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.
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
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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.
Wed, Apr. 15, 10:57 AM
- In a 447-patient study published in The Lancet, Novartis' (NVS -0.5%) Arzerra (ofatumumab) plus the chemotherapeutic agent chlorambucil demonstrated a statistically significant improvement in progression-free survival (PFS) compared to chlorambucil alone in previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy was considered inappropriate (due to advanced age or the presence of comorbidities). CLL is the most common form of leukemia, accounting for 25% of leukemia cases.
- Median PFS improved 71% in the ofatumumab/chlorambucil cohort versus chlorambucil alone (22.4 months vs. 13.1 months; p<0.0001).
- The FDA approved Arzerra in April 2014 followed by European Commission clearance in July.
Mon, Apr. 6, 1:23 PM
- Berkeley, CA-based Aduro Biotech (Pending:ADRO) is set for its IPO of 5M shares of common stock at $14 - 16.
- The clinical stage company develops technology platforms designed to stimulate strong immune responses against cancer. Its strategy aims to combine its technology platforms with immuno-oncology therapies based on their mechanisms of action, safety profiles and versatility.
- Its two proprietary platforms are based on Live, Attenuated, Double-Deleted ((LADD)) Listeria monocytogenes and cyclic dinucleotides (CDNs). The firm's lead LADD product candidate is Breakthrough Therapy-designated CRS-207 (in combination with the cellular vaccine GVAX) for the treatment of metastatic pancreatic cancer and unresectable (can't be removed surgically) malignant pleural mesothelioma. CRS-207 is also an Orphan Drug for both indications. A Phase 2a trial comparing the combination of CRS-207 with GVAX to GVAX alone was stopped based on the recommendation of the Data Monitoring Committee after an interim analysis showed the study met its primary efficacy endpoint of overall survival.
- The company is collaborating with Janssen Biotech (JNJ -0.2%) on two proprietary product candidates and with Novartis (NVS +0.7%) on CDN candidates, led by ADU-S100 for palpable tumors.
- 2014 Financials ($M): Operating Expenses: 32.5; Net Loss: (17.0); Cash Burn: (19.4).
Mon, Apr. 6, 10:37 AM
- Juno Therapeutics (JUNO -0.8%) settles the patent dispute with the Trustees of the University of Pennsylvania and Novartis (NVS +0.4%) regarding patents owned by St. Jude Children's Research Hospital. Juno became a party to the litigation on the basis of its December 2013 license agreement with St. Jude, an original party in the suit.
- The spat began in July 2012 in connection with a contract dispute between St. Jude and Penn which was broadened in March 2013 to include a dispute over St. Jude's U.S. Patent No. 8,399,645, entitled "Chimeric Receptors with 4-1BB Stimulatory Signaling Domain."
- Under the terms of the settlement agreement, Novartis will pay Juno an initial amount of $12.25M, future milestone payments, mid-single-digit royalties from U.S. sales of related products and a low double-digit percentage of the royalties Novartis pays Penn for global net sales of the related products. Payments received by Juno will be shared with St. Jude under the terms of the license agreement.
Tue, Mar. 31, 10:09 AM
Mon, Mar. 30, 7:06 PM
- The FDA approves Novartis' (NYSE:NVS) Jadenu (deferasirox), a new formulation of Exjade (deferasirox), for the treatment of patients at least two years old with chronic iron overload due to blood transfusions and patients at least 10 years old with chronic iron overload in non-transfusion-dependent thalassemia syndromes.
- Jadenu is a once-daily oral iron chelator (it removes iron from the body) in tablet form that can be swallowed whole with or without a light meal. This simplifies the administration of deferasirox which, in Exjade's case, has to be dissolved in liquid for precisely three minutes (timer needed), then immediately drunk at least 30 minutes prior to food, preferably at the same time each day.
- Exjade, the most prescribed chelator in the U.S., generates almost $1B ($926M the past four quarters) in sales for Novartis.
Mon, Mar. 30, 8:42 AM
- Novartis (NYSE:NVS) and privately-held Aduro Biotech establish a collaboration for the research, development and commercialization of novel immuno-oncology products based on Aduro's cyclic dinucleotides (CDN), small molecules that activate the STING (Stimulator of Interferon Genes) signaling pathway in immune cells. Preclinical testing has shown promising therapeutic activity of CDNs.
- Under the terms of the agreement, Aduro will receive an upfront payment of $200M and milestones of up to $500M. Novartis will also make a 2.7% equity investment in Aduro for $25M with a commitment to invest an additional $25M at a future date.
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