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.
Thu, May 21, 11:05 AM
Fri, May 8, 7:33 AM
- As expected, the European Commission approves Novartis' (NYSE:NVS) 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). The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion in February recommending approval.
- Ceritinib is a selective inhibitor of ALK, a gene that can fuse with other proteins to make a "fusion protein" which promotes the development and growth of certain cancers including NSCLC. The FDA approved it in April of last year.
- NSCLC is the most common form of lung cancer, accounting for up to 90% of NSCLC cases worldwide. 2 - 7% of this population are characterized by the rearrangement of the ALK gene.
Thu, May 7, 11:13 AM
- Spurred by the progress of a bill moving through Congress that will speed new drugs to market for conditions lacking cures, called The 21st Century Cures Act, the FDA has scheduled a public meeting this summer to address concerns by the drugs industry that regulatory restrictions on what they can say about the off-label use of their products violates their First Amendment right to free speech. Language in the bill is ratcheting up the pressure on the agency to relax its guidelines.
- Drug makers were emboldened on its prospects of changing the rules after an appeals court overturned the conviction of a pharmaceutical sales representative in 2012 who was convicted of promoting off-label uses of the narcolepsy drug Xyrem. The court ruling was based on First Amendment protection for truthful and non-misleading off-label speech.
- The American Medical Association supports the need for physicians to have access to accurate and unbiased information about off-label uses of drugs since it already accounts for as much as 20% of prescribing, with higher levels in oncology and pediatric rare diseases.
- Giving drug firms more leeway in this arena has its detractors, however. Rita Redberg, M.D., Professor of Medicine at the UC-San Francisco says, "At my own medical center we have banned pharmaceutical reps from coming because we don't think they are a good source of information. You don't ask the barber if you need a haircut."
- Pharma companies have a dubious history of breaking the rules governing off-label promotion. Over the past 10 years, 17 firms have paid more than $16B in settlements related to inappropriate off-label selling.
- Further complicating matters is the fact that up to 75% of published pre-clinical trial results cannot be reproduced in later studies.
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