Report: positive PII trial results with Melphalan/Lenalidomide/Dexamethasone in newly diagnosed AL amyloidosis patients:
Haematologica. 2017 May 18. pii: haematol.2016.163246. doi: 10.3324/haematol.2016.163246. [Epub ahead of print] Lenalidomide/Melphalan/Dexamethasone in newly diagnosed patients with AL Amyloidosis: results of a prospective phase 2 study with long-term follow-up.
Hegenbart U1, Bochtler T1, Benner A2, Becker N2, Kimmich C1, Kristen AV3, Beimler J4, Hund E5, Zorn M6, Freiberger A7, Gawlik M8, Goldschmidt H9, Hose D9, Jauch A10, Ho AD8, Schönland SO11. Author information Abstract Chemotherapy in light chain amyloidosis aims to normalize the involved free light chain in serum, which leads to an improvement or at least stabilization of organ function in most responding patients. We performed a prospective single center phase 2 trial with 50 untreated patients not eligible for high-dose treatment. The treatment schedule comprised 6 cycles of oral lenalidomide, melphalan and dexamethasone every 4 weeks. After 6 months complete remission was achieved in 9 patients (18%), very good partial remission in 16 (32%) and partial response in 9 (18%). Overall, organ response was observed in 24 patients (48%). Hematologic and cardiac toxicities were predominant adverse events. Mortality at 3 months was low with 4% (n=2) despite inclusion of 36% of patients (n=18) with cardiac stage Mayo 3. After a median follow-up of 50 months, median overall and event-free survival were 67.5 months and 25.1 months, respectively. We conclude that the treatment of lenalidomide, melphalan and dexamethasone is very effective to achieve a hematologic remission, organ response and consecutively a long survival in transplant ineligible patients with light-chain amyloidosis. However, as toxicity and tolerability are the major problems of 3 drug regimens a strict surveillance program is necessary and sufficient to avoid severe toxicities. This study is registered at www.clinicaltrials.gov as #NCT00883623 (Eudract2008-001405-41).
Ligand to Participate in Two Upcoming Investor Conferences
Business Wire Business WireMay 22, 2017 SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (LGND) announces that company executives are scheduled to participate in the following upcoming investor conferences: 14th Annual Craig-Hallum Institutional Investor Conference in Minneapolis. Conference takes place on Wednesday, May 31, 2017 with one-on-one meetings only. John Higgins, CEO; Matt Foehr, President and COO; and Matt Korenberg, CFO, will attend for Ligand. Jefferies Healthcare Conference in New York City. Presentation takes place on Thursday, June 8, 2017 at 4:00 p.m. Eastern time (1:00 p.m. Pacific time). John Higgins, CEO; Matt Foehr, President and COO; and Matt Korenberg, CFO, will attend for Ligand. A live webcast of the presentation will be available on Ligand’s website at www.ligand.com. A replay of the presentation will be archived on the website for 30 days.
Ligand Pharmaceuticals, Inc. (LGND)
I am not an accountant. I do not think enough effort was made on the last two calls to emphasize the changed accounting and the phantom impact of the change to the EPS. Or, to think about it differently, to emphasize the opportunity of having such a large cash flow. I'm sure they are looking at more acquisitions.
Ligand is unique, and the management team is conservative in its messaging. Getting the messaging right is hard. They don't want to forecast events that are uncertain. They are trying to do more. For example, they are talking about how many revenue-generating programs they are likely to have in 2020. But, they aren't giving any guidance to how those successes impact Captisol material sales, for example.
Bottom line - They have 155 funded programs. They have 90+ partners and stupendous deal flow. They have key IP. They have an internal GRA program with a novel mechanism of action in diabetes. This compound, if successful in Phase II and III, is a future blockbuster that can do billions in annual sales. They have an uber lean SG&A structure. No other companies have what Ligand has. Patience.
