Quarterly results from Novartis: Promacta sales in the quarter were 210 million dollars, "Promacta/Revolade (USD 210 million, +35% cc) grew at a strong double-digit rate, driven by continued worldwide uptake as well as growth of the thrombopoietin class for chronic immune thrombocytopenic purpura."
Will the 10m buy out income be reflected in this quarter?
LGND supply agreement with Amgen for Captisol: - for use in bispecific antibody: this is a rapidly growing segment across biotech - AMGN completed clinical validation on Captisol solubilized bi-Ab. - this development will significantly increase market for Captisol.
Ligand Enters Into Commercial License and Supply Agreement with Amgen for Rights to Use Captisol in the Formulation of AMG 330 :: Ligand Pharmaceuticals, Inc. (LGND)
Sean Williams gave a nice plug to LGND the other day::
"Ligand Pharmaceuticals Shares of Ligand Pharmaceuticals (NASDAQ:LGND), a biotech royalty company, have been on fire over the trailing five-year period, rising 573%. The best part is that I don't believe it's anywhere near done.
The beauty of Ligand is its business model. Rather than spending hundreds of millions or billions of dollars annually on the drug development process, Ligand licenses out its proprietary technology for a royalty on net product sales that typically ranges between 4% and 4.5%. Its best-known technology is Captisol, which helps with solubility and stability. Because Ligand focuses on licensing out its technology, it has minimal overhead expenses. In fact, the company's 2020 outlook calls for corporate gross margins in the mid-90% range!
What makes Ligand even more exciting is its "shots-on-goal" approach, as the company refers to it. Ligand has more than 90 partners spanning more than 155 compounds in various stages of the development process. Each of these therapies represents an opportunity for Ligand to "score." This means that even with a few therapies failing to succeed in clinical studies, Ligand still has plenty of opportunities for success. By comparison, it had just nine drugs being developed with its technology back in 2008 and one approved product. Today, there are 15 approved products using its technology.
Considering the foundation Ligand's management team has laid, it's not hard to imagine the company's sales exploding higher from the $109 million in reported in 2016 to the consensus of $272 million by 2020. Profit per share is also expected to top $6 per share by the turn of the decade. This hot biotech royalty stock is one you should consider gobbling up this July."
Second Phase 3 Study Shows KYPROLIS® (Carfilzomib) Regimen Significantly Improves Overall Survival In Patients With Relapsed Multiple Myeloma
KYPROLIS, Lenalidomide and Dexamethasone Reduced the Risk of Death by 21 Percent Versus Lenalidomide and Dexamethasone Patients Treated With the KYPROLIS-Based Regimen Survived 7.9 Months Longer Than Patients ...
Promacta (eltrombopag) trial data reported: robust efficacy and safety in persistent and newly diagnosed immunothrombocytopenia patients:
Int J Hematol. 2017 Jun 30. doi: 10.1007/s12185-017-2275-4. [Epub ahead of print] Efficacy and safety of eltrombopag in persistent and newly diagnosed ITP in clinical practice.
González-López TJ1, Fernández-Fuertes F2, Hernández-Rivas JA3, Sánchez-González B4, Martínez-Robles V5, Alvarez-Román MT6, Pérez-Rus G7, Pascual C7, Bernat S8, Arrieta-Cerdán E9, Aguilar C10, Bárez A11, Peñarrubia MJ12, Olivera P13, Fernández-Rodríguez A14, de Cabo E15, García-Frade LJ16, González-Porras JR17. Author information Abstract Eltrombopag is safe and effective in primary chronic ITP. However, lack of clinical trials avoids a clear demonstration of its utility in newly diagnosed and persistent ITP. Our aim here is to report Spanish results for this type of patients. We retrospectively evaluated 220 adult primary ITP patients. According to standard definition, patients were allocated to newly diagnosed (n = 30), persistent (n = 30), and chronic (n = 160) ITP. Groups were homogenous regarding most relevant parameters. 180 (90%) of 220 patients achieved a platelet response (R) with 167 (75.9%) complete responses (CR) after a 15-month follow-up. No statistical significant differences among groups but a trend towards a greater efficacy in newly diagnosed ITP were observed (93.3% of responses with 86.7% of CR). Efficacy in persistent ITP (83.3% of responses with 80.0% of CR) and chronic ITP (79.4% of responses with 73.1% of CR) was similar. 70 patients (31.8%) experienced adverse events. 15 of them were grade 3-4. Most common adverse effects were headache and hepatobiliary laboratory abnormalities (HBLAs). One persistent ITP had a venous thrombosis and one chronic ITP had grade II myelofibrosis. We consider Eltrombopag use for the early stage ITP as effective and safe as it is in chronic ITP.
