Sandoz Moves Its Biosimilar Development Strategy Forward
Sandoz, the generics division of Novartis, is currently the world leader in the biosimilar market. In fact, if it was not for Sandoz, the biosimilar industry may never have gotten started in the first place! As some of you may know, Sandoz sued FDA (and won) to gain approval of its biosimilar human growth hormone. While FDA contends that Omnitrope is not really a biosimilar (it was approved as a “drug” rather than a biologic) most analysts agree that it was the first biosimilar product ever approved and sold in the US.
As part of its global biosimilar strategy, Sandoz today announced that it had initiated Phase III clinical trails for US approval of biosimilar version of recombinant human granulocyte-colony stimulating factor(G-CSF) or filgrastim (Amgen’s Neupogen®) and another for global launch of PEG-filgrastim (Amgen’s Neulasta®); a PEGylated form of G-CSF.
The filgrastim study is designed to evaluate the efficacy and safety of Sandoz's biosimilar filgrastim versus Neupogen® in breast cancer patients eligible for myelosuppressive chemotherapy treatment. These trials expected to support extension of commercialization to the US, the largest global market for biologics. The pegfilgrastim study, which is being conducted in breast cancer patients undergoing myelosuppressive chemotherapy treatment, represents the next major step in the Sandoz global biosimilar development program. Previously, Sandoz announced that it had initiated late stage clinical trials for a biosimilar version of Roche’s monoclonal antibody cancer treatment Rituxan®). Finally, Sandoz has eight to ten different biosimilar molecules at various stages of development in its pipeline.
Sandoz currently markets and sells three biosimilars: filgrastim (Zario®), somatropin (Omnitrope®) and epoetin alfa (Binocrit®) in countries across Europe and elsewhere. As mentioned above Omnitrope is also sold in the US. However, because FDA has yet to craft a regulatory approval pathway for biosimilars (despite legislation mandating their approval) it is illegal to sell biosimilars (with the exception of Omnitrope) in the US.
Once vilified and staunchly opposed by most major pharmaceutical and biotechnology companies, the biosimilar business has been picking up steam in the past few years. To that end, companies like Merck, Pfizer, Teva and more recently Amgen and Biogen (all of whom lobbied against an approval pathway for biosimilars in the US) announced plans to compete on the global biosimilar market.
The decision of these companies to enter the biosimilar market is largely a result of downward pricing pressures on pharmaceutical and biotechnology drugs and near-empty drug pipelines at most major life sciences companies. Nevertheless, it is still not clear whether or not a robust biosimilar market truly exists. To wit, biosimilars have been in the market in the EU for the past fiver years and have not gained much traction there. However, the real biosimilar markets probably exist in China, Brazil and other emerging countries where there are large populations and emerging middle classes but drug prices are under tight government regulation. Because of this, the uptake of biosimilars in these markets will likely be greater than in Europe and the US.
Until next time...
Good Luck and Good Job Hunting!!!!!!!!!!!!!!!
A 
Merck
While Samsung is mostly know for flat screen televisions and other electronic appliances, one of South Korea’s largest companies has been quietly evaluating a play in the protein engineering and manufacturing space. For those of you who may not know, Korea possesses one of Asia’s most vibrant biotechnology industries. At present, there are over 600 Korean biotechnology companies in existence. In April 2011, Samsung created a business units called Samsung Biologics which specializes in biopharmaceutical manufacturing.
Not a day goes by without some report about pharma’s ongoing problems with illegal drug promotions, class action suits against blockbuster medications or civil or criminal settlements with state and federal governments. A quick perusal of articles posted to the Pharmalot Blog in November alone revealed no fewer than eight big pharma companies including 
Last week, I reported in a 
Over the past 10 years or so there has been an enormous amount of consolidation in the life science industry. While this activity has been very good for shareholders, it has had a devastating effort on pharmaceutical R&D says John LaMattina PhD, a chemist, .jpg)
Earlier this week Roche Holding AG 
After a relatively quiet summer, big pharma companies are beginning to ramp up layoffs once again.
As I scientist, I find it offensive that Republican Presidential candidates like Michele Bachmann and Rick Perry are allowed to spew false claims and scientifically-wrong information to the public without a peep from the scientific community. Perhaps many scientists choose to not publicly speak out--even though they know that the information is wrong or unsubstantiated--because they don't want to attract attention to their often arcane research for fear that their funding may be cut. Or, maybe,scientists too often believe that the public won't understand what they say anyway. Whatever the reason, I applaud two bioethicists, Art Caplan at the University of Pennsylvania and Steve Miles at the University of Minnesota, for standing up to Michele Bachmann, a tea party Republican presidential hopeful, assertions that human papillomavirus (HPV) vaccines--that protect against cervical cancer --cause mental retardation in those girls who are vaccinated with them.
