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
Poor Pipeline Productivity Has Left Roche More Vulnerable
Stephen Simpson, CFA
Stephen Simpson, CFA
Dec. 11, 2015, 9:59 AM
- Data from a Phase 1b clinical trial investigating Roche's (OTCQX:RHHBY +0.4%) atezolizumab (formerly MPDL3280A), in combination with nab-paclitaxel, in women with triple-negative breast cancer showed an overall response rate (ORR) of almost 71%. The results were presented at the San Antonio Breast Cancer Symposium in Texas.
- Patients received 800 mg of atezolizumab once every two weeks and nab-paclitaxel each week at a dose of 125 mg/m2 for three weeks in four-week cycles until loss of clinical benefit.
- The ORR (including investigator-assessed unconfirmed responses) was 70.8% (n=17/24), including one complete responder and 16 partial responders. Five patients (20.8%) experienced stable disease while two (8.3%) progressed.
- The ORR was highest (88.9%) in patients receiving first-line treatment for metastatic disease, including the one complete responder (n=8/9). The ORRs in patients receiving therapy as second-line and third-line treatment were 75.0% (n=6/8) and 42.9% (n=3/7), respectively.
- Responses were observed in both PD-L1-positive and PD-L1-negative patients.
- Triple-negative breast cancer (ER-, PR-, HER2-) is associated with a poorer prognosis. It accounts for up to 20% of breast cancer cases.
- Atezolizumab is a PD-L1 inhibitor and nab-paclitaxel (Celgene's Abraxane) is a chemotherapeutic. Roche's development of atezolizumab is ongoing.
Dec. 8, 2015, 5:04 PM
- The first presentation (Abstract P4-14-20) highlights data from a Phase 1b study of ONT-380 in HER2+ breast cancer patients who had failed treatment with Roche's (OTCQX:RHHBY) Herceptin (trastuzumab) and a taxane. The data show an overall response rate of 41% and a clinical benefit rate (CBR) of 59% in an advanced stage patient population [clinical benefit rate is considered vague but should include the overall response rate plus patients with stable disease (no progression); the term "disease control rate" is used more frequently]. 60% of the advanced stage population had a history of central nervous system metastases. The CNS CBR for patients with response assessable (unclear on how this is defined) CNS metastases was 64%.
- The second presentation (Abstract P4-14-19) combines data from the above trial and another Phase 1b assessing ONT-380 in combination with Herceptin and Roche's Xeloda (capecitabine). The data includes patients with previously untreated CNS metastases as well as those with progressive or new CNS metastases after prior treatment with radiation or surgery. No specific numbers are disclosed, only the statement "Responses and clinical benefit in the CNS were seen for both groups and in all combinations tested."
- The misdirection has clearly spooked investors. Shares are down 33% after hours on robust volume.
- In June, the company announced positive data from the Herceptin/Xeloda study that showed an 85% disease control rate (DCR) (partial responders + complete responders + those with stable disease) in all cohorts. The company also reported data from the Herceptin/taxane study that showed a 64% DCR (this equals the 64% CNS CBR stated above). Shares rallied that day.
- Previously: Oncothyreon up 46% premarket on ONT-380 study results (June 1)
Dec. 8, 2015, 8:53 AM
- Thinly traded nano cap Pieris Pharmaceuticals (NASDAQ:PIRS) is up 17% premarket on increased volume in response to its announcement that it has entered into a research collaboration and license agreement with Roche (OTCQX:RHHBY) in cancer immunotherapy. Specifically, Pieris will discover, characterize and optimize Anticalin-based drug candidates against an undisclosed target. Both firms will evaluate different drug formats against the target and advance them through preclinical development. Roche will be responsible for IND-enabling activities, clinical development and worldwide commercialization.
- Under the terms of the agreement, Pieris will receive an upfront payment of CHF 6.5M (~$6.4M), research funding, regulatory- and sales-based milestones and mid-single to low-double-digit royalties on net sales. Total payments to Pieris could reach CHF 415M (~$409M), excluding royalties, if all milestones are met.
- Anticalins are engineered lipocalins, endogenous proteins found in blood plasma and other body fluids that naturally bind, store and transport a wide range of molecules. They potentially offer improved efficacy and more convenient routes of administration versus existing biologics.
Dec. 2, 2015, 6:49 AM
- PDL BioPharma (NASDAQ:PDLI) reports that it received $133.7M in cash payments in November including:
- $14.0M royalty payment from Biogen (NASDAQ:BIIB).
- $104.9M royalty payment from Roche's (OTCQX:RHHBY) Genentech unit.
