Mon, Jul. 27, 12:51 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval for Merck's (MRK -1.2%) ZERBAXA (ceftolozane/tazobactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), acute pyelonephritis (kidney infection) or complicated urinary tract infections (cUTI).
- ZERBAXA, intravenously administered, is a combination of the cephalosporin antibacterial drug ceftolozane sulfate and the beta-lactamase inhibitor tazobactam sodium.
- A final decision by the European Commission usually takes ~60 days.
- ZERBAXA is cleared in the U.S. for the treatment of cUTI and cIAI (in combination with metrodinazole).
Fri, Jul. 24, 12:05 PM
- The FDA approves AbbVie's (ABBV -3%) Technivie (ombitasvir, paritaprevir, ritonavir), in combination with ribavirin, for the treatment of HCV genotype 4 infection in patients with poor liver function (cirrhosis) without scarring (fibrosis). Technivie is the first approved treatment for HCV-4 that does not require the use of interferon.
- About 3M Americans are chronically infected with HCV. Genotype 4 is the least common, representing ~1% of the total.
- Related tickers: (GILD -2.7%)(MRK -0.9%)
Thu, Jul. 23, 12:30 PM
- The European Medicines Agency (EMA) accepts for review Merck's (MRK -0.3%) Marketing Authorization Application (MAA) for its once-daily, single tablet formulation of grazoprevir 100mg/elbasvir 50 mg for the treatment of adult patients with hepatitis C genotype 1,3,4 or 6 infection. The EMA will review the application under its accelerated protocol.
- The company submitted a New Drug Application (NDA) to the FDA for HCV-1,4 or 6 in May of this year. In April, the agency designated grazoprevir/elbasvir a Breakthrough Therapy for HCV-1-infected patients with end stage renal disease and for HCV-4 infection.
- Related tickers: (GILD +0.1%)(ABBV -0.4%)
Wed, Jul. 22, 1:32 PM
Wed, Jul. 22, 10:28 AM
- As expected, the European Commission approves Merck's (MRK -0.6%) Keytruda (pembrolizumab) for the treatment of adult patients with advanced (unresectable or metastatic) melanoma.
- Pembrolizumab is PD-1-inhibiting monoclonal antibody. PD-1 (programmed cell death 1) is a protein found on the surface of T cells and pro-B cells that plays a key role in down-regulating the immune system. Binding to PD-1 enables the immune system to more effectively recognize and kill cancer cells.
- The FDA approved Keytruda for the treatment of melanoma in September 2014.
Tue, Jul. 7, 7:52 AM
- Allergan (NYSE:AGN) acquires the worldwide rights to Merck's (NYSE:MRK) investigational small molecule oral calcitonin gene-related peptide (CGRP) receptor agonists which are under development for the treatment and prevention of migraine.
- Under the terms of the agreement, Allergan will pay Merck an upfront fee of $250M, half when the deal clears antitrust review and half in April 2016. Merck will be eligible for development and commercial milestones and tiered double-digit royalties. Allergan will be responsible for the full development costs of the CGRP programs as well as manufacturing and commercialization.
- Specifically, Allergan obtains the rights to two CGRP receptor agonists:
- MK-1602, for the acute treatment of migraine. A Phase 2 study was just completed. After discussing the results with the FDA, a Phase 3 trial should begin in 2016.
- MK-8031, for the prevention of migraine. A Phase 2 trial is expected to commence in 2016.
- In July 2011, Merck discontinued development of an earlier oral CGRP antagonist, Telcagepant (MK-0974), due to potential liver toxicity. MK-1602 and MK-8031 belong to a different chemical series than Telcagepant and have shown no evidence of liver toxicity.
- Migraines affect ~36M Americans.
Wed, Jul. 1, 11:30 AM
- Galectin Therapeutics (GALT -0.7%) announces the screening of the first five patients in its Phase 2 study, called NASH-CX, evaluating GR-MD-02 in patients with nonalcoholic steatohepatitis (NASH). The randomized, placebo-controlled study will enroll 156 patients who will receive either one of two doses of GR-MD-02 (2 mg/kg or 8 mg/kg) or placebo. Final data collection is expected in October 2017. The study completion date is February 2018.
- The primary endpoint is the reduction in hepatic portal vein pressure versus placebo as measured by the hepatic venous pressure gradient (HVPG).
- GR-MD-02, the company's lead product candidate in its fibrosis program, is a complex carbohydrate drug that targets galectin-3, a protein that plays a key role in the pathogenesis of fatty liver disease and fibrosis. The FDA designated it for Fast Track review for the treatment of NASH in August 2013.
