Dec. 17, 2014, 3:52 PM
- The FDA approves Alcon Laboratories' (NVS +0.6%) Xtoro (finafloxacin otic suspension) for the treatment of acute otitis externa, an infection known as swimmer's ear.
- Acute otitis externa is an infection of the outer ear and ear canal, typically caused by bacteria in the ear canal. The infection causes inflammation that can lead to pain, swelling, redness and discharge from the ear.
- Xtoro is an ear drop approved to treat acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus.
Dec. 16, 2014, 7:33 AM
- Israel-based BioLineRx (NASDAQ:BLRX) enters into a strategic collaboration with Novartis (NYSE:NVS) to designed to facilitate the development and commercialization drug candidates identified by BioLineRx. The companies will co-develop up to three pre-clinical and early clinical therapeutic product candidates through clinical proof-of-concept. Projects reaching the clinical stage will be eligible for selection by Novartis. If selected, it will pay BioLineRx an option fee of $5M as well as fund 50% of the remaining development costs associated with establishing clinical proof-of-concept. The funding will be in the form of an additional equity investment in BioLineRx.
- As part of the agreement, Novartis has made an initial equity investment in BioLineRx of $10M (5M BLRX ADSs at $2.00 per share) which represents a 12.8% stake.
- BLRX is up 17% premarket on modest volume.
Dec. 16, 2014, 7:10 AM
- The FDA approves Novartis' (NYSE:NVS) Signifor long-acting release (LAR) (pasireotide) for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for who surgery is not an option.
- Acromegaly is an endocrine disorder caused by elevated growth hormone and insulin-like growth factor. It is characterized by increased bone growth including the hands, feet and face. The most frequent cause is a non-cancerous tumor on the pituitary gland.
- Signifor LAR is Orphan Drug designated in the U.S. for the treatment of acromegaly so it has a seven-year period of market exclusivity. It was cleared in Europe last month for this indication.
- The product was originally approved for the treatment of Cushing's disease.
- Related ticker: (OTCPK:IPSEY)
- Previously: Europe clears label expansion for Novartis' Signifor (Nov. 24, 2014)
Dec. 15, 2014, 10:03 AM
- Germany's healthcare cost watchdog, the German Institute for Quality and Efficiency in Health Care, determines that Bayer's (OTCPK:BAYRY +0.9%) (OTCPK:BAYZF) eye drug Eylea (aflibercept) offers no additional benefit over Novartis' (NVS -0.6%) Lucentis (ranibizumab) for the treatment of diabetic macular edema. The agency's decision could affect the amount of reimbursement for Eylea.
- In January, the Institute came to the same conclusion for the indication of macular edema. Last year, it determined that it could not assess the potential advantages of Eylea in wet age-related macular degeneration because Bayer has not provided the relevant data.
- Eylea was developed by Regeneron Pharmaceuticals (REGN -1.5%) and licensed to Bayer in ex-U.S. territories.
Dec. 12, 2014, 10:07 AM
- The Phase 3 trial evaluating Novartis' (NVS +0.3%) Afinitor (everolimus) for the treatment of patients with human epidermal growth factor receptor-2 positive (HER2+) breast cancer failed to achieve its primary endpoint of a statistically significant improvement in median progression-free survival (PFS). Patients receiving everolimus plus trastuzumab (T) and paclitaxel (P) demonstrated a median PFS of 15.0 months compared to 14.5 months with placebo plus T and P.
- The study also failed to achieve its second primary endpoint of a statically significant improvement in median PFS in the hormone receptor negative (HR-) subgroup of women with HER2+ advanced breast cancer, although a clinical benefit was observed. Median PFS for everolismus plus T and P was 20.3 months compared to 13.1 months for placebo plus T and P.
- Afinitor is currently approved in more than 90 countries for the treatment of postmenopausal women with HR+/HER2- advanced breast cancer in combination with exemestane after recurrence or progression following a non-steroidal aromatase inhibitor. HR+/HER2- is the most common form of the disease. HER2+ patients represent ~20% of advanced breast cancer cases.
Dec. 12, 2014, 7:34 AM
- In a Phase 3b study, Novartis' (NYSE:NVS) IL-17A inhibitor Cosentyx (secukinumab) demonstrated superiority to Janssen's (NYSE:JNJ) Stelara (ustekinumab) in psoriasis patients. The study met its primary endpoint of PASI 90 at week 16 as well as its secondary endpoint of PASI 75 at week 4. The results from the 679-patient study will be presented at a medical conference next year.
- In an earlier trial, Cosentyx demonstrated superiority to Amgen's Enbrel (etanercept).
- Regulatory approvals of secukinumab for the treatment of moderate-to-severe plaque psoriasis are pending.
- Previously: Ad Comm backs approval of secukinumab (Oct. 21, 2014)
- Previously: Europe Ad Comm gives thumbs up to Novartis psoriasis drug (Nov. 21, 2014)
Dec. 8, 2014, 3:26 PM
- In a 1,144-subject Phase 3 study of Novartis' (NVS +0.1%) Jakafi (ruxolitinib) in myelofibrosis, patients experienced a reduction in spleen size that was maintained over time with a clinically meaningful improvement in symptoms. 69% of the patients achieved >50% reduction in spleen size. The safety and efficacy profile was consistent with previous studies. The results were presented at the American Society of Hematology meeting in San Francisco.
- Jakafi is the only JAK inhibitor approved in more than 70 countries for patients with myelofibrosis.
