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
Thu, Jul. 21, 7:27 PM
- Puma Biotechnology (NYSE:PBYI) files its New Drug Application (NDA) with the FDA seeking approval of lead product candidate neratinib (PB272) for the extended adjuvant treatment of patients with HER2-overexpressed/amplified breast cancer who received prior adjuvant treatment with Roche's (OTCQX:RHHBY) Herceptin (trastuzumab).
- The data supporting the application was generated in the Phase 3 ExteNET study that showed treatment with neratinib reduced the risk of invasive disease recurrence or death 33% compared to placebo (p=0.009). The two-year invasive disease-free survival (DFS) rate for the neratinib group was 93.9% versus 91.6% for placebo. In patients with hormone receptor-positive breast cancer, the invasive DFS rates were 95.4% and 91.2%, respectively.
- The company filed its Marketing Authorization Application (MAA) in Europe last month.
- Shares are up 18% after hours on increased volume.
Thu, Jul. 21, 4:18 AM
- Helped by cost-control measures, Unilever (NYSE:UL) posted a profit rise and said it's ready for challenges ahead.
- Swatch (OTCPK:SWGAY) expects a recovery in the second half after net profit plunged 52% in H1.
- Roche (OTCQX:RHHBY) confirmed its outlook for 2016 and reported results that exceeded expectations.
- Driven by price and mix realization, SABMiller's (OTCPK:SBMRY) group net producer revenue grew 2% in Q1.
- Lufthansa (OTCQX:DLAKY) cut its full-year profit target, saying "terrorist attacks in Europe" weighed on its bookings.
- The fears also hit Easyjet (OTCQX:ESYJY), with shares under pressure after weak Q3 revenues.
Mon, Jul. 11, 8:51 AM
- Micro cap Organovo (NYSEMKT:ONVO) is up 10% premarket on increased volume in response to is announcement of positive preclinical results generated with its 3D bioprinted human liver tissues.
- The data, published in the journal PLOS One, showed Organovo's product was able to detect significant dose-dependent toxicity of trovafloxacin at clinically relevant doses compared to levofloxacin, a structurally similar but non-toxic compound. The hepatotoxicity of trovafloxacin, a broad based antibiotic launched by Pfizer (NYSE:PFE) but later withdrawn from the market because of the risk of serious liver damage, was not originally identified by traditional preclinical tests, including animal studies.
- The study was funded by Organovo and Roche Pharmaceuticals (OTCQX:RHHBY).
Thu, Jul. 7, 6:12 PM
- Nano cap Eleven Biotherapeutics (NASDAQ:EBIO) is up 44% after hours on robust volume in response to its announcement that the FDA has approved its Investigational New Drug (IND) application for EBI-031 for the treatment of ocular diseases. The company is now entitled to a $22.5M milestone payment from licensee Roche (OTCQX:RHHBY). The company filed the IND last month with the aim of conducting clinical trials in diabetic macular edema and uveitis.
- EBI-031 is a humanized monoclonal antibody that potentially binds to interleukin-6, a pro-inflammatory cytokine. It was designed and engineered for intravitreal (injected into the eye) delivery using Eleven's AMP-Rx platform.
- Previously: Eleven Bio inks development deal with Roche; shares up 61% premarket (June 13)
Thu, Jul. 7, 8:28 AM
Tue, Jul. 5, 11:16 AM
- Thinly traded micro cap pSivida (PSDV +5.4%) bucks the market's bearishness. Shares are up on average volume (only ~23K shares so far) in response to its announcement of positive results from preclinical animal studies assessing the effectiveness of a sustained-release insert based on its Durasert technology to deliver a tyrosine kinase inhibitor (TKI) for the treatment of wet age-related macular degeneration (wet AMD).
- The data showed the TKI insert was similar in efficacy to an injection of an FDA-approved AMD biologic in preventing choroidal neovascularization (formation of new blood vessels) and reducing vascular leakage.
- Based on the encouraging results, the company intends to advance the Durasert TKI insert into clinical development.
- TKIs are currently used to treat cancer, but some inhibit a growth factor called PDGF (platelet-derived growth factor) which plays a key role in blood vessel formation. The TKI used by pSivida inhibits both PDGF and VEGF (vascular endothelial growth factor). AMD meds Lucentis (ranibizumab) and Eylea (aflibercept) are both VEGF inhibitors. In cancer, TKIs are taken orally because systemic administration is too toxic. PSivida's approach aims to deliver a TKI dose directly to the retina that is 1,000 times less that the dose used to treat cancer.
