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March 31, 2014
13:41 EDTNVS, MRKNovartis rises after committee recommends early closure of study
Shares of drug maker Novartis (NVS) are climbing after the Data Monitoring Committee of its PARADIGM-HF study, which tested LCZ696 in comparison to patients who received standard care with enalapril, unanimously recommended early closure of the trial due to the drug's efficacy. WHAT'S NEW: Novartis announced that the committee unanimously recommended early closure of the study, indicating patients with chronic heart failure with reduced ejection fraction who received LCZ696 lived longer without being hospitalized for heart failure than those who received standard care with ACE-inhibitor enalapril. Based on the compelling efficacy and primary endpoint having been met, the trial was closed early. This follows two previous interim analyses that showed the safety profile of LCZ696 was acceptable. One of the two principal investigators, Dr. Milton Packer, said, "The finding that treatment with LCZ696 was superior to currently recommended doses of enalapril has profound implications for the care of patients with chronic heart failure. We now have compelling evidence that supports LCZ696 as a new cornerstone in the management of chronic heart failure." The company said the results of PARADIGM-HF will be submitted to a major medical conference for presentation and Novartis will now initiate discussions with global health authorities regarding approval for marketing. WHAT'S NOTABLE: Novartis said that the PARADIGM-HF study was initiated in December 2009 and currently is the largest clinical trial in heart failure ever undertaken. LCZ696 is a medicine that acts in multiple ways on the neurohormonal systems of the heart, blocking receptors exerting harmful effects while simultaneously promoting protective mechanisms. LCZ696 is thought to reduce the strain on the failing heart, promoting the ability of the heart muscle to recover. LCZ696 is the second treatment being developed by Novartis for patients with heart failure, along with RLX030 for acute heart failure. The standard ACE-inhibitor enalapril has been marketed as VASOTEC in the U.S. by Merck (MRK). Several companies sell generic enalapril under the name enalapril maleate tablets. PRICE ACTION: During afternoon trading, shares of Novartis were up by $3.31 or 4%, to $84.90.
News For NVS;MRK From The Last 14 Days
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September 18, 2014
08:48 EDTMRKNeogen's dairy genomic program to be marketed by Merck
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September 17, 2014
09:33 EDTMRKMerck announced positive results from Phase 3 data for omarigliptin
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08:31 EDTMRKMerck, Sun Pharma enter into licensing agreement for Tildrakizumab
Merck and Sun Pharmaceutical Industries, through their respective subsidiaries,announced an exclusive worldwide licensing agreement for Merck’s investigational therapeutic antibody candidate, tildrakizumab, which is currently being evaluated in Phase 3 registration trials for the treatment of chronic plaque psoriasis, a skin ailment. Under terms of the agreement, Sun Pharma will acquire worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of $80M. Merck will continue all clinical development and regulatory activities, which will be funded by Sun Pharma. Upon product approval, Sun Pharma will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product. Merck is eligible to receive undisclosed payments associated with regulatory and sales milestones, as well as tiered royalties ranging from mid-single digit through teen percentage rates on sales. The transaction is subject to customary closing conditions, including the requirements under the Hart Scott-Rodino Antitrust Improvements Act.
September 16, 2014
07:31 EDTNVS, MRKEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
07:25 EDTMRKMerck price target raised to $72 from $62 at SunTrust
After meeting with Merck's CEO and head of clinical development, SunTrust increased its price target on the company as the firm thinks that it is ideally positioned across five of the fastest growing therapeutic classes. The firm believes that the company's EPS growth rates from 2015-2020 will be three percentage points above Street estimates, while it has a first-mover advantage in oncology. It keeps a Buy rating on the shares.
September 15, 2014
13:30 EDTMRKMerck announces data from pivotal Phase 3 study for odanacatib
Merck announced data from the pivotal Phase 3 fracture outcomes study for odanacatib in postmenopausal women with osteoporosis. Odanacatib is Merck’s investigational once-weekly cathepsin K inhibitor. In the Long-Term Odanacatib Fracture Trial, odanacatib met its primary endpoints and significantly reduced the risk of osteoporotic hip, spine and non-vertebral fractures compared with placebo. The rates of adverse events overall in LOFT were generally balanced between patients taking odanacatib and placebo. Adjudicated events of morphea-like skin lesions and atypical femoral fractures occurred more often in the odanacatib group than in the placebo group. Adjudicated major adverse cardiovascular events were generally balanced overall between the treatment groups. There were numerically more adjudicated stroke events with odanacatib than with placebo.
07:27 EDTNVSIBC Life Sciences to hold a conference
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07:21 EDTNVSHeart Failure Society of America to hold annual meeting
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September 12, 2014
05:18 EDTNVSNovartis announces new data confirms high efficacy of Gilenya in achieving NEDA
Novartis announced new analyses presented at the Joint ACTRIMS-ECTRIMS Meeting in Boston, USA, which confirmed the high efficacy of Gilenya in achieving 'no evidence of disease activity', or NEDA, in people with relapsing-remitting multiple sclerosis, or RRMS, across four key disease measures - relapses, MRI lesions, brain shrinkage and disability progression. Specifically, patients taking Gilenya had a more than four-times greater likelihood of achieving NEDA across these four key measures. NEDA is currently defined as having no relapses, MRI lesions and disability progression. These new analyses from the phase III FREEDOMS and FREEDOMS II trials reinforce the value of including brain shrinkage to the definition of NEDA. The inclusion of brain shrinkage into the NEDA definition would allow physicians to obtain a more complete assessment of a patient's disease, including the underlying damage in MS.
September 10, 2014
16:00 EDTMRKOptions Update; September 10, 2014
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05:17 EDTNVSNovartis Gilenya data confirms reducing brain shrinkage matter for MS patients
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September 9, 2014
07:55 EDTNVSOphthotech earlier than expected Novartis payment positive, says Oppenheimer
After Ophthotech (OPHT) received a $50M Phase 3 enrollment payment from Novartis (NVS) earlier than expected, Oppenheimer thinks the payment highlights an underappreciated stock driver for Opthotech, and demonstrates that recent suggestions of Phase 3 enrollment timelines possibly slipping are unwarranted. The firm believes the company is executing well on the Fovista Phase 3 program and keeps an Outperform rating on the stock.
September 8, 2014
16:00 EDTMRKOptions Update; September 8, 2014
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09:27 EDTNVSLeerink biotech analyst holds a luncheon meeting with a conference call
Biotech Analyst Schwartz provides an update on key trends and controversies for marketed MS therapies and discusses new data presented at ACTRIMS-ECTRIMS at a Luncheon Meeting with an Analyst/Industry conference call to be held in Boston on September 11 at 12:15 pm.
08:38 EDTNVSMerus Labs acquires Sintrom from Novartis
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07:33 EDTNVSOphthotech achieves $50M milestone under ex-agreement with Novartis for Fovista
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