- $5.3M royalty payment from Valeant Pharmaceuticals (NYSE:VRX) related to Glumetza.
- $9.5M payment from kaleo subsidiary Accel 300, LLC, for note payments.
- For comparison purposes, PDL's total Q3 revenues were $124.6M, down 24% yoy due primarily to lower Depomed (NASDAQ:DEPO) royalty rights cash proceeds (none received) related to Valeant's commercialization of Glumetza, decreased interest revenues due to the early payoff of the AxoGen and Durata notes receivables and decreased Actemra royalties as a result of the conclusion of the license agreement.
Dec. 1, 2015, 7:10 AM
- Roche (OTCQX:RHHBY) and privately held Upsher-Smith Laboratories' UK subsidiary Proximagen Ltd. ink a global agreement to advance the development of a novel, oral small molecule inhibitor of Vascular Adhesion Protein 1 (VAP-1), a cell adhesion molecule that may have potential in treating inflammatory disease. The product candidate is currently being evaluated in a Phase 2 study.
- Under the terms of the agreement, Proximagen receives an upfront payment, milestones and tiered royalties on net sales. Roche secures a worldwide exclusive license to develop and commercialize the compound. Both firms will conduct additional Phase 2 studies to further define the product candidate's therapeutic potential. Roche will assume responsibility for late-stage development and commercialization. Specific financial terms are not disclosed.
- VAP-1 is an endothelial surface protein that appears to have two functions: an enzyme (monoamine oxidase) and an adhesion molecule for lymphocytes (white blood cells). Its specific role in leukocyte trafficking is unknown but blocking its action decreases the number of bound white blood cells at the site of inflammation thereby decreasing the inflammatory response.
Nov. 25, 2015, 9:50 AM
- As expected, the European Commission approves Roche's (OTCQX:RHHBY +1.5%) Cotellic (cobimetinib), in combination with Zelboraf (vemurafenib), for the treatment of adults with unresectable or metastatic BRAF V600 mutation-positive melanoma.
- Cobimetinib, co-developed with discoverer Exelixis (EXEL +1.1%), inhibits an enzyme called mitogen-activated protein kinase kinase (MEK), a mediator of downstream signaling of tumor growth factor receptors. Vemurafenib is a BRAF inhibitor that was discovered by Daiichi Sankyo's (OTCPK:DSKYF)(OTCPK:DSNKY) Plexxikon unit.
- Previously: European Ad Comm gives thumbs up to Roche's Cotellic/Zelboraf combo for certain type of melanoma (Sept. 25)
Nov. 23, 2015, 7:23 AM
- Results from a Phase 1b study show Roche's (OTCQX:RHHBY) investigational cancer immunotherapy candidate atezolizumab (MPDL3280A), in combination with Zelboraf (vemurafenib), produced a significant treatment effect in patients with previously untreated BRAF-positive unresectable or metastatic melanoma. In 17 patients, the objective response rate was 76% (n=13/17), including three complete responders. The data were presented at the Society of Melanoma Research 2015 International Congress in San Francisco.
- Objective response rate includes complete responders, partial responders and those with stable disease (progression-free).
- No dose-limiting toxicities or atezolizumab-related treatment discontinuations were observed, although staggering the dosing of atezolizumab and Zelboraf after Zelboraf run-in was better tolerated that concurrent dosing. The incidence of Grade 3 (severe) adverse events (AEs) related to atezolizumab and Zelboraf was 41% and 59%, respectively. Treatment-related AEs included pyrexia (high fever) and dehydration.
- Atezolizumab is a PD-L1 inhibitor while vemurafenib is a kinase inhibitor.
- The company's development of the combination is ongoing.
Nov. 19, 2015, 11:42 AM
- An analysis of completed clinical trials showed patients with recurrent glioblastoma multiforme (rGBM), the most common form of malignant brain tumor, treated with VBL Therapeutics' (VBLT -0.2%) lead oncology candidate, Fast Track- and Orphan Drug-tagged VB-111, experienced a significant jump in survival compared to Roche's (OTCQX:RHHBY +0.1%) Avastin (bevacizumab). The data will be presented tomorrow at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology in San Antonio, TX.
- The data compared the 12-month overall survival achieved with VB-111 in a mid-stage study in rGBM to the results from four studies of bevacizumab in rGBM (n=233). Results from a recent Phase 2 trial showed patients treated with VB-111, in combination with bevacizumab upon disease progression, demonstrated a survival rate of 57% at month 12, more than double the overall 28% survival rate at month 12 seen in the four bevacizumab-only trials (range: 16% - 38%).
