Tue, Apr. 14, 2:05 PM
- The Phase 3 segment of a Phase 2/3 trial, called STRIVE, evaluating the Ebola vaccine candidate, rVSV-ZEBOV-GP, has been initiated in Sierra Leone. The study will involve 6,000 health and front-line workers in several West African countries in the Basse Guinee region, which dealt with the most Ebola infections. The study in Guinea commenced a couple of weeks ago.
- rVSV-ZEBOV-GP was originally developed by the Public Health Agency of Canada. It licensed it to NewLink Genetics (NLNK) who, in turn, licensed it to Merck (MRK +2%).
- Previously: Phase 3 trials for Merck-NewLink Ebola vaccine start this week in Guinea (March 5)
Wed, Apr. 8, 9:56 AM
- Patient enrollment has begun in a Phase 1/2 study, called KEYNOTE-046, evaluating the combination of Advaxis' (ADXS +0.2%) Lm-LLO immunotherapy, ADXS-PSA, and Merck's (MRK +0.8%) PD-1 inhibitor Keytruda (pembrolizumab) for previously treated metastatic castration-resistant prostate cancer.
- The companies initiated the trial after preclinical studies of the combination showed a synergistic anti-tumor response.
- KEYNOTE-046 will enroll ~51 patients and will assess the safety and efficacy of ADXS-PSA as monotherapy and in combination with Keytruda. Part A of the trial is a dose escalating study to establish the maximum tolerated dose of ADXS-PSA alone. Part B will be a dose escalating study of the combination, followed by an expansion cohort phase. The primary endpoint is safety and tolerability. Secondary endpoints are anti-tumor activity and progression-free survival (PFS).
- ADXS-PSA is an immunotherapy that targets prostate-specific antigen (PSA). It secretes PSA fused to the immunostimulant tLLO to drive a cellular immune response to PSA. Keytruda is a humanized monoclonal antibody that binds to the PD-1 receptor on the surface of cancer cells, blocking the actions of PD-L1 and PD-L2, which then enables the immune system to attack and kill the cancer cells.
Wed, Apr. 8, 8:23 AMAbbVie to present 29 abstracts at upcoming liver meeting; ABT-493/ABT-530 shows SVR4 of 99% in Phase 2 study
- AbbVie (NYSE:ABBV) announces that 29 abstracts from its HCV programs have been accepted for presentation at the International Liver Congress in Vienna, Austria April 22 - 26.
- Data to be presented include sub-analyses from VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) plus EXVIERA (dasabuvir tablets), Phase 3b studies, including a direct comparison of the company's three direct-acting antiviral treatment with telaprevir-based therapy, Phase 2/3 studies assessing AbbVie's combination treatment in HCV-1 and HCV-4 and Phase 1s of ABT-493 and ABT-530.
- Preliminary results from a Phase 2b trial (n=79) evaluating ABT-493 and ABT-530 in non-cirrhotic HCV-1 patients show a sustained virologic response at four weeks post treatment (SVR4) of 99% (n=78/79). The results include GT1a and GT1b, treatment-naive and pegylated-interferon and RBV prior null responders. Data from this study will not be presented at ILC but will be released at future medical meetings.
- Related tickers: (NYSE:MRK) (NASDAQ:GILD)
Wed, Apr. 8, 7:58 AM
- The FDA designates Merck's (NYSE:MRK) investigational single tablet HCV regimen, grazoprevir/elbasvir, a Breakthrough Therapy (BTD) for the treatment of patients with chronic HCV genotype 4 infection and for the treatment chronic HCV genotype 1 infection in patients with end stage renal disease on hemodialysis.
- In October 2013, the FDA granted BTD status for grazoprevir/elbasvir for the treatment of chronic HCV-1 but rescinded it in January 2015. BTD status provides for more intensive guidance from the FDA, the involvement of more senior managers and a rolling review of the New Drug Application (NDA).
- Separately, Merck will be presenting 14 abstracts from studies evaluating grazoprevir/elbasvir at the upcoming International Liver Congress in Vienna, Austria April 22 - 28.
- Related tickers: (NASDAQ:GILD) (NYSE:ABBV)
Tue, Apr. 7, 8:23 AM
- Merck (NYSE:MRK) and privately-held New Haven, CT-based Arvinas LLC establish a multi-year strategic collaboration to develop novel therapeutics based on Arvinas' PROTAC technology, encompassing multiple disease targets across several therapeutic areas.
