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Galena Biopharma, Inc. Message Board

hofno2003 112 posts  |  Last Activity: 1 hour 38 minutes ago Member since: Jul 7, 2005
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  • hofno2003 hofno2003 1 hour 38 minutes ago Flag

    Not in this case. Again some feed for interested readers:

    RPRX approach means forcing the body to produce more T in the testes by bringing into the body an active drug which can pass the blood brain barrier to act within the brain on its impaired hypothalamus and impaired pituitary gland (impairment of the hormone releasing function of hypothalamus and pituitary gland is the reason for low T in secondary hypogonadism) in order to force them (= the hypothalamus, pituitary gland of the brain) to resume to produce some hormones (FSH, LH, gonadotropin, gonodotropin releasing hormon) in order to get the testes stimulated to produce more T.
    I think everybody understands that this is a much more complex and risky intervention than simple applying T from an external source.

    Concerning your issue on passing the liver: Yes, LPCNs and Clarus TRT drugs bypass the liver. Both are released by the cells of the small bowel into the lymphatic system and not into the blood vessels directed to the liver. So the first pass effect (degradation of the drug) in the liver is bypassed. This is how it works. So, no special liver stress is imposed on the liver by unnatural high doses of T from the drug flooding the liver is guaranteed and the T has enough time to act as signal molecule before it is again (but later) degraded in the liver.
    hofno
    Long position in RXII, LPCN, POZN;

    Sentiment: Strong Buy

  • hofno2003 hofno2003 11 hours ago Flag

    August 17-18: 221 new Ebola cases, 106 deaths have been reported today by WHO. We are now near 100 new cases/day .... this is not good news.
    hofno
    Long position in LPCN, RXII, POZN, CONX;

    Sentiment: Strong Buy

  • From Pernix PR concerning aquiring Treximet rights from GSK today:
    Transaction Details
    • Pernix has made an upfront payment to GSK of $250 million for the U.S rights to Treximet®
    • Pursuant to the recently issued FDA Written Request related to pediatric exclusivity, Pernix will pay GSK additional consideration of up to $17 million, subject to certain adjustments related to the resolution of the recent supply constraint. Pernix anticipates making this payment in September 2014, following resumption of supply from GSK.

    From POZNs website concerning treximet (MT 400) licencing deals:

    MT 400 is POZEN’s proprietary combination of sumatriptan and naproxen sodium, the first multiple mechanism triptan therapy for the treatment of migraine headaches. MT 400 has proven to be superior to triptan monotherapy on multiple efficacy endpoints. In March 2011, POZEN announced a license agreement with Cilag GmbH International, a division of Johnson & Johnson, for the development and commercialization of MT 400 in Brazil, Colombia, Ecuador and Peru. POZEN is actively seeking other licensing partners for the additional available territories

    So its reasonable to conclude that the deal of today has a substantial potential for upfront payments for POZN for Treximet in EU and ROW.

    hofno
    Long position in LPCN, RXII, POZN;

    Sentiment: Strong Buy

  • Altough POZN already soldout its Treximet royalty rights to a financial investor, todays deal is a substantial windfall profit for POZN.
    - Pernix lifted its 2015 forecast to $220 million and EbitA to $95 million. This should bring Pernix share price up to $15 (less than 3 times revenue) and at low EPS multiple
    - At $15 per share the exercised warrants make an extraordinary profit at POZN of $ 5 million
    - The exUS treximet rights for all dose strengths are again open for licencing for POZN - this is a big asset. Pernix payed more than $200 million to GSK for the US rights just now - this gives a clue about the deal value possible for POZN with EU and ROW rights!

    hofno
    Long position in LPCN, RXII, POZN;

    Sentiment: Strong Buy

  • Reply to

    Deal

    by tough1er 18 hours ago
    hofno2003 hofno2003 17 hours ago Flag

    Just a question for experienced Pernix poster: does this agreement mean that Pernix has to pay royalties, which should have been paid by GSK to POZN upon commercialication, now be borne by Pernix and payed to POZN? Any comment?
    hofno

