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Ligand Pharmaceuticals Incorporated (LGND)

  • Yesterday, 4:05 PM
    • Thinly-traded Ligand Pharmaceuticals (LGND +15.5%) jumps on a 5x surge in volume in response to the positive news on Amgen's (AMGN +1.1%) Kyprolis (carfilzomib) study. Ligand is eligible to receive milestone and royalty payments on sales of Captisol, which carfilzomib's IV formulation utilizes. Ligand and Proteolix entered into a collaboration in 2005 to explore the use to Captisol. Onyx Pharmaceuticals acquired Proteolix in 2009 and Amgen acquired Onyx in 2013.
    • Captisol is a formulation technology. It is a uniquely modified cyclodextrin, which improves the solubility, stability, bioavailability and dosing of active pharmaceutical ingredients.
    • Previously: Amgen's Kyprolis beats Takeda's Velcade in head-to-head study (March 1)
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  • Mon, Feb. 9, 8:34 AM
    • Ligand Pharmaceuticals (NASDAQ:LGND): Q4 EPS of $0.60 in-line.
    • Revenue of $23M (+56.0% Y/Y) misses by $0.65M.
    • Press Release
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  • Sun, Feb. 8, 5:30 PM
  • Mon, Feb. 2, 5:09 PM
    • Ligand Pharmaceuticals (NASDAQ:LGND) promotes EVP and COO Matthew W. Foehr to President and COO. President and CEO John Higgins will continue to serve as CEO.
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  • Tue, Jan. 27, 9:15 AM
    • Ligand Pharmaceuticals (NASDAQ:LGND) will report Q4 and full-year results on February 9 before the open. The conference call will begin at 9:00 am ET.
    • Consensus views for Q4 and 2014 are EPS of $0.60 and $1.53 on revenues of $23.9M and $65.4M, respectively.
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  • Fri, Jan. 9, 10:47 AM
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  • Dec. 26, 2014, 12:05 PM
    • Spectrum Pharmaceuticals (SPPI +0.9%) submits a New Drug Application (NDA) to the FDA seeking approval for Orphan Drug-designated Captisol-Enabled Melphalan (CE-Melphalan) for injection (propylene glycol-free) for the use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.
    • CE-Melphalan was developed by Ligand Pharmaceuticals (LGND +2.7%) and licensed to Spectrum in March 2013.
    • Among the benefits of Orphan Drug status is a seven-year period of market exclusivity if approved.
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  • Dec. 22, 2014, 11:48 AM
    • GlaxoSmithKline (GSK -0.1%) submits a supplemental New Drug Application (sNDA) to the FDA for the use of Promacta (eltrombopag) in pediatric patients at least six years old with chronic immune (ideopathic) thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
    • Promacta is currently approved for the treatment of thrombocytopenia in adult patients.
    • Related ticker: (LGND +0.9%)
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  • Dec. 19, 2014, 12:48 PM
    • Pfizer's (PFE +0.2%) receipt of the European Commission's marketing authorization for Duavive (conjugated estrogens/bazedoxifene) triggers a milestone payment for an undisclosed amount to development partner Ligand Pharmaceuticals (LGND +1.4%).
    • Duavive is indicated for the treatment of estrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom progestin-containing therapy is not appropriate. It pairs conjugated estrogens with an estrogen agonist/antagonist, known as a selective estrogen receptor modulator. Bazedoxifene is used instead of progestin in order to protect the uterine lining against hyperplasia that may result from estrogen alone therapy.
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  • Nov. 12, 2014, 12:01 PM
    • GlaxoSmithKline (GSK -0.7%) submits a variation to its Marketing Authorization in the European Union for Revolade (eltrombopag) seeking approval for the treatment of patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy. The FDA approved the use of eltrombopag for SAA on August 26, 2014.
    • Revolade's current labeling in Europe is for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura and patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.
    • The European Commission usually issues a final decision within 60 days.
    • Eltrombopag was co-discovered by Glaxo and Ligand Pharmaceuticals (LGND +0.2%).
