Mon, Mar. 30, 7:06 PM
- The FDA approves Novartis' (NYSE:NVS) Jadenu (deferasirox), a new formulation of Exjade (deferasirox), for the treatment of patients at least two years old with chronic iron overload due to blood transfusions and patients at least 10 years old with chronic iron overload in non-transfusion-dependent thalassemia syndromes.
- Jadenu is a once-daily oral iron chelator (it removes iron from the body) in tablet form that can be swallowed whole with or without a light meal. This simplifies the administration of deferasirox which, in Exjade's case, has to be dissolved in liquid for precisely three minutes (timer needed), then immediately drunk at least 30 minutes prior to food, preferably at the same time each day.
- Exjade, the most prescribed chelator in the U.S., generates almost $1B ($926M the past four quarters) in sales for Novartis.
Mon, Mar. 30, 8:42 AM
- Novartis (NYSE:NVS) and privately-held Aduro Biotech establish a collaboration for the research, development and commercialization of novel immuno-oncology products based on Aduro's cyclic dinucleotides (CDN), small molecules that activate the STING (Stimulator of Interferon Genes) signaling pathway in immune cells. Preclinical testing has shown promising therapeutic activity of CDNs.
- Under the terms of the agreement, Aduro will receive an upfront payment of $200M and milestones of up to $500M. Novartis will also make a 2.7% equity investment in Aduro for $25M with a commitment to invest an additional $25M at a future date.
Mon, Mar. 23, 4:26 PM
- According to Thomson Reuters' 2015 Drugs to Watch report, as many as 11 blockbuster drugs (peak sales of at least $1B within five years) are expected to clear the regulatory process this year. This is a significant jump from 2014's tally of three (Gilead's (NASDAQ:GILD) Sovaldi and Zydelig; Glaxo (NYSE:GSK) and Theravance's (NASDAQ:THRX) Anoro Ellipta). In reverse order (forecasted 2019 consensus sales in parentheses):
- 11. Novartis' (NYSE:NVS) Cosentyx (secukinumab) for psoriasis and psoriatic arthritis ($1.08B); 10. Sanofi's (NYSE:SNY) Toujeo (insulin glargine) for diabetes ($1.26B); 9. Otsuka Pharmaceutical (OTCPK:OTSKY) and Lundbeck's (OTCPK:HLUYY) Brexpiprazole for schizophrenia and depression ($1.35B); 8. Merck's (NYSE:MRK) Gardisil 9 HPV vaccine ($1.64B); 7. Amgen's (NASDAQ:AMGN) evolocumab for hypercholesterolemia/hyperlipidemia ($1.86B); 6. AbbVie's (NYSE:ABBV) Veikira Pak for hepatitis C (cleared 12/19/14) ($2.5B); 5. Vertex Pharmaceuticals' (NASDAQ:VRTX) lumacaftor plus ivacaftor for cystic fibrosis ($2.74B); 4. Pfizer's (NYSE:PFE) Ibrance (palbociclib) for breast cancer ($2.76B); 3. Novartis' LCZ696 for chronic heart failure ($3.73B); 2. Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) for hypercholesterolemia ($4.41B) and 1. Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for melanoma ($5.68B).
Fri, Mar. 20, 3:56 PM
- Following up on its December announcement about its comparative clinical trial evaluating Cosentyx (secukinumab) versus Janssen's (JNJ +0.7%) Stelara (ustekinumab) for the treatment of moderate-to-severe plaque psoriasis, Novartis (NVS +1.8%) presented more detailed data from the study during a research session at the American Academy of Dermatology meeting in San Francisco.
- Cosentyx showed superiority to Stelara as measured by the proportion of patients achieving a PASI 90 score (subjective improvement of 90%) at Week 16 (79.0% vs. 57.6%; p<0.0001). On the basis of PASI 100 score (completely clear skin), the results also favored Cosentyx (44.3% vs. 28.4%; p<0.0001). In addition, the proportion of patients achieving PASI 75 by Week 4 was 50.0% vs. 20.6%; p<0.0001) in favor of secukinumab.
- Secukinumab is a human monoclonal antibody that inhibits interleukin-17A, a protein found in high concentrations in psoriatic skin. Both the FDA and European Commission (EC) cleared it for the indication in January.
- Previously: Novartis' Cosentyx beats Stelara in Phase 3 trial (Dec. 12, 2014)
Fri, Mar. 20, 7:56 AM
- The U.S. District Court of San Francisco denies Amgen's (NASDAQ:AMGN) preliminary injunction to block the sale of Novartis' (NYSE:NVS) Zarxio, a biosimilar of the former's $1.2B Neupogen (filgrastim) that was approved by the FDA several weeks ago, the first biosimilar to clear the regulatory hurdle in the U.S. Amgen intends to appeal the decision.
