Nov. 11, 2014, 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)
Nov. 10, 2014, 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
Nov. 6, 2014, 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
Nov. 4, 2014, 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
Nov. 3, 2014, 1:06 PM
- The FDA accepts Boehringer Ingelheim's NDA for Spiriva Respimat (tiotropium bromide) for the maintenance treatment of asthma in patients at least 12 years old who remain symptomatic on at least inhaled corticosteroids.
- Spiriva is currently cleared for the maintenance treatment of bronchospasm (HandiHaler) associated with chronic obstructive pulmonary disease (COPD) and to reduce COPD exacerbations.
- The Respimat inhaler provides a pre-measured amount of medicine in a slow moving mist that helps the patient inhale the drug. It is designed to deliver the medication in a way that does not depend on how fast air is breathed in from the inhaler.
- Asthma and COPD-related tickers: (THRX -3%)(GSK -0.3%)(AZN -0.8%)(NVS -1.3%)(REGN +0.6%)(SNY -1.5%)(TEVA +1.5%)(OTCQX:RHHBY -1.3%)
Oct. 28, 2014, 8:40 AM
- CEO Joe Jimenez says Novartis' (NYSE:NVS) experimental heart failure drug, LCZ696, will should eventually generate $2B - 5B in sales. The company reported clinical trial data in August that showed the product cut the risk of cardiovascular death and hospital admissions by 20%.
- The company plans to submit its NDA to the FDA by December and expects a decision by late 2015.
Oct. 28, 2014, 7:22 AM
- Novartis (NYSE:NVS) Q3 results ($M): Total Revenue: 14,704 (+2.6%); Pharmaceuticals: 7,925 (+0.4%); Alcon: 2,665 (+5.0%); Sandoz: 2,401 (5.6%); Vaccines: 588 (-1.0%); Consumer Health: 1,125 (+8.3%).
- COGS: 5,096 (+3.8%); R&D Expense: 2,372 (-1.9%); SG&A Expense: 4,227 (+0.0%); Net Income: 3,240 (+43.1%); EPS: 1.37 (+52.2%); CF Ops: 4,011 (-8.4%); Quick Assets: 10,427 (+42.1%).
- Gross Profit: 9,877 (+2.4%); COGS: 34.7% (+1.2%); Gross Margin: 67.2% (-0.2%); Operating Profit: 2,980 (+11.6%); Operating Earnings Yield: 20.3% (+8.8%); Net Earnings Yield: 22.0% (39.5%).
- Product Sales: Gleevec/Glivec: 1,213 (+7.1%); Lucentis: 614 (+5.7%); Gilenya: 653 (+26.1%); Sandostatin: 433 (+8.0%); Afinitor/Votubia: 408 (+21.1%); Tasigna: 391 (+24.1%); Exforge: 365 (+1.7%); Exelon/Exelon Patch: 261 (+3.2%).
- 2014 Guidance: Group net sales growth: low to mid-single digit (unch); core group operating income: mid to high-single digit (unch).
Oct. 28, 2014, 6:12 AM
Oct. 27, 2014, 5:30 PM
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Oct. 27, 2014, 6:43 AM
- Novartis (NYSE:NVS) sells its global influenza vaccine business to Australian blood products firm CSL Ltd. for $275M. The transaction, part of Novartis' effort to focus on its most promising assets, concludes the company's overhaul of its units. The deal is expected to close in 2H 2015.
- Earlier this year, GlaxoSmithKline (NYSE:GSK) bought its vaccine business, ex-flu, for $5.25B plus milestones up to $1.8B and royalties.
Oct. 23, 2014, 9:00 AM
- Novartis' (NYSE:NVS) fully human mAb, AIN457 (secukinumab), meets its primary and key secondary endpoints in two Phase 3 clinical trials assessing its safety and efficacy as a treatment for the symptoms of ankylosing spondylitis. The company plans to present the data at an upcoming medical congress.
- Secukinumab neutralizes the action of IL-17A, a protein that stimulates inflammation. Several days ago, an FDA Advisory Committee voted unanimously in favor of approval for the mAb for the treatment of moderate-to-severe plaque psoriasis.
Oct. 21, 2014, 7:32 AM
- The Dermatologic and Ophthalmic Drugs Advisory Committee votes unanimously in favor of approving Novartis' (NYSE:NVS) interleukin-17A inhibitor secukinumab for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. A final decision by the FDA is expected in early 2015.
- Novartis has also submitted its regulatory application with the European Medicines Agency. A decision is expected in late 2014 to early 2015.
- Psoriasis-related tickers: (NYSE:JNJ) (NASDAQ:DERM) (NYSE:MRK) (NASDAQ:CELG) (NASDAQ:IDRA) (NYSE:HSP) (NYSEMKT:CANF) (NASDAQ:AMGN) (NYSE:AZN) (NYSE:PFE)
Oct. 19, 2014, 4:19 PM
Oct. 17, 2014, 1:02 PM
- Waltham, MA-based Proteon Therapeutics (PRTO) is set for its IPO of 4.7M shares at $12 - 14.
- The clinical-stage biopharmaceutical firm focuses on the needs of patients with renal and vascular disease. Its lead product is PRT-201, a recombinant elastase, for the prevention of vascular access failure in patients undergoing hemodialysis. The Fast Track and Orphan Drug-designated product candidate may inhibit neointimal hyperplasia, the growth of tissue inside blood vessels that can result in vessel narrowing and reduced blood flow. The company is positioning PRT-201 as a one-time application when a surgeon creates an arteriovenous fistula (AVF) for a dialysis patient, which has a failure rate as high as 70%.
- 2013 operating results ($M): Operating Expenses: 7.1 (-10.9%); Net Loss: (14.0) (-0.7%).
- 1H 2014 operating results ($M): Operating Expenses: 4.4 (+29.9%); Net Loss: (8.8) (-36.5%); Quick Assets: 25.4 (as adjusted: 79.9).
- A Phase 3 trial to assess PRT-201 in radiocephalic AVFs is underway. A second Phase 3 is scheduled to begin in 1H 2015.
- In March, Novartis (NVS +2.3%) walked away from a deal after negotiations on an acquisition price failed.
- ETFs: IBB, BIB, BIS (IPO +1.9%)
Oct. 16, 2014, 11:46 AM
- The Dermatologic and Ophthalmic Drugs Advisory Committee meets on Monday, October 20 to review Novartis' (NVS -1.7%) BLA for secukinumab, a human mAb, for the treatment of adults with moderate-to-sever plaque psoriasis who are candidates for systemic therapy or phototherapy.
- Briefing docs
- Psoriasis-related tickers: (JNJ -1%)(DERM -5%)(MRK -2.2%)(CELG -0.9%)(IDRA +6.8%)(HSP +1.1%)(CANF)(AMGN -1.5%)(AZN -1.1%)(PFE -1.3%)
Oct. 15, 2014, 4:13 AM
- The Supreme Court is due to hear oral arguments today over a patent for Teva's (NYSE:TEVA) top-selling multiple sclerosis drug Copaxone, which accounts for 50% of its profit.
- The patent was due to expire in September 2015, although in July 2013, the U.S. Court of Appeals for the Federal Circuit ruled that the patent was invalid. Copaxone has no IP protection at the moment.
- Two consortia are developing generic versions of Copaxone, with one involving Novartis (NYSE:NVS) and Momenta (NASDAQ:MNTA), and the other Mylan (NASDAQ:MYL) and Natco. The companies risk having to pay Teva hundreds of millions of dollars if they introduce Copaxone and then lose in the Supreme Court.
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