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Zogenix, Inc. (ZGNX) Message Board

bionerd51 92 posts  |  Last Activity: 12 hours ago Member since: Jan 2, 2007
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  • bionerd51 bionerd51 12 hours ago Flag

    JRRT1, The only off-target effects that I have heard has occurred in the lab. These "effects" are rare compared to the S-DNA's because the PMO design is longer and starts at the start codon

  • bionerd51 bionerd51 Dec 16, 2014 7:14 PM Flag

    JRRT1, That's the first check researchers do when targeting a virus or human genomic target. Are there "off-target" effects with PMO's? Yes, but at a much less significant rate. Depends on length of oligo

  • Reply to

    BMRN and SRPT IP

    by longshortbear Dec 12, 2014 2:58 PM
    bionerd51 bionerd51 Dec 16, 2014 3:10 PM Flag

    JRRT1, Here's independent knowledge of Iversen et al patent for PMO/PPMO/PMO-X and splice correction dated 2004. This patent was possible because of the Kole patent [1995] on splice correction. JRRT1, Here is "independent knowledge" of splicing patent approval dated 2004. This patent was made possible by the Kole patent [1995] Yahoo will not allow patent link Iverson 2004 patent issuance

    Sentiment: Strong Buy

  • Reply to

    3- Sarepta dmd Trials and counting

    by usagary1 Dec 12, 2014 9:22 AM
    bionerd51 bionerd51 Dec 12, 2014 11:23 AM Flag

    jrrt, They definitely have the data because it is being incorporated into the Phase II data set within the NDA. The entire Phase II data set is unblinded after they began to treat the control cohorts. I am not insinuating that CG is withholding the 168 week data. It's "all hands on deck" in data and statistical crunching of this data for the NDA but if CG needed funding at this point he would release the 168 week data to raise the price share.

  • Reply to

    3- Sarepta dmd Trials and counting

    by usagary1 Dec 12, 2014 9:22 AM
    bionerd51 bionerd51 Dec 12, 2014 9:40 AM Flag

    jrrt1, Does anyone not believe if CG needed money he would be releasing relevant data via PR's to raise the stock price? He has gone from biotech CEO of the year 2013 to witness protection.

  • Reply to

    Hammered

    by thigrlsrk Dec 10, 2014 6:40 PM
    bionerd51 bionerd51 Dec 10, 2014 7:53 PM Flag

    thing, It makes you wonder why Biomarin would choose sides with the loser in Duchennes. They are up to something.

    Sentiment: Strong Buy

  • Reply to

    What Drisapersen was designed to do

    by greyzone513 Dec 4, 2014 11:22 AM
    bionerd51 bionerd51 Dec 8, 2014 10:11 AM Flag

    RNA won biotech of year because they failed a pivotal Phase III trial. I guess standards have come down a bit since last years winner.

  • Reply to

    FromTwitter:

    by free_will_000 Dec 5, 2014 3:56 PM
    bionerd51 bionerd51 Dec 7, 2014 10:02 PM Flag

    Ru, Im sure you meant "primary way that etep enters muscle cells".

  • Reply to

    Infectious Disease

    by speedbll Dec 5, 2014 8:33 PM
    bionerd51 bionerd51 Dec 7, 2014 10:00 PM Flag

    Cook rushed the PPMO into the clinic because of the grab results with their porcine experimentation. Arginine concentrated exposure to arterial walls [coronary] can trigger cellular proliferation and that is exactly what happened. The occlusion rate in the Cook trial was significant. Cook should have checked the literature.

    Sentiment: Strong Buy

  • Reply to

    FromTwitter:

    by free_will_000 Dec 5, 2014 3:56 PM
    bionerd51 bionerd51 Dec 5, 2014 7:05 PM Flag

    jrrt1, Prolonged PMO treatment and increased uptake in hard to penetrate muscles like cardiac would support the myogenic hypothesis that is gaining traction. When this hypothesis is finally proven interested parties will say they heard it first on this board.

    Sentiment: Strong Buy

  • Reply to

    Upgrade.

    by jrfillion Dec 5, 2014 8:34 AM
    bionerd51 bionerd51 Dec 5, 2014 9:10 AM Flag

    Jr, RNA's Phase III trial failed all endpoints, hence the dump by GSK. Biomarin's cheap purchase of RNA is based on 2 main factors. First they are betting that they can carve out a subgroup for treatment with Drisa because there is no standard of care for Duchennes that makes a difference in these boys lives. Steroids are a borderline treatment. Second, The patents. !4 years ago they would have a chance in the upcoming infringement case but today they don't have a chance at all. This is a major miscalculation on their part. The FDA via infringement actions significantly limit broad patents. Their core oligo chemistry is the 2'OME. This oligo is not "novel" to the other phosphorotioate oligos but the PMO is brilliantly novel to the 2'OME. Here are some chemical differences: PMO- backbone contains a morpholine ring. 2'OME: a variation of natural DNA. PMO: phosphorodiamidate linkage. 2'OME uses a phosphorothiate linkage. The PMO is nonionic at physiologic pH. The 2'OME is highly cationic. The PMO is impervious to enzymatic degradation [synthetic]. The 2'OME is more stable then natural DNA but cannot compete with a synthetic backbone. PMO has More specificity with regards to targeting. The 2'OME has many "off-target effects" ™ value [binding affinity] greater then 2"OME. Most of all the DMD clinical data proves that the PMO is a more efficacious and safer oligo hence novel to the plaintiffs infringement claim

