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Rob_Cos 64 posts  |  Last Activity: 11 hours ago Member since: Dec 31, 1997
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  • I just posted the CELG chart on Investorvillage CELG message board.. unfortunately it wont paste here but go there and see it.One of the better charts on CELG I have seen in awhile - about to breakout here imo on GED-031 data publication in major medical journal.....

    Constructive Chart - Should explode once we break above that 109.17 area and then above all time intraday high 109.25. Should happen next week on GED-031 data publication (Thanksgiving week usually a good one for market as well)

    Yes - CELG is about to explode through all time highs to the upside on publication of GED-031 chrohns data next week,, ASH in 2 wks. with 160 presentations at the biggest hematology conference in the world and of the yr and then with 2020 and a few surprises at JPM healthcare conf in early January

  • CELG is about to explode through all time highs to the upside on publication of GED-031 chrohns data next week,, ASH in 2 wks. with 160 presentations at the biggest hematology conference in the world and of the yr and then with 2020 and a few surprises at JPM healthcare conf in early January

  • + Otezla CHMP opinion de-risks approval; Expected label a little more specific

    Celgene received positive opinions from CHMP on Otezla for psoriasis (PsO) and psoriatic arthritis (PsA) (see link http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/003746/WC500177621.pdf). It appears the EU label will have the same indications as the US label, but with more specifics on prior treatment experience. For PsO, the CHMP suggests patients failed to respond to or, who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA). For PsA, Otezla is for patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. In contrast, the US label does not specify the patient characteristics for PsA, and addresses PsO patients who are candidates for phototherapy or systemic therapy. Given the fact that the specified populations are the main targets of Otezla, we don't consider the differences to be commercially important. The timing is in line, and supports our 2015 forecast of $43m in EU sales. Given the long duration and positioning in the treatment paradigm of Otezla, we believe there is real upside to 2015-17 consensus.

    + Two-year data of Otezla at ACR may support the use before biologics

    The long term data in PsA were presented earlier this week at the ACR meeting, which showed Otezla continues to be efficacious and safe after 2yrs on drug. The new data strengthen our belief that more coverage plans may require patients fail Otezla before getting biologics (seehttps://neo.ubs.com/shared/d1jaAadfbKVAqow and https://neo.ubs.com/shared/d1T0IDx60v). We are aware this is already happening in some plans, but we think the lack of serious side effects supports an expansion of the policy.

    + Recent inflection in Rx trend suggests upside to 2015

    An upward inflection in Otezla scripts was seen following the approval in PsO in late Sept., and the growth trend has been linear since then, with a steady increase of 6-9% w/w. If the current trend continues, Otezla would track towards US sales of $43m for 4Q ex-inventory (Street/UBSe: $44m), and $488m for 2015 (vs. Street WW $344m; UBSe: US: $471m; WW $515m).

    + Valuation: Buy, $112 PT based on 21x 2015e EPS

    We still think Otezla can surprise to the upside and drive upward revisions.

  • Celgene Receives Positive CHMP Opinion for OTEZLA® (apremilast), the First Oral PDE4 Inhibitor for the Treatment of Patients with Psoriasis and Psoriatic Arthritis
    Celgene International Sàrl (CELG), a wholly-owned subsidiary of Celgene Corporation, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for OTEZLA® (apremilast), the Company’s oral selective inhibitor of phosphodiesterase 4 (PDE4), in two therapeutic indications: 1

    For the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or, who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).
    Alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
    Psoriasis is an immune mediated skin condition characterised by raised scaly lesions on the skin. It affects approximately 14 million people across Europe2 and about 125 million people worldwide.3 Plaque psoriasis, also called psoriasis vulgaris, is the most common form of the disease, representing about 80 percent of cases.4 Up to 30 percent of people with psoriasis may develop psoriatic arthritis, which involves pain and swelling in jointsand other manifestations and may lead to significant disability.5

    “This CHMP positive opinion is an important step forward for people with psoriasis and psoriatic arthritis in Europe. These immune mediated diseases are frequently debilitating and cause severe physical and emotional pain to the individual,” stated Tuomo Pätsi, President, Celgene Europe, the Middle East and Africa (EMEA). “We are proud to have moved one step closer to offering patients OTEZLA®, a new, oral treatment approach that could significantly help control their symptoms and make a considerable difference to their quality of life.”

    In the ESTEEM studies, which form the basis of CHMP’s positive opinion for apremilast in psoriasis, treatment resulted in significant and clinically meaningful improvements in plaque psoriasis as measured by PASI-75 (a 75 percent improvement in the Psoriasis Area Severity Index) scores at week 16, the primary endpoint.6,7 Patients on apremilast also benefited from significant improvements in difficult to treat areas, such as nail and scalp, and itch, known to have a marked impact on patients’ quality of life and perception of disease severity.8,9,10

    In the PALACE program, which forms the basis for CHMP’s positive opinion for apremilast in psoriatic arthritis, treatment resulted in significant and clinically meaningful improvements in the signs and symptoms of psoriatic arthritis, as measured by the modified ACR-20 (a 20 percent improvement in the American College of Rheumatology disease activity criteria) response at 16 weeks, the primary endpoint. 7,11 Patients on apremilast showed improvement across multiple disease manifestations specific to psoriatic arthritis, such as swollen and tender joints, as well as dactylitis, enthesitis and overall physical function.12,13,14

    In the two Phase III programs, PALACE and ESTEEM, the clinical response of OTEZLA was maintained through week 52 across multiple endpoints. 15,16

    Across these phase III clinical studies, the most commonly reported adverse reactions were consistently diarrhoea, nausea, upper respiratory tract infection, tension headache and headache.6,11 These adverse reactions were mostly mild to moderate in severity. Gastrointestinal adverse reactions generally occurred within the first two weeks of treatment and usually resolved within four weeks.6,11 During the placebo-controlled phase of the clinical trials, the rate of major adverse cardiac events, serious infections, including opportunistic infections, and malignancies, was comparable between placebo and apremilast groups.6,11

    OTEZLA® was approved on March 21, 2014 by the U.S. Food and Drug Administration (FDA) for the treatment of adults with active psoriatic arthritis and on September 23, 2014 for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. In Canada, OTEZLA was approved for the treatment of moderate-to-severe plaque psoriasis in November 2014. A New Drug Submission (NDS) for psoriatic arthritis was submitted to Canadian Health Authorities in the second quarter of 2013. Marketing authorisation applications are ongoing in other countries, including Australia and Switzerland.

    The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision within two to three months. If approval is granted, detailed conditions for the use of this product will be described in the Summary of Product Characteristics (SmPC), which will be published in the revised European Public Assessment Report (EPAR).

  • Jeffries - More Positive On Otezla And Baricitinib Prospects After ACR Feedback

    Biotechnology
    More Positive On Otezla And Baricitinib
    Prospects After ACR Feedback

    EQUITY RESEARCH AMERICAS

    Key Takeaway
    At the American College of Rheumatology (ACR) meeting in Boston, we spoke with 27 physicians about Celgene’s Otezla and Incyte’s baricitinib. Feedback on both drugs was generally positive and we would highlight the preponderance of feedback on earlier positioning of Otezla, including a number of physicians who would choose Otezla as a first-line agent over methotrexate, price notwithstanding, and interest in using Otezla with a biologic for severe patients.

