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Not too long ago, the mere mention of the word “vaccine” caused most big pharma executives to break out into a cold sweat. Once derided as low margin products and potential market busters—once most populations are immunized the incidence of disease declines and the market begins to falter—vaccines, primarily pediatric ones, have made a huge comeback over the last five years. 

One of the main reasons for the resurgence of the vaccine industry, was passage of US legislation that better-defined the legal obligations of vaccine makers and inclusion in the legislation of provisions that cap the size of awards made to persons claiming injury after vaccination. Another factor that contributed to the growing popularity of vaccines was emergence of the middle class in vast and concomitant improves in the healthcare systems of emerging markets that include South America, Asia and Africa. Unlike the mature vaccine markets in the US, Europe and Japan (because of low birthrates), the Asian, Latin American and African markets are poised for explosive growth over the next two decades.

In a recent article entitled “Vaccines-The Sustainable Blockbuster Business” Frost and Sullivan’s Senior Healthcare Analyst Barath Shankar Subramanian provides some interesting and insightful factoids about the vaccine industry. They are:

Pediatric vaccines are leading adult vaccines and represent the fastest growing segment of the global vaccine market

Europe is the world’s leading vaccine producer with over 90% of total production

The top five vaccine manufacturers (all big pharma companies) produce more than four-fifths of global vaccine revenues while other manufacturers (approximately 40) account for only one-fifth.

The North American market accounts for over 50 percent of the total spend on vaccines

North America and Europe supply only 14 percent of the world’s vaccine demand; the rest is met by suppliers in developing markets

Government investment, not-for-profit spending and industry alliances/ partnerships, in addition to private R&D spending, are helping to drive the current resurgence of the global vaccine industry

At present, there no fewer than 80 new candidates in late stage clinical development. Further, almost 40 per cent of the new vaccine candidates are for indications that currently have no vaccines on the market.  Finally, improvements in vaccine delivery are helping to drive the improved uptake of vaccines. For example, aerosols, transdermal skin patches, oral drops and even pills—all designed to eliminate needles and improve patient compliance and overcome cold chain supply issues are currently being developed.

From a business perspective—as far as sustainable markets go—the pediatric segment of the vaccine market is a clear winner. Currently, the leading global causes of vaccine-preventable, deaths for children under five include: pneumococcal disease, rotavirus, measles, Hemophilus influenzae b (Hib) infections, pertussis and tetanus. To that end, it is likely that governments in emerging markets will continue to add existing and new vaccines to government-mandated immunization programs. This is almost certain to propel the vaccine market to new heights over the next 10 years or more.

Until next time...

Good Luck and Good Job Hunting (think biologics!)

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Five years ago Amgen was the world’s largest biotechnology and was, by many accounts, the darling of Wall Street. But, today, there is little mention of the once formidable biotechnology company that many startups attempted to emulate. Like other companies, Amgen ran into pipeline problems, medical issues with existing blockbuster drugs (remember the whole hematocrit brouhaha over Epogen and Aranesp its flagship anemia products), lower drug sales and ultimately the perception that the company had lost its innovative edge. However, it now appears that Amgen is making something of a comeback and may have been quietly preparing itself for its  “rebirth” over the past few years.

According to an article in today’s NY Times, Amgen agreed to purchase BioVex, a closely held oncology company for $425 million and as much as $575 million in milestone payments. BioVex’s lead product, an experimental cancer vaccine Oncovex, is in late stage clinical development. It was developed to treat metastatic melanoma. Oncovex is also being evaluated for head and neck cancer.  Over the past five years, Amgen has acquired seven companies (with an average deal value of about $264 million) in oncology and other therapeutic areas indicating a willingness to create new drugs to treat diseases rather than symptoms commonly associated with them.

In other news, the company announced that it was raising it price for some of its largest selling drugs including Aranesp, Neupogen and Neulasta. Another sign that the once mighty company may be trying to get back into the game and compete with archrival Genentech (now a subsidiary of Roche) for the title of the world’s largest biotechnology company.

Until next time...

Good Luck and Good Job Hunting!!!!!!.

