Tue, Jun. 30, 3:12 PM
- The U.S. Department of Justice wants Novartis (NVS -0.1%) to cough up $3.35B in civil fines and damages as restitution for its alleged misconduct in promoting Myfortic (to prevent organ rejection in kidney transplant recipients) and Exjade (to treat iron overload from blood transfusions) to federal healthcare programs that resulted in substantial over-payments for the meds. Specifically, the feds accuse the company of using various schemes, such as rebates, to boost sales to specialty pharmacies.
- The Justice Department seeks $1.52B in damages, triple what Medicare and Medicaid paid for the two drugs as a result of the kickbacks between 2004 and 2013, and up to $1.83B in fines.
- The case stems from a whistleblower lawsuit filed in 2011 by a former sales manager.
- Another wrinkle in the situation is the impact the company's Corporate Integrity Agreement, signed in 2010, will have. It requires the firm to establish an internal compliance program and report violations, areas that appear to have been unaddressed.
Mon, Jun. 29, 9:22 AM
- Results from a Phase 3 trial, called FUTURE 2, show that 64% of psoriatic arthritis (PsA) patients treated with subcutaneous injections of Novartis' (NYSE:NVS) Cosentyx (secukinumab) (150 mg or 300 mg) continued to exhibit improvement after one year of treatment as measured by ACR20 (20% improvement of symptoms). In addition, ACR50 (50% improvement in symptoms) rates were maintained as well (39% and 44%, respectively).
- The study met its primary endpoint of ACR20 at week 24 versus placebo. The response rates for 150 mg, 300 mg and placebo were 51%, 54% and 15%, respectively (p<0.0001). The data were published in The Lancet.
- Secukinumab is the first IL-17A (interleukin 17-A) inhibitor to demonstrate efficacy in a late stage PsA study. IL-17A is a pro-inflammatory cytokine produced by activated T cells.
- Regulatory applications for PsA are in process. Consentyx is currently cleared for sale in the U.S. for the treatment of moderate-to-severe plaque psoriasis.
Mon, Jun. 29, 6:41 AM
- Novartis (NYSE:NVS) acquires Preston, Australia-based Spinifex Pharmaceuticals for $200M plus milestones. The deal is expected to close later this year.
- Spinifex's lead product candidate is Phase 2 stage EMA401, an orally available angiotensin II type 2 (AT2) receptor antagonist under development for the treatment of chronic pain, specifically neuropathic pain, without central nervous system (CNS) side effects. Neuropathic pain, such as post herpetic neuralgia, diabetic neuralgia or diabetic neuropathy, is caused by a lesion or disease of the CNS. Current treatments fail to work for all patients and are not well tolerated.
Fri, Jun. 26, 1:52 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for Novartis' (NVS -1%) Farydak (panobinostat), in combination with bortezomib (Takeda's Velcade) and dexamethasone, for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent. A final decision by the European Commission usually takes ~60 days. The FDA approved it in February.
- Multiple myeloma is a cancer of the plasma cells that affects ~84K Europeans. The cancer cells accumulate in the bone marrow where they crowd out healthy blood cells and produce abnormal proteins that cause kidney problems.
- Panobinostat is an HDAC (histone deacetylase) inhibitor. HDACs are a class of enzymes that play a key role in gene expression.
Thu, Jun. 18, 7:31 PM
- The meaning of tentative FDA approval takes on an added meaning for Intellipharmaceutics International (NASDAQ:IPCI). After receiving the tentative nod from the agency for its generic version of Novartis' (NYSE:NVS) Focalin XR (dimethylphenidate HCl) in November 2013, the regulator now informs the company that it needs to demonstrate bioequivalence of the 40 mg strength with Focalin XR under its new bioequivalence criteria.
- The currently marketed 15 mg and 30 mg strengths are not affected, but the 5 mg, 10 mg and 20 mg strengths are.
- The company will work diligently to address the issue.
- Shares are down a fraction after hours on light volume.
Thu, Jun. 18, 7:11 PM
- Sandoz (NYSE:NVS) announces the U.S. launch of Glatopa, the first generic equivalent of Teva Pharmaceutical Industries' (NYSE:TEVA) Copaxone (glatiramer acetate injection) 20 mg/ml for the treatment of patients with relapsing forms of multiple sclerosis.
- Glatopa was developed in collaboration with Momenta Pharmaceuticals (NASDAQ:MNTA). Under the terms of their agreement, the first commercial sale will trigger a $10M payment to Momenta, which is also eligible to receive up to $120M in remaining sales-based milestones.
- Copaxone is Teva's top seller by far, generating ~$4.1B in sales the past four quarters.