    Favorable Opinions On Earlier Use Of Otezla. We spoke to 18 physicians at ACR about Celgene’s (CELG, Buy) Otezla (apremilast), which has been approved in the U.S. for the treatment of psoriasis and psoriatic arthritis (PsA). Of the twelve rheumatologists who opined on when to use Otezla in the treatment of PsA, the majority favored use before biologics with six advocating second-line use (following methotrexate [MTX]), four favoring first-line use assuming reimbursement (before MTX), and just two advocating third-line use (following MTX and biologic failure). One of the more vocal first-line Otezla advocates was
    from the U.S., noting that half of his nearly fifty Otezla patients were treatment-naïve and that he used it as a better MTX. We note that three of the advocates of first-line use were from countries where Otezla is not currently approved for PsA (2 Canada, 1 UK), stipulating their preference would depend on government reimbursement. Second-line Otezla use was more common, with five U.S. physicians and one UK doctor who suggested he would use it over TNFs in his moderate patients if the cost is acceptable. This was a common refrain for physicians, with three of the five U.S. physicians noting that they would favor second-line usage primarily among mild to moderate patients, but prefer use biologics in the most severe patients. Of the two U.S. physicians who advocated third-line Otezla use, both voiced a familiarity with existing therapies, suggesting they would really only use second line Otezla in patients who were contraindicated against biologics or had a strong preference for oral therapies.
    Potential For New Otezla Uses. In addition incorporating Otezla into the PsA treatment paradigm, six physicians discussed their views on using Otezla in combination with other biologics for their more severe patients. This is not a setting where any data has been generated yet, but speaks to the emerging positioning of Otezla as a “better MTX.” Two U.S. physicians noted that they were currently treating two of their most severe PsA patients with both Otezla and a biologic. One physician noted that he was not worried about Otezla combination safety, but noted that immunogenicity remained to be seen (one of methotrexate’s potential advantages is to suppress any potential immunogenicity reaction to a biologic). That said, we do not believe that this will be much of an issue with human or humanized biologics. He also noted that reimbursement of the combination remains a challenge, but he is currently pursuing creative solutions to the reimbursement dilemma to enable other severe patients to receive the combination. The other physician noted that he planned to use Otezla to accelerate the patient’s clinical response a biologic, but also cited insurance as a challenge. Two physicians on the fence about a combination therapy noted they expected to see data from combination studies next year, with one having a preference for MTX and biologics until more data is available. Combination use could enhance our Otezla outlook as it would likely increase both penetration and duration of therapy in the third-line setting. Separately, we spoke to a Turkish physician about the use of Otezla in Behcet’s disease. Although she did not have access to Otezla yet, she mentioned that she would use it off-label in refractory Behcet’s patients rather than a biologic, except in severe disease. She noted that the cost difference between Otezla and colchicine may make it difficult to adopt as a first-line Behcet’s therapy. She further mentioned that she knew U.S. physicians were using Otezla off-label in Behcet’s, including a doctor in Oregon who has had two patients on the drug without a problem. Although not a large indication in the U.S., we believe Behcet’s could be a source of upside to our Otezla estimates

    Learning From PFE’s Mistakes: Pricing Likely To Be A Factor For Baricitinib
    Adoption. We spoke to seven doctors at ACR about their opinions on Jak inhibitors for the treatment of rheumatoid arthritis (RA), including the Phase 3 compound baricitinib under development by Incyte (INCY, Buy) and partner Eli Lilly (LLY, Hold), and Pfizer’s (PFE, Buy) approved Xeljanz, which has had a disappointing initial launch. The majority of commentary on Jaks and the limited use of Xeljanz despite oral convenience focused on
    its limited efficacy at the approved dose in comparison to similarly priced biologics. We note Pfizer priced Xeljanz similar to biologics at launch, although the annual cost has increased more slowly (currently $28k for Xeljanz v. $38k for Enbrel and Humira). One physician speculated that a Jak that shows success in biologic failures would be able to
    justify a premium. Another physician seconded the importance of a clean safety profile for a follow-on Jak to be competitive, and highlighted a bad PFE sales efforts and poor pricing decision likely contributed to the failure of the Xeljanz launch. This was further by a rural U.S. prescriber who complained that, with its perceived inferior efficacy, Xeljanz should have been priced at half its current cost, calling both the pricing and marketing effort “arrogant.” A VA physician noted that he has only been able to recently start his first patient on Xeljanz given the cost and continuing VA preference for injectable biologics. Two ex-U.S. physicians noted that they may use Xeljanz as an easier option in biologic failures with a Canadian doctor noting that there would likely need to be significant discounting. As we await further data from the four ongoing Phase 3 trials of baricitinib later this year and throughout 2015, we remain optimistic as we believe it offers the potential for both better safety and efficacy relative to Xeljanz and we believe LLY will have the benefit of PFE’s launch mistakes. We continue to believe that investors have prematurely dismissed the potential for upside to baricitinib royalties in the current INCY valuation.

  • Griffiin-ZIOP poised to expand clinical development-Controlled CAR T for proper efficacy/safety balance...will pique interest in XON/ZIOP stocks...IND's soon..underpin negotiations with multinational & regional pharma co's.....$12 target


    Griffin Securities

    Stock Symbol NYSE: ZIOP
    Current Price $3.65
    12 mos. Target Price $12.00

    Ziopharm BUY
    Company Update : Biotechnology

    New Immunotherapy Presentations Announced

    Ziopharm seems poised to expand its clinical development
    program. The Company and its partner, Intrexon Corporation,
    have four poster presentations at a meeting called Tumor
    Immunology and Immunotherapeutics: A New Chapter, which will
    be held on December 1 – 4. The meeting, which is sponsored by
    the American Association for Cancer Research, will provide an
    insight into the collaborators’ efforts to defeat cancer with powerful
    immunotherapies. Only the titles of the presentations are available
    presently, but the following are our impressions of the research
    until the abstracts become available:

    o Ziopharm will provide an update on the clinical results from
    its two Phase 2 trials of an interleukin- 12 gene therapy.
    The studies involved injecting directly into tumors the DNAbased
    medicine, which is controlled by Intrexon’s proprietary
    RheoSwitch® and an activator ligand. The studies were the first
    to demonstrate controlled expression of the powerful anticancer
    cytokine in vivo.

    O Intrexon has created a chimeric antigen receptor (CAR)
    targeting a biomarker of hematological malignancies,
    CD- 19. Importantly, expression of the CAR is regulated via the
    RheoSwitch, which means that activation of CAR T- cells may
    be controlled to achieve the proper balance between efficacy
    and patient safety.

    o A high- throughput assay permits the identification of
    targeting molecules for immunotherapeutics. This test
    should enable Intrexon to quickly evaluate huge numbers of
    potential synthetic receptors for CAR T- cells and other types of
    immune- activating cells.

    o Intrexon has created a stem cell to facilitate immunological
    targeting of malignant tissue. This novel approach uses the
    natural proclivity of stem cells to home into tumors by sensing
    the inflamed microenvironment of malignant growths. There,
    bispecific antibodies on the stem cells “show” the cancer to the
    immune system for destruction.

