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Sep. 3, 2015, 6:45 AM
- Wasting no time after the Appeals Court's decision not to intervene, Novartis' (NYSE:NVS) Sandoz unit launches Zarxio (filgrastim-sndz) in the U.S. It is the first biosimilar commercially available in America.
- Previously: Appeals court clears the way for Novartis' U.S. launch of Zarxio (Sept. 2)
Sep. 3, 2015, 4:41 AM
- Kicking off a new era in American medicine, Novartis (NYSE:NVS) has launched the first "biosimilar" copy of a biotechnology drug approved in the United States, following a green light from a U.S. appeals court.
- Biosimilars have been on the market in Europe since 2006, but the U.S. regulatory pathway for the drugs was only established by a healthcare reform in 2010.
- Novartis' Sandoz unit will now begin selling Zarxio, a knockoff version of Amgen's (NASDAQ:AMGN) Neupogen that was approved by the FDA in March.
Sep. 2, 2015, 1:41 PM
- The U.S. Court of Appeals for the Federal Circuit declines to stop Novartis (NVS +0.3%) from launching its biosimilar Zarxio in the U.S. Neupogen (filgrastim) maker Amgen (AMGN +0.7%) sought to extend the injunction by asking the court to clarify federal regulations on when biosimilars may be brought to market. The current injunction expires today.
- Biosimilars have been commercially available in Europe since 2006. Zarxio was approved by the FDA in March.
- Previously: Amgen shot down in attempt to bar Neupogen biosimilar in U.S. (July 21)
- Previously: FDA clears first biosimilar (March 6)
Sep. 2, 2015, 10:33 AM
- The FDA approves Tesaro's (TSRO +4.4%) VARUBI (rolapitant), in combination with other antiemetic agents, for the prevention of delayed nausea and vomiting associated with chemotherapy (CINV) in adult patients. Up to 50% of chemo patients experience delayed CINV (25 - 125 hours after treatment) even when taking a 5-HT3 receptor antagonist (Novartis' Zofran, formerly Glaxo's) and a corticosteroid.
- VARUBI, the company's first approved product, is an antagonist of human substance P/neurokinin 1 (NK-1) receptors with a plasma half-life of ~seven days. Phase 3 results showed a significant reduction in CINV or use of rescue medication when patients were administered a 180 mg dose one - two hours prior to chemo in combination with a 5-HT3 antagonist and dexamethasone.
- Related tickers: (NVS -0.1%)(HRTX +0.2%)(OPK +1%)(INSY +2.7%)(RDHL +1%) (OTC:ESALF) (OTCPK:ESALY) (GALE +0.6%)(GWPH +1.1%)(MRK -0.1%)
Sep. 2, 2015, 6:50 AM
- The European Commission approves the use of Novartis' (NYSE:NVS) Revolade (eltrombopag) for the treatment of adults with severe aplastic anemia (SAA) who are either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for hematopoietic stem cell transplant (IST). The approval is based on a pivotal mid-stage study that showed a 40% hematologic response in SAA patients treated with Revolade who failed to respond adequately to IST.
- SAA is a rare and life-threatening blood disorder where the bone marrow does not make enough red and white blood cells and platelets. It affects less than 2,000 Europeans each year.
- Revolade is cleared in over 100 countries for the treatment of thrombocytopenia (low blood platelets) in adults with chronic immune ideopathic thrombocytopenic purpura (ITP) (purple spots on the skin caused by internal bleeding from small blood vessels) who have had an inadequate response or are intolerant to other treatments and in over 45 countries for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy. Eltrombopag is marketed as Promacta in the U.S. for the treatment of SAA and children with chronic ITP who have failed to response adequately to other treatments.
Sep. 1, 2015, 5:28 PM
- Amgen (NASDAQ:AMGN) and Novartis (NYSE:NVS) enter into a collaboration agreement in neuroscience, specifically Alzheimer's disease (AD) and migraine.
- The agreement combines each firm's BACE (beta-site APP-cleaving enzyme-1) programs in AD into a global co-commercialization and co-development arrangement. Novartis' molecule, the Phase 1/2a-stage BACE inhibitor CNP520, will be the lead product candidate. Each company's preclinical BACE inhibitor programs will generate potential follow-ons. Amgen will make upfront and milestone payments and will be responsible for a majority of the R&D costs for an agreed-upon period. Thereafter, the partners will share costs and profits equally.
