News

Epidemiologists fear monkeypox outbreak could spread

John Carroll — Thu, 02 Sep 2010 08:58:25 -0400

An outbreak of monkeypox has hit Central Africa, raising fears among U.S. epidemiologists that the once rare variation of smallpox and cowpox could erupt as a lethal new threat if it undergoes fresh mutations.

Monkeypox was virtually unheard of back in the 1970s, when global vaccination campaigns eradicated smallpox. However, in recent months, the Democratic Republic of Congo reported that new cases had multiplied by a factor of 20. The current strain in circulation is still typically not deadly, but that could change.

"Each infection gives the virus the opportunity to evolve into a more virulent variant," UCLA epidemiologist Anne Rimoin tells The Scientist. "We're worried about what could happen. This study is a warning bell."

Squirrels, rats, mice, shrews, the dormouse and primate species all carry the virus, which had evidently been kept in check by the smallpox vaccine, which is no longer in use. "It's only a matter of time that infected rodents are sold and distributed in larger cities," notes Rimoin.

- here's the article from The Scientist

Medicare's Provenge review comes into clearer focus

John Carroll — Thu, 02 Sep 2010 07:43:10 -0400

With billions in revenue at stake, every new twist and turn in the saga revolving around the rollout of Provenge gets put under the microscope. Any possibility of market restrictions, a fear raised by CMS's decision earlier in the summer to review Provenge's use in the elderly, is enough to panic investors. To some, it looked as if the agency was considering that it might not pay for Provenge at all.

So when Medicare announced earlier this week that it's scheduled a Nov. 17 advisory panel meeting to discuss the "labeled and unlabeled use of autologous cellular immunotherapy treatment on health outcomes of patients with metastatic prostate cancer," investors generally decided that Dendreon had dodged a bullet. TheStreet's influential Adam Feuerstein set the tone with a piece outlining the likelihood that Medicare is preparing to make sure that the patients OK'd for the $93,000 therapy look a lot like the patients picked for the late-stage registration trial. That still leaves Provenge poised to develop into a blockbuster, and Dendreon's shares jumped 6 percent.

Dendreon already has most of the carriers who manage each of Medicare's 15 regions on board to pay for the therapeutic vaccine. And there was never really any serious question that CMS would deny coverage altogether. They have never denied coverage of an approved therapy and only rarely go out of their way to draw a line around a drug's label, specifically excluding non-labeled use.

Just in case Medicare was considering stepping over the line, Sens. John Kerry and Arlen Specter waved them off in a recent letter expressing their concern. Patients and physicians have already made their feelings known to CMS. The events leave Provenge not just on track to blockbuster status, but politically connected as well. It doesn't get much better than that.

- read the report from TheStreet
- and here's the WSJ story
- check out the FiercePharma report

NIAID awards $46.3 million in vax grants and contracts

Erica Teichert — Wed, 01 Sep 2010 22:45:55 -0400

The National Institute of Allergy and Infectious Diseases (NIAID) has awarded two grants to vaccine makers for anthrax and hepatitis B vaccines, respectively. Emergent BioSolutions received a contract worth up to $28.7 million for its third generation anthrax vaccine. Dynavax Technologies, based in Berkeley, CA, received a portion of a five-year, $17.6 million grant.

Emergent's new contract expands upon development efforts being conducted under a contract awarded in September 2008. The featured vaccine in the deal is a combination of the company's BioThrax vaccine and immunostimulatory VaxImmune. With this new contract, the potential funding from the U.S. government for this third generation anthrax vaccine candidate increases to more than $58 million, according to a statement. Emergent has previously won contracts worth more than $400 million for its anthrax vaccines, but the program seemed to be in trouble recently as Congress considered axing $2 billion of Project Bioshield's $5.6 billion budget.

NIAID's other grant was awarded to Dr. Jacques Banchereau of the Baylor Institute of Immunology Research. Part of that grant will be spent on Dynavax Technologies' promising hepatitis B vaccine, Heplisav. After some initial issues, Heplisav has performed promisingly in trials.

"Heplisav...has already demonstrated an ability to protect certain patients, for example, the elderly and chronically ill who are normally less- or non-responsive to conventional vaccines," says Robert Coffman, Dynavax's chief scientific officer, in a release. "With this grant we have the opportunity to study the underlying mechanisms that affect a target population's ability to respond to immunization."

- read the Emergent release
- and here's the Dynavax announcement
- check out the Washington Business Journal's article

Panels in U.S., U.K. issue opposite rulings in vax-autism cases

Liz Jones Hollis — Wed, 01 Sep 2010 15:04:17 -0400

The U.S. Court of Appeals for the Federal Circuit has upheld a special vaccine court's decision denying a link between vaccines and autism in the case of Michelle Cedillo. Her parents had been seeking compensation on her behalf, alleging she suffered from autism and other medical conditions as a result of receiving a MMR vaccine together with thimerosal-containing vaccines. A special master denied the Cedillos' petition, and the court of federal claims affirmed.

"[W]e have carefully reviewed the decision of the Special Master and we find that it is rationally supported by the evidence, well-articulated, and reasonable," the court says in its decision, which came last Friday. "We therefore affirm the denial of the Cedillos' petition for compensation." The family told CNN that they are "extremely disappointed" by the decision. Her case was part of a group of disputes over whether there is a causal relationship between childhood vaccines and autism, the Examiner notes.

