While You Were Getting Your Guthrie On

Welcome to the Inauguration Edition of your (long) weekend roundup here at the IN VIVO Blog, and remember: this blog was made for you and me. On to the news!

So, while you were bird-watching ...

• Is Lundbeck considering a takeout of up-for-sale Elan? According to The Independent it is, but the paper doesn't name any sources. (h/t Reuters) But after the Flurizan debacle it seems like a strange move to us, despite the therapeutic area tie up in CNS. Lundbeck is 70% privately owned, however, and so mightn't have difficulty moving forward with a deal if its investors are on-side.
  
• Swiss biotech Arpida received an FDA 'complete response' letter for its NDA on the intravenous version of its antibiotic iclaprim. FDA, says Arpida, is requesting new clinical studies. The drug was dinged by FDA's advisory committee back in November.
  
• Galapagos and GSK expanded their alliance in anti-infectives to cover three additional targets, triggering a payment of €2 million to the Belgian biotech.
• Put down the knife, and STEP AWAY FROM THE PEANUT BUTTER.
• What? Football? Well that didn't go very well, did it? Congratulations to the Steelers and the Cardinals and their fans.
  

Schuler: Not Sold on Selling Elan

At first, investor reaction to Elan's announcement that the drugmaker is looking to sell, merge or concoct some other maneuver was welcome as the stock moved up early today.

But as the day wore on, more shareholders may feel the same as Jack Schuler of Crabtree Partners, which holds about 5 million Elan shares. Schuler, a former Abbott Labs president, last month went public with an angry missive complaining that Elan ceo Kelly Martin is inexperienced and, moreover, a big spender. He called for Martin's ouster and is even more upset after hearing about the new 'strategic' review.

While walking the crowded halls at the JP Morgan conference, Schuler called us and has this to say:

"We are very disappointed and this is exactly what we were fearful of. We want to have a change at the top of the company. We feel the management team, particularly the top people, coming from Merrill Lynch is not the right background for running a company like this. There's a fair amount of arrogance, and very extensive spending.

They believe there is extreme value in the drugs and the Alzheimer's drug has tremendous potential. And Tysabri should be used for most all MS patients when you consider the alternative of not taking it. This management team has totally mismanaged that drug and we're fearful they'll mismanage the Alzheimer's drug. They don't need cash. Their debt is due in 2011 and were close to selling one division for more than $1 billion, and as soon as the credit crisis improves a bit, they'll be able to. And if they cancel the contracts for the planes and cut expenses and Tysabri sales go up, they'll get up there.

We're fearful he'll structure a deal that doesn't require shareholder approval, which he knows he would not get. This not the time to sell the company or give away the rights to your very promising drugs. There's no need to. We're fearful because he's under such pressure to resign he'll try some sort of desperate move like this. This is not the guy to be negotiating anything right now. We really are appealing to the board to take control of this company and put people in charge who have experience in pharmaceutical business, particularly marketing."

We'll have more on Elan in the next issue of The Pink Sheet DAILY...--Ed Silverman

While You Were BBQing (on Mars)

In the event your Memorial Day / Bank Holiday weekend didn't involve a glance at the news, let us inform you that NASA landed another probe on Mars, to scoop up some Martian ice and cook it up to 1800 degrees Fahrenheit to sniff out trace chemicals in the vapor, in an attempt to find signs of previous life there. With luck your own barbeques were less costly, not as burnt, involved fresher food and were at least a little tastier. It's tough to beat Phoenix's view, however, and we can't be the only ones who want a grill that looks like that (so long as it's made by Weber, naturally).

The budget for Phoenix's 422 million mile trip was about $420 million, most of which came from NASA aside from a $37 million weather instrument supplied by Canada (presumably already paid for, because now that Canada's mad at FDA--see below--checks could start bouncing).

With yet another big-upfront technology licensing deal (this time with Japan's big dealmaker Takeda), Alnylam Pharmaceuticals can probably afford to foot the bill for NASA's next mission, providing the destination may provide them access to new companies eager to spend a ton of money to non-exclusively license Alnylam's RNAi platform.

This time they didn't have to go as far afield, though for the first time they've branched out into Japan. We'll have more to say on the deal later today so watch this space. For now we give you the basics: $100 million in up-front cash and $50 million in near-term technology transfer payments for non-exclusive license to Alny's platform in oncology and metabolic disease, first right of negotiation on Alny's RNAi programs in Asia (excluding ALN-RSV01). Alnylam also gets opt-in rights for 50/50 co-dev/co-commercialization deals on Takeda programs in the US market, plus the usual gajillion biobucks in development and commercial milestone payments.

UPDATE: We've written a post on the Alnylam/Takeda deal, here.

And what else went on over the long weekend?

• On Monday Novartis said the EU had greenlit Extavia, its brand of interferon beta-1b for multiple sclerosis. Extavia is the same as Bayer-Schering's Betaferon/Betaseron; Novartis gained the right to market its version in a 2007 settlement with Bayer after it bought Chiron (which manufactured the drug for Schering) in 2006. Launch of the interferon in the US and Europe in 2009 should allow the company to secure a beachhead in the MS market before introducing its novel oral therapy fingolimod (FTY720), which is currently in Phase III.
  
• HHS Sec. Michael Leavitt says red tape is slowing FDA's push to get boots on the ground in China. (AP, at WSJ.)
  
• Health care stocks are no longer a port in an economic storm, reminds the Wall Street Journal on Sunday. The paper quizzes a few fund managers on why, and looks for exceptions to the rule.
  
• The Sunday Times is reporting that Elan is mulling a spin-off of its drug delivery business (Elan Drug Technology), but that any move will likely wait until later this summer when it has a better handle on the success or otherwise of its Alzheimer's disease program. (via reuters.) Wait. Haven't we heard this before?


• And finally ... look out FDA! You've gone and pissed off Canada ...

image: NASA