- Related tickers: (OTCQX:RHHBY -1.5%)(REGN -0.5%)
Mon, Jun. 13, 8:26 AM
- Nano cap Eleven Biotherapeutics (NASDAQ:EBIO) jumps 61% premarket on robust volume in response to its announcement that it has entered into an exclusive license agreement with Roche (OTCQX:RHHBY) to develop and commercialize EBI-031, a humanized monoclonal antibody that binds to interleukin-6 (IL-6), for the treatment of ocular diseases, initially diabetic macular edema and uveitis.
- Under the terms of the contract, Eleven will receive an upfront cash payment of $7.5M, up to $262.5M in milestones and royalties on net sales of EBI-031 or any other future products containing other Eleven IL-6 compounds. The first milestone, $22.5M, will be triggered if the FDA approves the Investigational New Drug (IND) application no later than September 15 of this year (it was filed today). The milestone drops to $20.0M if the IND becomes effective afterward.
Mon, Jun. 6, 8:33 AM
- Thinly traded nano cap Vascular Biogenics (NASDAQ:VBLT) is up 33% premarket on robust volume in response to its announcement of positive results from a Phase 1/2 clinical trial assessing lead product candidate VB-111 in women with recurrent platinum-resistant ovarian cancer. The data were presented at today at ASCO16 in Chicago.
- Results showed patients treated with a therapeutic dose of VB-111 experienced median overall survival of 810 days compared to 172 days in the lose dose arm. The difference was statistically significant (p=0.042). There was also a doubling of the durable response rate to 60% (as measured by the biomarker CA-125) compared to historical rates for Roche's (OTCQX:RHHBY) Avastin (bevacizumab) plus chemo.
- VB-111 was safe and well-tolerated. Eight serious adverse events were reported, two potentially related to VB-111. No dose-limiting toxicities were observed at any dose level.
- The company plans to have an end-of-Phase 2 meeting with the FDA to review the data and clarify the next steps in the clinical development of VB-111.
- VB-111 is an intravenously-administered next-generation anti-angiogenic agent that utilizes the company's Vascular Targeting System to target endothelial cells in the tumor vasculature.
Tue, May 24, 9:10 AM
- Thinly traded nano cap OXiGENE (NASDAQ:OXGN) is up 65% premarket on a 9x surge in volume in response to its announcement of successful results in a Phase 2 clinical trial, called Study GOG-01861, assessing lead product candidate, Fast Track-tagged CA4P (fosbretabulin), in women with recurrent ovarian cancer. The results were just published online in the Journal of Clinical Oncology.
- The open-label U.S.-based study randomized 107 patients across 67 sites to receive either CA4P with bevacizumab [Roche's (OTCQX:RHHBY) Avastin] or bevacizumab alone (control). It achieved its primary endpoint of showing a statistically valid improvement in progression-free survival (PFS) for the combination compared to Avastin alone (7.3 months versus 4.8 months; p=0.05).
- Preliminary median overall survival also favored the CA4P combination (24.6 months vs. 22.0 months), with a 15% reduction in the risk of cancer progression or death (hazard ratio: 0.85).
- No treatment-emergent serious adverse events were observed. The most common CA4P combination-related adverse events (grade 3 or higher) were hypertension (35%; n=18) versus 20% (n=10) for control.
- CA4P is a vascular disrupting agent. It fights tumors by compromising the blood vessels that feed them, causing widespread ischemia (insufficient blood flow) and necrosis (tissue death) of the cancer cells within the core of the tumor.
- A 436-subject Phase 2/3 study assessing CA4P + bevacizumab in platinum-resistant ovarian cancer is about to start. According to clinicaltrials.gov, the estimated study completion date is July 2018.
Mon, May 9, 4:57 PM
- Thinly traded nano cap EPIRUS Biopharmaceuticals (NASDAQ:EPRS) reprioritizes its pipeline, suspending development of lead product candidate BOW015, a biosimilar to J&J's (NYSE:JNJ) Remicade (infliximab), to focus on developing biosimilars for the treatment of rare diseases. For example, the company will allocate additional resources to advance BOW080, a biosimilar candidate to Alexion Pharmaceuticals' (NASDAQ:ALXN) Soliris (eculizumab), currently approved in the U.S. for the treatment of orphan diseases paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, and BOW070, a biosimilar candidate to Roche's (OTCQX:RHHBY) Actemra (tocilizumab) for the treatment of a rare lymphoproliferative disorder called Castleman's disease.
- The company intends to rationalize the BOW015 program including possible partnerships, divestitures or other alternatives.
