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News Breaks
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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February 25, 2015
12:54 EDTNVSPharmacyclics exploring options including sale, Bloomberg reports
According to sources, Pharmacyclics (PCYC), which develops cancer treatments, is currently exploring options, Bloomberg reports. One option may include a sale of the company, and the sources say Johnson & Johnson (JNJ) and Novartis (NVS) have expressed interest in the company. Pharmacyclics could fetch $17B-$18B in a sale, the sources add. Reference Link
12:53 EDTNVSPharmacyclics weighing sale to U.S. drugmaker, Bloomberg reports
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12:13 EDTNVSGlaxoSmithKline sees Novartis transaction closing next week
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08:08 EDTMRKMerck to present new data from IMPROVE-IT, TRA 2ºP studies
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08:07 EDTNVSNovartis' Farydak myeloma drug approved by FDA, to be distributed by Diplomat
Novartis' (NVS) drug Farydak for the treatment of patients with multiple myeloma Diplomat Pharmacy has been approved by the FDA. The drug is now a treatment option for patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent. Farydak will be distributed by Diplomat Pharmacy (DPLO).
February 24, 2015
16:19 EDTNVSAratana Therapeutics to pay Elanco up to $3M to regains rights to AT-004
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05:17 EDTMRKMerck collaborates with Medicines Patent Pool to expand Raltegravir access
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February 23, 2015
15:00 EDTNVSFDA approves Farydak for treatment of multiple myeloma
The FDA approved Farydak for the treatment of patients with multiple myeloma, a form of blood cancer that arises from plasma cells, a type of white blood cell, found in bone marrow. Farydak is the first HDAC inhibitor approved to treat multiple myeloma. It is intended for patients who have received at least two prior standard therapies, including bortezomib and an immunomodulatory agent. Farydak is to be used in combination with bortezomib, a type of chemotherapy, and dexamethasone, an anti-inflammatory medication. Farydak is marketed by Novartis.
13:40 EDTNVSAnalysts clash on Spectrum outlook after patent suit setback
Two research firms had divergent views on Spectrum Pharmaceuticals (SPPI) after a judge ruled that a drug which could compete with the company's Fusilev treatment does not infringe on the company's intellectual property. BACKGROUND: Late Friday, a federal judge ruled that Novartis' (NVS) levoleucovorin, a generic version of Spectrum's Fusilev, does not infringe on Spectrum's intellectual property. Fusilev is indicated after high-dose methotrexate therapy in osteosarcoma, a type of cancer that starts in the bones. It is also used to treat patients with advanced metastatic colorectal cancer. BEARISH TAKE: Roth Capital analyst Joseph Pantginis downgraded Spectrum to Neutral from Buy following the ruling, as he believes the risk to the company's revenue has risen. The company is meaningfully less likely to become profitable again, wrote Pantginis, noting that Fusilev accounted for about 50% of the company's product revenue. According to the analyst, Spectrum is becoming increasingly focused on developing its earlier stage drugs, and he expects those drugs to grow slowly. Pantginis slashed his price target on the shares to $7 from $15. BULLISH TAKE: In a note to investors earlier today, Reni Benjamin, an analyst at research firm H.C. Wainwright, wrote that the stock's plunge after the judge's ruling "creates a table-pounding buying opportunity," noting that Fusilev has been granted exclusivity as a colorectal treatment until 2018. Benjamin does not expect the company's revenue from Fusilev to decline at all until 2018, as a citizen's petition submitted by Spectrum to the FDA, along with an appeal the company is mounting to Friday's ruling, and the difficulty that Novartis will have launching its version of the drug while the appeal is ongoing, will help prevent Spectrum's revenue from dropping. Also likely to protect Spectrum's revenue are the strong relationships that the company has developed with hospitals and community doctors, the analyst stated. He kept a $15 price target and Buy rating on the shares. PRICE ACTION: In mid-afternoon trading, Spectrum tumbled $1.44, or 19.3% to $6.02.
