ISV (Insite Vision): Waiting to be Cleared for Take-Off

This share totally perplexes me. It's a company with a lot of success in getting products approved by the FDA yet investors have ignored it. Well, not this investor. I'm deep into this bad boy and I'm going to wait patiently until ground control gives us clearance for take-off.

So why am I sitting pretty? Back in April, InSite Vision won FDA approval for lead product AzaSite, which treats certain eye infections. It's planning a late-third-quarter domestic product launch from partner Inspire Pharmaceuticals which licensed the product back in February. If you need estimates, AzaSite is expected to launch in the late third quarter of this year, and Inspire has provided full-year 2008 sales guidance of $30 million to $45 million. My peak domestic sales estimate for AzaSite is $100 million in 2010, or roughly a 25% share of what should be a $417 million market, assuming just 5% compounded growth. So what it comes down to is that this is a company that currently makes no money and the estimates listed above are terribly conservative in that they don't even make mention of international sales at all.

I might also mention the public desire for this stock to be bought out by Inspire Pharma for $4-$5 a share.



Notes:
In Portfolio: In at 1.38
Duration: For the longterm Baby!
Remember: Snoopy Sno-Cone Machines?

NUVO (Nuvelo): Placing Bets On Hope

I've had a lot of trouble writing about this stock. Believe it or not, this humble penny stock used to rock $378.75 (February 18, 2000).

So today, this bad boy exploded for 50% during the day and another 15% in after hours trading and I'm sorry that I couldn't write about this sooner but I just didn't have any major insights like I do with some other stocks like ARNA or GM. So I apologize however I just wanted to share my notes on this bad boy while it's top of mind.

HOW IT GOT HERE:
Back in December (2006) the company's main pharmaceutical pony, Alfimeprase, got steamrolled when it failed a Phase 3 clinical trial of it's performance in acute peripheral arterial occlusion (in English: it fights blood clots and might be effective against stroke) and took an undeserved (okay, maybe deserved) drubbing.

Testing involves, at times, failures. My thoughts on the 80% drop in one day...Wow.

WHY YOU SHOULD BUY (HAVE BOUGHT) IT:
It just received fast track approval for several of their cancer drugs (see website for details). I've read that "usually (and I emphasize usually), bio techs receive final FDA approval when the FDA has already fast tracked their drug." But let's be honest... any drug is fast tracked if there is a disease out there with no treatment or cure. It's fools gold.

It also has a decent pipeline with cash on hand and no debt. It's also worth mentioning that Bayer, the 50 million sponsor for Alfimeprase didn't jump ship.

MY REASONS FOR BUYING IT:
I really didn't have any. I didn't write about this one early on because I didn't feel strongly about it or have any unique insight. I just saw a solid company with with a lot of potential, strong public (CAPs) support, that is trying it cure something that is very close to me. It all came down to a bet on hope.



Notes:
In Portfolio: This one's for hope... I'm in!
Duration: Until it hits $378.75 again! (hmm, we'll see)
Random Thought: Cats are clean, they're covered in spit.

ARNA (Arena Pharmasutcials): Phat for Fat

We're big and we ain't so bad. Although you as a reader might not be in this category, let's face it, or rather, we have to face it, Obesity is a serious issue.

More than 30 percent of Americans are obese, a figure that has risen sharply over the past decade, according to the Centers for Disease Control and Prevention. Substantial health risks (cardiovascular disease, hypertension, and type two diabetes) are associated with being overweight and obesity, leading to increased morbidity and mortality (2.6 million deaths annually worldwide from type two diabetes). The U.S. Surgeon General has estimated the direct and indirect economic costs of obesity at $117 billion per year.

So here's the big idea or rather, "the skinny." Arena has developed a top drug candidate Lorcaserin for Obesity entering phase 3 Insomnia APD125 in phase 2. Several more promising compound are also on deck (phase 1 or about to enter phase 1) and I'm liking the odds. What the drug essentially does is stimulates the 5-HT2C serotonin receptor, located in the part of the brain called the hypothalamus, which helps regulate satiety and influences metabolic rate. In English, it makes you feel full.

Data from a Phase 2b trial of lorcaserin demonstrated that patients who received the drug experienced significantly greater weight loss than patients who received placebo. So it's a miracle diet pill. Solid right? No you say? Okay, let's consider the alternatives we currently have:

Stomach Stapling: Needs strict patient compliance to diet, Vertical Banded Gastroplasty (the medical name for Stomach Stapling) is in no way a magic bullet or pill (ah, but Lorcaserin is). It must be emphasized that lifestyle changes (boo), i.e. diet (boo) and exercise (boo), are absolutely imperative for weight loss to occur and be maintained. As with any surgical procedure, there are risks of complications. It has been observed that approximately one in every hundred patients undergoing VBG die within a year.

Diets: Normal diets stress a lifestyle change and strange or extreme diets can be very dangerous, and they are often ineffective.

Liposuction: Who can afford it?

Fat Burners: There is no good reason for speeding up your heart but I guess the silver lining is that it proves that people are willing to pay for weight loss pills.

Richard Simmons: Side effects include embarrassment, a tacky wardrobe, and if you are a male, a significant increase of effeminate tendencies.

Let's face it, current weight loss systems are ineffective and in some cases, dangerous. As for alternatives involving medication, there are currently only two approved drugs to treat obesity and concerns about side effects and efficacy have limited the use of these, presenting an opportunity to help millions of patients with a new, safe and effective therapy and Arena has a viable drug candidate. The fate of this will turn initially on the results of the safety portion of the BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) trial in the 3rd Quarter of 2007 however the result will be huge if they pass.



Notes:
In Portfolio: Yesh. (Sean Connery in da house!)
Duration: Until obesity is eridacated.
Over with: American Idol (Booooring). It's all about the Search for the next Pussy Cat Doll! P-C-D-4-LYF!!!