The Elizabeth Birt Center for Autism Law and Advocacy (EBCALA), which submitted an amicus brief on behalf of 23 civil society organizations urging the court to reverse the special master's decision, also disagreed with the decision. The group says it is now focused on Bruesewitz v. Wyeth, a case scheduled to be argued before the U.S. Supreme Court Oct. 6. This case, according to the group, will determine whether families may bring claims of vaccine design defect to regular civil courts after having first filed in the Vaccine Injury Compensation Program.

The question of whether vaccines cause autism has lingered for years. Those who say there is no link seemed to get a win earlier this year when the Lancet formally retracted the report Dr. Andrew Wakefield authored 12 years ago that ignited the firestorm. And while the U.S. federal court found in favor of their position, a U.K. panel recently found in favor of a patient who alleged vaccines had caused him harm, the Telegraph reports.

Robert Fletcher, who is now 18, was a healthy 13-month-old baby when he received the MMR vaccine. He now suffers from frequent seizures, is incontinent and cannot care for himself. Although the Department of Health denied any link between his disabilities and vaccine, a medical assessment panel has determined his disabilities are a direct result of the MMR shot. He was been awarded £90,000 ($139,100).

Experts are speculating that the ruling in the Fletcher case could open the floodgates for other cases. "One case like this makes other people think that they will be able to get a similar ruling. In the past, when there has been a first ruling of this kind, it has opened the door to others," Malcolm VandenBurg, a medical legal authority, explains. However, a DOH spokesperson says the decision "reflects the opinion of a tribunal on the specific facts of the case and they were clear that it should not be seen as a precedent for any other case," the BBC reports.

- check out EBCALA's statement
- see the ruling here
- get more from CNN
- read the Examiner's coverage
- here's the Telegraph report
- get more from the BBC

Bill Gates on vaccines: "Our investment is mind-blowing"

John Carroll — Thu, 26 Aug 2010 10:16:10 -0400

In a recent interview with Technology Review, billionaire philanthropist Bill Gates explains his vaccine development strategy, noting he has enough money to make a market where none exists naturally.

"Like malaria: rich people don't need a malaria vaccine," says Gates. "They are rarely in malarial areas, and when they are, they can take prophylactic drugs and not worry about it. And yet for the people who live there, over a million a year, mostly kids in Africa, die. When we did our first $50 million grant for malaria, about a decade ago, we more than doubled the amount of money going into malaria research at the time. It's a horrific disease, but there's not a market reward for coming up with a malaria vaccine.

"Yes, you can create a market where there's no natural market. The biggest project, the one that's furthest along, is where GlaxoSmithKline is doing a vaccine called R2SS, which is now in phase 3 [trials]. It's not a perfect vaccine. It reduces mortality a bit more than 50 percent. And then we're funding a lot of other things that aren't as far along that--either by themselves or in combination--would get us a perfect vaccine. There are some very novel ideas in the early stages.

"But to go back to your question, the reason we're involved is because there's not a market. And so our investment is mind-blowing compared to anything else. And you do have that in diseases of the poor world."

- here's the Q&A from Technology Review

Will FDA reconsider hen vaccination program?

John Carroll — Thu, 26 Aug 2010 09:08:09 -0400

With the U.S. engaged in the biggest egg recall effort ever, the New York Times examines the FDA's recent decision that it would not require the vaccination of the country's chickens against salmonella. Faced with an outbreak of salmonella more than a decade ago, the U.K. initiated a vaccination program that has virtually eliminated the bacteria as a health threat. The cost: One cent per dozen eggs. Article

Antigenics shares gain on GSK's ambitious PhIII vax program

John Carroll — Thu, 26 Aug 2010 08:59:10 -0400

GlaxoSmithKline isn't the only company cheering this week's launch of a late-stage program for a shingles vaccine. Antigenics flagged its own role in the parade for the potential blockbuster and was rewarded with a 20 percent spike in its share price. Antigenics supplied the adjuvant for GSK's vaccine. And as CEO Garo Armen (photo) notes in a release, the Lexington, MA-based company stands to gain a fresh revenue stream in the event the Phase III program ends on a bright note.

GSK has already underscored just how important this program is, noting that it is one of the most important programs in its pipeline. Now the pharma giant is recruiting more than 30,000 people to test the effectiveness of the vaccine and adjuvant. "A significant number of products containing QS-21 continue to advance in the clinic," explains Armen in a statement. "This adjuvant has substantial revenue potential for Antigenics with no associated developments costs to the company."

Antigenics needs all the help it can get. Its shares have dropped 63 percent over the last year as its cancer vaccine, which cost hundreds of millions of dollars to develop, ran into trouble with regulators. European regulators had already rejected the therapy when Armen noted that U.S. regulators were "too rigid" to approve it. Russia approved Oncophage two years ago.

"The commencement of the Phase III programme for our candidate herpes zoster vaccine is a significant milestone," says Norman Begg, chief medical officer of GSK Biologicals, at the beginning of the week. "Shingles is an often debilitating condition for which there are limited treatment and prevention options. That is why progression into late stage development of our herpes zoster vaccine is an important milestone in ongoing efforts to potentially help address an important unmet need."

