Archive for the ‘Red Cross’ Category

There’s a ton of stuff going on this week, plus we’re in pre-ASCO mode (so lots of oncology news – scroll down for those headlines). Here we go:

What’s a vaptan? Maybe something pretty exciting – A new class of drugs called vaptans may be able to treat a wide variety of conditions including painful periods, brain hemorrhage, psychotic disorders and glaucoma, Belgian researchers report…more

One less tree in that Forest – Forest Laboratories Inc has ended its agreement with Daiichi Sankyo Co Ltd to co-promote Daiichi’s blood-pressure drug Azor, as Forest shifts resources to support other products, the companies said on Monday…more

Viagra: good for MD? – Researchers found the way the drug works to combat impotence may also help ward off heart failure in muscular dystrophy patients…more

OK, it’s not pharma per se, but it’s way too cool: Nanohealing – A startup based in Cambridge, MA, says that it plans to soon begin clinical trials of a nanostructured material that stops bleeding almost instantly…more

Here’s a switch: the FDA downgrading a warning – The FDA has eased restrictions on drugs used to enhance ultrasound images of the heart…more

Abbott’s new stent looking very good: interesting backstory – Abbott said this morning that its Xience stent outperformed Boston Scientific’s Taxus on several measures in a two-year study. The results mean the stent is likely to get the green light from the FDA soon…more

Merck and Ranbaxy: let’s develop something together – Merck signed a deal on Monday with Indian generics giant Ranbaxy to codevelop a new line of anti-infectives. As part of the agreement, Ranbaxy stands to receive more than $100 million for each drug that passes a certain milestone. That’s on top of an undisclosed upfront payment…more

Takeda’s financial results hiccup: no surprise when you’re buying another company!Japan’s largest drug manufacturer, Takeda Pharmaceutical, reported on Friday its first operating profit decline in 16 years and warned that the net profit in fiscal 2009 would diminish by more than a half as a result of its recent $8.8 billion deal to buy Millennium Pharmaceuticals in the United States…more

Daiichi Sankyo: the ups and downs of growth – Daiichi Sankyo Co., Japan’s third- largest drugmaker, had a 44 percent jump in quarterly net income, led by higher sales of its blood pressure treatments. The company predicts profit will drop this year…more

Trasylol bows out – Bayer AG is removing remaining supplies of its heart-surgery drug Trasylol from the U.S. market after a long-awaited study found it raised the risk of death compared to two alternatives, U.S. regulators said on Wednesday…more

Diabetes beating cholesterol on spending – Diabetes treatments are now the leading driver of prescription drug spending growth, displacing lipid-lowering drugs which fell precipitously after a decade of reigning in the top position, as generic drugs cut the cost of treating high cholesterol…more

The heartbreak of psoriasis to be lessened soon? – A top Johnson & Johnson research official said on Wednesday the company’s experimental drug ustekinumab could become the “gold standard” for treating psoriasis, in part because it would require only four injections a year…more

J&J gets crossed off in court – Remember that truth-is-stranger-than-fiction drama that featured Johnson & Johnson suing the American Red Cross over the use of the red cross logo? Turns out it’s not going so well for J&J. A judge today threw out most of what was left of the case, the Associated Press reportsmore

On the Oncology/pre-ASCO front:

Cancer drugs: the big growth area? – Sales of cancer drugs will grow at nearly double the rate of the global pharmaceutical market and could reach $80 billion by 2012, according to IMS Health, which tracks prescription drug sales…more

Can cancer cure Pfizer?

Novartis’ experimental RAD001 making strides with kidney cancer – Nearly two-thirds of kidney cancer patients taking Novartis AG’s RAD001 had progression of their disease delayed by a year, a significantly better result than in those taking placebo, investigators said…more

Novartis’ Zometa may slow cancer progression: A drug prescribed to prevent fractures in breast cancer patients whose tumors have spread may actually help slow the cancer itself, U.S. researchers reported on Thursday…more

Pharmalot has links to some other early ASCO news, including Avastin, Herceptin, Vectibix, Denosumab, and Alimta.

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A huge week for news, especially on the cardiovascular front:

Prasugrel, the Lilly/Daiichi-Sankyo blood thinner, was the biggest headline grabber. This potential blockbuster came in with mixed results – good efficacy, but troubling side effects with some patients. Meanwhile, a bit further back in the pipeline, Schering-Plough‘s experimental anti-clotting med continues to look very promising.

