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You may recall that last August, Johnson & Johnson sued the Red Cross for inappropriate use of its symbol —the red cross—that has universally become associated with the non-profit relief agency. that they reached a settlement in the dispute over the mark. Not surprisingly, a settlement was reached shortly after a judge threw out much of J &J’s trademark claim against the Red Cross. Of course, as it typically in these cases, the terms of the settlement were not disclosed.

J & J brought the suit against the Red Cross, because, starting in 2004, the Red Cross started licensing the symbol to other companies for use on commercial items sold in stores as part of the organization’s fund-raising program. J& J argued that the organization had promised not to engage in certain commercial activity—a part of the original trademark agreement that was struck between the drugmaker and relief agency almost 100 years ago. However, the judge presiding over the case ruled that Congressional charter gave the Red Cross the right to use the symbol even for business purposes.

Although J & J looked incredibly avaricious and took a PR hit by suing the Red Cross for trademark infringement, the company claimed that it had the right to vigorously protect its trademarks—after all, business is business. However, as several patent and trademark attorneys have repeatedly told me, it is advisable to settle or reach an agreement before any case goes to trial—you just never know what a judge is going to rule even if you think that you have a rock-solid claim! I guess J & J needs to hire some new attorneys!

Until next time…

Good Luck and Good Job Hunting!!!!!

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The newest culprit in the direct-to-consumer (DTC) television ad cat and mouse game between pharmaceutical manufacturers and US regulators is Cordis, a medical device subsidiary of Johnson & Johnson. The ad in question deals with promotion of the use of a cardiac stent called Cypher that is manufactured by the company. The television ad is the first ever to market a medical device. Nevertheless, according to an article published in this week’s New England Journal of Medicine, the ad overstates the benefits of the stent without mentioning possible adverse effects that can include heart attack and stroke.

The current brouhaha is nothing new in the ongoing battle between drug manufacturer (and now, medical device companies) and regulators over DTC advertising. As some of you may know, the US is one of a few industrialized countries in the world that allows DTC advertising.  Further, DTC ads don’t require FDA review or approval before they are aired or printed–although in some instances, companies do request FDA review. 

Because of growing problems with DTC ads (especially television spots), there is mounting pressure on FDA to limit consumer medical advertising or, at the very least, increase regulatory oversight of it. To that end, on Friday, an FDA advisory panel will convene to discuss whether television ads for prescription medications ought to include a statement encouraging consumers to report any adverse side effects via a toll free number to the agency. At present, this type of disclaimer is only required for DTC print ads.

For those of you who don’t know, FDA has (by law) a post marketing surveillance network in place to allow consumers to report any side effects (big or small) that they may experience after taking prescription or over the counter medications. Further, companies are required by FDA regulations to immediately report any and all side effects associated with their products.

Of interest, in a hearing last week on drug advertising (being conducted by the House Energy and Commerce Committee), several drug company representatives in attendance were asked whether or not they would support a toll free number on television ads to encourage viewers to report adverse side effects. Surprisingly (perhaps not) they could or would not directly answer the question. According to John D. Dingell, chair of the committee and advocate of greater regulatory oversight of DTC advertising, “Some ads appear to be misleading and others appear to be downright deceptive.” Imagine that!

What is particularly disturbing about the DTC controversy is that government officials and legislators are frequently incredulous when they learn about DTC advertising abuses. As I have stated time and time again, there are larges sums of money at stake here. This coupled, with little or no regulation, and mounting pressures to keep company stock price shares high, is a sure recipe for disaster (as we have begun to witness over the past 5 years or more). In my opinion, there is only a single solution to the problem–craft more stringent regulations and greater FDA oversight for DTC advertising. Asking drug and medical devices companies to regulate themselves in any area is tantamount to allowing a fox to live in a hen house—the pickings are easy and only the fox gets fat!

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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Bristol-Myers Squibb is quietly seeking a buyer Mead Johnson division, its baby formula business which is estimated to be worth around $7-$9 billion. According to word on the street, BMS may have approached PepsiCo, Danone, Nestlé, Kraft and Heinz as prospective buyers. BMS has also put out feelers to pharmaceutical companies which have nutritional divisions, including Johnson & Johnson, GlaxoSmithKline and Novartis.

The search for a buyer of Mead Johnson comes less than three months after BMS said it would conduct a strategic review of both its nutritionals business and ConvaTec, its wound care products division. Both divisions are highly profitable but are not consistent with the company’s strategic goal of refocusing corporate assets on its pharmaceutical and biopharmaceutical businesses. Both companies are located in New Jersey and sale of either or both companies could have a negative impact on its fragile economy which is already reeling from inordinately high property taxes.

BMS declined to comment on the sale, but said it "continued to evaluate its strategic options with Mead Johnson and ConvaTec". The company could also decide to spin off the units to shareholders, or do nothing.

Mead Johnson is best known for its Enfamil and Enfalac range of infant formula. ConvaTec sells a variety of wound care and ostomy products.

Until next time…

Good Luck and Good Job Hunting (not New Jersey)!!!!!!

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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!!!!!!!

