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Novartis announced today that it will open a new research facility and hire an additional 150 people by the end of 2009 for a Research Center of Excellence in Virology in Cambridge, MA. That will increase the number of people employed by the company in Cambridge to more than 1,800 workers. Researchers at the new center will study vaccines for HIV/AIDS influenza, cytomegalovirus (CMV) and respiratory syncitial virus (RSV). 

The vaccine business once avoided like the plague by most pharma companies, has been growing by leaps and bound over the past five years and is sizzling hot these days. According to analysts, vaccines generated about $16 billion dollars last year. For example, Merck’s anti-human papilloma virus vaccine Gardasil generated $1.5 billion in sales in 2007.

Novartis clearly sees an upside in the vaccine business and is willing to make a wise investment for the future.

Until next time….

Good Luck and Good Job Hunting!!!!!

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First, King Pharmaceuticals posted a non-branded high blood pressure video on YouTube in early 2007. Next, Novartis added a 60-second commercial (as part of its Fluflix campaign) asking people to submit videos about what it's like to have the flu. Earlier this year, Insmed upped the ante by posting a video lobbying for new legislation for the approval of follow-on biologics in the US. However, these pharma assaults on YouTube pale in comparison to the launch of Johnson & Johnson’s health channel on YouTube earlier this week.

The channel currently showcases a small selection of health information videos created by NBC News chief medical editor Nancy Snyderman while she worked J&J. Video sites, like YouTube and Vimeo, offer pharma companies a place to feature expensive off media advertising assets (that are currently collecting dust) and to post ads for new drugs and products that are ready for launch.  J &J is the first pharma company to recognize that it can leverage the current social media craze to increase its visibility, sell more drugs and bolster its stock price!

While companies could host videos on their own websites,YouTube’s massive traffic of more than 80 million users offers companies a much larger and diverse audience. And unlike blogs or forums, pharma companies have complete control over the content of the videos that they post on video websites. Moreover, they don't have to worry about negative comments being left after a post (YouTube comments can be turned off), and they can brand and edit video content to target a particular demographic or audience. Finally, videos can be changed or removed by companies as needed.

The bad news is, that like all other forms of media on the Internet, there are currently no regulations for videos posted by pharma companies on video websites sites like YouTube. In other words, pharma companies can do or say whatever they want in the videos that they post—never a good thing! I suspect that at some point FDA will draft a guidance document or two on the topic. But pharma companies need not worry, it will likely be many years before the agency divines regulations guiding the messaging and content of online pharmaceutical videos.

The appearance of pharma videos on YouTube, and the growing number of pharma profiles on social networking sites indicates that pharma is ready to embrace social media as the next best thing since DTC advertising. I was wondering what took them so long?

I hope that J&J doesn’t start following me on Twitter!

Hat tip to Eye on FDA for the story!

Until next time,

Good Luck and Good Job Hunting!!!

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Daiichi Sankyo will buy a controlling interest (50.1%) of Ranbaxy, India’s third largest generic manufacturer.  Daiichi will pay as much as $4.6 billion for the opportunity.

The deal will put Daiichi Sankyo into ninth place in the $120 billion generic-drug market behind leaders Teva Pharmaceutical Industries Ltd. and Novartis AG's Sandoz unit. According to the report “Daiichi Sankyo is mimicking strategies pursued by Novartis and Johnson & Johnson to weather turbulence in the branded-drug industry by diversifying into other markets. The acquisition also gives the Japanese company more reach in emerging regions including India, China and Eastern Europe. “

I think after this deal, that other pharmaceutical companies may consider buying profitable generics businesses. I am not sure why it has taken innovator companies so long to realize that it is much easier to join (buy??) rather than compete with generic manufacturers. It just seems so obvious to me—and I don’t even have an MBA!  Maybe there is some truth to the age-old aphorism “missing the forest for the trees.”

Until next time…

Good Luck and Good Job Hunting!!!!!

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Novartis announced today that it intends to purchase Malvern, PA-based Protez Pharmaceuticals for $400 million. Protez is developing a novel spectrum carbapenem antibiotic that is active against variety drug-resistant Gram positive (most notably MRSA )and Gram negative bacterial pathogens. Its lead compound, PZ-601, is in Phase II human clinical testing. Protez acquired PZ-601 (formerly SMP-216601) in 2005 from Dainippon Sumitomo Pharmaceuticals.   

