Sep. 26, 2014, 10:57 AM
- The EMA's CHMP adopts a positive opinion supporting the marketing approval of Novartis' (NVS -0.1%) next-generation somatostatin analog (SSA) Signifor (pasireotide) long-acting release formulation for the treatment of adult patients with acromegaly for whom surgery is not an option or who have been curative but are inadequately controlled on treatment with a first-generation SSA.
- Approximately 45% of acromegaly patients remain inadequately controlled with first-gen SSAs.
- A final decision by the European Commission usually takes ~60 days.
- Signifor is currently cleared as a treatment for Cushing's disease.
Sep. 25, 2014, 10:41 AM
- Novartis' (NVS -0.2%) product candidate for the treatment of psoriatic arthritis, AIN457 (secukinumab), meets its primary and secondary endpoints versus placebo in two Phase 3 clinical trials. The company will present the results at an upcoming medical conference.
- Secukinumab is a fully human mAb that stops the action of IL-17A, a protein that stimulates inflammatory disease.
- It is also in clinical trials for the treatment of ankylosing spondylitis and rheumatoid arthritis. Regulatory filings are currently review in the U.S. and Europe for moderate-to-severe plaque psoriasis.
Sep. 22, 2014, 4:24 PM| Sep. 22, 2014, 4:24 PM | Comment!
Sep. 19, 2014, 8:48 AM
- In a 768-patient 215-site Phase 3 clinical trial, Novartis' (NYSE:NVS) investigational compound LBH589 (panobinostat) demonstrated a statistically significant (p<0.0001) and clinically relevant 4-month improvement in median progression-free survival (PFS) in patients with relapsed or relapsed and refractory myeloma when used in combination with bortezomib and dexamethasone compared to placebo in combination with bortezomib and dexamethasone.
- The addition of LBH589 also led to clinically meaningful increases in complete or near complete response rates and duration of response.
- LBH589 is a pan-DAC inhibitor. If approved, it will be the first epigenetic regulator approved for relapsed or relapsed and refractory multiple myeloma.
Sep. 19, 2014, 7:18 AM
- The European Commission approves Novo Nordisk's (NYSE:NVO) Xultophy for the treatment of adult patients with type 2 diabetes to improve glycemic control in combination with oral glucose-lowering medicines when these alone or combined with basal insulin do not provide adequate glycemic control.
- Xultophy (IDegLira) is a once-daily injection combination of insulin degludec (Tresiba) and liraglutide (Victoza).
- Novo plans to launch the product in Europe in 1H 2015.
- Related tickers: (NYSE:NVS) (NYSE:LLY) (NYSE:MRK) (NYSE:SNY) (NYSE:AZN) (NYSE:GSK)
Sep. 18, 2014, 4:03 PM
- The FDA approves Eli Lilly's (LLY +1.1%) Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
- Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels.
- Related tickers: (NVS +0.1%) (MRK +0.7%) (SNY +0.7%)(AZN +1.3%)(GSK +0.4%)
Sep. 12, 2014, 12:30 PM
- When the FDA finally opens the door for biosimiars in the U.S. it could save as much as $250B per year by 2024 according to Express Scripts (ESRX -1.3%). There are 14 biotech meds being targeted by pharmaceutical firms who want to sell cheaper versions. Novartis (NVS -0.7%) submitted the first filing with the FDA in July for its version of Amgen's (AMGN -0.9%) Neupogen (filgrastim). Regulatory clearance could happen as early as March 2015.
- Drug companies have sought at least 76 meetings with the FDA to discuss the requirements to bring 14 different biosimilar drugs to market. Nothing will happen quickly, though. Work remains on how to name generics that are a little different from the branded versions due to different cell lines used to create them and how to design clinical studies the prove they can be safely swapped with the originals.
- The U.S. is far behind Europe. The EC began approving biosimilars in 2006. A generic version of Neupogen was cleared in 2008.
- A second biosimilar approved by the FDA may be Celltrion's version of J&J's (JNJ -0.2%) arthritis drug Remicade (infliximab). It filed its application last month.
- ETFs: DRGS
Sep. 8, 2014, 7:59 AM
- Ophthotech (NASDAQ:OPHT) achieves the first enrollment goal in its pivotal multi-national Fovista (anti-PDGF) Phase 3 clinical trial triggering a $50M milestone payment from commercialization partner Novartis Pharma AG (NYSE:NVS). It is the first of a potential total of $130M in enrollment-based milestones under the agreement.
- Fovista is an anti-platelet-derived growth factor compound being studied in combination with anti-vascular endothelial growth factor (VEGF) therapy for the treatment of wet age-related macular degeneration.
- Novartis has commercial rights to Fovista ex-U.S. while Ophthotech retains the rights in the U.S. Potential payments to Ophthotech could reach $1B, including the $200M upfront payment it received when the contract was signed.
