I want to try something new. Welcome to the first Biotech Notebook.
My goal here is to create a home for short, investable updates on biotech stocks -- stuff that I hear from my sources, riffs on company announcements, or even just random observations and rants.
I'd like the column to have a "bloggy" feel, so I'm going to be liberal with links. I may point out an interesting science or health story, highlight research studies, or comment on something interesting (or infuriating) posted on someone else's biotech blog.
These are the sort of things that fill my notebook on a regular basis, but too often, it doesn't go any further. I'm hoping that this column, which I'd like to do on a regular basis, will be another way to help you identify profitable biotech investment ideas.
So, let's get started.
completed enrollment in the phase III study of its Provenge prostate cancer drug known as Impact. That means the next big event will likely be the interim survival analysis, expected in the second half of next year.
While we wait, here's something to chew on: If the interim analysis of Impact shows a trend toward longer survival for Provenge patients, but the result isn't statistically significant, what does Dendreon do with the data?
David Miller, proprietor of the
Biotech Stock Research
(and a longtime Dendreon bull) contends that Dendreon will push ahead regardless and refile Provenge with the Food and Drug Administration.
This was news to me. I thought only a statistically significant result from the interim analysis would allow Dendreon to seek Provenge approval again. Dendreon already went to the FDA with Provenge data that was inconclusive and we all know what happened. So, what would be the point of doing it again?
I called Dendreon to clarify. CFO Gregg Schiffman was somewhat helpful, but vague at the same time. He said the FDA has agreed to accept a "positive interim or final analysis" as the basis for the approval of Provenge. But he wouldn't say if "positive" had to be statistically significant.
Confusion over Dendreon -- what's new?
announces a $3 billion stock
. A good move.
I've talked in the past about the super-blockbuster potential for any new drug that can modify or reverse the ravages of Alzheimer's disease. It's one of the reasons why there is so much investor interest in companies working on experimental Alzheimer's drugs.
But another potential commercial bonanza awaits any company that develops a diagnostic test to diagnose people with the disease. In the best case, such a test will identify those at risk for Alzheimer's early, before the disease does irreparable harm.
is a private company, so there isn't an immediate investment angle, but the company's Alzheimer's diagnostic is certainly intriguing. You can read about the experimental test in the company's
Coming up with an accurate Alzheimer's test will likely turn out to be just as tricky as developing new Alzheimer's drugs. For a smart and "realistic" look at the Sartoris test, check out the
by medical blogger and Big Pharma chemist Derek Lowe.
Speaking of Lowe, I'm a big fan of his
. He can write. Bookmark his site and check it often.
Good news. Cancer death rates in the U.S. are
beat Roche in court Tuesday,
I wrote about Affymax and its long-acting anemia drug
Hematide last month. I spoke with Affymax CEO Arlene Morris on Tuesday, after the Amgen-Roche verdict was announced. She was pleased, to say the least. With Roche's Mircera shot down in the U.S., Hematide is now in a position to be the next long-acting anemia drug launched here.
And no, Amgen has no way to block Hematide in the courts because it's a synthetic peptide, not a biologic protein. Therefore, Hematide steers clear of Amgen patents.
Hematide phase III studies have begun. There will be a bit of wait for data -- until 2010.
My grandmother was
A buy-side analyst friend was on the ground in rainy New Orleans for this week's annual meeting of the North American Association for the Study of Obesity. The buzz:
Using combinations of central nervous system (CNS) drugs like antidepressants and anti-psychotics to induce weight loss has some doctors worried about long-term safety. This means weight-loss drug combinations under development from
, in particular, are going to be under very close scrutiny.
The FDA, in particular, is expected to be very tough on these drug combos. (For more detail, click
More on Vivus: Expect to hear from the company very soon on the start of its phase III trial program, including details about the dosing being used, which to this point, has been kept under wraps.
The next big milestone for
is the 12-month safety check for its obesity drug Lorcaserin. The six-month check was clean, but that was easy. If heart valve damage shows up, doctors say it will likely do so between 12 and 18 months.
Investors are also waiting for Arena to sign a marketing partner for Lorcaserin, but isn't it more likely that any potential partner waits for the security of positive 12-month safety data? Just a question to ponder.
Question: What does
have in common with Microcyn, an experimental wound-healing product from
Oculus Innovative Sciences
Answer: They both basically kill germs, but you can buy a bottle of Clorox Anywhere in your local grocer for less than $5. Microcyn, on the other hand, will be sold as a prescription product costing more than $100 a bottle, if it's ever approved by the FDA (which is unlikely.)
Rodman & Renshaw, Wall Street's biggest table-pounder for Oculus, breathlessly claim that Microcyn has the potential to be a $1 billion product.
I wonder if
realizes what it's missing?
, a marketer of a controversial, expensive and clinically unproven drug treatment program, was kicked out of Pierce County, Wash. this week, which includes the city of Tacoma, according to a
in the local
The Pierce County Council voted Tuesday to end a $400,000 pilot program to treat drug offenders with Hythiam's three-drug cocktail called Prometa after a county-funded audit found the treatment doesn't work.
This news surely brings smiles to the faces of short-sellers, who have engaged in a long battle with Hythiam over the virtues of Prometa. Shorts, obviously, view Prometa as an expensive bit of snake oil, but Hythiam has been able to convince some local governments to buy into it as a way to treat drug offenders.
The news out of Pierce County, however, suggests that this revenue stream may be on the verge of drying up. UBS analyst Don Hooker yanked his outperform rating on Hythiam and placed it "under review" on the news.
Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
to send him an email.