- read the press release from Antigenics
- here's GSK's release
- check out the story from Reuters

CDC: More teens getting their recommended shots

Liz Jones Hollis — Wed, 25 Aug 2010 21:45:41 -0400

An increasing number of U.S. teens are getting immunizations against HPV, meningitis and other infectious diseases, the CDC says. However, as in 2008, there was wide variation in adolescent vaccination coverage among state and local areas.

The survey of more than 20,000 teens between the ages of 13-17 found that in 2009, there was an uptick in the percentage of those who had received vaccines routinely recommended for 11- and 12-year-olds. The survey specifically found that:

For one dose of the tetanus-diphtheria-acellular pertussis (whooping cough) vaccine (Tdap), coverage went up about 15 points to about 56 percent;
For one dose of meningococcal conjugate vaccine, coverage went up about 12 points to about 54 percent; and
For girls who received at least one dose of human papillomavirus (HPV) vaccine, coverage increased seven points to about 44 percent. However, for girls who received the recommended three doses of HPV vaccine, coverage was only about 27 percent (a nine percent increase).

For one dose of HPV vaccine, experts observed no differences between racial and ethnic groups. However, coverage was higher among teens living in poverty compared with those living at or above the poverty level, the CDC notes. For the recommended three doses of HPV vaccine, differences were observed between racial/ethnic groups, including significantly lower coverage for blacks and Hispanics versus whites.

According to the CDC's Anne Schuchat, the data show that more parents are deciding to protect their children from serious diseases, but there is room for improvement. "Pertussis outbreaks in several states and an increase in pertussis-related infant deaths in California highlight how important it is for pre-teens to receive the Tdap booster," Schuchat says in a statement. "It is important for teens and adults to get a one-time dose of Tdap to protect themselves and those around them from whooping cough."

California has been particularly hard hit by whooping cough this year. Safety fears have caused some parents to refuse to get their children vaccinated, and some believe failure to do so may have contributed to the whooping cough outbreak, which may become the worst 50 years.

Reuters notes there are two HPV vaccines--GlaxosmithKline's Cervarix and Merck's Gardasil. In addition, Novartis and Sanofi make vaccines against meningitis and several companies make Tdap vaccines.

- read the CDC release
- get more from Reuters

ALSO: The European Commission has approved an amendment to the licence of GlaxoSmithKline's cervical cancer vaccine Cervarix to better reflect the scope of protection it offers. Marketing authorization for the vaccine has been adjusted to show that its efficacy goes beyond the HPV strains 16 and 18 to provide protection against 80 percent of all cervical cancers. Report

Feds earmark $2B for new, faster vaccine tech

John Carroll — Wed, 25 Aug 2010 15:24:57 -0400

U.S. health officials have taken some of the lessons they learned during the swine flu pandemic to heart. And now they're taking action to prevent a recurrence of crucial problems that slowed vaccine development projects last fall.

The Centers for Disease Control in Atlanta is spending $2 billion to improve vaccine technology with an eye to cutting the amount of time between the development and production of a new vaccine. CDC director Dr. Thomas Frieden says that the government wants to develop new tools to optimize the strains identified for making a vaccine, a key bottleneck that slowed scientists involved in the round-the-clock effort to make a new swine flu vaccine. And they want a new approach to identify the correct amount of antigen in a vaccine, another problem that emerged in the pandemic.

"We want new technologies, we want game changers, but we should also tweak what we've got now to be able to make a big difference today," Frieden told reporters. The President's Council of Advisors on Science and Technology has also stepped up with a few new suggestions of its own.

PCAST wants to see new and improved vaccine production facilities, with new incentives for improved machinery. Improving potency assays "should be a high-priority effort," according to an in-PharmaTechnologist report, while new incubation technology could shave a week off the process.

- here's the WSJ story
- read the in-PharmaTechnologist report

MRSA vax breakthrough reported by UChicago team

John Carroll — Thu, 19 Aug 2010 09:33:11 -0400

With the deadly MRSA bacteria making the rounds at hospitals with increasing frequency, investigators have highlighted two new research developments that could help pave the way to a new vaccine for what is now the leading cause of death from infectious disease.

"Staph aureus is the world champion of immune suppression," says Olaf Schneewind, professor and chair of microbiology at the University of Chicago. But his team found that a mutant version of the Protein A molecule will spur an immune response in mice. The investigators were also successful at generating antibodies to two key clotting factors--coagulase and von Willebrand factor binding protein--helping to protect mice from a staph infection.

The team developed an anti-coagulase vaccine by injecting purified versions of the clotting factors from a different kind of bacteria (E. coli) into mice and allowing the mice time to produce antibodies. About two weeks later, they injected the mice with staph. Even when injected with the virulent strain USA300, mice vaccinated with both antigens had far fewer abscesses and survived longer.

"The establishment of abscess lesions can be blocked with antibodies specific for coagulases," the authors conclude. "These data further corroborate the concept that Coagulase and vWbp should be considered for staphylococcal vaccine development."

