Dec. 16, 2014, 8:19 AM| Comment!
Dec. 15, 2014, 7:14 AM
- Roche's (OTCQX:RHHBY) Genentech submits a New Drug Application (NDA) to the FDA for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of patients with BRAF V600 mutation-positive advance melanoma.
- Cobimetinib selectively blocks the activity of MEK, one of a series of proteins that make up a signaling pathway that helps regulate cell division and survival. Vemurafenib binds to mutant BRAF, another protein in the pathway, to interrupt abnormal signaling that can cause tumors to grow.
- Genentech is developing cobimetinib in collaboration with Exelixis (NASDAQ:EXEL).
Dec. 10, 2014, 8:06 AM
- The Phase 3 study of Acorda Therapeutics' (NASDAQ:ACOR) CVT-301 for the treatment of OFF episodes in patients with Parkinson's disease (PD) is underway with the enrollment of the first patient. An OFF episode is a period of time during which PD symptoms such as tremor, muscle stiffness and slow movement reemerge despite taking PD medications.
- CVT-301 is a self-administered inhaled therapy that delivers a precise dose of levodopa through the lungs to return PD patients to an ON state.
- The multi-center, double-blind, randomized Phase 3 trial will enroll ~345 subjects across three treatment arms: 50 mg, 35 mg or placebo. The primary endpoint is improvement on the Unified Parkinson's Disease Rating Scale (UPDRS) Part III.
- Acorda obtained the rights to CVT-301 via its acquisition of Civitas Therapeutics.
- Previously: Acorda to buy biopharma firm (Sept. 24, 2014)
- PD-OFF-related tickers: (OTCQX:CYNAF) (NASDAQ:NDRM) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRTA) (OTCQX:RHHBY)
Dec. 8, 2014, 12:37 PM
- Biotech investors are giving Seattle Genetics (SGEN -8.4%) the cold shoulder today on increased volume. It appears that all the love is being directed to the potential of competitors' PD-1 inhibitors in fighting cancer despite the company's presentations at the American Society of Hematology meeting of positive results for Adcetris (brentuximab vedotin), an antibody-drug conjugate directed to CD30 in Hodgkin lymphoma (HL).
- Long-term data from a Phase 1 trial of Adcetris combined with AVD (adriamycin, vinblastine, dacarbazine) demonstrated a 100% overall survival rate at year three and 92% failure-free survival rate at year 3 in frontline HL.
- Adcetris in combination with bendamustine as a second-line therapy demonstrated an objective response rate of 96% and a complete remission rate of 83% in patients with relapsed or refractory HL.
- In a Phase 2 trial in previously untreated HL patients aged 60 and older, Adcetris showed a 93% objective response rate.
- The company is collaborating with Takeda Pharmaceutical Co. (OTCPK:TKPHF) (OTCPK:TKPYY) on the development of the product.
- Previously: Positive results in Adcetris Phase 3 label expansion trial (Sept. 29, 2014)
- PD-1 inhibitor-related tickers: (BMY +0.2%)(FPRX +4.8%)(MRK -0.2%)(CELG +4.2%)(OTCQX:RHHBY -0.5%)(AZN -0.6%)
Dec. 2, 2014, 7:10 AM
- Roche (OTCQX:RHHBY) acquires privately-held San Jose, CA-based Ariosa Diagnostics for an undisclosed sum. Ariosa provides molecular diagnostic testing services, principally non-invasive prenatal testing using cell-free DNA technology.
- The company's Harmony Prenatal Test measures fetal cell-free DNA from a sample of the mother's blood. It is designed to assess the risk of Down syndrome.
Nov. 28, 2014, 9:23 AM
- The European Commission approves Boehringer Ingelheim's Vargatef (nintedanib), in combination with docetaxel, for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology, after first-line chemotherapy. Adenocarcinoma is the most common form of lung cancer.
- Nintedanib is an oral angiokinase inhibitor which simultaneously inhibits endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR) signalling pathways. It is currently being investigated in various other cancers.
- Earlier this month, Europe's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion supporting approval of nintedanib, branded as Ofev, for the treatment of ideopathic pulmonary fibrosis (IPF). The FDA approved it for IPF in October.