- Previously: Jakavi approval triggers milestone payment (July 8, 2014)
Dec. 8, 2014, 7:46 AM
- Novartis' (NYSE:NVS) investigational chimeric antigen receptor (CAR) therapy, CTL019, demonstrates profound efficacy in a 39-patient study in children and young adults with relapsed/refractory acute lymphoblastic leukemia (ALL). Thirty-six of the 39 patients (92%) experienced complete remissions.
- Sustained remissions were achieved up to one year or more. Event-free survival at six months was 70% and overall survival (OS) was 75%, in most cases without further therapy.
- Lead investigator Stephan Grupp, Ph.D., M.D., says, "We're seeing pediatric patients who have not responded to any other therapy achieve complete remission as a result of treatment with CTL019. Now that these patients have been followed for a longer period of time, we're seeing that a number of them remain in remission for one year or more. This lead me to believe the persistence and durability of CAR-modified cells may help protect against relapse."
- CTL019 used CAR technology to reprogram a patient's own T cells to attack cancer cells that express proteins called CD19. After the cells have been reprogrammed they are re-infused into the patient where they seek out and kill tumor cells.
- Novartis has worldwide rights to CARs developed through its collaboration with the University of Pennsylvania. The FDA designated CTL019 a Breakthrough Therapy in July.
Dec. 8, 2014, 7:08 AM
- In a 218-patient Phase 3 trial, Novartis (NYSE:NVS) unit Sandoz's investigational filgrastim biosimilar demonstrated similarity to Amgen's (NASDAQ:AMGN) Neupogen (filgrastim) in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also demonstrated that repeated switching at each cycle between in the investigative biosimilar and Neupogen showed no impact on efficacy, safety or immunogenicity.
- Neutropenia is an abnormally low number of neutrophils, a type of white blood cells that are the primary defense against infections.
- The FDA accepted for review Sandoz's application for filgrastim in July. It is the first such acceptance in the U.S. under the Biologics Price Competition and Innovation Act of 2009.
- Neupogen generated ~$1.2B in sales the past four quarters.
Dec. 3, 2014, 6:33 PM
- Array BioPharma (NASDAQ:ARRY) +24% AH says it reached a deal with Novartis (NYSE:NVS) to regain global rights to its binimetinib cancer treatment as well as an upfront payment of $85M.
- The agreement is subject to NVS and GlaxoSmithKline (NYSE:GSK) completing a series of transactions which were unveiled in April and remain subject to regulatory approval.
- ARRY says binimetinib is advancing in three phase 3 clinical trials and that it plans to file for its first regulatory approval in H1 2016.
Dec. 1, 2014, 3:52 PM
- Italy's drug regulator AIFA determines that Novartis' (NVS -0.3%) FLUAD vaccine is safe. Last week, the agency suspended two lots of the product after three people died shortly after being vaccinated.
- Previously: Italian drug regulator suspends two batches of Novartis flu vaccine after deaths
Dec. 1, 2014, 12:26 PM
- Teva Pharmaceutical Industries (TEVA) launches its generic equivalent to Novartis' (NVS -0.1%) high blood pressure med Exforge HCT (Amlodipine, Valsartan, Hydrochlorothiazide) Tablets in the U.S.
- Teva was the first to file so it has marketing exclusivity against other generic firms for 180 days.
- Per IMS Health, Exforge HCT generates annual sales in the U.S. of ~$158M.
Dec. 1, 2014, 7:12 AM
- Novartis' (NYSE:NVS) Gilenya (fingolimod), approved for relapsing multiple sclerosis (MS) in the U.S. and highly active relapsing-remitting MS in Europe, failed to demonstrate a significant difference compared to placebo on a combination of disability measures in a Phase 3 trial evaluating the drug in primary progressive multiple sclerosis (PPMS). PPMS is a disorder of the central nervous system which affects ~10% of the 2.3M MS sufferers worldwide.
- Two other Phase 3 trials assessing Gilenya in pediatric MS and chronic demyelinating polyradiculoneuropathy are ongoing.
Nov. 28, 2014, 8:15 AM
- After three people died shortly after receiving Novartis' (NYSE:NVS) Fluad influenza vaccine, Italy's drug regulator AIFA suspends two lots of the product. In an e-mailed statement, Novartis says, "A review of the two batches confirmed that they conform with all production and quality standards and no casual relationship to the vaccine have been established."
- Fluad was approved in 1997 and has an extensive history of safe use.
- The three deaths, and another serious adverse event, all occurred in the southern regions of Sicily and Molise. One of the deaths was a 68-year-old man who died ten minutes after being vaccinated.
Nov. 28, 2014, 7:28 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) grants accelerated assessment to Novartis' (NYSE:NVS) LCZ696, an investigational drug for the treatment of heart failure with reduced ejection fraction. This is the first time CHMP has extended such a review for a cardiovascular medicine. The designation shortens the committee's review period by 60 days (210 to 150) so a decision should be forthcoming in 2015.
- Novartis expects to submit its Marketing Authorization Application (MAA) in early 2015. The basis for the submission is he Paradigm-HF study where LCZ696 demonstrated superiority compared to ACE-inhibitor enalapril.
- The drug candidate is under Fast Track review in the U.S. The company's rolling submission should be complete by the end of next month.
- Previously: Novartis chief says new heart failure drug will be a winner
- Previously: Novartis heart failure drug candidate beats enalapril
Nov. 26, 2014, 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%).
NVS vs. ETF Alternatives
Other News & PR