    Sentiment: Strong Buy

  • Reply to

    Stock really moves on low volume

    by ajdoha234 21 hours ago
    hofno2003 hofno2003 18 hours ago Flag

    ad 1) Yes, Clarus is a private company which is in a holding portfolio of an institutional investment company. The institution intents to go public with Clarus - but they redeemed their respective filing two times - citing unfavorable conditions. Nevertheless Clarus has a lot of debt and is poor capitalized - making it difficult to go public without a major catalyst like a successfull oral testosterone project with a clear potential for approval.
    ad 2) phase IV trials are often mandated by the FDA - if some unclear (e.g. minor safety) concerns araised and need for clarification. This phase IV trials after approval are called post marketing trials. In the case of Clarus I think this additional phase IV extention trial was necessary - because Clarus didn't meet the secondary safety endpoints, furthermore they had some patients with unacceptable elevated testosterone levels. Maybe that Clarus tries to shed some light on this issues with the phase IV trial. Nevertheless they will provide the data of this phase IV trial (as per Clarus statement) to the FDA in August 2014 - thats just now.
    hofno
    Long position in LPCN, RXII, POZN;

    Sentiment: Strong Buy

  • Reply to

    Stock really moves on low volume

    by ajdoha234 21 hours ago
    hofno2003 hofno2003 19 hours ago Flag

    Exciting times ahead - anyway. We should get our phase III top line efficacy results within a short period of time and I think afterwards we will see a wilde ride ...
    Clarus also will get its phase IV data now - but not sure whether they will publish any statement. If the Clarus data are not as good as Clarus hopes - then we will hear nothing, if the data are exceptional good then I think they will be release - because Clarus of course depends on some positive spin as Clarus intends to do an IPO which was already 2 times cancelled/postponed.

    hofno
    Long position in LPCN, RXII, POZN;

    Sentiment: Strong Buy

  • hofno2003 hofno2003 20 hours ago Flag

    Of course each cooperation contract is a good sign because its a proof of CONX competences - nevertheless we have more important milestones ahead, such like approval of the HA test kit in US, the approval TxB cardio in US, approval of Lassa virus rapid test kit in US,.... all which are due ...
    hofno
    Long position in LPCN, RXII, POZN, CONX;

    Sentiment: Strong Buy

  • Reply to

    Seeking Alpha article metrics

    by trocket72 Aug 17, 2014 9:48 AM
    hofno2003 hofno2003 23 hours ago Flag

    and of course: the US PA user base could also be 2 million and the revenue base $700 million in US alone (at $1 / pill) = 20% thereof = $140 mill / 30 million shares = 4 usd x 15 = 60 usd share price target for US market alone.
    hofno
    Long position LPCN, POZN, RXII;

    Sentiment: Strong Buy

  • Reply to

    Seeking Alpha article metrics

    by trocket72 Aug 17, 2014 9:48 AM
    hofno2003 hofno2003 23 hours ago Flag

    Nevertheless - with 800,000 users in US and once 800,000 users in EU we get $500 mill revenue and 20% royalty = 100 million at 30 million shares = 3 usd per share without costs x 15 = share price target of $45.
    Thats quite a lot and reason enough to wait for approval in US and partnering for EU and ROW which will furthermore give us some licencing prepayments on hand for cash distributions.
    hofno
    Long position in RXII, LPCN, POZN;

    Sentiment: Strong Buy

  • hofno2003 hofno2003 23 hours ago Flag

    Just some feed for you to check your hypothesis:

    Both, primary and secondary hypogonadism, can be equally treated by direct Testosterone replacement - thats why LPCN has access to ALL patients, while RPRX can only treat the subclass (although a big subclass) of patients with impairment of endocrine hormon function of pituitary gland and/or hypothalamus. Pituary gland and hypothalamus (located in the central nervous system) are necessary to stimulate (via other hormones, gonadotropins, gonadotropin releasing hormones, LH, FSH) the testes to produce testosterone and for spermatogenesis. Therefore secondary hypogonadism can be selectively treated by intervening on hypothalamus/pituitary gland in the brain also, while primary AND secondary hypogonadism are both treatable with the more universal approach by direct testosterone replacement. Active drugs intervening within the central nervous system (brain) are more likely to have side effects, because their receptor affinity may allow to target and stimulate (perhaps with lower rate, but enough to show biological effects) other receptors too.
    I think physicians tend in general to use the smallest possible intervention to get low T under control - and this is replacement therapy rather than intervention in the CNS, stimulating other hormones like LH, FSH and gonadotropin in order to get in consequence upregulated testosterone. To keep it short: RPRX itself therefore doesn't claim to have a TRT (Testosterone Replacement Therapy) because it doesn't replace the "missing" T, no, its another class of treatment intervening more distant and more indirect by stimulating the production of other hormones to get finally more T produced in the testes. I personally think a minimal intervention for low T patients by replacing the missing T has to be prefered and should be the gold standard (as it is today) before doing a broader intervention via stimulation in the CNS.
    Hope this helps.
    hofno
    Long position in RXII, LPCN, POZN

