Roche Holding Ltd ADROTCQX
Everything's Coming Up Roches
Stephen Simpson, CFA
Stephen Simpson, CFA
Stronger First Quarter Sales Help Roche, But ASCO Probably Matters More
Stephen Simpson, CFA
Stephen Simpson, CFA
Today, 10:04 AM
- The European Commission conditionally approves Roche's (OTCQX:RHHBY) Venclyxto (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have the 17p deletion or TP53 mutation and who are unsuitable or have failed treatment with a B-cell receptor pathway inhibitor and for the treatment CLL patients without the mutations who have failed treatment with both chemo-immunotherapy and a B-cell pathway inhibitor.
- The European Medicines Agency's advisory committee CHMP adopted a positive opinion recommending approval in October.
- Venclyxto is being co-developed with AbbVie (ABBV -1.2%), who, with Genentech, will commercialize in the U.S. under the brand name Venclexta. AbbVie will commercialize ex-U.S.
- Venetoclax is a small molecule inhibitor of a protein called B-cell lymphoma-2 (BCL-2) which plays a key role in apoptosis (programmed cell death). Blocking BCL-2 is believed to restore the signaling system that tells cancer cells to self-destruct.
Tue, Dec. 6, 3:35 PM
- The FDA approves the use of Genentech's (OTCQX:RHHBY) Avastin (bevacizumab), in combination with the chemo agents carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Avastin alone, for the treatment of women with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
- The cancer is considered platinum-sensitive if at least six months elapses before a relapse occurs from the last regimen of platinum-based chemo.
- In November 2014, the FDA approved Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, for the same patient population who have relapsed less than six months following the last chemo regimen.
Mon, Dec. 5, 7:13 AM
- Results from a Phase 3 clinical trial, GALLIUM, evaluating Roche's (OTCQX:RHHBY) Gazyva//Gazyvaro in treatment-naive patients with follicular lymphoma experienced longer progression-free survival (PFS) than those treated with MabThera/Rituxan. The data were presented at the 58th American Society of Hematology (ASH) annual meeting in San Diego.
- At a preplanned interim analysis in May, the results showed that treatment with Gazyva/Gazyvaro reduced the risk of disease worsening or death by 34% (hazard ratio = 0.66) compared to treatment with MabThera/Rituxan. Median PFS has yet to be reached.
- Overall response rate slightly favored Gazyva/Gazyvaro, 88.5% vs. 86.9%, as did overall survival at year 3 (94.0% vs. 92.1%). The exploratory endpoint of the proportion of patients with minimal residual disease also favored Gazyva/Gazyvaro, 92.0% vs. 84.9% (p=0.0041).
- The interim analysis performed by the independent data monitoring committee determined that the study met its primary endpoint.
Fri, Dec. 2, 9:16 AM
- Amgen (NASDAQ:AMGN) and collaboration partner Allergan (NYSE:AGN) announce the filing of a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) seeking approval of ABP 215, a biosimilar candidate to Roche's (OTCQX:RHHBY) cancer drug Avastin (bevacizumab).
- Under a 2011 collaboration agreement, the companies (then Watson Pharmaceuticals) agreed to develop and commercialize four oncology-focused biosimilars. Amgen has primary responsibility for developing, manufacturing and initially commercializing the products.
- Watson acquired Actavis in 2013 which acquired Allergan in 2015.
Thu, Dec. 1, 8:41 AM
- Roche (OTCQX:RHHBY) builds on its distribution alliance with Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) by adding the qPCR and endpoint PCR portfolios from Kapa Biosystems, a company Roche acquired in late 2015. The deal excludes Kapa's Next-Gen Sequencing products.
- The distribution agreement is worldwide except the U.S., Japan and Brazil.
Wed, Nov. 30, 8:54 AM
- A Phase 3 clinical trial, REFLECTIONS B3271002, comparing the safety and efficacy of Pfizer's (NYSE:PFE) biosimilar PF-05280014 to Roche's (OTCQX:RHHBY) Herceptin (trastuzumab) met the primary endpoint of showing equivalence as measured by objective response rate (ORR), taken in combination with paclitaxel, in first-line patients with HER-positive metastatic breast cancer.
