« August 2007 | Main | October 2007 »

September 2007 Archives

September 4, 2007

Ready to Recover

Amgen (AMGN) scored two straight wins in their patent lawsuit against Roche, and the next big win for the company will be with the FDA on September 11. The Federal District Court in Boston ruled that Roche's CERA drug clearly infringes on one of the five patents that Amgen alleged, and the court granted Amgen's motion for summary judgment. This was the same composition-of-matter patent that Amgen used to beat Transkaryotic Therapies, before the same judge. The judge also ruled against Roche on a number of its other defenses. A trial starts on September 4 on the other patents, if Roche really wants to fight an endgame before settling and paying legal costs and royalties.

On September 11, the FDA's Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will hold a joint meeting to consider the risks and benefits of Aranesp, Epogen and Johnson & Johnson's Procrit in kidney dialysis. The agenda will be available about 48 hours prior to the meeting. I do not expect any change to the current treatment recommendations, but these types of meetings can be unpredictable.

The new Medicare rules on when Aranesp and Epogen will be reimbursed when used for cancer patients have been out long enough for the medical community to come to a consensus: They are unworkable and will not save any money. Private payers, which account for 60% of cancer reimbursement, are likely to adopt an 11 grams per deciliter (g/dl) cutoff for hemoglobin before using the drugs, down from the current 12 g/dl but more practical than Medicare's 10 g/dl limit. At some point, Medicare will be forced up to 11 g/dl due to stresses on the blood supply and poor patient outcomes, but that could take a year or two.

With the patent win, the September 11 meeting soon to be behind us and private payers about to adopt a less damaging hemoglobin policy than Medicare, Amgen's stock should be ready to recover.

September 7, 2007

The Gutter-Cleaning Robot

Last week, we discussed robotics and some the military contracts out there. I want to discuss robots again, but this time focus on some of the new ones in the pipeline.

iRobot (IRBT) will introduce two more types of home robots on September 27 at the Digital Life Expo in New York. Management is being coy, just saying that they are "very cool" and "very different" from the Roomba and Scooba. The CEO said: "They're not floor-cleaning robots. They're not lawn mowers, and they're not butlers. But that's all we've said so far. These robots are going to make you think."

That made me think that I should try to find out exactly what they are, and I found one in an FCC filing: A gutter-cleaning robot. iRobot has to get FCC approval because there is a remote control antenna on it, and they filed the whole owner's manual.

I don't know where "Looj" came from, but this looks just like the toy that your Dad wanted when he was five years old. Will this be the Dad holiday gift of the year? It has two cool treads, a handle to put it in position that detaches to become a remote control (requiring FCC approval), and a very cool "distruptor/ejector/sweeper" auger assembly out front for clearing out the drains. Then a 500 RPM rotating sweeper scrubs the gutter. The manual says that it does one gutter at a time, so it has to be moved by hand at any gutter junction. It has a belt clip to make it easier to move around -- how can your local Tom The Toolman hold up his head if he doesn't have a Looj on his belt? I want one, and I have gutter covers.

I haven't been able to find the other new product -- laundry? Ironing? Walk the dog? The company released the Verro pool cleaning robot in April, so they could be going in any direction. "These robots are going to make you think." Hmmm -- will it be a chess robot? A football coach robot? We'll see on the 27th.

September 12, 2007

Avian Flu

A new analysis confirmed that bird flu did spread from person to person in Indonesia in April. Since 2003, the H5N1 avian flu virus has infected 322 people and killed 195. Almost all of the victims have been infected directly by birds. But a few clusters of cases have been seen for which no other explanation can be found except person-to-person transmission.

The Indonesian cluster began with a 37-year-old woman who had been exposed to dead poultry and chicken feces. It appears she then passed the virus to her 10-year-old nephew who then passed it on to his father. The possibility that the boy infected his father was supported by genetic sequencing data. All but one of these flu victims died.

Researchers now estimate that the secondary-attack rate, which is the risk that one person will infect another, is at about 29%. That is much higher than previously thought, and probably indicates that there is a mutated version of the virus that passes more easily from human-to-human. It is still not pandemic level -- yet -- but while the general public has forgotten about bird flu, virologists are more worried than ever about a pandemic.

There are a few companies out there working to create vaccines and antivirals in preparation for a possible avian flu pandemic. One of my favorites it BioCryst (BCRX), which has a vaccine in trials right now.

September 18, 2007

Anti-Coumadin

Recently, I've been thinking about how fast life is changing. My older kids are likely to make it well into that 100- to 150-year-old range, which will soon be the norm. And when I mention that the average female baby born in the U.S. in 2007 will live to see 2107, I have a personal interest because we are expecting another little girl by the end of the year. So, I have to make it into triple digits, too. But the biggest event behind these ruminations was my mother's death a little over a week ago. She went gently at the age of 89, held by my sister, as my brother and I scrambled to get to Des Moines. Like so many of her generation, she spent four years with infants and toddlers while my dad was away at war, and afterwards just kept working that hard her whole life. She earned her retirement.

