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The FDA's Oncologic Drugs Advisory Committee Will Likely Vote Against Novartis' Panobinostat
- Panobinostat did not distinguish itself as being more effective than standard care in its pivotal Phase III trial, the only data being considered.
- In fact, results showed an increased risk of death and serious side effects when adding panobinostat to standard care.
- However, a rejection will likely not move the share price.
- Novartis' third quarter operating results indicated continued pricing strength despite ongoing patent losses and pressure from generics, with growing revenues in emerging markets.
- The company's pipeline remains robust, and I expect the company's upcoming LCZ696 heart failure medication to add incrementally to both top and bottom lines, though management soft-pedaled revenue expectations.
- I view shares as fairly valued currently, but with the stock offering the prospect of solid high single-digit to double-digit returns in the future, I am considering it for purchase.
Novartis LCZ696: 'New Wonder Drug' OR 'Old Paradigm With Reduced Side Effects'
- Back in 2012, study results, for Novartis’ new drug Serelaxin, for treatment of heart failure, were announced with a good deal of fanfare.
- Like Serelaxin, results for Novartis’ new drug for heart failure, LCZ696, have been announced with a great deal of publicity. The media reports have similarities to those for Serelaxin.
- In March 2014, an FDA committee questioned the design and outcomes of the Serelaxin trial, and unanimously rejected approval of the drug.
- While I believe the case for LCZ696 is far stronger than the Serelaxin case ever was, the title of this article reflects concerns and reservations reflected in the article below.
- Novartis’s investigational heart failure medicine has been found to be superior to current standard of care.
- LCZ696 has the potential to be a blockbuster drug.
- Based on my assumptions, the drug is worth around $5.5 billion or $2.20 per share.
- If LCZ696 is approved for treatment of heart failure patients with preserved ejection fraction, the drug could be worth $8.1 billion, or $3.3 per share.
- The new cardiovascular drug by Novartis indicated a 16% improvement in the survival rate compared to the generic drug’s performance.
- The drug testing also indicated a 21% reduced risk of hospitalization compared to the generic rival.
- According to the WHO, cardiovascular diseases are a leading cause of death across the globe and are responsible for as much as 17.3 million deaths worldwide.
- The market for cardiovascular monitoring and diagnostic devices is expected to increase at a CAGR of 9.7%.
- Novarits’s experimental drug is showing remarkable efficiency as it reduces the risk of dying from cardiovascular diseases and the risk of being hospitalized for worsening heart failure by around 20%.
- The drug will provide Novartis with a large customer base due to the high incidence rate of heart failure, the drug’s effectiveness and the competition-free environment.
- Novartis’s portfolio transformation and its achievements in the second quarter will further strengthen the company consequently increasing its revenue growth and the operating margin.
- Novartis’s current financial position is also quite strong as its per share earnings grew 4% and its free cash flow grew 38% year-over-year in the latest reported quarter.
Novartis' LCZ696: A New Paradigm For Heart Failure Treatment
- Results of the PARADIGM-HF trial showed excellent results for Novartis' novel heart failure medication, which promises to utterly replace ACE inhibitors and angiotensin receptor blockers for certain patients.
- With prevalence and incidence of heart failure increasing around the world, Novartis' potential market for the medication numbers in the millions, and sales of the drug could hit $6 billion.
- The article discusses a fair value estimate for Novartis, with a base case as well as a case taking into account this potential additional revenue.
- Nominal health care spending is expected to nearly double in the next decade due to the evolving pharmaceutical industry.
- The drug developed by Novartis which reduced cardiovascular deaths by 20% improved Novartis’s chance to add a multi-billion dollar product to its pipeline.
- Novartis is going to invest $35 million in Gamida cells in exchange for a 15% equity stake and the option to fully acquire the company.
- Novartis is a company with a strong financial position and attractive valuation.
Novartis: The Case Of The Undervalued Biosimilar Pioneer
- Which mistake healthcare investors often make, and how to avoid it.
- Which are the main future trends in this sector?
- Generics/Biosimilars - which is the best option?
Novartis - Outstanding Strategic Initiatives Rendering The Sluggish Growth Irrelevant
- Some of Novartis’ bestselling products under performed over the quarter as they lost patent protection.