Speaking of Schering and blood clots, it appears that smaller doses of Integrilin are just as effective as the more traditional (higher) dosing.

AstraZeneca‘s Crestor gets a new indication, for treatment of artery-clogging. However, it did not show efficacy for heart failure patients.

Bayer launches a huge study for its promising blood clot drug rivaroxaban.

Why did Pfizer‘s torcetrapib fail? Some reasons may be surfacing.

Surprise – diarrhea drug effective for Hepatitis C?? Surprise, surprise – sleep drug awakens comatose patients.

Novartis Tasigna moving forward. Galvus moving backward.

Court case: Red Cross 1, J&J 0. But this ain’t over yet…

Cephalon: Loss posted, and Corporate Integrity Agreement signed.

BMS‘s oncology drug Sprycel – new labeling for CML.

J&J/Schering-Plough experimental arthritis drug meets goals in study.

JUST IN: Merck to pay huge amount to settle bulk of Vioxx claims?

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Amgen finally feels the heat from declining market demand; big cuts coming.

Novartis takes a hit on Prexige (COX-2 inhibitor); withdrawn in Australia.

New cancer killers? Electric fields, gene switch. Cool emerging research.

Very lean little biotech (Koronis) pursues a new approach to combating HIV.

GSK and Takeda have to add black box warnings to Avandia and Actos.

J&J taking public blows with Ortho Evra Patch side effects. Also, the company re-affirms its preference for mediation in the ongoing dispute with the American Red Cross over the red cross symbol.

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The recent legal spat between the American Red Cross (ARC) and Johnson and Johnson (J&J) (back story here, with more reportage and comment here, here, and here) brings to the surface a very important issue. While many have focused on the public relations aspect of this messy situation, and some see it as just another opportunity to jump on Big Pharma, what it really comes down to is this: will principle, or pragmatism, carry the day?

At the core, this is a legal dispute, having to do with intellectual property, copyright laws, and interpretation of agreements. J&J believes that there is an important legal precedent at stake here, and I have no doubt that they knew, going in, that a P.R. nightmare was going to be the cost of moving forward on principle. I respect that. Justice requires that there are no favorites – the small as well as the great are held to the same standard. Legal behavior and respect for property are bedrock principles of the rule of law, and we see multiplying examples around us of smaller, poorer nations casting aside such inconveniences as patent law in order to steal pharmaceutical formulations. Pharmaceutical companies, like any other companies, have every right to defend their property; intellectual, tangible, and whatever else.

When you compare the press releases of the 2 parties in this battle, you see a very clear differentiation. The Red Cross is claiming victim status, using the “big company is bullying us” argument, the pragmatic “we’re only trying to do good” argument, and the “they’re only doing it for the money” argument (note: the same type of arguments used by developing nations that break patents on drugs). In no instance do they actually seem to address the core legal principles. Here is their press release:

WASHINGTON, Wednesday, August 08, 2007Today, Johnson & Johnson (J&J) filed a lawsuit against the American Red Cross and four of its licensing partners for “unlawful conduct” related to the nonprofit’s use of the Red Cross emblem.

Specifically, J&J demands that the Red Cross:

  • Stop the Red Cross and its licensing partners from using the Red Cross emblem permanently on first aid, preparedness and related products sold to the public;
  • Surrender to J&J for destruction the Red Cross’ inventory of accused products;
  • Hand over to J&J all Red Cross proceeds from the sale of these products with interest; and
  • Pay punitive damages to J&J along with attorney fees related to its legal action against the Red Cross.

“For a multi-billion dollar drug company to claim that the Red Cross violated a criminal statute that was created to protect the humanitarian mission of the Red Cross—simply so that J&J can make more money—is obscene,” said Mark W. Everson, President and CEO of the American Red Cross.

Research has found that only seven percent of Americans have taken the necessary steps to be prepared—and that more people would get prepared if preparedness products were more available, including at retail locations. Since 2004, the Red Cross has worked with several licensing partners to create first aid, preparedness and related products that bear the Red Cross emblem.

All money the Red Cross receives from the sale of these products to consumers is reinvested in its humanitarian programs and services.

“The Red Cross products that J&J wants to take away from consumers and have destroyed are those that help Americans get prepared for life’s emergencies,” said Everson. “I hope that the courts and Congress will not allow Johnson & Johnson to bully the American Red Cross.”

