Today, 9:38 AM
- Incyte (NASDAQ:INCY) and Merck (NYSE:MRK) expand their ongoing clinical collaboration with a new Phase 3 trial assessing Incyte's selective IDO1 inhibitor, epacadostat, in combination with anti-PD-1 Keytruda (pembrolizumab), for the first-line treatment of advanced/metastatic melanoma. The co-funded trial should commence in H1 2016.
- Under the terms of their partnership, the companies have agreed not to initiate new pivotal studies of an IDO1 inhibitor in combination with a PD-1/PD-L1 antagonist in advanced/metastatic melanoma with a third party for two years. During the period, each company will offer the other the opportunity to collaborate on any new pivotal study involving the two product classes for types of melanoma as well as lines of therapy outside of their current collaboration agreement.
Yesterday, 8:00 AM
- Results from a randomized, double-blind, double-dummy Phase 4 study showed Amgen's (NASDAQ:AMGN) Prolia (denosumab) achieved greater gains in bone mineral density (BMD) than the intravenous biphosphonate zoledronic acid [Novartis' (NYSE:NVS) Zometa] in postmenopausal women with osteoporosis following treatment with oral biphosphonates. The data were presented at the American Society for Bone and Mineral Research Annual Meeting in Seattle.
- Biphosphonates [e.g. Merck's (NYSE:MRK) Fosamax (alendronate sodium)] are commonly used as first-line treatment for osteoporosis.
- The 12-month study enrolled 643 postmenopausal women with osteoporosis who had been taking oral biphosphonates for at least two years. They were randomized 1:1 to receive either subcutaneous denosumab 60 mg every six months plus intravenous placebo once yearly (n=321) or intravenous zoledronic acid 5 mg once yearly plus subcutaneous placebo every six moths (n=322).
- The primary endpoint was the change from baseline in lumbar spine BMD at month 12. The change in the denosumab arm was greater (+3.2%) than the zoledronic acid arm (+1.1%). The results were highly statistically significant (p<0.0001). The denosumab cohort also beat the zoledronic acid group in changes in BMD in the total hip, femoral neck and 1/3 radius.
- No new safety issues were identified. Both arms showed similar incidences of adverse events.
- Prolia, cleared by the FDA in June 2010, is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, for the treatment of men with osteoporosis at high risk of fracture and men/women who are at high risk of fracture receiving certain therapies.
- Prolia generated almost $1.2B in sales over the past four quarters.
Fri, Oct. 9, 8:29 AM
- The UK's National Institute for Health and Care Excellence (NICE) issues a draft recommendation, called a Final Appraisal Determination or FAD, recommending Merck's (NYSE:MRK) KEYTRUDA (pembrolizumab) for the first-line treatment of adult patients with advanced melanoma.
- Several days ago, NICE issued final guidance recommending KEYTRUDA for the treatment of advanced melanoma after disease progression with ipilimumab [Bristol-Myers Squibb's (NYSE:BMY) Yervoy].
- KEYTRUDA, currently cleared in 39 countries, was the first medicine available through the UK Early Access to Medicines Scheme (EAMS), introduced in 2014, to help patients with life-threatening or debilitating diseases gain access to promising treatments before regulatory clearance is granted.
- NICE advises the National Health Service on costs, procedures and technologies with the aim of better managing the cost/benefit of services.
Thu, Oct. 8, 7:37 AM
- Australian biotech Bionomics Limited (OTCQX:BNOEF) extends its strategic collaboration, originally inked in July 2013, with Merck (NYSE:MRK) for the discovery and development of drugs for the treatment of chronic and neuropathic pain based on Bionomics' ionX and MultiCore drug discovery platforms.
- Specific financial aspects of the partnership are not disclosed, but Merck has agreed to purchase 21,659,230 ordinary shares of Bionomics at A$0.5938 which is a 29% premium to yesterday's closing price.
Fri, Oct. 2, 3:44 PM
- The FDA approves Merck's (MRK +1.1%) Keytruda (pembrolizumab) for the treatment of patients with advanced/metastatic non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and that express a protein called PD-L1 [such as Bristol-Myers Squibb's (BMY +3.2%) Opdivo (nivolumab)].
