Mon, Oct. 12, 8:00 AM
- Results from a randomized, double-blind, double-dummy Phase 4 study showed Amgen's (NASDAQ:AMGN) Prolia (denosumab) achieved greater gains in bone mineral density (BMD) than the intravenous biphosphonate zoledronic acid [Novartis' (NYSE:NVS) Zometa] in postmenopausal women with osteoporosis following treatment with oral biphosphonates. The data were presented at the American Society for Bone and Mineral Research Annual Meeting in Seattle.
- Biphosphonates [e.g. Merck's (NYSE:MRK) Fosamax (alendronate sodium)] are commonly used as first-line treatment for osteoporosis.
- The 12-month study enrolled 643 postmenopausal women with osteoporosis who had been taking oral biphosphonates for at least two years. They were randomized 1:1 to receive either subcutaneous denosumab 60 mg every six months plus intravenous placebo once yearly (n=321) or intravenous zoledronic acid 5 mg once yearly plus subcutaneous placebo every six moths (n=322).
- The primary endpoint was the change from baseline in lumbar spine BMD at month 12. The change in the denosumab arm was greater (+3.2%) than the zoledronic acid arm (+1.1%). The results were highly statistically significant (p<0.0001). The denosumab cohort also beat the zoledronic acid group in changes in BMD in the total hip, femoral neck and 1/3 radius.
- No new safety issues were identified. Both arms showed similar incidences of adverse events.
- Prolia, cleared by the FDA in June 2010, is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, for the treatment of men with osteoporosis at high risk of fracture and men/women who are at high risk of fracture receiving certain therapies.
- Prolia generated almost $1.2B in sales over the past four quarters.
Mon, Oct. 5, 1:53 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Novartis' (NVS +1.2%) Entresto (sacubitril/valsartan) for the treatment of adults with symptomatic chronic heart failure and reduced ejection fraction.
- A final decision by the European Commission usually takes ~60 days.
- Entresto (formerly LCZ696) was cleared by the FDA in July and by Swissmedic several weeks ago.
- Entresto should be a blockbuster. Analysts predict peak sales of ~$4B.
Mon, Oct. 5, 8:03 AM
- Baxalta (NYSE:BXLT) and collaboration partner Momenta Pharmaceuticals (NASDAQ:MNTA) announce the initiation of a pivotal clinical trial comparing the safety, efficacy and immunogenicity of their biosimilar candidate, M923, to AbbVie's (NYSE:ABBV) HUMIRA (adalimumab) in patients with chronic plaque psoriasis.
- The companies expect to file their first regulatory application in 2017 followed by commercial launch in 2018.
- HUMIRA is world's top selling therapeutic. Over the past four quarters, it posted $13.3B in sales.
- Indian firm Cadila Healthcare launched its HUMIRA biosimilar in India in December 2014 under the brand name Exemptia. It projects FDA clearance in 2019. Sandoz's (NYSE:NVS) HUMIRA biosimilar candidate is currently in a Phase 3 study that should be completed in April, according to clinicaltrials.gov.
Fri, Oct. 2, 7:09 AM
- The FDA accepts for review Sandoz's (NYSE:NVS) Biologics License Application (BLA) for its biosimilar to Amgen's (NASDAQ:AMGN) Enbrel (etanercept) for all indications.
- Enbrel generated over $4.9B in sales over the most recent four quarters.
- This is Sandoz's second biosimilar filing. It recently launched Zarxio (filgrastim-sndz), a biosimilar to Amgen's Neupogen (filgrastim), cleared by the FDA in March.
- Previously: FDA clears first biosimilar (March 6)
Thu, Oct. 1, 8:30 AM
- Nano cap (NASDAQ:XOMA) zooms up 62% premarket on robust volume in response to its announcement that it has exclusively licensed global development and commercialization rights to its anti-transforming growth factor-beta (TGFb) antibody program to Novartis (NYSE:NVS).
- Under the terms of the agreement, XOMA will receive an upfront payment of $37M, up to $480M in various milestones and mid-single-digit to low double-digit royalties on net sales. Novartis also agrees to extend the maturity date of the XOMA's ~$13.5M in outstanding debt to September 20, 2020. In exchange for the extension, XOMA agrees to reduce the royalties it will earn from Novartis' clinical stage anti-CD40 antibodies.
