Today, 8:18 AM
- Results from an open-label Phase 3 study, ASCEND-4, evaluating Novartis' (NYSE:NVS) Zykadia (ceritinib) for the first-line treatment of patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) showed a significant improvement in progression-free survival (PFS) compared to chemotherapy. The data are being presented at the 17th World Conference on Lung Cancer in Vienna, Austria.
- Patients treated with Zykadia experienced median PFS of 16.6 months versus 8.1 months (p<0.001) for patients treated with standard first-line chemo with maintenance with 45% less risk of disease progression (hazard ratio = 0.55).
- The overall response rate also favored Zykadia, 72.5% vs. 26.7%.
- Zykadia's safety profile was consistent with earlier studies. The most common adverse events, mostly mild or moderate, were diarrhea (84.7%), nausea (68.8%), vomiting (66.1%), ALT increase (60.3%) and AST increse (52.9%). ALT and AST are liver enzymes that are biomarkers for liver stress.
Yesterday, 9:32 AM
- A Phase 3 study, BFORE, assessing Pfizer's (PFE -0.6%) BOSULIF (bosutinib) compared to Novartis' (NYSE:NVS) Gleevec (imatinib mesylate) for the first-line treatment of patients with chronic phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) met its primary endpoint of showing BOSULIF's superiority as measured by major molecular response at month 12.
- Pfizer will pursue global regulatory approvals for the expanded use.
- BOSULIF is currently approved in the U.S. and EU for patients with Ph+ CML resistant to or intolerant of prior therapy. Bosutinib is an oral once-daily tyrosine kinase inhibitor that interferes with an enzyme called Bcr-Abl kinase which promotes CML. It was first approved in the U.S. in September 2012.
Yesterday, 2:53 AM
- Novartis (NYSE:NVS) CEO Joe Jimenez has played down suggestions the drugmaker could bid for Swiss biotech group Actelion (OTCPK:ALIOY), which is in talks with Johnson & Johnson (NYSE:JNJ) about a transaction.
- Asked by SonntagsBlick whether Novartis could emerge as a white knight, he said: "We have always said that we will concentrate on complementary acquisitions in the range of $2B-$5B."
- Actelion is worth nearly $20B at Friday's closing price.
Sun, Dec. 4, 3:54 PM
- Results from a Phase 2 clinical trial, SUSTAIN, assessing Novartis' (NYSE:NVS) crizanlizumab (SEG101) for the treatment of sickle cell-related pain crises (SCPC) showed a significant treatment benefit. The data were presented at the 58th American Society of Hematology (ASH) annual meeting in San Diego and published simultaneously in The New England Journal of Medicine.
- The 198-subject three-arm study met its primary endpoint by demonstrating a statistically significant reduction in the annual rate of SCPC compared to placebo. In the high-dose (5.0 mg/kg) arm, the relative reduction in SCPC was 45.3% (p=0.01) and 32.6% in the low-dose (2.5 mg/kg) arm (p=0.18). Time-to-first SCPC was 2.9x and 2.0x longer, respectively, in the two arms compared to placebo.
- Treatment-related adverse events that were elevated at least 2x over placebo were arthralgia, pruritis, vomiting, chest pain, diarrhea, fatigue, myalgia, musculoskeletal chest pain, abdominal pain, influenza, oropharyngeal pain and road traffic accident.
- Crizanlizumab is a humanized monoclonal antibody that binds to P-selectin, a protein found on the surface of endothelial cells and platelets. P-selectin drives the vaso-occlusive process, a painful complication of sickle cell disease that occurs when the circulation of blood vessels is obstructed by sickled red blood cells. One of the most severe forms of SCPC is acute chest syndrome which occurs when blood flow to the lungs is restricted.
- The company obtained the rights to the product candidate via its recent acquisition of Selexys Pharmaceuticals, following through on an option to buy the company it held since 2012. Its development is ongoing.
Sun, Dec. 4, 12:19 PM
- Results from a pivotal Phase 2 study, ELIANA, evaluating Novartis' (NYSE:NVS) CAR T candidate, Breakthrough Therapy-tagged CTL019, showed an 82% complete remission rate (n=41/50) in pediatric and young adults with relapsed/refractory B-cell lymphoblastic leukemia. The data were presented at the 58th American Society of Hematology (ASH) annual meeting in San Diego.