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Amgen announced today that US regulators added black box warnings to its erythropoietin drugs, Epogen and Aranesp. Similar warnings were also added to Johnson and Johnson’s Procrit which is licensed from Amgen. For those of you who don’t know, getting a black box warning on a drug label is like getting the “kiss of death” from a marketing and sales perspective. It certainly will not help sales of these products!

The new warnings approved by the Food and Drug Administration warn that the company's drugs increased death and accelerated tumor growth in patients with several types of cancer, including breast and cervical. Prior labeling warned of similar risks in other types of cancers.

The actions taken by the agency were not unexpected but suffice it to say there are a lot of unhappy Amgen and Johnson & Johnson employees in a Thousand Oaks, CA and New Brunswick, NJ

Until next time….

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

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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!!!!!!!!!!!!

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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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The US Food and Drug Administration said Monday it still had several "outstanding issues" with televancin an antibiotic being developed by Theravance Inc and Astellas Pharma of Tokyo. to treat skin infections.

The agency had canceled an advisory committee meeting scheduled for Wednesday that was set to evaluate the drug, televancin.

In a statement, the agency said that the meeting was being canceled to "allow time for the FDA to review and resolve several outstanding issues." The FDA said it would schedule an advisory committee meeting in the future, if needed.

Televancin is a once-daily injectable antibiotic that would be used to treat skin infections, including those caused by resistant bacteria like methicillin-resistant Staphylococcus aureus (MRSA). In October the FDA issued a so-called approvable letter for televancin, suggesting it needed a re-analysis of clinical data and the resolution of manufacturing issues at a third-party manufacturer that was not specifically related to televancin. The FDA said it continues to review televancin's application but didn't give a timetable for completion of the review.

Earlier this month the FDA canceled a Feb. 28 meeting for another antibiotic, ceftobiprole that would also be used to treat skin infections. That drug is being developed by a unit of Johnson and Johnson Co. and Switzerland-based Basilea Pharmaceutica Ltd. The FDA is expected to make a decision on whether to approve ceftobriprole sometime next month.

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You gotta give Biogen/IDEC and Elan credit for winning regulatory approval for a product that was previously pulled from the market because of serious and potentially life-threatening side effects. On Monday, the US Food and Drug Administration granted regulatory approval for Tysabri as a treatment for patients with severe Crohn’s disease who do not respond to more conventional biotechnology treatments like Humira (Abbott Laboratories) and Remicade (Johnson & Johnson). About 500,000 patients in the US suffer from Crohn’s disease (an autoimmune disease) and usually causes diarrhea, fever and severe intestinal inflammation and bleeding. Currently, there is no known cure for the disease.

As many of you may recall, Tysabri, a treatment for multiple sclerosis, was temporary pulled from the market in 2005 after three patients treated with the drug developed a rare and sometimes fatal nervous disorder called multifocal leukoencephalopathy (MFL). FDA allowed the drug back on to the market in 2006 but only under a restricted distribution program. Tysabri is used by more than 12,000 Americans with multiple sclerosis . Since its reintroduction, there have been no new reports of MFL or other serious side effects. Because of its past safety record, patients with Crohn’s disease who use the drug must also enroll in a distribution program similar to the one required for MS patients treated with Tysabri.

The approval of Tysabri for a new therapeutic indication may make Biogen/IDEC a more attractive  takeover candidate. As many of you may know, Biogen/IDEC put itself up for sale about 3 months ago and was unable to find a buyer.

Until next time….

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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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A Johnson & Johnson Co. plant in Bedford MA that manufactures medical devices was sold for $45 million in cash to an Indiana-based provider of orthopedic products used in arthroscopy, dental and other medical professions.

The plant’s 200 workers will keep their jobs, and additional jobs could be added in the future depending on customer demand, said Fred L. Hite, senior vice-president and chief financial officer of Symmetry Medical Inc.

Symmetry, a public company listed on the New York Stock exchange, purchased the 82,000 square-foot facility from DePuy Orthopaedics, Inc., which is owned by Johnson & Johnson. Both Symmetry and DePuy are headquartered in Warsaw, Ind., known to some as the orthopedic capital of the country.

According to a release from Symmetry, DePuy is required to make minimum purchases from the New Bedford plant for four years following the acquisition, which is expected to be completed within 60 days.

Until Next Time.....

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

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Johnson & Johnson announced a “series of organizational changes, including the creation of a new strategy and growth organization to sharpen its focus on opportunities outside its traditional areas of interest and in the growing intersections of health care and the creation of two new business operating groups.”

Scott Hensley over at the WSJ Health Blog wrote “It’s no secret that the diversified health-products giant faces some gargantuan challenges. Sales of anemia drugs, for years the company’s biggest franchise, have been under intense pressure. Stents, another J&J hallmark, are hurting”.

J&J announced a plan last July to cut 3% to 4% of its roughly 122,000-person work force or approximately 4,820 jobs. According to my colleagues at J & J, job cuts have been taking place since the announcement and will continue into 2008.

Times are certainly tough for the life sciences industry. Is this a harbinger of things to come for other sectors of the US economy? I hope not…..

Until next time….

Good luck and Good Job Hunting!

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