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  • Nov. 11, 2014, 9:37 AM
    • At The Liver Meeting in Boston, Merck (NYSE:MRK) presented data from a Phase 2 clinical trial evaluating the combination of the company's investigational NS3/4A inhibitor, grazoprevir, and its investigational NS5A inhibitor, elbasvir, with and without ribavirin, in treatment-naive and treatment-experienced HCV-1 patients. The length of treatment was either eight,12 or 18 weeks.
    • SVR12 rates in treatment-naive non-cirrhotic patients were: 8-week regimen with RBV: 80%; 12-week regiment with and without RBV: 93% and 98%.
    • SVR12 rates in treatment-naive patients with cirrhosis were: 12-week regimen with and without RBV: 90% and 97%; 18-week regimen with and without RBV: 97% and 94%.
    • SVR12 rates for treatment-experienced patients with and without cirrhosis: 12-week regimen with and without RBV: 94% and 91%; 18-week regimen with and without RBV: 100% and 97%.
    • SVR12 rates for HCV-1 patients co-infected with HIV: 12-week regimen with and without RBV: 97% and 87%.
    • Results from a Phase 3 trial are expected in 1H 2015.
    • Previously: Merck triple therapy HCV candidate fails as a four-week regimen
    • HCV-related tickers: (GILD +0.4%)(JNJ -0.2%)(BMY -0.1%)(ABBV +0.3%)(ACHN +3%)(ENTA +0.4%)(CNAT)(LGND +0.5%)(RGLS)
  • Nov. 11, 2014, 9:05 AM
    • At The Liver Meeting in Boston, Gilead Sciences (NASDAQ:GILD) presented data from three Phase 2 studies evaluating an all-oral pan-genotypic regimen, Sovaldi (sofosbuvir) + the company's investigational NS5A inhibitor GS-5816, for the treatment of HCV infection. The specific regimens were Sovaldi 400 mg plus GS-5816 25 mg or 100 mg, with and without ribavirin, for eight or 12 weeks.
    • The first study, GS-US-342-0109, evaluated Sovaldi + GS5816 with and without ribavirin for 12 weeks in treatment-experienced HCV-1 and HCV-3 patients with and without cirrhosis. SVR12 rates: SOF + GS-5816 100 mg: 100% for GT1 with and without cirrhosis; 100% for GT3 without cirrhosis and 88% for GT3 with cirrhosis. SVR12 rates: SOF + GS-5816 + RBV: 100% for GT1 without cirrhosis and GT3 without cirrhosis; 90% in GT1 with cirrhosis and 96% in GT3 with cirrhosis.
    • The second study, ELECTRON 2, evaluated the same regimen as the first study for eight weeks in non-cirrhotic treatment-naive genotype 3 patients. The SVR12 rate inclusive of ribavirin was 100% and 96% for the ribavirin-free approach.
    • The third study, GS-US-342-0102, evaluated the same regimen as first study in non-cirrhotic treatment-naive patients. Results from Part A evaluating 12 weeks of treatment were presented at The International Liver Congress in April 2014. The results from Part B, presented this week, evaluated eight weeks of treatment in HCV-1 and HCV-2 patients. SVR12 rates were: G1: 81% and 90% with and without RBV; G2: 88% with and without RBV.
  • Nov. 10, 2014, 7:49 AM
    • At The Liver Meeting in Boston, Merck (NYSE:MRK) presented interim data on its triple-therapy regimen for HCV-1 infection. The investigational product combines the company's NS3/4A protease inhibitor, grazoprevir and its NS5A inhibitor, elbasvir, with Sovaldi (sofosbuvir).
    • SVR4/8 for the 8-week regimen in treatment-naive cirrhotic patients was 94.7% (18 of 19). SVR4/8 values for other treatment groups, however, appear low. For the six-week regimen in treatment-naive cirrhotic patients, SVR4/8 was only 80% (16 of 20) with four relapses. For treatment-naive non-cirrhotic patients, the six-week regimen SVR4/8 was 86.7% (26/30) with four relapses while the four-week regimen failed to come anywhere close to efficacy at 38.7% (12/31) with 19 relapses.
