Between the time I finish writing my Top Companies profiles and the time the issue goes to press, Something Always Happens. This year, nothing too severe occurred, certainly not on the order of Sanofi’s “secret” negotiations with an undisclosed $20 billion acquisition target. The biggest news this time around was that an FDA panel reaffirmed the agency’s decision to remove the breast cancer indication from Roche’s Avastin. In other last-minute news, Pfizer elected to keep a small (350-person) staff at the Sandwich, UK R&D site that it planned to shut down, Amgen and J&J took another hit when the FDA recommended lower dosing of Aranesp and Epogen/Procrit, and Novartis’ Afinitor will likely get filed for a breast cancer indication this year. 

Then there was the news about Pfizer’s smoking cessation drug Chantix: a meta-analysis of the troubled product’s trials  revealed that it may actually cause cardiovascular problems in patients with no CV history. A few years ago, I joked that Chantix’ psychological side effects — you can look them up — “sound awfully similar to what I’ve seen people go through when they quit cold turkey.” Throw in an increased risk of heart attacks, and you may have the proverbial cure worse than the disease. Pfizer expressed concern about the validity of the meta-study and stands behind Chantix’ benefit/risk profile.

To me, the biggest late news was the double-whammy of a pair of Reuters interviews with Lilly CEO John Lechleiter and former Pfizer R&D head John LaMattina, in which both industry veterans condemned the notion of slashing R&D budgets. Both men seemed to express a sense of revulsion toward the idea of satisfying shareholders in this manner.

Dr. Lechleiter remarked, “I never thought I’d live to see this, but investors are actually thinking to cut R&D. [. . .] This is kind of nuts, but this is what’s being talked about.”

Said Dr. LaMattina, “What’s going on here? R&D is our engine and we have got to basically support it as best as we can.”

Like most of us, I feel that R&D is the lifeblood of the pharma and biopharma industry. I think you’ll find that perspective shapes most of the profiles you’ll read in our Top Companies reports; sometimes, I fear it’s to my detriment that I don’t focus on reimbursement strategies and arcane accounting tricks.

That said, the more I look at shrinking approval figures, complete response letters, mediocre trial results and the like, the more I’m coming around to the point of view that if you can’t get a meaningful new drug to the market with year after year of $8 billion-plus R&D budgets, maybe you do need to slash some programs and rethink what you’re funding.

—GYR

What I’m Reading

Because this is the Top Companies issue, most of my time was spent reading 10-K statements, analyst reports, news releases, and other background information. Still, I did make a little time to read non-Top Companies material.

Online

Strategic partnerships: a good deal for CROs, or just a cost-cutting measure by big pharma?

Suz Redfearn, CenterWatch News Online

Comment: An analyst discusses the trend for strategic partnerships between major pharma and CROs, and finds a CRO (Medpace) whose president dismisses the partnership concept pretty authoritatively. It’s a great read.

Exploring the Abandoned Pfizer Chemical Plant in Brooklyn

Nick Carr, Scouting New York (blog)

Comment: A film location scout in NYC offers a haunting photo-essay of the Pfizer factory in Brooklyn, opened in 1849 and shut down in 2008. He doesn’t have any pharma background, so some of his commentary is almost like an archeologist’s perspective on an ancient civilization.

Non-Pharma

Nemesis, by Philip Roth

Comment: A short novel about a polio epidemic in Newark, NJ during WW II. I’m averse to stories that involve life-threateningly ill children, but Roth never makes them a cheap prop to evoke an emotional reaction in the reader. It’s a heartbreaking story about the limits of devotion.

I also received my first What I’m Reading note from a reader! Nuclear pharmacist Jack Coupal suggested I take up Nassim Nicholas Taleb’s The Bed of Procrustes: Philosophical and Practical Aphorisms, noting, “All it contains are maxims that apply to everyday life. It can be read in a couple of hours, but you’ll be thinking about it for weeks after.” That’s a glowing recommendation (har-har)! As a thank-you for turning me on to a good book, our devoted reader wins a copy of last issue’s Non-Pharma recommendation, Lampedusa’s novel, The Leopard.

What are you reading? Let me know at gil@rodpub.com, www.linkedin.com/groups?gid=1775433 or www.facebook.com/contractpharma
 

Gil Roth has been the editor of Contract Pharma since its debut in 1999. He can be reached at gil@rodpub.com.