- XOMA says the funds from this deal, along with its planned cost saving measures, will be sufficient to fund operations into 2017.
- TGFb is an immune suppressive cytokine that plays a role in the progression of advanced cancer and fibrosis if elevated.
Wed, Sep. 30, 9:18 AM
- United Therapeutics (NASDAQ:UTHR) settles its litigation with Sandoz (NYSE:NVS) over the latter's Abbreviated New Drug Application (ANDA) seeking clearance for a generic version of Remodulin (treprostinil). Under the terms of the settlement agreement, United grants Sandoz a non-exclusive license to manufacture and commercialize its generic version beginning June 26, 2018, earlier under certain circumstances.
- The license does not allow Sandoz to make generic versions of Tyvaso (treprostinil) Inhalation Solution or Orenitram (treprostinil) Extended-Release Tablets nor convey any rights to its implantable and pump systems currently under development.
- Remodulin is United's top seller. It accounted for 39% ($136M) of its Q2 revenues.
Sun, Sep. 27, 5:09 PM
- Results from a Phase 3 clinical trial, RADIANT-4, evaluating Novartis' (NYSE:NVS) Afinitor (everolimus) in patients with advanced, progressive, nonfunctional neuroendocrine tumors (NET) originating in the GI tract or lung showed treatment with the mTOR inhibitor reduced the risk of cancer progression 52% (p<0.00001) versus placebo. The data were presented at the European Cancer Congress in Vienna, Austria.
- Median progression-free survival (PFS) in the Afinitor cohort was 11.0 months compared to 3.9 months for placebo. Overall survival (OS), a secondary endpoint, was not mature at data cutoff. Overall response rate, another secondary endpoint, was 64% versus 26% in favor of Afinitor.
- The most common adverse events in patients treated with Afinitor were stomatitis (9%), diarrhea (7%) and infections (7%).
- The results will support global regulatory submissions seeking approval for Afinitor for the treatment of advanced, progressive, non-functional GI and lung NET. Afinitor is currently cleared in more than 95 countries for NET of pancreatic origin in addition to four other indications.
- NET are a rare type of cancer that originates in the neuroendocrine cells throughout the body.
Fri, Sep. 25, 5:40 PM
Thu, Sep. 24, 3:50 PM
- The U.S. Court of Appeals of the Federal Circuit upholds the ruling by the U.S. District Court for the District of New Jersey that 18 claims from four Shire (SHPG +0.5%) patents covering Vyvanse (lisdexamfetamine dimesylate) are valid. The patent claims cover the lisdexamfetamine dimesylate compound and a method of using the compound for the treatment of attention deficit hyperactivity disorder (ADHD).
- The ruling means that Shire's patents will be valid until 2023 which is, obviously, bad news to the five would-be generic competitors who filed Abbreviated New Drug Applications (ANDAs): Actavis (AGN +1.4%), Amneal Pharmaceuticals, Mylan (MYL +0.7%), Roxane Laboratories and Sandoz (NVS -0.6%).
Sun, Sep. 20, 8:27 PM
- The FDA designates Genmab A/S's (OTC:GNMSF) (OTCPK:GMXAY) ofatumumab for Priority Review for the maintenance therapy of patients with relapsed chronic lymphocytic leukemia (CLL). The PDUFA date is January 21, 2016. The supplemental Biologics License Application (sBLA) was submitted by licensee Novartis (NYSE:NVS) via its acquisition of GlaxoSmithKline's (NYSE:GSK) oncology business.
- The data supporting the application was generated in the Phase 3 PROLONG study which evaluated ofatumumab maintenance therapy compared to no further treatment in CLL patients who experienced a complete or partial response after second or third line treatment.
- The FDA approved ofatumumab, branded as Arzerra, for treatment-naive CLL patients who are not being treated with the chemo agent fludarabine in April 2014.
- Priority Review status shortens the review clock to six months versus the normal 10 months.
Fri, Sep. 18, 7:32 AM
- Swissmedic clears Novartis' (NYSE:NVS) Entresto (sacubitril/valsartan), previously LCZ696, to reduce the risk of cardiovascular mortality and morbidity in patients with heart failure with reduce ejection fraction. About 150K people in Switzerland live with heart failure.
- The FDA approved Entresto in July.
