Roche Holding Ltd ADR
 (RHHBY)

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  • Aug. 7, 2015, 8:14 AM
    • A new class of cancer therapeutics has been rekindled of late led by Pfizer (NYSE:PFE) and Bristol-Myers Squibb (NYSE:BMY). They are called immune system accelerators, antibodies that target a protein called 4-1BB, also known as CD137.
    • When the immune system's T-cells and natural killer (NK) cells identify cancer cells, the 4-1BB protein appears on their surfaces which accelerates their attack. The protein was discovered over 20 years ago, but its development was abandoned in 2008 after early-stage studies done by Bristol showed signs of liver damage. Scientists eventually realized that lower doses of 4-1BB, given at the right time, could elicit the desired anti-cancer effect without the unwanted toxicity. Early results have been impressive. A 38-subject study done by Pfizer, 40% of patients with follicular lymphoma and a third of those with mantle cell lymphoma experienced a reduction in cancer with no serious side effects.
    • Phase 1 studies are underway assessing combinations of immune checkpoint inhibitors, like Roche's (OTCQX:RHHBY) Rituxan (rituximab) and accelerators. Studies are planned for Pfizer's 4-1BB candidate in combination with Herceptin (trastuzumab) and the combination of Bristol's 4-1BB candidate, urelumab, with Eli Lilly's (NYSE:LLY) Erbitux (cetuximab). Bristol in currently enrolling patients in five Phase 1 studies in multiple myeloma, lymphomas and solid tumor cancers. Pfizer is planning trials with an immunotherapy from Kyowa Hakko Kirin and Merck's (NYSE:MRK) Keytruda (pembrolizumab).
    • Johnson & Johnson (NYSE:JNJ) and AbbVie (NYSE:ABBV) are a step behind doing preclinical work on their accelerator candidates.
    | Aug. 7, 2015, 8:14 AM | 6 Comments
  • Jul. 31, 2015, 7:13 AM
    • The European Commission (EC) approves Roche's (OTCQX:RHHBY) Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy, for the neoadjuvant (before surgery) treatment of adult patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer at high risk of recurrence.
    • The regimen is the first neoadjuvant breast cancer treatment approved by the EC based on pathological complete response (pCR) data, which means that there is no tumor tissue detectable at the time of surgery in the affected breast or in the affected breast and local lymph nodes. This measure can be assessed more quickly that traditional endpoints in early breast cancer (eBC).
    • Perjeta was previously cleared for the neoadjuvant treatment of HER2-positive eBC in the U.S. and 21 other countries.
    | Jul. 31, 2015, 7:13 AM
  • Jul. 30, 2015, 7:57 AM
    • Roche (OTCQX:RHHBY) submits its Premarket Approval (PMA) application to the FDA seeking clearance for its cobas EGFR Mutation v2, a companion diagnostic test for AstraZeneca's (NYSE:AZN) Orphan Drug-, Fast Track- and Breakthrough Therapy-tagged AZD9291.
    • Patients with non-small cell lung cancer (NSCLC) who have adenocarcinoma with tumor containing an EGFR (epidermal growth factor receptor) sensitizing mutation respond initially to current EGFR TKI therapies. About 67% relapse and develop drug resistance due to, in large part, the acquisition of a mutation called T790M. Patients with this mutation will most likely benefit from treatment with AZD9291.
    • Roche's second generation test is built upon its current FDA-cleared assay for EGFR mutations. It is designed to identify a broad spectrum of EGFR mutations in patients with NSCLC, including T790M.
    | Jul. 30, 2015, 7:57 AM
  • Jul. 28, 2015, 12:57 PM
    • Privately-held Boehringer Ingelheim (BI) enters into an exclusive license and collaboration agreement with Seoul, Korea-based Hanmi Pharmaceutical to develop and commercialize HM61713, a third generation epidermal growth factor receptor (EGFR)-targeted therapy for the treatment of EGFR mutation-positive lung cancer.
    • Under the terms of the agreement, Hanmi will receive an upfront payment of $50M, milestones up to $680M and tiered double-digit royalties on net sales. BI will have exclusive global commercialization rights to HM61713 except South Korea, China and Hong Kong.
    • HM61713 is an orally active, irreversible EGFR mutation-selective tyrosine kinase inhibitor (TKI). It is currently in Phase 2 development for the treatment of patients with non-small cell lung cancer with T790M mutations who have developed resistance to other EGFR-targeting agents. A Phase 3 study will commence next year.