Translation: J&J is big, greedy, and bad; we’re victims just trying to do good here; and they want to hurt Americans. OK – nice job with the ad hominem attack…now, can we have your legal reasoning, please??

On the other hand, J&J appears to be focusing on the legal issues, with a concern for the long-term principles and the precedents that are at stake. Their press release:

Johnson & Johnson Statement on Civil Complaint Against The American National Red Cross and Commercial Licensees

Skillman, NJ (August 9, 2007) – Johnson & Johnson has great respect for the relief work of the American Red Cross (ARC) and over the decades has consistently supported the organization through cash donations, product donations and employee volunteering. The Company remains committed to supporting their mission through its philanthropic efforts.

Both Johnson &Johnson and the American Red Cross have long-held separate and distinct rights to the use of the Red Cross Design trademark.

Johnson & Johnson began using the Red Cross design and “Red Cross” word trademarks in 1887, predating the formation of the American Red Cross. The Company has had exclusive rights to use the Red Cross trademark on commercial products within its longstanding product categories for over 100 years. Since its creation, the American Red Cross has at all times possessed only the rights to use the Red Cross trademark in connection with its non-profit relief services.

After more than a century of strong cooperation in the use of the Red Cross trademark, with both organizations respecting the legal boundaries for each others’ unique legal rights, we were very disappointed to find that the American Red Cross started a campaign to license the trademark to several businesses for commercial purposes on all types of products being sold in many different retail and other commercial outlets. These products include baby mitts, nail clippers, combs, toothbrushes and humidifiers. This action is in direct violation of a Federal statute protecting the mark as well as in violation of our longstanding trademark rights.

For the past several months, Johnson & Johnson has attempted to resolve this issue through cooperation and discussion with the ARC, and recently offered mediation, to no avail. The Company was left with no choice but to seek protection of our trademark rights through the courts.

On Wednesday, August 8th, 2007, a civil complaint was filed in the United States District Court, Southern District of New York by JOHNSON & JOHNSON and JOHNSON & JOHNSON CONSUMER COMPANIES, INC against THE AMERICAN NATIONAL RED CROSS and its commercial licensees, LEARNING CURVE INTERNATIONAL, INC., MAGLA PRODUCTS, LLC, WATER-JEL TECHNOLOGIES, INC., and FIRST AID ONLY, INC.

The goal of this civil complaint is to restore the long-held legal boundaries surrounding the use of the Red Cross trademark.

I don’t know who will win this battle in the courts. If J&J is right, I hope that ARC’s case is crushed, and that they retreat with their tail between their legs – a very important legal precedent having been reinforced. After which, I hope J&J then turns around and makes a sizable donation to some tangible Red Cross humanitarian work (though perhaps not to their legal fund!). And, if J&J is in the wrong, then let’s hope they get a legal spanking, and volunteer to cover all costs for the proceedings.

But at least in this initial skirmish, I have to say that I think J&J’s reasons for going to battle are sound. They tried to resolve it behind the scenes. The stakes are high – matters of legal principle are in dispute, which have long-term consequences. They have the right to see it resolved in the courts. And I’d sure like, at some point, to see the Red Cross come out with a well-reasoned defense of their actions rather than this bald appeal to victim status.

Pragmatism will tend to justify the means by the end. Those driven by principle tend to be willing to pay a short-term price for the sake of seeing what is right triumph, for the long-term benefit of all. Count me among the latter.

Full disclosure: I have no financial relationship with J&J by way of investment or current contract work, nor do I have any financial relationship with ARC.

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jj-red-cross.jpgI can just imagine the beating Johnson and Johnson will take over this one. After long negotiations got nowhere, J&J is suing the venerable Red Cross over the commercial use of the red cross symbol (to which J&J has held the trademark for well over 100 years). Traditionally, the Red Cross organization did not use the trademark in any commercial activities, but J&J contends that this has recently changed.

Of course, it appears, on the surface, like unconscionable bullying. But I actually sympathize with J&J’s business stance here. I’m no trademark lawyer, but it appears to me that the Red Cross folks took a couple of steps down a slippery slope, and the J&J people recognize that once this mark starts getting used commercially, there will be no end of violations. Here is the official corporate justification for the suit.

As with the recent case of Novartis and the Indian government, some cases brought as a matter of principle (and I’m sure the profit motive wasn’t absent, of course – this is business), to try to settle long-term case law, will bring plenty of short-term odium.

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