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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Mon, Apr. 27, 12:47 PM
- A 365-patient Phase 3 clinical trial (COMPLEMENT 2) assessing Danish biotech Genmab A/S's ofatumumab plus fludarabine (FL) and cyclophosphamide (CY) compared to FL and CY alone in patients with relapsed lymphocytic leukemia (CLL) met its primary efficacy endpoint of improved progression-free survival (p=0.0036).
- Licensee Novartis (NVS +0.5%) (via Glaxo), which markets ofatumumab under the brand name Arzerra, plans to analyze the data and then share the findings with regulatory authorities to evaluate the potential for filing for the expanded indication. The FDA cleared Arzerra for treatment-naive patients with CLL where fludarabine-based therapy is considered inappropriate. The European Commission approved it, in combination with chlorambucil or bendamustine, for treatment-naive patients with CLL who are not eligible for fludarabine-based therapy. It is cleared for first-line use in Russia, Iceland, Norway, Luxembourg and Brazil.
Fri, Apr. 24, 12:57 PM
- Privately-held French biotech medDay Pharmaceuticals reports results from a Phase 3 clinical trial (MS-SPI) evaluating MD1003, a pharmaceutical-grade biotin, for the treatment of primary and secondary progressive multiple sclerosis. The study met its primary endpoint in the intent-to-treat population with 12.6% of patients treated with MD1003 showing an improvement in EDSS (Expanded Disability Status Scale) or TW25 (a timed 25-foot walk) at Month 9 compared to 0% for placebo (p=0.0051).
- Secondary analyses showed evidence of a decrease in the risk of disease progression. Mean EDSS scores in the treatment group between the start of treatment and Month 12 decreased (-0.03) compared to progression (+0.13) in the placebo cohort (p=0.015). Four percent of patients in the MD1003 group showed EDSS progression at Month 9 confirmed at Month 12 compared to 13% for placebo (p=0.07).
- Biotin is a B-vitamin known as vitamin H or coenzyme R. It plays a key role in cell growth, the production of fatty acids and the metabolism of fats and amino acids.
- The data were presented at the American Academy of Neurology Annual Meeting in Washington, DC. Full results will be submitted for publication in a peer-reviewed journal.
- MS-related tickers: (BIIB -5.9%)(SNY +0.3%)(NVS -0.9%)(TEVA +1.4%)(FWP -0.3%)(OPXA)(RCPT +0.1%)(CHRS -3.3%)(ABBV +1.7%)
Thu, Apr. 23, 7:37 AM
- Novartis (NYSE:NVS) Q1 results ($M): Total Revenues: 11,935 (-14.9%); Pharmaceuticals: 7,140 (-5.6%); Alcon: 2,558 (-3.2%); Sandoz: 2,237 (-3.5%).
- Net Income: 13,005 (+338.2%); EPS: 5.32 (+347.1%); CF Ops: 1,704 (+27.1%); Quick Assets: 7,363 (-4.6%); Operating Earnings: 2,785 (-20.2%).
- Key Product Sales: Gleevec/Glivec: 1,070 (-2.5%); Gilenya: 638 (+15.6%); Lucentis: 539 (-13.1%); Afinitor/Votubia: 388 (+8.7%); Sandostatin: 385 (+0.3%); Diovan/Co-Diovan: 372 (-53.7%); Tasigna: 372 (+10.4%).
- 2015 Guidance: Group Net Sales Growth: Mid-single digit (unch).
Thu, Apr. 23, 5:26 AM
Thu, Apr. 16, 1:07 PM
- The FDA approves Sandoz's (NVS -0.1%) Abbreviated New Drug Application (ANDA) for once-daily Glatopa (glatiramer acetate) injection 20 mg/mL, a generic equivalent to Teva Pharmaceutical Industries' (TEVA -2.9%) Copaxone for the treatment of relapsing forms of multiple sclerosis.
- Glatopa, the first approved substitutable generic to Teva's top seller, was developed under a collaboration between Sandoz and Momenta Pharmaceuticals (MNTA +13.5%). Under the terms of the collaboration agreement, Momenta is eligible to receive up to $140M in milestones, including $10M upon the approval of the ANDA and $10M upon the first commercial sale.
- Copaxone generated $4.2B in sales for Teva the past four quarters, accounting for 21% of its revenues.
Thu, Apr. 16, 7:46 AM
- The FDA approves Alcon's (NYSE:NVS) AcrySof IQ ReSTOR +2.5 Diopter Intraocular Lens (IOL) for patients undergoing cataract eye surgery who choose to address their near, intermediate and distance vision at the same time. The lens is indicated for adult patients with or without presbyopia (age-related gradual loss of near vision) who want a full range of vision with increased independence from glasses.
- The +2.5 D model, delivering enhanced distance vision, complements the company's existing +3.0 D model.
- More than 3M cataract surgeries are performed in the U.S. each year.
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