- Patient recruitment is underway in a Phase 3 study, GLOBE, comparing VB-111 in combination with Avastin to Avastin alone in rGMB. Interim results should be available in Q1 2017. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is December 2017.
Nov. 17, 2015, 7:06 AM
- Roche's (OTCQX:RHHBY) Genentech unit exercises its option to participate in the financial arrangements related to Novartis' (NYSE:NVS) rights under its ex-U.S. agreement with Ophthotech (NASDAQ:OPHT) for Fovista (pegpleranib) for the treatment of wet age-related macular degeneration (wet AMD). Roche's option originates from a pre-existing agreement with Novartis. Specific financial terms are not disclosed.
- Ophthotech's deal with Novartis, inked in May 2014, remains in effect. Ophthotech retains exclusive rights to Fovista in the U.S. while Novartis owns exclusive rights ex-U.S. Ophthotech has the potential to earn more than $1B in upfront and milestone payments during the course of the collaboration.
- Last month, patient recruitment was completed in a Phase 3 clinical trial assessing the combination of Fovista and Roche's Lucentis (ranibizumab) in wet AMD. Top line data should be available in Q4 2016.
- Previously: Ophthotech completes enrollment in second late-state study of Fovista in wet AMD (Oct. 26)
- Previously: Novartis acquires rights to ophthalmic drug (May 19, 2014)
- Previously: More on Novartis/Ophthotech commercialization deal (May 20, 2014)
Nov. 16, 2015, 11:43 AM
- Based on the recommendation from the independent Data Monitoring Committee, a Phase 3 clinical trial, Study 115, evaluating Gilead Sciences' (GILD -0.7%) Zydelig (idelalisib) added to standard therapy in patients with relapsed chronic lymphocytic leukemia (CLL) will be unblinded early based on a statistically significant benefit in progression-free survival compared to standard therapy alone. Full results will be presented at the American Society of Hematology Annual Meeting in Orlando, FL December 5-8.
- Study 115 is a 416-subject, double-blind, placebo-controlled trial. Participants were randomized 1:1 to receive six cycles of the chemo agent bendamustine and rituximab over 24 weeks combined with Zydelig 150 mg or placebo taken orally twice/day continuously until disease progression or unacceptable toxicity.
- Zydelig is approved in the U.S., in combination with Roche's (OTCQX:RHHBY -1%) Rituxan (rituximab), for the treatment of relapsed CLL. It inhibits a protein called phophoinositide 3-kinase (PI3K) delta which plays a key role in the activation, proliferation and survival of the immune system's B cells.
Nov. 13, 2015, 9:59 AM
- Under its accelerated review process, the FDA approves AstraZeneca's (AZN +0.6%) Breakthrough Therapy-, Priority Review- and Orphan Drug-tagged Tagrisso (osimertinib) for the treatment of patients with T790M+ non-small cell lung cancer (NSCLC) whose disease has progressed after treatment with other EGFR-blocking therapies.
- In clinical studies, as many as 61% of T790M+ NSCLC patients treated with osimertinib (formerly AZD9291) experienced a complete or partial reduction in their tumor size.
- Concurrently, the FDA approves Roche's (OTCQX:RHHBY -0.8%) companion diagnostic test for T790M+ NSCLC for use in selecting patients for treatment with Tagrisso. It also detects NSCLC with exon 19 deletions or L858R mutations to select suitable patients for treatment with Tarceva (erlotinib).
Nov. 13, 2015, 8:33 AM
- Based on its analysis of unblinded trial data, the independent Data Monitoring Committee (DMC) recommends Merck's (NYSE:MRK) REVEAL outcomes study of anacetrapib continue with no changes. According to clinicaltrials.gov, the estimated completion date for the 30,000-subject trial is January 2017.
- Anacetrapib inhibits a protein called cholesterol ester transfer protein (CETP), which is designed to elevate HDL cholesterol (the "good" cholesterol). CETP inhibitors were all the rage a few years ago over their potential to provide more cardioprotective benefits than lowering LDL cholesterol (the "bad" cholesterol). Big Pharma's efforts to push CETP inhibitors over the finish line hit fell flat due to toxicity and less-than-expected efficacy. Eli Lilly (NYSE:LLY), Roche (OTCQX:RHHBY), and Pfizer (NYSE:PFE) all abandoned their programs.
- Merck has not given up, however. It ran a 1,623-subject study, DEFINE, which showed that anacetrapib was both safe and effective and raised HDL by 150%. REVEAL, initiated in 2011, is designed to settle the issue once and for all. The trial will cost upwards of $500M to complete so the company is banking on a positive outcome.
