Achillion has a good knowledge base to design protease inhibitors, after all they've been at it for a decade or so. Some of their candidates have proved safe and effective in the Comp D pathway in NHP trials. They likely have a short list of candidates that they can run additional NHP trials on, before filing an IND and getting FDA approval to start P1 trials for a selected orpah disease indication in humans, slated for Q1 2016. The trials will be relatively short, unlike in oncology, and the potential payout can be immense. All of this will be financed via milestone payments from J&J and cash on hand. In addition, there will be a royalty stream of $400+ a year, once the Hep C combos hit the market. ALS-335 POC trial results will be out soon, if it's as good as sofosbuvir at 400 mg QD, GILD will soon find itself looking at J&J as the Hep C market leader with the 335-3102 combo.
you are right ... ALS 335 is similar to ACH 3102 ... same ribose moiety, phosphoramidate pro-drug, uridine ring at 1-position ... where it differs ... 335 has one or two Fs at 4-position, no deuterium.
faosto, the poc trial results for als-335 will be out soon ... may be june ... if the viral kill equals or betters sovaldi's 4.2 at 400 mg dose, it's a no-brainer that 335 + 3102 will deliver a 6 week cure pan GT. it will also be eligible for fast-track designation and could hit the market next year.
ACHN now has a collaborative partnership with J&J that will yield the best Hep C drug regimens. They have 2 nukes, one best-in-class NS5A, and two protease inhibitors to work with. These can now be used in various combinations to address ALL Hep C patient classes -- all genotypes, and those with cirrhosis or advanced liver disease. J&J has the resources needed to run the trials and get to the finish line. And Achillion gets 15-22% royalty payments for the full value of the drug regimen (which will include ACH 3102 at a minumum). This equates to very hefty royalty payments!
J&J provides ALS-335 ... ACHN provides ACH-3102 ... the best doublet ever! 6 weeks pan GT ... they may add Olysio or sovaprevir later for even shorter cures :)) ALS-516 is in the parking lot ... will not be developed further.
ALS-335 is in POC trials, and if ends up showing better efficacy than ACH-3422 (results due out soon), that's the one they will advance to the combo trials. It does not change ACHN royalty payments though because ACH-3102 will be an essential part of any combo they advance. It turns out that the particular NS5A agent used is the determinant of failures of DAA regimens, and 3102 has a better resistance profile than any other NS5A. This explains why sofosbuvir + 3102 delivers a 6 week cure in patients with baseline RNA exceedding 6 MM IU/ml, whereas sofosbuvir + ledipasvir cannot deliver even a 8 week cure and needs 12 weeks if the baseline RNA exceeds 6 MM IU/ml. J&J-ACHN now has all the pieces and they will be used to beat Gillead in Hep C!
The Yale Art Gallery and British Art Museium are terrific and open to the public.
In fact, New Haven is attracting a lot of biotechs and pharmas, much like Boston. Good work force to tap into at Yale U, where Boston has Harvard and MIT. The ACHN HQ is no more than 5 blocks away from the picturesque Ylay U campus. I visited both while on vacation last year.
ACHN HQ at 300 George St in New Haven is blocks away from the new ALXN HQ building that's under construction :))
Very very good likelihood of ACHN-JNJ getting to a 6-week pan-GT cure well ahead of GILD or MRK! That will change the Hep C landscape quickly. The FDA wants to have multiple drug regimens on the market to benefit patients. But of course, the best and shortest regimen will get the major share of the market. It's GILD in the lead now. But as I said, that can change. And change quickly!
I called ACHN IR today and was told that they are in meetings all day. Don't know if the meetings are with J&J or some other topic.
binary, there are a lot of questions to be answered on the factor D compounds and a lot of work ahead to determine the efficacy and lack of toxicity in animal models. The good news is that they have leveraged their protease inhibitor discovery program into this new and lucrative area and have invented a lot of potentially useful compounds. Another piece of good news is that the human trials are relatively short in duration (like Hep C trials). They are planning to start the P1 trials in Q1 2016. They also have good consultants working with them in this area.
Kevin, I'll gladly second that, the guy is a WEIRDO, part of the reason he's on IGNORE! as are the other bashers here.
BTW, the royalty is not small, it's large ... it's 15-22% of the full value of the drug regimen, as long as it includes an ACHN compound, and it will include 3102 at a minimum, both the doublet and triplet. I expect the doublet will be 335/3102 and the triplet 335/3102/olysio.
UPDATE: William Blair Upgrades Achillion (ACHN) to Outperform; Janssen Deal Makes 'Tremendous Sense', D Program Has Potential, Says Analyst
(Updated - May 20, 2015 9:07 AM EDT)
William Blair upgraded Achillion Pharmaceuticals (NASDAQ: ACHN) from Market Perform to Outperform and raised its price target to $18 (from $14).
Yesterday Janssen announced that it has entered into an exclusive worldwide license and collaboration arrangement with Achillion to develop and commercialize one or more of Achillion's lead hepatitis C virus (HCV) assets which include ACH 3102, ACH-3422 and sovaprevir.
In the view of analyst Y. Katherine Xu, ACH 3102 drove the deal. Despite dashed M&A hopes and weakness in the stock, she thinks think the deal makes "tremendous sense."
Xu explained, "The market reacted negatively to the news after hours, likely partly because of prior expectations of a straight takeout of the company, much the same as Idenix’s acquisition by Merck."
"We believe the strategy of handing off the HCV franchise to an industry leader with the expertise and resources to broaden and accelerate development to markets worldwide and focusing on a high-value proprietary program targeting orphan diseases that is manageable by a small company makes tremendous sense. The factor D program is expected to enter the clinic in early 2016 with proof-of-concept data in PNH during first half 2016; it could create tremendous value in a relatively short period, in our opinion," continued the analyst.
Xu added, "We are also increasing our price target from $14 to $18 by updating our model with the deal terms and two major changes: doubling the peak sales estimate of an Achillion-compound- containing HCV combo from $2.7 billion to $5.4 billion, and increasing the probability of success from 50% to 60%. The factor D program is not currently factored into our valuation and remains large potential upside. We plan to add it to our valuation when we review proof-of-concept data in PNH during first half 2016. Our probability-adjusted net present value (NPV) model currently assumes a probability of 60% for an Achillion HCV asset to successfully reach the market in 2018, with a peak worldwide revenue estimate at $5.4 billion. At midyear 2016, we model $15 per share attributable to the HCV franchise, and taking into account net cash of $3, we derive our price target of $18."