    Sentiment: Strong Buy

  • There was a recent decision in the Identix/Glead infringement case which proves that the USPTO strikes down overly broad patents in infringement cases and the justification is the following from above case…" As a result, Idenix had not shown that the selection of individual compounds covered by its patent was justified or credible as "the claimed inventions do not make any technical contribution to the [treatment of Flaviviridae]", Mr Justice Arnold said. Mr Justice Arnold said….and" However, its claims were thrown out by Mr Justice Arnold after the judge ruled that the Idenix patent was invalid on a number of grounds including that the invention was not novel". The judges infringement cases look to limit broad patent claims for drugs and if the core chemistry in prosensa's patent case [Drisa] does not have "technical advantages" over the PMO [SRPT they lose the infringement case. Just because the defendant [SRPT] in this case answers specific questions requested by plaintiffs in the Infringement case response this does not mean these are the only issue in this case that are important. The USPTO regulators review all patent filings and have experts go over the chemical differences of competing compounds, including the pharmacokinetic/dynamic properties. The PMO patent [core patent] is novel compared to natural DNA/RNA and the 2'OME chemistries. This infringement case will be struck down.

    Sentiment: Strong Buy

  • Reply to

    confusion on IP strategy

    by immediatereliefxxx Dec 2, 2014 1:53 PM
    bionerd51 bionerd51 Dec 2, 2014 4:14 PM Flag

    jrrt1, alternative splicing of pre-mRNAs by PMO steric blockade of the spliceosome falls under the category "alternative splicing" which is part of Kole's 1995 patent on "abherrent splicing" . His team discovered the underlining mechanism of abherrent splicing and all the possible oligo uses therein. Kole labeled them "splice switching oligos. This patent is on point.

  • bionerd51 bionerd51 Dec 2, 2014 9:45 AM Flag

    Yahoo deleting. cont'd: Both the Summerton [PMO] and the Kole [targets] patents precedes RNA/Leiden's patents in both areas.

  • bionerd51 bionerd51 Dec 2, 2014 9:40 AM Flag

    jrrt1, What's interesting in the SRPT IP strategy is that their position does not make the Kole patent the central issue. The EU Patent Office negated SRPT's patent claim based on the Kole patent which they disregarded due to the fact that it was going to expire

  • bionerd51 bionerd51 Dec 2, 2014 9:12 AM Flag

    jrrt1, One caveat to your interference thoughts is that the USPTO will review ALL the evidence of both parties patents and claims. The Ryszard Kole patent for exon-skipping [inventor] precedes Leiden's. How much weight the USPTO gives the Kole patent will rule the day. The Kole patent expired a couple of years ago. There is also a second consideration that will bear weight in this preceding and that is the USPTO's "new limiting" approach of all broad patent applications and patent decisions [years ago] in an effort to free up innovation.

    Sentiment: Strong Buy

  • Reply to

    Did someone on Wednesday

    by free_will_000 Nov 28, 2014 9:48 AM
    bionerd51 bionerd51 Nov 29, 2014 12:40 PM Flag

    Starfe, What is this "RNA set to close Europe"?? You know that is false so why are you pumping Drisa?? Let me change it around to a more plausible future……Eteplirsen closes down RNA and Drisa. Why, because eteplirsen is safer and more efficacious then Drisa. This takes care of Orphan status [exclusivity] and worse case patent scenario a low single digit royalty pays for use of exon 51. If I was SRPT I wouldn't pay the royalty and set up shop in a non-EU country

    Sentiment: Strong Buy

  • Reply to

    Who is "Arnold"?

    by sswilton Nov 25, 2014 11:25 AM
    bionerd51 bionerd51 Nov 26, 2014 8:54 AM Flag

    Grey, Patents: The basic PMO patents had it's design origins in the late 1970's. Check James Summerton/morpholino patent. The exon-skipping patents that precedes the Dutch's claim inventor: Ryzard Kole.

  • Reply to

    CATCHING RNA'S DRAFT

    by starfe11 Nov 24, 2014 9:45 AM
    bionerd51 bionerd51 Nov 24, 2014 10:04 AM Flag

    Starfe, The Prosensa deal was made because of weakness, not because of strength. 680 mil is pitiful for a platform, if approved, that is worth north of 4 billion. Biomarin ripped them off. It's obvious that BIOmarin received a deep discount because the low probability of FDA approval. The EU is a home rule entity. Also Biomarin is fully cognizant that when eteplirsen is approved their first-to-market " "status" will be shattered when eteplirsen receives approval because eteplirsen meets 2 out of the 2 requirements to breach the Orphan exemption, "safer" OR "more efficacious".

    Sentiment: Strong Buy

  • Reply to

    My take aways on the Iverson talk

    by thigrlsrk Nov 20, 2014 7:28 PM
    bionerd51 bionerd51 Nov 21, 2014 6:22 PM Flag

    A Chief Scientific Officer is the second most important position in a small biotech company. CG couldn't wait to fire PI. He blamed him for slowing down preclinical research and which oligos should enter the clinic. According to CG, Pat couldn't replicate experiments after reporting outstanding results in earlier experimentation. Pat went on a road trip and could not duplicate an antiviral study at a big pharma lab prior to a partnership. Once the exon 51 data came in his first act was to let him go. The company will deny this and say Pat didn't want to move to Mass. but that is BS. Anyone that knows anyone at Corvalis will tell you this. So what does CG do…he hires an RNAi guy who has never work with steric blockers. Brilliant. CG was only interested in the CV of his future CSO, not whether he would be a good fit with SRPT's strength and core platforms.

    Sentiment: Strong Buy

ZGNX
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