- The company is betting on its new multiple sclerosis drug Gilenya to propel the top line growth into the future.
- Novartis’ Vaccines and Diagnostics division is to be sold to GlaxoSmithKline for $7.1 billion while Novartis intends to add GSK’s oncology department to its portfolio in exchange for $16 billion.
- Novartis and GSK are to join hands and establish a leading consumer healthcare business.
- Novartis is divesting its Animal Healthcare department to Eli Lilly for proceeds of $5.4 billion.
Novartis: Will Restructuring Prove Fruitful For The Company?
- Novartis is undergoing a transformation as it enters deals with GSK and Eli Lilly.
- Novartis is going to buy GlaxoSmithKline’s oncology unit for $14.5 billion.
- The oncology market has huge potential and acquiring GSK’s oncology assets will bode well for Novartis.
- Novartis is selling its animal healthcare segment to Eli Lilly in a $5.4 billion deal.
- These multibillion dollar deals will help Novartis focus on its global scale business more acutely.
Novartis' Lead Ceritinib Could Capture Market Share From Pfizer
- Novartis A.G. and worldwide collaborators published results of their Phase I clinical trial of the ALK inhibitor Ceritinib (LDK378) in the New England Journal of Medicine on March 27.
- Ceritinib is 20X more potent than Crizotinib, more selective, has a similar side-effect profile and offers a second chance when Crizotinib resistance develops.
- Two follow-up Phase II clinical trials are fully enrolled and in progress and two more Phase III trials are currently enrolling.
- In 2013, Crizotinib did $282m in sales and should do $1.2bn in 2017. Huge potential exists if Novartis’ Ceritinib can get 1st line indication against NSCLC and worldwide rights.
Novartis: 2 Novel Cancer Therapies Show Promising Results
Today, 3:48 PM
- The Federal Trade Commission approves GlaxoSmithKline's (GSK +0.4%) proposed acquisition of Novartis' (NVS +0.6%) vaccines business and the proposed creation of a consumer healthcare joint venture between the two firms.
- As a condition of the positive vote, Novartis will divest its private label nicotine replacement therapy transdermal patch, Habitrol, in the U.S. to Dr. Reddy's Laboratories SA (RDY +1.5%).
Yesterday, 8:18 AM
- Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
- Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
- Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (NYSE:NVS) (NYSE:AZN) (NASDAQ:AMGN) (NASDAQ:BIIB) (NASDAQ:CELG) (NYSE:LLY) (NYSE:SNY) (NYSE:ABT) (NYSE:ABBV) (NYSE:BMY) (NYSE:MRK) (NYSE:GSK)
Yesterday, 7:10 AM
- The FDA extends its priority review period by up to three months for Novartis' (NYSE:NVS) panobinostat in combination with bortezomib and dexamethasone for the treatment of patients with previously treated multiple myeloma.
- The company submitted the NDA in March 2014. The FDA granted priority review status in May which reduced the standard 12-month review period to eight months. The extension follows the Oncologic Drugs Advisory Committee meeting earlier this month which voted 5-2 that the the benefits of panobinostat do not outweigh the risks.
- Previously: Ad Comm votes against panobinostat
Mon, Nov. 24, 8:18 AM
- The European Commission approves Novartis' (NYSE:NVS) Signifor (pasireotide) for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadaquately controlled on treatment with a first-generation somatostatin analogue (SSA).
- The once monthly injection directly targets the pituitary tumor and gives patients an alternative treatment option for those who are inadaquately controlled by SSAs.
- Signifor is currently approved in over 60 countries for the treatment of Cushing's disease.
Mon, Nov. 24, 8:02 AM
- The European Commission approves AstraZeneca's (NYSE:AZN) Duaklir Genuair (aclidium bromide/formoterol fumarate 340/12 mcg) for the maintenance bronchodilator treatment in adults with chronic obstructive pulmonary disease (COPD).
- The product is a fixed dose combination of two approved long-acting bronchodilators with different mechanisms of action. Aclidium bromide is an anticholinergic or long-acting muscarinic antagonist that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a long-acting beta-agonist that stimulates the B2-receptors in the bronchial smooth muscle resulting in bronchodilation. Both are currently approved as stand-alone therapies for the maintenance treatment of COPD in the U.S. and Europe.