Efficacy and safety of eltrombopag in persistent and newly diagnosed ITP in clinical practice
Eltrombopag is safe and effective in primary chronic ITP. However, lack of clinical trials avoids a clear demonstration of its utility in newly diagnosed and persistent ITP. Our aim here is to report
I have owned this for a while, and since the DB downgrade it's been a struggle, even good news sends it down a buck fifty. I only have 316 shares at 8.00. I've owned it since they bought PCOP. I sometimes think, all those partnered programs, but nothing much good seems to happen exect Promacta. and Kryopolis. We'll see, I'm on the fence, today is not good.
Posted on the SPPI board: "A new Evomela phase 2 trial, sponsored by Medical College of Wisconsin, NCT03159702, was started in July. Official Title: Propylene Glycol-Free Melphalan HCl (EVOMELA®) in Combination With Fludarabine and Total Body Irradiation Based Reduced Intensity Conditioning for Haploidentical Transplantation. To remind you, current indication for Evomela is autologous stem cell transplantation in multiple myeloma. Haploidentical stem cell transplantation is allogeneic transplantation. As a treatment, it is used for many blood cancers. "The advantage of having a haploidentical transplant is that it increases the chance of finding a donor as almost everyone has at least one haploidentical relative. Relatives can usually be asked to donate stem cells much more quickly than unrelated volunteer donors, particularly when the volunteer donors live in other countries, thereby allowing transplants to be done in a more timely way."
Viking announced today they have completed enrollment in their phase 2 trial of 5211. Previous guidance stated topline results should be available in about 14 weeks. That is some time around October 18.
After long wait, New Haven's Melinta heads to market
New Haven-based Melinta Therapeutics is headed to market with its first drug, following a key approval this week from the U.S. Food and Drug Administration.
Captisol use? My research suggests that the amount of Captisol used for a given agent is ~5x the mass of the API. Anyone know differently? I am always interested as new CE products get approval to try to estimate the impact on material sales. To me, the fact that Baxdela carries a 2.5% royalty suggests that there may be a substantial Captisol component. The patient population that is addressable with Baxdela is far larger than myleoma or thrombocytopenia.
Does anyone have an idea what type of information Ligand would ask the SEC to allow them to not report until a specific time?
AMGN will present PIII data from Kyprolis+Dex trial at upcoming EHA conference:
LGND partner SAGE Therapeutics reports positive Brexanolone PII trial results in post-partum depression: robust efficacy and safety demonstrated
Lancet. 2017 Jun 12. pii: S0140-6736(17)31264-3. doi: 10.1016/S0140-6736(17)31264-3. [Epub ahead of print] Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial.
Kanes S1, Colquhoun H1, Gunduz-Bruce H1, Raines S2, Arnold R1, Schacterle A1, Doherty J1, Epperson CN3, Deligiannidis KM4, Riesenberg R5, Hoffmann E1, Rubinow D6, Jonas J1, Paul S1, Meltzer-Brody S7. Author information 1 Sage Therapeutics Inc, Cambridge, MA, USA. 2 2b Analytics, Wallingford, PA, USA. 3 Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. 4 University of Massachusetts Medical School, Worcester, MA, USA; Women's Behavioral Health, Zucker Hillside Hospital, New York, NY, USA. 5 Atlanta Center for Medical Research, Atlanta, GA, USA. 6 Department of Psychiatry, UNC School of Medicine, Chapel Hill, NC, USA. 7 Department of Psychiatry, UNC School of Medicine, Chapel Hill, NC, USA. Electronic address: email@example.com. Abstract BACKGROUND: Post-partum depression is a serious mood disorder in women that might be triggered by peripartum fluctuations in reproductive hormones. This phase 2 study investigated brexanolone (USAN; formerly SAGE-547 injection), an intravenous formulation of allopregnanolone, a positive allosteric modulator of γ-aminobutyric acid (GABAA) receptors, for the treatment of post-partum depression. METHODS: For this double-blind, randomised, placebo-controlled trial, we enrolled self-referred or physician-referred female inpatients (≤6 months post partum) with severe post-partum depression (Hamilton Rating Scale for Depression [HAM-D] total score ≥26) in four hospitals in the USA. Eligible women were randomly assigned (1:1), via a computer-generated randomisation program, to receive either a single, continuous intravenous dose of brexanolone or placebo for 60 h. Patients and investigators were masked to treatment assignments. The primary efficacy endpoint was the change from baseline in the 17-item HAM-D total score at 60 h, assessed in all randomised patients who started infusion of study drug or placebo and who had a completed baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Patients were followed up until day 30. This trial is registered with ClinicalTrials.gov, number NCT02614547. FINDINGS: This trial was done between Dec 15, 2015 (first enrolment), and May 19, 2016 (final visit of the last enrolled patient). 21 women were randomly assigned to the brexanolone (n=10) and placebo (n=11) groups. At 60 h, mean reduction in HAM-D total score from baseline was 21·0 points (SE 2·9) in the brexanolone group compared with 8·8 points (SE 2·8) in the placebo group (difference -12·2, 95% CI -20·77 to -3·67; p=0·0075; effect size 1·2). No deaths, serious adverse events, or discontinuations because of adverse events were reported in either group. Four of ten patients in the brexanolone group had adverse events compared with eight of 11 in the placebo group. The most frequently reported adverse events in the brexanolone group were dizziness (two patients in the brexanolone group vs three patients in the placebo group) and somnolence (two vs none). Moderate treatment-emergent adverse events were reported in two patients in the brexanolone group (sinus tachycardia, n=1; somnolence, n=1) and in two patients in the placebo group (infusion site pain, n=1; tension headache, n=1); one patient in the placebo group had a severe treatment-emergent adverse event (insomnia). INTERPRETATION: In women with severe post-partum depression, infusion of brexanolone resulted in a significant and clinically meaningful reduction in HAM-D total score, compared with placebo. Our results support the rationale for targeting synaptic and extrasynaptic GABAA receptors in the development of therapies for patients with post-partum depression. A pivotal clinical programme for the investigation of brexanolone in patients with post-partum depression is in progress. FUNDING: Sage Therapeutics, Inc.
