Arrowhead Pharmaceuticals is a biopharmaceutical company developing targeted RNAi therapeutics.
Targeting Innovation
Arrowhead Pharmaceuticals develops novel drugs to treat intractable diseases by silencing the genes that cause them. Using the broadest portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep and durable knockdown of target genes. Arrowhead’s most advanced drug candidate in clinical development is ARC-520, which is designed to treat chronic hepatitis B infection by inhibiting the production of all HBV gene products. The goal is to reverse the immune suppression that prevents the body from controlling the virus and clearing the disease. Arrowhead’s second clinical candidate is ARC-AAT, a treatment for a rare liver disease associated with a genetic disorder that causes alpha-1 antitrypsin deficiency.
Lead Products
ARC-520 is an RNAi-based therapeutic designed to treat chronic hepatitis B virus (HBV) infection. It is the first clinical-stage drug candidate from Arrowhead’s Dynamic Polyconjugate® delivery platform. It is designed to treat chronic HBV infection by reducing the expression and release of new viral particles and key viral proteins with the goal of achieving a functional cure for HBV.
ARC-AAT is a novel unlocked nucleobase analog (UNA)-containing RNAi-based therapeutic for the treatment of liver disease associated with Alpha-1 Antitrypsin Deficiency (AATD), a rare genetic disease that can severely damage the liver and lungs of affected individuals. The goal of treatment with ARC-AAT is to reduce the production of the mutant Z-AAT protein to prevent and potentially reverse accumulation-related liver injury and fibrosis.
The companys pre-clinical stage drug candidates include ARC-521, an RNAi-based therapeutic for the treatment of chronic hepatitis B virus; ARC-F12, an RNAi-based therapeutic to treat hereditary angioedema and thromboembolic diseases; ARC-HIF2, an RNAi-based therapeutic to treat renal cell carcinoma; and ARC-LPA, an RNAi-based therapeutic for the treatment of cardiovascular diseases. It also holds patents related to Adipotide for the treatment of obesity and related metabolic disorders. The company has research collaboration and license agreement with Shire AG to develop and commercialize targeted peptide-drug conjugates.
Platform Delivery Technology
The Dynamic Polyconjugate (DPC®) platform is an RNAi delivery system that has been demonstrated to preferentially deliver to hepatocytes, induce efficient endosomal escape, promote high levels of gene knockdown in multiple animal models, and appears to be well tolerated using a variety of RNAi trigger molecules. It is a modular system that can be optimized on a target-by-target basis and may be targeted in the future to address multiple organ systems and cell types.
Pipeline Development Strategy
Arrowhead’s internal drug pipeline is intended to drive value directly through the clinical development of novel therapeutics and to provide proof of concept for our platform technologies. In addition to our two lead product candidates, ARC-520 and ARC-AAT, we intend to nominate additional clinical candidates that utilize the DPC delivery system. Our core areas of focus for expanding our internal pipeline of RNAi therapeutics are: (1) develop intravenous (IV) administered liver-targeted candidates; (2) develop subcutaneously administered liver-targeted candidates; and (3) explore extra-hepatic targets, including oncology.
You have a problem with the polls. I voted 3 times for I think it will be granted. LOL.
I don't see any problem with the polls....each user's vote is registered only once. As you can see there are currently 6 votes by 6 voters (click on the view voters to see them). end2war if you have questions or comments related to the board's functionality please PM me or post it in the board's logistics section and not in the thread where you think there is an issue as that disrupts the flow of the discussion for that thread. Thanks !
Post by Think2Succeed on Jan 7, 2016 4:52:07 GMT -5
Yes that's how I interpreted as well...let's wait for the final decision then we'll take it from there.
Edit: It's now posted on pace monitor, the motion to dismiss has been denied:
"MINUTES OF Motion Hearing held before Judge Consuelo B. Marshall: RE Plaintiffs Motion to consolidate the related actions and appointplaintiff lead counsel17 AND Plaintiff Weismans counter-motion for consolidation and appointment of co-lead plaintiffs and co-lead counsel38 .The Court and counsel confer regarding the status of the case. Following discussions with the parties, the Court denies without prejudice both motions.Court Reporter: Deborah Gackle. (lc)"
The motion to dismiss has not been denied at this point. It is still under advisement. The 2 motions that were denied were both related to plaintiff motions related to lead plaintiff and lead counsel.
Post by Think2Succeed on Jan 7, 2016 12:29:59 GMT -5
Thanks Kreyn...yes now it seems that it is under advisement but when I checked earlier there was a different text there as you can see from my quoted paragraph. Well at least there is still a chance it might be granted after all.
I was in the undecided group, but am now leaning towards this going to trial. In my mind, the longer it takes the more likelihood this goes to trial. I still think its a waste of time and money but the circus has to finish its show.
Post by christopher2206 on Feb 4, 2016 4:37:38 GMT -5
T2S,
Has there been anything new published on the lawsuit since January 6? I am somewhat unclear on the status of the case moving forward. Has anything ever been made public in regards to what the plaintiffs are seeking in terms of damages? I hope maybe Dr. A will address this in the Feb 9 call. I look at the suit as a potential threat to cash on hand and if they are made to pay anything I look for it to be an unfortunate, but great buying opportunity. I of course hope they do not have to pay anything in regards to damages but the possibility is very real, and they expressed that very clearly in their year end proxy statement in the legal section.
I am not aware of any publicly made statement since Jan 6th. The last official information I know of is that the motion to dismiss it taken under submission so we're basically waiting for a decision to be made before knowing what is going to happen next. The judge assigned to the case is certainly very slow and if we have to go to trial that might actually help (in the sense that the trial hearings and relevant decisions are going to be far apart...hopefully by then the science will clearly take the lead and make this case useless). I wouldn't worry about the cash burn related to this lawsuit...it is more of an annoyance than a real financial hit (you can for example compare the quarterly cash burn pre-lawsuit and post-lawsuit and you'll see there is no major expense increase related to it).
While the motion to dismiss has been taken under submission, I looked up the local rule for the time limit. Looks like we might have to wait another couple of months.
L.R. 83-9.2 Duty of Counsel. If the Court does not render and file its
decision on a submitted matter within 120 days of submission, all
counsel shall, within 130 days after the matter is submitted for
decision, file with the Court a joint request that such decision be made
without further delay. A copy of such request shall be sent to the
T2S, Is it too late to vote? I think the motion w/b denied. I spoke with a really strong litigator about this. He said judges don't like to look stupid. If they get overturned on appeal they look stupid. There is little upside to approving the MTD from the judge's perspective.. Better to just let each side argue its case. Much as I would like it to be dismissed, I don't think it will be. What was also deceptive was a headline that read, "Arrowhead Can’t Ditch Investor Suit Over Hep B Drug Trial" on Law360
Post by Think2Succeed on Mar 8, 2016 6:59:22 GMT -5
I opened the poll again for those who still wish to vote...it will remain open until an official decision is made. As I mentioned before, I also think the motion will be denied but the case will be won. To me this is just a little distraction from regular business and i doubt the stock will react much either way. A settlement might also be a decent compromise for both parties..