- NASH is one of the "next big things" for drug makers. It affects as many as 5% of Americans.
- Related tickers: (TBRA +1.7%)(ICPT -1%)(DRRX +0.4%)(MNOV +1.9%)(GLMD)(RGLS -6.3%)(AZN +1.2%)(OTCPK:GNFTF)(CNAT +4.3%)(VBLT +0.2%)(RPTP +2.7%)(LJPC +10.4%)(MRK +1.3%)(SHPG +1.4%)(OTCQB:ISLT)(GILD -0.4%)
Mon, Jun. 29, 10:19 AM
- Results from a Phase 3 trial evaluating Merck's (MRK -1%) EMEND (fosaprepitant dimeglumine) for injection, in combination with other anti-vomiting medicines, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic (vomit inducing) chemo (MEC) met its primary endpoint of a statistically significant improvement in the control of CINV versus placebo. The data were presented at the Multinational Association of Supportive Care/International Society of Oral Oncology Annual Meeting on Supportive Care in Cancer in Copenhagen, Denmark.
- The study assessed a single 150 mg injection of EMEND plus ondansetron (16 mg) and dexamethasone (20 mg) versus placebo plus ondansetron and dexamethasone administered on day one. The primary endpoint was complete response (NYSE:CR) (no vomiting and no rescue medications) in the delayed phase (25 to 120 hours after the initiation of chemo). CR in the test group was 78.9% compared to 68.5% for control (p<0.001). In the acute phase (0 to 24 hours after the start of chemo), CR in the EMEND arm failed to reach statistical significance (p=0.184). In the overall phase (0 to 120 hours), CR in the AMEND group was statistically superior to placebo, 82.7% vs. 72.9% (p<0.001).
- EMEND, a substance P/Neurokinin -1 receptor antagonist, is currently cleared in the U.S., in combination with other antiemetic agents, for the prevention of CINV in patients receiving highly emetogenic chemo. Merck intends to submit a supplemental New Drug Application (sNDA) to the FDA for the expanded use of EMEND to prevent CINV in MEC later this year.
Thu, Jun. 18, 12:50 PM
- Merck (MRK +1.5%) agrees to pay $5.9M to settle a Justice Department case involving the promotion of a treatment for bacterial conjunctivitis or pink eye, for an unapproved (off-label) indication. The alleged misbehavior occurred in its Inspire Pharmaceuticals unit, which the company eventually sold to Akorn Pharmaceuticals (AKRX +3.4%). The company promoted the product, AzaSite, for the unapproved indication of blepharitis (inflammation of the eyelids).
- This is not the first time Merck has been slapped with such a penalty. In 2011, it paid over $950M to settle allegations pertaining to its promotional practices of the anti-inflammatory blockbuster Vioxx.
Wed, Jun. 17, 11:48 AM
- Piper Jaffray analysts have been busy in the pharma space. They initiate coverage of Merck (MRK +0.2%) with a Neutral rating and $65 (12% upside) price target.
- The firm also starts Eli Lilly (LLY -0.8%) with an Overweight rating and $97 (15% upside) price target and Bristol-Myers Squibb (BMY +0.3%) with an Underweight rating and $60 (9% downside risk) price target.
Wed, Jun. 3, 10:23 AM
- Merck (MRK +0.9%), through a subsidiary, extends its existing collaboration and license agreement with Agenus (AGEN +1.6%) for the discovery and development of therapeutic antibodies to Merck's proprietary immune checkpoints to April 2016.
- Under the terms of the original agreement, Agenus will discover and optimize fully human antibodies against two undisclosed Merck checkpoint targets using its Retrocyte Display platform. Agenus is eligible to receive up to $100M in milestones and royalties on global commercial sales.
Mon, Jun. 1, 5:08 PM
- The FDA accepts under Priority Review Merck's (NYSE:MRK) supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) for the treatment of patients with advanced non-small cell lung cancer whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for epidermal growth factor receptor (EGFR) or ALK genomic tumor mutations. The PDUFA date is October 2.
- Keytruda, a PD-1 inhibitor, is currently cleared for the treatment of advanced melanoma.
Mon, Jun. 1, 4:20 PM
- Merck (MRK -0.2%) and Dynavax (DVAX -1%) enter into two clinical trial collaboration agreements to investigate the potential benefits of combining immunotherapies in the treatment of cancer. One collaboration will assess the combination of Merck's Keytruda (pembrolizumab) and Dynavax's toll-like receptor agonist, SD-101 and the other, Merck's investigational anti-interleukin-10 immunomodulator, MK-1966 with SD-101.
