kicks off this week's Biotech Stock Mailbag.
Chris A. writes,
"Thanks for all you do here on TheStreet. I've been reading your articles for about three and half years now and I have found you to be an excellent reporter. I have always had a passion for the markets, but I didn't think much of biotech investing until I was diagnosed with cancer a little over three years ago. Having that life-changing event got me interested in the sector, and your articles were one of the first sources I looked at to start educating myself. This morning, with the help from your reporting, my family and some of my friends scored big time with Amarin. Keep up the great work and thank you for helping us make some real money."
Thank you for the kind words and congratulations. I'm glad my earlier reporting on Amarin contributed a little to your success.
On a related note, Nancy M. emails,
"What's next for Amarin? I know in the past you've discussed a possible takeover. Can you update us with your new thoughts?"
released on Monday were great -- a statistically significant reduction in triglycerides at both doses versus placebo; and more importantly, AMR101 didn't raise levels of LDL, or "bad" cholesterol levels. In fact, the higher AMR101 high dose lowered LDL by 6.2% compared to placebo -- a stellar and statistically significant result.
Obviously, investors loved the data -- Amarin shares have almost doubled since Monday. The company is now an even sweeter acquisition target than before the Anchor results were released.
AMR101 looks very much like a blockbuster cardiovascular drug in the making, which should attract Big Pharma attention.
all have existing cholesterol-lowering and HDL-raising drug businesses that could easily find a comfortable and profitable home for AMR101.
The timing of a potential acquisition is hard to predict. It could happen before AMR101 is approved next year for patients with very high triglyceride levels (the
), although I'd expect any interested acquirer will want resolution on a couple of key questions before taking the plunge. Those questions include the possibility of extended patent protection for AMR101 based on the Anchor data; and clarity on the timing of the clinical outcomes study that FDA says is necessary before AMR101 can be approved as a treatment in the much larger Anchor study population of patients with "high" triglyceride levels.
I hesitate to guess at a possible acquisition price, but I will caution that Amarin at $17 isn't a cheap stock. The fully diluted share count is around 150 million (almost all the warrants and options are in the money now), so Amarin's current enterprise value tops $2.4 billion.
This not to say that Amarin, if acquired, won't fetch a premium, but just remember that it's easy to get carried away when thinking about possible takeover prices. Clinical Data was bought by Forest Labs but at a price that disappointed some of the company's table-pounding shareholders.
One hedge fund investor who's owned Amarin for quite some time told me that his fair value for the stock is in the $18-20 range. Will he sell out completely if the stock gets there? Not likely because he, like everyone else, hopes Amarin finds a buyer willing to overpay. It wouldn't be the first time.
One more Amarin question from KGN32:
"Are you concerned about the insider selling this week?"
No. I'm assuming that investors selling Amarin now have owned the stock since it was trading in the low- to mid-single digits. They've made a ton of money so why not book profits? Sounds like a fiscally prudent thing to do.
"Lots of news from Delcath Systems (DCTH) but no word from you yet. You've been skeptical in the past but wondering if the European approval changes your mind at all? This looks like an exciting opportunity for Delcath to me and the stock is up."
I see no reason to be any more optimistic about Delcath. European regulators granted a CE Mark to Delcath for its Chemosat Delivery System, but getting a medical device approved in Europe is a relatively easy task, basically requiring proof that the device is safe for use in patients. Much more difficult is obtaining reimbursement for use of the device, which Delcath hasn't done. Without reimbursement, Delcath will find it difficult to generate significant Chemosat sales.
To gain European reimbursement for use of Chemosat and to convince doctors there to try the device on their patients, Delcath needs clinical data demonstrating a significant clinical benefit. Again, Delcath doesn't have that data, especially in Europe, where Chemosat has never been used.
Chemosat is a medical device that isolates and bathes the liver with an ultra-high dose of the tumor-killing chemotherapy drug melphalan.
Delcath CEO Eamonn Hobbs told investors last week that the CE Mark for Chemosat allows the company to address a potential commercial opportunity of 100,000 liver cancer patients.
Really? Based on what data? The only phase III clinical trial of Chemosat conducted by Delcath enrolled melanoma patients with liver metastases. Delcath is running a small phase II study in patients with various tumors of the liver but no data have been presented or published yet. Neither of these studies enrolled any European patients.