    • EGFR-related tickers: (AZN +0.3%)(OTCQX:RHHBY +1.3%)(OTCPK:ALPMY) (OTCPK:ALPMF) (BMY +0.1%)(LLY +1.4%)(GSK -0.1%)(AMGN +4.3%)
    | Jul. 28, 2015, 12:57 PM
  • Jul. 28, 2015, 10:08 AM
    • The European Medicines Agency validates Teva Pharmaceutical Industries' (TEVA -1.6%) Marketing Authorization Application (MAA) for reslizumab for the treatment of inadequately controlled asthma in adult patients with elevated blood eosinophils despite an inhaled corticosteroid-based regimen. A final decision by the European Commission is anticipated in H2 2016.
    • Reslizumab is an investigational humanized monoclonal antibody that binds to interleukin-5 (IL-5), a cytokine that plays a key role in the activation and growth of eosinophils, a type of white blood cell that is elevated in the lungs and blood of many asthmatics. High levels of eosinophils correlate with disease severity so binding to IL-5 inhibits its ability to stoke eosinophil levels.
    • Teva's Biologics License Application (BLA) is currently under review by the FDA. A decision is expected in March 2016.
    • Asthma-related tickers: (SNY -0.1%)(GSK -0.4%)(AZN -0.7%)(OTCQX:RHHBY)(AMGN +2.2%)(MRK -1.1%)(NVS +0.7%)(THRX +1.5%)
    | Jul. 28, 2015, 10:08 AM
  • Jul. 24, 2015, 12:26 PM
    • The FDA approves Novartis' (NVS -0.5%) Odomzo (sonidegib) for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy or who are not candidates for surgery or radiation therapy.
    • Odomzo is a once-daily pill that inhibits the molecular pathway called Hedgehog. It will compete with Roche's (OTCQX:RHHBY -0.9%) Erivedge (vismodigib), an antagonist of part of the hedgehog signaling pathway called smoothened receptor (SMO), that was cleared in January 2012. It will generate ~$175M in sales this year.
    | Jul. 24, 2015, 12:26 PM
  • Jul. 24, 2015, 8:10 AM
    • Roche (OTCQX:RHHBY) launches its improved CARDIAC point-of-care (POC) Troponin T test for suspected acute myocardial infarction (heart attack). The new test can detect troponin concentrations as low as 40 ng/L compared to the previous version's detection limit of 100 ng/L. The hand-held diagnostic, which requires no sample preparation or lengthy setup, can generate a result in 12 minutes, making it ideal for a non-laboratory setting such as an emergency room, ambulance or physician office.
    • The test is used as an aid to rule-in suspected heart attack patients and triage them appropriately. Patients with Troponin T levels <50 ng/L are at lower risk and can be sent to a local hospital for further evaluation. The pre-hospital triage can reduce the time to treatment and potentially save costs.
    • In the U.S. and Europe, as many as 20M patients each year visit hospital emergency rooms complaining of chest pain and symptoms consistent with heart attack.
    • Troponin T is a protein found in striated muscle. In a heart attack, it becomes elevated two to four hours after the onset of myocardial necrosis (tissue death due to lack of blood supply) and can remain elevated for up to 14 days.
    | Jul. 24, 2015, 8:10 AM
  • Jul. 23, 2015, 9:46 AM
    • Roche (OTCQX:RHHBY +0.8%) Q2 results (CHFm): Total Revenues: 11,752 (+2.4%); Pharmaceuticals: 9,028 (+2.7%); Diagnostics: 2,724 (+1.5%).
    • Key Product Sales: MabThera/Rituxan: 1,752 (+3.5%); Avastin: 1,644 (+7.3%); Herceptin: 1,613 (+3.7%); Lucentis: 375 (-10.9%); Actemra/RoActemra: 341 (+15.6%); Perjeta: 337 (+60.5%); Tarceva: 307 (-11.5%).
    • 2015 Guidance: Sales growth: low-to-mid single digit (unch); Core earnings growth: ahead of sales growth (unch).
    | Jul. 23, 2015, 9:46 AM
  • Jul. 16, 2015, 8:04 AM
    • The FDA grants a Clinical Laboratory Improvement Amendments (CLIA) Waiver to privately-held Theranos for its diagnostic test system. The waiver allows the testing to be performed in non-traditional locations such as Theranos Wellness Centers, currently 42 in Arizona, one in Palo Alto, CA and one in Harrisburg, PA.