- The data supporting the sBLA was generated from a subgroup of 61 NSCLC patients within a larger study who progressed following platinum-based chemo and targeted therapies for EGFR/ALK mutations, if present. The subgroup's tumors all expressed PD-L1 as determined by the 22C3 pharmDx companion diagnostic test. Participants received 10 mg/kg of Keytruda every two to three weeks. The results showed that treatment with Keytruda shrank tumors in 41% of patients with the effect lasting as long as 9.1 months.
- The FDA designated Keytruda a Breakthrough Therapy for this indication.
- Reference labs Quest Diagnostics (DGX +2%) and LabCorp (LH +1.9%) will offer the 22C3 pharmDx test as a service. The kit was developed by Agilent's (A +2.7%) Dako unit.
Fri, Oct. 2, 10:46 AM
- Today is the FDA's PDUFA date under its Accelerated Review program for Merck's (MRK +0.3%) supplemental Biologics License Application (sBLA) seeking clearance of Keytruda (pembrolizumab) for the treatment patients with advanced non-small cell lung cancer whose disease has progressed on or after platinum-based chemo and an FDA-approved therapy for EGFR or ALK mutations, if present.
- Keytruda is currently cleared for the second-line treatment of melanoma.
Mon, Sep. 28, 1:56 PM
- The Japanese Ministry of Health, Labour and Welfare approves Merck's (MRK -2.7%) MARIZEV (omarigliptin) for the treatment of adults with type 2 diabetes. Japan is the first country to approve the medication.
- MARIZEV is a once-weekly DPP-4 inhibitor. The marketing application was supported by Phase 3 data that showed comparable efficacy and tolerability compared to once-daily DPP-4 inhibitor JANUVIA (sitagliptin).
- DPP-4 (dipeptidyl peptidase 4) inhibitors reduce glucagon and blood glucose levels by increasing incretin levels. Lowering glucagon increases insulin secretion.
Wed, Sep. 23, 9:54 AM
- Provectus Biopharmaceuticals (PVCT -3.2%) initiates a Phase 1b/2 clinical trial evaluating the combination of PV-10 and Merck's (MRK -0.5%) Keytruda (pembrolizumab) in patients with Stage IV melanoma. The study is expected to commence later this year. The primary endpoint in the Phase 1b portion is tolerability. Secondary endpoints include progression-free survival and objective response rate. The estimated final data collection date for the primary endpoint in the Phase 2 portion is November 2018. The estimated study completion date is November 2023.
- Orphan Drug-tagged PV-10, an injectable formulation of rose bengal disodium, is currently in Phase 3 development for Stage III melanoma.
Wed, Sep. 23, 7:27 AM
- An open-label 551-subject Phase 3b/4 clinical trial, called STRIIVING, assessing the safely, efficacy and tolerability of switching from an antiretroviral therapy (ART) to ViiV Healthcare's (NYSE:PFE) (NYSE:GSK) once-daily fixed dose Triumeq (abacavir/dolutegravir/lamivudine) in virologically suppressed adults with HIV-1 infection showed that viral suppression was non-inferior (no worse than) in patients who switched to Triumeq.
- The study recruited HIV-1-positive patients from a broad range of protease inhibitor (n=234), integrase strand transfer inhibitor (n=146) and non-nuclease reverse transcriptase inhibitor (n=171)-based regimens who had similar clinical profiles. The treatment satisfaction score improved significantly for those patients who switched to Triumeq (p<0.001) although there was an increase in adverse events (AEs) (4% versus 0%). The most common AEs were nausea (10%), diarrhea (7%), fatigue (7%), upper respiratory infection (7%), cough (5%) and headache (5%).
- ViiV Healthcare Chief Scientific and Medical Officer John Pottage, M.D., says, "For clinicians, choosing among antiretroviral therapies now involves balancing efficacy with factors such as tolerability, dosing, ability to use with other medications and resistance profile. These data support the use of once-daily abacavir/dolutegravir/lamivudine as a treatment option in the switch setting for appropriate patients."