- check out the University of Chicago release for more info

Critics deride WHO's ties to vaccine industry

John Carroll — Thu, 19 Aug 2010 09:06:46 -0400

Five of the 15 experts who sat on the WHO's emergency swine flu panel had financial ties to the drug industry, stirring fresh accusations that the group helped spur huge profits for drug companies like GlaxoSmithKline by whipping up a global frenzy over the H1N1 pandemic. WHO officials have steadfastly denied that financial considerations played any role in the pandemic declaration, which helped create a multibillion-dollar market for Big Pharma. Story

CSL predicts profit drop on lower vax sales

Liz Jones Hollis — Thu, 19 Aug 2010 08:07:14 -0400

Australian vaccine maker CSL said full-year profit will decline as much as 6.9 percent as the end of the swine flu pandemic cuts vaccine sales, Bloomberg reports. The company predicts that net income will fall to between $884 million and $927 million in the year ending June 30, from the $945 million that CSL reported. Excluding last year's swine flu vaccine earnings, profit will rise 10 percent.

The company noted the rising Australian dollar offset revenue from overseas product sales, while growth in royalties from its cervical cancer vaccine Gardasil slowed, according to the Wall Street Journal. The company also predicted drop in sales of its H1N1 swine flu vaccine and unveiled a $815 million share buyback. CSL expects weaker sales due to U.S. and European healthcare reforms and austerity measures, the Australian Life Scientist reports.

CEO Brian McNamee pretty much ruled out in major acquisition at this time. "As we know, a lot of M&A is just passing rent from one shell to another...without clarity on whether true value is created," he explains, as quoted by The Australian. "There's nothing that leaps out at us today that says we would want to conserve our cash for a significant transaction." However, the company hasn't nixed the idea of smaller acquisitions, as Reuters notes.

- get more from Bloomberg
- see The Australian's coverage
- read the WSJ report
- check out the Australian Life Scientist's report
- see more from Reuters

ALSO: Europe and the U.S. have banned an Australian-made flu vaccine for young children, after a surge in febrile fits in Australian children. The U.S. Advisory Committee on Immunization Practices has taken stronger action than Australia's Health Department, by recommending that children younger than 9 not be vaccinated with CSL's seasonal flu vaccine. Europe has followed Australia's decision to suspend the CSL vaccine only for the under-5s. Report

Selecta gets a new CEO, $3M for nicotine vax program

John Carroll — Wed, 18 Aug 2010 14:20:42 -0400

Selecta Biosciences has turned to a veteran of the pharma world to lead it through the startup phase. Werner Cautreels, who helmed Solvay Pharmaceuticals through its $6.6 billion sale to Abbott in February, is taking the reins at Selecta, which is developing new nanoparticle vaccine technology pioneered by Bob Langer at MIT.

A chemist by training who came up the corporate ladder through the R&D side of the development business, Cautreels had a seasonal flu vaccine in Solvay's product mix when Abbott bought the company. But Selecta is developing a new vaccine that is made synthetically, opening the door to a new production process which can rapidly ramp up supplies. And the company is targeting a new nicotine vaccine as one of its lead products.

Watertown, MA-based Selecta is getting some help from the feds for its nicotine vaccine. At the same time the company announced its selection of Cautreels for the top job, Selecta also revealed that it had won a $3 million grant from the National Institute of Drug Abuse.

"We view a nicotine vaccine as one of our promising programs that are poised to advance into human clinical trials based on our progress with Selecta's technology platform," said Cautreels. The money, he added, would be used to select a vaccine candidate and get it into the clinic. Selecta has 25 employees and Cautreels plans a few new hires to round out its staff roster.

- here's the Selecta release on Cautreels
- and here's another on the $3 million grant
- read the Xconomy story
- check out the MassHighTech report

Vaccine sales surge 16% as industry eyes $35B mark

Maureen Martino — Fri, 13 Aug 2010 15:29:30 -0400

Vaccine sales hit $22.1 billion in 2009, up a healthy 16 percent from 2008. And forecasts predict that sales will continue to rise annually at a rate of 9.7 percent for the next five years. Wider adoption of currently available vaccines and the introduction of new products could push annual sales as high as $35 billion by 2015.

Merck, GlaxoSmithKline, Sanofi Pasteur, Pfizer and Novartis are the world's largest producers of vaccines, according to Kalomora Information, with GSK dominating about a quarter of the total market. Pediatric vaccines account for more than half of the total market, and is growing at a fast rate than the adult segment. Pneumococcal and "combination" DTaP vaccines are driving growth in the pediatric sector, while influenza and hepatitis vaccine products fuel the adult segment of the market.

"We've forecasted a high growth rate for vaccines over the past few years and market events have matched our predictions," said Bruce Carlson, publisher of Kalorama Information. "The vaccine business is not without its risks, but for some companies, vaccines were the only bright spot in their portfolio in 2009. It's not a surprise therefore that development is heavy in this sector, and that will contribute to growth over the next five years."

