, CERVARIX®, versus Gardasil®. The primary objective of the head-to-head trial is to compare the immune responses to HPV types 16 and 18 in U.S. women 18 to 26-years-old. Secondary objectives include evaluating the immune responses to HPV 16 and 18 in women 27 to 35-years-old and 36 to 45-years-old. In addition, the study will compare immune responses to other cancer-causing HPV types. Initial study results are anticipated 12 months after studyenrollmentis completed, and extended follow up will continue for another 17 months.

"Vaccination to prevent cervical cancer may be the most significant healthcare breakthrough for women in our lifetime,” said Dr. Mark M. Blatter, Medical Director of Primary Physicians Research in Pittsburgh, PAand study investigator. “This unprecedented trial, which willenrollmore than 1,000 women,will provide the first scientific evidence to demonstrate how the two vaccines differ with respect to inducing strong and sustained immune responses in women who may be appropriate for vaccination.”

Data published in Vaccine in August 2006 demonstrated GSK’s cervical candidate vaccine, formulated with the proprietary adjuvant system AS04, induced higher antibody levels and more robust immune memory response compared to the same HPV vaccine composition conventionally formulated with aluminium hydroxide adjuvant alone. Furthermore, data published in The Lancet in April 2006 provided evidence that GSK’s cervical cancer candidate vaccine demonstrated protection up to 4.5 years against persistent infection with HPV 16 and HPV 18 — the two most common cancer-causing HPV types — and protection from pre-cancerous lesions. Protection was also demonstrated against infection with the third and fourth most prevalent cancer-causing types of HPV, namely types 45 and 31. Collectively, HPV types 16, 18, 45 and 31 are responsible for approximately 80 percent of cervical cancer cases globally.

“GSK is focused on protecting women from cervical cancer, a devastating disease that often strikes women in the prime of their lives,” said Gary Dubin, Vice President, HPV Vaccines, GlaxoSmithKline. “By conducting this study, we hope to further the scientific understanding of the role of strong and sustained immune responses to HPV vaccination for the benefit of all women.”

Notes to editors:

About the Study

This is a Phase III, randomized, observer-blind, multicenter study, to be conducted among 1,042 patients in the United States. There will be two arms of the study, one arm receiving GSK’s cervical cancer candidate vaccine, one arm receiving Gardasil®, and each arm will be stratified by age (18-26 [n=374], 27-35 [n=334], 36-45 [n=334]). The primary objective of the study is to compare GSK’s cervical cancer candidate vaccine to Gardasil®, in terms of immune responses to the two most common cancer-causing HPV types 16 and 18, which are responsible for at least 70 percent of all cervical cancers worldwide, in adult women aged 18 to 26. Secondary objectives will assess immune responses to cancer-causing HPV types 16 and 18 in adult women aged 27 to 35, and 36 to 45 as well as evaluate immune responses to other cancer-causing HPV types. Results are expected 12 months after patient enrollment is complete, with extended follow up continuing for approximately 17 months after the last study visit (month 7 through month 24).

About Cervical Cancer

The American Cancer Society estimates that in 2006, nearly 10,000 women were diagnosed with cervical cancer and nearly 4,000 died from this disease in the Unites States in a single year. After breast cancer, cervical cancer is the second most frequently occurring cancer in women ages 20 to 39 in the United States.

About GlaxoSmithKline’s Cervical Cancer Candidate Vaccine

GSK’s cervical cancer candidate vaccine was developed to prevent infection and lesions from the two most prevalent cancer-causing types of HPV, specifically HPV 16 and 18. It is formulated with the proprietary adjuvant system, AS04, selected to ensure that this vaccine confers strong and sustained antibody levels over time.

More than 16,000 women worldwide have been vaccinated with GSK’s cervical cancer candidate vaccine as part of completed and ongoing clinical trials.Phase III studies are under way in more than 25 countries with more than 35,000 subjects enrolled in ongoing trials.

GSK plans to file a biologics license application for CERVARIX® for U.S. Food and Drug Administration review by April 2007 for its cervical cancer candidate vaccine. The company submitted a marketing application review to the European Agency for the Evaluation of Medicinal Products in March 2006. Other international regulatory filings followed in Australia, parts of Asia and parts of Latin America in March 2006.

About GlaxoSmithKline

In the next two to five years, GSK expects to launch more major new vaccines in the United States, for example, a vaccine against rotavirus, an improved flu vaccine for the elderly and a meningitis combination vaccines for various ages, including infants.