- Genuair is a multi-dose pre-loaded dry powder inhaler that utilizes optical and acoustic signals to inform the patient that the correct dose has been delivered.
- COPD-related tickers: (NYSE:GSK) (NYSE:NVS) (NASDAQ:THRX) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
Mon, Nov. 24, 7:05 AM
- On December 18 GlaxoSmithKline (NYSE:GSK) shareholders will vote on the company's planned acquisition of Novartis' (NYSE:NVS) vaccines business, the latter's acquisition of Glaxo's cancer products and the combination of their consumer healthcare businesses. The total value of the assets involved is ~$20B.
- Previously: Novartis announces billions of dollars in deals with GSK, Eli Lilly
- Previously: Why Glaxo bids adieu to cancer drugs
Fri, Nov. 21, 7:19 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting regulatory approval for Novartis' (NYSE:NVS) secukinumab for the first-line systemic treatment of adult patients with moderate-to-severe plaque psoriasis. A final decision by the European Commission usually takes about 60 days.
- Secukinumab is an interleukin-17A inhibitor and will be sold under the brand name Cosentyx. It will compete with Amgen's (NASDAQ:AMGN) Enbrel (etanercept) which generated $4.6B in sales the past four quarters. In clinical trials, secukinumab demonstrated superiority to etanercept in skin clearance measurements.
- Last month, an FDA advisory committee voted unanimously in favor of approval for secukinumab for the same indication.
- Previously: Ad Comm backs approval of secukinumab
Tue, Nov. 18, 7:47 AM
- At this week's American Heart Association meeting in Chicago, Novartis (NYSE:NVS) presented additional data on its heart failure drug candidate, LCZ696, compared to the ACE inhibitor enalapril.
- LCZ696, an ARNI inhibitor, demonstrated a 20% reduced risk of dying suddenly; reduced first and subsequent HFrEF (heart failure with reduced ejection fraction) hospitalizations by 21% and 23%, respectively; reduced hospitalizations for a cardiovascular reason or by any reason both by 16%; reduced the need for more intense treatment at home by 16% and reduced emergency room visits due to rapid symptom worsening by 30%.
- The hospitalization periods for LCZ696 and enalapril were similar, but patients receiving LCZ696 had 18% fewer stays in intensive care and were 31% less likely to need IV drugs to help their heart pump.
- LCZ696 is a twice a day medicine being investigated for heart failure. Its mode of action enhances the protective neurohormonal systems of the heart while simultaneously suppressing the harmful system ((RAAS)). Current drugs only block the harmful effects so mortality remains high with up to 50% of patients dying within five years of a heart failure diagnosis.
- The company expects to complete its PMA submission to the FDA by the end of 2014 and its MAA to Europe's EMA in early 2015.
Sat, Nov. 15, 5:11 PM
- More than 60% of secukinumab 150mg patients achieved significant improvements in ankylosing spondylitis (AS) symptoms, seen as early as Week 1 and sustained through one year of treatment.
- Primary endpoint measure 1: 60.8% and 59.7% for secukinumab 150mg and 75mg, respectively, vs. 28.7% for placebo.
- Primary endpoint measure 2: 61.1% and 41.1% for secukinumab 150mg and 75mg, respectively, vs. 28.4% for placebo.
- Secukinumab is the first selective IL-17A inhibitor to significantly improve signs and symptoms of AS versus placebo in Phase III studies.
- AS is a common type of spondyloarthritis, a family of long-term, inflammatory diseases impacting joints, which affects up to 1% of the general population.
- Source: press release
Thu, Nov. 13, 11:56 AM
- The FDA's Anesthetic and Analgesic Drug Products Advisory Committee meets on November 24, 25 to discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also review the efficacy of ESI and the overall risk benefit profile of injecting steroids in the epidural space to treat pain. Regulatory options will also be discussed which could include changes to product labeling.