- Interleukin-10 is an anti-inflammatory cytokine.
- A Phase 1b/2 trial evaluating the Keytruda combo in advanced melanoma will commence in H2. A Phase 1 study assessing the MK-1966 combo in solid or hematological malignancies will also commence in H2.
- Under the terms of the agreement, Dynavax will sponsor and fund the Keytruda study and Merck will sponsor and fund the MK-1966 study. The contracts include provisions to extend the collaboration into Phase 3 development. Additional details are not disclosed.
- This partnership is another example of the prevailing opinion in the oncology community that combining therapies with different mechanisms of action offers the best chance of success in fighting many cancers.
Mon, Jun. 1, 8:09 AM
- TheStreet's Adam Feuerstein reports from ASCO in Chicago. On the plus side, he says Oncothyreon (NASDAQ:ONTY), Roche (OTCQX:RHHBY), Merck (NYSE:MRK), ImmonoGen (NASDAQ:IMGN), Celldex Therapeutics (NASDAQ:CLDX) and CTIBiopharma (NASDAQ:CTIC) all presented impressive data.
- On the negative side, Clovis Oncology (NASDAQ:CLVS) and Puma Biotech (NYSE:PBYI) fell short of wowing the crowd while Bristol-Myers Squibb (NYSE:BMY) was a bit of a mixed bag.
Sat, May 30, 7:35 PM
- Tesaro (NASDAQ:TSRO) and Merck (NYSE:MRK) will collaborate in a Phase 1/2 clinical trial assessing Tesaro's niraparib and Merck's Keytruda (pembrolizumab) in patients with triple negative breast cancer or ovarian cancer. The study will commence later this year.
- Breast cancer patients that test negative for three receptors have limited treatment options because the most effective new therapies specifically target them: estrogen receptors (ER), progesterone receptors (PR) and human epidermal growth factor receptor 2 (HER2). Ovarian cancer is one of the more difficult cancers to treat. There are over 21K new cases per year in the U.S. The five-year survival rate is less than 45%.
- The prevailing opinion in the oncology community is that combining drugs with different mechanisms of action offers the best chance of success in many cancers. This collaboration is an example of this. Niraparib inhibits an enzyme called poly ADP ribose polymerase ((PARP)) while pembrolizumab inhibits (binds to) a protein called programmed cell death 1 (PD-1).
- Merck is advancing Keytruda in a wide variety of cancers, with more than 100 clinical trials planned or in process across more than 30 tumor types.
Fri, May 29, 5:24 PM
- Bristol-Myers Squibb (NYSE:BMY) stumbled 7% today on a 4.5x surge in volume in response to the presentation of an abstract (#109) at ASCO that underwhelmed many investors. The data were from Phase 3 study, called CheckMate-057, assessing the company's PD-1 inhibitor, Opdivo (nivolumab) compared to the standard-of-care chemotherapy agent docetaxel in treatment-experienced patients with advanced, non-squamous non-small cell lung cancer, the most common form of lung cancer. A drug used after another (treatment experienced) is called a second line setting.
- The study met its primary endpoint of a statistically significant 27% reduction in the risk of cancer progression or death compared to docetaxel (p=0.0015). The trial also evaluated the efficacy of Opdivo compared to docetaxel by the level of PD-L1 expression, 1%, 5% and 10%. As expected, the median overall survival (OS) in the Opdivo group was significantly longer than the chemo cohort for all three levels where PD-L1 was highly expressed (greater than or equal to 1, 5, 10%).
- What raised eyebrows was the absence of a treatment benefit compared to docetaxel in the three groups with low PD-L1 expression (<1%, <5%, <10%). Median OS was barely higher in the Opdivo group with <1% expression and lower than docetaxel in the other two. This potentially opens the door for eventual competitors such as Roche (OTCQX:RHHBY) and Merck (NYSE:MRK) whose offerings show strong efficacy in tumors that highly express PD-L1. Had Opdivo shown a significant OS advantage in low PD-L1 expression tumors, its dominance in the second line setting would have been virtually assured.
- CheckMate-057 was stopped early based on the successful achievement of its primary endpoint, per the recommendation of the independent Data Monitoring Committee.
- Previously: Phase 3 study stopped early after Bristol-Myers' Opdivo hits efficacy endpoint (April 17)
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