- BACE initiates the production of beta amyloid, the primary constituent of amyloid plaques which are believed to play a key role in the development of AD. Inhibiting BACE could potentially reduce the production of amyloid plaques.
- In the migraine space, Novartis will have global co-development rights and commercial rights, exclusive of the U.S., Canada and Japan, to Amgen's investigative molecules in its migraine portfolio, including AMG 334 and AMG 301. It will also have the option to commercialize an additional early-stage Amgen molecule in its territories. Novartis will fund the majority of global R&D expenses for an agreed-upon period and pay Amgen double-digit royalties on commercial sales.
- Specific financial terms of the deal are not disclosed.
Sep. 1, 2015, 7:13 AM
- As expected, the European Commission approves the combination of Novartis' (NYSE:NVS) Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation, the most aggressive form of skin cancer. There are ~100K new cases worldwide each year.
- In clinical studies, the combination slowed tumor growth more effectively than either drug alone.
- The FDA granted Priority Review for the same patient population in July. The combination has been cleared in the U.S. since January 2014 for the treatment of BRAF V600E/K mutation-positive unresectable or metastatic melanoma.
- Previously: Europe's CHMP backs Novartis' Tafinlar and Mekinist for BRAF-positive melanoma (July 24)
Aug. 24, 2015, 2:13 PM
- The FDA has approved a label expansion for Novartis' (NYSE:NVS) Promacta (eltrombopag), a treatment for chronic immune thrombocytopenia (ITP) -- a rare blood disorder -- to include children 1 year or older who aren't responding sufficiently to other treatment.
- The product, which uses Captisol platform technology from Ligand Pharmaceuticals (NASDAQ:LGND), was approved in June for children 6 years and older, and in 2008 for adults.
- The new label includes an oral suspension formulation, better for younger children who might not be able to swallow tablets.
- Ligand is up 0.5%; Novartis is trading down 1.5%.
Aug. 21, 2015, 3:29 AM
- Novartis (NYSE:NVS) has agreed to buy all remaining rights to an experimental drug from GlaxoSmithKline (NYSE:GSK) for as much as $1B, bolstering the Swiss drugmaker's stable of treatments for multiple sclerosis.
- Novartis will pay $300M upfront to Glaxo for ofatumumab, followed by another $200M after late-stage clinical trials, and may pay another $534M if certain milestones are met during the drug's development.
Aug. 20, 2015, 7:10 AM
- The European Commission approves Novartis' (NYSE:NVS) Odomzo (sonidegib) for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.
- BCC, accounting for more than 80% of non-melanoma skin cancers, consists of abnormal, uncontrolled lesions that arise from the basal cells of the skin. Advanced BCC accounts for as many as 10% of all BCC cases.
- Odomzo is a once-daily pill that inhibits the molecular pathway called Hedgehog. It will compete with Roche's (OTCQX:RHHBY) Erivedge (vismodigib), an antagonist of part of the hedgehog signaling pathway called smoothened receptor, approved in January 2012. It will generate ~$175M in sales this year. The FDA cleared Odomzo about a month ago.
- Previously: FDA clears Novartis' Odomzo for skin cancer (July 24)
Aug. 17, 2015, 6:58 AM
- Nano cap AVEO Oncology (NASDAQ:AVEO) enters into an exclusive worldwide license agreement with Novartis (NYSE:NVS) for the development and commercialization of AV-380, AVEO's humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), and related antibodies.
- GDF15 is a pro-inflammatory cytokine whose elevated circulating levels have been associated with cachexia (weakness and wasting of the body) in cachectic cancer patients. Preclinical data show that inhibiting GDF15 may reverse the effects of cachexia by switching from catabolism (destructive metabolism) to anabolism (constructive metabolism).
- Under the terms of the agreement, AVEO will receive an upfront payment of $15M, potential milestones totaling $311M and tiered royalties from high single-digit to low double-digit. Novartis will be responsible for all clinical development, manufacturing and commercialization activities and costs.