GlaxoSmithKline–one of the world’s leading research-based pharmaceutical and healthcare companies–is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, please visit www.gsk.com.

GSK Biologicals (GSK Bio), one of the world’s leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline’s activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2005, GSK Bio distributed more than 1.2 billion doses of vaccines to 165 countries in both the developed and the developing world, an average of more than 3 million doses per day.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the ‘Operating and Financial Review and Prospects’ in the company's Annual Report on Form 20-F for 2005.

Press Release: GSK Awarded $63 Million HHS Contract for Pandemic Vaccine Research and Development

Maureen Martino — Wed, 17 Jan 2007 12:38:17 -0500

GlaxoSmithKline Awarded $63 Million HHS Contract for Pandemic Vaccine Research and Development

Company Begins Government and Retail Shipments of its Antiviral Relenza(R)
PHILADELPHIA, Jan. 17 -- GlaxoSmithKline, one of the world's largest vaccine manufacturers, has been awarded a contract from the U.S. Department of Health and Human Services (HHS) for the development of pre-pandemic and pandemic flu vaccines. With a value of at least $63.3 million, the contract supports GSK's ongoing pandemic vaccine research in using the company's innovative adjuvant technology in combination with antigens to induce a strong immune response.
Under the terms of the contract, GSK will engage in research and development leading towards licensure of antigen-sparing pre-pandemic and pandemic vaccines with adjuvant that will help the U.S. Government extend the limited North American supply of pandemic flu vaccines to protect larger populations in the event of a flu pandemic. The 5-year contract also gives the U.S. Government the option to fund an additional $44 million of future clinical development programs related to antigen-sparing pandemic vaccines.
"A limited global supply capacity of flu antigen makes it critical that we use innovative adjuvant system technology to produce a new generation of flu pandemic vaccines," said David Stout, President of Pharmaceuticals at GlaxoSmithKline. "GSK's research in adjuvant technology over the past two decades uniquely positions our company to develop adjuvants designed to boost immune response and give broader protection while using smaller amounts of antigen. This award leverages our adjuvant expertise, and supports GSK's short and long-term vision of helping governments around the world in their pandemic preparedness efforts."
In a separate action related to pandemic preparedness GSK also announced that the company has begun shipping up to 15.5 million treatment courses of its antiviral Relenza® (zanamivir for inhalation). The Relenza shipments are part of GSK's agreement with the Federal Government announced last year to provide the U.S. Government and the states with Relenza for building their flu pandemic stockpiles. GSK also has started to ship Relenza to retail pharmacies to fulfill patient prescriptions for seasonal flu treatment and prevention.
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and health care companies, and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: http://www.gsk.com.
About GSK Biologicals
GSK Biologicals, based in Rixensart, Belgium, is the vaccine division of GlaxoSmithKline. As one of the world's leading vaccine manufacturers, GSK Biologicals employs more than 1,500 scientists devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems.
GSK's 2005-2007 Milestones in Pandemic Preparedness
January 2007: GSK begins supplying its antiviral Relenza® zanamivir for inhalation), to the U.S. Government and begins working with private-sector businesses and other organizations to provide Relenza as part of their business continuity planning.

December 2006: GSK received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use CHMP) for its candidate alum-adjuvanted pandemic vaccine. GSK plans to submit a file to the European regulatory authorities in the coming weeks for the licensing of both a pandemic and a pre-pandemic vaccine with our proprietary adjuvant system technology.

November 2006: GSK received a $40 million initial order for bulk H5N1 antigen from HHS.

2006: GSK signs contracts with several countries for pre-pandemic vaccines.

September 2006: GSK reached an agreement with the Simcere Pharmaceutical Group of Nanjing, China, granting the right to manufacture and sell the antiviral influenza treatment zanamivir in China, Indonesia, Thailand, Vietnam and all Least Developed Countries.

July 2006: Clinical studies announced by GSK showed promising preliminary results on the potential immunogenicity of a vaccine for pandemic flu using a GSK novel proprietary adjuvant system.

May 2006: GSK received an award of $274 million to develop cell-culture technology to speed the development of new cell-culture-based seasonal and pandemic influenza vaccines scale-up cell-culture manufacturing capability at GSK's Marietta, PA site.

