Piven on Biologics Exclusivity: Ten Years!

By now you've heard that the White House thinks seven years exclusivity for biologics is the right way to go. The branded firms were shooting for 12 or 14. Here's the Pink Sheet Daily coverage and the White House letter from Nancy Ann De Parle and Peter Orszag.

Breaking news: PhRMA and BIO have hired a new agent, who responds, uh, point blank:



Hmmm. The ball's in your court, Waxman. Happy Friday.

Imagining Lunch With Dick Clark

INT. MERCK CAFETERIA, WHITEHOUSE STATION, N.J.

12:30PM. Merck CEO DICK CLARK enters, selects a few assorted items for lunch, and approaches the counter, where he is greeted by the CLERK.

Merck Cafeteria Clerk: Oh, uh, hi Mr. Clark. OK let’s see, diet coke, turkey sandwich, kettle chips, ooh those are good. Have you tried the angry chili flavor? That’ll be $12.35, sir.

Dick Clark: Just hold on a second there [sends blackberry message to general counsel] ... Hi. No i prefer the unsalted. Better for the ticker. Anyway ... [checks blackberry] ... OK, see, I’d like to structure this transaction so that my lunch buys me.

Clerk: What? Ha, that’s funny. Are you going to pay cash?

Dick Clark: Well yes [gets wallet] ... but I'm going to put some of it on this card. But we need to have the sandwich buy me, seriously. If the lunch buys me I don’t have to share it with Kellogg. I kind of promised Pete half my turkey and swiss, but if it’s not my sandwich, technically I don’t have to give him any. And it’s the last one in the fridge over there. Plus … lets see [checks blackberry] … yes. If we do it this way the calories don’t count either.

Clerk: Uh, I don’t know how to do that. There’s no button for that on the register.

Dick Clark: Just ring it up as you normally would, and I’ll get Bruce Kuhlik down here in a minute to draw up the agreement and rename the sandwich. Oh and I might as well pre-pay for—I mean tomorrow’s sandwich might as well pre-pay for me, right now. That way there’s no confusion. Today's lunch and tomorrow's lunch, all together.

Clerk: I’m sorry, Mr Clark, I still don’t know how we’re going to do this.

Dick Clark: [doesn't answer]

Clerk: Sir?

Dick Clark: Sorry, were you talking to me or the lunch?

Clerk: [sighs] I'm not even supposed to be here today.

RNAi IP: Glover Goes Down

"Man I'm gettin' too old for this sh!t."

Alnylam's "Glover" patent has been overturned in Europe. Alnylam has their say here, Silence Therapeutics' slant is here.

We've often noted that with no RNAi therapies on the market and companies effectively operating under the research exemption granted via the 2005 Merck v Integra Supreme Court decision that it's difficult to weigh in on RNAi IP (we do however acknowledge that a good proxy for determining the eventual IP winner is watching where deal dollars wind up, and by that measure Alnylam is lightyears ahead).

So do we know what the European Patent Office decision means in the long run? No. Does it give us an opportunity to entertain you on a sunny summer Friday with Lethal Weapon references? Yes.

The Return of Lord Kesslermort

Where am I going with this, you ask? Well, he's been in hiding for years and all of a sudden there are ominous signs of him everywhere. While he doesn't literally carry the Dark Mark, he may as well from the drug industry's perspective (note: if you are not getting these Harry Potter references, my apologies, but I just finished the last book.)

I'm talking about former FDA Commissioner David Kessler, who served as head of the agency from 1990, under Bush I, to 1997, when he was succeded by Jane Henney in the twilight years of the Clinton I Administration. Kessler is arguably the most controversial commissioner in recent times for the way he took on drug companies, Big Tobacco and even orange juice producers. His pursuit of having FDA regulate tobacco products resulted in the FDA vs. Brown & Williamson Tobacco Co. case, which the agency lost.

In 1996, with the voices opposing him growing louder and louder, Kessler announced he was stepping down, and subsequently took a position as Dean of Yale Medical School in 1997. In September 2003, Kessler was appointed Dean of the University of California, San Francisco School of Medicine. Now 56, Kessler has reemerged from his quiet life as an academic and has been very vocal in the wake of criticisms against the FDA.

Kessler participated in a roundtable discussion of former FDA commissioners organized by the George Washington University School of Public Health on February 21st. Here's a few things he had to say:

On PDUFA:"We are willing to continue to support PDUFA...But if PDUFA is a negotiation with the regulated industry, I don't think that is going to be trusted," Kessler said at the GW panel discussion.

On FDA leadership stability: "You can’t have a commissioner every 18 months. You can’t run an agency if a commissioner is there for such a short period of time."

On personalized medicine: "The model that pharmaceutical development is based on is not a sustainable model. The notion that there are going to be drugs that we are going to be able to come up with and have millions and millions of people take safely—the blockbuster—that is the thing that has gotten us in this trouble."

After the GW panel, Kessler showed up a few months later at a May 7 House Oversight & Government Reform hearing on food safety. "Simply put, our food safety system is broken," Kessler testified at the hearing.

