Key Developments: Novartis AG (NOVN.VX)

NOVN.VX on Virt-X Level 1

27 Aug 2014
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Latest Key Developments (Source: Significant Developments)

France's competition authority investigates Roche Holding AG and Novartis AG in relation to eye disease treatments - Reuters
Wednesday, 9 Apr 2014 08:00pm EDT 

Novartis AG:France's competition authority is investigating Roche and Novartis on suspicion they were involved in anti-competitive practices in relation to eye disease treatments - Reuters.This is second time in as many months that Swiss drugmakers have faced regulatory scrutiny over treatments for wet age-related macular degeneration (AMD)- cause of blindness among elderly.Last month, prosecutors in Rome opened investigation into four executives at Swiss drugmakers on suspicion of fraud and manipulation of pharmaceutical market, according to judicial sources.Earlier in March, Italy's antitrust authority said Roche and Novartis colluded to try to stop cancer drug Avastin from being used to treat AMD and fined companies 182.5 million euros ($254.2 million).Regulator accused firms of striking alliance to prevent distribution of Roche's Avastin in favour of the more expensive drug Lucentis made by Novartis.  Full Article

FDA Advisory Committee votes against approval for Novartis AG's RLX030
Thursday, 27 Mar 2014 05:08pm EDT 

Novartis AG:Announces US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted against approval for RLX030 (serelaxin) for treatment of acute heart failure (AHF.Data presented included phase II and III efficacy and safety data from the RLX030 clinical development program, including pivotal phase III RELAX-AHF study.In this study RLX030 improved symptoms of acute heart failure (AHF) through reducing rate of worsening heart failure, measure of symptom deterioration that requires intensification of therapy.RLX030 under review to improve symptoms of AHF through reduction of rate of worsening of heart failure.  Full Article

Novartis AG study published in NEJM shows LDK378 demonstrates overall response rate of 58 pct in patients with ALK+ NSCLC
Wednesday, 26 Mar 2014 05:00pm EDT 

Novartis AG:Announces New England Journal of Medicine (NEJM) published clinical trial results showing investigational compound LDK378 (ceritinib) achieved overall response rate of 58 pct.Says LDK378 median progression-free survival (PFS) of seven months in adults with advanced anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) who received 400 mg or higher of LDK378 per day.Study evaluated 114 ALK+ NSCLC patients treated with LDK378, including patients who had progressed during or following treatment with commonly prescribed ALK inhibitor called crizotinib and those who had not received prior treatment with an ALK inhibitor.This study is part of ongoing Novartis clinical trial program in this patient population.Says most frequent adverse events were nausea (82 pct), diarrhea (75 pct), vomiting (65 pct), fatigue (47 pct) and increased alanine aminotransferase levels (35 pct).  Full Article

New phase III psoriasis data show rapid, significant skin clearance and convenient administration with Novartis AG' secukinumab
Saturday, 22 Mar 2014 02:15am EDT 

Novartis AG:Announces results from pivotal phase III FEATURE and JUNCTURE studies showing secukinumab (AIN457), interleukin-17A (IL-17A) inhibitor, demonstrated consistent high efficacy when administered with convenient pre-filled syringe (PFS) or autoinjector/pen (AI).These results, along with patient-reported outcomes showing high patient satisfaction with PFS and AI 3,4, are being presented for first time at 72nd annual meeting of the American Academy of Dermatology (AAD) in Denver, USA.In both studies more secukinumab 300 mg patients experienced almost clear skin, described as Psoriasis Area and Severity Index 90 (PASI 90), at Week 12 (60.3 pct. for FEATURE and 55 pct. for JUNCTURE, p <0.0001) compared to placebo.PASI 90 is considered best evidence of efficacy, and a more robust measure of the extent of skin clearance compared to standard efficacy measures that have been used in most psoriasis clinical studies, such as PASI 75.  Full Article

Novartis AG announces FDA approval of Xolair (omalizumab) for chronic idiopathic urticaria
Friday, 21 Mar 2014 02:59pm EDT 

Novartis AG:Says the US Food and Drug Administration (FDA) for the treatment of chronic idiopathic urticaria, a form of chronic hives.Xolair is the first medicine approved by the FDA for CIU since H1-antihistamines.  Full Article

Novartis AG acquires CoStim Pharmaceuticals, Inc. for undisclosed amount
Monday, 17 Feb 2014 06:31am EST 

MPM Capital and Atlas Venture:Says portfolio company CoStim Pharmaceuticals, Inc. has been acquired by Novartis for an undisclosed amount.CoStim, founded in 2012 by MPM Managing Director Luke Evnin together with MPM Managing Director-Operations Robert Millman.Says MPM provided the initial capital to found CoStim, and later co-led the formal Series A investment in early 2013 with Atlas Venture.  Full Article

Morphosys AG gets payment from Novartis for trials in anti-inflammatory program
Monday, 17 Feb 2014 01:31am EST 

Morphosys AG:Says received payment from Novartis in connection with the clinical trial application (CTA/IND) and projected initiation of a phase 1 clinical trial.The HuCAL-derived, fully human antibody will be developed in the therapeutic area of inflammatory diseases.  Full Article

Novartis AG to cut or transfer up to 4,000 pharma jobs - Reuters
Sunday, 2 Feb 2014 05:34am EST 

Novartis AG:Newspaper NZZ am Sonntag reported on Feb. 2, 2014 citing an internal email that Novartis AG is planning to cut or transfer up to 4,000 jobs - Reuters.Says the plan affecting up to 6 percent of its pharmaceuticals workforce comes on top of a programme to reduce the number of production sites and is part of a larger drive to cut costs.The paper said that part of the 4,000 jobs will be transferred to India, where Novartis rented an office building able to house 8,000 employees in Hyderabad.  Full Article

Novartis AG gives FY 2014 revenue guidance in line with analysts' estimates - Conference Call
Wednesday, 29 Jan 2014 08:00am EST 

Novartis AG:Expects FY 2014 net sales to grow low to mid-single digit in constant currencies.The company reported revenue of $57.92 billion in FY 2013.FY 2014 revenue of $59.06 billion - Thomson Reuters I/B/E/S.  Full Article

Novartis AG proposes final dividend
Wednesday, 29 Jan 2014 01:00am EST 

Novartis AG:Proposes a dividend payment of 2.45 Swiss Francs per share for 2013, up 7 pct from 2.30 Swiss Francs per share in 2012, representing the 17th consecutive dividend increase since the creation of Novartis in December 1996.  Full Article


No biotech copycat drug lift off before 2017: Novartis CEO

BASEL Switzerland - Swiss drugmaker Novartis AG does not expect copycat versions of biotech drugs to play an important role in the healthcare system for another three to five years, its chief executive said on Monday.

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