- Cachexia, a serious complication in advanced cancers and other chronic diseases, affects ~5M Americans.
- Shares are up 126% premarket on robust volume.
Aug. 14, 2015, 12:00 PM
- Nano cap Prima BioMed (PBMD +42.5%) jumps on a 9x surge in volume in response to its announcement that it will receive an disclosed clinical milestone payment from Novartis (NVS) related to the Phase 1 study of its IMP701 LAG-3 antibody for the treatment of cancer.
- The license and collaboration agreement was signed in September 2012 between Immutep (acquired by Prima in December 2014) and CoStim Pharmaceuticals (acquired by Novartis in February 2014).
- Prima is eligible to receive additional development-related milestones and royalties on commercial sales.
- IMP701 binds to LAG-3 (Lymphocyte Activation Gene 3), an antibody that plays a key role in controlling the signaling pathways in both effector T cells and regulatory T cells. Binding to LAG-3 removes two brakes that prevent the immune system from responding to and killing cancer cells.
Aug. 12, 2015, 12:11 PM
- RBC Capital's Michael Yee maintains his Outperform rating on Amgen (AMGN -1.2%) with a price target of $190 (14% upside). His rationale is based on the potential for a delay in the U.S. launch of the Neulasta (pegfilgrastim) biosimilar from Toronto, Canada-based Apotex, still under FDA review.
- He feels that there is a chance that the product will not be approved (unlikely) or Amgen's litigation will tie matters up until at least mid-2016 (likely). Amgen sued Apotex accusing it of infringing on two patents ('138 and '784). The case is scheduled to be heard in July 2016.
- Amgen is also accusing Apotex of violating the Biosimilar Price Competition and Innovation Act (BPCIA) by failing to provide 180-day effective notice of commercial marketing. Apotex has not provided the notice because its offering has not been cleared yet (FDA filing was December 2014). Amgen successfully employed this delaying tactic in its suit against Novartis' (NVS -0.9%) Sandoz unit over its Neupogen (filgrastim) biosimilar Zarxio, approved by the FDA in March but unable to be launched until September.
- Mr. Yee believes that the legal maneuverings will give Amgen sufficient time to convert many Neulasta customers to its on-body formulation even if it does not prevail in its case against Apotex.
Jul. 29, 2015, 8:52 AM
- In exchange for an equity stake, Novartis (NYSE:NVS) transfers three product candidates to UK-based Mereo BioPharma Group. The three are: BPS-804 for the treatment of brittle bone syndrome; BCT-197 for acute exacerbations in chronic obstructive pulmonary disease (COPD) and BGS-649 for normalize testosterone levels in obese men with hypogonadotrophic hypogonadism.
- Under the terms of the agreement, Novartis will share on milestones and royalties on future commercial sales.
Jul. 28, 2015, 10:08 AM
- The European Medicines Agency validates Teva Pharmaceutical Industries' (TEVA -1.6%) Marketing Authorization Application (MAA) for reslizumab for the treatment of inadequately controlled asthma in adult patients with elevated blood eosinophils despite an inhaled corticosteroid-based regimen. A final decision by the European Commission is anticipated in H2 2016.
- Reslizumab is an investigational humanized monoclonal antibody that binds to interleukin-5 (IL-5), a cytokine that plays a key role in the activation and growth of eosinophils, a type of white blood cell that is elevated in the lungs and blood of many asthmatics. High levels of eosinophils correlate with disease severity so binding to IL-5 inhibits its ability to stoke eosinophil levels.
- Teva's Biologics License Application (BLA) is currently under review by the FDA. A decision is expected in March 2016.
- Asthma-related tickers: (SNY -0.1%)(GSK -0.4%)(AZN -0.7%)(OTCQX:RHHBY)(AMGN +2.2%)(MRK -1.1%)(NVS +0.7%)(THRX +1.5%)
Jul. 24, 2015, 1:47 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting the approval of Novartis' (NVS -1.1%) Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. A final decision by the European Commission usually takes ~60 days. The FDA has granted Priority Review for the same patient population.
- The combination has been cleared in the U.S. since January 2014 for the treatment of BRAF V600E/K mutation-positive unresectable or metastatic melanoma.
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