This quote, however, is what really grabbed my attention. In a great article by one of my favorite writers, Geeta Anand in the Wall Street Journal, Kessler says it's time to get novel, potentially life-saving therapies to market even faster than is currently being done. "We have to find creative ways of getting cancer drugs to patients even if we end up being wrong a few times,"Kessler said in the piece. Anand highlights the birth of the accelerated approval process under Kessler's watch. And despite his "anti-industry" reputation, he's the one that made the user-fee system work.

This seems to be an attempt by Kessler to remind the drug industry, "Hey, I'm for accelerating drug approvals." In my humble opinion, it appears that Kessler's recent high profile means he's angling for something, but what? When it comes to the FDA, it's a case of "been there, done that" for Kessler. CMS Administrator? I don't think so. In his stints at Yale and UCSF, he's worked jointly with their respective hospitals and health systems and he has an Advanced Professional Certificate in Management from New York University Graduate School of Business. But I don't think that's his cup of tea. It's more difficult to have a broad brush-stroke impact on healthcare at CMS compared to other agencies in the government.

That leaves two positions: director of the National Institutes of Health with its enormous budget or Secretary for Health & Human Services. I think Kessler would be a perfect fit for the former in a Democratic administration. He's an academic at heart and has led very large academic research institutions/budgets. But I think he wants the latter, where he could lead the public health agenda and finish off his crusade against tobacco which he started over a decade ago.

He's got ties to the Clintons, should Hillary Clinton win the election. However, she may want to distance herself from such a lightning rod as she seeks to stay in the political center. Kessler also has ties to Illinois, receiving his law degree from the University of Chicago in 1978. I'm not sure how much that would help him if Barack Obama were elected President. If a Republican takes the White House for a third consecutive term, I think it's back to the quiet of academia for Kessler.

Nevertheless, drug industry watchers should stay vigilant for anymore signs that He-Who-Must-Not-Be-Named will return.

While You Were Watching the Finale

We hear the onion rings are great

So what else happened (didn't happen?) this weekend? A few stories below that IN VIVO Blog picked up on ...

• The New York Times writes on pharmaceutical and biotech companies' efforts to fight Alzheimer's disease. Wyeth and its "professorial" chief exec Robert Essner take center stage.
  
  
• Endo Pharmaceuticals presented positive data from a Phase III study of its Frova migraine therapy in menstrual migraine. The company has been hoping for years that a menstrual migraine indication would allow Frova to make some noise in the crowded triptan class. A supplemental NDA for the indication is on file with the FDA.

• And a few notes from this morning--IN VIVO Blog is on deadline for the monthly magazines so we mightn't get to these later on: Merck KGAA and Archemix expanded their aptamers alliance in a deal that sees Merck taking a $30mm stake in the biotech co. And good news for Schering-Plough; one of Organon's top prospects, the anesthesia drug sugammadex, posted solid data in a Phase III pivotal trial.


• So, David Chase's The Sopranos ended its eight year run last night, with a twisted reminder for viewers that not everything (not even every television show) achieves, deserves, or even needs resolution. Cop-out or genius?

While You Were in the Cheap Seats

Go Phils!

IN VIVO Blog took in the Phillies-Giants game at Citizens Bank Park in Philly on Sunday. Hopefully our readers had better weather (though the game was excellent!). A few tidbits from the weekend ...

• It seems like Dr. John Buse's Congressional testimony on Wednesday will sure be interesting. The American Diabetes Association president-elect issued a statement on Friday (perhaps in an attempt to avoid mis-quotes), intended to be his only public communication until the testimony, that addresses the notion that GSK tried to silence his criticism of Avandia's risks in the past. NYT has the story, and Buse's statement.


• ASCO ... ASCO, ASCO. Have you heard, there's an oncology conference in Chicago? Lots of news from Pfizer, GSK, BMS and the rest. Covered well over at the WSJ's Health Blog.


• Wouldn't it be NICE? J&J has made the UK's National Institue for Clinical Excellence an offer it would be tough to refuse: the drugmaker will cover the cost of Velcade for patients who don't respond. The NIH would only pay when patients did well on the drug. Of course the details need to be ironed out. Full story at the FT. Hat tip Pharmalot.


• Insider at Pharmagossip highlights Big Pharma's latest new media problem: Youtube. He also directs us to this recent Simpsons excerpt: "Nappien activates your brain's napping centers, and attacks your body's awakegens."

Eternal Sunshine of the Spotless ... ooh cheese!

Great news for rats everywhere--with some upside for humans as well.

NYU scientists have demonstrated the ability to erase a single memory from rat brains, while leaving other memories intact. The study, published this week in Nature Neuroscience, suggested that certain drugs can inhibit the process of transforming short-term memory to long-term memory, dubbed reconsolidation.

The upshot for psychiatry may be the greater understanding of memory processes and potential inroads to treating conditions like post-traumatic stress disorder.

may cause memory impairment!