[2016-MAY] Ligand Pharmaceuticals Inc. NASDAQ : LGND Correlation Histogram
X axis : Stocks Price Correlation Coefficient Y axis : Quantity of stocks May-2016 1,000 Day Parameter 2,830 NASDAQ Stocks Price Analysis This stock mode of correlation coefficient is 0.9 In other words, the correlation coefficient of the other stock
Announced today--Kyprolis approved by NICE for use in the UK. Another win by the Amgen team which will open an important door for growth. It is great news and a testament that Amgen is a partner who can perform well.
CHAMPION-2 trial results published; Carfilzomib in combination with Cyclophosphamide and Dexamethasone demonstrates robust efficacy in newly diagnosed multiple myeloma pts:
Clin Lymphoma Myeloma Leuk. 2017 May 10. pii: S2152-2650(16)30910-7. doi: 10.1016/j.clml.2017.05.009. [Epub ahead of print] A Multicenter, Open-Label, Phase 1b Study of Carfilzomib, Cyclophosphamide, and Dexamethasone in Newly Diagnosed Multiple Myeloma Patients (CHAMPION-2).
Boccia RV1, Bessudo A2, Agajanian R3, Conkling P4, Harb W5, Yang H6, Pinchasik D6, Kimball AS6, Berenson JR7. Author information 1 Center for Cancer and Blood Disorders, Bethesda, MD. Electronic address: RBoccia@ccbdmd.com. 2 Cancer Care Associates for Research and Excellence, Encinitas, CA. 3 The Oncology Institute of Hope and Innovation, Downey, CA. 4 US Oncology Research, Virginia Oncology Associates, Norfolk, VA. 5 Horizon Oncology Center, Lafayette, IN. 6 Amgen Inc, Thousand Oaks, CA. 7 Institute for Myeloma & Bone Cancer Research, West Hollywood, CA. Abstract INTRODUCTION: This phase 1b study evaluated the safety and efficacy of 3 dose levels of carfilzomib when provided with fixed dose oral cyclophosphamide and dexamethasone (KCyd) in patients with newly diagnosed multiple myeloma (MM). PATIENTS AND METHODS: CHAMPION-2 was a multicenter single-arm study. Patients with newly diagnosed secretory MM were enrolled and received KCyd treatment for up to 8 cycles. A 3 + 3 dose escalation scheme was used to evaluate twice-weekly carfilzomib at 36, 45, and 56 mg/m2 dose levels, followed by a dose expansion. RESULTS: No dose-limiting toxicities were observed in any of the dose evaluation cohorts. The KCyd regimen that included the maximum planned carfilzomib dose of 56 mg/m2 twice weekly was brought forward into dose expansion. A total of 16 patients were treated at this dose level. At 56 mg/m2 the overall response rate was 87.5% (95% confidence interval, 61.7-98.4), and the median time to response of 14 patients whose disease responded to therapy was 1 month. At this dose level, common adverse events of grade 3 or higher were anemia (25.0%), neutropenia (18.8%), acute kidney injury (12.5%), and decreased white blood cell count (12.5%). Ten of 16 patients who received carfilzomib at 56 mg/m2 completed all 8 cycles, 5 patients discontinued study therapy before cycle 8 as a result of adverse events, and 1 patient discontinued therapy as a result of progressive disease. CONCLUSION: Carfilzomib in combination with cyclophosphamide and dexamethasone is effective and has manageable toxicity for patients with newly diagnosed MM.