Bio Job Blog : Bio Jobs : Biotechnology Jobs : Biopharmaceutical Jobs : Bioscience, Biotech Jobs : Bio Job Blog : Biocareer : Bio-Business Training, Biotechnology Training : Jobs in Biology : Internships in Biology : Internships in Biotechnology

e-Patients Connections 2009 (#epatcon) was held this past Monday and Tuesday at the Park Hyatt hotel in Philadelphia, PA. BioCrowd was one of several co-sponsors of the event. The theme of the conference, organized by Kevin Kruse a veteran medical communication and training expert, who now runs Kru Research, was to “reach, engage and educate empowered digital health consumers.” And, boy, did it deliver! While this was Kru Research’s first official conference, it was well organized, extremely interactive and the quality of the speakers was second to none! Topics that were featured included social media and the life sciences industry, technological advances in e-based healthcare delivery, the relationship between the news media and healthcare information and the continuing evolution of online and e-based healthcare communities.

Conference attendees included representatives from the life sciences industry, medical communications experts, advertising and marketing professionals and a multitude of social media enthusiasts and consultants who kept the Twitter screen humming throughout the meeting (a big shout out to the “troublemaking table”). And, surprisingly, there was a representative from the Division of Drug Marketing and Advertising and Communications (DDMAC) at the US Food and Drug Administration, who I believe, was one of the most sought after individuals at the meeting. CNN reporter Elizabeth Cohen who writes the Empowered Patient and racecar driver Charles Kimball, a type I diabetic and company spokesperson for Novo Nordisk also gave talks.

My favorite talks were those presented by online patient community organizers including Tricia Geoghegan of Ortho-McNeil-Janssen Pharmaceuticals who created the Facebook ADHD Allies community, Lisa Tate of WomenHeart and Robert Schumm of Bayer Consumer Care who created Facebook Strong@ Heart and Rachel Lewinson of the Juvenile Diabetes Research Organization and Susan Harrow Rago of Novo Nordisk who created Juvenation.org a website dedicated to those with Type I diabetes. These communities are outstanding examples of how partnerships between pharmaceutical companies and advocacy groups can help to better educate the public and heighten awareness about potentially life-altering diseases. Another example of a great online community and healthcare portal is Insomnia 123.com. This website was conceived and constructed by Christine Macadams and her partners’ one of whom is a practicing physician. Unlike the other online communities, which are sponsored and mainly supported by consumer healthcare division of large pharmaceutical companies, Insomnia 123.com was exclusively created by a group of concerned individuals who wanted to better educate and improve the lives of people with insomnia—a largely unreported and self-medicated condition.

On the technical side, the talks presented by Lee Segal of Klick, Kevin Durr of Avantera , Ian Kelly of Red Nucleus and Scott Ballenger of ListenLogic were illuminating and extremely informative. Some of the innovations taking place in digital media are exciting and almost overwhelming at times (even for a social media enthusiast like me). I think the company to watch is ListenLogic which uses semantic search engines to collect real time data and “chatter” on the web. This technology may provide a cost-effective solution to assuage the concerns of many life sciences companies that claim that collecting and analyzing overwhelming amounts of data is one of the main reasons why they are reluctant to entry the social media space.

Marc Monseau of Johnson and Johnson gave an illuminating talk on his experiences as a corporate blogger and Twitter user and described some of the challenges that had to be overcome before his company was able to break the “social media barrier.” Janice McCallum, an economist by training and a healthcare communications and media expert gave an informative talk about the growing role and impact of patient-generated healthcare content on patient awareness and education.

Finally, the novel and innovative Pecha Kucha sessions were outstanding and extremely well done! While all were expertly crafted, Dr. Val’s and Jonathan Richman’s Pecha Kucha were memorable. Dr. Val’s, which was extremely powerful and moving, was performed entirely in verse and Jonathan’s was—well, one of Jonathan’s always entertaining and informative presentations.

In summary, the “e-Patient Connections 2009” was a resounding success and in my opinion reached its goal to “reach engage and educate empowered digital health consumers.” That said, I can’t wait for “e-Patient Connections 2010” meeting!!!