- Arvinas will receive an undisclosed upfront payment, up to $434M in milestones and tiered royalties on commercial sales. Merck, at its discretion, may elect to expand the partnership to include additional disease targets. This decision will trigger an additional one-time payment and milestones and royalties on a product specific basis.
- PROTACs (proteolysis-targeting chimeras) are bifunctional small molecules that target proteins for degradation and removal from a cell. They induce a cell's quality control system to bind to a particular protein, "label" it for degradation and remove it. This is a different mechanism of action compared to the traditional approach of inhibiting proteins. Only 25% of the body's 20K proteins can be drugged via traditional methods. Arvinas' technology potentially applies to all proteins.
Wed, Apr. 1, 8:14 AM
- Racing rivals Bristol-Myers Squibb (NYSE:BMY), Merck (NYSE:MRK) and AstraZeneca (NYSE:AZN) for a leadership position in immuno-oncology, Roche (OTCQX:RHHBY) says that finding combination therapies that attack cancer on different fronts would be "extremely important." CEO Severin Schwan confirms that his organization is ready to collaborate with competitors to develop these new treatments. "Partnering is absolutely fundamental," he says.
- Roche, with its robust internal product development capabilities, has not collaborated with other firms as readily as its rivals, choosing instead to acquire. Its most recent deal was buying a majority stake in Foundation Medicine, for example. Its collaboration with Exelixis (NASDAQ:EXEL) is bearing fruit, though. Last month, the FDA accepted their New Drug Application (NDA) under Priority Review for the combination of cobimetinib and Zelboraf (vemurafenib) for the treatment of advanced melanoma.
- Previously: Roche extends expiration of tender offer for Foundation Med shares (March 2)
- Previously: Roche's melanoma combo NDA gets Priority Review (Feb. 19)
Tue, Mar. 31, 12:37 PM
- Former Nomura analyst Amit Roy says the market for cancer immunotherapies called PD-1 inhibitors will only be ~$10B, far below the $20B - 30B forecasts being circulated today. He cites two main factors that could hamper growth: they only work for certain groups of cancer patients plus several layers of selection will be required for some cancers such as breast and colorectal, and there is a growing evidence that shorter therapy, cutting the treatment period to eight from 16 weeks, may be sufficient. If this comes to fruition, it would shrink the market by almost half (although a price increase could mitigate some of the shrinkage).
- PD-1 (programmed cell death protein 1) is found on the surface of cancer cells. It is used by tumors to evade the immune system so blocking its action enables the body to attack and kill cancer.
- Current FDA-approved PD-1 inhibitors are Bristol-Myers Squibb's (BMY -1.2%) Opdivo (nivolumab) and Merck's (MRK -0.7%) Keytruda (pembrolizumab).
- PD-1-related tickers: (MDVN -2.4%)(FPRX -1.2%)(CELG -3.1%)(OTCQX:RHHBY +0.6%)(AZN -1.7%)(SRNE +3.4%)
Tue, Mar. 31, 10:01 AM
- Privately-held Syndax Pharmaceuticals and Merck (MRK -0.4%) enter into a clinical collaboration to evaluate the combination of Syndax's investigational epigenetic therapy, entinostat, with Merck's PD-1 inhibitor, Keytruda (pembrolizumab). A Phase 1b/2 study assessing the combination in patients with either advanced non-small cell lung cancer or melanoma will commence in H2.
- Breakthrough Therapy-designated entinostat is a histone deacetylase (HDAC) inhibitor. HDACs are a class of enzymes that play a key role in regulating gene expression through a chemical modification to DNA-associated proteins called histones. This chemical modification is part of epigenetics, the regulatory system that controls gene expression. HDACs are over-expressed in cancer cells which leads to abnormal gene regulation which leads to uncontrolled cell growth and resistance to cancer therapies.
Fri, Mar. 27, 9:19 AM
- The experimental Ebola vaccines from GlaxoSmithKline (NYSE:GSK) and NewLink Genetics (NASDAQ:NLNK) (NYSE:MRK) appear to be safe, based on interim results in a mid-stage trial in Liberia. The vaccines, administered as a single injection, are being evaluated for safety and efficacy on more than 600 people there. Based on the positive results, the study will now progress to the next phase of efficacy testing where additional volunteers will be injected with one of the vaccines or placebo to see if their immune systems produce anti-Ebola antibodies.
