Novartis AG (NVS) - NYSE
  • Wed, Feb. 10, 3:42 PM
    • Novartis (NVS +0.5%) inks a pricing deal with Cigna (CI +0.9%) and Aetna (AET +2.5%) for its heart drug Entresto (sacubitril/valsartan) that is based on its ability to reduce the proportion of patients who are admitted to the hospital for heart failure. The performance-based scheme applies to the insurers' commercial business, not Medicare or Medicaid.
    • Entresto costs $12.50 per day or $4,560 per year, not the most expensive new drug but higher than expected. The deal specifies a base price and modest rebate that will fluctuate based on the number of hospitalizations and savings to the plan.
    • Analysts expect more performance-based drug pricing arrangements going forward since it holds the manufacturer accountable for the product's claimed efficacy. Insurers like the deals because they will save money if the drug's benefits are realized and will pay a premium only in such instances, thereby derisking including the drug in their formularies.
    | Wed, Feb. 10, 3:42 PM | 1 Comment
  • Thu, Jan. 28, 8:59 AM
    • Incyte (NASDAQ:INCY) is down 12% premarket on light volume in response to its announcement that it terminated a Phase 2 sub-study, INCB 18424-267, assessing Jakafi (ruxolitinib) or placebo in combination with Bayer's (OTCPK:BAYRY) Stivarga (regorafenib) in patients with relapsed/refractory metastatic colorectal cancer with high C-reactive protein (CRP), a potential new indication for the drug. An interim analysis of the high CRP group revealed that ruxolitinib plus regorafenib failed to demonstrate a sufficient level of efficacy to justify continuing the study.
    • Ruxolitinib, a JAK1/JAK2 inhibitor, is cleared in the U.S. for the treatment of a type of blood cancer called polycythemia vera and a bone marrow disorder called myelofibrosis.
    • Regorafenib, a kinase inhibitor, is approved for the treatment of colorectal cancer and gastrointestinal stromal tumor.
    • Incyte markets Jakafi in the U.S. and Novartis (NYSE:NVS) sells it elsewhere under the brand name Jakavi.
    | Thu, Jan. 28, 8:59 AM | 1 Comment
  • Wed, Jan. 27, 7:15 AM
    • Novartis (NYSE:NVS) Q4 results ($M): Total Revenues: 12,520 (-4.2%); Pharmaceuticals: 7,865 (+0.1%); Alcon: 2,349 (-13.1%); Sandoz: 2,306 (-8.2%).
    • Net Income: 1,056 (-29.0%); EPS: 0.44 (-29.0%); CF Ops: 4,157 (-20.1%).
    • Key product sales: Gleevec/Glivec: 1,219 (-1.5%); Gilenya: 742 (+11.4%); Lucentis: 499 (-15.1%); Afinitor/Votubia: 382 (-10.3%); Sandostatin: 413 (-0.7%); Tasigna: 432 (+0.9%); Galvus: 294 (+999%); Diovan/Co-Diovan: 292 (-23.0%); Exforge: 249 (-16.4%); Exjade/Jadenu: 248 (+2.1%); Cosentyx: 121.
    • 2016 Guidance: Group Net Sales and core operating income in line with 2015.
    | Wed, Jan. 27, 7:15 AM
  • Wed, Jan. 27, 4:49 AM
    • Novartis (NYSE:NVS): Q4 EPS of $1.14 misses by $0.04.
    • Revenue of $12.52B (-4.3% Y/Y) misses by $120M.
    • The board announces plans to accelerate growth at Alcon, streamline group operations to generate annual cost savings over $1B by 2020.
    • The board proposed dividend of CHF 2.70/share, up 4%.
    • FY16 net sales and core operating income are expected to be broadly in line with FY15 at constant currency.
    | Wed, Jan. 27, 4:49 AM
  • Wed, Jan. 27, 4:26 AM
    • Novartis' (NYSE:NVS) fourth quarter earnings missed expectations as the group prepared to overhaul its Alcon eyecare division.
    • Royal Bank of Scotland (NYSE:RBS) warned it would slump to yet another full-year loss after it put aside £2.5B to cover a slew of regulatory issues.
    • Strength in its U.K. business helps Santander (NYSE:SAN) offset weakness in Latin America and Spain, with Q4 earnings coming roughly in line with expectations.
    • Ericsson (NASDAQ:ERIC) reported a 67% increase in quarterly net profit, helped by a stronger dollar and higher revenue from a new global license deal with Apple.