Hat tip to @ellenhoenig and @eileenobrien for inviting me to my first tweetup (great fun) and finally meeting @janice McCallum, @christianeTrue, @stevewoodruff and Silja aka @whydotpharma! 

Until next time...

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Advances made in DNA sequencing technology and genomic analysis has lowered the cost of sequencing a genome from millions of dollars a decade ago to less than $500 today. And, because of this, there are a growing number of companies that are willing to quickly and cheaply sequence and analyze your DNA. While this may be medically beneficial and appealing to some, it may not be for everyone. Moreover, and perhaps more importantly, who will control access to and insure the privacy of your genetic information if you choose to have your genome sequenced and analyzed. 

Alan McHughen, PhD, a molecular biologist and Professor of Botany and Plant Sciences at the University of California-Riverside, who has previously written about privacy and access to personal genomic data, wrote an article for BioJobBlog that explores the ramifications and possibility of DNA identity theft in the future. Also, he has written a book 'Pandora's Picnic Basket; The Potential and Hazards of Genetically Modified Foods' to refute the myths and explore the genuine risks of genetic modification technology

Genetic Privacy

By Alan McHughen

For just $399 (plus shipping and handling), the scientists at 23and me.com will scan your complete genome. The DNA analysis reports on 118 different medical and health dispositions, your maternal and paternal ethnic ancestry, and a curious bunch of genetic trivia concerning your persona (is your earwax sticky or flaky?). All you do is pay the money and spit into a collection tube; they extract your DNA from the spit and look for half a million single nucleotide polymorphisms (SNPs) scattered throughout your genome, including many in or near genes associated with particular traits. Other companies offer similar services. For example, Decodeme.com charges $985, but catalogs twice as many SNPs, and you collect your DNA with a cheek swab.

Alternatively, if you don’t need the complete genome scan but are curious about specific medical conditions or family lineage, you can get less expensive gene tests from an increasing number of companies willing to take your money and DNA sample in exchange for the genetic information their scientists reveal. If heart disease runs in your family, you may either relieve or exacerbate your anxieties by shelling out $200 to have a cardio scan for relevant genetic predispositions. Or, for as little as $99, a man can have his Y chromosome probed to confirm his place in the family patrilineage, and possibly connect to ancient and famous princes or pirates.

These genetic information services, with prices now well into recreational and hobby budget range, provide the most personal, private — and unchangeable— information possible about you. The sinister side of this fascinating field is all too often overlooked—it can reveal your most intimate genetic details to strangers and nosy neighbors. While the various testing labs assure confidentiality, there is little to no control over personal genetic information. In the US, anything you discard is salvageable by anyone else, and your trash can become another’s treasure if it carries blood, saliva, hair, semen or any other DNA-laden bodily secretions.

While we worry about identity theft, personal financial or other private information, our uniquely personal information is up for grabs. The Genetic Information Nondiscrimination Act (GINA) of 2008 offers some protection, but it is limited to employment and medical insurance issues. GINA does not protect your genetic information from being abused by life insurers. Or nosey neighbors. 

Genetic privacy raises a whole spectrum of social, ethical, legal and medical issues. Suppose your neighbor salvages your trash and has your DNA analyzed. This local gossip then shares the juicy news that you have a “higher than average predisposition” to, say, alcoholism. Soon, everyone in the community shuns you as a latent alcoholic, and you have no idea why. The community knows more about your genetic makeup than you do. And, because they don’t know how to interpret statistical language such as “a higher than average predisposition”, those conditions may easily be exaggerated into probabilities, if not certainties.

If people have a right to know their own genetic information, they have the obverse right to NOT know. People can choose to remain ignorant about their genetic makeup. Consider, for example, Huntington’s disease (HD). This death sentence is one of the few health conditions almost due to genetics, and the DNA assay has been available for years. Curiously, most people at risk, i.e., those with HD in their direct lineage, choose NOT to take the test; they prefer not to know until (or if) symptoms appear. What happens when the local busybody lets the cat out of the bag on HD? Word will get around and the at-risk person will inevitably find out, if only by the ‘different’ treatment by neighbors, thus obliterating the exercise of their right to remain ignorant. Whether the test result is positive or negative on HD is immaterial at this point, the rights will have been violated. The DNA test for HD is currently more elaborate than the simple SNP analysis, but because SNPs associated with HD are being reported, it’s only a matter of time before they come generally available.