Sep. 7, 2014, 1:41 PM
- In a 26-week 56-site double-blind parallel-group study conducted across China, Argentina, Chile and Taiwan, Novartis' (NYSE:NVS) once-daily Ultibro Breezhaler (indacaterol/glycopyrronium bromide) was superior in reducing exacerbations and improving lung function compared to GlaxoSmithKline's (NYSE:GSK) twice-daily Seretide Accuhaler (salmeterol/fluticasone) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
- The study showed Ultibro Breezhaler reduced the rate of moderate-to-severe exacerbations by 31% compared to Seretide Accuhaler in COPD patients with a history of one exacerbation or none in the previous year. Ultibro patients also had a statistically significant improvement in lung function compared to Seretide after 26 weeks of treatment.
- The results support the use of Ultibro Breezhaler as an alternative steroid-free treatment to Seretide Accuhaler in patients with moderate-to-severe COPD.
- The results of the study, called LANTERN, were presented at this week's European Respiratory Society International Congress in Munich, Germany.
Sep. 1, 2014, 8:20 AM
- EU antitrust authorities will decide whether to clear Eli Lilly's (NYSE:LLY) $5.4B offer for Novartis' animal health division (NYSE:NVS) by Oct. 3.
- The acquisition is part of several deals recently announced in the healthcare industry, and would create the world's second-largest animal health company.
Aug. 30, 2014, 12:05 PM
- In the largest study of its kind ever done, Novartis' (NYSE:NVS) investigational heart failure drug candidate, LCZ696, demonstrated superiority over the ACE-inhibitor enalapril on several key endpoints.
- LCZ696 reduced the risk of death from cardiovascular disease by 20%, reduced heart failure hospitalizations by 21% and reduced the risk of all-cause mortality by 16%. All the results were highly statistically significant.
- The twice-daily tablet acts to enhance the protective neurohormonal systems of the heart while simultaneously suppressing the harmful system. Current therapies act only to block the harmful effects.
- Novartis intends to submit its NDA to the FDA by the end of 2014 and its MAA to the EC in early 2015.
- Related tickers: (NYSE:VRX) (NYSE:TEVA) (NASDAQ:MYL) (NYSE:TARO) (NYSE:RDY)
Aug. 29, 2014, 11:52 AM
- Shares of United Therapeutics (UTHR +23.1%) jump on 5x surge in volume after a court rules that Sandoz (NVS +0.3%) failed to prove that United's '007 and '117 Remodulin (treprostinil) patents are invalid and that United proved that Sandoz's ANDA will infringe on patent '117.
- Remodulin accounted for almost 45% of United's 1H sales of $612.2M.
Aug. 29, 2014, 10:29 AM
- The FDA approves InnoPharma's ANDA for decitabine for injection, a generic version of Eisai's Dacogen. Sandoz (NVS -0.2%) will market and distribute the product in the U.S.
- Decitabine is a treatment for patients with myleodysplastic syndromes (bone marrow disorders).
- InnoPharma is in the process of being acquired by Pfizer (PFE). The deal was announced on July 16, 2014.
Aug. 20, 2014, 1:22 PM
- A federal judge issues a temporary restraining order against the FDA's decision to allow the sale of generic versions of Hospira's (HSP +1.4%) sedative Precedex (dexmedetomidine HCL injection) In its lawsuit filed yesterday, Hospira claims that the agency violated its own rules by allowing generic firms to launch competing products as long as the labeling omitted information about the drug's uses (intensive care unit sedation) covered by Hospira's patent.
- In his order, Judge Jarrod Hazel says that Hospira would likely win its suit because the FDA's decision as "at odds with relevant authority" and "tantamount to a change of the rules."
- Generic firm Sandoz (NVS +0.3%) intervened on Hospira's behalf because the ruling would deprive it of the six-month exclusivity it negotiated in its patent infringement settlement with Hospira in December.
- Related ticker: (MYL +2.8%)
Aug. 20, 2014, 10:06 AM
- Novartis (NVS -0.2%) signs a licensing agreement with the Global Alliance for TB Drug Development for its experimental tuberculosis drugs that have been discovered at the Novartis Institutes for Tropical Diseases. Among the product candidates is a class of meds called indolcarboxamides which target drug resistant and multi-resistant strains of TB. One of the compounds, NITD304, works by blocking a protein this is essential for the TB bacterium's survival.
- The company did not ask for an upfront or milestone payments.
- The move reflects Novartis' intent to concentrate its research on its core areas of cancer, respiratory, heart failure and dermatology.
Aug. 19, 2014, 1:17 PM
- Boehringer Ingelheim commences patient enrollment in its international Phase 3 trial evaluating the safety and efficacy of its oral anticoagulant dabigatran etexilate in patients with non-valvular atrial fibrillation (AF) who have undergone a percutaneous coronary intervention (PCI) with stent placement. Patients in this population have a higher risk of stroke due to blood clots from the heart and from the stent.
- The 8,500-patient study will compare dabigatran etexilate plus clopidogrel or ticagrelor versus the current standard triple antithrombotic therapy of warfarin plus clopidogrel or ticagrelor plus acetylsalicylic acid.
- Related tickers: (BMY -0.2%) (MRK +0.1%) (NVS +1.2%) (AZN +0.3%)
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