- read the Kalomora release
- here's the AP story for more

WHO says H1N1 pandemic has run its course

John Carroll — Thu, 12 Aug 2010 09:23:09 -0400

The swine flu virus will be with us indefinitely, but the World Health Organization says that the H1N1 pandemic it triggered is over. For the vaccine industry, the pandemic presented an opportunity to do its best research work, turning out a new vaccine in record time, while highlighting how the world's manufacturing system still relies on old technology that is far too slow to guard against a wildfire breakout. Fortunately, the swine flu turned into a dry run of sorts. Far more mild than originally feared, it caused relatively few deaths. The next time around the virus may not be so unthreatening. In the meantime, a lineup of biotech companies has been working feverishly to develop new vaccines that can be made much faster. Story

Team tackles therapeutic Parkinson's vax

John Carroll — Thu, 12 Aug 2010 09:12:36 -0400

Investigators engaged in preclinical studies have already seen how blocking a particular protein can reduce the level of nerve damage associated with Parkinson's disease. Now researchers at the University of Texas Health Science Center at Houston want to see if that same approach can be followed to develop a therapeutic vaccine for the debilitating ailment.

"We're creating a vaccine to target a protein (alpha synuclein) that accumulates in the brains of people with Parkinson's disease," said Rowen Chang, the lead researcher on the project. "If we can slow the protein buildup, I believe we will also slow the deterioration of nerve cells tied to body movement."

Chang's team is currently working to identify the best immunogen for the vaccine, which is being tested in mice. Their work is supported by the Michael J Fox Foundation for Parkinson's Research, which has devoted millions of dollars to cutting-edge research in the field. Other investigators at UTHealth are engaged in developing new and better diagnostics for Parkison's.

- check out the full article from UT

Emergent forms JV for new pandemic vaccine

John Carroll — Thu, 12 Aug 2010 08:30:19 -0400

Rockville, MD-based Emergent BioSolutions has reached halfway around the world to join hands with a new partner to quickly develop a broad spectrum pandemic vaccine against multiple H5 strains. Singapore's Temasek Life Science Ventures will be the junior partner in the joint venture, Epic Bio, which is being split 60/40.

Emergent says it plans to start ramping up production of the H5 pandemic vaccine next year using a cell-based manufacturing system--avoiding the traditional need to use chickens and eggs in vaccine manufacturing work. A clinical trial is planned for 2012. The JV plans to incorporate three H5HA antigens within the vaccine candidate, including the Vietnam strain.

"Epic Bio's viability and success will be anchored on TLV's extensive experience in cutting-edge research combined with Emergent's core competencies in product development, manufacturing, and commercialization," says Daniel Abdun-Nabi, president and chief operating officer of Emergent BioSolutions.

- here's the Emergent release

Medicago to develop vax facility in NC

Liz Jones Hollis — Wed, 11 Aug 2010 15:18:05 -0400

Canada's Medicago is developing a 90,000-square-foot facility in Research Triangle Park, North Carolina for the company's VLP plant-based vaccine technology to combat flu. Medicago received the funding from DARPA as part of the Accelerated Manufacture of Pharmaceuticals program to revolutionize current egg-based models and yield vaccines within three months of "emerging and novel biological threats," as Wired notes. Just under 90 jobs will be created as a result, according to the Triangle Business Journal.

In addition to the $21 million grant, Medicago will contribute $7.5 million and Alexandria Real Estate Equities will give $13.5 million, according to a company statement.

Vaccines are traditionally produced in eggs--a process that can take six months or more. But Medicago uses tobacco plants, which has shown it can produce a vaccine in only a month, according to Wired. During the recent H1N1 influenza outbreak, Medicago's plant-based VLP vaccine technology was able to successfully develop a vaccine candidate in less than a month after identifying the H1N1 strain, the company notes in a statement.

"This DARPA funding is...in line with our development plan for both our pandemic and seasonal influenza products as we will now have a U.S. facility ready to participate in the $7B pandemic and seasonal influenza markets," Andy Sheldon, president and CEO of Medicago, says in a statement. "In addition, our U.S. facility will provide us enhanced access to the various grant programs in the U.S.A. and we will be ready to take part in these additional funding opportunities."

And facility is a lot less expensive than it would be to build an egg- or cell-culture- based facility. "The capital expense to build such a facility--we would generally estimate that it's somewhere between 10 to 15 times less than if was an egg-based or cell-culture facility," CEO Andy Sheldon explains to Reuters, adding that the cost of goods is also much less than egg-based or cell-based production.

A number of companies are looking to alternatives to egg-based production, including fungi, bacteria and bugs.

- get the DARPA release
- read Wired's coverage
- here's the Reuters report
- check out the Triangle Business Journal's report

ALSO: Shares of Medicago plunged nearly 18 percent on Tuesday following its announcement of a $7 million equity offering. The company subsequently announced an increase of the equity offering to $7.5 million. Report

Crucell forges ahead with combo AIDS vax trial

John Carroll — Wed, 11 Aug 2010 14:47:32 -0400

Joining with a host of collaborators, Crucell plans to take a promising combo approach for a new AIDS vaccine into the clinic in the U.S. in an ambitious effort to forge ahead on one of the most challenging fronts in vaccine R&D.

Working with researchers from Harvard University's Beth Israel Deaconess Medical School and the Ragon Institute, the Dutch biotech plans to mix its vaccine with a candidate from the International AIDS Vaccine Initiative in what they call a prime-boost approach. The investigators will track the combination vaccine's safety as well as its ability to provoke an immune response among healthy volunteers.

