Friday, August 29, 2008

DotW: Yes We Can

As the US prepares for its last chance to check out of the office early on Friday, Dems converged this week on the Mile High Stadium in Denver to listen to ordinariness and outstanding oratory. The GOP will be hard pressed to match the rhetoric as they bear down on the Twin Cities for their own back-slapping event.

There was no shortage of rhetoric in our industry either. Amylin and Lilly finally decided to publicly address Byetta's potential role in pancreatitis in a late day conference call Tuesday. Clearly the speechifying--"Yes we can get through what ought to be a non-event"-- didn't convince a majority of investors. The stock prices of both companies continue to suffer.

Also on Tuesday came news from BMS and Pfizer that their eagerly anticipated Phase III clotting drug Apixaban--pitted in a head-to-head against Sanofi-Aventis's Lovenox for the prevention of venous thromboembolism in knee replacement surgery patients--just barely failed to show non-inferiority. The market reacted--but more modestly--with the share price of each company dipping slightly as Wednesday's trading began. For Pfizer it was a "Yes we can weather another round of negative news" moment. For Bristol, it was proof that the company's risk-sharing strategy makes sense.

Then there was Cell Genensys's announcement that it was stopping a Phase III trial of its prostate cancer vaccine GVAX due to potential safety concerns. Many believe the drug's future is in question, though a different pivotal trial of the product is still on-going. At least the Cell Genesys team has this consolation: "Yes we can ink a lucrative deal with a mid-size Pharma on limited data."

And having failed to partner its lead program, faropenem, Replidyne announced it was restructuring, reducing headcount to just 5 employees and taking a charge of $3.1 million. Undoubtedly the remaining staffers will have a "yes we can moment" that involves selling everything not already nailed down, including their investigational drug to treat C. difficile infection and additional anti-infective compounds. With nearly $61 million in cash on hand, they might even say "Yes, we can pull off a reverse merger."

We aren't going to call roll and ask readers to vote for their favorite weekly run-down of news. It's official. By acclamation, we bring you...

GlaxoSmithKline/Valeant: GSK made another valiant--er, we mean Valeant--attempt to add late stage, specialty focused products to its pipeline this week. On Thursday it announced a tie-up with Valeant for the specialty pharma's late stage epilepsy drug retigabine in a co-commercialization deal worth $125 million up-front and more than $500 million in potential milestones. In addition, the deal also involves earlier stage Valeant programs, and gives GSK world-wide rights to both its VRX698 as well as downstream potassium channel opening drugs. Milestones for these candidates could eventually reach $150 million. The two companies expect to file for approval in both the EU and US for retigabine in early 2009. As The Pink Sheet Daily notes, the deal shores up a looming gap in GSK's epilepsy franchise. The pharma's Lamictal, which will go off patent in 2010, posted global sales of $2.2 billion last year. But GSK will have to master the potentially tricky side-effect profile that comes with retigabine's first-in-class mechanism. In one trial of the drug, nearly 27% of patients withdrew due to problems that included dizziness, somnolence, headache, and fatigue. For J. Michael Pearson, Valeant's CEO, the deal validates his turn-around vision for the specialty pharma. Since coming on-board in February, Pearson has made partnering the company's retigabine and Phase II HepC drug taribavirin a priority.

Genzyme/Medicines for Malaria Ventures/Advinus: There’s a certain irony to a company that’s made its fortune finding treatments for rare diseases to go after a mega-disease and eschew all profits from it. But that’s what Genzyme is doing with the not-for-profit MMV – one of a growing number of groups, operating largely through virtual organizations, focused on just one or two diseases that can be attacked via collaborations with academics and companies. It’s likely Genzyme, along with help from MIT’s Broad Institute and Harvard, will do most of the discovery work while the Indian Advinus – a unique combination CRO and biotech firm – will do most of the development. And while Genzyme is doing its work gratis, the Advinus collaboration will also advance its nascent ambitions in India, where it is one of the few major biotechs with an R&D presence--Roger Longman.

Isis/Novosom: So many targets, so little time. As Isis and others grapple with that dilemma a variety of smaller biotechs are maneuvering to gain access to sequence- or target-specific IP from platform players to move from technology purveyors to drug development companies. Germany’s Novosom—which boasts a nucleotide-agnostic, charge-reversible systemic and topical delivery platform called Smarticles—this week exercised its option (which it lined up in an April 2007 deal with the antisense specialist) to develop antisense oligos targeting CD40, a target in B-cell cancers and inflammatory diseases. That deal lands it worldwide rights to Isis’ CD40 related IP and “non-exclusive worldwide and sublicensable access to certain aspects of Isis’ core technology patents.” Isis gets upfront and milestone payments and royalties on sales. Smarticles (animation here) should not to be confused with Nestle’s Smarties, the colorfully coated chocolate candies that taste delicious but are crap at delivering RNAi and antisense molecules to the inside of cells--Chris Morrison.

QLT/Reckitt Benckiser: Canadian biopharma QLT says "yes we can" continue to sell off assets, announcing the licensing of its Atrigel drug delivery technology to Reckitt Benckiser Pharmaceuticals for $25 million plus potential milestones payments of up to $5 million. (This should give Replidyne hope.) As part of the deal, Reckitt took some of QLT's infrastructure off its hands, acquiring 18 employees and a facilty in Fort Collins Co. QLT has been selling off assets since January, when it announced its intention to focus on its macular degeneration treatment Visudyne. The company has already sold its headquarters, cut staff, and offloaded its acne gel, Aczone, to Allergan for $150 million. Next up: the company will sell QLT USA in its entirety.

Photo courtesy of Flickr user davidhanddotnet via a creative commons license.

1 comment:

Anonymous said...

My name is Lewis Spence and i would like to show you my personal experience with Lamictal.

I am 27 years old. Have been on Lamictal for at least 10 months now. This is an excellent medication that has significantly improved my life. After having tried Lithium, Depakote, and many other anti-depressants, I was frustrated. But after taking Lamictal, and sticking with it, the results have been exceedingly positive. I strongly recommend it.

I have experienced some of these side effects-
Very few; especially compared to other mood stabilizing medications I have taken in the past. For the first few weeks I had some difficulty with memory and word recall, but this went away with time. I sometimes experience more vivid dreams, but that is not necessarily a bad thing. Otherwise, no side effects of note.
I hope this information will be useful to others,
Lewis Spence