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Without fanfare, GlaxoSmithKline (GSK) quietly announced today that the US Food and Drug Administration (FDA) granted approval for CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

It has taken GSK over three years to garner US regulatory approval for CERVARIX® which has been approved and used in over 100 other countries in the world. Early "unspecified concerns" delayed approval and, as recently as two weeks, FDA delayed a decision despite recommendations from an advisory panel to approve the vaccine. Coincidentally, a week before the agency was expected to announce approval for the vaccine, a British girl died after she was vaccinated with Cervarix. While FDA spokespersons claimed that the girl’s death following vaccination had nothing to do with the delaying a decision on Cervarix, many industry pundits believe that the FDA was reluctant to approve the vaccine in light of the sensational media coverage in the UK surrounding the incident. After an autopsy was performed on the girl, British authorities announced that a massive cardiac tumor that had infiltrated one of her lungs, not Cervarix was responsible for her death.

Today’s approval of Cervarix provides American consumers with an alterative to Gardasil, Merck’s cervical cancer vaccine that was approved about two years ago. That said, the ability to protect girls and young women from the possibility of developing cervical cancer is more important than which of the two vaccines is used to induce immunity. I plan on immunizing my daughter when she is old enough!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

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The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that clinical data support both the efficacy and safety of Cervarix®, GlaxoSmithKline (GSK) cervical cancer vaccine.

In a press release, the company announced that “Cervarix was shown to be highly effective and well tolerated in girls and young women for the prevention of cervical pre-cancers and cervical cancer related to human papillomavirus (HPV) types 16 and 18, the two most common virus types that cause cervical cancer. The committee also discussed data demonstrating the efficacy of  Cervarix against additional cancer-causing virus types.”

The Committee’s favorable recommendation, although not binding, will be considered by the FDA in its final review of the Biologics License Application (BLA) for the candidate vaccine.

In March 2009, GSK submitted final data from its Phase III pivotal study (HPV-008), the single largest efficacy trial of a cervical cancer vaccine to date. The file included data from clinical trials in more than 30 countries involving nearly 30,000 participants receiving Cervarix, which reflect an ethnically and racially diverse population and a broad range of women. It also included a thorough safety assessment relevant to 10-25 year old girls and young women.

Cervarix® has been approved in nearly 100 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. Licensing applications have been submitted in more than 20 additional countries, including Japan and the United States. GSK also received World Health Organization (WHO) prequalification in July 2009.

The likely approval will provide girls and women with an alternative to Merck’s cervical cancer vaccine Gardasil which has been on the market for almost two years. Gardasil has recently come under fire by religious and anti-vaccine groups and sales have been lackluster lately. It will be interesting what effect if any Cervarix will have on the US anti-HPV/cervical cancer market. That said, I doubt whether Merck executives will be sleeping as well as they have been prior to today’s advisory panel recommendation!

For a great comparison of the two vaccines check out an article in today's New York Time business section.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

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Since the beginning of the pandemic last spring, BioCrowd founder and virologist extraordinaire Vincent Racaniello has been vigilantly writing at his at his Virology Blog about HIN1 pathogenesis, epidemiology, immune responses and vaccines.  When not blogging about HIN1, Vincent also writes about other viral diseases and does a weekly virology podcast called This Week in Virology (TWIV).

In a very short time, Professor Racaniello has amassed a huge collection of original articles that could be compiled into a virology textbook with a title like “Everything you ever wanted to know about H1N1.” And, not surprisingly, his Herculean efforts have not gone unnoticed: today his Virology Blog was recognized and listed as a legitimate source of H1N1 information by the New York Times. 

For those of you who haven’t been overwhelmed by the unrelenting swine flu media frenzy and are seeking sound information about the H1N1 epidemic, I highly recommend that you check out Vincent’s blog. Also, you can talk with Vincent at BioCrowd when he is not too busy blogging, podcasting or conducting laboratory research.

Until next time...

Good Luck and Remember to Wash Your Hands !!!!!

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The Public Library of Science (PLOS) announced that it has launched a new website called PLOS Currents that is intended to serve as a vehicle for the rapid publication of scientific research and new ideas and themes. Not surprisingly, the first theme for PLOS Currents is influenza. On his Virology blog, Vincent Racaniello, a BioCrowd cofounder and prominent virologist, discusses why PLOS Currents is important and timely for scientist actively engaged in influenza research and vaccine development.  

The opening of PLoS Currents: Influenza was announced by Harold Varmus, Chairman and Co-Founder of PLoS. He wrote about the reasons for starting this website at The Official Google Blog:

The key goal of PLoS Currents is to accelerate scientific discovery by allowing researchers to share their latest findings and ideas immediately with the world’s scientific and medical communities. Google Knol’s features for community interaction, comment and discussion will enable commentary and conversations to develop around these findings. Given that the contributions to PLoS Currents are not peer-reviewed in detail, however, the results and conclusions must be regarded as preliminary. In time, it is therefore likely that PLoS Currents contributors will submit their work for publication in a formal journal, and the PLoS Journals will welcome these submissions.

