Pharma’s Cutting Edge

Pharma’s Cutting Edge
Vol. 3 Number 5 - May 2005

Genentech Continues Its Spectacular Spring Romp in May

Investors are celebrating Genentech’s vernus mirabilis, when nearly everything they touch turns to gold. Recently, I haven’t bothered ruminating much on individual companies’ successes and failures, because so much of that depends on intangible, stage-dependent risk factors…what otherwise might be called luck.

But I have to believe that Genentech’s recent run is a bit different. Sure, luck is playing a role, but I believe there are real lessons for investors and other drug developers to learn from Genentech’s ongoing example.

Genentech’s most recent apparent triumph came last week when they announced preliminary, interim results from the 716-subject MARINA trial, in which Lucentis (ranibizumab), an anti-VEGF-A humanized monoclonal antibody fragment, was compared with placebo in the treatment of minimally classic or occult wet age-related macular degeneration (AMD). Approximately 95 percent of Lucentis-treated subjects maintained or improved vision compare to approximately 62 percent of those treated with sham injection. Patients treated with Lucentis for 12 months had, on average, a significant improvement in visual acuity compared to their visual acuity at study entry.

If substantiated, Lucentis would be the first therapy to improve vision in AMD patients; other therapies merely halt progression. Of course, some ‘analysts’ took the press release for a full data release and were already proclaiming Lucentis the clear winner in the wet AMD wars, in which Genentech will battle Eyetech (Macugen) and Alcon (Retaane) for market domination in the near future. One easily swayed analyst, who shall remain nameless, already forecasted Genentech stealing 80% of Eyetech’s market share! Ummm…I don’t think so.  Nevertheless, Lucentis seems to work at least as well as Genentech had intended. Read the rest of this entry »

The Boston Globe (Editor: Drug firms don’t disclose enough - Boston.com - Business) has done a nice job reporting the details behind the NEJM editorial published online yesterday (subscribers can the download editorial here NEJM Editorial).

The bottom-line? The ICMJE (medical journal editors) have drawn their line in the sand. They want transparency when they publish studies. They want to be sure that what they are publishing is representative of the body of data available for a therapy and not just a snippet of what worked. They want to be sure that companies have not self-selected parts of a study to submit for publication.

Are they being reasonable? You bet your ass they are. Pharma’s reputation when it comes to publishing fairly is deeply tarnished. A brief anecdote. A few years ago, at an advisory board meeting called by my former employer, the issue of biased publication was raised. Speaking on behalf of my employer, I confidently asserted to the hushed group of thirty or so experts that we would never suppress data harmful to a drug we were developing. In my mind, the next few seconds replay like a cartoon reel…a comedic pause followed by uproarious mocking laughter, accusatory pointing, sub-lethal pratfalls, and red-faced gasps for air. Investigators and opinion leaders that I had assumed trusted me personally, had, in reality, no faith that I could control the avarice of my employer when push came to shove. They were sure that my employer would do whatever necessary to put its drugs in the best light.

Well…I still strongly believe that they were mistaken. But it matters not. Pharma now has no choice but to comply with the wishes of medical editors, the U.S. Congress and the lay public when it comes to publication transparency. They must register their trials in advance of their conduct. And they must register them in a way that allows the drugs under study to be tracked easily. Registering all drugs as “investigational drug” is not going to suffice. Companies that try such tactics past the ICMJE deadline this summer are going to be publicly burned at the stake. The writing is now literally on the wall. Pharma better learn to read.

The Bioshield II (S.975) legislation first proposed by Sen. Lieberman on April 27th was published online today and may be read here:
Bioshield-II

I might have some more to say about the legislation in an upcoming newsletter. Suffice for now to say that, if passed, the wildcard patent extension is just huge for large pharma, as they can reap two years of peak sales with no additional R&D investment. That could mean billions heading right for the bottom line. Stay tuned to the debates on this one.

Sen. Lieberman’s press release on the bill is here:
Press-Release

A nice UPI piece on the legislation’s compromises was written by Dee Ann Divis:
UPI-Story

Finally, have a look at what the Generic Pharma Industry has to say about the bill:
Generic-Pharma-Industry