Yet, she also went too young. Her mother lived to 95 and her slightly younger brother, a Rear Admiral and ex-Commandant of Kings Point, is driving, sailing and leading an active life. But 15 years ago Mom went on Coumadin, which is a killer, and I could not talk her out of it. Aside from giving people Lipitor without telling them that they need to take big doses of CoQ-10 to avoid muscle weakness and death, I think the warfarin rat poison with the sanitized name Coumadin has to be one of the worst things modern medicine does to people. Just check out this article. And that's why I'm also very interested in the better, life-saving medical technologies that are already being developed, or will be, in the upcoming years.

So, In Memoriam, Jane Austin (King) Murphy, March 22, 1918 to September 8, 2007. And don't let any of your loved ones take Coumadin.

September 21, 2007

Perfectly Positioned: SiRF Technologies

SiRF Technologies (SIRF) will have their GPS technology embedded in the two new Motorola (MOT) phones coming in October. In 2007 there should be about eight follow-on phones that use the SiRF Global Positioning System (GPS) chips, including some using the GSM/EDGE standard to target China and others using the WCDMA/HSDPA standard to target Europe. Some of these phones will be very high-volume devices, and others will be expensive, high-feature models.

Wall Street is seeing SiRF's domination of personal navigation devices, such as those made by Garmin (GRMN) and TomTom (TMOAF), under attack. What The Street is missing is that the market for GPS chips in cell phones is literally 100 times as large. SiRF has about 75% of the personal navigation device market, but the opportunity in cell phones is much, much larger. As long as the company can keep driving costs down to protect their margins as chip prices fall, Wall Street will be positively surprised by the results. The carriers want to sell smartphones with more features and extra revenue from additional services, so we can be sure that GPS will continue to spread rapidly into almost all handsets. SiRF is already in the new BlackBerry 8300, which is a big success.

September 24, 2007

Content on Demand

I talk a lot about content on demand in my New World Investor service. That's because more and more people want to watch what they want to watch, when they want to watch it, without having to plan ahead and record it. This is a huge trend that is shaping the world around us, and it is just unfolding. Just take a look around you. On the bus or train commuting to work, people are hooked up to their iPods listening to music or catching up on this week's season premieres. Or just think about the advancements in digital TV. You can actually pause a show or fast forward through commercials.

Another example of the content on demand phenomenon is the ability of people to download last nights episode onto their iPod or home PC. I recently came across a September 20 post on the A VC blog about NBC's announcement that they're going to provide free downloads for seven days after the show airs. I have to agree with this blogger that eventually big media companies are going to have to come to the realization that people want to have access to this content all the time -- not on a limited seven-day schedule.

September 28, 2007

Beating the Bears: Amgen

Amgen (AMGN) presented at the Merrill Lynch European Conference, and it was one of the most level-headed presentations that I have ever been exposed to. These folks are good! They went through the Medicare decision very carefully, and said that they will let the angry doctor groups like the American Society of Clinical Oncology (ASCO) carry the fight to overturn it. After the Congressional recess, the Senate voted 100-to-0 for a "Sense of the Senate" resolution to overturn it. Those doctors are organized! During the recess, they brought Senators in to see their treatment facilities, and then pointed out that they will have to ask aging, often infirm cancer patients to take periodic 100-mile roundtrips from a radiation clinic to a hospital to get a blood transfusion.

The company also said that with very few exceptions, the private payers are not following the Medicare guidelines, but are sticking to ASCO guidelines. Regarding the September 11 meeting on the use of Epogen and Aranesp for kidney dialysis, they were very pleased with the outcome. I know you may have read some other newsletter editors advising buying puts on AMGN before that meeting because "they are going to get creamed again," but they were wrong. The stock has been up $2 to $3.50 a share since the meeting.

Another of the bear stories is that Amgen has a weak pipeline. So, management mentioned upcoming data on three different products in Phase III trials, with numerous Phase II programs behind that. The company is going to do another "open the kimono" meeting in February in New York, spending a whole day discussing all their clinical work. The last time they did this, the stock took off.

The patent trial against Roche is also underway. I thought Roche would settle rather than proceed with what looks like a sure loser, but to each their own. Amgen management seemed very confident of victory, as they should be.

About September 2007

This page contains all entries posted to New World Investor Blog in September 2007. They are listed from oldest to newest.

August 2007 is the previous archive.

October 2007 is the next archive.

Many more can be found on the main index page or by looking through the archives.

blog_rss_NewWorld.gif
blog_try_NewWorld.gif