LGND appears to suggest upside opportunity. Im not sure about you guys but aw-esomeSTOCKS has provided me with some pretty good trade ideas. I messed up executing some of them but thats on me.
Delafloxacin clinical trial successfully clears drug-drug interaction study with CY3P substrate Midazolam:
Clin Ther. 2017 May 8. pii: S0149-2918(17)30244-8. doi: 10.1016/j.clinthera.2017.04.009. [Epub ahead of print] The Pharmacokinetics of the CYP3A Substrate Midazolam After Steady-State Dosing of Delafloxacin.
Paulson SK1, Wood-Horrall RN2, Hoover R3, Quintas M4, Lawrence LE4, Cammarata SK5. Author information Abstract PURPOSE: Delafloxacin is a novel anionic fluoroquinolone in Phase III development for the treatment of serious skin infections. The objective of this study was to evaluate the effects of delafloxacin on the pharmacokinetics of midazolam, a cytochrome P450 (CYP) 3A substrate. METHODS: CYP3A activity using midazolam as a probe was assessed before and after multiple doses of delafloxacin to reach steady state. In this nonrandomized, open-label, single-sequence, Phase I study, 22 healthy male and female subjects were administered a single 5-mg oral dose of midazolam on days 1 and 8, with oral delafloxacin 450 mg every 12 hours administered from days 3 to 8. Full pharmacokinetic profiles were obtained on days 1 and 8 (midazolam and 1-hydroxymidazolam) and days 3 and 7 (delafloxacin). FINDINGS: The geometric mean ratios (90% CIs) for AUC0-∞ and Cmax of midazolam coadministered with delafloxacin versus midazolam alone were 89.4 (83.2-96.0) and 93.6 (83.7-104.6). Similarly, the geometric ratio for the AUC0-∞ of 1-hydroxymidazolam, the primary metabolite of midazolam, was 105.7 (97.7-114.3); the ratio of Cmax was not equivalent at 116.1 (101.7-132.4), which was outside the CI of 80% to 125%. Multiple doses of oral delafloxacin for 6 days were generally well tolerated. IMPLICATIONS: Steady-state dosing of delafloxacin produced no significant changes in midazolam pharmacokinetics, except for a small but not clinically relevant change in the Cmax of 1-hydroxymidazolam. ClinicalTrials.gov identifier: NCT02505997.
Ono Pharmaceuticals reports sales of Kyprolis in the quarter of approximately 8 million dollars which was their projection. Their projected sales of Kyprolis over the next twelve months is 54 million dollars.
Earnings were good, the future looks brighter. The Conference Call names other partners products that have a lot of potential, especially Lillys.
LGND now down over $6 as of 11am because both earnings and revenues missed, and management is making things worse with undeserved stock comp packages and expenses in the face of mediocre to poor results...it is questionable if they are even deserving of their salaries let alone these egregious bonuses and they should be held accountable...
SPPI Conference Call & Earnings for Evomela: EVOMELA, which is our most recently launched product had sales of $6.3 million. This number was in line with our expectation. As we mentioned in our last earnings call, we did see some stocking at a few hospitals based on initial orders which accounted for $2 million to $3 million dollars of sales in the fourth quarter. In the first quarter, these orders did not repeat, as these customers worked through their inventory.
We are pleased with the launch trajectory of EVOMELA, end user demand for this drug remains strong and continues to grow. We believe we have a differentiated product and the market response is validated the merits of this brand.
CONT SPPI CC call: When asked about sales stuck around $6 million a quarter. Answer: you normalize for that stocking, you know, we're seeing growth here. So as I said in my comments, we're seeing our market share continue to grow here.
I don't remember a period when Ligand volume has been this low and I've been in for almost 20 years.