    We think the new data on the Ziopharm-Intrexon immunotherapy program will pique investors’ interest in both companies’ stocks and underpin partnering discussions. The program has a solid foundation that includes CARs and antibodies expressed in a controlled manner by T-cells and stem cells, plus IL-12 as a therapy in its own right and as a cytokine that improves engraftment and persistence of cell therapies. ZIOP shares are rated BUY.

    POSTER SESSIONS ON IMMUNOTHERAPIES

    Intrexon and its partner Ziopharm Oncology will have four poster presentations at a conference sponsored by the American Academy of Cancer Research called Tumor Immunology and Immunotherapy: A New Chapter. The meeting is called for December 1 – 4, but the four posters are scheduled for December 3rd from 12:30 – 2:45. The poster number, title and author information is shown below:

    B11 Ad-RTS-hIL-12 + veledimex regulation of IL-12 expression in advanced breast cancer (BC) and melanoma patients. John J Nemunaitis, Gerald P Linette, Haythem Ali, Francois Lebel, John A Barrett,Thomas Reed, Suma Krishnan, Jonathan Lewis.

    B16 Development of a high-throughput imaging screen for the functional assessment of cell-linking moieties using effector and target cells in a cell kill assay. Jeffrey Rosenbloom, Jason Isaacson, Srinivas Rengarajan, Paul Szymanski, Jennifer Buenviaje, Kristi Elliott, Francois Lebel, John A Barrett, Richard Einstein.

    B24 Construction and validation of a RheoSwitch® (RTS®) regulated CD19 chimeric antigen receptor. Dina Schneider, Darong Wu, Paul Szymanski, Nadia Sinitsyna, Jennifer Buenviaje, Srinivas Rengarajan, Gustaf Angelborg, Catherine Tran, John Beaber, Stephen Schauer, Charles Reed, Jonathan Carson, Kristi Elliott, John Barrett, Francois Lebel, Daniel Bednarik.

    B25 Controlled production of a bispecific antibody by a genetically-modified stem cell triggers T cell activation and cytolysis in non-small cell lung carcinoma. Amy Wesa, Yumei Xiong, Tim Chan, Jeff Rosenbloom, Srinivas Rengarajan, Paul Szymanski, John A Barrett, Francois Lebel, Farzad
    Haerizadeh, Richard Einstein.

    The B11 presentation will provide an update on the status of patients with melanoma and breast cancer treated with Intrexon/Ziopharm’s IL-12 therapy Ad-RTS-hIL-12. The B24 title indicates that Intrexon has created a chimeric
    antigen receptor, regulated by the RheoSwitch®, that recognizes a biomarker, CD-19, found on B-cell lymphomas.

    In another (B25), a stem cell that expresses a bispecific antibody in a controlled manner is used to activate cytolytic T cells against non-small cell lung cancer. The use of a stem cell in this manner is exciting because it serves as a homing device for cytotoxic T-cells. Stem cells have the natural tendency to home into tumors, but are not affected by the same signals that malignant cells employ to evade the immune system. Intrexon’s modified stem cells have the ability to identify the tumor and then to effect an immunological attack. Finally, we interpret the title of B16 to mean that Intrexon has created a rapid screen to assess the binding properties of such molecules as synthetic receptors, antibodies, and saccharides. (We note, for instance, that the sugar moiety of the anti-cancer agent
    bleomycin binds to certain cancer cells and that derivatives of the disaccharide have improved binding properties.1,2)

    These presentations indicate that Intrexon has addressed important issues involved in creating safe and effective cell therapies against cancer. Hence, we believe Ziopharm will soon submit INDs on innovative immunotherapeutics and that the data provided in these presentations will underpin negotiations with multinational and regional pharmaceutical companies seeking to participate in this exciting new field of medicine.

  • I have posted links to both NEJM Online First & Lancet Online First publications on Investorvillage CELG board (yahoo does not allow links) - GED-031 Crohn's Disease Trial Full data set should hit any day now (9 days ago mgt said "We should immediately see publication in major medical journal coming very,very soon")...

    ISI said this publication would cause a "crescendo" in Celgene share price - has to be soon soon soon.

    NEJM online first

    NEJM Gastroenterology Specialty Site

    Lancet online first

    see investorvillage celgene board for links

    CELG at CS Healthcare conference November 11th:

    We are quite excited and you’ve heard us speak about this a lot lately. You saw data earlier on the GED-0301 late stage product that we acquired earlier this year. And you will hear us speak more about the plans for taking that through to Phase 3 and then approval as we move through our regulatory discussions and can give you some more details on that soon.

    But the data and the potential for transforming the treatment of Crohn’s with this product is quite striking. We are very excited about it and are anxious to add it into the franchise alongside OTEZLA and treat unmet medical needs in Crohns’s.

    SO WE HEAR A LOT MORE ABOUT THAT. WE SHOULD IMMEDIATELY SEE THE PUBLICATION OF THE PHASE 2 RESULTS FOR THIS COMPOUND IN A MAJOR MEDICAL JOURNAL. SO IT SHOULD BE COMING VERY, VERY SOON AND YOU WILL HEAR MORE ABOUT OUR DEVELOPMENT PLANS FOR THE PRODUCT OVER THE COMING WEEKS AND MONTHS

    Sentiment: Strong Buy

  • Must read MS analysis of CELG partners/drugs.CELG has $0 in current stock price for this "stealth pipeline" & I believe CELG will get $3 to $5 billion a yr INCREMENTAL revenue from these partnerships....

    ...they also own equity in some of these companies (for instance the 14% of AGIO CELG owns has increased $50 million in value yesterday and over $100 million the past 2 months)
    Here is a nicely detailed list of the main partners by MS after their Bus Tour to visit CELG and their partners....some of the charts don't past so I will send to my distribution list. There is also a slide deck by company I will be posting one by one over the next day or so...There is ZERO dollars in current CELG stock price for all of the drugs controlled by CELG under those deals and also the EQUITY STAKES. Remember CELG owns 14% of AGIO (stake worth $50 million+ more on yesterdays AGIO increase/ +$100 million in past 2 months), 10% Acetylon, 14% XLRN, 11% EPZM, 3% Morphosys. 14% NantBioScience &5% of Sutro as of Sept 30th
    I personally believe the 25+ partnerships will ultimately result in CELG incremental sales of at least $3 to $5 billion a yr...AGIO's -120 & AG- 221, Morphosys' MOR202, XLRN's sotatercept (ACE-011) & lupatercept (ACE-536). , OMED's demcizumab (and perhaps OMP-305B83 & OMP-131R10 someday) & Concert's CTP-730 are particularly exciting imo. Time will tell.


