Before I get to your email, an
update: I didn't attend Elan's investor meeting Wednesday in Boston. I wanted to go, but I was denied an invitation. Elan told me the room was too small to accommodate everyone who wanted to be there.
Funny, but several people in attendance at the event told me afterward that the room was half full. There were plenty of seats available.
One New York hedge fund analyst who also requested an invite in advance but was turned down nevertheless showed up at the conference center hoping Elan would let him sit in on the meeting. No way, the Elan officials told him, asking him to leave.
Having nowhere else to go, the analyst decided to sit in the lobby of the conference center building and listen to the Webcast of the Elan meeting on his laptop. After a few minutes, a police car pulled up and a Boston cop approached, telling him he needed to leave the building immediately. (There's a great picture of the cop confronting the analyst, snapped by another Elan meeting attendee, that has made the rounds of Wall Street.)
Caroline Stewart is an analyst for Piper Jaffrey. She has a neutral rating on Elan, in part because she says she's not sure that bapineuzumab, Elan's experimental Alzheimer's drug, is going to actually work. She, too, ran into trouble snagging an Elan invite.
A month or so ago, Stewart was planning to conduct a consulting call with an Alzheimer's expert for her clients, in part to discuss bapineuzumab. Elan wanted to listen to the call live, but Stewart explained that it was a call for Piper Jaffrey clients only. The company, however, was free to listen to the replay.
Stewart says that Elan insisted on listening to her consulting call live, and if not, she wouldn't be allowed to attend the company's analyst meeting. Stewart explained again that Piper rules forbade Elan from listening to her consulting call live. She also got angry, and asked Elan whether it was legal for the company to exclude her from attending a meeting where other analysts were invited.
Elan backed down and allowed Stewart to attend.
"The whole experience makes you wonder what they're trying to hide," she says, adding that she suspects her neutral rating on the stock had something to do with Elan's attitude. "They do some good science at Elan, but their behavior is bad."
More Elan meeting weirdness: No question-and-answer session? That's right, Elan didn't take any questions from the attendees after they wrapped up the presentations.
"The meeting was a total waste of time," says Stewart. "Why did Elan hold an investor and analyst meeting but then not allow any of us to ask questions?"
I've asked Elan to comment on why it seems like only "friends" were invited to its investor meeting. I haven't heard back. If and when I do, I'll let you know.
On a related note: Bob Ruffolo, head of drug research at
, announced his retirement April 30. He is 58 and was at Wyeth for about eight years.
As the top R&D guy at Wyeth, Ruffolo, naturally, was responsible for Wyeth's work on bapineuzumab, which is being conducted jointly with Elan.
Why would Ruffolo retire now, with key bapineuzumab data from the phase II study coming out in a couple of months, or even sooner? (He also sold a lot of Wyeth stock immediately after Wyeth and Elan announced in May 2007 that bapineuzumab was moving into phase III studies.) The timing of his retirement sure seems strange.
Now, before I get to your mail, a housekeeping item: I'm going on vacation, so the Biotech Mailbag will go on hiatus for the next two weeks. I'll miss you all. Well, maybe not so much since I'll be in Italy. But I will return in time, rested and ready, for the big ASCO cancer meeting. And eager to write more Mailbags, of course.
Hey, any recent travelers to Rome and Tuscany out there? If you are, and have some tips on things not to miss (great food, wine and gelato, especially), send me an email, please.
Speaking of ASCO, if you missed it earlier this week, check out my research abstract planner,
Asco Abstract Preview
. This should help prepare you for Thursday, when ASCO releases abstracts online. My colleague at
, will be working to bring you all the news. I'll try to comment as well, probably while sitting in a Roman café sipping espresso. (Does it sound like I'm looking forward to this vacation?)
Onward to your email.
B. Van comments on my
, specifically my decision to use a quote from Alzheimer's expert Dr. Paul Aisen, who authored a recent editorial on Myriad's Alzheimers drug Flurizan.
"Thanks for the update on Myriad Genetics and Flurizan," writes B. Van. "I appreciate your perspective and you raise some good concerns about the slim chances for success of Flurizan. However, ever stop to think that the author of the article, Dr. Paul Aisen, might have an agenda? He clearly works for some of Myriad's competitors who are also developing Alzheimer's drugs."