Contributions that will be welcome at PLoS Currents: Influenza include research into influenza virology, genetics, immunity, structural biology, genomics, epidemiology, modeling, evolution, policy and control. The manuscripts will not be subject to peer-review, but unsuitable submissions will be screened out by a board of expert moderators. This policy will enable rapid publication of research.

The path to publishing original scientific research is often long and tortuous.  A manuscript describing the findings is prepared and submitted to a scientific journal (such as Nature, Cell, Journal of Virology). The manuscript is assigned to two or three expert reviewers, generally scientists involved in the same area of research. If their reviews are favorable, the paper is published. Usually additional experiments are called for, which may require additional time to complete. Many months to a year may pass before the paper is published, although some manuscripts (e.g. those on 2009 pandemic influenza) may be expedited. The point is that PLoS Currents: Influenza will allow everyone – including non-scientists – to read about research soon after the authors have prepared the paper.

PLoS Currents: Influenza is a terrific idea, and I welcome this venture with great enthusiasm. I hope that PLoS Currents will grow to include other areas of science. But Varmus warns:

Given that the contributions to PLoS Currents are not peer-reviewed in detail, however, the results and conclusions must be regarded as preliminary. In time, it is therefore likely that PLoS Currents contributors will submit their work for publication in a formal journal, and the PLoS Journals will welcome these submissions.

During peer review of submitted manuscripts, new experiments may be suggested that change some of the conclusions of the research. Hence, the papers that appear in PLoS Currents: Influenza may be different from final versions that are published elsewhere.

I wonder how other scientific journals will react to submissions of manuscripts that have appeared in PLoS Currents. Many journals do not accept manuscripts that have already appeared elsewhere. For example, the instructions to authors for the Journal of Virology state:

By submission of a manuscript to the journal, the authors guarantee that they have the authority to publish the work and that the manuscript, or one with substantially the same content, was not published previously, is not being considered or published elsewhere, and was not rejected on scientific grounds by another ASM journal.

It’s time for scientific journals to change this policy, and allow for preliminary publication at sites such as PLoS Currents.

Rapid and open-access publication will drive research forward and help inform and educate the public about science.

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Colony Collapse Disorder (CDD) a mysterious syndrome that kills adult worker bees outside of the hive has been plaguing Europe and the US in recent years. The US Department of Agriculture (USDA) reports that American beekeepers have lost 37% of their hives to CCD in 2008 after losing 31% the year before. The government estimates that a third of the US food supply may be at risk--$15 billion annually in vegetables, nuts and fruits from plants that depend on bee pollination. The cause of CDD is still hotly debated but many scientists believe that it is caused by a virus

A start up company in Miami FL (my old stomping grounds) called Beeologics is developing a vaccine against all of the apiary viruses that could be responsible for CDD. The company was started by two Israelis, Eyal Ben-Chanoch at tech entrepreneur who helped design the first Intel Pentium chip and Ilan Sela a bee genomics expert. 

The vaccine is pending FDA approval and Beeologics expects it to hit the US market this summer and sell it for $2 per dose. A hive will need one dose per month and current estimates suggest that there are 2.5 million hives in the US. Not a bad revenue stream!

For those of you who may not know, bee keeping is big business and can be lucrative for beekeepers. I learned everything I know about bee keeping as an undergraduate at Cornell when I took Introduction to Beekeeping in my senior year. It was one of the best courses that I ever took at Cornell because it was taught by an entomologist who was also a commercial beekeeper!   Since then, I have always been extremely fond of honey bees—they are fascinating creatures.

Until next time…

Good Luck and Good Job Hunting!!!!!!

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If you are not convinced that vaccines are safe, please listen to a conversation between Dr. Ginger Campbell of the Brain Science Podcast and Dr. Paul Offit.

Dr. Offit is a pediatrician who is also Chief of Infectious Diseases and Director of Vaccine Education at the University of Pennsylvania School of Medicine. He is co-developer of the rotavirus vaccine and author of the book Autism’s False Prophets: Bad Science, Risky Medicine, and the Search for a Cure. This book should be read to obtain a complete appreciation of the vaccine-autism controversy. However, I found the podcast also highly compelling, because Dr. Offit is extremely knowledgeable and an excellent speaker.