- Previously: Europe Ad Comm supports approval for BI pulmonary fibrosis drug
- Previously: BI begins enrollment in Phase 3 CRC trial
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Lung cancer-related tickers: (NYSE:BMY) (NYSE:MRK) (NASDAQ:CLVS) (NASDAQ:FPRX) (NASDAQ:BIND) (NYSE:GSK) (NASDAQ:ARIA) (NASDAQ:ECYT) (NYSE:AZN) (OTC:MKGAF) (OTCPK:MKGAY) (NASDAQ:ONTY) (NYSE:PFE) (NASDAQ:HTBX) (OTCQX:RHHBY) (NASDAQ:INCY)
Nov. 25, 2014, 8:18 AM
- Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
- Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
- Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (NYSE:NVS) (NYSE:AZN) (NASDAQ:AMGN) (NASDAQ:BIIB) (NASDAQ:CELG) (NYSE:LLY) (NYSE:SNY) (NYSE:ABT) (NYSE:ABBV) (NYSE:BMY) (NYSE:MRK) (NYSE:GSK)
Nov. 24, 2014, 8:40 AM
- Tetraphase Pharmaceuticals (NASDAQ:TTPH) is reportedly considering selling itself after being approached by interested suitors. Sources say the acquirer could be Acetelion (OTCPK:ALIOF) (OTC:ALIOY) or Roche (OTCQX:RHHBY).
- The attraction is Tetraphase's antibiotic eravacycline, currently in Phase 3 development. Both oral and IV formulations of the drug have demonstrated higher dose response rates than Johnson & Johnson's (NYSE:JNJ) Levaquin (levofloxacin) for the treatment of complicated urinary tract infections. In the Ignite-2 study, patients receiving 200 mg eravacycline IV-to-oral doses achieved a response rate of 70.8% while patients receiving 250 mg IV-to-oral doses achieved 64.3%, both significantly ahead of Levaquin's 52.2% response rate.
- A trial comparing eravacycline to Merck's (NYSE:MRK) Invanz (ertapenem) for the treatment of complicated intra-abdominal infections is underway.
- TTPH is up 18% premarket on light volume.
- Previously: Tetraphase completes eravacycline Phase 3 enrollment
Nov. 24, 2014, 8:02 AM
- The European Commission approves AstraZeneca's (NYSE:AZN) Duaklir Genuair (aclidium bromide/formoterol fumarate 340/12 mcg) for the maintenance bronchodilator treatment in adults with chronic obstructive pulmonary disease (COPD).
- The product is a fixed dose combination of two approved long-acting bronchodilators with different mechanisms of action. Aclidium bromide is an anticholinergic or long-acting muscarinic antagonist that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a long-acting beta-agonist that stimulates the B2-receptors in the bronchial smooth muscle resulting in bronchodilation. Both are currently approved as stand-alone therapies for the maintenance treatment of COPD in the U.S. and Europe.
- Genuair is a multi-dose pre-loaded dry powder inhaler that utilizes optical and acoustic signals to inform the patient that the correct dose has been delivered.
- COPD-related tickers: (NYSE:GSK) (NYSE:NVS) (NASDAQ:THRX) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
Nov. 23, 2014, 3:21 PM
- Group says Genentech's (OTCQX:RHHBY) change to distribution of oncology drugs will negatively impact U.S. hospitals, clinics, and their patients.
- Says that while the distribution shift may improve Genentech's model, "it does so at the expend of the efficiencies, quality and safety within U.S. hospitals and clinics."
- Asks that Genentech "reverse this ill-advised decision."
- Source: Gautam Kollu
Nov. 20, 2014, 7:41 AM
- According to IMS Health (NYSE:IMS) global drug spending will top $1T this year led by Gilead's (NASDAQ:GILD) Sovaldi (sofosbuvir) for hep C and new cancer drugs. The projected spend of $1.06T represents a 7% increase from last year.
- By 2018, drug spending is projected to rise to $1.3T. Hepatitis C and cancer meds will add ~$100B each, while diabetes care will contribute $78B. Leading the charge in cancer will be Roche's (OTCQX:RHHBY) Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine), Pharmacyclics' (NASDAQ:PCYC) Imbruvica (ibrutinib) and Amgen's (NASDAQ:AMGN) Kyprolis (carfilzomib).
- The ever-increasing tab for meds will be controversial because payers' budgets are being stressed while drug developers defend their prices citing high development costs.
- There is already some push back in cancer. Britain's National Institute for Health and Care Excellence (NICE), which sets guidelines for the National Health Service on costs, procedures and technologies, is balking at approving Roche's Gazyvaro (obinutuzumab) and Kadcyla citing their high cost relative to additional benefits over existing therapies.
- Previously: Roche's Gazyvaro not NICE in the UK
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
Nov. 17, 2014, 9:07 AM| Comment!
