I don’t typically do this, but there have been a flurry of press releases with news from companies I cover so below you will find quick comments on each:
Alnylam $ALNY presented phase 1 data from its ALN-TTR01 RNAi program on 11/21/2011 at the VIIIth International Symposium on Familial Amyloidotic Polyneuropathy conference.
Click here for ALNY research page.
Click here for slide deck.
Check out the complete webcast recording on EarningsCast.com.
Also read my notes from a related Burrill Report podcast with ALNY management
Keep reading for my notes from the conference call.
Alnylam $ALNY President and COO Barry Greene appeared on a Burrill Report podcast following the announcement of phase 1 ALN-TTR01 data demonstrating RNAi proof of concept in humans.
Visit the ALNY research page for additional company, partnership, and drug candidate info.
Keep reading below for my notes from this podcast. ALNY also held a conference call on 11/21 and I will post notes separately from that event.
Pfizer this morning announced a buyout of privately-held Excalliard. Excalliard is developing EXC001, an antisense drug against CTGF for scarring (their trials to date have been in abdominal and breast revision surgery). You can get more info on the drug, clinical trials, and some photos of results on my ISIS research page. This is a surprise to me, because while PFE is interested in fibrosis, they have appeared to be the large pharma least inclined to delve into the realm of antisense and RNAi drugs.
EXC001 has successfully completed several phase 2 studies, but they announced the need for additional phase 2 work before phase 3. Since the company didn't have the money to execute this program, a buyout is not a huge surprise. The terms are not disclosed, but consist of an upfront payment plus contingent payments.
The details in a press release from ISIS, plus knowledge of their license agreement with Excalliard can put a reasonable estimate on the terms. ISIS receives $4.4m of the upfront and currently owned somewhere less than 10% of Excalliard. I believe the ownership stake is at least 5% if it mirrors similar deals by ISIS (and they have participated in later financings by Excalliard to maintain their stake), which would value the upfront payment at $88m. The minimum upfront value would therefore be $44m. ISIS stands to receive up to $9.6m regulatory and commercial contingent payments from PFE, placing the total deferred amount in the range of $96-192m. Of course if I am wrong and the ISIS stake was lower than 5%, then the size of the deal is even larger. Not back for a virtual biotech started about 4 years ago.
Isis also still can receive payments under the terms of their license agreement with Excalliard. ISIS can receive up to $10.5m additional milestone payments, plus (presumably single digit) royalties on sales of EXC-001.
EXC001 was the subject of an IND filing in 2009 and positive phase 2 data from three trials was announced in early 2011. A new phase 2 trial initiated in 2q2011 and appears to have completed enrollment. A presentation at the last ISIS annual shareholders meeting projected a 2015 NDA filing for this program.