The furor surrounding childhood vaccines began when Wakefield, a British gastroenterologist, published a Lancet article in 1998 claiming to show a link between the measles-mumps-rubella vaccine (MMR) and development of autism in children. Although the study was flawed, it established a clear question: does MMR cause autism? This question has been addressed in 12 different epidemiological studies involving millions of children who either did or did not receive the vaccine. The answer is quite clear: that vaccine never caused autism. Here are Dr. Offit’s thoughts on this:

…science is enormously self-correcting. Andrew Wakefield stands up in 1998 and says, ‘I believe MMR causes autism.’ Well, he raises a hypothesis. It’s a testable hypothesis. It’s been tested. He was wrong. And that’s what I love about science. It’s just enormously self-correcting, and I just think people don’t see it that way¹

The original Wakefield paper has been retracted by 10 of the 13 authors. However, the damage has been done: immunization rates with MMR have dropped in the UK, Europe, and the US. The incidence of measles is increasing and there have been deaths of children from the disease. Deaths that could have been prevented had parents chosen to have their children immunized with MMR. The controversy over MMR has lead the public to distrust all viral and bacterial vaccines, and consequently the incidence of other preventable diseases is rising.

The notion that MMR causes autism was accompanied by safety concerns about thimerosal - a mercury-containing preservative used in some vaccines to prevent microbial contamination. The results of several large epidemiological studies found no connection between autism and thimerosal. Nevertheless, the preservative was removed from most childhood vaccines - probably an error, according to Dr. Offit, which simply made parents more suspicious. Autism rates have not dropped since the use of thimerosal was discontinued.

Many parents still do not believe the conclusion that vaccines do not cause autism. Part of the problem is that the etiology of autism is not understood. To a parent, the temporal association of immunization with onset of autism is difficult to ignore. Dr. Offit recalls a story which addresses this issue:

…it’s hard to make a statistical argument, or an epidemiological argument, to a parent who’s seen something that’s very emotional. There’s a story that I tell, because I think it’s a powerful one. My wife is a privately practicing pediatrician in the suburbs. And she was in the office one day and there was a four-month-old sitting on her mother’s lap. And my wife was drawing a vaccine into a syringe that she was about to give this child. Well, while she was drawing the vaccine into a syringe the child had a seizure, and actually went on to have a permanent seizure disorder—epilepsy. And there had been a family history of epilepsy, so she was certainly at risk for that. If my wife had given that vaccine five minutes earlier, I think there’s no amount of statistical data in the world that would have convinced that mother that anything other than the vaccine caused the seizure, because I think those sort of emotional events are very hard to argue against.

Some have accused Dr. Offit of pandering to the pharmaceutical establishment and enriching himself by publishing Autism’s False Prophets. I don’t think these arguments contain a shred of truth. Dr. Offit is donating all the royalties from the boook to autism research. More compelling are his words from the interview:

I worked on that (rotavirus) vaccine because I thought that it could do a tremendous amount of good for children. It’s the same reason that I stand up for the science of vaccines and the science of vaccine safety. I care about children. That’s my motivation.

¹Quotations by Dr. Offit are taken from a transcript of his conversation with Dr. Ginger Campbell.

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As many of you may recall, Merck tried unsuccessfully last year to lobby state and federal officials to pass legislation that would require mandatory vaccination of girls aged 9-26 with Gardasil, its anti-HPV, cervical cancer vaccine. Merck came under fire for its efforts (which seemed ethically disingenuous to many). Consequently, the company’s image took a hit and its stock price started to tumble. Although Merck stopped its lobbying campaign (mostly because of bad press and a flagging stock price), Gardasil ads continued to run and went largely unnoticed.

Because GlaxoSmithKline may be close to launching Cervarix^Tm—its cervical cancer vaccine—  the company recently decided that it was time to ramp up its Gardasil advertising efforts. Starting this past Saturday and continuing through June 26, Gardasil ads will be gracing the screens of a theater  near you. The ads will be shown with films like “Sex and the City” (hmmm, clever wouldn’t you say?), “Get Smart” (who doesn’t remember Barbara Feldon), “The Happening” (what woman doesn’t love a scary movie), “You Don’t Mess with the Zohan” (Adam Sandler is hot) and several others. I want to thank Ed Silverman over at Pharmalot for the heads up on this story!  I don't know about you, but I think that showing commercials at the movies, especially those hawking pharmaceutical products, is just plain wrong!!!!!!!!