Nov. 17, 2014, 8:57 AM
- Celldex Therapeutics (NASDAQ:CLDX) is up 20% premarket on robust volume in response to its announcement of interim data from is Phase 2 clinical trial assessing the safety and efficacy of rindopepimut in patients with EGFRvIII-positive glioblastoma (GBM). The results demonstrate signs of clinical activity including groups both naive and refractory to Avastin (bevacizumab) (OTCQX:RHHBY).
- Rindopepimut (Rintega) is an investigational immunotherapy that targets the tumor-specific oncogene EGFRvIII. Patients in this category have a worse prognosis that the overall glioblastoma population and poor long term survival prospects.
- In the bevacizumab-naive group, the primary endpoint is progression-free survival at six months (PFS-6). The value for the rindopepimut arm is 27% compared to 11% in the control arm (p=0.048). Statistically significant overall survival (OS) benefit: rindopepimut median: 12.0 months versus control median of 8.8 months (p=0.0208). Hazard ratio: 0.47.
- In the bevacizumab-refractory group, rare but prominent anti-tumor activity did not meet the hurdle for expanded accrual. Noteworthy OS compared to historical values. Rindopepimut plus bevacizumab was well-tolerated, no serious adverse events attributed to rindopepimut. Early anti-EGFRvIII immune response correlates with survival benefit.
Nov. 14, 2014, 2:00 PM
- The FDA approves a label expansion for Genentech's (OTCQX:RHHBY) Avastin (bevacizumab). The new indication is, in combination with chemotherapy, for the treatment of women with platinum-resistant, recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who have received no more than two prior chemotherapy regimens.
- Avastin is also approved in the U.S. as part of a combination therapy for colon, lung, kidney and cervical cancer.
Nov. 13, 2014, 5:02 PM
- In a 479-patient Phase 2 clinical trial, Puma Biotechnology's (NYSE:PBYI) tyrosine kinase inhibitor, PB272 (neratinib), with paclitaxel demonstrated comparable results to Roche's (OTCQX:RHHBY) Herceptin (trastuzumab) plus paclitaxel as a first-line treatment in patients with HER2-positive locally recurrent or metastatic breast cancer.
- The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR) and the incidence of central nervous system (CNS) metastases, including metastases of the brain.
- PFS and ORR for the neratinib/paclitaxel arm were 16.6 months and 74.8%, respectively versus 16.7 months and 75.1%, respectively for the trastuzumab/paclitaxel arm. The differences were not statistically significant.
- There was a 52.6% reduction in CNS metastases in the neratinib/paclitaxel group compared to the trastuzumab/paclitaxel group (7.4% vs. 15.6%) (p=0.006). The difference was statistically significant.
- The safety results showed a 30% incidence of grade 3 diarrhea in the neratinib/paclitaxel arm compared to 4% in the trastuzumab/paclitaxel arm. When high dose loperamide was administered in another trial, though, the incidence of grade 3 diarrhea dropped to 8% in patients receiving neratinib as monotherapy.
- The results of the study will be presented at a future scientific meeting.
- PBYI is down 7.9% after hours on average volume.
Nov. 11, 2014, 7:44 AM
- Dupilumab, a fully-human monoclonal antibody being co-developed by Sanofi (NYSE:SNY) (OTCQB:SNYNF) and Regeneron Pharmaceuticals (NASDAQ:REGN), showed showed positive results in a 776-patient Phase 2b dose-ranging clinical trial in adults with moderate-to-severe uncontrolled asthma.
- The three highest doses of dupilumab in combination with standard-of-care therapy met the primary endpoint of a statistically significant improvement from baseline in forced expiratory volume over one second (FEV1) at week 12 in patients with high blood eosinophils (>= 300 cells/microliter) compared to placebo in combination with standard-of-care therapy. Also, two doses of dupilumab (200 mg every other week and 300 mg every other week) showed a statistically significant improvement in mean percent change in FEV1 and a reduction in severe exacerbations, both in the high eosinophils group and the overall study population.
- Dupilumab blocks IL-4 and IL-13, two cytokines required by the Th2 immune response. Some researchers believed that targeting the Th2 pathway would limit the benefit in asthmatics with high eosinophils, but this study demonstrated that it could be effective. Final results from the trial will be presented at a future medical conference.
- Sanofi plans to proceed to Phase 3 development.
- Asthma-related tickers: (NYSE:GSK) (NYSE:TEVA) (NYSE:AZN) (OTCQX:RHHBY) (NASDAQ:AMGN) (NYSE:MRK) (NYSE:NVS) (NASDAQ:THRX)
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