"A different prime-boost AIDS vaccine approach has been shown in the RV144 trial (Thai Trial) to protect against HIV in humans, for the first time in the history of AIDS vaccine development," said Crucell CSO Jaap Goudsmit. "Our program to develop this combination vaccine represents one of the most advanced AIDS vaccine programs in the world and is based on the best science available today."

If the Phase I trial is successful Crucell says they can pursue plans to mount a proof-of-concept Phase IIb study. The research work is supported by the National Institute of Allergy and Infectious Diseases.

- check out the Crucell release
- here's the Bloomberg story

Manufacturers get an early start on flu vax shipments

John Carroll — Thu, 05 Aug 2010 09:03:11 -0400

Vaccine manufacturers have begun to deliver huge shipments of the new seasonal flu vaccine ahead of schedule. This year's shot protects against two strains of seasonal flu as well as H1N1, doing away with the two-shot approach that failed miserably last fall.

MedImmune is near the head of the line of manufacturers, triggering early shipments of its FluMist nasal spray vaccine. Novartis has also started shipping its Fluvirin early. GlaxoSmithKline (NYSE: GSK) and Sanofi-Aventis (NYSE: SNY), two other major distributors, are also busy sending out vaccine supplies.

Every year manufacturers engage in what is essentially a crap shoot, designing a jab that can guard against the flu strains that raise the greatest fears. But this year's annual campaign will test public attitudes about flu vaccines. The mass attack against swine flu ended in a whimper, with public health officials around the globe either sending back or destroying millions of doses of unused vaccine. And the seasonal flu had only a mild impact in the U.S.

Meanwhile, health officials are for the first time urging that everyone from the age of 6 months and up get a shot ahead of any outbreak. However, any new public resistance to the flu shot may prevent the U.S. from achieving the 'herd' immunity needed to stop an epidemic before it starts.

- read the story fom the Baltimore Sun
- here's the piece from the Wall Street Journal

New poll taps strong public fear about HIV vaccines

John Carroll — Thu, 05 Aug 2010 08:46:53 -0400

One of the biggest problems vaccine manufacturers now face is the deeply ingrained fear that a vaccine will give you the very disease it's designed to guard against. And that fear was evident in a new Canadian poll showing that many would reject a new HIV vaccine, even if they run a high risk of getting infected.

Fewer than half of the people polled said they would get a shot that is 50 percent effective, while a completely effective jab would still be rejected by a quarter of the population. And the Toronto Sun reports that researchers even found resistance among intravenous drug users and homosexuals, who bear the highest risk of contracting AIDS.

If an effective vaccine is developed, the researchers have urged health officials to make it freely and widely available. Public health clinics would be a good place to start--rather than AIDS clinics--which would help ease any "social stigma" associated with the vaccine. And a major public education campaign should be mounted ahead of any vaccination program.

"With more than 2.7 million people worldwide newly infected with HIV every year, the need for safe and effective HIV vaccines is greater than ever," said Dr. Peter Piot, director of the Institute for Global Health at Imperial College. "We are now in one of the richest phases in HIV vaccine research since the beginning of the epidemic. Following up on each of the most promising advances in HIV vaccine research will require appropriate funding, high levels of collaboration and information sharing and the full support of researchers and governments around the world."

- here's the story from the Toronto Sun

New therapeutic vax targets multiple cancers

John Carroll — Thu, 05 Aug 2010 08:18:14 -0400

Investigators are reporting promising results from their early-stage trial of a new therapeutic cancer vaccine. Scientists say the new vaccine uses an alphavirus to deliver a gene for the carcinoembryonic antigen. Alphaviruses are known to naturally track down dendritic cells, a powerful stimulator of the immune system. In a small human trial involving 28 participants suffering from a variety of late-stage cancers, the vaccine was able to help five of the patients. Story

Scientists working on chronic stress vax

Liz Jones Hollis — Wed, 04 Aug 2010 22:33:04 -0400

Stanford scientists may be on the verge of a vaccine to combat chronic stress. For 30 years, Dr. Robert Sapolsky, a neuroscience professor at Stanford, has been studying stress, and now he and his team are starting to see the fruits of their labor--a genetic therapy that can prevent the struggles of life from wrecking brain and body, according to a report in Wired.

Chronic stress is linked to a range of conditions and diseases, including diabetes and heart attacks, the Daily Mail reports. Sapolsky, who has been studying hormones called glucocorticoids, first noted the damage caused by stress on animals in Kenya. When a person experiences stress, a tiny circuit in the base of their brain triggers the release of glucocorticoids, thus putting the body in a heightened state of alert. But glucocorticoids can linger in the bloodstream, leading to damage. This also can prove toxic to the brain, slowing the production of new neurons, according to Wired.

But Sapolsky's team has adapted a herpes virus--a good candidate because it's able to slip easily into brain cells--to carry engineered neuroprotective genes into the brain and neutralize the hormones. And this approach has yielded success rats; those given the herpes treatment were able to stave off practically all cell loss, while control rats lost nearly 40 percent of neurons in a given region.