LGND partner Alder starts PIII trial enrollment in NI anterior uveitis:
Aldeyra Therapeutics Announces First Patient Enrolled in Noninfectious Anterior Uveitis Phase 3 Clinical Trial
LEXINGTON, MA -- (Marketwired) -- 04/27/17 -- Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology company focused primarily on the development of new products for inflammation, inborn errors of metabolism, and other diseases that are thought to be related to endogenously generated toxic and pro-inflammatory chemical species known as aldehydes, today announced that it has enrolled the first patient in a Phase 3 clinical trial of topical ocular ADX-102 for the treatment of noninfectious anterior uveitis (NAU).
"Based on positive results from our Phase 2 clinical trial announced last year, we are excited to commence Phase 3 clinical testing of our novel aldehyde trap, ADX-102, in noninfectious anterior uveitis," commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "NAU is a rare and potentially blinding ocular disorder that affects an estimated 150,000 patients in the United States. In contrast to corticosteroids, which are often used to treat NAU, ADX-102 does not appear to cause increases in intraocular pressure -- a precursor to glaucoma -- and thus may represent a safer therapeutic option than the current standard of care."
ADX-102 and other product candidates generated from Aldeyra's aldehyde trap platform sequester and facilitate the degradation of aldehydes, a class of endogenously generated pro-inflammatory mediators. In a Phase 2 clinical trial in NAU, 0.5% topical ocular ADX-102 led to the resolution of inflammation to the same degree as corticosteroid therapy, but without the increases in intraocular pressure observed in corticosteroid-treated patients.
The Phase 3 clinical trial is expected to enroll up to 100 NAU patients with active disease, randomized equally to receive either 0.5% topical ocular ADX-102 or vehicle for four weeks. Consistent with the Phase 2 trial, the primary endpoint will be the resolution of inflammation. Results of the Phase 3 trial are expected in the second half of 2018.
About Noninfectious Anterior Uveitis Noninfectious anterior uveitis is a rare, potentially blinding disease that may be mediated in part by pro-inflammatory aldehydes, and is characterized by inflammation in the front of the eye, pain, impaired vision, and photophobia.
LGND - Technical Breakout is currently underway. 5-1/2 months of sideways movement between 100-110 may be broken depending on the close. The Bollinger Bands, 50day, 200day & 40 week moving average have been broken to the upside. GO LGND GO.
Report: Carfilzomib based regimens have superior efficacy in relapsing multiple myeloma pts after ASCT:
Leukemia. 2017 Apr 25. doi: 10.1038/leu.2017.122. [Epub ahead of print] Efficacy and safety of carfilzomib regimens in multiple myeloma patients relapsing after autologous stem cell transplant: ASPIRE and ENDEAVOR outcomes.
Hari P1, Mateos MV2, Abonour R3, Knop S4, Bensinger W5, Ludwig H6, Song K7, Hajek R7, Moreau P8, Siegel DS9, Feng S10, Obreja M10, Aggarwal SK10, Iskander K10, Goldschmidt H11. Author information Abstract Autologous stem cell transplantation (ASCT) is a standard treatment for eligible multiple myeloma (MM) patients, but many patients will relapse after ASCT and require subsequent therapy. The proteasome inhibitor carfilzomib is approved for relapsed or refractory MM (RRMM). In phase 3 trials, carfilzomib-based regimens (ASPIRE, carfilzomib-lenalidomide-dexamethasone; ENDEAVOR, carfilzomib-dexamethasone) demonstrated superior progression-free survival (PFS) compared with standard therapies for RRMM (ASPIRE: lenalidomide-dexamethasone; ENDEAVOR, bortezomib-dexamethasone). This subgroup analysis of ASPIRE and ENDEAVOR evaluated outcomes according to prior ASCT status. In total, 446 patients in ASPIRE and 538 in ENDEAVOR had prior ASCT. Median PFS was longer for carfilzomib-based regimens vs non-carfilzomib-based regimens for patients with prior ASCT (ASPIRE: 26.3 vs 17.8 months [hazard ratio (HR)=0.68]; ENDEAVOR: not estimable vs 10.2 months [HR=0.61]), those with one prior line of therapy that included ASCT (ASPIRE: 29.7 vs 17.8 months [HR=0.70]; ENDEAVOR: not estimable vs 11.2 months [HR=0.46]), and those without prior ASCT (ASPIRE: 26.4 vs 16.6 months [HR=0.76]; ENDEAVOR: 17.7 vs 8.5 months [HR=0.43]). Overall response rates also favored the carfilzomib-based regimens. No new safety signals were detected. This analysis suggests that carfilzomib-based treatment may lead to improvement in PFS and response rates regardless of prior transplant status. Further evaluation is warranted.Leukemia accepted article preview online, 25 April 2017.
