Mon, Jul. 20, 5:30 PM
Mon, Jul. 20, 9:06 AM
- A Phase 3 clinical trial, called CheckMate-025, comparing Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) to Novartis' (NYSE:NVS) Afinitor (everolimus) in patients with advanced/metastatic renal cell carcinoma (RCC) has been stopped early after an assessment by the independent Data Monitoring Committee concluded that the study met its primary endpoint of demonstrating superior overall survival (OS) in patients receiving Opdivo. Secondary endpoints include objective response rate and progression-free survival.
- BMY will complete a full analysis of the data and will share the results with health authorities in the near future. It plans to present the information at a future medical meeting and submit it for publication.
- Bristol-Myers SVP, Head of Development, Oncology, Michael Giordano says, "The results of CheckMate-025 mark the first time an immuno-oncology agent has demonstrated a survival advantage in advanced RCC, a patient group that currently has limited treatment options. Through our Opdivo clinical development program, we aim to redefine treatment expectations for patients with advanced RCC by providing improved survival."
- Opdivo, a programmed death-1 (PD-1) immune checkpoint inhibitor, is approved in the U.S. for the treatment of metastatic melanoma and previously treated advanced squamous non-small cell lung cancer.
Mon, Jul. 20, 7:42 AM
- Top-line results from a Phase 3 clinical trial, called METEOR, show Exelixis' (NASDAQ:EXEL) Cometriq (cabozantinib) reduced the risk of disease progression or death by 42% compared to Novartis' (NYSE:NVS) Afinitor (everolimus). The late-stage study compared the two drugs in 658 patients with renal cell carcinoma (RCC) who had experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor.
- The trial met its primary endpoint of a statistically significant increase in progression-free survival (PFS) in the first 375 randomized patients (p<0.0001) as determined by an independent radiology committee.
- Data on Overall Survival (OS) in the population of 658 patients were immature at the data cutoff, although an interim analysis showed a trend in OS favoring cabozantinib. Final analysis of OS is expected around August 2016.
- Exelixis plans to complete regulatory filings in the U.S. and Europe early next year. The FDA designated cabozantinib for Fast Track review for RCC in April. It originally approved it in November 2012 for the treatment of progressive metastatic medullary thyroid cancer.
- The company will host a conference call this morning at 8:30 am ET to discuss the data.
- Shares are up 33% premarket on robust volume.
Thu, Jul. 16, 8:34 AM
- Small cap Radius Health (NASDAQ:RDUS) is up a modest 2% premarket on light volume in response to its announcement that its investigational drug RAD1901, in combination with CDK4/6 inhibitors [Pfizer's (NYSE:PFE) Ibrance (palbociclib)] and mTOR inhibitors [Novartis' (NYSE:NVS) Afinitor (everolimus)] showed anti-tumor activity in preclinical breast cancer models with either wild type or mutant ESR1 (estrogen receptor 1). Tumor shrinkage was much greater when exposed to the combination including RAD1901 compared to the other agents alone.
- RAD1901 is a selective estrogen receptor degrader (SERD) that crosses the blood-brain barrier. If approved, it will be the first ER-targeted therapy to have this capability thereby enabling the treatment of intracranial metastatic breast cancer tumors.
- The company is currently enrolling patients in a Phase 1 dose escalation study of RAD1901 in postmenopausal women with advanced estrogen receptor-positive and HER2-negative breast cancer. The study will determine the recommended dose for a Phase 2 trial.
Thu, Jul. 9, 9:14 AM
- The Medicines Company (NASDAQ:MDCO) announces an agreement with Sandoz (NYSE:NVS) allowing the latter to launch an authorized generic version of Angiomax (bivalirudin) in the U.S.
- Recently, MDCO lost an appeal of a court ruling that found its Angiomax patents were valid but not infringed by Hospira's generic version. The appeals court ruled that the patents were actually invalid. In October of last year, MDCO prevailed in a patent suit against Mylan.
- Previously: The Medicines Company loses appeal of Angiomax patent suit against Hospira (July 2)
- Previously: Medicines Co. prevails in patent challenge from Mylan (Oct. 28, 2014)
Tue, Jul. 7, 4:43 PM
- The FDA approves Novartis' (NYSE:NVS) LCZ696, branded as Entresto (sacubitril/valsartan), for the treatment of heart failure with reduced ejection fraction. The agency's assessment was done under its Priority Review and Fast Track designations.
- Entresto's mechanism of action enhances the protective neurohormonal systems of the heart while simultaneously suppressing the harmful RAAS (renin-angiotensin-aldosterone system). Analysts project peak sales for the blockbuster of almost $4B.
- Heart failure affects over 5M Americans.
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.
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