    Sentiment: Strong Buy

  • hofno2003 hofno2003 Aug 19, 2014 1:31 PM Flag

    Overall this subdermal pellets are no commercial success and didn't get a relevant market share. From MedScape:

    The main AEs with T pellets include pellet extrusion; minor bleeding, which is typically insignificant and controlled by applying pressure to the surgical wound; and infection, which is infrequent and may also result in pellet extrusion. Some patients develop fibrosis (scarring, nodules) around implantation sites, but this typically does not prevent further implantations.

    Prospective randomized clinical trials have demonstrated that neither washing T pellets in filtered sterile alcohol nor soaking them with an antibiotic (gentamicin) prior to implantation significantly reduces the likelihood of pellet extrusion.[65, 66] However, the use of povidone-iodine skin disinfectant prior to the procedure does appear to lower pellet extrusion rates. The likelihood of pellet extrusion may decline with increasing operator experience.

    User and Prescriber Considerations

    In an office procedure lasting approximately 15 min, T pellets are implanted into the subdermal fat of the lower abdominal wall using a stainless-steel wide-bore trocar under sterile conditions and a local anesthetic. Through a small (0.5–1.0 cm) incision ≥5 cm from the midline at the umbilical level, a 7.5 F gauge 7-cm long trocar with an inner diameter of 5 mm is introduced and the implants discharged into fan-like tracks 5–10 cm from the puncture site using an obturator. In addition to the lower abdomen, implantation sites include the deltoid, proximal thigh, or buttocks. Most patients return to work the day of, or the day after, implantation but are advised to avoid bending or vigorous physical activity.

    hofno

    Sentiment: Strong Buy

  • hofno2003 hofno2003 Aug 19, 2014 12:50 PM Flag

    Yes, thats right for sure. Its good to have well educated investors like Elan on board to prevent an easy and low ball takeover.
    hofno
    Long position on LPCN, RXII, POZN;

    Sentiment: Strong Buy

  • Reply to

    Dumb question for the board

    by ajdoha234 Aug 16, 2014 9:26 AM
    hofno2003 hofno2003 Aug 19, 2014 11:07 AM Flag

    From Lipocines website ("Technology") we can learn the following, which might be independant from your quoted PIII protocol requirement to ingest some (fatty) food before:
    """"""""""""""""""""""""""""Lipocine:
    Lip'ral is a patented technology based on lipidic compositions which form optimal dispersed phase in the gastrointestinal environment for improved absorption of the insoluble drug. Lip'ral presents insoluble drugs efficiently to the intestinal absorption site, thus bringing the absorption process under formulation control and making the product robust to physiological variables such as dilution, pH and food effects.

    hofno
    Long position in LPCN, RXII, POZN (all together STRONG BUY).

    Sentiment: Strong Buy

  • Good piece overall. Balanced view.
    Peak sales much higher than I expected and calculated for my $60+ price target. If oral T ist successfull and with SA given peak sales the companies market cap should be beyond 1 billion usd and the share price beyond $100 ....
    Nice
    hofno
    Long position in RXII, LPCN, POZN;

    Sentiment: Strong Buy

  • hofno2003 hofno2003 Aug 19, 2014 7:20 AM Flag

    From above link provided by maytepper, source SA:

    H.C. Wainwright Reiterates Buy On RXi Pharmaceuticals Following 2Q14 Update
    August 15, 2014 11:57 AM EDT by SA Team in Exclusive Area, Healthcare, Most Popular

    In a research note published today, H.C. Wainwright analyst Reni Benjamin reiterated a Buy rating on shares of RXi Pharmaceuticals (RXII) with a $9 price target, following the company’s second-quarter update. RXi reported a 2Q14 net loss of ($3.2) MM, or ($0.23) per share, exceeding Benjamin’s estimate of ($2.4) MM, or ($0.17) per share. RXi’s grant based revenue of $12,000 was less than Benjamin’s estimate of $29,000. Overall operational losses of ($2.0) MM were comparable to Benjamin’s estimate of ($2.3) MM for the quarter.

