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)
Tue, Mar. 17, 7:35 AM
- The European Commission approves Novartis' (NYSE:NVS) Jakavi (ruxolitinib) for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea. Polycythemia vera is a rare blood cancer associated with the overproduction of blood cells, principally red blood cells. It is caused by a mutation in the Janus kinase 2 (JAK2) gene. It affects ~180K people in the European Union.
- The goal of treatment is to reduce the thickness of the blood and prevent bleeding and clotting. If left untreated, the disorder can lead to blood clots, stroke and heart attack. About 25% of PV patients develop resistance to or intolerance of hydroxyurea and are considered to have uncontrolled disease.
- Jakavi is an oral inhibitor of the JAK1 and JAK2 tyrosine kinases. It was previously approved for the treatment of myelofibrosis, a disorder of the bone marrow in which the marrow is replaced by scar tissue.
- Novartis licensed ruxolitinib from Incyte (NASDAQ:INCY) for development and commercialization ex-U.S. Incyte retains commercialization rights in the U.S.
Tue, Mar. 10, 7:48 AM
- Ophthotech (NASDAQ:OPHT) earns a $50M enrollment milestone from commercial partner Novartis (NYSE:NVS) for reaching the second enrollment goal in its Phase 3 trial evaluating Fovista (anti-platelet-derived growth factor) in combination with anti-vascular endothelial growth factor (VEGF) therapy for the treatment of wet age-related macular degeneration (AMD).
- The company will record $40.6M of the payment as revenue in Q1. The remaining $9.4M will be deferred and recognized as revenue on a proportional basis through 2017.
- Under the terms of the license and commercialization agreement signed in May 2014, Novartis has exclusive rights to Fovista in all markets ex-U.S. while Ophthotech retains exclusive rights in the U.S. Potential payments to Ophthotech could reach over $1B, not including royalties on ex-U.S. net sales. The company expects Fovista to be the first anti-PDGF therapy approved for wet AMD.
- Previously: Ophthotech earns $50M milestone (Sept. 8, 2014)
- Previously: Novartis acquires rights to ophthalmic drug (May 19, 2014)
Tue, Mar. 10, 3:55 AM
- Prescription drug spending rose by a record 13% in the U.S. last year, the biggest annual increase in over a decade.
- "For the past several years, annual drug spending increases have been below the annual rate of overall health-care inflation in the U.S.," said Glen Stettin, senior vice president at Express Scripts. "But that paradigm is shifting dramatically as prices for medications increase at an unsustainable rate."
- Spending on specialty medicines, such as those for inflammatory diseases, multiple sclerosis, cancer and hepatitis C rose an unprecedented 31%.
Fri, Mar. 6, 9:12 AM
- The FDA approves Sandoz's (NYSE:NVS) Zarxio, a biosimilar to Amgen's (NASDAQ:AMGN) Neupogen (filgrastim), for the same indications as Neupogen.
- Zarxio is approved for the treatment of patients with cancer receiving myelosuppressive chemotherapy, patients with acute myeloid leukemia receiving induction or consolidation chemotherapy, patients with cancer undergoing bone marrow transplantation, patients undergoing autologous peripheral blood progenitor cell collection and therapy and patients with severe chronic neutropenia.
- The placeholder nonproprietary name for Zarxio is "filgrastim-sndz."
- Previously: FDA Ad Comm gives thumbs up to Sandoz biosimilar filgrastim (Jan. 7)
- Related tickers: (NYSEMKT:PFNX) (NASDAQ:ESPR) (NYSE:HSP) (NASDAQ:CHRS)
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