"To be honest, I'm still amazed that it works," Sapolsky tells Wired. "It's not going to help anybody soon"--human trials are years away--"but we've proved that it's possible. We can reduce the neural damage caused by stress."

- get more from CBS news
- see the Daily Mail's account
- read the Wired report

New Hutch president looks for real cures among research

Erica Teichert — Wed, 04 Aug 2010 14:49:09 -0400

Though the Fred Hutchinson Cancer Research Center is best known for its studies on cancer risks, the Hutch is widening its field with the help of its next president. After a yearlong search, the Center chose Dr. Lawrence Corey (photo), an expert on AIDS and vaccines, to take the reins on January 1, 2011 after 13-year president Lee Hartwell retires. Corey has found inspiration for his new post in the Hutch's innovative breakthroughs.

"Cures of numerous cancers thanks to bone marrow transplantation, which was invented at the Center by Nobel laureate Dr. E. Donnall Thomas, and the marked reduction in breast cancer rates that has emanated from the Center's leading role in the Women's Health Initiative are just two examples of the pioneering work we will expand upon in the next decade," Corey says in a release. Corey's main concern is making sure that the Hutch's breakthroughs translate into real cures for patients. And he has already proven his worth. During his tenure as head of the Center's Vaccine and Infectious Disease Division, he created the first U.S. cancer clinic in Africa, which studies and treats various cancers, including virus-caused Burkitts lymphoma.

"Larry is one of those rare individuals who has a wonderful feel for great basic science, and is as successful as anyone I know in figuring out how to bring that...science to the clinic," said Richard Klausner, former director of the National Cancer Institute, to the Seattle Times.

The Hutch already has three Nobel laureates on staff, including the retiring Hartwell, and has been credited with numerous cancer, HIV and treatment breakthroughs. In January, researchers found that umbilical cord blood has potential to treat leukemia patients instead of painful bone marrow transplants, which were originally pioneered at the Center.

- here's the Hutch release
- read the story

Dendreon: Provenge on course to hit blockbuster goal

John Carroll — Wed, 04 Aug 2010 13:55:46 -0400

In the first three months following the FDA's approval of the revolutionary new prostate cancer vaccine Provenge, Dendreon was able to gin a mere $2.8 million in sales as it began to ramp up production. But sales are rising at a fast pace and July saw more than $5 million in new Provenge revenue as the Seattle-based company picks up the pace as it heads towards its blockbuster goal of $1 billion a year.

Analysts have been following every step Dendreon takes as it gears up production of Provenge at three different manufacturing sites around the country. A New Jersey facility will be online in early 2011 with two other manufacturing centers in Atlanta and Orange County beginning production by the middle of next year. Analysts appeared pleased to see that 500 prescriptions of the therapy--a three-course treatment program costs $93,000--puts it on course to treat 2,000 patients in its first year.

Every hint of trouble, including a review of the drug by Medicare, has ruffled analysts and roiled Dendreon's stock price, which soared to $57 on the euphoria over Provenge's approval and then swiftly plunged. On Wednesday the stock jumped 17 percent as investors registered their approval of the biotech's quarterly report, rising to close to $40 a share.

Leerink Swann's Howard Liang was glad to hear that most Medicare contractors are already covering the therapy in advance of next year's review. "The current coverage is much broader than we expected based on our search of announced CMS coverage, which we already viewed positively," he noted.

Concern over the upcoming review spurred the American Society of Clinical Oncology, which represents 28,000 oncology specialists, to send the agency a letter outlining its worry that Medicare may be on the verge of setting an unsettling precedent. Medicare is required to cover drugs approved by the FDA, says ASCO, urging the agency to issue clear statements on its reimbursement policy.

- read the Reuters story
- here's the Wall Street Journal report

Biovest wins orphan drug status for cancer vax

John Carroll — Thu, 29 Jul 2010 10:20:25 -0400

Biovest International has announced that the FDA has granted orphan drug designation to BiovaxID, its personalized cancer vaccine, for a second lymphoma indication. "With promising clinical trials now complete in both follicular lymphoma and mantle cell lymphoma, we are preparing to seek regulatory approvals for BiovaxID in two separate indications," says Dr. Carlos Santos, Biovest's VP, product development & regulatory affairs. Release

Merck, Sanofi outline plans for new animal health JV

John Carroll — Thu, 29 Jul 2010 10:16:38 -0400

The newly created Merial-Intervet is being forged by Merck and Sanofi-Aventis into a global powerhouse in the animal health industry, and it will rely heavily on income from some best-selling vaccines to garner an expected $5 billion in annual sales.

The company will sell Recombitek, a vaccine that guards horses against West Nile virus, Eclipse for cats and Galaxy for dogs, among other shots. Earlier this week, the two pharma companies tapped the new CEO of the JV: Raul Kohan, currently president of Intervet/Schering-Plough, Merck's animal health business. Kohan joined Schering-Plough in 1984 and was one of the assets Merck picked up in its buyout of the company.

The worldwide animal health market reached $19 billion in 2008, according to the two companies, and is expected to continue to grow at a healthy clip of 5 percent per year for the next five years, driven in part by a growing demand for protein therapeutics.

