March 21, 2012

EASL Can't Even Decide on a Date to Unfairly Disclose Key Hep C Data

By Adam Feuerstein 03/21/12 - 07:19 AM EDT

BARCELONA (TheStreet) -- Yesterday, I used the words "misguided," "unfair" and "unworkable" to describe a plan by the European Association for the Study of Liver (EASL) to selectively disclose hepatitis C research abstracts ahead of its important and closely followed conference next month.

I'd like to amend my description of EASL today to include "confused" and "incompetent" because the medical research society can't seem to get straight which date it plans to selectively distribute those research abstracts.

On Tuesday, EASL sent an email to a registered attendee of its International Liver Congress, taking place April 18-22 in Barcelona, explaining that the online posting of research abstracts would be delayed until March 27 due to technical difficulties. Abstracts were originally scheduled for release on March 22.

"Please be advised that there has been a delay with the posting of the abstracts online," EASL's email states. "This year EASL have a new programme in place which will allow only paid registrants and EASL Members access to the abstracts. We have been informed that the programme is still being tested and that it should be ready for posting online on Tuesday, 27 March."

Several sell-side analysts spoke independently to EASL officials Tuesdays and were also told that the release of research abstracts was being delayed until March 27.

But when I asked EASL spokesperson Jacqui Sisto to confirm and further explain the abstract posting delay, she denied it:

"I do not know the source of your information, but it is incorrect. EASL will release the abstracts on March 22 as planned," said Sisto in an email sent Wednesday morning.

Hopefully, EASL will get its act together soon and let us all know when research abstracts will be posted. These abstracts are important because they contain potentially stock-moving clinical data pertaining to new hepatitis C drugs.

EASL's International Liver Congress is the must-follow medical meeting of the spring. Gilead Sciences(GILD_), Bristol-Myers Squibb(BMY_), Abbott(ABT_), Idenix Pharmaceuticals(IDIX_), Vertex Pharmaceuticals(VRTX_) and Merck(MRK_) are among the companies rolling out new clinical data on experimental hepatitis C therapies.

As far as I know, EASL still has no plans to alter its plan to distribute these important research abstracts only to EASL members or registered attendee of the EASL meeting -- a group which includes hedge fund and mutual fund portfolio managers and sell-side analysts, all of whom can pay for early access.

EASL's research abstracts will not be made available to the public. That means a select group of investors will have access to potentially stock-moving clinical data while a majority of investors will be kept in the dark.

Journalists registered to cover the EASL meeting will also be granted early access to hepatitis C research abstracts but they are still barred by EASL's restrictive embargo rules from writing about any new data until the start of the April meeting.

At EASL, amateur hour continues.

--Written by Adam Feuerstein in Boston.

Source


EASL Gives Wall Street's Privileged Investors Sneaky Preview to Key Hep C Data

87753812

By Adam Feuerstein 03/20/12 - 10:45 AM EDT

Update: After this column was published, EASL announced a delay in the release of research abstracts for the International Liver Congress to Tues. March 27.

BARCELONA (TheStreet) -- Investing in hepatitis C drug stocks is a suckers bet this week because the European Association for the Study of the Liver, better known as EASL, has rigged the game so that Wall Street's privileged investors get a sneak peek at new clinical data ahead of an important and closely followed conference next month.

EASL's International Liver Congress, taking place April 18-22 in Barcelona, is the must-follow medical meeting of the spring. Gilead Sciences(GILD_), Bristol-Myers Squibb(BMY_), Abbott(ABT_), Idenix Pharmaceuticals(IDIX_), Vertex Pharmaceuticals(VRTX_) and Merck(MRK_) are among the companies rolling out new clinical data on experimental hepatitis C therapies.

But if you want an advance look at potentially market-moving hepatitis C drug data, you'll have to be an EASL member or a registered attendee of the EASL meeting -- a group which includes hedge fund and mutual fund portfolio managers and sell-side analysts, all of whom can pay for early access.

EASL plans to selectively distribute hepatitis C drug research abstracts to these folks on Thursday. The same documents will not be made available to the public. That means a select group of investors will have access to potentially stock-moving clinical data while a majority of investors will be kept in the dark.

Journalists registered to cover the EASL meeting will also be granted early access to hepatitis C research abstracts but they are barred by EASL's restrictive embargo rules from writing about any new data until the start of the April meeting.

EASL's abstract distribution policy is misguided, unfair and quite frankly unworkable. Smarter medical and scientific groups like the American Society of Clinical Oncology (ASCO) realized years ago that trying to compartmentalize research abstracts was futile. Information cannot be selectivity disclosed and expected not to leak, especially information that will weigh on the market valuations of biotech and drug firms involved in new hepatitis C drug research.

That's why most medical and scientific groups made research abstracts freely available to everyone in advance of major conferences.

Jacqui Sisto, an EASL spokesperson, explained via email that selective disclosure of research abstracts "ensures the integrity of the International Liver Congress." Really? EASL appears to be corrupting its most important meeting, not making it more honest.

EASL's integrity will not be bolstered when analysts and select investors begin madly downloading and discussing new hepatitis C data on Thursday -- taking advantage of the fact that most of the investing public won't have access to the same information.

It's like insider trading -- only perfectly legal, aided and abetted by EASL!

For those investors not fortunate enough to be allowed inside the velvet ropes of EASL's research abstract release party on Thursday, here's a company-by-company summary of the hepatitis C data expected to garner the most attention by Wall Street:

Gilead Sciences:

Data from two separate but similar studies (ELECTRON and QUANTUM), both involving the two-drug combination of GS-7977 plus ribavirin in treatment-naive genotype 1 patients.

Gilead has said results from the QUANTUM study could be announced in a press release early in the second quarter i.e. before the start of the EASL meeting. Investors are sure to scour the EASL web site Thursday for any early patient data that may give a hint about the later '7977 results. Much is riding on the outcomes from these treatment-naive patient studies because '7977's potency was cast in doubt due to poor results in so-called "null responder" patients.

Bristol-Myers Squibb:

Interim results from a phase II study combining Bristol's NS5a inhibitor daclatasavir (BMS-52) with Gilead's GS-7977 in genotypes 1, 2, and 3 is the most highly anticipated data presentation at the EASL meeting this year. The study is important because it will be one of the first glimpses at the Hep C-killing potency of these two classes of direct-acting antivirals combined into a single, all-oral therapy.

If this study is successful, Bristol is expected to swap out GS-7977 for its newly acquired nuke INX-189, gained from the Inhibitex acquisition. Gilead may also capitalize on the study by combining GS-7977 with its own NS5a inhibitor.

Abbott:

Data from a phase II study of its own all-oral Hep C regimen consisting of protease inhibitor ABT-450, a ritonavir booster and the non-nuke polymerase inhibitor ABT-333. The study enrolled treatment naive genotype 1 patients as well as treatment-experienced non-responders.

Merck:

The potential for additional data on its pan-genotypic protease inhibitor MK-5172.

Idenix Pharmaceuticals:

An update on the phase IIb study of nuke IDX-184 plus early data on NS5a inhibitor IDX719.

--Written by Adam Feuerstein in Boston.

Source

No comments:

Post a Comment