Layoffs at big pharma tend to slow during the summer as most people are on vacation and nobody wants to fire folks when the kids are out of school. However, the failing economy has prompted several companies to abandon tradition and fire people during the summer anyway.
There is no longer any doubt that big pharma companies are beginning to 
Merck & Co, which yesterday completed its $430 million acquisition of Inspire Pharmaceuticals, (1).jpg)
Mathew Herper, who writes at the Forbes Blog, .jpg)
BioJobBlog readers who understand .jpg)
Two years ago Merck 
Over the past few years, life sciences companies have shed over 200,000 jobs. Unfortunately, downsizing at some of these companies may not be over yet. Nevertheless, companies are always looking to recruit new talent to keep up with normal job turnover rates or to replace highly specialized employees whose skills sets are essential to successfully running the business. Because many of these former life sciences employees possessed special or arcane talents and skill sets, advertising for their replacements using conventional methods like 
It is no secret that Sanofi-Aventis is facing a steep “patent cliff” in 2013 when some of its top selling drugs, most notably Plavix, will lose patent protection. Some analysts contend that the company can lose as much as a quarter of its annual revenue because of generic encroachment on blockbuster brands. Sanofi is narrowing its business to three areas -- diabetes, heart problems, and cancer -- and is seeking partnerships and acquisitions.
Merck has finally gone where no pharmaceutical company has ever gone before; it (1).jpg)
The era of blockbuster drugs was officially declared over several years ago by many pharmaceutical analysts and pundits. Nevertheless, as the old adage goes “it’s difficult to treat old dogs’ new tricks!” After all, the blockbuster drug model has been the major driver of pharmaceutical and biotechnology markets for close to 50 years. Consequently, big pharma and biotech companies haven’t truly abandoned the possibility of finding potential new blockbusters. And, it appears that the blockbuster heir apparent may be drugs to treat rare aka orphan disease indications. 
I am certain that many of you may have noticed that the size of the life sciences industry is shrinking at an unprecedented rate. Big pharma companies flush with cash, near- empty pipelines and impending patent cliffs have embarked on a buying spree that is likely to continue for next years (or at least until the economy shows clear signs of resuscitation). Pfizer’s .jpg)
The New York Times
Merck & Co today .jpg)
Earlier this month, Merck BioVentures, the company’s new division focused on developing follow-on biologics aka biosimilars announced that it was .jpg)
The US Food and Drug Administration (FDA) has advised GlaxoSmithKline (GSK) to .jpg)
Merck of Germany .jpg)
Last week, the market-analyst firm 
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It is getting difficult to keep track of the job cuts that are happening almost daily at Pfizer. A quick perusal of the job cuts to date indicate that the company has eliminated about 1200 jobs in the past week;.jpg)
Just when you thought things couldn’t get much worse for New Jersey, Merck and Pfizer 
Merck & Co. Inc., and Avecia Investments Limited 
I realize that I have been blogging about adverse events for the past couple of day but, let’s face it; the pharmaceutical industry lives or dies by the number of adverse events (AEs) that are reported for approved and marketed drugs. In any event, I came upon an interesting post in a Pharmaceutical Processing e-blast about the results of a .jpg)
I suspect that many of you (after reading the title of this post) might be expecting another rant about the need for new antibiotics to treat infections caused by multiple drug resistant strains of bacteria. Sorry to disappoint you because that isn’t what this post is about. After reading and listening to several seemingly disparate radio and newspaper stories this morning, I decided to combine three different stories into a single post that touches on several common themes.
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it would eliminate as many as 8,200 jobs, or 7% of its work force, to help the company cope with what it expects will be a slow economic recovery amid damped demand for drugs, medical devices and consumer products. J&J employs about 117, 000 workers globally. While the job cuts will be global, many losing their jobs will be outside of the US. 
Late last week, the US Food and Drug Administration (FDA) .jpg)
Without fanfare, .jpg)
My son, who is a 9th grader, was recently asked to write an essay for his social studies class about the application of Machiavellian principles to modern day rulers and governments. One of 
A spokesperson at the US Food and Drug Administration (FDA) 
The Belgian chemical manufacturer Solvay .jpg)
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..jpg)
Yesterday, (1).jpg)
The 
As expected, Merck announced today that it would eliminate an additional 16,000 job after the merger with Schering Plough is completed. The combined company is trying to get its headcount down to around 90,000 employees. The new job cuts represent a 15% reduction in the workforce of the combined company.