- Novartis previously agreed to delay Zarxio's U.S. launch until the court's decision or April 10, whichever came first. If it proceeds with the launch and Amgen wins its appeal, it would have to pay costly damages. In a statement, Novartis said, "Given the importance of this case for future biosimilars, we agreed with Amgen before this hearing to jointly request expedited review of any appeal to the Federal Circuit." It is unknown how long Amgen's appeal will take.
- Previously: FDA clears first biosimilar (March 6)
Wed, Mar. 18, 7:45 AM
- Two 24-week Phase 3 trials (PINNACLE 1 & 2) evaluating AstraZeneca's (NYSE:AZN) PT003 in patients with chronic obstructive pulmonary disease (COPD) achieved their primary efficacy endpoints of statistically significant improvement in lung function compared to placebo.
- PT003 is a twice-daily fixed-dose combination of glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-2 agonist (LABA). It is the first LAMA/LABA combination to be delivered in a pressurized metered dose inhaler using the porous particle co-suspension technology developed by Pearl Therapeutics, which AZN acquired in 2013. The successful outcomes of the PINNACLE studies are the first from a series of pipeline candidates using Pearl's technology.
- PT003 was assessed in over 3,700 patients in over 275 study sites. The primary efficacy endpoint was trough forced expiratory volume in one second (FEV1). PT003 demonstrated statistically significant improvements in FEV1 versus placebo and the individual components glycopyrronium (PT001) and formoterol fumarate (PT005). PT001 and PT005 also showed statistically significant improvements in FEV1 compared to placebo.
- The company plans to file regulatory applications beginning this year. It will present the study results at a scientific meeting later this year.
- Related tickers: (NYSE:GSK) (NASDAQ:THRX) (NYSE:NVS) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
Tue, Mar. 17, 7:35 AM
- The European Commission approves Novartis' (NYSE:NVS) Jakavi (ruxolitinib) for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea. Polycythemia vera is a rare blood cancer associated with the overproduction of blood cells, principally red blood cells. It is caused by a mutation in the Janus kinase 2 (JAK2) gene. It affects ~180K people in the European Union.
- The goal of treatment is to reduce the thickness of the blood and prevent bleeding and clotting. If left untreated, the disorder can lead to blood clots, stroke and heart attack. About 25% of PV patients develop resistance to or intolerance of hydroxyurea and are considered to have uncontrolled disease.
- Jakavi is an oral inhibitor of the JAK1 and JAK2 tyrosine kinases. It was previously approved for the treatment of myelofibrosis, a disorder of the bone marrow in which the marrow is replaced by scar tissue.
- Novartis licensed ruxolitinib from Incyte (NASDAQ:INCY) for development and commercialization ex-U.S. Incyte retains commercialization rights in the U.S.
Tue, Mar. 10, 7:48 AM
- Ophthotech (NASDAQ:OPHT) earns a $50M enrollment milestone from commercial partner Novartis (NYSE:NVS) for reaching the second enrollment goal in its Phase 3 trial evaluating Fovista (anti-platelet-derived growth factor) in combination with anti-vascular endothelial growth factor (VEGF) therapy for the treatment of wet age-related macular degeneration (AMD).
- The company will record $40.6M of the payment as revenue in Q1. The remaining $9.4M will be deferred and recognized as revenue on a proportional basis through 2017.
- Under the terms of the license and commercialization agreement signed in May 2014, Novartis has exclusive rights to Fovista in all markets ex-U.S. while Ophthotech retains exclusive rights in the U.S. Potential payments to Ophthotech could reach over $1B, not including royalties on ex-U.S. net sales. The company expects Fovista to be the first anti-PDGF therapy approved for wet AMD.
- Previously: Ophthotech earns $50M milestone (Sept. 8, 2014)
- Previously: Novartis acquires rights to ophthalmic drug (May 19, 2014)
Tue, Mar. 10, 3:55 AM
- Prescription drug spending rose by a record 13% in the U.S. last year, the biggest annual increase in over a decade.
- "For the past several years, annual drug spending increases have been below the annual rate of overall health-care inflation in the U.S.," said Glen Stettin, senior vice president at Express Scripts. "But that paradigm is shifting dramatically as prices for medications increase at an unsustainable rate."
- Spending on specialty medicines, such as those for inflammatory diseases, multiple sclerosis, cancer and hepatitis C rose an unprecedented 31%.
Fri, Mar. 6, 9:12 AM
- The FDA approves Sandoz's (NYSE:NVS) Zarxio, a biosimilar to Amgen's (NASDAQ:AMGN) Neupogen (filgrastim), for the same indications as Neupogen.