2005: GSK made three important acquisitions in North America: a vaccine manufacturing site in Marietta for cell-culture-based flu vaccines and secondary operations; Corixa Corporation, for its work in developing innovative adjuvants designed to stimulate immunity; and ID Biomedical, which offered a significant increase in flu vaccine manufacturing capacity to help address both seasonal and pandemic influenza threats.

Press Release: Juvaris BioTherapeutics Announces First Round Closing Of Series A Financing

Maureen Martino — Tue, 09 Jan 2007 10:46:39 -0500

Juvaris BioTherapeutics Announces First Round Closing Of Series A Financing

PLEASANTON, Calif., Jan. 8 -- Juvaris BioTherapeutics, a private company, today announced it has closed the first of two rounds of a Series A financing with a $6 million investment from Kleiner Perkins Caufield & Byers Pandemic & Biodefense Fund. The second closing will occur within 120 days from the date of the first closing, bringing the total Series A Round to $12 million.

The funds will enable the Company to advance its lead vaccine products for influenza and pneumonia indications to clinical trials. The Company will also pursue immunotherapy products for Hepatitis B and Biodefense applications. The funds permitted the Company to close asset purchase agreements negotiated with Valentis. The purchased assets include relevant intellectual property that had been the subject of a worldwide exclusive license and a fully operational 10,800 sq. ft. manufacturing plant in Burlingame, CA. As part of this transaction, Juvaris has hired seven former Valentis employees engaged in production and QA/QC activities.

In commenting on the investment, Juvaris Co-Founder, Chairman, and CEO Martin D. Cleary said, "There could not have been a more favorable outcome for our program, employees and shareholders than to have KPCB take this investment interest in Juvaris. Their long-term view and willingness to help guide our strategic direction has already made a major contribution to our effort. Together we will build a very successful company."

In commenting for the KPCB Pandemic & Biodefense Fund, Partner Thomas P. Monath M.D. recently appointed to Juvaris' Board of Directors said, "The Juvaris team has done a superb job of demonstrating the potential of their proprietary adjuvant and immunotherapeutic platform for multiple disease targets. With the acquisition of manufacturing assets from Valentis, the Company can now rapidly progress to clinical proof of concept."

About Juvaris

Juvaris BioTherapeutics was created in 2003 to develop an immunotherapeutic product platform for the treatment of infectious diseases and cancers using lipid-DNA complexes. Cationic lipids are formulated with non-coding DNA (plasmid) to create the JuvImmune Immunostimulant, a lipid-DNA complex, which as a single product will have utility in multiple infectious disease and cancer applications. The JuvImmune product has been shown to be at least 50-times more potent at triggering innate immune activation and interferon release than current immune stimulants.

When combined with disease-specific antigens, the technology creates JuvaVax vaccines capable of activating substantial antibody- and cell-mediated immune responses, particularly induction of cytotoxic T lymphocytes (CTL). Immunological responses elicited by the lipid-DNA complexes have been successfully demonstrated in both prophylactic and therapeutic settings in a variety of mammals including rodents, rabbits, cats, dogs and non-human primates. Moreover, substantial immune responses have been induced following oral and intranasal administration. This platform provides the opportunity to develop many disease-specific immunotherapy products, for which there are significant unmet medical needs.

In January 2006, the Company announced the award of a two-year Small Business Technology Transfer (STTR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) of the NIH for the development of an influenza A virus vaccine. In March 2006, the Company announced the award of an 18-month Small Business Innovation Research-Advanced Technology (SBIR-AT) grant from NIAID for the development of an HIV vaccine, and in September 2006, the Company announced the award of a two-year biodefense SBIR grant from NIAID for the development of an immunotherapeutic treatment for Tularemia. Recently, the Company announced the award of an SBIR grant from the National Cancer Institute for the development of a vaccine for leukemia.

About Kleiner Perkins Caufield & Byers

Since its founding in 1972, Kleiner Perkins Caufield & Byers has backed entrepreneurs in 475 ventures, including AOL, Align, Amazon.com, Citrix, Compaq Computer, Electronic Arts, Genentech, Genomic Health, Google, Hybritech, IDEC Pharmaceuticals, Intuit, Juniper Networks, Netscape, Lotus, Nuvasive, Sun Microsystems, Symantec, Verisign and Xilinx. KPCB portfolio companies employ more than 250,000 people. More than 150 of the firm's portfolio companies have gone public. Many other ventures have achieved success through mergers and acquisitions. KPCB has broadly invested in both life sciences and information technology since inception in 1972. In the last six years, KPCB has expanded its focus to include Greentech and pandemic preparedness.