- The Ebola epidemic, its course winding down, has claimed more than 10,000 lives.
Tue, Mar. 24, 5:15 PM
- Merck (NYSE:MRK) has upped its buyback authorization by $10B to $11.7B. That's good for repurchasing 7% of shares at current levels.
- The drug giant still expects its 2015 average diluted share count to be around 2.86B, down from 2014's 2.93B and Q4's 2.88B. It spent $13B returning cash last year via buybacks and dividends.
- MRK +1.2% AH to $59.32.
Tue, Mar. 24, 9:08 AM
- A Phase 3 study (KEYNOTE-006) comparing Merck's (NYSE:MRK) Keytruda (pembrolizumab) to Bristol-Myers Squibb's (NYSE:BMY) Yervoy (ipilimumab) in the first-line treatment of patients with advanced melanoma met its two primary endpoints of statistically significant improvements in progression-free survival (PFS) and overall survival (OS). Based on the recommendation of the independent Data Monitoring Committee, the trial will be stopped early. The results will be presented at the American Association of Cancer Research Annual Meeting in Philadelphia, April 18 - 22.
- The trial randomized 834 patients to receive Keytruda 10 mg/kg every three weeks, Keytruda 10 mg/kg every two weeks or four cycles of Yervoy 3 mg/kg every three weeks. Secondary endpoints were overall response rate, duration of response and safety.
- An earlier Phase 2 comparing the two in advanced melanoma also favored Keytruda. Yervoy is big seller for BMY, generating almost $1B in sales the past four quarters.
- Previously: Merck PD-1 inhibitor extends PFS in melanoma (Nov. 17, 2014)
Mon, Mar. 23, 4:26 PM
- According to Thomson Reuters' 2015 Drugs to Watch report, as many as 11 blockbuster drugs (peak sales of at least $1B within five years) are expected to clear the regulatory process this year. This is a significant jump from 2014's tally of three (Gilead's (NASDAQ:GILD) Sovaldi and Zydelig; Glaxo (NYSE:GSK) and Theravance's (NASDAQ:THRX) Anoro Ellipta). In reverse order (forecasted 2019 consensus sales in parentheses):
- 11. Novartis' (NYSE:NVS) Cosentyx (secukinumab) for psoriasis and psoriatic arthritis ($1.08B); 10. Sanofi's (NYSE:SNY) Toujeo (insulin glargine) for diabetes ($1.26B); 9. Otsuka Pharmaceutical (OTCPK:OTSKY) and Lundbeck's (OTCPK:HLUYY) Brexpiprazole for schizophrenia and depression ($1.35B); 8. Merck's (NYSE:MRK) Gardisil 9 HPV vaccine ($1.64B); 7. Amgen's (NASDAQ:AMGN) evolocumab for hypercholesterolemia/hyperlipidemia ($1.86B); 6. AbbVie's (NYSE:ABBV) Veikira Pak for hepatitis C (cleared 12/19/14) ($2.5B); 5. Vertex Pharmaceuticals' (NASDAQ:VRTX) lumacaftor plus ivacaftor for cystic fibrosis ($2.74B); 4. Pfizer's (NYSE:PFE) Ibrance (palbociclib) for breast cancer ($2.76B); 3. Novartis' LCZ696 for chronic heart failure ($3.73B); 2. Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) for hypercholesterolemia ($4.41B) and 1. Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for melanoma ($5.68B).
Fri, Mar. 13, 4:56 PM
- The FDA cancels its March 18 meeting of the Anesthetic and Analgesic Advisory Committee where it planned to review Merck's (NYSE:MRK) resubmitted New Drug Application (NDA) for sugammadex, a reversal agent for the muscle relaxants rocuronium or vecuronium, used in surgical procedures to facilitate endotracheal intubation and to relax the skeletal muscles during surgery or mechanical ventilation. The agency said that it plans to conduct additional site inspections related to a hypersensitivity study (Protocol 101) and that it wants to complete the inspections prior to an Ad Comm meeting and the completion of its review. Merck expects to receive a Complete Response Letter (CRL) by April 22.
