They have to take 3102, dump all star sovaldi, add 700 mg of the third or fourth best nuc. And go from a tiny trial 12 patients to hundreds of patients ? Does anyone think this will go any better than their old protease trial that was suspended ? Get ready for an offering to finance this trial. Their first serious trial in many years.......12 whopping patients for this last 3102 trial! Wow i love it.....what are the chances tox creeps up as they transition from 12 patients to hundreds, similar to what happened to the protease......?
So in summary, not only gild and abbvie already way ahead of achn, but now mrk too. When would P3 studies for achn potentially be done? 3 yrs? Longer ? When? Meanwhile gild and abbvie curing tons of patients .......and then mrk third.......and the price for the medicine just went WAY down.......
BOSTON (TheStreet) -- Sorry to play the Scrooge in front of Christmas, but the data released Monday on Achillion Pharmaceuticals' (ACHN) hepatitis C "nuc" ACH-3422 falls short of spectacular. Tamp down your hopes and dreams if you were expecting Achillion to be the next hepatitis C buyout candidate.
Achillion shares are up 18% to $16.84.
The efficacy bar for ACH-3422 was a 4-log reduction in viral load after seven days of dosing in genotype 1 hepatitis C patients. Achillion fell short, achieving a 3.4-log reduction at seven days with the highest, 700 mg dose of '3422.
Achillion decided to extend treatment for another week. After 14 days, the 700 mg dose of ACH-3422 demonstrated a 4.8-log reduction in viral load. Three of the six patients treated had hepatitis C virus that was undetectable in their system at the end of the 14 days.
These Achillion results aren't great because the speed at which drugs kill the hepatitis C virus matters. Slower-acting drugs leave patients vulnerable to viral rebound or relapse. Gilead Sciences' (GILD) Sovaldi -- the only approved hepatitis C "nuc" on the market -- and Merck's (MRK) MK-3682, the still-experimental nuc acquired through the purchase of Idenix Pharmaceuticals -- both achieved larger viral load reductions faster than Achillion's ACH-3422.
It's also noteworthy -- and concerning -- that Achillion need to dose up to 700 mg of ACH-3422 in order to achieve a 4-log reduction in viral load. The company hoped to see better results with a 400 mg dose of the drug.
Achillion argues faster is not necessarily better if a slower-acting nuc, combined with other powerful drugs, can still achieve rapid and sustained cures. To prove its point, the company also released results Monday from a "proxy" study of ACH-3102, a second-generation NS5A inhibitor, combined with Gilead's Sovaldi.
In this study, 100% of genotype 1 hepatitis C patients were cured following six weeks of therapy with a combination of ACH-3102 and Sovaldi. Impressive for sure, particularly since the currently approved treatment course for hepatitis C runs 12 weeks and achieves cure rates between 94% and 99%.
The next step for Achillion will be to develop a proprietary combination of ACH-3102 and ACH-3422. The company hopes it can swap out the Sovaldi nuc for its wholly owned nuc (ACH-3422) and still maintain the strong results seen in the "proxy" study.
Investors don't want Achillion to have the opportunity to develop this new combination therapy on its own. They'd like to see a larger hepatitis C player without a nuc in its arsenal -- Bristol-Myers Squibb (BMY) or Abbvie (ABBV) -- acquire Achillion for a sweet premium.
An Achillion takeout is certainly still possible, but today's ACH-3422 data makes it less likely, in my opinion. Sovaldi looks to be a more potent nuc than ACH-3422 which raises concerns that the "proxy" study results won't be duplicated -- at least not enough to demonstrate significant superiority over currently approved treatments.
And the value of any future hepatitis C therapy was significantly eroded Monday now that pricing for hepatitis C drugs has been reined in by the exclusive pharmacy access deal negotiated between Express Scripts (ESRX) and Abbvie. I suspect Big Pharma hepatitis C players are re-evaluating their appetite for risk, which makes paying a premium for Achillion more difficult to accept.
If there's a longer-term winner today, it's Merck. After posting disappointing results from a three-drug cocktail of drugs in November, Merck is moving ahead with newer combination therapies focused around the potent nuc MK-3682 acquired from Idenix.
Achillion demonstrated Monday that a nuc-NS5A inhibitor combination could achieve 100% hepatitis C cure with six weeks of treatment. I think Merck and not Achillion is in a better position today to get quick cure into pivotal studies and approved.
My answer, it never will, its inferior and too far behind. Common sense. The only good news that achn released today was due to a study with sovaldi, which achn does NOT own. Comical
I love it, 3422 comes up way short and you change the subject and pump the express scripts angle. Why on earth would ES pay for a drug that is fourth best in class , inferior to harvoni and at least 3 yrs behind harvoni? Pls lay out for me when 3102 / 3422 will be done w p2 and then p3?
You are an utterly clueless pumper. He predicted the need for a 700 mg dose when all the other pumpers on here said no way. One of the pumpers even claimed they called Ir and achn confirmed no 700 mg dose. You cant make this stuff up.
Do ur own DD. They are third in nuc race behind sovaldi and merck nuc and many years behind. They are also 4th in class to harvoni (behind abbvie and merck also, possibly behind bms and others too) and many years behind. No worries you dont have to sell now. Achn will pump their combo and clueless people will buy the pump. But achn is just too far behind in a very crowded very well funded space. Did you really believe achn could outresearch and outspend gilead, abbvie and merck? Good luck., pay attn to insider buy/sells going forward
Why are you making fun of him? You know he took the time to contact IR and they said they never dosed to 700 mg? Gotta give him credit for the DD. Wheres his buddy binary?
Sorry not covering yet. Pls tell me you know how bad the 3422 results were and all that matters is the nuc? Lol
Its not as efficacious as sovaldi and identix nuc. Third in class will never make it to market. Too far behind in yrs to sovaldi AND not as efficacious. Horrible combo. Just sell and move on
Plasma exposure is far inferior despite all the bs they spouted about deuterium effects ( which they probably tried to argue for their weak IP position). Did Achn IR really tell you that they didnt dose up to 700? Lmfao