    The analyst noted, “The company has three Phase 2 clinical studies on going with the potential to report preliminary data in hypertrophic scarring and earlobe keloids over the next 4-6 months. With a strong proprietary platform technology focused on anti-scarring and ophthalmologic applications, a de-risked lead asset with the potential to enter multiple therapeutic areas, and a cash position of $11.9 MM, we believe RXi Pharmaceuticals represents an undervalued player with significant upside for the longterm investor.”

    Just for your convenience.
    hofno
    Long position in RXII, LPCN, POZN (all STRONG BUYs)

    Sentiment: Strong Buy

  • Reply to

    RXi RECENT & NEAR-TERM MILESTONES

    by wildbullus Apr 24, 2014 8:59 PM
    hofno2003 hofno2003 Aug 19, 2014 5:01 AM Flag

    You can successfully tick the items. Just the predicted Mid, '14 items are due - and the results are awaited any day now!
    hofno
    Long position with RXII, LPCN, POZN;

    Sentiment: Strong Buy

  • hofno2003 hofno2003 Aug 18, 2014 4:39 PM Flag

    Just to remember and to check whether the company is on track. Most of the events have been successfull managed and the overall picture of the company is far better than half a year ago. This will continue in the second half of 2014 and beyond.
    hofno
    Long position in LPCN, RXII, POZN;

    Sentiment: Strong Buy

  • hofno2003 hofno2003 Aug 18, 2014 4:34 PM Flag

    Your statements need some clarification. Patients with keloids or hypertroph scarrings have not really a problem with effective healing of wounds. The problem of this patients is that too much connective tissue (extracellular matrix, collagen deposition, cells of the inner layer of the skin) outgrowths the epidermis (keratinocytes, outer layer of the skin). This is due to too much CTGF expression or unnatural prolongued CTGF expression (hypertroph scarring is the result), or if CTGF expression can not be downregulated anymore (Keloid formation is the result, keloids are benign tumors as result of permanent CTGF expression after skin injury, inducing mechanism is unknown).

    Therefore the phase 2 studies of RXI-109 for hypertroph scares and keloid prevention depend on a balanced (not too much and not too less) reduction of CTGF during the early phase of wound healing. This balanced reduction was already demonstrated in earlier trial and a lot of preclinical work. It will work again in the actual trials - no doubt for me.

    best regards
    hofno
    Long position in LPCN, RXII, POZN;

    Sentiment: Strong Buy

  • LPCN: will compete with AUXL with Oral Testosterone, Price Target $60+ (act. SP: $8), will x-fold on positive PIII data to be published now
    LPCN develops an oral Testosterone replacement therapy. Its development is in Phase III, top line data are confirmed for the 3rd quarter of 2014 – just some weeks ahead.
    The testosterone replacement therapy (TRT) market today is dominated by Testosterone gels and other transdermal applications and the market size is about $2.5 billion. The market is growing in double % digits annually and some analysts predict $6 billion in 2018.
    Testosterone gel applications are associated with potential severe side effects and the label contains a BLACK BOX WARNING. Gel applications bear the risk of unintentional transfer of testosterone to other contact persons by skin-skin contact or laundry-skin contact. This poses females and children at high risk for severe and dangerous effects.
    LPCN has a successful testosterone prodrug for oral administration twice daily (PIII top line data in 3rd quarter), the release of data was just confirmed.
    There is no oral testosterone available for TRT today and this new drug will easily catch a good market share of the overall market of $2.5 billion which is growing with double digit %.
    If LPCN gets 10% market share (low ball estimate) this would result in $250 million. A fair market cap for LPCN would be 3 times revenue = 3 x 250 mill = $750 million. We have about 12.5 million shares outstanding , therefore a price target, given that the oral testosterone is approved, results in $750 mill / 12.5 mill shares = $60 per share faire value. There is enough additional upside, because 10% market share is low ball estimate.
    This is just my humble opinion – the risk:reward ratio is outstanding – but you have to do your own DD. This co depends strictly on a success of this drug – and if the drug is a failure in PIII (what is unlikely but possible) the share price will nosedive. LPCN has also other pipeline products.

    Sentiment: Strong Buy

GALE
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