Johnson & Johnson (JNJ) is trying to regain sole marketing rights to Remicade, its lucrative anti-TNF treatment for arthritis and psoriasis, because Schering Plough (SGP)—which has most of the marketing rights to the drug outside of the US—is being acquired by Merck. JNJ is seeking arbitration to determine whether or not Centocor, its subsidiary that manufactures Remicade and Simponi, can terminate a marketing agreement for the two drugs—based on terms stipulated in the original contract —if there is a “change of control” at SGP.
The FDA has approved Johnson and Johnson’s Simponi (golimumab), a new treatment for adults with moderate-to-severe 
Since 2007, approximately 80,000 pharmaceutical jobs have been eliminated. The recent consolidation in the industry, e.g., Merck-Schering, Pfizer-Wyeth and Roche-Genentech suggests that many more life sciences jobs will be lost over the next year or so. Typically, to avoid law suits and possible discrimination claims, most companies will layoff a mixture of experienced and entry level employees that cover the racial, religious and age spectra. For those of you who may not know, Americans who are 40 and older constitute a “protected class of employees.” In other words, companies that layoff employees cannot disproportionately give pink slips to employees 40 years of age or older. This law was enacted because older employees typically have higher salaries and have accrued more benefits and vacation time than their more junior counterparts and eliminating them can drastically cut costs. While most companies are careful to layoff a mixture of junior and senior employees during large layoffs, a quick perusal of the demographics of employees who lose their jobs reveals that many of them are older, more experienced workers. Sacrificing a few entry level employees (to prevent any red flags) is worth it to the accountants who charged with cutting costs and orchestrating large corporate layoffs..jpg)
Today's New York Times reported that the US Food and Drug Administration (FDA) issued warning letters and ordered 14 pharmaceutical and biotechnology companies to stop running what it calls misleading ads on internet search pages displayed by search engines like Google. The agency faulted the companies for failing to identify product names (brand) and not listing potential side effects (only benefits) for the drugs. In other words, the ads lacked “fair balance” something that FDA stresses and that all drug makers are very familiar with. 
The old baseball adage which says that “you can’t tell the players apart without a program” is particularly apt when it comes to tracing the M &A activity that led to the creation of some today's largest pharmaceutical companies.
As you all know by now, 
Some of you may have been wondering why the.jpg)
Merck announced today that it was buying Schering Plough, the Kenilworth-New Jersey based drug maker, for $41.1 billion. The deal comes only six weeks after Pfizer said that it would purchase NJ-based Wyeth Pharmaceuticals. Superficially, the deal may make sense for the two struggling drug makers—they co-market the cholesterol-lowering drug Vytorin and also have collaborations in the respiratory diseases area. Also, Schering Plough has the European rights to the anti-arthritis drug Remicade and its 2007 purchase of the Dutch biopharmaceutical company Organon Biosciences NV provides access to several potential biotechnology drugs. Nevertheless, the impending merger will ultimately result in job losses and higher unemployment in the state of New Jersey..jpg)
A team of researchers at the University of Wisconsin-Madison (my alma mater) genetically engineered a strain of Streptomyces platensis to 
Pfizer is the largest pharmaceutical company in the world. It was able to garner that distinction by going on a decade-long buying spree that began in the mid 1990s. To date, Pfizer has acquired Warner Lambert, Pharmacia and a host of smaller specialty pharmaceutical and biotechnology companies. Despite these acquisitions, which yielded top selling blockbuster drugs like Lipitor and Celebrex, Pfizer’s stock has never performed up to analyst’s expectations. In fact, while it’s smaller and more nimble pharmaceutical competitor’s stock prices were soaring, Pfizer’s stock price was either flat or falling. While conventional wisdoms suggest that “bigger is always better” this has proven not to be the case when companies, like Pfizer, attempt to win greater market share through mergers and acquisition and also loss sight of their core business..jpg)
At its annual business briefing, 
The Pharmalot blog reported today that 
Astra Zeneca announced today that it would cut 1400 jobs and close several manufacturing facilities worldwide. 
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The Centers for Disease Control and Prevention said about 25% of teenage girls received at least one dose of Merck & Co.'s Gardasil vaccine in 2007
Beginning in 2009, Eli Lilly and Merck will post in online databases all payments made to doctors for speaking and consulting services. 
Despite an increase in profits, .jpg)
A post at the Pharmalot blog.jpg)
The old adage “When it rains, it pours” is particular apt for the bad news that has plagued the once venerable Merck & Co for the past five years. First, there was the Vioxx scandal, followed in short order by the Vytorin and Singulair messes and now it appears that the company’s new anti-cervical cancer vaccine, Gardasil, may have —pardon the expression — a few “warts” on it. 