- TEVA is down 1% after hours on light volume. MNTA is up 3% on increased volume.
Tue, Jun. 16, 7:23 AM
- Alcon (NYSE:NVS) receives CE Mark clearance for its AcrySof IQ PanOptix trifocal intraocular lens (IOL) for patients undergoing cataract surgery with or without presbyopia (age-related gradual loss of near vision). The trifocal nature of AcrySof enables the patient to satisfy his/her near, intermediate and distance vision needs without the need for glasses or contact lenses.
- More than 3M cataract surgeries are performed in Europe each year. Without presbyopia-correcting IOLs, most patients will need additional vision correction.
Fri, Jun. 12, 10:32 AM
- Data from two new clinical trials show that Novartis' (NVS -0.9%) Cosentyx (secukinumab) was effective in treating patients with plaque psoriasis of the palms, soles and nails, traditionally difficult locations to treat. The data were presented at the 23rd World Congress of Dermatology in Vancouver, Canada.
- In the Phase 3 GESTURE study, 33.3% of patients with moderate-to-severe palmoplantar (hands & feet) psoriasis treated with Cosentyx achieved clear or almost clear palms and soles at week 16 compared to 1.5% for placebo (p<0.0001).
- In the Phase 3 TRANSFIGURE study, patients with significant nail psoriasis treated with Cosentyx showed a mean improvement in their condition from baseline at week 16 of 45.3% compared to 10.8% for placebo (p<0.0001).
- Vasant Narasimhan, Novartis' Global Head of Development says, "These are the largest trials to prospectively compare an active therapy to placebo in patients with psoriasis affecting the palms, soles and nails, an area where a high unmet need for an effective treatment still exists. These results add to the growing body of evidence that Cosentyx is setting a new standard of care for patients with even the most challenging types of psoriasis."
- Secukinumab is a human interleukin-17A antagonist. IL-17A is a pro-inflammatory cytokine produced by the immune system's T cells.
- Cosentyx was cleared in January by both the FDA and European Commission.
Fri, Jun. 12, 8:36 AM
- Data from a Phase 3 study, called COMPLEMENT 2, show that Novartis' (NYSE:NVS) Arzerra (ofatumumab) plus fludarabine and cyclophosphamide improved median progression-free survival (PFS) by 54% compared to treatment with fludarabine and cyclophosphamide alone in patients with relapsed chronic lymphocytic leukemia (CLL). Median PFS in the Arzerra arm was 28.9 months compared to 18.8 months the chemo-only arm (p=0.0032). The data were presented at the 20th Congress of the European Hematology Association in Vienna, Austria.
- Patients receiving Arzerra showed an improved overall response rate (ORR) compared to chemo alone: 84% versus 68% (p=0.0003) with a significantly better complete response (CR) rate: 27% versus 7%. Median overall survival (OS) in the two groups was 56.4 months and 45.8 months, respectively, but the difference was not statistically significant (p=0.1410).
- The company intends to share the data with regulatory authorities in the near future.
- Ofatumumab is a human monoclonal antibody that binds to CD20, an antigen found on the surface of CLL cells and normal B lymphocytes.
Fri, Jun. 12, 7:43 AM
- The FDA approves Novartis' (NYSE:NVS) Promacta (eltrombopag) for the treatment of children six years and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was cleared by the FDA in 2008 for the same condition in adults.
- ITP, affecting ~5 in 100K children each year, is characterized by a low platelet count. It is an autoimmune disorder in which the patient's immune system produces autoantibodies and specialized white blood cells that destroy their platelets. Children with ITP carry a high risk of significant bleeding.
- Promacta is a once-daily oral thrombopoietin receptor agonist that works by inducing stimulation and differentiation of large cells found in the bone marrow called megakaryocytes from bone marrow stem cells thereby increasing platelet production.
Wed, Jun. 10, 8:02 AM
- A Phase 3 clinical trial, called MEASURE 2, evaluating Novartis' (NYSE:NVS) Cosentyx (secukinumab) in patients with ankylosing spondylitis (AS) met its primary endpoint of ASAS20 response at Week 16 compared to placebo (p<0.001). In addition, ~74% of patients achieved clinically significant improvement in their symptoms after one year of treatment. ASAS20 (ASsessment in AS working group - 20% improvement in AS symptoms) is a measure of efficacy of AS-directed therapies. The data were presented at the European League Against Rheumatism Annual Congress in Rome, Italy.
- AS is a form of arthritis that frequently causes the vertebrae in the spine to fuse together, greatly affecting posture, mobility and quality of life.
- Secukinumab is a human interleukin-17A antagonist that is currently cleared for the treatment of adult patients with moderate-to-severe plaque psoriasis. IL-17A is a pro-inflammatory cytokine produced by the immune system's T cells.
