Not many are feeling that pain more from the weak U.S. dollar than Novo Nordisk — the world’s No. 1 provider of insulin. Chief Financial Officer Jesper Brandgaard’s sighs bookend his response to just how bad currency is hurting his Danish company.

With at least $60 billion in U.S. annual sales of brand name medicines going off patent between now and 2012 — Medco is in a sweet spot.

The question on investors’ minds? What will spur growth beyond the generic windfall five years out? CEO David Snow told the Reuters Health Summit expansion plans in Europe will be one of those drivers, and said talks are going on right now.

Biogenerics in the U.S. will happen — it’s just a matter of when, according to Teva Pharmaceuticals’ head of North America.

George Barrett told the Reuters Health Summit that while next year is a toss-up given it’s an election year, setting up the regulatory pathway for biogeneirics to get to market is critical in the next two years ahead of wave of patents due to expire in five years.

Barrett was one of the featured speakers in the final day of the annual Reuters Health Summit speaking from our New York headquarters.

FDA reviewers are under more and more pressure on drug approvals — from Congress, the media, families…
 
The spotlight doesn’t mean the agency has changed its standards, FDA Chief Medical Officer Janet Woodcock told the Reuters Health Summit.
 
But staff are worried they might be held individually accountable for any post-approval safety problems, and that means they’re looking ever more closely at the safety of new drugs before approving them. – By Sam Cage

Medco’s rival last year linked-up with CVS to create CVS/Caremark. But getting into retail is not for Medco CEO David Snow.

At the Reuters Health Summit, Snow listed his concerns regarding the reatail business — mainly the perception of a conflcit of interest — that lead him to embrace a neutral role as an independent benefits manager.  

Barr acquired Pliva. Teva gobbled up Ivax. Watson ate Andrx.

But the generic drug industry is not done consolidating, according to Barr Pharmaceuticals CEO Bruce Downey.

Aside from the top players in the industry, a second tier of generic drug companies could be the next acquisition targets, he told the Health Summit in a phone interview.

Barr Pharmaceuticals CEO Bruce Downey projected that its new brand-name oral contraceptive Seasonique would exceed sales of its older Seasonale. How will the company do it?

Part of the strategy is a wave of television advertisements on prime-time network shows.  Downey declined to comment on how much the company would spend on such consumer ads but said they were already paying dividends.

Patients beware: A lawyer is running the world’s biggest drugmaker, Pfizer, while an efficiency expert is leading Merck.

And that means one thing — developing treatments for your ailment of tomorrow is not at the top of their list, according  to Thermo Fisher CEO Marijn Dekkers. Instead, major drugmakers weighed down with regulatory and legal issues are turning to new CEOs who don’t own a lab coat to steer them through these rocky waters.

It’s a short-sighted move, in his opinion, that puts another hurdle in front of their pursuit to discover new medicines.  

Industry critics of the FDA often charge the agency is too conservative and under funded.

But Shire Pharmaceuticals CEO Matthew Emmens tells the Reuters Health Summit there is an unrealistic expectation by society about complex drugs on the market that is making the regulatory environment  that much tougher. 

GlaxoSmithKline may trail Merck & Co in bringing to market a vaccine for cervical cancer, but Glaxo CEO JP Garnier says its Cervarix will eventually split the market with Merck’s Gardasil. 

Cervarix is already available in Europe, but is still pending approval in the United States, where Gardasil is well established. It may take a few years, but Garnier tells the Reuters Health Summit in a phone interview this week that Glaxo will build the brand and catch-up.