Law under the Microscope

Jury Awards Blockbuster Damages in Vioxx Lawsuit

Last year saw the beginning of grumblings that drug companies may be keeping certain trial results out of the public, and that the FDA may also not be getting out cautions when needed.  Merck had been accused of hiding research that showed that its blockbuster arthritis drug, Vioxx, could cause heart problems.  One of the first liability suits filed against Merck just came out with the verdict - an award against Merck for $253 million to the widow of a marathon runner and Wal-Mart worker in Texas who blamed her husband's death on the drug.

There are many more lawsuits to come, but this was a fairly large blow (Merck is sure to appeal both the damages awarded and the liability issues).  I don't envy either the plaintiff or defense counsel. Many people who take Vioxx also had or potentially had other health problems, and it can be very difficult to prove the existence or absence of causation. Sounds like the plaintiff's lawyer here did a great job hitting an emotional vein with the jury (news reports don't really present much of the actual evidence, so no way of knowing how well he was also able to connect the dots to the husband's health status).

More later ...

FDA and SEC to Work Together to Monitor Biotech Companies

Like the superheroes in the Hall of Justice pledging to stand by one another, the SEC and FDA have finally come together and agreed to cooperate better in investigating claims made by biotech/pharma companies about their dealings with regulators.  Ever since the incident in 2002 regarding Sam Waksal's sale of shares of Imclone right before it was announced that the FDA would likely not approve its drug (which also lead to the Martha Stewart trial for obstruction of justice).

This is my favorite quote from the article the talks about the recent meeting in which the SEC and FDA announced their new alliance:

Some executives at the session said they weren't pleased by the extra work taken on by the FDA.

''It amazes me that people at the FDA have time to read securities filings," said one executive, who asked not to be named.

At least he had the good sense to ask not to be named.

Brazil Signs Biotech Safety Law

After months (ok, years) of struggling over whether and how to allow genetically modified crops to be planted in its land, Brazil has just signed a biotech safety law that will allow for such crops, with certain protections. Monsanto is a winner from this law, as it wants to plant more of its Roundup Ready soybeans there.  On Tuesday, Monsanto signed a royalty accord with soybean growers in the southern state of Rio Grande do Sul, one of the larger agriculture centers in Brazil.

With Brazil's national technical commission for biosafety (CTNBio) already having approved the introduction of Monsanto's anti-boll weevil cotton, Bollgard, a week before, it looks like Monsanto is taking no time to start research and production.  It might not be surprising that Monsanto's stock price has also increased by a couple percentage points over the last couple days (MON). 

Cancer Vaccine Companies May See Boost Soon

For the last few decades, scientists have been searching for cures to cancer. There are 5 companies now that, while not offering a cure, are offering what might be a safer therapy for different kinds of cancers - a cancer vaccine. These 5 companies are now in a race to see which one's Phase III clinical trial returns positive results first.

It's rather exciting news, and highlights just how tense a Phase III trial can be, especially when most of your predecessors in the theory have not been successful.

Monitoring Your Trademarks

Raise your hand if you have recently received an email touting "really cheap Via*gra" or similar variation lately. Is your company tired of having its trademarks and trade names misused and abused on the Internet, through spam or other unauthorized marketing? It's can be a big problem for pharmaceutical companies. While it should be pretty obvious that spam touting less expensive, misspelled drugs isn't from a particular drug maker, the public is clearly gullible and there are likely to be many people who somehow think they are getting the real drug either directly from the manufacturer or some distributor.

Luckily for Pfizer, Wyeth and other pharma companies concerned about whether their trademarks are being misused or infringed (also consider domain names that mimic or use their trademarks, "marketing" materials being used on suspect websites, etc.), there are a couple outfits that will help to track and alert companies about nefarious trademark hijackers. One such outfit is MarkMonitor. It has a couple terrific products that basically comb the web in a matter of seconds, and repeat the cycle every few minutes, to monitor the use (or, if you prefer, misuse) of its customers' trademarks. In the interest of disclosure, MarkMonitor is not a client of mine nor do I hold any financial interest in the company. I had the pleasure of meeting its CEO the other day, and was struck by the comprehensive products and services they offer in this area and by its client roster (the list here is a very abbreviated list - they work with several pharma companies, too). If you want a good weapon in your arsenal for the retention of the value of your trademarks, this is something your company may want to consider.

Median VC Investment in Life Science Companies Jumps 30% in 2004

Some good news for Friday - industry researcher VentureOne has released data showing that the median valuation for a start-up life science company went up in 2004 from $10MM to $13MM (that value being the value of a company prior to receiving venture capital).

Venture One's explanation for this was more capital being available as well as a fairly finite number of "promising investment opportunities."  That's to be expected, though - as the investors get savvier about the industry and what really has a shot, they are going to narrow the field of potential ideas.

Will Tysabri Withdrawal Revive Call for Stronger Drug Safety?

Yesterday, I noted that Biogen and Elan had taken their joint blockbuster drug, Tysabri, which treats MS, off the market temporarily because 2 patients had developed progressive multifocal leukoencephalophathy (PML). Each of these patients were taking another drug, and one of them has died from the condition.

Tysabri had been approved under the FDA's "fast-track" approval system, and some articles are now saying that this recent series of events may bring about another bout of hysteria about drug safety and call the FDA's fast-track system into question (this last link is to a WSJ article and requires a subscription). I say "poppycock" to that.

Support for Fledgling Life Science Companies - Savvier and More Comprehensive

Coming off of a large project that kept me from blogging for a bit there, I was thinking more about how great some of the incubators I've recently visited are both for the companies they house and for the regions that host them. The energy you feel in these places, and the enthusiasm that the incubator directors display is infectious and makes you smile from seeing their passion and love for what they do. So I'm a big fan of incubators (the well-run ones, that is).

As more states, cities and regions struggle to find ways to encourage and support more innovation and entrepreneurialism, one idea that is starting to catch on and make some progress is incubators.  These have been around for manufacturers and tech companies for years, and several incubators for software and e-companies came and went during the late 90s. More and more incubators are now popping up that are either exclusively for life science companies or that house some life science companies among other tech companies. These can be critical for the very early-stage companies, before they get the larger rounds of funding.

            

Viagra Ads too "Wild"

With all the murky, muddy news that seems to be filling the media these days about the biotech/pharma industry, there are a couple bright points that have made me smile.

The first bright point (at least for us television viewers - Pfizer might not be as amused) is the FDA demanding that Pfizer pull its Viagra ads featuring the song "Wild Thing."  It doesn't seem that the FDA is taking a page from Michael Powell's book at the FCC and is calling the ads racy; rather, Pfizer fails to clearly state that the drug is for erectile dysfunction and to list all of the drug's side effects in the ad.

More Troubles for Merck

I really do hate to harp on one major company's woes that are in the news, especially as I'm not a plaintiff's attorney and they are sure to do an excellent job highlighting the various ways that Merck failed to provide needed evidence regarding Vioxx research results. However, the latest bit to come out about Merck merits some discussion, if for no other reason but as guidance for other companies of all shapes and flavors about what not to say or use for lingo in your internal documents.