- The company intends to submit regulatory applications for AS (and active psoriatic arthritis) this month.
Thu, Jun. 4, 10:17 AM
- A Phase 3 clinical trial, RADIANT-4, evaluating Novartis' (NVS +0.1%) Afinitor (everolimus) plus best supportive care in patients with advanced nonfunctional neuroendocrine tumors (NET) of gastrointestinal or lung origin met its primary endpoint of a statistically significant improvement in progression-free survival (PFS) compared to placebo plus best supportive care.
- The data will be presented at a future medical meeting. Global regulatory applications are planned for this year.
- NET is a rare type of cancer that originates in the hormone-producing cells of the body's neuroendocrine system. It affects ~10K Americans each year. Patients with advanced NET have limited treatment options.
- Afinitor, a kinase inhibitor, is currently cleared for the treatment of a certain type of breast cancer, advanced kidney cancer, renal angiomyolipoma, subependymal giant cell astrocytoma and advanced pancreatic NET.
Tue, Jun. 2, 8:28 AM
- Perrigo (NYSE:PRGO) enters into a agreement to acquire a portfolio of over-the-counter brands from GlaxoSmithKline (NYSE:GSK) related to the latter's commitment to the European Commission to divest the businesses in connection with its consumer health joint venture with Novartis (NYSE:NVS).
- Perrigo will buy GSK's NiQuitin nicotine replacement therapy (NRT) business, mostly in the European Economic Area (EEA) and Brazil and Novartis's Australian NRT business, including Nicotinell; several OTC brands including Coldrex (cold and flu med) in the EEA and Panodil (pain relief), Nezeril (nasal decongestant) and Nasin (nasal decongestant) in Sweden and Novartis's legacy cold sore management business in the EEA (Vectavir, Pencivir, Fenivir, Fenlips, Vectatone).
- Financial terms are not disclosed.
- CEO Joseph Papa says, "This acquisition demonstrates Perrigo's ability to execute on our "Base Plus Plus Plus" strategy in which we make selective, accretive transactions to expand our durable base business. We are building on the global platform we established with the Omega Pharma acquisition to capture an even greater share of the $30B European OTC market opportunity with several well-established complementary brands that bolster our OTC product portfolio." Mylan N.V. (NASDAQ:MYL) will, no doubt, have to sharpen its pencil yet again.
- The transaction will be immediately accretive to Perrigo's 2015 non-GAAP EPS, excluding estimated tangible amortization and transaction-related costs. The deal should close in Q3.
Wed, May 27, 12:22 PM
- Novartis (NVS +1.6%) will showcase the strength of its oncology portfolio at this week's American Society of Clinical Oncology (ASCO) meeting in Chicago by virtue of over 185 data presentations covering 21 drugs and 11 investigational compounds.
- Key presentations include data on Tafinlar (dabrafenib) and Mekinist (trametinib) in melanoma (Abstract #102) and lung cancer (Abstract #8006), Zykadia (ceritinib) in lung cancer (Abstract #8060) and Afinitor (everolimus) in breast cancer (Abstract #512).
- The company will host a dedicated webpage (www.novartisoncology.com/asco-2015.jsp) during the event that will provide additional insights into emerging aspects of the cancer space.
Tue, May 26, 9:21 AM
- The FDA approves privately-held Boehringer Ingelheim's once-daily Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray for the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is not cleared for the treatment of asthma or acute deterioration of COPD.
- Tiotropium, a long-acting anticholinergic, is the active ingredient in Spiriva, the most prescribed COPD maintenance treatment worldwide. Olodaterol, a long-acting beta2-agonist that complements the efficacy of Spiriva, has a fast onset of action that improves airflow in five minutes after dosing.
- COPD-related tickers: (NASDAQ:TBPH) (NYSE:GSK) (NASDAQ:THRX) (NYSE:AZN) (NYSE:NVS) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY) (NASDAQ:AQXP)
Thu, May 21, 1:02 PM
- A Phase 3 clinical trial, called RADIANT-4, evaluating Novartis' (NVS +1.5%) Afinitor (everolimus) in 302 patients with advanced nonfunctional neuroendocrine tumors (NET) of gastrointestinal or lung origin met its primary endpoint of a statistically significant extension of progression-free survival (PFS). Complete results will be presented at a future medical meeting. Worldwide regulatory filings are planned for this year.
- Patients with NET, a rare type of cancer that originates in neuroendocrine cells found throughout the body, have limited treatment options.
- Afinitor is approved in various countries for the treatment of neuroendocrine tumors of pancreatic origin, renal cell carcinoma and HR+ breast cancer.
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