Perhaps you’ve suspected the woman down the street had a child from an adulterous one night stand a few years ago, and the cuckold husband remains a doting, if clueless, dad. Now, with just $89 (including overnight FedEx delivery!) and a little misdemeanor creativity, well within the standard ethical bounds of busybodies, you can satisfy your suspicions with a surreptitious and discrete paternity test. And, to provoke some real excitement in your sleepy small town, show the results to the husband.

A few minutes of thought and discussion generates many other issues and examples of the precarious security of personal genetic information and identity, and the potentially dire consequences of genetic information getting out. Society is yet to discuss the privacy issues surrounding genetic identity as vigorously as we have with personal financial or medical records. It’s getting late. Do you know where your DNA is?

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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.

As you may recall, Merck was acutely aware of the terms of marketing agreement before it decided to purchase SGP and cleverly engineered the acquisition as a reverse merger— to prevent triggering provisions that could return Schering’s marketing rights for Remicade and Simponi to JNJ if their were leadership changes or a change of control at SGP. JNJ’s announcement contesting wasn’t unexpected after the Merck-Schering Plough deal was announced early last winter—sales of Remicade outside of the US topped $2.0 billion in last year. Simponi, Remicade’s highly touted successor (which recently received FDA approval), is also expected to reach blockbuster status after it reaches the market. 

The Merck-Schering deal left JNJ with few alternative or choices. The company could have counter offered to purchase SGP in its entirety or simply, as it did, invoke terms of the original agreement that would terminate SGP’s marketing rights if there was a “change of control” at the company. JNJ rightfully believes that a change of control will occur when Merck acquires SGP. According to a JNJ spokesperson “As its public statements make clear Merck is acquiring Schering Plough. The acquisition constitutes a change of control and trigger’s Centocor’s right to terminate.” It will be interesting to see how an arbitrator rules in the case.

While the loss of Remicade and Simponi isn’t likely to jeopardize the Merck-Schering Plough deal (according to Merck executives), it may affect the financial terms and overall benefit or upside of the acquisition. The expected completion of the deal is scheduled for the fourth quarter of this year.

Until next time...

Good Luck and Good Job Hunting!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The FDA has approved Johnson and Johnson’s Simponi (golimumab), a new treatment for adults with moderate-to-severe rheumatoid arthritis , psoriatic arthritis, and ankylosing spondylitis. Unlike Enbrel, Remicade and Humira, other anti-TNF-alpha monoclonal antibody products—which require multiple monthly intravenous infusions—Simponi is injected under the skin and requires only a single monthly injection. 

Simponi is intended for use in combination with the immune-suppressing drug methotrexate in patients with rheumatoid arthritis. It also may be used with or without methotrexate for psoriatic arthritis and alone in patients with ankylosing spondylitis, a chronic inflammatory arthritis of the spine.

In clinical trials, patients who received Simponi for one of the three conditions showed improvements in the signs and symptoms common to their form of arthritis.

Like other anti-TNF-alpha monoclonal antibody products, Simponi labeling includes a boxed warning alerting patients and health care professionals to the risk of tuberculosis and serious fungal infections with use of the drug. The most common side effects of Simponi include upper respiratory tract infection, sore throat, and nasal congestion.

I have no doubt that Simponi will provide much-needed relief to patients suffering from immune arthritis. However, I think that the marketing folks at J& J could have come up with a better name—it reminds me of Spumoni (the Italian ice cream) and The Simpsons television program. But, then again, the name is distinctive and easy to remember!

Until next time...

