Mon, Aug. 24, 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%.
Fri, Aug. 21, 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.
Thu, Aug. 20, 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)
Mon, Aug. 17, 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.
Fri, Aug. 14, 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.
Wed, Aug. 12, 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.
Wed, Jul. 29, 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.
Tue, Jul. 28, 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%)
Fri, Jul. 24, 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.
Fri, Jul. 24, 12:26 PM
- The FDA approves Novartis' (NVS -0.5%) Odomzo (sonidegib) for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy or who are not candidates for surgery or radiation therapy.
- Odomzo is a once-daily pill that inhibits the molecular pathway called Hedgehog. It will compete with Roche's (OTCQX:RHHBY -0.9%) Erivedge (vismodigib), an antagonist of part of the hedgehog signaling pathway called smoothened receptor (SMO), that was cleared in January 2012. It will generate ~$175M in sales this year.
Fri, Jul. 24, 10:10 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval of Novatis' (NVS +0.3%) Revolade (eltrombopag) for the treatment of adult patients with acquired severe aplastic anemia who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for hematopoietic stem cell transplantation. A final decision by the European Commission usually takes ~60 days.
- Novartis acquired Revolade, branded as Promacta in the U.S., from GlaxoSmithKline earlier this year. It is currently approved for the treatment of thrombocytopenia (low blood platelets).
- Revolade utilizes Ligand Pharmaceuticals' (LGND +0.2%) Captisol technology which optimizes its solubility and stability.
Wed, Jul. 22, 11:43 AM
- Novartis (NVS -1.4%) submits a supplemental Biologics License Application (sBLA) to the FDA seeking approval for Arzerra (ofatumumab) for the maintenance treatment of patients with relapsed chronic lymphocytic leukemia (CLL). It is currently cleared, in combination with chlorambucil, for treatment-naive CLL patients who are not candidates for fludarabine or who are refractory to fludarabine and alemtuzumab.
- Ofatumumab is a human monoclonal antibody that binds to CD20, an antigen found on the surface of CLL cells and normal B lymphocytes. It was approved by the FDA in April 2014 and by the European Commission in July 2014.
- Novartis is developing ofatumumab for cancer indications as part of its acquisition of GlaxoSmithKline's (GSK -1%) oncology business. GSK will continue to develop and commercialize it for autoimmune indications. The antibody was discovered by Danish biotech Genmab A/S (OTC:GNMSF) (OTCPK:GMXAY).
Tue, Jul. 21, 12:36 PM
- The U.S. Court of Appeals for the Federal Circuit rejects Amgen's (AMGN -0.5%) attempt to block Novartis' (NVS -1.7%) Sandoz unit from launching Zarxio (filgrastim - sndz), a biosimilar to Neupogen (filgrastim), in the U.S. The current injunction will remain in place until September 2.
- A district court rebuffed Amgen in March. The FDA approved Zarxio on March 6.
- Previously: Court rejects Amgen's bid to block Neupogen biosimilar (March 20)
- Previously: FDA clears first biosimilar (March 6)
Tue, Jul. 21, 7:37 AM
- Novartis (NYSE:NVS) Q2 results ($M): Total Revenues: 12,694 (-5.3%); Pharmaceuticals: 7,847 (-4.3%); Alcon: 2,559 (-9.2%); Sandoz: 2,288 (-1.8%).
- Net Income: 1,838 (-28.9%); EPS: 0.75 (-27.2%); CF Ops: 2,910 (-12.9%); Gross Profit: 8,409 (-12.1%).
- Key Product Sales: Gleevec/Glivec: 1,184 (-1.3%); Gilenya: 700 (+15.5%); Lucentis: 537 (-13.2%); Afinitor/Votubia: 423 (+10.2%); Sandostatin: 413 (-1.0%); Diovan/Co-Diovan: 333 (-55.2%); Tasigna: 412 (+10.5%); Galvus: 273; Exforge: 272 (-26.5%).
- 2015 Guidance: Group Net Sales Growth: mid single digit (unch); Core Group Operating Income Growth: high single digit (unch); Pharmaceuticals Sales Growth: mid single digit (unch); Alcon Sales Growth: low single digit from mid-to-high single digit; Sandoz Sales Growth: high single digit from mid single digit.
Tue, Jul. 21, 6:16 AM
Tue, Jul. 21, 3:45 AM
- Novartis' (NYSE:NVS) second-quarter profit fell 32% from the same period last year, as the drug giant got hit by a strong dollar and weak results from its eye-care treatment business.
- Net income fell to $1.86B, or $0.77 per share in the quarter ended in June vs. $2.72B a year earlier. Core net income fell 8%.
- Novartis also confirmed its full year outlook, with net sales expected to grow in the mid-single digits and core operating income to grow at a faster, high-single-digit rate.
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