Thu, Jan. 8, 8:39 AM
- Novartis (NYSE:NVS) files two New Drug Applications (NDA) with the FDA for medicines (QVA149 and NVA237) for the treatment of chronic obstructive pulmonary disease (COPD) after both Phase 3 programs achieved their safety and efficacy endpoints.
- The first Phase 3 study, called Expedition, evaluated twice-daily doses of QVA149 (indacaterol/glycopyrronium bromide) compared to its monotherapy components in patients with moderate-to-severe COPD as measured by FEV1 at Week 12. The product is intended as maintenance treatment to relieve the symptoms in adult patients with COPD.
- The other Phase 3 program, GEM, assessed twice-daily doses of NVA237 (glycopyrronium bromide) versus placebo in patients with moderate-to-severe COPD measured by FEV1 at Week 12. The product is intended for the maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.
- The safety trials, Flight 3 and GEM 3, achieved their endpoints.
- Both product candidates have been submitted for U.S. registration only. Outside of the U.S., QVA149 is marketed as Ultibro Breezhaler while NVA237 is marketed as Seebri Breezhaler.
Wed, Jan. 7, 9:52 PM
- The FDA's Oncologic Drugs Advisory Committee recommends the approval of Sandoz's (NYSE:NVS) biosimilar to Amgen's Neupogen (filgrastim) including all indications on Neupogen's label.
- If approved, which seems virtually certain at this point, Sandoz will market the product under the brand name Zarxio.
- Previously: Ad Comm approaches for Neupogen biosimilar (Jan. 5)
Wed, Jan. 7, 8:22 AM
- Novartis (NYSE:NVS) inks a license and collaboration agreement with Intellia Therapeutics for the discovery and development of new drugs utilizing CRISPR genome editing technology and Caribou Biosciences for the development of drug discovery tools.
- Clustered regularly interspaced short palindromic repeats, or CRISPR, enables the easy and precise editing of the genes of targeted cells. It is a powerful tool for creating very specific disease models in drug discovery and has substantial potential as a therapeutic modality for treating disease at the genetic level.
- R&D activities will focus on the use of CRISPR ex vivo to engineer chimeric antigen receptor T cells (CARTs) and hematopoietic stem cells (HSCs).
- Under the terms of the agreement with Intellia, Novartis receives exclusive rights to develop all collaboration programs focused on engineered CARTs and the right to develop an undisclosed number of targets for ex vivo editing of HSCs. It also receives non-exclusive rights for limited in vivo therapeutic applications of CRISPR systems.
- Novartis will increase its equity investment in Intellia, make an upfront payment and provide technology access fees and R&D funding during the five-year term of the contract. Intellia is eligible to receive development-based milestones and royalties on commercial sales.
- Under the terms of the agreement with Caribou, Novartis receives non-exclusive rights to Caribou's CRISPR platform for research conducted during the collaboration and will fund the one-year research program. It will also make an equity investment in Caribou.
Tue, Jan. 6, 8:18 PM
Mon, Jan. 5, 2:00 PM
- The FDA's Oncologic Drugs Advisory Committee meets Wednesday to review the Biologics License Application (BLA) submitted by Sandoz (NVS +0.1%) for a biosimilar version of Amgen's (AMGN -0.8%) Neupogen (filgrastim).
- In the briefing documents, reviewers determined that there are no clinically meaningful differences compared to Neupogen. This bodes well for the approval of the first biosimilar in the U.S.
- Briefing doc
Thu, Jan. 1, 9:27 AM
- Novartis (NYSE:NVS) has completed the $5.4B sale of its animal-health division to Eli Lilly (NYSE:LLY).
- The sale of the unit is part of a complex overhaul at NVS that will focus the company on three core businesses: innovative pharmaceuticals, eye care, and generics.
- As a result of the transaction, Novartis will record an exceptional pretax gain of about $4.6B in Q1 of 2015.
Dec. 26, 2014, 11:54 AM
- The Japanese Ministry of Health, Labour and Welfare approves Novartis' (NVS +0.1%) Cosentyx (secukinumab) for the treatment of adult patients with psoriasis vulgaris and psoriatic arthritis who are not adequately responding to systemic therapies, except for biologics.
- Secukinumab inhibits IL-17A, a proinflammatory cytokine that is activated by T cells.
- Regulatory approvals in the U.S. and Europe are pending.
- Previously: Europe Ad Comm gives thumbs up to Novartis psoriasis drug (Nov. 21)
- Previously: Ad Comm backs approval of secukinumab (Oct. 21)
Dec. 23, 2014, 7:20 AM
- The European Commission approves Alcon's (NYSE:NVS) Travatan (travaprost ophthalmic solution) to decrease elevated intraocular pressure in pediatric patients, aged two months to less than 18 years, with ocular hypertension or pediatric glaucoma.
- Travatan is currently indicated to decrease elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma.
- Pediatric glaucoma is responsible for 5% of childhood blindness worldwide. There is no cure for glaucoma and, if vision is lost, it cannot be restored.
Dec. 22, 2014, 4:26 PM
- Novartis (NYSE:NVS) and Vanda Pharmaceuticals (NASDAQ:VNDA) agree to settle their dispute over the rights to Fanapt (iloperidone) and to release each other from all related claims. Per the settlement agreement, Novartis will transfer all rights to Fanapt in the U.S. and Canada to Vanda, make a $25M equity investment in Vanda at a price of $13.82 per share and grant Vanda an exclusive worldwide license to AQW051, an alpha-7 nicotinic acetylcholine receptor partial agonist currently in Phase 2 development for the treatment of schizophrenia.
- Novartis originally licensed Fanapt in October 2009 but sales never took off.
- Previously: Vanda seeks award in Fanapt licensing dispute (July 17, 2014)
- Previously: Vanda Pharmaceuticals (VNDA -1.6%) dips after receiving a thumbs down from the European... (Dec. 14, 2012)
Dec. 22, 2014, 12:32 PM
- The Federal Trade Commission approves Eli Lilly's (LLY -1.7%) acquisition of Novartis' (NVS +0.7%) animal health unit on the condition that it divest the latter's Sentinel line of products for treating heartworm in dogs. The FTC required the sale because Lilly's Trifexis and Novartis' Sentinel are the only two canine heartworm medicines that are administered once per month, contain the same primary ingredient and treat other parasites at the same time.
- French firm Virbac SA will buy the Sentinel line.
- Previously: More color on Lilly/Novartis deal (April 22, 2014)
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)
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