- Merck also received a CRL for its resubmitted NDA for sugammadex in September 2013. In that CRL, the FDA stated that had concerns about operational aspects of a hypersensitivity study that it requested in 2008.
- The FDA issued a CRL in August 2008 to then-owner Schering-Plough stating that it had concerns over hypersensitivity or allergic reactions. The agency's action was unexpected considering an earlier Ad Comm vote unanimously recommending approval.
- Sugammadex was discovered by Organon, which was acquired by Schering-Plough in 2007, which was acquired by Merck in 2009.
Thu, Mar. 12, 3:49 PM
- The FDA accepts for review Bristol-Myers Squibb's (BMY +1.6%) resubmitted New Drug Application (NDA) for daclatasvir in combination with Gilead's (GILD +0.8%) sofosbuvir (Sovaldi) for the treatment of chronic hepatitis C (HCV) genotype 3. BMY amended the original NDA to include data from the Phase 3 ALLY-3 study which showed high cure rates for the regimen, with sustained virologic response 12 weeks after treatment (SVR12) in 90% of treatment-naive and 86% of treatment-experienced HCV-3 patients. The FDA will review the submission within a six-month time frame.
- HCV-3 is the second most common HCV genotype after HCV-1, affecting over 54M people worldwide compared to over 83M for HCV-1. HCV-3 is generally more aggressive and carries a higher risk of hepatocellular carcinoma (liver cancer).
- Daclatasvir is an nonstructural protein 5A (NS5A) replication complex inhibitor. The precise mechanism of action is unknown, but it is suspected that it deregulates the relationship between NS5A and intracellular HCV replication sites.
- Related tickers: (ABBV +2.4%)(MRK +0.1%)(ACHN +0.8%)(RGLS -3%)
Wed, Mar. 11, 10:56 AM
- Biotech investors, giddy over the robust demand for hepatitis C drugs like Gilead's (GILD +0.4%) Sovaldi and Harvoni, are eagerly anticipating the next wave of new therapies for non-alcoholic steatohepatitis (NASH) or "fatty liver disease." It resembles the alcoholic variety but affects people who drink little or no alcohol. According to the NIH, it affects 2 - 5% of Americans.
- Publicly-traded companies with NASH-related development programs include: Tobira Therapeutics (RGDO +2.3%), Islet Sciences (OTCQB:ISLT), Merck (MRK -0.5%), Intercept Pharmaceuticals (ICPT +3.4%), Gilead Sciences, Shire plc (SHPG -0.6%), Galectin Therapeutics (GALT), La Jolla Pharmaceutical (LJPC -1.5%), Conatus Pharmaceuticals (CNAT -1.2%), Raptor Pharmaceutical (RPTP -1.3%), Galmed Pharmaceuticals (GLMD +1.9%) and Genfit (OTCPK:GNFTF).
- TheStreet's Adam Feuerstein says that comparing clinical trial results between firms will require scrutiny because of differences in the designs of the studies, including efficacy criteria and treatment duration. In an article published today, he compares the ongoing trials of Genfit and Intercept. Genfit's efficacy endpoint of its mid-stage study is less stringent than Intercept's but it may make it more difficult to demonstrate a statistically significant benefit versus placebo. Results from Genfit's trial are expected later this month. If positive, it should rally NASH-related stocks.
Wed, Mar. 11, 7:28 AM
- Merck's (NYSE:MRK) PD-1 inhibitor Keytruda (pembrolizumab) is now available in the U.K. despite not having an approved Marketing Authorization Application (MAA) by the European Medicines Agency (EMA). The cancer immunotherapeutic is the first treatment to be accepted under the U.K.'s new Early Access to Medicines Scheme (EAMS) for the treatment of advanced melanoma based on the significance of early study results and unmet medical need. Pembrolizumab received the Promising Innovative Medicine (PIM) designation in the U.K. in October 2014.
- Last year, the U.K. Medicines and Healthcare Products Regulatory Authority (MHRA) introduced EAMS to order to provide patients access to promising, innovative treatments before an MAA has been granted. Under the voluntary program, the MHRA gives a scientific opinion of the benefit/risk profile of the treatment, based on the data submitted to EAMS. The opinion is valid for one year and can be renewed.
- Pembrolizumab's MAA is currently under review by the EMA.
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