- Zarxio is approved for the treatment of patients with cancer receiving myelosuppressive chemotherapy, patients with acute myeloid leukemia receiving induction or consolidation chemotherapy, patients with cancer undergoing bone marrow transplantation, patients undergoing autologous peripheral blood progenitor cell collection and therapy and patients with severe chronic neutropenia.
- The placeholder nonproprietary name for Zarxio is "filgrastim-sndz."
- Previously: FDA Ad Comm gives thumbs up to Sandoz biosimilar filgrastim (Jan. 7)
- Related tickers: (NYSEMKT:PFNX) (NASDAQ:ESPR) (NYSE:HSP) (NASDAQ:CHRS)
Thu, Mar. 5, 8:06 AM
- Arrowhead Research (NASDAQ:ARWR) acquires Novartis' (NYSE:NVS) RNA interference (RNAi) R&D portfolio and associated assets, including certain patents and patent applications, an exclusive license to other patents and patent applications owned or controlled by Novartis, the assignment of a third party license and three preclinical product candidates.
- Specific assets include multiple patent families covering RNAi-trigger design rules and modifications that fall outside of competitors' patents which provides Arrowhead freedom to operate for any target or indication, the assignment of Novartis' license from Alnylam (NASDAQ:ALNY) that gives Arrowhead access to Alnylam IP, excluding delivery, covering 30 gene targets and three product candidates with varying amounts of preclinical data.
- Under the terms of the agreement, Arrowhead will pay $10M in cash (includes $7M paid previously) and $25M in ARWR stock within 30 days. Novartis is eligible to receive milestones and single-digit royalties on net sales.
- Arrowhead will host a conference call this morning at 8:30 am to discuss the deal.
Wed, Mar. 4, 11:39 PM
- Both boards have signed off on AbbVie's (NYSE:ABBV) $21B surprise acquisition of Pharmacyclics (NASDAQ:PCYC), announced a short while ago amid speculation that Johnson & Johnson (NYSE:JNJ) (or, earlier, Novartis (NYSE:NVS)) would be the one to acquire the cancer biotech.
- With the deal, AbbVie gets Pharmacyclics' blockbuster Imbruvica drug for hematologic malignancies -- which logged $548M in revenues in 2014 (Q4 earnings) and might go all the way to $5B/year. Imbruvica has received four indications in less than 15 months -- the latest being for Waldenström's Macroglobulinemia at the end of January.
- And with Imbruvica, AbbVie can lessen its reliance on its key drug Humira, an aging rheumatoid arthritis medication.
- The acquisition is expected to close in the middle of the year.
- Question: What happened to Pharmacyclics' Imbruvica partner JNJ on this deal?
- Previously: Pharmacyclics Q4 revenue up 135%, Imbruvica growing exponentially (Feb. 18 2015)
Mon, Mar. 2, 2:58 AM
- GlaxoSmithKline (NYSE:GSK) and Novartis (NYSE:NVS) have completed a series of asset swaps worth more than $20B that will reshape both drugmakers.
- Glaxo is forming a consumer health joint venture with Novartis, while at the same time buying the Swiss company's vaccines business and divesting its cancer drugs portfolio to Novartis.
- Following completion of the transactions, Glaxo plans to return £4B ($6.16B) to shareholders.
- Previously: Novartis announces billions of dollars in deals with GSK, Eli Lilly (Apr. 22 2014)
Fri, Feb. 27, 3:26 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion for Novartis' (NVS -0.4%) Zykadia (ceritinib) for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib (Pfizer's Xalkori). If approved, it will be the first treatment option for ALK+ NSCLC patients previously treated with crizotinib in the E.U.
- NSCLC is the most common form of lung cancer, accounting for 85 - 90% of all cases worldwide. Of those, 2 - 7% are characterized by a rearrangement of the ALK gene, which increases the growth of cancer cells.
- A final decision by the European Commission usually takes ~60 days.
- The FDA approved Zykadia for ALK-positive NSCLC patients in April of last year.
- Previously: FDA approves Novartis breakthrough therapy cancer drug (April 29, 2014)
Fri, Feb. 27, 11:56 AM
- By order of the Japanese Ministry of Health, Labor and Welfare, Novartis' (NVS -0.3%) Japanese unit will suspend its operations for 15 days in March (5th - 19th) as punishment for not reporting side effects from its products in a timely fashion. The ministry stated that the company failed to report 3,264 cases of side effects pertaining to 26 drugs within the time frame specified by law.
- Novartis Japan has accepted the punishment and apologized to patients and doctors for "causing trouble and worry." It also said that it bolstered employee education to ensure that safety reports are submitted correctly.
- This is the first time the ministry has issued a suspension for failure to report side effects.
Wed, Feb. 25, 1:43 PM
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