Nov. 12, 2015, 12:35 PM
- Citing excess manufacturing capacity precipitated by the evolution of its small molecule portfolio to lower-volume specialized medicines, Roche (OTCQX:RHHBY +0.8%) initiates plans to exit four manufacturing sites located in Clarecastle, Ireland, Leganes, Spain, Segrate, Italy and Florence, SC in the United States. In order to minimize job cuts, which could reach 1,200 if the sites are shuttered, it is actively seeking buyers for the facilities. The transition will begin in 2016 and is expected to conclude in 2021.
- The move, along with other efficiency efforts, will result in non-core structuring costs of 1.6B Swiss francs until 2021, CHF600M in cash.
- The company intends to invest CHF 300M in a dedicated facility in Kaiseraugst, Switzerland to manufacture specialized drugs.
Nov. 10, 2015, 11:37 AM
- The FDA approves Roche's (OTCQX:RHHBY -1.1%) Cotellic (cobimetinib), in combination with Zelboraf (vemurafenib), for the treatment of BRAF V600E mutation-positive or V600K-positive metastatic or unresectable melanoma.
- Cobimetinib slows cancer cell growth by inhibiting an enzyme called MEK (Mitogen-activated protein kinase kinase) which plays a key role in activating melanoma. Restraining MEK signaling slows cancer cell proliferation and induces apoptosis (controlled cell death).
- Zelboraf was approved by the FDA in August 2011 for the treatment of advanced BRAF V600E+ melanoma.
- In clinical studies, patients receiving the combination experienced an average increase in progression-free survival of over five months (12.3 months vs. 7.2 months) compared to those patients treated with Zelboraf alone. Additional benefits of the combination were longer overall survival (65% of combo patients were alive 17 months after beginning treatment versus 50% for Zelboraf alone) and a greater proportion experiencing complete or partial shrinkage of their tumors (70% vs. 50%).
- According to the National Cancer Institute, almost 74K Americans will be diagnosed with melanoma this year and almost 10K will die from it.
- Previously: Roche's Cotellic + Zelboraf improves survival in melanoma patients vs Zelboraf alone (Oct. 6)
Nov. 5, 2015, 9:57 AM
- Roche (OTCQX:RHHBY +1.6%) updated investors today on its pipeline of products across a range diseases. Key points:
- Cotellic (cobimetinib) is currently under regulatory review in the U.S. and Europe for BRAF+ unresectable metastatic melanoma, in combination with Zelboraf (vemurafenib). Decisions from the FDA and EMA are expected in November and December, respectively.
- March 4, 2016 is the PDUFA date for the FDA's review of Breakthrough Therapy-tagged alectinib for ALK+ non-small cell lung cancer (NSCLC). The MAA was filed in Europe in September.
- Global regulatory applications are planned in early 2016 for ocrelizumab in primary progressive and relapsing forms of multiple sclerosis.
- Rolling NDA submission to the FDA underway for PD-L1 inhibitor atezolizumab (MPDL3280A) for certain types of metastatic bladder and lung cancer. Final data submission expected in Q1.
- First results expected in 2017 from several Phase 3 studies evaluating atezolizumab plus chemo in first-line NSCLC. Atezolizumab is also being evaluated in combination with a variety of targeted therapies across a range of cancers.
- Expanded label for Gazyva/Gazyvaro (obinutuzumab) currently under FDA review for follicular lymphoma. The sBLA was accepted under Priority Review in October.
- Venetoclax, a small molecule Bcl-2 inhibitor being co-developed with <<AbbVie>>, is currently in Phase 2 & 3 trials various blood cancers. Regulatory application completed by AbbVie to FDA for CLL with 17p deletion.
- Other near-term products are lebrikizumab for severe asthma, ACE910 for hemophilia A and lampalizumab geographic atrophy, an advanced form of age-related macular degeneration.
Oct. 29, 2015, 9:31 AM
- Seattle Genetics (NASDAQ:SGEN) initiates a randomized Phase 2 clinical trial evaluating denintuzumab mafodotin (SGN-CD19A), in combination with the second-line salvage regimen of Roche's (OTCQX:RHHBY) Rituxan (rituximab), ifosfamide, carboplatin and etoposide (RICE), for the treatment of relapse/refractory diffuse large B-cell lymphoma (DLBCL). The 150-subject, open-label study will compare the combination regimen to RICE alone. The primary endpoint is the comparison of complete remission rates between the two treatment arms.
- Denintuzumab mafodotin is an antibody-drug conjugate (ADC) targeting CD19, a protein highly expressed on the surface of malignant B cells.
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