arrowhead läuft - zu recht
Zu Fidelity:
http://www.sec.gov/Archives/edgar/data/315066/...614002753/filing.txt
Den Absturz erkläre ich mir so: Hexensabat plus shortys plus Dirk Hausseckers Kommentare bezüglich max.Dosis von 2mg/kg könnte nicht genug sein und die Erweiterung von Phase I - das dürfte aber durch die neueste Pressemitteilung vom tisch sein.
Wie dem auch sei lest das alles bei investorvillage nach - bildet eure eigene Meinung darüber.
Ich bleibe dabei und warte auf die Ergebnisse von 2a.
jetzt auch verkaufen aus Panik denn das können doch keine Kleinanleger mehr sein.
Bald ist die Aktie gar nichts mehr wert. Ich bin echt am überlegen, ob ich jetzt hier aussteige und zumindest noch ein paar meiner Euros hier retten kann.... Den Höchstwert werden wir hier so schnell bzw. vielleicht sogar nie wieder sehen!
ja das sehe (hoffe) ich auch so.
Aber Charts hin und her - hast du dich denn etwas um die Medizintechnik informiert ?
Mich würde interessieren was für Erwartungen zu den 2a Ergebnissen hier bestehen.
Wie seht ihr die Diskusion zu den 2mg/kg Maximaldosis ?
Welche KD-werte können wir erwarten, gibt es eine Immunstimulanz?
Na dann legt mal los
Gädda
http://www.arrowheadresearch.com/programs-overview
http://ir.arrowheadresearch.com/releasedetail.cfm?ReleaseID=854653
Und die Meinungen gehen da auseinander doch die Frage ist letzlich eine juristische - dabei hat ARWR keine so schlechten Karten - das kann man jetzt auch an der Marktreaktion sehen.
ARC 520 wird in Hongkong getested und in Deutschland (?) hergestellt. Gerichtsstand ist dann nicht USA.
ARWR hat mit ALNY eine Kooperationsvertrag mit gegenseitigen Rechten - da ist es nicht so leicht ein Patentstreit zu gewinnen.
Will ALNY überhaupt einen fraglichen Missbrauch von ARWR einklagen oder war das eine gezielte Spekulation um den Kurs zu drücken?
11. Final Thought 2: $ARWR will enjoy FDA infringement “Safe Harbor” for USA clinical trial activities for foreseeable future. 35 USC §271(e)(1) “It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . .solely for uses reasonably related to the development and sub¬mission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”
12. Final Thought 3: $ALNY and $ARWR are friends – to a degree. In January 2012, Arrowhead granted Alnylam Pharmaceuticals, Inc., (“Alnylam”) a license to utilize the Dynamic Polyconjugate delivery technology for a single RNAi therapeutic product. Alnylam is collaborating with Arrowhead to develop this technology for an undisclosed target in its "Alnylam 5x15" pipeline.
In then end, with all the existing IP cross-licensing, (especially the #HBV co-devel agreement between $ALNY and $ARWR) and overlapping HBV patent claim scope, it makes little sense to “patent-block” each other. Way too much #RNAi money to be made. Any possible final legal decisions (including distant CAFC appeals) will occur well into the future, long after $ARWR ARC-520 demonstrates clinical efficacy. Patents may be invalidated or held unenforceable, contract terms disputed, and so on.
Besides, this is just HBV. $ARWR DPC tech is broadly applicable to myriad diseases.
Look at it as a buying opportunity based on the oldest market inefficiency known to man – fear mongering.
New hepatitis drug could be 'transformational': CEO
Tuesday, 29 July 2014 5:00 PM ET
The potential market for a promising new hepatitis drug could be significant for Arrowhead Research, CEO Chris Anzalone says.
Source: CNBC.com | By: Leanne Miller
Miracle drug for Hepatitis B?
Monday, 28 July 2014 11:45 PM ET
Chris Anzalone, Arrowhead Research president and CEO, discusses a breakthrough in the search for a cure to Hepatitis B.
Source: CNBC.com
§
$ 14.57
ARWR
0.43§
Daily Short Sale Volume
view§
Short Interest (Shares Short)
11,497,200§
Days To Cover (Short Interest Ratio)
2.9§
Short Percent of Float
§24.07 %
Short Interest - Prior
7,009,900§
Short % Increase / Decrease
64.01§
Wenn wir gute Zwischendaten sehen von IIa (also 0.8 log KD oder besser bei 2mg/kg) dann gehts ab.
Es kann aber auch sein wir warten bis November und sehen dann erst die Zahlen.
Eine Frage bleibt aber: wie können die Shortys die 11 Mill. Stück auftreiben - das kann sehr teuer werden selbst bis November. Da wäre noch die Möglichkeit bis November sich durchzushorten aber das ist angesichts der zu erwartenden Ergebnisse
riskant. Bliebe die Hoffnung (für die Shortys) das die Zahlen schlecht sind.
