BioWorld Bytes: The Farewell Column

Cranky commentary by Cynthia Robbins-Roth

I just got the sad (to me, anyway) news that this will be my last "BioWorld Bytes." BioWorld readers are just too trendy for me — getting your BioWorld fix off of the new BioWorld Perspectives blog and Twitter feed!

So let's see what fun stuff summer has had to offer.

Best Biotech Headline of the Summer!
"Life Sciences: The Rodney Dangerfield of Venture Capital" was the title of the joint blog by Bruce Booth of Atlas Venture and Bijan Salehizadeh of Highland Capital Partners. The blog — MUCH longer than the typical blog entry — expanded from their more sedately titled "In defense of life sciences venture investing" from the July 11, 2011, issue of Nature Biotechnology.

The gist of their argument is that while the life sciences sector "gets no respect" from tech VCs, it has dramatically out-performed tech venture investing in the 2000s. And they have lots of cool colored charts and graphs to prove their point — plus a great reproduction of the Rodney Dangerfield "No Respect" album cover.

Check it out for yourselves and see if you agree.

It's NOT a Breath Mint, It's NOT a Floor Wax . . .
Unlike the late, great product touted on Saturday Night Live way back in the day, it turns out that Pfizer Inc.'s Chantix (varenicline) doesn't excel in any product category. Chantix, a nicotinic receptor partial agonist, hit the market in 2006 to help folks quit smoking.

Wikipedia lists nausea as a common side effect, with headache, difficulty sleeping and abnormal dreams as less common. OK, that's not great but still a marketing possibility given the terrible side effects of smoking.

The first big dent in the expectations of multi-billion-dollar annual sales came in 2007, when FDA announced it was getting post-marketing reports of suicidal thoughts and actions along with erratic behavior. This concern escalated to requirement for a black box warning in 2009, telling folks to watch for depression and suicidal thoughts and actions.

Sort of a problem, especially when you think about the very high rate of tobacco addiction in folks already dealing with depression and other brain disorders that might be exacerbated by an additional source of depression and suicidal thinking.

Hit No. 2 came this summer. In early June, the FDA sent out a safety announcement that Chantix may "be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease."

This month, collaborators from the medical schools at Johns Hopkins and Wake Forest, and the University of East Anglia, published a review of 8,216 patients participating in 14 double-blind studies in the Canadian Medical Association Journal. They reported that Chantix has increased risk of serious adverse cardiovascular events compared with placebo (1.06 percent vs. 0.82 percent).

This is a controversial paper, with folks associated with Pfizer (directly, or via research funding) noting that the risk for cardiovascular events is much lower than the risk of serious illness or death from smoking.

How effective is Chantix? Pfizer sponsored studies show that 23 percent of folks taking Chantix are still not smoking a year later vs. 10 percent for the placebo group and 16 percent for the Wellbutrin (bupropion, GlaxoSmithKline plc) group.

And there you have the crux of the matter. Not fabulous efficacy, some pretty nasty side effects, and oodles of dollars spent on development and marketing already . . . Not to mention the Pfizer decision to chop its R&D budget for next year by $1 billion to $1.5 billion.

The Classic Non-Repeatable Experiment
Amgen Inc.'s anti-sclerostin antibody is going to space on the last trip for NASA's space shuttle. The team hopes to find out if blocking sclerostin will prevent the bone loss suffered by astronauts in low gravity.

Thirty mice will participate in this historical experiment, half given a pre-flight injection of the antibody and the rest getting placebo.

The mice will hang out in NASA's scientifically named Commercial Biomedical Test Module (CBTM-3) — sounds like one of those interesting cytokines, right?

The Ultimate Virtual Company
For years, the fad of virtual companies has come and gone. The idea sounds good — keep your burn rate as low as possible until you reach milestones that will support significant corporate partnership or investor interest.

Of course, many entrepreneurs who actually tried the virtual approach found that investors whined about wanting to see real "bricks and mortar" labs and worried about whether the work was going as quickly as possible.

Dennis Goldberg created and runs neXus Therapeutics Inc. out of his living room, funded solely by his Charles Schwab account. A contract research organization is doing the research on his cholesterol controlling candidate, and he is acting as his own business development department.

Living in the Boston area certainly helps — lots of experienced folks hanging around looking for something to do. Goldberg estimates it will take $6 million to move the molecule far enough along to get a licensing deal in place that may support further development.

(The NPR interview can be found here.)

And Finally — A Great Biotech Cartoon
See what happens when biotech merges with fine dining.

Have a great rest of your summer and good luck with the rest of the year!

Robbins-Roth, Ph.D., founding partner of BioVenture Consultants, can be reached at biogodess@gmail.com. Her opinions do not necessarily reflect those of BioWorld Today.