Monoclonal antibodies (MAbs)
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 
Merck announced last week that it will cut 1,200 sales jobs in the U.S. by the end of July. The company also confirmed a plan to eliminate a small natural products group in Spain and Rahway, NJ. Whereas the salespeople who lost their jobs were given notice by the company, the natural products researchers in Spain (and Rahway) learned of their imminent demise via a power point presentation given by a Merck executive (whose name has not been disclosed)..jpg)
As I mentioned in previous posts, things are simply not going Merck’s way. Merck has been .gif)
seems like nothing is going right for Merck these days. 
As I mentioned in a .jpg)
There is 
There has been some confusion surrounding the reporting of results from the Enhance Trial. As you know, the results from this study showed that the cholesterol-lowering drug Vytorin—a combination of Zetia and Zocor (a statin) —was no better than a generic version of Zocor by itself at controlling atherosclerosis..gif)
An editorial published in this week’s New England Journal of Medicine and 
After weathering the Vioxx storm for the past three years, Merck again finds itself in choppy and unchartered waters. Still reeling from the Vytorin flap that erupted two months ago, there are new allegations that its blockbuster allergy and asthma medicine, Singulair, may be linked to suicide. The US Food and Drug administration (FDA) was quick (this time) to announce that it is launching an investigation into reports that suggest that Singulair may cause patients taking the medication to commit suicide. Merck received approval for Singulair in 1998 and it had sales of $4.3 billion in 2007..jpg)
Oh, what a difference a couple of years or results from a pivotal clinical trial can have on a company’s financial outlook. As you may recall in 2005, Merck was in a shambles after the Vioxx scandal broke. Its CEO was ousted, its stock was trading at less than $35 per share and employee morale was at an all time low. After two short years, Richard Clark, a life-long Merck employee, was able to turn the company around. Merck’s stock reached a high of almost $61 last December and many of its employees were dancing in the streets of Rahway because their stock options were now worth more than the paper that they were printed on. But, like many things in life, all good things must come to an end..jpg)
him when he assumed leadership of the company in May, 2005. At that time, Merck had withdrawn Vioxx from the market, its stock price had plummeted and the company was being sued by tens of thousands of people. Thanks to the launch of several new products, including Vytorin and Gardasil, a brilliantly-conceived Vioxx legal strategy which resulted in a $4.85 billion settlement for much of the litigation, Merck‘s stock price is soaring and has been able to restore some of its former glory.
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.
Last December, the US Food and Drug Administration (FDA) asked GlaxoSmithKline for additional information related to its cervical cancer vaccine Cervarix. The company has yet to reply to unspecified queries in the FDA's "complete response letter" that it received last December. .jpg)
Amgen announced yesterday.jpg)
Merck and Schering Plough have taken out two-page ads in several major newspapers defending their cholesterol drugs Zetia and Vytorin
for his intrepid reporting on the Vytorin scandal and keeping BioJobBlog abreast of all late-breaking news and rumors that are flying about. 
Fred Hassan joined Schering Plough as its CEO five years ago. At that time, Mr. Hassan inherited a company that was being investigated by FDA for regulatory compliance violations and the SEC was investigating it former CEO for investing and accounting irregularities. Since his arrival at the company, Mr. Hassan increased sales of key products, filled an empty product pipeline and returned profitability to a company that posted losses in 2003 and 2004. 
As many of you know, the pharmaceutical industry has been trending downward for the past year or so. Weak pipelines, uncontrolled corporate expansion and soaring drug prices have been offered to explain the recent down turn. However, the real back story to the downturn is the loss of future revenues that is expected to occur starting in 2010 when many current blockbuster pharmaceutical products, .jpg)
Despite the Martha Stewart-Sam Waksal insider trading scandal in 2001, ImClone, the company founded by Waksal in 1984, is doing well and managed to sell $1.1 billion of its anti-cancer drug 
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Several lawyers representing people who sued Merck over Vioxx
There is a storm brewing around .jpg)
laxoSmithKline announced today 
Let me say from the outset that I have always been a big Merck fan (not withstanding the Vioxx scandal). Many people who I went to graduate school with in the late 1970s at the University Of Wisconsin Department of Bacteriology wound up getting jobs at Merck (more than 15 at last count). It goes without saying that there is a world of difference between Madison (“yeah, baby”) and Rahway NJ but, nevertheless, there has been a long standing relationship between UW and Merck dating back to the 1960s– I guess good science begets good science! That said, Merck showed the world with the Vioxx debacle that even one the best and most respected pharmaceutical companies is fallible and can make mistakes when it loses sight of what earned it its reputation in the first place–good science and better drugs. .jpg)
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I have to tip my hat to Merck. I thought it was silly that company executives decided not to settle all of the litigation surrounding the Vioxx debacle. Instead, the company decided to challenge all of the individual Vioxx lawsuits filed against it. That said, the 