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

As you all know by now, Merck announced on Monday that it will purchase Schering Plough for $41.1billion in a deal constructed as a reverse merger. The reverse merger strategy was concocted to prevent the new company from losing the international sale rights to Remicade, Johnson and Johnson’s lucrative, blockbuster rheumatoid arthritis drug. According to the original deal inked by Johnson and Johnson and Schering Plough, Schering would have to surrender its rights to Remicade— which generated $2.1 billion in sales outside of the US last year —and golimumab (which is pending approval in Europe) if current ownership of Schering changes. Golimumab (CNTO 148) is Johnson and Johnson’s Centocor division next-generation human anti-TNF-alpha monoclonal antibody be developed as monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.  Since the merger was announced on Monday, Johnson and Johnson hasn’t issued any public statements about the deal—prompting some analysts to speculate that Johnson and Johnson may well make a counteroffer to acquire Schering Plough. Others believe that Johnson and Johnson will challenge the new company’s international rights to Remicade and golimumab despite the great lengths that Merck and Schering Plough management went to structure the acquisition as a reverse merger. Stay tuned for updates.

In other merger news, US-based Gilead announced that it will acquire CV Therapeutics for about $1.4 billion. The deal tops the hostile takeover offer from Astellas Pharma of Japan. Gilead, an HIV drug manufacturer is purchasing CV Therapeutics—which sells the cardiovascular drugs Ranexa (chronic angina) and Lexican (reduces stress during cardiovascular surgical procedures)—to expand its therapeutic repertoire beyond virology. The stock prices of shares of Gilead and CV Therapeutics jumped after the announcement signaling Wall Street’s approval of the deal.   Nevertheless, it may be premature for Gilead and CV Therapeutics to begin celebrating—Astellas may very well tender a counteroffer!

Until next time...

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

• Email This
• Print
• Comments (2)
• Trackbacks
• Share Link

According to a report on NPR’s All Things Considered program, the Obama Administration has nominated Margaret Hamburg, MD to head the US Food and Drug Administration. Dr. Hamburg is a former health commissioner in New York City who has worked on issues surrounding infectious diseases and bioterrorism. In New York, she instituted a needle-exchange program to help prevent the spread of HIV. She also set up a program, in which health workers went to tuberculosis patients’ homes to help them manage their drug regimens.

A Harvard Med School graduate, Dr. Hamburg was an assistant secretary of health and human services during the Clinton administration and now works at the Nuclear Threat Initiative, which tries to cut the threat from nuclear, chemical, and biological weapons. She opposes abstinence-based sex education in public schools and has been a critic of the marketing practices of the pharmaceutical industry. Further, Dr. Hamburg is a leading advocate for changes in the nation’s public health policies and infrastructure, from local health departments to the highest levels of government. Finally, after eight years of mismanagement and poor leadership, the agency has somebody at the helm with intelligence, experience and is an advocate for change. 

Kudos to Team Obama!

Until next time...

Good Luck and Good Job Hunting (FDA is hiring)!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Some of you may have been wondering why the$41.1 billion Merck-Schering Plough merger announced yesterday was designed as a reverse merger. For those of you who are not familiar with the reverse merger strategy, this is how it works. Generally speaking, a failing or failed publicly traded company that is listed on one stock exchange or another merges with a privately held company. The privately held company takes over the public stock listing and manages the day-to-day operations of the new business. Private companies that engage in reverse mergers are usually looking for cash infusions for product development or a stock listing (without going through an initial public offering) which offers it shareholders immediate cash value.  Investors who previously held stock in the public company are either compensated for their shares in cash or given shares (at a negotiated price) in the new entity. Any cash (or assets) left in the public company can be used to develop the formerly private company’s product(s) and if successful, shareholders in the old public company can eventually benefit. 