12:21 EDTNVSOn The Fly: Midday Wrap
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11:17 EDTNVSFTC puts conditions on Novartis's proposed acquisition of GSK oncology drugs
According to the FTC, Global pharmaceutical company Novartis (NVS) has agreed to divest all assets related to its BRAF and MEK inhibitor drugs, currently in development, to Boulder, Colorado-based Array BioPharma (ARRY) to settle charges that Novartis’s $16B acquisition of GlaxoSmithKline’s (GSK) portfolio of cancer-treatment drugs would likely be anticompetitive...If the acquisition goes forward as proposed, Novartis would likely delay or terminate development of both its BRAF and MEK inhibitors, as well as the combination product. For that reason, Novartis’s acquisition of GSK’s portfolio of cancer-treatment drugs would likely cause significant competitive harm in the U.S. markets for both the BRAF and MEK inhibitors, ultimately raising prices for consumers and depriving them of potentially superior products. Under the terms of the proposed consent agreement, Novartis is required to provide transitional services to Array BioPharma to ensure that development of the BRAF and MEK inhibitors continues uninterrupted and that competition in BRAF and MEK inhibitor markets is not reduced. Reference Link
08:27 EDTMRKNGM Biopharmaceuticals to hold a teleconference
NGM Biopharm discusses the strategic collaboration with Merck to discover, develop and commercialize novel biologic therapeutics on a teleconference to be held on February 23 at 9:30 am. Webcast Link
07:14 EDTNVSSpectrum says plans to appeal patent suit loss to Novartis unit
Spectrum Pharmaceuticals (SPPI) confirmed in a regulatory filing that on February 20, the U.S. District Court for the District of Nevada ordered that judgment be entered in favor of defendant Sandoz in the matter entitled Spectrum Pharmaceuticals, Inc. et al v. Sandoz Inc. "Spectrum Pharmaceuticals Inc. intends to appeal this decision and the ultimate outcome of this litigation remains uncertain," the company stated. Sandoz is the generic pharmaceuticals division of Novartis (NVS).
07:04 EDTMRKMerck, NGM Biopharmaceuticals announce multi-year collaboration
NGM Biopharmaceuticals and Merck announced they have entered into a multi-year collaboration to research, discover, develop and commercialize novel biologic therapies across a wide range of therapeutic areas. This agreement will become effective upon the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The collaboration includes multiple drug candidates currently in preclinical development at NGM, including NP201, which is being evaluated for the treatment of diabetes, obesity and nonalcoholic steatohepatitis. NGM will lead the research and development of the existing preclinical candidates and have the autonomy to identify and pursue other discovery stage programs at its discretion. Merck will have the option to license all resulting NGM programs following human proof of concept trials. If Merck exercises this option, Merck will lead global product development and commercialization for the resulting products, if approved. Under the terms of the agreement, Merck will make an upfront payment to NGM of $94M and will purchase a 15 percent equity stake in NGM for $106M at a price per share that represents a 20% premium to NGM’s most recent financing. Merck will commit up to $250M to fund all of NGM’s efforts under the initial five-year term of the collaboration, with the potential for additional funding if certain conditions are met. Prior to Merck initiating a Phase 3 study for a licensed program, NGM may elect to either receive milestone and royalty payments or, in certain cases, to co-fund development and participate in a global cost and revenue share arrangement of up to 50%. The agreement also provides NGM with the option to participate in the co-promotion of any co-funded program in the United States. Merck will have the option to extend the research agreement for two additional two-year terms.
February 20, 2015
07:08 EDTNVS, MRKAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.
February 19, 2015
08:38 EDTMRKNewLink reports clinical development milestone achieved with Merck for rVSV-EBOV
NewLink Genetics (NLNK) announced that it had received notification from Merck (MRK) that the milestone event specified in the license and collaboration agreement between the two companies relating to the further development of the rVSV-EBOV, Ebola, vaccine candidate had been achieved. Under the terms of the agreement, NewLink Genetics will receive a payment of $20M in connection with the achievement of the milestone. The milestone pertains to the initiation of a key clinical trial for the vaccine.
07:12 EDTNVSWharton Health Care Club to hold a conference
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February 13, 2015
11:31 EDTNVSNovartis says heart failure medicine LCZ696 granted FDA piority review
Novartis announced that the U.S. FDA has granted priority review designation to LCZ696, an investigational medicine for the treatment of heart failure with reduced ejection fraction. The designation accelerates the review of therapies that offer a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious condition[4]. For LCZ696 this reduces the total review time from 12 to 8 months, meaning the FDA could make a decision on approval in August 2015. The New Drug Application was submitted under the agency's Fast Track program and is based on results from the landmark PARADIGM-HF study, the largest ever conducted in heart failure, which showed LCZ696 was superior to ACE-inhibitor enalapril on key endpoints, including significantly reducing the risk of CV death or heart failure hospitalization. Patients' reports of how well they felt were significantly better with LCZ696 than enalapril, whilst maintaining an acceptable safety profile. In the EU the Committee for Medicinal Products for Human Use has granted accelerated assessment to LCZ696.
08:23 EDTNVSPiper Jaffray biotech/healthcare analysts hold analyst/industry conference call
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08:19 EDTMRKAckman noncommittal on McDonald's rumors, Bloomberg reports
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