    • BASF (OTCQX:BASFY) issued a profit warning, knocked down by lower oil and gas prices, which have led to write-downs of its energy business.
    | Wed, Jan. 27, 4:26 AM | 1 Comment
  • Tue, Jan. 26, 5:30 PM
  • Wed, Jan. 20, 3:39 PM
    | Wed, Jan. 20, 3:39 PM | 6 Comments
  • Wed, Jan. 20, 7:41 AM
    • In an update to investors published today, GenVec (NASDAQ:GNVC) says it is still waiting to hear from collaboration partner Novartis (NYSE:NVS) on the status of its Phase 1/2 clinical trial assessing lead product candidate, CGF166, for the treatment of severe-to-profound bilateral hearing loss. Patient enrollment was paused on January 8 after the Data Safety Monitoring Board reviewed the results from nine subjects. Novartis will continue to collect safety and efficacy data on the nine patients while it determines whether to proceed with enrollment.
    • CEO Douglas Swirsky says, "While we are disappointed with the pause, as with any first-in-man study, it is important to proceed with care to gain a broad understanding of a product's therapeutic profile. While there is no certainty the trial will continue and timing is also uncertain, we hope enrollment can resume in the coming months and that the trial will be completed sometime in 2017, as previously expected."
    • CGF166 is an advanced adenoviral vector engineered to deliver the human atonal gene under the control of a tissue-specific promoter. Novartis licensed it in January 2010.
    • The company ended 2015 with $8.7M in quick assets, sufficient to fund operations into Q2 2017.
    • Previously: GenVec tanks 64% over CGF166 clinical trial halt by Novartis (Jan. 11)
    | Wed, Jan. 20, 7:41 AM
  • Sat, Jan. 16, 2:21 PM
    • The FDA approves Novartis' (NYSE:NVS) IL-17A inhibitor, Cosentyx (secukinumab), for the treatment of adults with active ankylosing spondylitis and active psoriatic arthritis, both life-long painful and debilitating inflammatory diseases that affect the joints and/or spine.
    • The European Commission approved the two new indications in November.
    • In January 2015, Cosentyx was cleared in the U.S. and EU for the treatment of adults with moderate-to-severe plaque psoriasis.
    • Cosentyx is one of the company's anticipated blockbusters that is expected to generate peak sales of $1B+. Through Q3, it has posted $140M in sales.
    | Sat, Jan. 16, 2:21 PM
  • Tue, Jan. 12, 8:33 AM
    • Cellectis S.A. (NASDAQ:CLLS) is up 9% premarket on light volume in response to the news that it has developed a new chimeric antigen receptor (CAR) architecture that permits control over CAR-T cell functions, potentially enabling the ability to control unwanted risks such a cytokine-release syndrome and "on-target, off-tumor" effect. Currently, the only remedies for these effects rely on suicide mechanisms that completely eradicate the engineered T-cells which results in a premature end of the treatment.
    • Cellectis scientists engineered a system directly integrated with the CAR architecture by adding a small molecule that turns a CAR-T cell from an "off" state to an "on" state, thereby controlling activation and mitigating the risk of CAR-induced toxicities. It also creates opportunities for spatial activation of the engineered CAR-T cells using local targeted drug delivery.
    • The study was just published in the journal Scientific Reports.
    • Related tickers: (NASDAQ:JUNO)(NASDAQ:KITE)(NASDAQ:BLUE)(NASDAQ:BLCM)(NYSE:NVS)(NASDAQ:SRNE)
    | Tue, Jan. 12, 8:33 AM | 3 Comments
  • Mon, Jan. 11, 12:05 PM
    • Thinly traded nano cap GenVec (GNVC -63.6%) plummets on a 7x surge in volume, albeit on turnover of only 550K shares, in response to a regulatory filing disclosing that Novartis (NVS -0.6%) has paused patient enrollment in its Phase 1/2 clinical trial assessing GenVec's lead product candidate, CGF166, for the treatment of severe-to-profound bilateral hearing loss. Novartis took action on the basis of a recommendation from the independent data safety monitoring board. No other details are provided.
    • CGF166 is an advanced adenoviral vector engineered to deliver the human atonal gene under the control of a tissue-specific promoter. Novartis licensed it in January 2010.
    | Mon, Jan. 11, 12:05 PM
  • Wed, Jan. 6, 8:36 AM
    • Novartis (NYSE:NVS) and Qualcomm (NASDAQ:QCOM) subsidiary Qualcomm Life will collaborate on the development of a digital version of Novartis' Breezhaler inhaler device used to treat patients with chronic obstructive pulmonary disease (COPD).
    • The next-generation device, incorporating a small, disposable low power module, will enable patients to have access to their own real-time data related to their use of the product. The module will wirelessly transmit the data to the user's smartphone and a Novartis COPD mobile app, which sends the data to the cloud, allowing patients and their healthcare providers to monitor their condition. The connected device will be ready to use with no assembly required. Novartis plans to launch it in 2019.
    | Wed, Jan. 6, 8:36 AM | 1 Comment
  • Dec. 21, 2015, 11:48 AM
    • In a regulatory filing, GlaxoSmithKline (GSK +0.5%) reports that it has completed its sale of ofatumumab in the autoimmune space to Novartis (NVS -0.3%). Total consideration for Glaxo could reach more than $1B if all milestones are met.