Wed, Sep. 16, 10:06 AM
- The FDA designates Bristol-Myers Squibb's (BMY +0.5%) Opdivo (nivolumab) a Breakthrough Therapy for the treatment of advanced or metastatic renal cell carcinoma (RCC).
- The designation is based on the results from a Phase 3 study called CheckMate -025 in which nivolumab showed superior overall survival compared to everolimus (Novartis' (NVS +0.6%) Afinitor), the current standard of care for treatment-experienced kidney cancer. The company will be presenting data from CheckMate-025 at the European Cancer Congress in Vienna, Austria later this month. Regulatory filings in the U.S. and Europe are expected later this year.
- Opdivo is currently cleared for the treatment of metastatic melanoma and previously treated advanced squamous non-small cell lung cancer.
- Breakthrough Therapy status allows for more intensive guidance from the FDA, access to more senior agency personnel and a rolling review of the NDA.
Wed, Sep. 16, 8:32 AM
- The first patient has been dosed in a Phase 2 clinical trial, called IMbark, evaluating imetelstat in patients with myelofibrosis, a bone marrow disorder characterized by scarring (fibrosis) in the bone marrow which leads to severe anemia, weakness, fatigue and an enlarged spleen and liver. The study is being conducted by Janssen Biotech (NYSE:JNJ) under the terms of its November 2014 exclusive global imetelstat license from discoverer Geron (NASDAQ:GERN).
- The mid-stage trial will assess two doses (9.4 mg/kg every three weeks or 4.7 mg/kg every three weeks) of imetelstat as monotherapy in ~200 high risk MF patients who have relapsed or failed to adequately respond to Janus Kinase (JAK) inhibitor treatment [Novartis' (NYSE:NVS) Jakafi (ruxolitinib)]. An interim review of the data will be done after ~20 subjects in each arm have been dosed and followed for at least 12 weeks. The review will be the basis for any modifications going forward.
- The co-primary endpoints are spleen response rate, determined by the percentage of patients who achieve at least a 35% reduction in spleen volume from baseline at week 24, and symptom response rate, determined by the percentage of patients who experience at least a 50% reduction in Total Symptom Scores from baseline at week 24.
- According to clinicaltrials.gov, the final data collection date for the primary endpoints is March 2017. The estimated study completion date is March 2018.
- Imetelstat inhibits an enzyme called telomerase by binding to its RNA template. Most cancers have a high level of telomerase activity and relatively short telemeres (caps at the end of each strand of DNA) compared to normal cells. Inhibiting telomerase inhibits the proliferation of malignant progenitor cells.
Mon, Sep. 14, 6:56 AM
- Sanofi (NYSE:SNY) enters into a multi-target peptide discovery and optimization collaboration with Tokyo-based PeptiDream.
- Under the terms of the agreement, PeptiDream will use its proprietary Peptide Discovery Platform System technology to generate certain peptides against multiple targets of interest selected by Sanofi. PeptiDream will receive an undisclosed upfront payment, research funding, preclinical and clinical milestones and royalties of commercial sales.
- PeptiDream also has collaborations with Amgen (NASDAQ:AMGN), AstraZeneca (NYSE:AZN), Bristol-Myers Squibb (NYSE:BMY), Eli Lilly (NYSE:LLY), GlaxoSmithKline (NYSE:GSK), Novartis (NYSE:NVS), Mitsubishi Tanabe (OTCPK:MTZPY), Daiichi Sankyo (OTCPK:DSNKY), Merck (NYSE:MRK) and Ipsen (OTCPK:IPSEY).
Fri, Sep. 11, 5:37 PM
Fri, Sep. 4, 7:33 AM
- As expected, the European Commission approves Novartis' (NYSE:NVS) Farydak (panobinostat), in combination with bortezomib [Takeda's (OTCPK:TKPYY) Velcade] and dexamethasone, for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least two prior lines of therapy including bortezomib and an immunomodulatory agent. Farydak is the first histone deacetylase (HDAC) inhibitor cleared in the EU. The EMA's CHMP adopted a positive opinion supporting approval in late June.
- HDAC inhibitors control cancer by inducing cell cycle arrest, differentiation and/or apoptosis (cell death).
- The FDA cleared Farydak in late February despite a negative Ad Comm vote.
- Previously: Novartis works around negative Ad Comm vote for panobinostat approval (Feb. 23)
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