Novartis is buying Protez to sure up its antibacterial drug pipeline. Novartis already sells Cubicin, (manufactured by Massachusetts-based Cubist Pharmaceuticals Inc.,) in Europe and is developing other antimicrobials including Aurograb and Tifacogin to treat infections.

Like many of the newly marketed antibiotics, PZ-601 is injected and not orally bioavailable. Nevertheless, it is likely that PZ-601 will provide much needed help against the ever increasing number of drug resistant bacterial isolates. Swiss companies Basilea Pharmaceutica AG and Arpida Ltd. are also working on experimental medicines to treat MRSA.

It is not clear how the acquisition will affect Protez employees.  I suspect that most of the employees will keep their jobs except for Company officers.

Until next time…

Good Luck and Good Job Hunting!!!!!

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Takeda Pharmaceutical Co., Japan’s largest pharmaceutical manufacturer, announced that it has agreed to buy Cambridge MA-based Millennium Pharmaceuticals for $8.8 billion. Millennium, founded in 1993 by high profile MIT researchers and once heralded as one the most innovative American biotechnology companies, never lived up to analyst’s expectations. That said, the company did develop and win regulatory approval for an anti-cancer drug, Velcade, which is expected to garner additional approval for wider use in oncology later this year.

Velcade, which is used to treat relapsed multiple myeloma after other drugs fail generated more than $800 million last year. Millennium anticipates U.S. approval by June to promote Velcade as an initial therapy to treat these disorders. Millennium markets Velcade in the US and shares revenue with Johnson & Johnson which markets Velcade in 85 other countries. Analysts predict that the Takeda acquisition will help to propel Velcade to blockbuster status.

The Takeda-Millennium deal follows Eisai Co.’s (another Japanese company) agreement in December to buy the U.S.'s MGI Pharma Inc. for $3.9 billion as Japanese companies, aided by a weak dollar against the yen, seek growth abroad. Japanese companies have been hampered by government-ordered price cuts, weak pipelines and a lack of new products  As one financial analyst put it ``There's no doubt the weak dollar against the yen is making U.S. biotech very attractive right now to potential Japanese buyers,''

Takeda’s best seller is the diabetes drug Actos which is slated to lose patent protection in the near future. Acquisition of Millennium provides Takeda with an entrée into the oncology and cardiovascular markets both of which are poised for expansive growth in the next five years. Analysts also believe that the Millennium acquisition will boost Takeda’s drug discovery and development flow. Millennium is conducting human trials with experimental drugs for cancer, heart disease, gastrointestinal disorders and rheumatoid arthritis.

The ongoing acquisition of American biotechnology companies by Japanese pharmaceutical companies reminds me of  the Japanese foray into the US real estate market in the early 1990s. Only time will tell whether the Japanese will be able to hang on to their acquisitions this go around (they weren’t the last time).  Earlier this week, Switzerland's Novartis AG agreed to buy 77 percent of eye-care company Alcon Inc. in a two-step transaction totaling $39 billion. Does anybody else see a troubling trend developing here as a result of the recession that we are in or heading into?

Don’t be surprised to see some “asset reallocation” and downsizing at Millennium. The Japanese are well recognized for increasing efficiency and work output with smaller numbers of employees.

Until next time….

Good Luck and Good Job Hunting (not in Cambridge MA)!!!!!!!!

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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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Novartis announced late last year that it intends to invest about $700 million to build a new biomanufacturing facility in Singapore. Construction will begin in early in 2008 and the plant is expected to be fully-operational by 2012. The new cell culture production facility will employ approximately 300 people and support manufacturing of both clinical and commercially-available products, mostly monoclonal antibodies.

At present, biologics and protein-based biotechnology products represent about 25% of Novartis’ drug pipeline. Most of these products are owned and manufactured by Novartis’ wholly owned subsidiary .

You gotta tip your hat to Singapore—their government-sanctioned plan to invest billions of dollars into biomedical research seems to be paying off!