    MORGAN STANLEY & CO. LLC
    Celgene Corp ( CELG.O , CELG US )
    Celgene Corp
    Sorting Through The Partnered Pipeline
    Celgene has 20+ partnerships with early-stage biotechs. We provide high-level takeaways and a comprehensive list of all the partnered assets.
    26 disclosed partnerships offer potential: 5 are in inflammation and 21 in
    hematology/oncology (hem/onc), of which three are multiple myeloma (MM)
    add-ons. 10 partnerships have clinical-stage assets. We provide key takeaways
    on the clinical assets inside (Exhibit 1). Please see our companion slide deck
    for details on all the partnerships.
    38% of partners have clinical-stage assets with 12% in PhII: Acceleron's
    ACE-011/ACE-536 (TGF-beta ligand traps), VentiRx's VTX-2337 (TLR8) and
    OncoMed's demcizumab (NSCLC) are in PhII studies. Acetylon's HDACs are in
    PhI, Agios' IDH-1/2 compounds are in PhI (though offer a fast path to market),
    Concert's CTP-730 recently entered a healthy volunteer study, Epizyme's
    DOT1L remains in PhI, InhibRx's CD47 appears IND ready, MorphoSys'
    MOR202 (antiCD38) is in PhI and Triphase's marizomib (GMB) is in PhI. We
    believe AG-221 in AML and ACE-011/536 in Beta Thalassemia have enough
    data to suggest they have greater than a 50% chance of making it to market.
    We believe MOR202 offers the highest potential value as the mechanism is derisked
    (J&J and Sanofi have CD38 clinical data) and peak sales could be multibillion
    as it is a Revlimid add-on. We await initial data in 2015.
    62% of partnerships are preclinical: Many of the preclinical partnerships are
    researched-based without any disclosed targets. Of the preclinical assets with
    disclosed targets, Bluebird is working on CAR-T cells (2015 clinical candidate),
    AnaptysBio is working on novel antibody inflammation targets (it has an
    unpartnered IL-33, but Celgene targets are undisclosed), NantBio has two
    targets - a chemotherapeutic agent NTB-011 and an HSP90 inhibitor NTB-010,
    Presage Biosciences has developed a novel injection system to increase the
    throughput of combination testing in preclinical models and Sutro Biopharma
    is developing novel ADCs and bispecific antibodies.
    Pipeline helps the multiple, but sig. visibility is far away for the
    majority of deals: The positive side of this development strategy is that it
    offers mgt. a wide array of targets, novel science and potentially better R&D
    productivity than an in-house only R&D engine. The negative is that the PhII
    pipeline is of limited scope and many of the assets are for niche targets. Of the
    clinical candidates, only a few appear to have $1B+ potential. Further, with
    development times of at least 5 years from IND to approval, only those assets
    in the clinic now are likely to offer diversification at the time when Revlimid
    goes generic. Thus, while the effort is broad, given that the majority of the
    deals have yet to make it into the clinic we believe we have to wait before
    these deals could cause sig. multiple expansion.
    Clinical Stage Assets
    Acceleron
    Assets: Celgene has licenced sotatercept (ACE-011) and lupatercept (ACE-536). Both compounds target red blood cells via the TGF-beta superfamily of ligands. Both molecules are in Phase II testing for beta thalassemia and myelodysplastic syndromes (MDS). Sotatercept is also being studied for chronic Kidney Disease (CKD).
    Celgene Deal: Celgene has licenced both molecules and owes royalties and milestones on development and commercial sales. For development there are $320M of remaining milestones and Celgene pays all clinical costs.
    For commercialization there are $230M of remaining milestones, Celgene will pay a tiered royalty of low-to-mid 20% to Acceleron and fund an Acceleron sales force.
    Current Data: Acceleron will be presenting Phase II data of ACE-011 (abstract #3251) and ACE-536 (abstract #533 & 411) in patients with beta-thalessemia and myelodysplastic syndrome (MDS) on December 7-8th at ASH. The most recent data on both compounds was presented at EHA. Data in β-thal suggests a durable dose dependent hemoglobin response (430 days follow-up). Given sotatercept’s impact on bone, mgt. is pursuing the CKD/dialysis market with this antibody. ACE-536 has the same mechanism as sotatercept, but contains the extracellular domain of activin receptor type IIB instead of IIA. Data in β-thal are very similar to sotatercept with~3g/dL max Hb changes. In MDS, similar effects were observed with 6/16 transfusion dependent pts able to reduce their RBC units by ≥ 50% and 2/3 non-transfusion dependent pts able to incr. their Hb by ≥1.5g/dL (at the highest-dose).
    Our take: On sotatercept, we see the see the pursuit of CKD/dialysis as a much harder market given the need for long-term safety, entrenched EPO and the long drug half-life (13 days). That said, mgt. believes that morphology changes, incl. bone and vascular calcification could differentiate sotatercept. On ACE-536, we see MDS as the most direct path to market, though note that β-thal incl. 40k pts globally (Italy, Greece, Turkey, etc). β-thal likely needs less long-term follow-up and thus could be more relevant from a valuation prospective. We believe a β-thal Phase III study is likely to start in 2015 while Celgene assess the path forward in MDS.
    Acetylon
    Assets: Celgene has an exclusive option to acquire Acetylon for its portfolio of HDAC inhibitors, including its lead asset ACY-1215. ACY-1215 is HDAC 6 selective inhibitor that potentially is additive to Velcade or Revlimid. It is currently in Phase I/II trials. Acetylon is also developing ACY-738, an HDAC 1/2 inhibitor, for neurological diseases.
    Celgene Deal: In July 2013 Acetylon and Celgene entered into an exclusive strategic collaboration for an $100M upfront payment to advance Acetylon’s clinical and pipeline programs, including the ongoing combination clinical trial of ACY-1215 with Celgene’s Revlimid + dexamethasone in multiple myeloma, and combinations of ACY-1215 with other anti-cancer agents. The agreement includes an exclusive option for the potential acquisition of Acetylon by Celgene. If Celgene exercises its right to acquire Acetylon, in addition to the purchase price based upon independent company valuations to be paid at the time of the acquisition, Acetylon shareholders will be eligible to receive up to $250M for regulatory milestones and $850M for sales milestones for an aggregate amount of $1.1B. Celgene had previously made a $15M strategic equity investment in Acetylon in February 2012.
    Current Data: Acetylon will be presenting Phase Ib data of AYC-1215 in combination with Revlimid + dexamethasone (abstract #4764) and ACY-1215 in combination with Velcade + dexamethasone (abstract #4772) in patients with R/R multiple myeloma on December 6-8th at ASH. The company last reported data from the studies at EHA in June stating all 22 evaluable patients receiving ACY-1215 in combination with Revlimid demonstrated stable disease or better, with 64% having partial response or better, including 1 complete response, 5 very good partial responses, 8 partial responses, and 3 minor responses; 10 of the evaluable patients were previously refractory to Revlimid. In combination with Velcade, patients demonstrated an overall response rate 53% in 19 evaluable patients, or 36% of the intention-to-treat population; 10 patients were previously refractory to Velcade (See Acetylon Press Release.)