Good point. I should have pointed out that Aisen is, or has been, a paid consultant to numerous companies, some of which are seeking to develop Alzheimer's drugs, including Elan, Wyeth and
Does that make him biased against Myriad Genetics? I wouldn't jump to that conclusion. The Flurizan phase II data are not so hot, whether Aisen thinks so or not. But as I also said last week, Flurizan may not really matter all that much to the stock price of Myriad Genetics because of the company's successful genetics testing business.
Next, an email from John P. "I enjoy your articles and would like your opinion on
," he writes.
Immunogen's near-term fortunes are likely tied to the work being done in partnership with
on Trastuzumab-DM1 (T-DM1), which takes the breast cancer drug Herceptin and attaches to it a potent cancer-cell-killing agent. It is Immunogen's technology that secures the toxic payload to monoclonal antibodies like Herceptin.
Look to the ASCO meeting next month for some new phase I data on T-DM1 to be presented. A phase II study is under way, with data expected in December. Genentech has also said it will make a go/no-go decision on a phase III study this year.
Immunogen has a pipeline of its own proprietary cancer drugs, but the market isn't going to give them much credit until further progress is made with T-DM1. The Genentech go/no-go decision is key. So far, there hasn't been any indication that Genentech won't move forward into phase III, but you can't be sure until the announcement is made.
I'd also expect Immunogen to raise money if T-DM1 moves forward and the stock pops as a result.
As for Titan, wasn't the retirement of founder and chairman Lou Bucalo strangely timed? After all, why would he leave now, with the U.S. Food and Drug Administration expected to issue an approval decision in July on the company's schizophrenia drug Fanapta, also known as iloperidone. (
is in charge of Fanapta's development, with Titan receiving royalties.)
I'm not a fan of Fanapta, as I've
. It's a me-too drug in a regulatory environment that frowns on such things. I don't expect the drug to get a first-time approval from the FDA.
And yes, I know there's more to the Titan story than Fanapta, but not too much more and certainly not until the FDA rules on Fanapta.
Leo G. makes a prediction: "
will soon be the biggest winning stock of 2008, how about doing a write up on it?"
I did write about Avant after
. There will be data presented on CDX-110 at the ASCO meeting. Stay tuned.
As I wrote this week, ASCO research abstracts will be released to the public on May 15. The CDX-110 abstract number is 2011, titled, "Effect of EGFRvIII-targeted vaccine (CDX-110) on immune response and TTP when given with simultaneous standard and continuous temozolomide in patients with GBM."
Next up, some controversy. Is the FDA unfairly favoring Genentech over
? That's a question from a guy with the moniker "StocksinmySocks."
Mr. Stock Socker says the FDA appears biased against Medarex because the FDA approved Genentech's Avastin in breast cancer on the basis of a progression-free survival benefit, yet the agency will not apply the same, seemingly lower standard to Medarex's melanoma drug ipilimumab, which must show a survival benefit in order to be approved.
I've heard variations of this question/complaint ever since Medarex and partner
announced, with little surprise last month, that it was delaying an ipilimumab filing originally planned for midyear, after consulting with the FDA. At the same meeting, apparently, the FDA told the companies to change the primary endpoint of an ongoing front-line melanoma study to overall survival instead of progression-free survival.
The FDA has stated that it views progression-free survival as an approvable endpoint for cancer drugs because PFS, unto itself, has clinical benefit for patients. (There is much debate over this point, but that's for another time.)
The Avastin study in breast cancer showed a clear benefit on PFS, but not on survival, and after much debate, the FDA did approve it.
Now the situation with Medarex is a bit different. The fact that the company is delaying an FDA filing tells us that data from the phase III study in treatment-resistant melanoma patients was not very compelling. Again, no surprise there. While we haven't seen the actual data from this study yet, I would bet that if PFS data were collected, they wouldn't be very strong. Melanoma patients are probably progressing rather rapidly, too much for ipilimumab to show any benefit.
Therefore, the only hope on efficacy would be if the drug can somehow boost survival in melanoma patients. For this reason, the FDA likely suggested that the ongoing front-line melanoma study of ipilimumab be altered to assess overall survival as the primary endpoint.
When it comes to thinking about Medarex and ipilumumab and the FDA, I think the better analogy is
and Provenge in prostate cancer, not Genentech-Avastin in breast cancer. Remember, Provenge wasn't able to demonstrate a statistically significant PFS benefit, but did show a trend toward survival. This is why the current Provenge study was changed to measure overall survival as the primary endpoint.
Sounds a lot like what Medarex is doing with ipilimumab.
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;
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