- here's the press release on Kohan
- and here's the AP's list of the JV's top products

NEJM lays out questions--and facts--about Provenge

John Carroll — Thu, 29 Jul 2010 09:46:38 -0400

Shares of Dendreon (NASDAQ: DNDN) soared into the stratosphere in the lead-up to Provenge's approval--and then promptly started tumbling fast as all sorts of questions arose about supply issues and efficacy. The company is likely to benefit enormously from the publication of its biggest study of the innovative prostate cancer vaccine in the prestigious New England Journal of Medicine, which carries biblical weight with providers.

The facts about the Provenge data have been known for some time; the drug demonstrated a 22.5 percent reduction in the risk of death and a 4.1 month increase in median survival rates compared with a placebo. Earlier stage patients benefited with significantly longer survival rates. Forbes' Matthew Herper notes that it's significant that the survival data is consistent, and he offers kudos for getting Dana Farber's well-respected Philip Kantoff as the lead author.

"These results represent the beginning of a new era in the treatment of cancer, one in which a patient's own immune system is harnessed to fight the disease," says Kantoff in a statement. "Furthermore, the magnitude of the survival benefit coupled with the side effect profile and short duration of therapy place Provenge as a new standard of care for men with asymptomatic or minimally symptomatic mCRPC."

But there was also some skepticism about the new drug. In particular, Herper notes, the study raises questions about the drug's benefit, including the absence of a "measurable effect on tumors." Dan Longo, a deputy editor at the New England Journal of Medicine, calls that "hard to understand" in an accompanying editorial.

Provenge is also radically more expensive than current prostate cancer therapies. At $93,000, physicians and payers will have to question a drug that costs $23,000 a month versus the $1,800 monthly fee they currently face.

- check out the press release
- here's Herper's report in Forbes
- read the story from TheStreet

Vaccination gaps contribute to pertussis outbreak

Liz Jones Hollis — Thu, 29 Jul 2010 07:52:29 -0400

Over the past few years, safety fears have caused some parents to refuse to get their children vaccinated against certain diseases. And some believe failure to do so may have contributed to a whooping cough (pertussis) outbreak in California that may become the worst 50 years.

Experts say there is no single factor contributing to the rise of pertussis cases. However, in addition to some parents refusing vaccines, a number of doctors aren't offering all the recommended immunizations because of payment issues, American Medical News reports. These two factors may be the main reasons for the resurgence of the disease, experts speculate.

"I'm saddened, but I can't truly say I'm surprised," says Dr. Saad Omer, an assistant professor with Emory University's Rollins School of Public Health, as quoted by MSNBC. "We know and we have known for a while that we have these gaps in protection at the local level." Rising cases of the disease also have been reported in Idaho, Texas, Michigan and South Carolina. And Michigan is another state where parents have often refused recommended vaccinations.

"We encounter lots of patients' families who are pretty clear that they're suspicious of vaccines. It's a frustrating issue, because these are often people... who don't understand the possible effects of going without the pertussis or mumps vaccines," Dr. Sumana Reddy, a California physician, tells American Medical News.

Financial challenges of vaccinating patients also may be a factor in the rising pertussis incidence. A December 2008 Pediatrics study that surveyed 597 U.S. pediatricians and family physicians found that 49 percent of the doctors practiced in an office that had delayed purchasing a new vaccine due to financial concerns, American Medical News notes.

Through July 13, 1,496 cases of pertussis were reported in California, a five-fold increase from the same period last year when 304 cases were reported, according to a statement from the state's Department of Health. To combat the outbreak, the department is recommending an adolescent-adult pertussis booster vaccine for anyone 7 years and older who is not fully immunized, including those who are more than 64 years old; women of childbearing age, before, during, or immediately after pregnancy; and other people who have contact with pregnant women or infants.

- read the CDPH's release
- get more from American Medical News
- check out the story from MSNBC

Vax nanopatch offers stick-on alternative to a needle

John Carroll — Wed, 28 Jul 2010 14:50:07 -0400

During the next pandemic, people may be able to get their vaccines delivered in the mail rather than having to wait in line for a jab.

Prof. Mark Kendall of the Australian Institute for Biotechnology and Nanotechnology says he has developed a nanopatch no bigger than a postage stamp that can be used to deliver a vaccine. And unlike most vaccines today, it doesn't need to be refrigerated, and it eliminates any nasty injuries caused by injections.

"The World Health Organization estimates that 30 percent of vaccinations in Africa are unsafe due to cross-contamination caused by needle-stick injury," Kendall tells the Australian Broadcasting Association. But the nanopatch--which should also be cheaper than vaccines delivered with a needle--uses thousands of tiny projections to inject the vaccine through the skin directly to target cells. The stamp dissolves on administration.

"Currently most vaccines are delivered with the needle and syringe into muscle, which has few immune cells," he adds. "In contrast, the skin is abundant in immune cells, offering great potential for vaccines, if we can successfully exploit it with practical delivery devices."

There are a number of R&D projects focused on a new generation of vaccine patches. As we reported last week, Georgia Tech investigators have been engaged in their own project using microneedles arranged on a bandaged-sized patch.

- here's the story from the Australian Broadcasting Association
- check out the article from Science Alert