- The primary endpoint of the study was overall remission rate (complete remission + complete remission with incomplete blood count recovery three months after infusion with CTL019) at Month 6. There was no minimal residual disease detected in any of the 41 complete responders. The estimated relapse-free rate among the responders was 60% six months after infusion.
- Grade 3 (severe) or grade 4 (life threatening) cytokine release syndrome (cytokine storm) was observed in 48% (n=24/50) of patients. No treatment-related deaths occurred. 15% of patients experience grade 3 neurological and psychiatric events including encephalopathy (brain disturbance) and delirium.
- 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 intends to file a Biologics License Application (BLA) in the U.S. in early 2017 followed by a marketing application in Europe sometime later.
Sat, Dec. 3, 9:03 AM
- Rather than chase surging stocks at fancy valuations, the team at Barron's looked for laggards when making its picks, writes Andrew Bary.
- The names, nevertheless, aren't exactly unfamiliar ones: Alphabet (GOOG, GOOGL), Apple (NASDAQ:AAPL), Citigroup (NYSE:C), Delta Air Lines (NYSE:DAL), Deutsche Telekom (OTCQX:DTEGY), Merck (NYSE:MRK), Novartis (NYSE:NVS), Toll Brothers (NYSE:TOL), Unilever (NYSE:UL), Disney (NYSE:DIS).
- Eight of these ten are trailing the S&P 500 this year, including the three European stocks (Deutsche Telekom, Novartis, and Unilever), and all of the names except Google sell for less than 20x 2017 estimates.
- At just 10x earnings, Toll Brothers, Citi, and Delta are better ways to play an improving economy than Caterpillar at nearly 30x.
- As for the "pricey" Google, it's an example of the Buffett maxim that he'd rather buy a wonderful business at a fair price rather than a fair business at a wonderful price.
- Barron's top picks for 2016 as a group are trailing the S&P 500 by more than 600 basis points.
Mon, Nov. 28, 5:49 PM
- Akorn (NASDAQ:AKRX) perks up 2% after hours on light volume in response to its announcement that the U.S. Patent Office's Patent Trial and Appeals Board (PTAB) ruled in its favor in its inter partes review of U.S. Patent No. 6,114,319 covering Alcon's (NYSE:NVS) Durezol (difluprednate ophthalmic emulsion).
- The ruling paves the way for full FDA approval of Akorn's Abbreviated New Drug Application (ANDA) for a generic version of the drug. It was the first to file an ANDA so it will have a 180-day period of market exclusivity after approval before other generics can enter the market.
- According to IMS Heath, Durezol sales in the U.S. are ~$190M.
Wed, Nov. 23, 3:43 PM
- The potential haircut to future revenue that PDL BioPharma (PDLI -15.2%) faces from Eli Lilly's (LLY -10.5%) solanezumab flop was already priced into the stock says RBC's Adnan Butt. PDL was eligible to receive royalties on solanezumab sales.
- He calls the sell-off an "overreaction" and adds that the most significant near-term catalyst is Novartis' (NVS +1%) hypertension drug Tekturna (aliskiren), which the company owns a piece of through its initial $75M equity investment in Noden Pharma DAC (Noden acquired global rights from Novartis). PDL expects to invest an additional $64M by next year.
Mon, Nov. 21, 8:58 AM
- BioLineRx (NASDAQ:BLRX) in-licenses a novel anti-inflammatory treatment for dry eye syndrome (DES) from Hebrew University of Jerusalem. The product candidate, BL-1230, is the third project in the company's strategic collaboration with Novartis Pharma AG (NYSE:NVS).
- BL-1230 is a selective cannabinoid receptor type 2 (CB2R) agonist. BioLineRx plans to explore its use in treating systemic inflammatory conditions as well.
- The financial terms of the license are not disclosed.
Mon, Nov. 21, 4:44 AM
- Expanding its pipeline of medicines to combat blood diseases, Novartis (NYSE:NVS) is buying Selexys Pharmaceuticals, a research lab in blood and inflammatory disorders, for $665M.
- The deal has been in the works since 2012, when Novartis obtained the option to buy Selexys and its sickle cell disease drug SelG1, depending on how its trials fared.