This isn’t the first appearance of Gardasil ads at the cinema—I recall seeing an ad for Gardasil the last time I went to the movies (I don’t remember the movie but I clearly can recall the ad!). According to a Merck spokeswoman (aren’t pharmaceutical companies clever?), “We purchased advertised space that is relevant for our older female target audiences; specifically for the summer movies that are relevant to those aged 19 through 26.” 

As Ed so eloquently stated in his Pharmalot post: “Of course, plenty of teenagers will be seeing some of these flicks, too. Zohan and Get Smart are rated PG-13. And Sex and The Happening are rated R, but the restrictions only apply for kids under 17– some of whom will, no doubt, see them anyway.  In any event, Gardasil is unlikely to be available as a value pack that includes soda and popcorn. But we (Pharmalot) are curious to know whether the Gardasil beach towel is about to make a comeback.”

 Until next time….

Good Luck and Good Movie Watching!!!!!!!!!!

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Pfizer the world’s largest and least innovative pharmaceutical company  announced yesterday that its profits dropped by 18% last year. The company attributed the loss to reductions in the sale of its blockbuster anti-cholesterol drug Lipitor, which is slated to lose patent protection in the next few years.

Pfizer, which has about $25 billion in cash, has been on something of a buying spree the past couple of years. The company is desperately trying get into biotechnology (too little, too late?) and believes, as it always has, that the best way to enter a new therapeutic area is to buy its way into it! To that end, Pfizer has already purchased two “biotech” companies in 2007 (more purchases are likely on the way) and entered into financially-lucrative, long term research collaborations with several others. Although this strategy has previously worked for Pfizer in the short term, it has proved to be financially disastrous for the company in the long term. Nevertheless, Pfizer said it still expects earnings this year to grow about 11%, due largely to a cost-cutting program that has eliminated 25,000 jobs, or 23% of its work force since 2004.

Until Pfizer executives realize that a robust internal drug discovery and development program is the key to success, Pfizer will continue to be the world’s biggest pharmaceutical company with a constantly flagging stock price.

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!!!

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Is it luck or good planning that has prompted many pharmaceutical and biotechnology companies to set up manufacturing and research operations in Ireland? In my opinion, the recent Irish pharma and biotech explosion has little to do with luck and everything to do with strategic vision, excellent planning and a well trained, inexpensive workforce.

Currently, 28 out of the 50 top pharmaceutical/biotechnology companies in the world have facilities in Ireland. Some of these companies are Merck, Wyeth, Genzyme, GlaxoSmithKline, Pfizer, Johnson and Johnson, Schering-Plough and Bristol-Myers Squibb. Seven out of 10 of the world’s top selling blockbuster drugs are now manufactured in Irish production facilities. 

Pharmaceutical companies were the first to set up shop in Ireland. However, biotechnology is growing rapidly and biomanufacturing is starting to over shadow traditional small molecule production. Companies including Wyeth, Centocor, Bristol-Myers Squibb, Organon Biosciences (now part of Schering Plough) and Allergan manufacture biologics and biotechnology products in Ireland. In fact, Ireland is home to the world’s largest biomanufacturing facility, Wyeth’s € 1.3 billion Grange Castle near Dublin.

So why pharma and biotech are companies flocking to Ireland? First, the Irish labor force is well trained, everyone speaks English (albeit with an Irish lilt) and wages are still low. Second, Ireland has the lowest corporate taxes in the entire European Union. Further, there are R&D tax credits and financial support for start ups.  For example, there is financial support to purchase consultancy and innovation vouchers worth €10,000, a substantial amount of money for any startup! Finally, and perhaps most importantly, the Irish government had the foresight to create a public/private enterprise known as the National Development Plan (2000-2006) that invested € 2.5 billion to create an Irish R&D infrastructure.

The Irish strategy–“built it and they will come”– has certainly paid off handsomely for Ireland. Another country that has embraced a similar strategy is Singapore–which through a public/private initiative has been building a vibrant life sciences and biotechnology industry since 1999. Both countries now compete for pharma and biotech business. For example, in late 2007, Merck decided to build a € 200 million vaccine facility at Carlow Town in Southeast Ireland. Novartis, on the other hand, opted for Singapore to build a new $180 million pharmaceutical tabletting facility along side of its API production plant.

Unlike Ireland, the American pharmaceutical and biopharmaceutical industries are in trouble and losing their competitive edge. Perhaps the US can learn a thing or two from the Irish to give its bioscience industry a much needed shot-in-the arm.

Until next year….

Good Luck and Good Job Hunting (try Ireland)!!!!!!!!!!

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