Nov. 17, 2014, 9:07 AM| 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)
Nov. 10, 2014, 12:31 PM
- At the Biennial Meeting of the International Gynecologic Cancer Society in Melbourne, Australia, investigators presented Phase 2 data for OxiGene's (OXGN -7.4%) fosbretabulin combined with Roche's (OTCQX:RHHBY +0.5%) Avastin (bevacizumab) for the treatment of recurrent ovarian, tubal and peritoneal carcinoma.
- The study achieved its primary endpoint of a statistically significant increase in progression-free survival (PFS) for the combination compared to bevacizumab alone (p=0.049). Mean PFS for the combo was 7.3 months (n=54) versus 4.8 months for bevacizumab (n=53).
- In a post hoc subgroup analysis, there was also a statistically significant improvement in PFS in patients who were platinum-resistant (n=27). Median PFS for the combo group was 6.7 months compared to 3.4 months for bevacizumab alone (p=0.01).
- Patients receiving the combo also showed a higher objective response rate (ORR) but the results were not statistically significant.
Nov. 6, 2014, 8:03 AM
- In a setback for India's generic drug firm Ranbaxy Laboratories Ltd., the FDA revokes its previously granted tentative approvals for its lower cost versions of AstraZeneca's (NYSE:AZN) heartburn med Nexium and Roche's (OTCQX:RHHBY) antiviral Valcyte.
- The agency informed the company that while there were no data integrity issues related to its filings, its decisions granting the approvals were "in error."
- The revocation also terminates its six-month first-to-file market exclusivity.
- Management says in a statement, "Ranbaxy is disappointed with this development and is actively evaluating all available options to preserve its rights."
Nov. 5, 2014, 7:34 AM
Nov. 3, 2014, 1:06 PM
- The FDA accepts Boehringer Ingelheim's NDA for Spiriva Respimat (tiotropium bromide) for the maintenance treatment of asthma in patients at least 12 years old who remain symptomatic on at least inhaled corticosteroids.
- Spiriva is currently cleared for the maintenance treatment of bronchospasm (HandiHaler) associated with chronic obstructive pulmonary disease (COPD) and to reduce COPD exacerbations.
- The Respimat inhaler provides a pre-measured amount of medicine in a slow moving mist that helps the patient inhale the drug. It is designed to deliver the medication in a way that does not depend on how fast air is breathed in from the inhaler.
- Asthma and COPD-related tickers: (THRX -3%)(GSK -0.3%)(AZN -0.8%)(NVS -1.3%)(REGN +0.6%)(SNY -1.5%)(TEVA +1.5%)(OTCQX:RHHBY -1.3%)
Oct. 28, 2014, 12:44 PM
- Roche's (OTCQX:RHHBY +0.5%) Ventana Medical Systems enters into an agreement with ImmunoGen (IMGN +2.2%) to develop biomarker assays and a companion immunohistochemistry diagnostic test for one or more of ImmunoGen's product candidates. The initial test in the partnership is for folate receptor alpha (FRa) that is being used in the trials of ImmunoGen's FRa-targeting antibody-drug conjugate, IMGN853. Certain cancers such as epithelial ovarian and endometrial, highly express FRa.
- Specific financial terms are not disclosed.
Oct. 20, 2014, 10:40 AM
- Laboratory Corporation of America (LH -0.2%) launches its HIV GenoSure Archive, the first laboratory test that helps clinicians optimize antiretroviral (ARV) drug regimens for virally suppressed HIV patients. The test was developed using the Next Generation Sequencing Platform (NGS).
- Previous lab testing to guide ARV drug selection required higher viral loads than many HIV patients have. GenoSure Archive is performed by amplifying cell-associated HIV-1 DNA from infected cells in whole blood samples and then analyzing the polymerase region using NGS methods. The assay is analytically validated to identify mutations associated with resistance to all members of the most widely used ARV drug classes.
- HIV-related tickers: (ABBV +1.2%)(GILD +1.6%)(BMY +0.1%)(PFE -0.2%)(GSK -0.3%)(ABT +0.2%)(JNJ +0.1%)(PGNX +3%)(MRK +0.1%)(OTCQX:RHHBY +0.6%)
Oct. 20, 2014, 7:51 AM
- New Link Genetics (NASDAQ:NLNK) and Roche's Genentech (OTCQX:RHHBY) enter into an exclusive worldwide license agreement for the development of New Link's IDO pathway inhibitor, NLG919.
- Under the terms of the agreement, New Link will receive an upfront payment of $150M and will be eligible to receive more than $1B in milestones plus escalating double-digit royalties on commercial sales of multiple products by Genentech. The latter will fund R&D, manufacturing and commercialization costs and will provide research funding to New Link which will continue to pursue development activities associated with NLG919 in combination with its HyperAcute vaccine platform. New Link will retain the option for co-promotion rights for NLG919 and potential next generation IDO/TDO compounds in the U.S.
- NLNK is up 30% premarket on increased volume.
Oct. 17, 2014, 8:12 AM
- Roche (OTCQX:RHHBY) and Merck (NYSE:MRK) are set to present data from their respective immunotherapy drugs for the treatment of triple negative breast cancer (TNBC) at December's San Antonio Breast Cancer Symposium. TNBC does not respond to either of two types of hormonal therapy or drugs that target HER2 receptors, such as Roche's Herceptin.
- Both companies' products are PD-1 inhibitors. Roche is also testing its candidate, called MPDL3280A, for the treatment of melanoma and lung, bladder, kidney, bowel and blood cancers. Merck's product, Keytruda (pembrolizumab) injection, is currently cleared for the treatment of melanoma.
- Bristol-Myers Squibb (NYSE:BMY) and AstraZeneca (NYSE:AZN) are also players in the space.
Oct. 17, 2014, 7:40 AM
- In a comparative study sponsored by the National Institutes of Health and run by the Diabetic Retinopathy Clinical Research Network (DRCR.net), Regeneron's (NASDAQ:REGN) Eylea (aflibercept) injection demonstrated a significantly greater improvement in mean change in best-corrected visual acuity from baseline at week 52 compared to both Genentech's (OTCQX:RHHBY) Avastin (bevacizumab) and Lucentis (ranibizumab) injection. The was the study's primary endpoint.
- The mean number of injections using the protocol-specified retreatment regimen was one fewer in the Eylea cohort compared to Avastin and Lucentis and fewer patients in the Eylea group received criteria-based macular laser treatments.
- DRCR.net is finalizing and verifying the data before submitting it for publication.
Oct. 16, 2014, 10:43 AM
Oct. 16, 2014, 9:29 AM
- Roche (OTCQX:RHHBY) financial results ytd through Q3 (Millions of CHF): Group Sales: 34,757 (-0.3%); Pharmaceuticals: 26,965 (-0.8%), U.S. Pharma: 11,528 (+0.9%), Europe Pharma: 7,070 (+1.7%), Japan Pharma: 2,406 (-3.5%), International Pharma: 5,961 (-5.6%); Diagnostics: 7,792 (+1.5%).
- 2014 Guidance: Group sales growth: low-to-mid-single digit; Core EPS growth: >Group sales growth; Dividend outlook: further increase.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world?s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and... More
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