Hobbs has a credibility problem when it comes to discussing the commercial potential for Chemosat. He consistently overplays his hand, first with the potential for U.S. sales and now in Europe. Why would a doctor, in Europe or the U.S., treat a primary liver cancer patient with Chemosat in the absence of any data to support that use?
I don’t fault investors for rewarding Delcath a little for the CE Mark grant, but I'd be much more concerned about the stateside regulatory status of Chemosat. I used to assume Chemosat approval by the U.S. Food and Drug Administration was a given, but now it seems to me that the risk of an FDA rejection is very real.
Delcath disclosed last week that FDA has asked to see hospitalization data from patients in all three Chemosat clinical trials -- phase I, phase II and phase III. Not only is Delcath being forced to compile far more safety data than previously disclosed, but the company also admitted needing to rewrite nearly the entire Chemostat new drug application.
Instead of refiling Chemosat with the FDA in September, as Delcath previously thought possible, the resubmission won't be ready until the end of the year. That means Chemosat's U.S. approval is delayed at least one year. Delcath originally filed for approval last December, which was followed in February by the FDA's refuse-to-file letter.
To allay investor fears, Delcath's Hobbs insists that FDA has not asked the company to conduct additional clinical trials. I believe him, but why would FDA ask for new clinical trials today when the agency hasn't even been provided sufficient safety data from the old clinical trials? Delcath screwed up by submitting a hugely deficient data package in the first place. As a result of its incompetence, Delcath wasted a year just getting to the FDA review starting line. Nothing prevents the FDA from asking for new clinical trials later on, after the agency's reviewers get a look at the data that Delcath should have submitted long ago.
It's not like Delcath has a hugely compelling benefit profile to brag about. In the phase III study, Chemosat treatment delayed the progression of tumors in the liver compared to patients treated with best supportive care. However, Chemosat did not help patients live longer than the control patients. On the risk side, five Chemosat patients died because of the Chemosat procedure, according to the investigators of the phase III study.
Granted, this is cancer we're talking about, so relatively more risk is acceptable. But the FDA's request for lots more patient hospitalization data suggests heightened scrutiny on Chemosat's safety profile relative to its purported benefit.
Via Twitter, @Detroitblues comments on my
, the "prescription medical food" that
( AEN) wants to market to people with Alzheimer's disease.
"$AEN what awesome work by @adamfeuerstein on the Alzheimer's test results. Ton of $ could've been made. Tip of the hat Adam and all for free."
Thank you. I'm just wondering if Adeona CEO James Kuo has found the time to read the column yet.
More tweets, this one from @aeroforce: "What's your outlook on
for the year?"
First, think about the first-quarter results. Dendreon reports on May 2, with the current analyst consensus for Provenge sales at $29 million.
A more important near-term focus for investors will be second-quarter Provenge sales.
Current consensus: $59 million. That's because second-quarter sales will provide the truest measure of real patient demand to date, given the FDA's recent approval for the manufacturing capacity expansion at Dendreon's New Jersey plant.
After that, look for when Dendreon reaches the 2,000th prescription for Provenge, now forecasted by the company to occur in July. If patient No. 2,000 occurs before July, investors will be more confident that Provenge is on track to meet 2011 revenue targets. Obviously, if patient 2,000 comes much later, like in the fall, investors won't be happy.
Right now, however, Dendreon is riding a strong wave of investor optimism. The malaise that hit the stock in February and March seems to be dissipating with a very strong April, buoyed by research reports indicating stronger Provenge demand.
Heather D. writes,
"Any word on FDA approval of abiraterone acetate for prostate cancer? Thanks for any info you can share."
Johnson & Johnson
has not disclosed a precise FDA approval decision date for abiraterone but the best guess is June 20, based on when the drug was filed. I have heard unconfirmed rumors that the abiraterone approval might come early.
Abiraterone's initial approval will be for the treatment of post-chemotherapy prostate cancer patients, so the drug should not compete with Dendreon's Provenge, at least not right away. J&J is conducting clinical studies to move abiraterone treatment before chemotherapy, which could make the drug more directly competitive against Provenge.
Opinions differ on that point.
I'm curious to see how high J&J prices abiraterone after approval. I've heard chatter of a whopping $100,000-plus price tag. If J&J goes there, Dendreon will no longer wear the black hat as the prostate cancer drug pricing scoundrel.
And there's certainly recent precedent for stratospheric cancer drug pricing outside of Provenge --
priced its melanoma immunotherapy Yervoy at $120,000 for a four-course treatment.
Written by Adam Feuerstein in Boston
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Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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