Gruß und alles Gute für die longs.
“RNAi has come out of the experimental realm into the clinical realm,” Lewis says. “We’re in a hugely exciting time right now. It’s not often you get a chance to be part of a nascent field like this that will really make an impact on human medicine.”
The days of wondering whether RNAi will be effective in humans are behind us.David Lewis, Arrowhead Research
Arrowhead Receives Notice of Patent Allowance for New Protease Sensitive Masking Chemistry for DPC siRNA Delivery System
PASADENA, Calif. — February 28, 2013 — Arrowhead Research Corporation, a targeted therapeutics company, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for U.S. Patent Application Number 13/336,028 entitled, “In Vivo Polynucleotide Delivery Conjugates Having Enzyme Sensitive Linkages.” This new IP expands the Dynamic Polyconjugate (DPC) platform, broadly protecting Arrowhead's next generation DPC polymer masking technology. Using this masking technology, DPCs can be engineered for long circulation times and improved tissue-targeting characteristics. In addition, hepatocyte-targeted DPCs formulated using this new masking technology have shown to be highly potent upon subcutaneous administration. The company has previously reported target gene knockdown of 99% in monkeys after a single subcutaneous injection of 1 mg/kg, with >80% knockdown for 3 months. Additional data will be reported at upcoming scientific conferences and through peer-reviewed publications.
“This patent protects a new masking chemistry that broadens the reach of DPC-enabled RNAi therapeutics. It enables efficient subcutaneous delivery of siRNA and opens up new therapeutic area targets including oncology,” said Dr. Chris Anzalone, President and CEO of Arrowhead. “Arrowhead scientists continue to discover innovative solutions for siRNA delivery and we look forward to providing updates on how these technologies are being deployed to create new drug candidates.”
http://ir.arrowheadresearch.com/releasedetail.cfm?ReleaseID=841010
Das beste Liefersystem für die Leber laut Website
DPCs™ for Liver Diseases
Hepatocytes, the key parenchymal cells of the liver, are a particularly attractive target cell type for siRNA delivery given their central role in several infectious and metabolic diseases. Latest generation DPCs have shown high effectiveness in rats and non-human primates with ED80 (dose producing 80% knockdown of the gene of interest) values of ~0.1 mg/kg siRNA after a single dose. Increasing the dose two-fold in non-human primates results in >99% knockdown with a duration of effect of nearly 7 weeks. DPCs are also well tolerated and have single-dose therapeutic indices of >10 in non-human primates, indicating that there is a ten-fold safety margin between the effective dose and the toxic dose. The magnitude of the safety margin and efficiency of gene knockdown in non-human primates is, to our knowledge, unprecedented in the therapeutic RNAi field as compared to available data generated with competing delivery systems, and position DPC technology as a leading technology for siRNA delivery to liver.
http://www.arrowres.com/technology/dynamic-polyconjugates
Hier muss Vertrauen reinkommen, mit starken klinischen Ergebnissen?
Am besten wären noch Verträge mit Pharma, damit das ganze Untermauert wird?
Gruss
Arrowhead Extends Lead as ISIS Pharmaceuticals Goes Back to Drawing Board
During the Q&A session of the recent quarterly conference call, ISIS Pharmaceuticals revealed a setback in its HBV program. The compound that had entered the clinic last year has been shelved in favor of finding a more potent GalNAc-based version of ISIS-HBVRx. It is likely that this decision has been driven by competitive considerations as well as the dilemma presented by rapidly progressing technology platforms: at what point do I settle on a development candidate?
Competition and technology improvements
We may never find out about the knockdown results from the clinical studies, if such data has indeed been gathered. However, based on the presentation on ISIS-HBVRx at EASL 2014 in April, the generation 2.0 (2’ MOE gapmer) compound did not appear to have particularly impressive potency in the rodent models (ED50 for HBsAg knockdown in transgenic HBV mice of ~5mg/kg).
Especially in light of Regulus’ spectacular GalNAc-based results in HCV last month, it should have been an easy decision to terminate a compound that would have struggled to achieve 80% knockdown in Man in favor of a much more potent compound. The combination of the gen 2.5 cET chemistry and GalNAc are predicted to increase potency by 10-50 fold, giving the RNAi competition a good run for their money.
As a result of that decision, the first-in-class lead of Arrowhead Research has significantly widened with ARC520 now being the only compound in active clinical development. Tekmira’s candidate should be next with an IND expected in the coming months. Meanwhile Alnylam’s candidate appears to exist only in the form of press releases and ISIS with partner GSK have now gone back to the drawing board.
So yes, Arrowhead, get that subQ and especially much more potent single molecule DPC backup ready. There is still time for it.