    • Of the 28 total relapses, 25 were genotype 1a and three were genotype 1b.
    • The company plans to initiate Phase 2 clinical trials to assess the safety and efficacy of two short-duration triple therapy regimens: MK-3682 in combination with grazoprevir/elbasvir and MK-3682 in combination with grazoprevir and MK-8408 in non-cirrhotic HCV patients. MK-3682 is an investigational oral prodrug HCV nucleotide analogue NS5B polymerase inhibitor. MK-8408 is an investigational early-stage NS5A inhibitor.
  • Nov. 9, 2014, 6:04 PM
    • At The Liver Meeting in Boston this week, Bristol-Myers Squibb (NYSE:BMY) presented data from its Phase 3 UNITY program investigating a 12-week all-oral TRIO regimen of daclatasvir (DCV) with asunaprevir and beclabuvir for the treatment of HCV-1 infection.
    • In the UNITY-1 trial, a 12-week regimen of DCV-TRIO without ribavirin was evaluated in treatment-naive and treatment-experienced non-cirrhotic HCV patients. SVR12 was 91% overall, 92% for the treatment-naive group and 89% for the treatment-experienced group.
    • In UNITY-2, a 12-week regimen of DCV-TRIO was evaluated in cirrhotic patients. SVR12 was 98% in the treatment-naive group and 93% in the treatment-experienced group with ribavirin and 93% and 87%, respectively, without ribavirin.
    • In October, the company announced it would not pursue FDA approval for the dual regimen of asunaprevir and daclatasvir for the treatment of HCV-1b infection.
  • Nov. 9, 2014, 5:37 PM
    • At The Liver Meeting in Boston this week, Bristol-Myers Squibb (NYSE:BMY) presented data from its ALLY Phase 3 clinical trial investigating a 12-week ribavirin-free regimen of daclatasvir in combination with Sovaldi (sofosbuvir) in HCV genotype 3 patients, a population that has emerged as one of the most difficult to treat. The SVR12 in treatment-naive patients was 90% and 86% in treatment-experienced patients. SVR12, sustained viral response 12 weeks after the completion of therapy, is considered cured.
    • The results compare favorably with SVR12 in 89% of patients with HCV-1,2 and 3 in an open-label randomized study of a 24-week regimen of the two drugs.
  • Nov. 9, 2014, 5:06 PM
    • At this week's Annual Meeting for the Study of Liver Diseases in Boston, Achillion Pharmaceuticals (NASDAQ:ACHN) gave poster presentations on two of its HCV product candidates.
    • In a Phase 2 pilot study evaluating eight-week treatment of its NS5A inhibitor, ACH-3102, in combination with Sovaldi (sofosbuvir) in treatment-naive HCV genotype 1 patients, the interferon-free, ribavirin-free regimen demonstrated 100% SVR12 in 12 patients. SVR12 or sustained viral response 12 weeks after the completion of therapy, is considered cured. Sovaldi's SVR12 (in combination with peg-interferon alfa and ribavirin) is 90% for HCV-1. Harvoni's (sofosbuvir + ledipasvir) is 94 - 99%.
    • The company presented three posters on preclinical results for its uridine analog prodrug, ACH-3422. The data showed improved potency against HCV-3 compared to sofosbuvir. The combination of ACH-3422 with ACH-3102 or sovaprevir (Achillion's Phase 2 NS3/4A inhibitor) displayed additive synergistic activity in vitro. Also, ACH-3422, in combination with other direct-acting antiviral agents, demonstrated the ability to block the appearance of resistant colonies in vitro.
    • According to recent research, the global prevalence of HCV genotypes is: type 1: 46%; type 2: 13%; type 3: 22% and type 4: 13%.
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Company Description
Ligand Pharmaceuticals Incis a biopharmaceutical company with a business model that is based upon the concept of developing or acquiring royalty revenue generating assets and coupling them with a lean corporate cost structure.
Sector: Healthcare
Industry: Biotechnology
Country: United States