Pharma’s Cutting Edge

GlaxoSmithKline (GSK) to Acquire Sirtris Pharmaceuticals, a World Leader in “Sirtuin” Research and Development for $720M - FierceBiotech

In what must be the highest valuation paid for a Phase 2 drug and a pipeline of follow-ups (all in the same pharmacological category mind you), GSK is paying nearly three-quarters of a billion dollars for Sirtris. 

That’s $180 million for each of Sirtris’ four years of existence.

Okay, so Sirtris has its share of sirtuin-activator patent applications pending (at least 180, according to the company).  But those aren’t issued patents, are they? 

Three-quarters of a billion.  That’s roughly three-quarters of a billion for each of Sirtris’ one issued U.S. patent.

And they’ve got a small-molecule drug that apparently has cleared Phase 2.  But that leaves another development phase and a regulatory review to go before even getting to market by my math.  

Three-quarters of a billion with at least four more years of development time.

History tells me that pioneering small molecules for diabetes that have cleared this development hurdle have roughly a coin’s toss odds of eventually gaining major marketing approval, and a much lower chance of making it to market and becoming blockbusters.

And yet.

Three-quarters of a billion.  Roughly $9 milion per Sirtris employee.

Are you feeling valued yet?

Symbollon Pharmaceuticals Announces Results of IoGen Phase III Clinical Trial

Normally, I wouldn’t give a company so small in stature space in these pages, but this news release from tiny Symbollon (market cap pre-announcement circa $10M) stirred some memories for me.  You see Iogen, an oral formulation of molecular iodine–Symbollon’s entire pipeline–was also the first drug I was asked to evaluate for possible in-licensing.

That was back in 1998, or maybe 1999.  I remember feeling expertish.

At the time Symbollon was beginning its Phase 2 study of Iogen, but I believe they had some clinical data already in hand too. 

I remember being relatively unimpressed with the efficacy potential but also thinking: “Why not license the thing? It’s probably safe, there’s a chance it works, and it certainly will be cheap.”  Yeah…I was still pretty green then, not fully appreciating the substantial out-of-pocket and opportunity costs associated with any clinical-phase drug acquisition.  Other people more wizened than me realized the true costs, and my employer, also unimpressed with the efficacy data gathered at the time, took a pass.  As apprently did every other pharmaceutical company who saw the package. 

From a glance at the Symbollon website, it looks like the company went it alone for a while and even initiated the pivotal study referenced above by themselves.  Although it appears that they initiated the same study some six months later, after recruiting a license partner in Gardent Pharmaceuticals (nee Bioaccelerate Holdings).  Start a study twice?  Hey, why not?  Give investors their money worth I say.

I have no idea what became of Gardent, but they bailed on Iogen in 2006, leaving Symbollon to go it alone to the bitter end.  Symbollon had initially expected Phase 3 to wrap up in 12 months; it ended up taking nearly 40.  A lack of timely funds and a skeletal management team will do that.  Oh, and they blew through $20 million.  Not much to big pharma, but the opportunity cost would have been several times more.

Pity poor Symbollon, with it’s tiny market cap barely registering a blip and it’s hopes all faded.  My lesson finally complete.