    • Under the terms of the deal, Glaxo receives $300M at closing, $200M at the start of a Novartis-run Phase 3 trial in relapsing remitting multiple sclerosis, up to $534M in additional milestones and up to 12% in royalties from autoimmune-rated sales.
    • Previously: Novartis to acquire rights to Glaxo MS treatment (Aug. 21)
    | Dec. 21, 2015, 11:48 AM | 1 Comment
  • Dec. 10, 2015, 1:31 PM
    • A Florida district court grants Amgen (AMGN +1.5%) a preliminary injunction against Toronto, Canada-based Apotex preventing it from launching its biosimilar of Neulasta (pegfilgrastim) for 180 days. Judge James Cohn based his ruling on his interpretation of the Biologics Price Competition and Innovation Act which stipulates that biosimilar makers give the brand holder 180 days notice before bringing their knockoff to market. This provides sufficient time for the original developer to determine if any of its patents are being infringed.
    • The same ruling delayed Novartis (NVS +1.4%) from launching Zarxio (filgrastim-sndz). Its U.S. launch commenced in September, six months after being cleared by the FDA.
    • Previously: Novartis launches Zarxio in the U.S. (Sept. 3)
    • Previously: FDA clears first biosimilar (March 6)
    | Dec. 10, 2015, 1:31 PM | 1 Comment
  • Dec. 7, 2015, 3:41 PM
    • Results from a Phase 3 clinical trial, RATIFY, showed patients with newly-diagnosed FLT3 mutation-positive acute myeloid leukemia (AML) who received Novartis' (NVS -0.8%) investigational kinase inhibitor, PKC412 (midostaurin), in addition to standard induction and consolidation chemotherapy, experienced a 23% improvement in overall survival (OS) compared to those who received standard induction and consolidation chemotherapy alone (p=0.0074). In addition, median OS in the PKC412 cohort was 74.7 months versus 25.6 months for placebo. The results were presented at the American Society of Hematology annual meeting in Orlando, FL.
    • The trial assessed the addition of either PKC412 or placebo to daunorubicin/cytarabine in the induction phase, followed by high-dose cytarabine in the consolidation phase. Patients who achieved complete remission after consolidation therapy continued treatment with PKC412 or placebo as a single agent for up to one year. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is October 2021.
    • No statistically significant differences were observed in the overall rate of grade 3 or higher adverse events.
    • RATIFY study chair Professor Richard Stone, M.D., says, "The overall results for midostaurin, plus standard chemotherapy, in treating FLT3-mutated AML is a long-awaited advancement for hematologists and the AML community. FLT3 is a common genetic mutation in AML and is currently associated with poorer prognoses, underscoring the critical need for new treatment options."
    • PKC412 (midostaurin) is an oral, multi-targeted kinase inhibitor. Kinases help regulate many essential cell processes so interfering with their activity interrupts the ability of cancer cells to grow and multiply. It is also being investigated for the treatment of aggressive systemic mastocytosis/mast cell leukemia.
    • The company is proceeding with global regulatory applications.
    | Dec. 7, 2015, 3:41 PM
  • Dec. 7, 2015, 10:29 AM
    • Novartis (NVS -0.4%) announces encouraging results from a Phase 2a clinical trial assessing CAR T candidate CTL019 in adults with certain types of relapsed/refractory non-Hodgkin lymphoma. The data were presented at the American Society of Hematology annual meeting in Orlando, FL.
    • At three months, the overall response rate was 47% (n=7/15) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and 73% (n=8/11) in those with follicular lymphoma (FL). Three DLBCL patients who achieved a partial response converted to complete response by month 6, as did three FL patients. Median progression-free survival in DLBCL and FL patients was 3.0 months and 11.9 months, respectively.
    • Four patients developed cytokine release syndrome (CRS) (cytokine storm) of grade 3 (severe but not life-threatening) or higher after CTL019 infusion. Neurologic toxicity occurred in two, including one grade 3 episode of delirium and one possibly related grade 5 (death) encephalopathy.
    • A CAR T therapy is specifically manufactured for each individual patient. The person's T cells are collected and isolated and then reprogrammed to detect and attack cancer cells that express a protein called CD19. The engineered cells are then infused back into the patient.
    • The company expects to file regulatory applications in 2017.
    • Previously: Novartis hits a home run with CAR-T therapy in ALL (Dec. 8, 2014)
    | Dec. 7, 2015, 10:29 AM
Company Description
Novartis AG develops, manufactures, and markets healthcare products. It operates through the following segments: Pharmaceuticals, Alcon, Sandoz, Vaccines & Diagnostics, and Consumer Health. The Pharmaceuticals segment provides patent-protected prescription medicines. The Alcon segment offers... More
Sector: Healthcare
Industry: Drug Manufacturers - Major
Country: Switzerland