- Related tickers: (NASDAQ:GILD) (NYSE:JNJ) (NYSE:MRK) (NYSE:ABBV) (NYSE:BMY) (OTCQX:RHHBY)
Mon, Sep. 21, 10:33 AM
- ANI Pharmaceuticals (ANIP +5.2%) acquires the NDAs for purified corticotropin gel and corticotropin-zinc hydroxide from Merck (MRK -0.4%) for $75M in cash plus a percentage of future net sales. The products are approved for a range of disease states including multiple sclerosis, rheumatic disorders, dermatologic diseases, collagen, ophthalmic and respiratory diseases and allergic and edematous conditions.
- ANI estimates the current U.S. market for the two products to be ~$1B, based on H.P. Acthar gel sales.
- The company intends to form a subsidiary that will effect the acquisition as well as the manufacture of the products. The move, which should result in a lower tax bill, is part of its broader acquisition strategy.
Thu, Sep. 17, 1:44 PM
- Eli Lilly (LLY +6.7%) jumps on 30% higher volume in response to its announcement of results from a Phase 3 clinical trial, called EMPA-REG, that showed patients with type 2 diabetes at high risk of cardiovascular (CV) events treated with Jardiance (empaglifozin), in addition to standard-of-care treatment, experienced a significant reduction in both CV risk and death.
- Specifically, patients taking Jardiance showed a 14% reduction in the risk of the combined endpoint of CV death, non-fatal heart attack or non-fatal stroke and a 38% reduction in the risk of CV death. Treatment with Jardiance also resulted in a 32% reduction in all-cause mortality and a 35% reduction in heart failure-related hospitalization, all versus placebo. The data were presented today at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden and published in the New England Journal of Medicine.
- EMPA-REG was a long-term, multicenter, double-blind, placebo-controlled study involving more than 7,000 people across 42 countries with type 2 diabetes at high risk of CV events. The median observation period was 3.1 years.
- Almost 400M people worldwide have diabetes. As many as 95% of the cases are type 2.
- Jardiance was co-developed with privately held Boehringer Ingelheim under the companies' January 2011 diabetes alliance.
- Related tickers: (SNY +0.1%)(NVO -0.7%)(MRK -0.8%)
Thu, Sep. 17, 7:59 AM
- Interim results from a Phase 2 clinical trial evaluating Achillion Pharmaceuticals' (NASDAQ:ACHN) NS5A inhibitor odalasvir (ACH-3102), in combination with Gilead Sciences' (NASDAQ:GILD) Sovaldi (sofosbuvir), without ribavirin, in HCV-1 patients showed a 100% cure rate (SVR12) in HCV-1 patients (n=6/6) after six or eight weeks of treatment.
- The Phase 2 trial was an open-label, randomized, partial-crossover study to assess the safety, tolerability and efficacy of six or eight weeks of odalasvir and sofosbuvir, without ribavirin, in patients with HCV-1 infection. Eighteen patients were initially enrolled, including six as observational (group 1). Twelve patients completed eight weeks of treatment (50 mg odalasvir/400 mg sofosbuvir) while the observational group received nothing. All twelve subjects achieved SVR24. Following this phase, the six observational patients plus six additional patients (group 2) received six weeks of treatment with the same combo regimen. All achieved SVR24. Six additional rollover patients (group 3) were treated for six weeks with the combo regimen and all achieved SVR12.
- In a summary that is a bit confusing, the company states that 18 subjects (groups two and three) achieved SVR12 after six weeks of therapy, although it states that only group 3 (n=6) achieved this. Also, the total number of patients in groups 2 and 3 is 12 (6 + 6). Group 1 (n=6) is apparently included as well?
- In May, the company inked a global license and commercialization deal with Janssen Pharmaceuticals (NYSE:JNJ) for HCV products containing one or more of Achillion's HCV assets, including odalasvir, ACH-3422 and sovaprevir.
- Previously: Achillion inks collaboration deal with J&J's Janssen Pharmaceuticals in hep C (May 19)
- ACHN is up 5% premarket on light volume.