Until next time

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

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As the debate continues to rage in the US about how to regulate biogeneric drugs, the European Medicines Agency (EMEA) has given the go-ahead to Hospira and Stada to sell their copycat version of Johnson & Johnson's anemia drug Procrit.

The European Commission approved Retacrit (epoetin zeta), a biosimilar version of erythropoietin (EPO), to treat anemia associated with chronic renal failure and chemotherapy. EMEA regulators determined that the drug was comparable in efficacy and safety to Procrit.

The EPO market is a large one and more than 250,000 patients in Europe are estimated to be treated with epoetin alfa, which is marketed under various brand names, Procrit (JNJ; US), Eprex (JNJ; Europe) and Epogen (Amgen; US). Worldwide annual sales of EPO drugs are estimated at more than $7 billion, $600 million of which comes from Europe.

The approval for Retacrit comes some three months after Novartis’ generics unit Sandoz got the first go-ahead in Europe to develop its version of epoetin alfa. Sales of Retracrit will begin in Germany in early 2008.

When are American pharmaceutical and biotechnology executives going to wake up and realize that they will lose millions in revenue to biosimilar competition?  I think the old adage; “If you can’t beat ‘em, join ‘em” is apt when talking about the biogenerics industry.

Until next time…

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

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Ed Silverman at Pharmalot alerted me to this tidbit. Daniel Vasella, CEO of the Swiss drug maker Novartis AG, mentioned in an interview with The Wall Street Journal that he is planning a companywide restructuring aimed at reducing “layers of management and bureaucracy—following through on reorganization comments he made several months ago.

Novartis, plans to disclose more about its restructuring plans by mid-month and elaborate further in February, adding that the restructuring will involve some job cuts, but Vasella declined to say how many. In an October briefing for analysts, Novartis executives said there would be 240 jobs cut in US headquarter functions Hanover, NJ) and 510 sales reps and 510 contracted rep positions eliminated, for savings of $230 million.

Novartis is one of several big drugmakers to cutback - AstraZeneca, Pfizer, Bristol-Myers Squibb, Glaxo and Johnson & Johnson have all announced layoffs in the past year. And Merck and Wyeth continue to trim selectively as part of ongoing savings programs.

According to the Journal, the changes at Novartis will follow recent management changes and comes after a tough year for Novartis. The drugmaker, faced generic competition on some of its

biggest drugs and failed to gain FDA approval for two new products–including the anti-diabetes drug Galvus (vildagliptin) which was predicted to be a blockbuster. Earlier this year, it also was forced to withdraw from the US and Swiss markets its drug for irritable-bowel syndrome, Zelnorm, after safety concerns.

One new rule Vasella has set: There should be no more than six layers of employees in any Novartis division, from the lowest-ranking person up to the division head. Novartis has four divisions: pharmaceuticals, generics (Sandoz), vaccines and diagnostics, and consumer health, which includes over-the-counter medicines.

Vasella says he realized the pharma division, in particular, was bogged down with bureaucracy after he had recent lunch with a group of its employees. The reorganization will also cut costs from Novartis’s procurement activities. One area that will come under particular scrutiny: the use of third-party CROs to oversee Novartis’s clinical trials which has been extremely costly for the Company.

Until next time....

Good Luck and Good Job Hunting (China and India?)!!!!!!

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Ed Silverman who runs the  Pharmalot blog reported that Novartis is slated to cut about 1,200 jobs to save the company about $230 million a year.  According to the post at Pharmalot, Novartis will let 240 employees go at its US- based headquartersin Hanover, New Jersey and eliminate over 1,000 full time and contract sales representatives from its workforce.  Also reported was that Novartis is planning to create a biologics division within the company.  I find this extremely interesting because Novartis already has a strong footprint in the biologics biz  via its wholly-owned subsidiary Sandoz, which is one of the market leaders in the follow-on biologics aka biosimilar sector.

I guess having a biologics division is de rigueur these days if you are a big pharma company.  I am still wondering why it took so long for all of these high paid pharmaceutical executives to figure out that biotechnology was the next  big thing?  You would think that after 30 years, they would get the hint.  But then gain these are some of the same people who brought us Vioxx, Avandia, Exubera and ...go ahead ....pick your favorite.

Until next time....

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

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