Fri, Nov. 18, 8:28 AM
- Seventh Sense Biosystems receives a $10M funding round from a group of investors that includes Novartis (NYSE:NVS) and LabCorp (NYSE:LH). The Medford-MA-based firm is developing a disposable blood collection device called Touch Activated Phlebotomy which used microscopic needles to collect a fingerstick-sized blood sample.
- Controversial diagnostic start-up Theranos tried to develop a similar product before crashing amid investigations and failed operations.
Thu, Nov. 17, 6:59 AM
- Britain's advisor to its National Health Service (NHS), the National Institute for Health and Care Excellence (NICE) continues its success with corralling prices from drug makers. Roche (OTCQX:RHHBY) and Bristol-Myers Squibb (NYSE:BMY) are the latest to extend discounts for access to the NHS.
- Roche cut the price to breast cancer drug Perjeta earlier this year as did BMY with leukemia med Sprycel.
- Novartis (NYSE:NVS) and Pfizer (NYSE:PFE) have also offered increased discounts of late. The specific amounts are confidential, however.
Wed, Nov. 16, 6:41 PM
- A Phase 3 clinical trial, STRIVE, assessing Amgen's (NASDAQ:AMGN) erenumab (AMG 334) for the prevention of migraine met its primary endpoint of a statistically valid change from baseline in mean monthly migraine days at week 24 compared to placebo.
- STRIVE randomized participants to receive either 70 mg or 140 mg of erenumab or placebo administered subcutaneously once per month for six months. At baseline, patients were experiencing an average of 8.3 migraine days per month. At week 24, the average reductions in migraine days per month for the 70 mg, 140 mg and placebo arms were 3.2, 3.7 and 1.8, respectively.
- Erenumab's safety profile was comparable to placebo and was consistent with previous studies. The most common adverse events were nasopharyngitis, upper respiratory infection and sinusitis.
- The analysis of the data is ongoing. Detailed results will be submitted for publication and for presentation at a future medical conference.
- It was also successful in another Phase 3 study called ARISE. Regulatory submissions are on tap for 2017.
- Erenumab, a fully human monoclonal antibody, inhibits the calcitonin gene-related peptide (CGRP) receptor, which is believed to transmit signals that cause incapacitating pain. It is being co-developed with Novartis (NYSE:NVS). Amgen retains commercial rights in the U.S., Canada and Japan and Novartis has commercial rights elsewhere.
- Shares are up 1% after hours on average volume.
- Previously: Amgen's erenumab (AMG 334) successful in late-stage study in migraine prevention (Sept. 28)
Mon, Nov. 14, 10:02 AM
- The FDA accepts under Priority Review Novartis' (NVS -2.2%) New Drug Application (NDA) seeking approval of Breakthrough Therapy-tagged PKC412 (midostaurin) for the treatment of acute myeloid leukemia (AML) in newly diagnosed adults with a genetic mutation called FMS-like tyrosine kinase-3 (FLT3) and for the treatment of advanced systemic mastocytosis (SM).
- The late-stage data supporting the filing was generated in the RATIFY study which showed treatment with PKC412 plus standard chemo in FLT3-positive AML patients significantly extended overall survival compared to placebo plus chemo with 23% less risk of death (hazard ratio = 0.77; p=0.0074).
- Data from a Phase 2 study in SM showed a 60% response rate in the PKC412 cohort with a median duration of response of 24.1 months.
- The company's marketing application in Europe for these two indications is currently under review.
- Priority Review status shortens the review clock to six months from the standard 10 months.
- 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.
Mon, Nov. 14, 6:31 AM
- Novartis (NYSE:NVS) is in talks to acquire U.S. generic-drugs maker Amneal Pharmaceuticals as it seeks to bolster its Sandoz business amid consolidation in the industry.
- A sale of could value closely held Amneal at as much as $8B depending on the structure of the deal, sources told Bloomberg.
- NVS -1.3% premarket
Sun, Nov. 13, 8:00 AM
- Novartis (NYSE:NVS) is considering selling its struggling eye care division, Chairman Joerg Reinhardt told SonntagsZeitung, but all options - including a turnaround - are still on the table.
- The drugmaker has blamed a failure to innovate and inconsistent customer service for the problems at Alcon, a business that Novartis gradually bought from Nestle in deals totaling $51B.