Vaccines: The New Blockbusters?

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!)

 

Merck Acquires Contract Manufacturer Avecia as it Positions Itself to Enter the Follow on Biologics Market

Merck & Co. Inc., and Avecia Investments Limited today announced that they have entered into a definitive agreement by which Merck will acquire the biologics business of UK-based Avecia; a contract manufacturing organization with specific expertise in microbial-derived biologics. A Merck executive commented on the deal:

"At Merck we continue to execute on our strategy of expanding our biopharmaceutical expertise and manufacturing capacity, This transaction follows an initial strategic development and supply relationship with Avecia Biologics and will provide us with an operational facility staffed by an experienced workforce that is highly skilled in a broad portfolio of bioprocess systems."

The Avecia acquisition follows Merck’s announcement late last year that the company will enter the global follow-on biologics (aka biosimilar) market. Merck’s decision was likely based on strategic acquisitions several years ago of a small biotech company, Glycofi, which developed a humanized yeast protein production platform, and Insmed, a Richmond, VA-based, follow-on biologics company, which was acquired last summer. Avecia provides Merck with the biomanufacturing capacity and expertise that it will need for clinical development and commercial manufacturing of its follow-on biologics. The company expects to bring its biosimilar products to market by 2017 or earlier.

Until next time...

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

 

How to Make Flu Vaccine: A Tutorial

Flu season is upon us and, not surprisingly, there is no dearth of information available to the public about the seasonal and H1N1 flu vaccines. Mostly there are stories about the lack of availability of the vaccines, underreporting of deaths associated from H1N1 infections and perhaps, most importantly concerns about flu vaccine safety. Despite attempts by the CDC and a few dedicated virologists like BioCrowd co-founder Vincent Racaniello, flu vaccine manufacturing is an enigma to the lay public.

While I am a card-carrying microbiologist, my knowledge of the manufacturing of flu vaccine is admittedly lacking. With this in mind, I came across an outstanding tutorial about flu vaccine manufacturing published by the College of Agriculture at the University of Wisconsin-Madison (my alma mater). The UW tutorial is easy to understand and will shed light on and help to demystify flu vaccine production for lay people (and a few scientists like me).

 

Luck of the Irish-Ireland is a Great Place for Pharma and Biotech

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)!!!!!!!!!!

The Beat Goes On: Merck Sells Antibiotic Manufacturing Facility

Reuters reported today that Merck & Co Inc has sold a manufacturing plant in Pennsylvania to PRWT Services Inc, as part of Merck's global restructuring of its manufacturing operations.

PRWT Services has entered into a five-year supply agreement with Merck valued at $100 million to $200 million a year, the companies said in a statement.

The Cherokee manufacturing plant in Riverside, Pennsylvania, employs 400 people, and produces antibiotics for humans and animals. As many of you may know, Merck’s CEO, Richard Clark ran manufacturing operations at Merck for 30 years before being appointed its top executive. Maybe he knows something that we don’t about the future of antibiotics?

Until next time…

Good Luck and Good Job Hunting!!!!!