If reverse mergers are designed to bolster the prospects of private companies in need of cash why was the Merck-Schering Plough deal structured as a reverse merger? As I mentioned in a post yesterday, Schering-Plough markets Remicade outside of the US under an agreement with Johnson and Johnson which sells the drug in America. A termination clause in the original marketing agreement stipulates that the ex-US rights to Remicade (and another drug being developed) would revert to Johnson and Johnson if control or ownership of Schering Plough changes. Remicade, a treatment for rheumatoid arthritis, developed by Johnson and Johnson’s subsidiary Centocor, represented $2.1 billion in sales for Schering in 2008. Further, about 70% of Schering Plough’s revenue comes from outside the US. That said, the success or failure of the deal really hinges on whether or not Johnson and Johnson will challenge the change-in-control clause for Remicade. To obviate that possibility, Merck devised an unusual reverse merger strategy in which ownership of Schering Plough will not change hands—at least on paper anyway. Instead, even though Merck is putting up the money to purchase Schering, and Richard Clark, Merck’s Chairman and CEO, will run the newly combined company, Merck would technically become a subsidiary of Schering Plough and consequently there would be no change in Schering Plough management! Recall that Fred Hassan, Schering Plough’s CEO will remain with the newly formed entity during the transition. After the deal closes, Fred would step down as CEO, Merck’s current CEO—Richard Clark—would assume leadership and quietly change the name of the company from Schering Plough to Merck.

Of course, Johnson and Johnson could challenge the deal anyway, and if Merck was to lose in arbitration, it could possibly jeopardize the entire financial upside of the deal. Merck contends that even if it loses the rights to Remicade, the deal still makes sense.  Not so, said one Wall St analyst, “I think that is a lot of malarkey. You don’t take out 20 percent of a company’s revenue and their core international growth driver and say it is not worth anything,” he said. Other analysts think that the uncertainty over Remicade puts Schering Plough shareholders at a disadvantage and one response may be for Johnson and Johnson to make a higher bid for the company.  Still others believe that, while sale of Schering Plough makes sense, the $41.4 billion price offered by Merck is too low. Johnson and Johnson didn’t comment on the deal.

Schering Plough employees who I talked with yesterday after the deal was announced are not pleased with it either. They feel that Johnson and Johnson would be a more suitable partner and that Fred Hassan, who was under enormous shareholder pressure, had no choice but to sell the company as quickly as possible. It is not surprising that many Schering Plough employees would rather have the company sold to Johnson and Johnson rather than Merck. Unlike most pharmaceutical companies, Johnson and Johnson tends to leave the companies it purchases alone and runs them as wholly-owned after it purchases them.  Another reason why a merger with Johnson and Johnson makes more sense than one with Merck is that Johnson and Johnson has a very profitable consumer products division. This would be a better fit for Schering which has several highly visible and profitable consumer products like Coppertone and Dr. Scholl’s. In contrast, Merck sold its consumer products division years ago and will almost certainly divest itself of Schering’s consumer products division after the deal closes.

Now that Schering Plough is no longer in play, all eyes are on Bristol-Myers Squibb (BMS). BMS is about the same size as Schering Plough, has plenty of cash on hand and is thought to have a robust biotechnology pipeline. And, like Schering Plough,  it has been rumored to be a takeover target for the past 20 years!

Until next time...

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

• Email This
• Print
• Comments
• Trackbacks (1)
• Share Link

In the February issue of Genetic Engineering and Biotechnology News, J. Leslie Glick a former CEO of Genex and veteran of the biotechnology industry put forward a novel solution to financial crisis that is currently gripping the life sciences industry and the rest of the US economy. Dr. Glick proposed that the US government ought to consider injecting taxpayer monies into venture capital firms (VC) which, he believes, would foster creation of new companies, create more jobs, stimulate the ailing economy and also provide the government with an outstanding return on its investment.

According to Dr. Glick, “historical results reported by the National Venture Capital Association for the 20 year period ending December 31, 2007, show an annualized return of 16.7% to investors in some 1,860 U.S. venture capital and private equity partnerships. If the U.S. government had made annual investments of $10 billion in VC firms throughout the U.S. during that 20year period, the $200 billion total investment would have yielded a total return of almost $1.5 trillion.” Further, he asserts that according to the  International Trade Administration of the Department of Commerce, from 1970 to 2000, U.S. VC firms invested over $270 billion in more than 16,000 companies. In 2000, the surviving VC-backed companies employed 7.6 million people, representing 5.9% of all U.S. jobs, and generated sales of $1.3 trillion, accounting for 13.1% of the U.S. GDP.