    Our take: HDAC inhibitors clearly have a mechanistic rationale in myeloma. Clearly, Novartis' panobinostat suggest solid activity; hwr, the safety profile (and the dropouts it causes) have created issues in its ability to be approved. Given the current limited data, the more selective HDAC 6 compound from Acetylon appears to be better tolerated. We await a broader dataset to more completely judge the safety. We would expect this combination to be pursued in combination with Pomylast for the refractory population.
    Agios
    (Rob note: this was authored BEFORE the stunningly positive AG-120 data Weds)
    Assets: Celgene has licensed AG-221, an IDH2 inhibitor, and secured ex-U.S. option rights to Agio's IDH1 inhibitor AG-120. Both compounds are currently being studied in hematologic malignancies and solid tumors. AG-221 has received orphan drug designation for AML and fast track designation for patients with IDH2-mutant AML. In addition, a Phase I/II of AG-221 in patients with advanced solid tumors with an IDH2 mutation recently initiated in October 2014.
    Celgene Deal: Celgene exercised its option to ex-US rights for AG-120 in February 2014 and AG-221 in June 2014 as a part of the global strategic collaboration entered between the companies in 2010. Agios is eligible for up to $120M in milestone payments and tiered royalty on any net sales of AG-221. For AG-120, Agios is eligible for up to $120M in milestones, keeps US rights while Celgene has exUS rights and each party pays a cross royalty on sales in their territories. Under the agreement, Celgene is responsible for all development costs of AG-221 and the parties share the costs for Ag-120.
    Current Data: Agios will be presenting new safety, PK/PD, and efficacy data from the Phase I study of AG-221 in advanced hematologic malignancies on December 7th at ASH (abstract #115). Initial results from the abstract indicate AG-221 is well tolerated and patient responses have been durable. Most AEs have been grade 1 or 2; however, there has been 9 deaths, 8 of which occurred within the first 28 days of receiving AG-221, with one of the deaths reported as possibly related to AG-221. In the last full dataset at EHA, data included 35 patients up from 10 at AACR. EHA responses (ORR) were 44% (14/32, 19% CR with 3 patients not yet at day 28) down from 60% (6/10, 30% CR) at AACR. Patients with CRs achieved 2.5+ months of duration. On AG-120, Phase I data in patients with hematologic malignancies will be presented at EORTC-NCI-AACR on November 19th (abstract code 1LBA).
    Our take: AG-221 is clearly active. However, given that IDH2m is a favorable marker that confers longer PFS, we believe the larger sample size at EHA more closely represents its true activity than the data at AACR. That said the path to market appears clear and we would not be surprised to see break-through therapy designation given the target and responses. Commercially, AML is a small indication with ~2,500-5,000 US patients. Thus, AG-221’s potential value to Celgene comes from expanding into other cancers with IDH2m (MDS, NHL). We await the initial data for AG-120.
    Concert
    Assets: Celgene has worldwide rights to CTP-730, a deuterated compound being investigated for the treatment of inflammatory diseases. Concert announced the initiation of a randomized, double-blind, single ascending dose Phase I study in CTP-730 in September 2014.
    Celgene Deal: In May 2013 Concert entered into a strategic collaboration with Celgene which initially focuses on one program, but has the potential to encompass multiple targets. Concert received a $35M upfront payment from Celgene and is eligible to receive greater than $300M in development, regulatory, and sales milestone payments for each program selected for development by Celgene. The next milestone payment under the initial program is $8M upon completion of Phase I clinical trials of CTP-730. Concert will also receive tiered royalties ranging from mid-single digits to low double digits below 20% on any product sales for each of the programs advanced.
    Current Data: None available.
    Epizyme
    Assets: Celgene has an exclusive ex-U.S. license to Epizyme's DOT1L program which includes EPZ-5676, a small molecular inhibitor of DOT1L currently in Phase I clinical trials for the treatment of two types of genetically defined acute leukemias: MLL-r and MLL-PTD. In addition, Celgene has the option to license ex-US rights of other histone methyltransferases (HMT) programs not covered by existing collaborations.
    Celgene Deal: In April 2012, Epizyme received a $90M upfront fee and equity payment in a collaboration and license agreement with Celgene to develop compounds that inhibit HMT. Epizyme is responsible for development costs of Phase I clinical trials for EPZ-5676 after which Celgene and Epizyme will equally co-fund global development. Each company will fund development costs specific for its territory. Celgene will also pay royalties ranging from the mid-single digits to the mid-teens on net product sales outside of the U.S. for each target selected.
    Current Data: Epizyme will be presenting preliminary data from the dose escalation and expansion stages of the EPZ-5676 Phase I study on December 8th at ASH (abstract #387 & 2187). The abstract indicated that of the 36 patients evaluable for safety across six dosing cohorts (12, 24, 36, 54, 80 and 90 mg/m2/day), EPZ-5676 was safe and well-tolerated, with predominantly Grade 1 or Grade 2 AEs and only two patients who discontinued treatment due to possible drug-related AEs. Of the 28 patients evaluable for efficacy, 2 MLL-r patients in the 54 mg/m2 dosing cohort achieved complete responses.
    Our take: We believe the efficacy of this compound is uncertain. There does not appear to be a linear doser esponse curve, suggesting that the signal seen at 54mg could be noise (there were no more responses at higher doses). We await a larger dataset.
    GlobeImmune
    Assets: Celgene has licensed the GI-6300 program, including GI-6301,a Tarmogen targeting the brachyury protein. GI-6301 is currently in Phase I clinical trials in patients with late-stage cancers known to express the brachyury protein including chordoma. Celgene also has the option for GI-6207 a Tarmogen targeting carcinoembryonic antigen, which is being developed for the treatment of medullary thyroid cancer, currently in Phase II clinical trials.
    Celgene Deal: In May 2009, GlobeImmune entered into a worldwide strategic collaboration and option agreement with Celgene for product candidates for the treatment of cancer. Upon the achievement of certain development, regulatory and commercial milestones, the company would be eligible to receive milestone payments and tiered royalties based on net sales of each licensed product. Under this agreement, in July 2013 Celgene exercised its option for a worldwide, exclusive license to the GI-6300 program.