    • The automated system the company has developed utilizes microfluidics to perform a wide array of tests on small volume blood samples, including those from a finger stick. Some observers believe Theranos will upend the clinical diagnostics industry with its modest costs. The company's herpes test, for example, will sell for only $9.07 compared to ~$175 from leading reference labs.
    • Theranos founder and CEO Elizabeth Holmes is one the newest celebrity entrepreneurs. Based on the company's current valuation, she is the youngest self-made female billionaire in U.S. history.
    • Related tickers: (NYSE:ABT) (OTCQX:RHHBY) (NYSE:TMO) (NYSE:DGX) (NASDAQ:BRLI) (NYSE:LH)
    | Jul. 16, 2015, 8:04 AM | 1 Comment
  • Jul. 14, 2015, 7:14 AM
    • Epirus Biopharmaceuticals (NASDAQ:EPRS) inks a collaboration deal with Polpharma Group for certain Epirus biosimilar candidates, including BOW015 [reference product: J&J's (NYSE:JNJRemicade (infliximab)], BOW050 [reference product: AbbVie's (NYSE:ABBV) Humira (adalimumab)] and BOW070 [reference product: Roche's (OTCQX:RHHBY) Actemra (tocilizumab)].
    • Polpharma is a leading generics firm based in Poland with annual sales of ~$1B.
    • Under the terms of the agreement, both companies with jointly fund clinical development and will collaborate on regulatory filings in the specified territories. Epirus will be responsible for process development, scale-up and manufacturing while Polpharma will be responsible for commercialization. Clinical development costs and eventual operating profit will be split 51/49 in favor of Polpharma. Polpharma will contribute ~$30M toward development costs and cover product launch costs across the three programs.
    • Epirus retains commercial rights in Switzerland, Norway, Austria, Belgium, Denmark, Finland. Luxembourg, the Netherlands and Sweden. It also retains commercial rights in North America and other global markets not covered in the agreement.
    | Jul. 14, 2015, 7:14 AM
  • Jul. 13, 2015, 8:42 AM
    • Results from a 20-subject Phase 2 trial assessing Ohr Pharmaceutical's (NASDAQ:OHRP) OHR-102 (squalamine lactate ophthalmic solution 0.2%) in patients with macular edema secondary to branch and central retinal vein occlusion show that treatment with a combination of OHR-102 and Roche's (OTCQX:RHHBYLucentis (ranibizumab injection) produced greater gains in visual acuity compared to Lucentis alone. At week 38, the mean gain in visual acuity from baseline in the combination arm was +27.8 letters compared to +23.3 letters for Lucentis. The difference was clinically meaningful but unclear as to statistical significance. The data were presented at the 2015 Annual Meeting of the American Society of Retina Specialists in Vienna, Austria.
    • Shares are up 23% premarket on robust volume.
    | Jul. 13, 2015, 8:42 AM | 14 Comments
  • Jul. 13, 2015, 6:44 AM
    • A Phase 2 trial, called IMvigor 210, evaluating Roche's (OTCQX:RHHBY) Breakthrough Therapy-tagged atezolizumab (MPDL3280A) in patients with locally advanced or metastatic urothelial bladder cancer (UBC) who had progressed on initial treatment met its primary endpoint of objective response rate (ORR). In addition, patients with high amounts of PD-L1 (Programmed Death Ligand-1) correlated with increased response to atezolizumab.
    • The results will be presented at an upcoming medical conference and will be reviewed with regulators as soon as possible to clarify an approval path.
    • A Phase 3 study, IMvigor 211, assessing atezolizumab with standard-of-care chemo in patients with relapsed UBC is ongoing. Another Phase 3, IMvigor 010, in patients with early stage muscle-invasive bladder cancer who are PD-L1 positive and at risk of recurrence is expected to start shortly.
    • Bladder cancer is the ninth most common cancer globally, with 430K new cases each year resulting in 145K deaths.
    | Jul. 13, 2015, 6:44 AM
  • Jul. 2, 2015, 4:07 PM
    • The FDA issues 510(k) clearance for privately-held Theranos' diagnostic testing system and its test for herpes simplex 1 IgG, the 153rd test that the company provides for less than $10 in its service offering. The automated system the company has developed utilizes microfluidics to perform a wide array of tests on small volume blood samples, including those from a finger stick. Some observers believe Theranos will upend the clinical diagnostics industry with its modest costs. The herpes test, for example, will sell for only $9.07 compared to ~$175 from leading reference labs.