- A separate study, REFLECTIONS B3271004, in early breast cancer patients was also successful.
- The development of PF-05280014 is ongoing. According to ClinicalTrials.gov, there are four studies currently recruiting patients and five that are active with recruiting completed.
Mon, Nov. 28, 10:15 AM
- Patheon N.V. (PTHN -1.2%) inks an agreement with Roche Holdings (OTCQX:RHHBY) to acquire its active pharmaceutical ingredient (API) manufacturing operation located in Florence, SC.
- Under the terms of the deal, Patheon will assume ownership for an "immaterial" sum plus the cost of inventory and spare parts. It has also inked a multi-year supply contract with Roche which will help defray the costs of running the site for the next few years while its adds new client work into the facility. Patheon expects the site to eventually have a similar financial profile as its other manufacturing operations in its drug substance segment.
- The 300,000 square-foot South Carolina facility covers 1,100 acres. It enables Pantheon to expand its capacity for manufacturing highly potent compounds and extends its capabilities to support solid-state chemistry, micronization and, eventually, spray drying.
Mon, Nov. 28, 8:46 AM
- Chugai Pharmaceutical (OTCQX:RHHBY) and Berlin-Chemie Menarini, a company of the Menarini Group, announced that both companies have entered into a global license agreement for PA799, a class I PI3K inhibitor.
- PA799 is the PI3K inhibitor originated by Chugai, which conducted phase I study for solid tumors in Europe. With its high selectivity for class I enzyme, the drug candidate showed a good safety profile in the clinical trial.
- Under the agreement, Chugai will grant Menarini Group an exclusive license for the manufacturing, development and marketing of PA799 worldwide. Under the terms of the agreement, Chugai will receive an upfront, milestone and royalty payments from Menarini Group. Specific financial terms are not disclosed.
Mon, Nov. 21, 11:56 AM
- Roche (OTCQX:RHHBY) launches its DISCOVERY 5-Plex procedure and reagents for use in research applications, the first fully automated multiplex procedure that can be performed on the VENTANA DISCOVERY ULTRA instrument.
- DISCOVER 5-Plex enables the investigation of up to five biomarkers on a single slide.
Thu, Nov. 17, 6:59 AM
- Britain's advisor to its National Health Service (NHS), the National Institute for Health and Care Excellence (NICE) continues its success with corralling prices from drug makers. Roche (OTCQX:RHHBY) and Bristol-Myers Squibb (NYSE:BMY) are the latest to extend discounts for access to the NHS.
- Roche cut the price to breast cancer drug Perjeta earlier this year as did BMY with leukemia med Sprycel.
- Novartis (NYSE:NVS) and Pfizer (NYSE:PFE) have also offered increased discounts of late. The specific amounts are confidential, however.
Tue, Nov. 15, 4:10 PM
- Amgen (NASDAQ:AMGN) and development partner Allergan plc (NYSE:AGN) announce the submission of a Biologics License Application (BLA) to the FDA seeking approval of a biosimilar to Roche's (OTCQX:RHHBY) cancer med Avastin (bevacizumab). The biosimilar, ABP 215, is the most advanced of the four oncology biosimilars that the companies are collaborating on under their December 2011 agreement.
- Under the terms of the partnership, Amgen has primary responsibility for developing, manufacturing and initially commercializing the products.
Sun, Nov. 13, 9:51 PM
- A Phase 3 clinical trail, GiACTA, assessing Roche unit Genentech's (OTCQX:RHHBY) Actemra (tocilizumab) for the treatment of giant cell arteritis (GCA) met its primary efficacy endpoint. The data were presented at the American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting in Washington, D.C.
- Tocilizumab, initially combined with a six-month steroid taper regimen, demonstrated superiority to a six-month steroid taper regimen alone as measured by the proportion of patients achieving sustained remission at one year. Specifically, 56% of patients in the once/week dose cohort and 53.1% of patients in the once-every-other week dose cohort achieved sustained remission at Year 1 compared to 14% for the six-month steroid taper regimen alone. No new safety signals were observed.