    Current Data: In October 2014 GlobeImmune reported results to date from the 11 chordoma patients in the Phase I study. Of the 11 patients, 8 (73%) have stable disease at day 85 restaging (2 had stable disease at study entry) and 1 patient had a confirmed partial response (9%) that has continued past one year. GI-6301 was generally well tolerated with mild/moderate injection site reactions as the most common AEs. A Phase II study design for GI-6301 is now in progress (see GlobeImmune Press Release).
    Our take: While the brachyury protein is expressed on lung, breast, colon, bladder, kidney, ovary, uterus and prostate cancers, the only data to date is in the rare bone cancer chordomas. Thus, it is very difficult to judge the relevance of this therapeutic in the more prevalent (and thus more relevant to valuation) cancers. Both MTC and chordomas are too small to significantly impact Celgene.
    MorphoSys
    Assets: Celgene has licensed MOR202, a fully human monoclonal HuCAL antibody directed against CD38. MOR202 is currently being tested in a Phase I/IIa trial in patients with relapsed/refractory multiple myeloma.
    Celgene Deal: In June 2013 Celgene entered a strategic alliance with MorphoSys for a $92M upfront license fee to jointly develop MOR202 (anti-CD38) globally and to co-promote MOR202 in Europe. MorphoSys could receive up to EUR 511 million (US $664.5M) in development, regulatory and sales milestones and tiered royalties on net sales of MOR202 outside the co-promotion territory. In the co-promotion territory, MorphoSys retains a 50/50 profit sharing right on MOR202 in exchange for paying one third of the MOR202 development costs. Should MorphoSys choose to opt out of its co-promotion rights, MorphoSys would receive tiered royalties on net sales of MOR202 globally.
    Current Data: MorphoSys last reported pre-clinical data of MOR202 at ASH in 2012 demonstrating MOR202 mediated antibody-dependent cell-mediated cytotoxicity in multiple myeloma cells derived from patients invitro.
    Our take: CD38 is clearly a validated target with daratumumab from Genmab/J&J and SAR650984 from Sanofi. Given that Revlimid will likely be a backbone in this combination therapy, MOR202 has the potential to be one of the more relevant collaboration agreements. We await initial clinical data on the compound in 2015.
    OncoMed
    Assets: Celgene has the option to obtain, demcizumab, an anti-DLL4 monocolonal antibody that is designed to block the Notch signaling pathway in cancer stem cells, currently in Phase II trials. Celgene also has the option for OMP-305B83, an anti-DLL4/anti-VEGF antibody with an IND filing planned in 2014, and OMP-131R10, an anti-RSPO3 antibody with an IND filing planned in early 2015.
    Celgene Deal: In December 2013 Celgene entered a collaboration agreement with OncoMed for a $155M upfront payment to jointly develop/commercialize up to six anti-cancer stem cell (CSC) product candidates from OncoMed’s pipeline. OncoMed will control and conduct initial clinical studies. Celgene also has R&D and commercialization rights to small molecule compounds in another cancer stem cell pathway, with ncoMed eligible to receive milestones and royalties on any resulting products. The collaboration also includes up to five preclinical or discovery-stage biologics programs.
    Current Data: OncoMed most recently presented clinical data on demcizumab at ESMO in September. In the Phase Ib clinical study of demcizumab in combination with gemcitabine plus Abraxane in patients with first-line metatstatic pancreatic cancer 9 of 22 patients (41%) achieved partial responses and 10 (45%) had stable disease, resulting in an overall clinical benefit rate of 86% (see demcizumab poster). Additionally, in the Phase Ib study of demcizumab in combination with pemetrexed and carboplatin in non-small cell lung cancer (NSCLC) patients, of 33 patients evaluable for efficacy, 1 (3%) had a complete response, 15 (45%) had a partial response and 13 (39%) had stable disease. The overall clinical benefit rate was 88% (see demcizumab poster).
    Our take: The efficacy in pancreatic cancer appears interesting, esp. given the poor standard of care. That said, demcizumab has had sig. safety problems, with DLL4 upregulating VEGF and thereby causing cardiac toxicity. While management believes it has found the right schedule to ameliorate these safety signals, we await data in a larger cohort before getting comfortable with the safety profile.
    Triphase
    Assets: Marizomib is a protease inhibitor derived from a novel marine-obligate actinomycete and is being evaluated for the treatment of multiple myeloma and glioblastoma (GBM). An intravenous formulation has been evaluated in 240 patients across four Phase 1 studies, and now Triphase is developing an oral formulation of marizomib.
    Celgene Deal: In October 2014, Triphase expanded its strategic collaboration with Celgene adding a Phase I development program that will explore IV formulation of marizomib with bevacizumab in glioblastoma.
    Triphase will receive additional development funds through a cost sharing agreement with Celgene (payment undisclosed) and Triphase will control product development and retain all commercial rights to marizomib unless Celgene exercises its option to acquire the product from Triphase for an undisclosed payment at which time Triphase would be eligible to receive regulatory and sales milestone payments.
    Current Data: Triphase presented preclinical data of marizomib + Pomalyst in multiple myeloma in June 2014 at ASCO. The results demonstrated a significant decrease in viability of all cell lines in response to treatment with combined marizomib and Pomalyst compared with either agent alone (see marizomib poster).
    VentiRx
    Assets: VTX-2337/Motolimod is a monoclonal antibody that binds to the TLR8 receptor inside myeloid-derived dendritic cells (mDCs) currently being investigated in Phase II clinical studies.
    Celgene Deal: In October 2012, Celgene paid $35M upfront to fund further research and development of VTX- 2337 through pre-defined clinical endpoints. During the option period, VentiRx will be eligible to receive additional funding, including a potential equity investment by Celgene.
    Current Data: In November 2014 VentiRx presented data of VTX-2337 in combination cetuximab + chemotherapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (see VTX- 2337 Poster). 12 patients were enrolled in the study and 10 were evaluated for disease response. The best overall responses were partial response in 2 patients (16.7%) and stable disease in 4 patients (33%), with an overall disease control rate of 50%.
    Our Take: TLR7/8s are well known to have anti-cancer effects. Imiquimod (a topical TLR) has demonstrated an impact on many skin cancers. Thus, from a mechanistic stand-point, the TLR8 pathway is interesting. However, given the limited amount of data thus far, we prefer to wait for the larger Phase II studies.