Company Contact: Martin D. Cleary Juvaris BioTherapeutics, Inc. 925.399.6200 mdcleary@juvaris.com

Juvaris BioTherapeutics
CONTACT: Martin D. Cleary of Juvaris BioTherapeutics, Inc.,+1-925-399-6200, mdcleary@juvaris.com

Bird flu vaccine effective in animal trial

Thu, 19 Oct 2006 20:01:34 -0400

Vical says its bird flu vaccine proved 100 percent effective in protecting ferrets from bird flu. Vical announced earlier that two doses of DNA vaccine was effective in protecting mice and ferrets. Vical's vaccine candidate is mixed with Vaxfectin adjuvant and viral proteins. Vical says it wants to begin human trials as soon as possible.

- here's the AP report on Vical

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Sanofi vaccine effective against new bird flu strains. Report
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Low-dose bird flu vaccine effective in trial. Report

Low-dose bird flu vaccine effective in trial

Wed, 06 Sep 2006 20:01:37 -0400

China's Sinovac Biotech says that its low-dose bird flu vaccine proved effective in generating an immune response from 80 percent of the 120 volunteers taking part in the trial. The vaccine was developed by using a part of the whole H5N1 virus and combining it with an adjuvant that increases the potency of the therapy. Researchers have been scrambling to find a low-dose vaccine that might work against bird flu. A low-dose vaccine would make it possible to produce enough vaccines to vaccinate large numbers of people.

- read the article on the vaccine from The International Herald Tribune

ALSO: An Indonesia teenager has died from bird flu, bringing the country's death toll to 47. Report

ALSO NOTED: Takeda, Galaxy Biotech ink licensing deal; Protalex raises $15.2M in private placement; and much more...

Sun, 09 Jul 2006 20:00:50 -0400

> Antigenics has expanded its licensing and supply deals for QS-21 Stimulon adjuvant with a vaccine division of GlaxoSmithKline. Release

> New Hope, PA-based Protalex has raised approximately $15.2 million in a private placement of 6.1 million shares of common stock. Release

> BioSante Pharmaceuticals announced a $7.6 million private placement. Release

> Takeda has signed an agreement to develop, manufacture and sell Galaxy Biotech's monoclonal antibody and will earn additional payments if the drug reaches certain milestones. Report

> AnorMED has completed enrollment in two Phase II trials for Mozobil for stem cell transplant. Release

And Finally... Florida's Supreme Court has ruled that pharmacists are responsible if a patient is harmed by a prescription drug combination. Report

GSK upbeat on bird flu vaccine trials

Thu, 30 Mar 2006 19:01:37 -0500

The race for a new vaccine to fight a human outbreak of H5N1 has heated up as GlaxoSmithKline says it has begun human trials of two experimental bird flu vaccines. Researchers have made this new vaccine with an that boosts the vaccine's effectiveness. It is also boosting the hopes of GSK researchers, who believe that the new vaccines may be much more effective at combating bird flu than a competing vaccine that is being advanced by Sanofi-Aventis. Sanofi researchers said earlier this week that their vaccine has proven effective in only its highest dose for half of the patients taking it. GSK believes the adjuvant may also play a major role in making the vaccine effective for slightly evolved viruses.

- here's the Boston Globe article for more

FDA approves Halozyme's Hylenex to amplify drugs

Sun, 04 Dec 2005 19:01:38 -0500

The FDA has approved Halozyme Therapeutics' Hylenex recombinant (hyaluronidase human injection) for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs. "We are thrilled that the FDA has approved our first NDA filing," said Jonathan Lim, M.D., Halozyme's chairman and CEO.

- read this press release for more information

FDA warns ISTA on Vitrase ad

Thu, 03 Nov 2005 19:01:35 -0500

ISTA Pharmaceuticals received a letter from the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) concerning a journal advertisement for Vitrase, an adjuvant to increase the absorption and dispersion of other injected drugs. The DDMAC said the ad was misleading and did not mention the most common and serious side effects of taking the drug. The FDA demanded that ISTA retract the materials.

- read this press release for the full FDA letter

ALSO: At the American Academy of Ophthalmology annual meeting, ISTA presented phase 3 data that indicates Vitrase significantly improves vision in patients with vitreous hemorrhage and eye disease for which there is no treatment. Article