- According to ClinicalTrials.gov, the estimated study completion date is April 2018.
- GCA is an inflammation of the lining of the arteries, typically those in the temples. If untreated, it can lead to stroke or blindness. It affects ~0.2% of Americans over the age of 50.
- Actemra is currently approved for the treatment of certain kinds of arthritis.
Thu, Nov. 10, 10:00 AM
- Halozyme Therapeutics (HALO +11.9%) and Roche's (OTCQX:RHHBY -1.3%) Genentech will collaborate in clinical trials assessing the combination of Tecentriq (atezolizumab) and Halozyme's PEGPH20 in up to eight tumor types beginning next year.
- The first study will be an open-label Phase 1b/2 led by Genentech that will evaluate the combination in six tumor types, with an initial focus on gastrointestinal malignancies, including pancreatic and gastric cancers, some of whom will have high levels of hyaluronan (HA). Halozyme's role will be supplying product.
- Halozyme will lead the second study, an open-label Phase 1b assessing the combination along with chemo in patients with advanced/metastatic biliary and gallbladder cancers. Only patients with high HA levels will be enrolled.
- PEGPH20 is an investigational drug administered intravenously that temporarily degrades HA, a chain of natural sugars that builds up around cancer cells inhibiting the effectiveness of cancer-killing therapies.
- Atezolizumab is a PD-L1 antagonist that is designed to block inhibitory T-cell checkpoints thereby allowing cytotoxic T cells to reach the tumor.
Tue, Nov. 8, 8:09 AM
- Mylan N.V. (NASDAQ:MYL) submits a Biologics License Application (BLA) to the FDA seeking approval of its biosimilar to Roche's (OTCQX:RHHBY) cancer med Herceptin (trastuzumab). This is the company's first BLA filing for a biosimilar in the U.S.
- Its trastuzumab biosimilar, co-developed with Biocon Ltd., is currently being sold in 11 countries, including India.
Mon, Nov. 7, 7:02 AM
- Based on encouraging results in two early-stage studies, Roche (OTCQX:RHHBY) initiates two Phase 3 clinical trials assessing the combination of TECENTRIQ (atezolizumab), Cotellic (cobimetinib) and Zelboraf (vemurafenib) in patients with metastatic melanoma (MM). The data were presented as the International Congress of the Society for Melanoma Research in Boston, MA.
- Results from a Phase 1b study in 30 patients with BRAF-positive MM who were treated with the combination showed an 83% (n=24/29) response rate including three complete responders. Grade 3 or 4 adverse events were observed in 40% of the patients but all resolved after intervention.
- Results from another Phase 1b that assess the combination of TECENTRIQ with Cotellic in 22 patients with metastatic melanoma who had received a median of one prior line of therapy but not a PD-1/PD-L1 inhibitor showed an overall response rate of 45% (n=10/22) (50% in BRAF wild-type patients and 40% in BRAF-mutant patients). Median progression-free survival was 12 months in non-ocular melanoma patients (15.7 months in BRAF wild-type and 11.9 months in BRAF-mutant). Grade 3 or 4 adverse events were reported in 59% (n=13/22) of subjects but all were manageable.
- The Phase 3s will assess TECENTRIQ with Cotellic plus Zelboraf in treatment-naive BRAF-mutant metastatic melanoma and TECENTRIQ with Cotellic in treatment-naive BRAF wild-type metastatic melanoma.
Thu, Nov. 3, 9:05 AM
- The FDA accepts for review Genentech's (OTCQX:RHHBY) Biologics License Application (BLA) seeking approval of a subcutaneous formulation of rituximab in a range of blood cancer indications. It is a co-formulation with Halozyme's (NASDAQ:HALO) ENHANZE platform, marketed ex-U.S. as MabThera SC.
- ENHANZE is based on a proprietary recombinant hyaluronidase enzyme (rHuPH20) that temporarily degrades a natural chain of sugars in the body called hyaluronan. This helps in the dispersion and absorption of injected drugs which enables subcutaneous administration of medicines that are currently restricted to the intravenous route.