  • There is NOTHING in CELG current stock price for ANY of the drugs they control from the 25 top tier small bio partnerships. NOTHING from AGIO 2 drugs, XLRN, BLUE, OMED, MPSYY, EPZM, CNCE, etc CELG owns equity in many of these companies like AGIO, EPZM, XLRN, etc and controls drugs from almost all of them,.

  • Bionor Pharma Announces That the Combination of Vacc-4x + Revlimid(R) Is Safe and Increases CD4 Counts in People Living With HIV



    OSLO, NORWAY--(Marketwired - Nov 17, 2014) - Bionor Pharma ASA (OSLO: BIONOR)
    • Treatment with Vacc-4x + Revlimid (lenalidomide) was safe and well tolerated
    • Increase in CD4 count in both treatment groups notably in Vacc-4x + Revlimid group
    • Qualitative immune response analyses support the quantitative findings
    Bionor Pharma ASA (OSLO: BIONOR) announces the results from the Vacc-4x + Revlimid (lenalidomide) study also known as the "Boost & Kill" study. The Phase II trial was an exploratory double-blind placebo controlled immunogenicity study of Vacc-4x + Revlimid versus Vacc-4x in HIV subjects on ART (HIV standard of care treatment).
    Bionor Pharma CEO Dr. Anker Lundemose commented, "We are encouraged by today's results with data demonstrating that the effects of Vacc-4x can be boosted by lenalidomide. This gives the option to add the 'Boost & Kill' to our current 'Kick & Kill' development strategy towards achieving a functional cure for HIV."
    The study's principal objective was to assess the combination of Vacc-4x + Revlimid in people living with HIV on ART but who have not regained a healthy CD4 level. Twenty four patients were randomized into two groups where one group received Vacc-4x + placebo and one group received Vacc-4x + Revlimid. Patients received six cycles of Vacc-4x vaccination with Revlimid or placebo over a 13 week period. Key endpoints were observed at week 13 and at week 26 (study end).
    CD4 counts, the key primary efficacy endpoint, increased in both groups. The largest increase was in the Vacc-4x + Revlimid group where CD4 count increased by 30% (p=0.009) from baseline. In the Vacc-4x + placebo group the CD4 count increased with 17% (p=0.10). However, this was an exploratory study, with a limited number of patients and no statistical difference was observed between the two groups.
    The three other primary endpoints investigating immune response were T-cell response to Vacc-4x, antibody titer to Vacc-4x peptides and p24, and assessment of antibody titers to a commonly used tetanus toxoid. These immune markers supported the quantitative findings of the CD4 cells.
    Only one serious adverse event was observed and deemed unrelated to treatment and overall both Vacc-4x and the combination treatment of Vacc-4x + Revlimid were safe and well tolerated.
    "Study results announced today point to a novel step in the clinical research of a functional cure for HIV infection and these findings deserve to be further studied and confirmed as a part of a larger clinical trial," said Prof. Dr. Jan Van Lunzen University of Hamburg, Principal Investigator of the study.
    "This trial demonstrated that Revlimid combined with Vacc-4x in people living with HIV is well tolerated. The results of this trial confirm our hypothesis that Revlimid may enhance the effects of Vacc-4x," said Jerome B. Zeldis MD, PhD, CMO Celgene Inc, CEO Celgene Global Health and Bionor Pharma ASA Board member.
    Full data analysis is ongoing and will be submitted to a future major HIV medical conference. Furthermore the results will be discussed with FDA and EMA. The study is a collaboration between Celgene Corp (NASDAQ: CELG) and Bionor Pharma. Bionor Pharma has been the study sponsor and Celgene has co-funded the trial and supplied lenalidomide. This study, an important outcome of this collaboration, will be further discussed and analysed by the companies.
    About the Trial
    The Phase I/II trial was an exploratory double-blind placebo controlled immunogenicity study of Vacc-4x + Revlimid (lenalidomide) versus Vacc-4x with an initial open label dose escalation assessment of lenalidomide in HIV infected subjects on antiretroviral therapy, ART (SOC HIV treatment). Part A, the Phase I part of the trial, was an open label dose escalation assessment of lenalidomide, showed that all three doses tested were well tolerated, and the highest dose has been chosen for Part B of the study. Part B was a double-blinded placebo controlled parallel design, multicenter study. Both parts were in HIV infected subjects who are on ART but have not fully regained a healthy CD4 level (CD4 counts 200x106/mL and 6/mL. The trial was conducted in four centers in Germany.
    The primary objective of this study is in Part A to establish the maximum tolerated dose of lenalidomide and in Part B to evaluate the immunomodulatory effect of lenalidomide under immunization with Vacc-4x (Vacc-4x + lenalidomide versus Vacc-4x + placebo) on CD4 counts, T-cell response to Vacc-4x and assessment of antibody titer to Vacc-4x peptides and p24, and four vaccine peptides to a non-HIV vaccine antigen (tetanus toxoid antibody titer) as measured from week 21 to week 26.
    Study period for part B, Phase II of the trial, was 26 weeks (13 weeks immunization period + 13 weeks follow-up). Twenty four patients were randomized into two groups where one group received Vacc-4x + placebo and one group received Vacc-4x + Revlimid. Patients received six cycles of Vacc-4x vaccination with Revlimid or placebo over a 13 week period. Key endpoints were observed at week 13 and at week 26 (study end).
    During treatment period all patients remained on ART and received six immunizations (four primary immunizations and two booster immunizations) at weeks 1, 2, 3 and 4 and booster immunizations at weeks 12 and 13 with either Vacc-4x +lenalidomide or placebo over a 13 week period. Key endpoints were observed at week 13 and at week 26 (study end). The patients received lenalidomide or placebo two days prior and on each day of vaccination.
    One serious adverse event reported (SAE) in this study was a case of subcutaneous abscess that appeared 45 days after the patient was vaccinated. The SAE was evaluated and classified as unrelated by study investigators. The overall clinical and laboratory tolerance profile was satisfactory.
    About the Bionor Pharma
    Bionor Pharma is a leading biotechnology company, searching for breakthrough products for the treatment and prevention of life-threatening viral diseases. The Company is listed on the Oslo Stock Exchange, and is developing vaccines for viral infections. The vaccines are based on a proprietary technology platform developed following more than two decades of research into peptides, and they are designed to safely stimulate the immune system to combat viral diseases.

  • AGIO/CELG late breaker title VERY positive-full abstract out tomorrow. "Clinical safety/activity in AG-120,a 1st in class,selective,potent IDH1-mutant protein inhibitor,in patients with IDH1 mutant positive advanced hema malignancies

    VERY positive titlle...Stock hits 90s after this then ASH 2 more drugs new data in 2 wks

    The FULL abstract will be out tomorrow (Tues) the latest. Presentation Weds..title is VERY positive imo.
    LATE BREAKING ABSTRACT: Clinical safety and activity in a phase I trial of AG-120, a first in class, selective, potent inhibitor of the IDH1-mutant protein, in patients with IDH1 mutant positive advanced hematologic malignancies
    Speaker: D. Pollyea (USA)

    Oral and abstracts where authors did not consent to have their abstract available 2 weeks prior to the meeting, will become available the first day of the meeting. Late Breaking and media selected abstracts will become available on the day of presentation.

  • Reply to

    Time to take Profits?

    by redtr4 Nov 17, 2014 8:49 AM
    rob_cos rob_cos Nov 17, 2014 10:45 AM Flag

    Take near 100 after Weds and ASH - 3 presentations

  • Should get multiple P/Rs from ACR on Otezla including 2 yr data today and Crohns detailed data publication any day now and $AGIO AG-120 (IDH1 proteing inhibitor) late breaker Weds (CELG owns OUS rights)

    Next three days:

    November 14 – 19, 2014 – American Academy of Rheumatology (ACR) 2014 Annual Meeting in Boston, Massachusetts. 19 Otezla abstracts including the very important 2 yr Phase 3 Otezla Palace-1 data. Celgene was outwardly excited about this data on Q2 call – efficacy improves with time vs biologics where it declines (safety should be fine vs increased infection/lymphoma/leukemia risk with time on biologics). This data could be powerful ammunition for more insurers to REQUIRE safer, cheaper, Otezla pill until failure BEFORE approving reimbursement for dangerous, injectable biologics for non-life threatening diseases. Key CELG presentations are TODAY November 17 at 9 to 11 am. Expect press releases. Abstracts (Particularly important are the 104 wk data abstracts)…online - links at Investorvillage

    November 17/18 (Mon/Tues)- NEJM comes out online Weds Nov 19 but some people have been getting hard copy on Monday/Tuesday. CELG mgt said publicly they expect detailed GED-031 publication shortly on Oct 23 earnings call & this week at Credit Suisse said "publication in a major medical meeting "very, very soon". Company and analysts expect positive details to clear up some uncertainties. ISI said the GED-031 publication of GED-031 data could cause a “crescendo” in Celgene stock price. (Should be very very soon). Could be in Lancet, NEJM or other pub. Most of these have “Online First” websites so news can be published online at any time.

