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)
Fri, May 29, 12:19 PM
- Bayer's (OTCPK:BAYRY) (OTCPK:BAYZF) current #5 rank in the global animal health market could change once it divests its low margin plastics business either via an IPO or direct sale, possibly to a private equity firm. Analysts believe the unit could fetch as much as 11B euros ($12.1B).
- CEO Marijn Dekkers says animal health is a "very attractive business for us. We've always looked with interest in it. It hasn't happened with us yet."
- The top acquisition target would be Zoetis (ZTS +0.8%) which generated $4.8B in sales in 2014. Bayer will probably have competition, though. Valeant Pharmaceuticals (VRX -1.7%) and Merck (MRK +0.2%) have been mentioned as likely suitors.
Fri, May 29, 9:32 AM
- Furthering their cooperative work in cancer that began in late 2014, Amgen (NASDAQ:AMGN) and Merck (NYSE:MRK) will start a Phase 1 trial to assess Amgen's talimogene laherparepvec (T-Vec) and Merck's Keytruda (pembrolizumab) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). In addition, a Phase 3 study evaluating the combination in regionally or distally metastatic melanoma is being initiated.
- T-Vec is an immunotherapy that is designed to selectively replicate in tumors and to initiate an immune response to tumors. Keytruda is PD-1-inhibiting monoclonal antibody. PD-1 (programmed cell death 1) is a protein found on the surface of cancer cells that enables them to avoid detection by the immune system. Binding to PD-1 enables T cells to recognize and kill cancer cells.
- This collaboration is one of many in the cancer space. The current consensus is that drug combinations with different mechanisms of action offer the most promising potential to fight cancers.
- Previously: Amgen and Merck team up in melanoma (Dec. 8, 2014)
- Previously: Ad Comm gives thumbs up to Amgen's T-Vec for melanoma (April 29)
Thu, May 28, 4:47 PM
- Merck (NYSE:MRK) submits a New Drug Application (NDA) to the FDA seeking approval for its single-tablet combination therapy of grazoprevir/elbasvir (100 mg/50 mg) for the treatment of adult patients with chronic hepatitis C genotypes 1,4 or 6 infection.
- The FDA has designated the combo a Breakthrough Therapy (BTD) for the treatment of patients with HCV-1 with end-stage renal disease and for patients with chronic HCV-4 infection. BTD status allows for more intensive guidance from the FDA, the involvement of more senior managers and a rolling review of the NDA.
- It plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency by the end of the year.
- Related tickers: (NASDAQ:GILD) (NYSE:ABBV)
Thu, May 28, 10:22 AM
- As expected, the European Commission approves privately-held Boehringer Ingelheim's single-pill Synjardy (empagliflozin/metformin hydrochloride) for glycemic control in adult type 2 diabetics. The product was developed under its alliance with Eli Lilly (LLY +0.3%).
- Diabetes-related tickers: (SNY -0.5%)(JNJ +0.1%)(OTCQB:ISLT)(OTCQB:BTHE)(VTAE -2.4%)(MRK +0.4%)(NVO -1.5%)(ABT +0.2%)(VKTX +1.4%)(HPTX)(OTCPK:TKPYY +0.3%)(ALR -0.4%)(MNKD -0.8%)(TNDM -1.6%)
- Previously: European Ad Comm recommends approval of combo pill for type 2 diabetes (March 30)
Thu, May 28, 9:52 AM
- Merck (MRK +0.3%) and NanoString Technologies (NSTG +1.4%) establish a clinical research collaboration to develop an assay that will optimize immune-related gene expression signatures and evaluate the potential to predict patient benefit from Keytruda (pembrolizumab), Merck's anti-PD-1 therapy for melanoma.
- The gene expression signatures will be optimized using NanoString's nCounter Analysis System.
- Merck Research Laboratories' Dr. Eric Rubin says, "Our commitment to advancing the science of immuno-oncology includes pursuing cutting edge RNA and DNA approaches to identify a range of biomarkers, such as immune-related gene expression signatures, that in addition to PD-L1 expression, may help to identify patients who may be more likely to experience improved benefit with Keytruda."
Wed, May 27, 7:30 AM
- A Phase 3 study, GIFT-1, evaluating AbbVie's (NYSE:ABBV) investigational, all-oral, interferon-free, ribavirin-free, two direct-acting (2-DAA) antiviral combination of ombitasvir/paritaprevir/ritonavir for the treatment patients with HCV-1b infection met its primary endpoint demonstrating a high cure rate.
- In a subgroup of treatment-naive, non-cirrhotic adult HCV-1b Japanese patients who were eligible for interferon therapy and had a high viral load, the cure rate was 95% (n=106/112) determined by sustained virologic response 12 weeks after the completion of therapy (SVR12). The cure rate in HCV-1b patients with compensated cirrhosis was 91% (n=38/42).
- In an intent-to-treat analysis, the cure rate was 98% (n=104/106) in HCV-1b patients without cirrhosis. This population included every patient that was randomized to placebo during the test period and then received at least one dose of 2-DAA combo in the open label stage.
- The data were presented at the Annual Meeting of the Japan Society of Hepatology in Kumamoto, Japan.
- AbbVie's regulatory application for the 2-DAA candidate is currently under priority review by the Japanese Ministry of Health, Labour and Welfare.
- As many as 2M Japanese are infected with HCV. Up to 70% are infected with genotype 1. About 95% of the HCV-1s are sub-type 1b.
- Previously: AbbVie's 2-DAA HCV-1 candidate gets priority peview in Japan (April 16)
- Related tickers: (NASDAQ:GILD) (NYSE:MRK) (NASDAQ:ENTA)
Tue, May 26, 1:43 PM
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