- Briefing doc
- Related tickers: (MRK +0.7%)(PFE +0.2%)(BMY -1.3%)(NVS +2%)
Wed, Nov. 12, 1:13 PM
- The FDA's Ophthalmic Devices Panel of the Medical Devices Advisory Committee meets tomorrow to discuss Alcon Laboratories' (NVS -0.1%) premarket approval application (PMA) for its AcrySof IQ ReSTOR Multifocal Toric Posterior Chamber Intraocular Lens. The applied-for indication is the visual correction of aphakia and pre-existing astigmatism secondary to removal of a cataractous lens in adult patients with and without presbyopia.
- Briefing doc
Tue, Nov. 11, 4:52 PM
- A Phase 3 study evaluating Amgen's (NASDAQ:AMGN) brodalumab versus Janssen's (NYSE:JNJ) Stelara (ustekinumab) and placebo at week 12 in patients with moderate-to-severe plaque psoriasis met its primary endpoints. Brodalumab was superior to ustekinumab in achieving total clearance of skin disease as measured by PASI-100. Compared to placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75% improvement from baseline in disease severity at week 12 (measured by PASI-75). All key secondary endpoints were also met.
- Proportion of patients achieving total clearance of disease: brodalumab-210 mg: 36.7%; brodalumab-140 mg: 27.0%; Stelara: 18.5%; placebo: 0.3%.
- Proportion of patients achieving PASI-75: brodalumab-210 mg: 85.1%; brodalumab-140 mg: 69.2%; Stelara: 69.3%; placebo: 6.0%.
- Amgen plans to present the complete results at a future medical conference.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NASDAQ:CELG) (NYSE:NVS) (NASDAQ:DERM) (NASDAQ:IDRA) (NYSE:HSP) (NYSE:PFE) (NYSEMKT:CANF) (NYSE:MRK)
Tue, Nov. 11, 7:44 AM
- Dupilumab, a fully-human monoclonal antibody being co-developed by Sanofi (NYSE:SNY) (OTCQB:SNYNF) and Regeneron Pharmaceuticals (NASDAQ:REGN), showed showed positive results in a 776-patient Phase 2b dose-ranging clinical trial in adults with moderate-to-severe uncontrolled asthma.
- The three highest doses of dupilumab in combination with standard-of-care therapy met the primary endpoint of a statistically significant improvement from baseline in forced expiratory volume over one second (FEV1) at week 12 in patients with high blood eosinophils (>= 300 cells/microliter) compared to placebo in combination with standard-of-care therapy. Also, two doses of dupilumab (200 mg every other week and 300 mg every other week) showed a statistically significant improvement in mean percent change in FEV1 and a reduction in severe exacerbations, both in the high eosinophils group and the overall study population.
- Dupilumab blocks IL-4 and IL-13, two cytokines required by the Th2 immune response. Some researchers believed that targeting the Th2 pathway would limit the benefit in asthmatics with high eosinophils, but this study demonstrated that it could be effective. Final results from the trial will be presented at a future medical conference.
- Sanofi plans to proceed to Phase 3 development.
- Asthma-related tickers: (NYSE:GSK) (NYSE:TEVA) (NYSE:AZN) (OTCQX:RHHBY) (NASDAQ:AMGN) (NYSE:MRK) (NYSE:NVS) (NASDAQ:THRX)
Mon, Nov. 10, 11:21 AM
- At the upcoming American College of Rheumatology Congress in Boston, MA, Novartis (NVS +0.6%) will present Phase 3 data for secukinumab for the treatment of psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
- Four oral presentations are scheduled for November 16 and 18. Four posters will be presented on November 16.
- Secukinumab is a human monoclonal antibody that inhibits IL-17A. It is the first such inhibitor to demonstrate positive Phase 3 results in PsA and AS.
- Previously: More positive results for secukinumab
Thu, Nov. 6, 12:53 PM
- The Oncologic Drugs Advisory Committee votes 5 -2 that the benefits of Novartis' (NVS -0.7%) panobinostat do not outweigh the risks.
- Previously: Ad Comm review approaches for Novartis cancer drug
Tue, Nov. 4, 1:24 PM
- The FDA's Oncologic Drugs Advisory Committee meets on Thursday, November 6 to review Novartis' (NVS +0.1%) NDA for panobinostat. The proposed indication is in combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
- Briefing doc
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