This financial upside sound enticing but who is going to keep track of the money and keep an eye on how and what the VCs are investing in? Dr. Glick proposes creation of a non-partisan funding mechanism, possibly overseen by an independent panel of business people that would disburse $10 to $25 billion annually of taxpayer’s dollars to vetted and certified VC firms. Because of its investment, the US government would become a limited partner in these firms and could direct them to invest in technologies that would help to reduce health care costs, develop energy alternatives or improve food production capacity. While this proposal is unprecedented and controversial, we are living in extremely uncertain financial times that may necessitate innovative and out-of-the-box solutions to restore normalcy to the US economy. That said, all proposals—no mater how unconventional or outrageous—ought to be carefully evaluated and vetted to determine whether or not they have merit to help overcome our deepening recession.

Kudos to Dr. Glick!

Until next time,

Good Luck and Good Investing!!!!!!

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

After beating Wall Street expectations and disclosing positive results from an osteoporosis (densomab) clinical trial, Amgen was ordered by the US Food and Drug Administration (FDA) yesterday to change the labels for its EPO drugs (Epogen and Aranesp) that will likely further restrict their use in treating patients with cancer.

The label changes ordered by FDA represent the first time that the agency has invoked its power to change prescribing information for drugs that it previously approved. In the past, FDA could only negotiate with drug manufacturers about changes to labels and prescribing information. In my opinion, it’s about time that FDA has been empowered to unilaterally order these types of changes. I have long contended that negotiations between the agency and drug makers about labeling and prescribing information is not in the best interests of Americans who use prescription drugs. To that end, it was negotiations between FDA and Merck about whether the serious cardiovascular risks associated Vioxx should appear on the Vioxx label (they didn’t) that lead to the misuse, safety problems and ultimate recall of the drug.

While the ordered label changes are not good news for Amgen and its partner Johnson and Johnson which sells Procrit (EPO manufactured by Amgen and sold by J&J), they are in the best interests of all Americans who use these drugs to treat anemia caused by cancer chemotherapy and kidney disease.

Until next time….

Good Luck and Good Job Hunting (avoid A Thousand Oaks, CA)!!!!!!!!!!

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

This month Kevin has reviewed an eclectic bunch of websites. Continuing with his “down under” theme from last month, Kevin offers the Australian National Herbarium and the Darwin Correspondience Project websites (okay so Darwin was English but he did visit Australia!). The Darwin site complements an interesting site called the Origin of Life Prize (check it out).  

Another Australian website called the Sea Snake Homepage covers everything you ever wanted to know about sea snakes (and then some) but as Kevin put it may not be for everyone. There is a technical site called Microscope-Microscope.org which has some terse but valuable information on well—microscopes.

My personal favorite is the Biomedia Associates Educational Biology site. Although it is a commercial site, it is an education website and offers some valuable resources for biology teachers and students.

Until next time…

Good Luck and Good Surfing!!!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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!!!!!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Erythropoietin (EPO) is a hormone (protein) that regulates red blood cell production in humans. Back in the 1980s, scientists at a fledgling biotechnology company called Amgen determined that recombinant EPO was highly effective for treating anemia. Amgen owned the intellectual property rights to the EPO gene and decided to sell the recombinant protein encoded by EPO (called epoetin) as a treatment for anemia.EPO is known to alleviate fatigue caused by anemia by stimulating red blood cell production.

Amgen’s first EPO product, called Epogen, was approved in 1989 to treat patients suffering from anemia associated with renal failure. Procrit, Johnson and Johnson’s version of EPO (which was licensed from Amgen) was approved four years later in 1993 to treat chemotherapy-induced anemia. Aranesp, a longer acting version of EPO which is also manufactured by Amgen was approved in 2001 for anemia associated with chronic renal failure and in 2002 for chemotherapy-induced anemia in cancer patients.  All of the EPO drugs have gained blockbuster status and, over the past five years or so, the annual revenue generated by these drug is estimated to be $6.0 to $12 .0 billion.