    • Theranos founder and CEO Elizabeth Holmes is one the newest celebrity entrepreneurs. Based on the company's current valuation, she is the youngest self-made female billionaire in U.S. history.
    • Some diagnostics-related tickers: (NYSE:ABT) (OTCQX:RHHBY) (NASDAQ:QDEL) (NYSE:BIO) (NASDAQ:QGEN) (NASDAQ:CPHD) (NASDAQ:CEMI) (NASDAQ:TRIB) (NASDAQ:AXDX) (NASDAQ:CBMX) (NYSE:TMO)
    | Jul. 2, 2015, 4:07 PM
  • Jul. 1, 2015, 11:08 AM
    • Exelixis (EXEL -7.7%) slumps on average volume in response to the FDA's decision to extend its action date for its review of Genentech's (OTCQX:RHHBY) New Drug Application (NDA) for cobimetinib to November 11 from August 11. The agency feels that the extension is necessary in order for it to review additional data from coBRIM, the Phase 3 trial of cobimetinib and vemurafenib (Zelboraf) in patients with BRAF V600 mutation-positive advanced melanoma. The additional data were requested by the regulator.
    • Cobimetinib was discovered by Exelixis. Its collaboration with Genentech began in late 2006.The companies will co-promote the product in the U.S. while Genentech will promote it ex-U.S.
    • Previously: Roche's melanoma combo NDA gets Priority Review (Feb. 19)
    • Previously: Roche submits NDA for skin cancer med (Dec. 15, 2014)
    | Jul. 1, 2015, 11:08 AM | 2 Comments
  • Jun. 26, 2015, 10:48 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for Roche's (OTCQX:RHHBY +0.1%) Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy, for the neoadjuvant treatment (before surgery) of adult patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer at high risk of recurrence. A final decision by the European Commission usually takes ~60 days.
    • This is the first CHMP recommendation in the neoadjuvant setting based on pathological complete response (pCR), which means that there was no evidence of tumor tissue detectable at the time of surgery in the affected breast and local lymph nodes. In a mid-stage trial, called NeoSphere, almost 40% of patients receiving Perjeta + Herceptin + taxane chemo showed a pCR compared to 21.5% of patients who received Herceptin and taxane alone.
    • There are ~100K cases of HER2-positive breast cancer diagnosed in Europe each year. Breast cancers that are positive for HER2 (human epidermal growth factor receptor 2) are more aggressive than those negative for the oncogene.
    • The FDA approved Perjeta for this indication in September 2013. The agency approved it in 2012 for advanced late-stage HER2-positive breast cancer.
    | Jun. 26, 2015, 10:48 AM | 2 Comments
  • Jun. 23, 2015, 7:46 AM
    • Data from a Phase 1 extension study show that patients with severe hemophilia A who received a once-weekly subcutaneous injection of Roche's (OTCQX:RHHBY) humanized bispecific antibody ACE910 experienced significant reductions in bleeding events for up to 18.5 months. The data were presented yesterday at the International Society on Thrombosis and Haemostasis annual meeting in Toronto, Canada.
    • Patients were divided into three ACE910 dose-related cohorts: 0.3 mg/kg, 1 mg/kg and 3 mg/kg. Maximum reductions in annualized bleeding rates for the three arms in patients not receiving factor VIII inhibitors were 82.7%, 100% and 100%, respectively. The maximum reduction for patients receiving factor VIII inhibitors was 100% in all three arms. The follow up periods were 5.6 - 18.5 months. A total of 18 patients were involved.
    • The company intends to start a Phase 3 study in patients with Factor VIII inhibitors by the end of the year and another Phase 3 study in patients without Factor VIII inhibitors in 2016.
    • ACE910 is an investigational humanized FVIIIa-mimetic bispecific monoclonal antibody engineered to simultaneously bind factors IXa and X, thereby mimicking the cofactor function of factor VIII. Roche obtained the rights from Chugai Pharmaceutical in 2014.
    | Jun. 23, 2015, 7:46 AM
Company Description
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
Sector: Healthcare
Country: Switzerland