Leukemia - Abstract of article: Efficacy and safety of carfilzomib regimens in multiple myeloma patients relapsing after autologous stem cell transplant: ASPIRE and ENDEAVOR outcomes
Leukemia is one of the leading journals in hematology and oncology. It is published monthly and covers all aspects of the research and treatment of leukemia and allied diseases. Studies of normal hemopoiesis are covered because of their comparative r
Is it time to make a move on LGND? It certainly looks like it based on a return on investment of 5.70%. google awesomesto-cks - they offer pretty good trade alerrts. you dont have to trade their tickers but it definetly helps you recognize possible patterns for stocks you're trading.
AMGN CC cont: KYPROLIS realized 137 million US + 53 million Non-US = 190 Total versus 154 last year for a 23% year-on-year growth during the quarter. And most of this growth was volume-driven, including our international markets. As you know, KYPROLIS is indicated in the U.S. for second and third-line multiple myeloma. In second-line, triplet regimens are used in approximately one-third of patients. And despite new entrants, we've been able to achieve about 50% market share for new patient starts in this segment.
The other two-thirds of second-line patients are treated with doublet regimens. And recent data from our ENDEAVOR study had demonstrated that KYPROLIS plus dexamethasone improved overall survival by 21% or nearly 8 months when compared to the Velcade plus dexamethasone.
Improving overall survival is the gold standard measurement when treating cancer. This data clearly establishes KYPROLIS as the proteasome inhibitor of choice and will be a compelling differentiator in our strategy to displace Velcade in this setting. KYPROLIS is well accepted in large academic centers that treat high numbers of multiple myeloma patients. And we are now focusing on extending KYPROLIS's reach into the community oncology practices.
Despite the introduction of new competing products in the U.S., we have also regained share in new third-line patients over the last few quarters. We expect proteasome inhibition to be foundational therapy in multiple myeloma for many years to come and are focused on growing in second and third lines of therapy with plans to expand KYPROLIS's use in newly diagnosed patients. Outside the U.S., we continue to enter into new markets and secure reimbursement with the benefit of the new KYPROLIS overall survival data. In multiple myeloma, we received the overall survival data from the ENDEAVOR study in relapsed or refractory patients, which confirm the superiority of KYPROLIS plus dexamethasone over Velcade plus dexamethasone. In fact, ENDEAVOR was the first head-to-head study to demonstrate a survival benefit versus a current standard-of-care regimen in this setting, and we're preparing to submit these results to regulators as well.
We also remain on track to begin enrollment this quarter in our Phase 3 study of KYPROLIS in combination with DARZALEX in relapsed or refractory multiple myeloma, and also recently began enrolling a Phase 1b study of new formulations of oprozomib.
Activity in leukemia would be big!
AMGN cont: we received the overall survival data from the ENDEAVOR study in relapsed or refractory patients, which confirm the superiority of KYPROLIS plus dexamethasone over Velcade plus dexamethasone. In fact, ENDEAVOR was the first head-to-head study to demonstrate a survival benefit versus a current standard-of-care regimen in this setting, and we're preparing to submit these results to regulators as well.
We also remain on track to begin enrollment this quarter in our Phase 3 study of KYPROLIS in combination with DARZALEX in relapsed or refractory multiple myeloma,