    Weds November 19, 2014 (2:50 p.m. CET) - Phase 1 study of Celgene partner AGIO's compound, AG-120, an orally available, selective, potent inhibitor of the mutated IDH1 protein, will be highlighted in a late breaking oral presentation at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics taking place November 18 - 21, 2014, in Barcelona, Spain. Celgene has all the Outside of US rights for Agios' AG-120.

  • CELG: Otezla TRx 2042, +12% wk/wk (+83% QTD); NRx 1388, +20% wk/wk in 32nd week of launch


    Event: Reporting week 6 of Q4:14 IMS scripts (ending 11/07/14).

    CELG: Otezla TRx 2042, +12% wk/wk (+83% QTD); NRx 1388, +20% wk/wk in 32nd week of launch

    •Scripts are tracking much higher than Xeljanz's launch. PFE's Xeljanz reported TRx/NRx of 839/ 428 in its 32nd week of launch (ending 06/21/13), and $68M during its first full 3 quarters (Q1-Q3:13) of launch.

    •Consensus for Otezla is $44M for Q4 and $66M for 2014.

    •Early launch trajectory exceeds those for other inflammatory diseases, and Sept psoriasis approval will contribute to Q4.

    PCYC/JNJ: Imbruvica TRx 1216, -2% wk/wk (+16% QTD); NRx 414, -5% wk/wk
    •Our Imbruvica APP predicts $168M for Q4, slightly below cons $170M. We estimate 3-5% of Sept +7% price increase flows through, supporting $165-170M for Q4. Using QTD scripts growth, Q3 Imbruivca $142M * 1.16 = $ 165M, in-line with our estimate and suggesting Q4 cons is achievable.

    GILD: Zydelig week 15 TRx is 85, -12% wk/wk; NRx is 46, -18% wk/wk; compare to week 15 TRx/NRx of 476/332 (week ending 02/21/14) for Imbruvica
    •GILD's Zydelig was FDA approved this July; scripts could be mostly from iNHL and not much CLL. Consensus is 10-15% share for Zydelig (cons ~$12M for Q3) vs. 85% share for PCYC. Trends are still early, although Zydelig scripts have been at less than one-quarter of what Imbruvica was.
    •GILD reported Q3 2014 Zydelig US sales of $4.9M with ~ 350 pts treated.

    ARIA: Iclusig TRx/NRx are 107/34, +24%/ -3% wk/wk, in week 42 since the January re-launch
    •Week 42 of the initial launch (ending 10/18/13) saw higher TRx/NRx of 128/42.
    •IMS stopped projections that actually overstated 8-15/14-9/5/14 Iclusig prescriptions by 28%; we are awaiting downwards revisions to historical data.
    •Q4 WW cons is ~ $23M.


    BIIB: Tecfidera TRx 7742, -2% wk/wk (+5% QTD), while "true" NRx is 540, -6% wk/wk (reported NRx is 2062, -3% wk/wk)

    Q3 had first slight miss ($63

  • rob_cos rob_cos Nov 13, 2014 8:56 PM Flag

    Much easier to read version and other comments from the XON call on the ZIOP message board on InvestorVillage

  • Critically important narrowing of "significant transactions" mentioned in PR....RJ Kirk on CAR T partnering "...We eluded in PR to significant transactions underway and I think we will just leave it ...with that....

    Analyst Question: "Are you able to talk about your plans around CAR T...obviously locked up with ZIopharm but are you able to comment about kind of commercialization plans and how you think about partnering of that technology"

    RJ Kirk: "Yeah....thanks you for the question but the short answer is....no. As you know, its a field of intense interest around the world - we eluded to in the press release to "significant transactions underway" and I think we will just leave it...we will just leave the statement with that".

    This is a critically important narrowing of "significant transactions" (not "DISCUSSIONS" but "TRANSACTIONS") mentioned in PR (copied at bottom of this post) - during the call he clearly indicated these "significant transactions UNDERWAY" are in the CAR - T area . TRANSACTIONS UNDERWAY!

    _______________________________________________________________________________________

    Wells Fargo Question: "Nice quarter...all my questions were just answered but let me add one final question - with respect to CAR therapy - manufacturing seems to be a big issue - can you guys talk a little about your ability to manufacture allogeneic approach vs autologous and shed some light on that.

    RJ Kirk: Not really, for the reasons I just eluded to Daryl. We have not made a secret of the fact that we think we have a lot of contributions to make in this filed and they are in the areas that....the one you just named and in other areas as well in this field."

    "We view CAR T as an extremely important - I think ultimately historic transition in the field of therapeutics...we think ultimately we will be viewed as the 1st exemplar of a new generation of therapeutics...since no one else has named it we will be bold enough to name it - we call it "Synthetic Immunology" and as such obviously it just a tremendous time to be focused on what we believe is going to be a generational change in therapeutics...."

    What areas can they contribute in?

    RJ Kirk: "But you are right ....manufacturing, off target toxicity issues - that really goes to the ability to regulate the expression of the targeting protein among other issues and we feel very well equipped to make a solid contribution in this area and we look forward to doing so"

    Another analyst asked about potential deal partners - domestic vs international and.....

    RJ Kirk said "In general we are in talks with more multinational companies than we ever have been".... I think we said in the last quarter our deal que was heavily weighted in favor of discussions with larger companies and I would say its certainly even more true today.

    FROM THE PR:
    Mr. Kirk continued, "Looking forward, considering the significant transactions upon which we currently are engaged, the programmatic progress being made under our existing collaborations and our team's steady performance improvements, we are optimistic and confident that we have the opportunity of making all involved with Intrexon proud of their association with the company. No one at Intrexon takes this opportunity lightly so we are committed to execute commensurately.

  • CS ■ Management reiterated that GED0301 data is coming out "very, very soon" in prestigious medical journal. -- Perhaps its Lancet or something...feels like this week? (ISI says it will cause "crescendo" in stock price)

    Dr Fouse told CS VERY VERY SOON - Remember ISI said this publication will cause a "crescendo" in CELG stock price

  • Strong Buy
    Dr Fouse presents TODAY at 3 PM eastern at Credit Suisse 2014 Healthcare Conference in AZ - her first HC conference presentation since becoming President, Global Hematology and Oncology - Link to webcast.....

    November 11 - Celgene presents at Credit Suisse 2014 Healthcare Conference in Arizona. Dr Fouse will present, her first HC conference presentation since becoming President, Global Hematology and Oncology. Should be interesting to hear her perspective from this position for the first time.

    WEBCAST LINK:

    (Can't post - link is on Celgene message board on investorvillage or you can go to Celgene website under Investor Relations)

    Credit Suisse 2014 Healthcare Conference
    November 10-13, 2014
    Phoenix, Arizona

    Celgene Corporation
    Tuesday, November 11, 2014 1:00:00 PM MT

  • rob_cos rob_cos Nov 10, 2014 7:25 PM Flag

    XLRN Celgene partner...check out that company - have posted some reports on CELG investorvillage board

  • Great data - ACR Otezla (Apremilast) abstracts posted on IV Celgene board

    Too much to post here won't fit - go to investorvillage Celgene message board

AMGN
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