Since their approvals, EPO, Aranesp and Procrit have been administered to tens of millions of kidney dialysis and cancer patients undergoing chemotherapy with minimal safety concerns and generally positive outcomes. However, with the looming specter of generic biologics (EPO lost patent protection in 2004) and competition from companies like Roche developing competing EPO products, Amgen stepped up its efforts to promote and sell EPO and Aranesp. This, in turn, caused EPO drugs to be used by many physicians, which ultimately resulted in additional safety warnings and a label change for all EPO products. The label change coupled with unrelenting negative publicity about Amgen’s promotion of its EPO franchise, caused its stock price to plummet and forced the company late last year to lay off 14% of its workforce.

Like other biotechnology and pharmaceutical companies, Amgen sought to find ne indications for its EPO products. To that end, there was some compelling evidence several years ago which suggested that EPOmight increase survival of cancer patients, when used with radiation and chemotherapy. The idea was that higher oxygen levels in the blood would make the radiation or chemotherapy being used to treat the patients' cancer more effective. With this in mind, several groups of investigators initiated human clinical trials to determine whether EPO treatment would benefit non-anemic cancer patients. Unfortunately, the New York Times reports that results from no fewer than eight clinical trials suggest that EPO drugs might actually promote rather than slow tumor growth and hasten the death of cancer patients.

Amgen believes that the increased trial deaths among EPO-treated patients resulted from blood clots rather than by promoting tumor progression or growth. The company contends that the amounts of EPO used in the trials exceeded what is recommended in the drug label and, at those levels, blood clots are a known common side effect. On the other hand, there is a growing body of evidence from a variety of sources which suggests that some types of human tumors express EPO receptors, which when stimulated by EPO binding, induces tumor cell proliferation. To make matters worse, when Procrit was first approved to treat chemotherapy-induced anemia, FDA regulators suggested in briefing documents that there may be a “hypothetical risk” that EPO could stimulate tumor cell growth. Nevertheless, neither FDA nor most EPO experts believe at this time that a direct link between EPO use and tumor growth has been established. Everyone agrees that more research must be conducted to verify or refute this idea.

Tomorrow, an advisory committee to FDA will consider placing further safety restrictions on the use of EPO drugs.  If they feel that blood clots were responsible for increased death among EPO-treated cancer patients then the recommendation would be relatively simple–only use the recommended modest levels of EPO to treat cancer patients as indicated on the product label.  However, if they believe that EPO directly stimulates tumor growth then even the currently recommended modest doses of the drug may be too risky to treat cancer patients. Regardless of the outcome of the tomorrow’s FDA advisory meeting, it is clear that Amgen’s flagship EPO franchise may be in serious jeopardy.

Until next time….

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Where have the folks at FDA been hiding for the past decade?  I thought that by now everybody had heard about multi-drug resistant bacteria and the need for new antibiotics. Why, I bet that even President Bush knows this –hmmmm– well, okay– but you get my point!

FDA announced today that it needs more data and time to evaluate Johnson and Johnson’s “new indication” NDA for its antibiotic Doribax (doripenem). The antibiotic is already approved to treat urinary tract and intra-abdominal infections. The company is seeking approval to expand treatment to cover nosocomial or ‘hospital-acquired’ pneumonia as well as ventilator-associated pneumonia.

The new application was submitted in June 2007 but the FDA’s request for new data means that the review period has been extended by at least three months. Doribax is licensed from Japanese drug maker Shionogi and is currently undergoing regulatory review in Europe, Canada and in other countries.

This delay comes less than a month after the agency cancelled a meeting of its anti-infective drugs advisory committee which was scheduled for February 28. At that meeting, the agency was scheduled to review another J&J antibiotic ceftobiprole, which is being co-developed with Switzerland’s Basilea Pharmaceutica. No reason was given by the agency for cancellation of the ceftobiprole meeting which is being evaluated as a treatment of complicated skin and skin structure infections, including diabetic foot infections.

I am not sure why FDA can’t make up its mind about the approvability of new antibiotics. They certainly had little difficulty approving Vioxx, Zyprexa and Avandia.  Maybe FDA ought to hire some more microbiologists? 

Until next time….

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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)!!!!!!!!!!

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link