- Related tickers: (NYSE:MRK) (NYSE:BMY) (NYSE:ABBV)
Wed, Sep. 16, 12:52 PM
- Merck's (MRK +0.4%) omarigliptin, an investigational DPP-4 inhibitor administered once weekly for lowering blood sugar in type 2 diabetics, successfully achieved its primary endpoint in a Phase 3 study of showing non-inferiority to once-daily Januvia (sitagliptin) in lowering A1C levels at week 24. The data were presented at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden.
- The average A1C reduction for patients receiving omarigliptin was -0.47% versus -0.43% for those taking Januvia. In a subset of patients with higher baseline A1C (at least 8.0%), treatment with omarigliptin reduced A1C -0.79% versus -0.71% for Januvia. The percentage of patients achieving their A1C goals was similar in both arms as were the incidences adverse events.
- The company intends to submit its marketing application in the U.S. by the end of the year. It filed its application in Japan in November 2014.
Mon, Sep. 14, 6:56 AM
- Sanofi (NYSE:SNY) enters into a multi-target peptide discovery and optimization collaboration with Tokyo-based PeptiDream.
- Under the terms of the agreement, PeptiDream will use its proprietary Peptide Discovery Platform System technology to generate certain peptides against multiple targets of interest selected by Sanofi. PeptiDream will receive an undisclosed upfront payment, research funding, preclinical and clinical milestones and royalties of commercial sales.
- PeptiDream also has collaborations with Amgen (NASDAQ:AMGN), AstraZeneca (NYSE:AZN), Bristol-Myers Squibb (NYSE:BMY), Eli Lilly (NYSE:LLY), GlaxoSmithKline (NYSE:GSK), Novartis (NYSE:NVS), Mitsubishi Tanabe (OTCPK:MTZPY), Daiichi Sankyo (OTCPK:DSNKY), Merck (NYSE:MRK) and Ipsen (OTCPK:IPSEY).
Fri, Sep. 11, 10:22 AM
- Baltimore, MD-based Cerecor (Pending:CERC) is set for its IPO of 4,230,769 shares of common stock at $6 - 7.
- The clinical stage biopharmaceutical firm develops drugs for neurological and psychiatric disorders. One of its lead product candidates, licensed from Merck (MRK -1.4%), is CERC-301, currently in Phase 2 development for the treatment of major depressive disorder (MDD). The product candidate belongs to a class of compounds known as NMDA receptor antagonists (e.g., ketamine). The value proposition of CERC-301 is oral administration with a rapid onset of antidepressant effect without the side effects seen with other NMDA therapies.
- Another lead candidate is CERC-501, licensed from Eli Lilly (LLY -0.2%), currently in Phase 2 development for the treatment of substance abuse disorders and as adjunctive therapy for MDD. CERC-501 is a selective kappa opioid receptor antagonist.
- 2014 Financials ($M): Operating Expenses: 17.1 (+32.6%); Net Loss: (3.5) (+73.2%); Cash Burn: (15.5) (-34.8%).
- 2015 Financials ($M) (6 mo.): Operating Expenses: 5.4 (-26.0%); Net Loss: (6.2) (+19.5%); Cash Burn: (4.8) (-7.9%).
Tue, Sep. 8, 12:08 PM
- Korea's Ministry of Food and Drug Safety approves BRENZYS, a biosimilar to Amgen's Enbel (etanercept) co-developed by Merck (MRK +1.6%) and Samsung Bioepsis. BRENZYS is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and psoriasis in adult patients at least 18 years old. Merck plans to initiate the commercial launch by the end of the year or early 2016.
- The companies established their collaboration in February 2013 to develop and commercialize biosimilars in certain territories. Their pipeline includes five late-stage candidates: SB4 [Enbrel biosimilar]: worldwide except U.S./EU/Japan; SB2 [Remicade (infliximab) biosimilar]: worldwide except EU/Russia/Turkey; SB5 [Humira (adalimumab) biosimilar]: worldwide except EU/Russia/Turkey; SB3 [Herceptin (trastuzumab) biosimilar]: worldwide and MK-1293 [Lantus (insulin glargine) biosimilar]: worldwide.
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