- The reallocation of resources will include a workforce reduction of up to 40%. Concurrently, President & CEO Amit Munshi has stepped down, replaced by board member Scott Rocklage, Ph.D., former CEO of Cubist Pharmaceuticals.
Tue, Mar. 29, 3:37 PM
- Thinly traded micro cap Ohr Pharmaceutical (OHRP +16.8%) is up on a 6x surge in volume in response to its announcement that it has initiated a Phase 3 clinical trial assessing lead product candidate, Fast Track-tagged squalamine lactate ophthalmic solution, 0.2% (OHR-102), in combination with Roche's (OTCQX:RHHBY +2.2%) Lucentis (ranibizumab), for the treatment of neovascular age-related macular degeneration (wet AMD). The study will enroll ~650 treatment-naive patients. The primary endpoint will be the change in visual acuity at Month 9.
- The product candidate failed to beat placebo in a Phase 2 study, called IMPACT, which precipitated a plunge in valuation.
- Squalamine, a small molecule drug in an eye drop formulation, blocks the development of abnormal microvascular networks in the eye (a process called neovascularization) by inhibiting vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF) and basic fibroblast growth factor (bFGF). All play key roles in angiogenesis (formation of new blood vessels from existing ones) and ocular neovascular disease.
- Lucentis is a monoclonal antibody fragment that binds to VEGF.
- Previously: Ohr Pharma presents data from failed Phase 2 study; Phase 3 planned for H2 (May 8, 2015)
Tue, Feb. 2, 5:37 PM
- Pacific Biosciences (NASDAQ:PACB) jumped into the close in the last hour, up 24.3%, on news that Roche Holding (OTCQX:RHHBY -2.3%) approached the firm to talk buyout, Reuters reports.
- Price disagreement means the talks haven't advanced yet, sources said.
- Roche's interest lies in Pacific Biosciences' advanced gene sequencing technology. The two formed a development/distribution partnership in 2013.
- A deal in this area would show continued signs of life in life science M&A. Roche has been making small deals over the past year to fill out some therapeutic areas.
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.
Oct. 12, 2015, 10:44 AM
- Thinly traded nano cap Celsion (CLSN +9.2%) moves up on a healthy 10x surge in volume in response to its announcement of positive preclinical results for its GEN-1 IL-12 immunotherapy. Specifically, the combination of GEN-1 IL-12 with Roche's (OTCQX:RHHBY +0.7%) Avastin (bevacizumab) and J&J's (JNJ +0.9%) Doxil (doxorubicin HCl liposome injection) showed a greater than 98% reduction in tumor burden compared to the combination of Avastin and Doxil alone in an ovarian cancer cell line called SKOV3 implanted into immunocompromised mice.
- GEN-1 is an immunotherapy consisting of an interleukin-12 (IL-12) DNA plasmid vector encased in a nanoparticle delivery system. It is administered via an intraperitoneal (body cavity) injection.
- The company is currently enrolling patients in a Phase 1b trial called OVATION. A Phase 1/2 combination study should commence in mid-2016.
Sep. 18, 2015, 8:43 AM
- Thinly traded micro cap Tracon Pharmaceuticals (NASDAQ:TCON) is up 70% premarket on average volume in response to its announcement that a patient with an aggressive form of uterine cancer is experiencing an ongoing complete response after being treated with the company's investigational TRC105 in combination with Roche's (OTCQX:RHHBY) Avastin (bevacizumab). The results were presented at the 18th World Congress on Gestational Trophoblastic Diseases in Bali, Indonesia.
- The single patient was suffering from persistent and unresectable metastatic choriocarcinoma which is an aggressive form of gestational trophoblastic neoplasia (GTN), a rare form of uterine cancer. Under a compassionate use protocol, she was dosed with TRC105 10 mg/kg weekly, in combination with Avastin 10 mg/kg every other week. After 28 weeks of treatment (seven cycles), her beta human chorionic gonadotropin (bHCG), a reliable biomarker in choriocarcinoma, decreased from more than 3,000 IU/L to less than 1 IU/L from cycles four through seven, indicating a complete response.
- Choriocarcinoma is the second tumor type known to express high levels of a protein called endoglin, which plays a key role in angiogenesis (development of new blood vessels that "feed a tumor"). The other, angiosarcoma, also responds well to treatment with TRC105 and a VEGF inhibitor like Avastin.
- TRC105 is a novel antibody to endoglin.
- The company plans to initiate a Phase 2 study in GTN in Q4 and apply to the FDA for Orphan Drug status in GTN and soft tissue sarcoma by the end of the year.
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
Industry: Drug Related Products
Other News & PR