Yesterday, 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.
Mon, Mar. 23, 4:26 PM
- According to Thomson Reuters' 2015 Drugs to Watch report, as many as 11 blockbuster drugs (peak sales of at least $1B within five years) are expected to clear the regulatory process this year. This is a significant jump from 2014's tally of three (Gilead's (NASDAQ:GILD) Sovaldi and Zydelig; Glaxo (NYSE:GSK) and Theravance's (NASDAQ:THRX) Anoro Ellipta). In reverse order (forecasted 2019 consensus sales in parentheses):
- 11. Novartis' (NYSE:NVS) Cosentyx (secukinumab) for psoriasis and psoriatic arthritis ($1.08B); 10. Sanofi's (NYSE:SNY) Toujeo (insulin glargine) for diabetes ($1.26B); 9. Otsuka Pharmaceutical (OTCPK:OTSKY) and Lundbeck's (OTCPK:HLUYY) Brexpiprazole for schizophrenia and depression ($1.35B); 8. Merck's (NYSE:MRK) Gardisil 9 HPV vaccine ($1.64B); 7. Amgen's (NASDAQ:AMGN) evolocumab for hypercholesterolemia/hyperlipidemia ($1.86B); 6. AbbVie's (NYSE:ABBV) Veikira Pak for hepatitis C (cleared 12/19/14) ($2.5B); 5. Vertex Pharmaceuticals' (NASDAQ:VRTX) lumacaftor plus ivacaftor for cystic fibrosis ($2.74B); 4. Pfizer's (NYSE:PFE) Ibrance (palbociclib) for breast cancer ($2.76B); 3. Novartis' LCZ696 for chronic heart failure ($3.73B); 2. Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) for hypercholesterolemia ($4.41B) and 1. Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for melanoma ($5.68B).
Fri, Mar. 20, 3:56 PM
- Following up on its December announcement about its comparative clinical trial evaluating Cosentyx (secukinumab) versus Janssen's (JNJ +0.7%) Stelara (ustekinumab) for the treatment of moderate-to-severe plaque psoriasis, Novartis (NVS +1.8%) presented more detailed data from the study during a research session at the American Academy of Dermatology meeting in San Francisco.
- Cosentyx showed superiority to Stelara as measured by the proportion of patients achieving a PASI 90 score (subjective improvement of 90%) at Week 16 (79.0% vs. 57.6%; p<0.0001). On the basis of PASI 100 score (completely clear skin), the results also favored Cosentyx (44.3% vs. 28.4%; p<0.0001). In addition, the proportion of patients achieving PASI 75 by Week 4 was 50.0% vs. 20.6%; p<0.0001) in favor of secukinumab.
- Secukinumab is a human monoclonal antibody that inhibits interleukin-17A, a protein found in high concentrations in psoriatic skin. Both the FDA and European Commission (EC) cleared it for the indication in January.
- Previously: Novartis' Cosentyx beats Stelara in Phase 3 trial (Dec. 12, 2014)
Fri, Mar. 20, 7:56 AM
- The U.S. District Court of San Francisco denies Amgen's (NASDAQ:AMGN) preliminary injunction to block the sale of Novartis' (NYSE:NVS) Zarxio, a biosimilar of the former's $1.2B Neupogen (filgrastim) that was approved by the FDA several weeks ago, the first biosimilar to clear the regulatory hurdle in the U.S. Amgen intends to appeal the decision.
- Novartis previously agreed to delay Zarxio's U.S. launch until the court's decision or April 10, whichever came first. If it proceeds with the launch and Amgen wins its appeal, it would have to pay costly damages. In a statement, Novartis said, "Given the importance of this case for future biosimilars, we agreed with Amgen before this hearing to jointly request expedited review of any appeal to the Federal Circuit." It is unknown how long Amgen's appeal will take.
- Previously: FDA clears first biosimilar (March 6)
Wed, Mar. 18, 7:45 AM
- Two 24-week Phase 3 trials (PINNACLE 1 & 2) evaluating AstraZeneca's (NYSE:AZN) PT003 in patients with chronic obstructive pulmonary disease (COPD) achieved their primary efficacy endpoints of statistically significant improvement in lung function compared to placebo.
- PT003 is a twice-daily fixed-dose combination of glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-2 agonist (LABA). It is the first LAMA/LABA combination to be delivered in a pressurized metered dose inhaler using the porous particle co-suspension technology developed by Pearl Therapeutics, which AZN acquired in 2013. The successful outcomes of the PINNACLE studies are the first from a series of pipeline candidates using Pearl's technology.
- PT003 was assessed in over 3,700 patients in over 275 study sites. The primary efficacy endpoint was trough forced expiratory volume in one second (FEV1). PT003 demonstrated statistically significant improvements in FEV1 versus placebo and the individual components glycopyrronium (PT001) and formoterol fumarate (PT005). PT001 and PT005 also showed statistically significant improvements in FEV1 compared to placebo.
- The company plans to file regulatory applications beginning this year. It will present the study results at a scientific meeting later this year.
- Related tickers: (NYSE:GSK) (NASDAQ:THRX) (NYSE:NVS) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
NVS vs. ETF Alternatives
Other News & PR