Roche Holding Ltd ADR (RHHBY) - OTCQX
  • Thu, May 19, 9:46 AM
    • Oncolytics Biotech's (OTCQX:ONCYF) REOLYSIN (reovirus variant), in combination with the chemo regimen FOLFOX-6 and Roche's (OTCQX:RHHBY) Avastin (bevacizumab), failed to beat FOLFOX-6 and Avastin alone in a Phase 2 study in patients with advanced/metastatic colorectal cancer (CRC). The data will be presented in an abstract at ASCO in Chicago, June 3-7.
    • REOLYSIN showed no statistically valid improvements in any cohorts in terms of objective response rate (ORR), progression-free survival or overall survival. Female patients offered the only ray of hope, in which those receiving REOLYSIN (n=19) showed an ORR of 63.2% compared to 23.8% for control (n=21) (FOLFOX-6 and Avastin alone) (p=0.0054).
    • In an apparent attempt to salvage something, the company conducted an additional analysis in patients with liver metastases. The objective tumor response rates favored REOLYSIN 55% (n=40) versus 28.6% (n=42)(p=0.0077). REOLYSIN failed to beat control in patients with no liver metastases.
    | Thu, May 19, 9:46 AM | 16 Comments
  • Wed, May 18, 1:25 PM
    • The FDA approves Roche (OTCQX:RHHBY +0.5%) unit Genentech's atezolizumab, branded as Tecentriq, under Priority Review status for the treatment of urothelial carcinoma, the most common form of bladder cancer. The specific indication is for patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or following platinum-containing chemo or within 12 months of receiving platinum-containing chemo, either before or after surgery.
    • This is a great example of the benefit of accelerated review. The FDA designated it for Priority Review only two months ago with a PDUFA date of September 12.
    • Atezolizumab is a PD-L1 antagonist that is designed to block inhibitory T-cell checkpoints thereby allowing cytotoxic T cells to reach the tumor.
    | Wed, May 18, 1:25 PM
  • Mon, May 16, 10:44 AM
    • Mabtech Ltd., a biosimilar development and commercialization partner with Sorrento Therapeutics (SRNE +3.1%), completes a successful Phase 2/3 clinical trial in China assessing Sorrento's STI-004, a biosimilar antibody of Roche (OTCQX:RHHBY +0.8%) and Novartis' (NVX +0.2%) asthma and urticaria med Xolair (omalizumab).
    • STI-004 is one of four monoclonal antibodies licensed by Sorrento from Mabtech last year for the territories of North America, Europe and Japan.
    • Previously: Sorrento inks biosimilar antibody deal with China's Mabtech (Aug. 3, 2015)
    | Mon, May 16, 10:44 AM
  • 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.
    | Mon, May 9, 4:57 PM | 9 Comments
  • Mon, May 9, 9:56 AM
    • Laboratory Corporation of America (LH +0.9%) launches Epi proColon, the first FDA-approved DNA-based blood test for colorectal cancer (CRC) screening. The product was developed by Epigenomics AG (OTCQX:EPGNF)(OTCQX:EPGNY) and is available under a joint commercialization agreement with Polymedco in North America.
    • Epi proColon detects a DNA methylation biomarker for CRC called Septin9 in cell-free DNA circulating in the blood. The FDA approved it on April 13.
    • CRC screening-related tickers: (EXAS +3.7%)(VNRX +0.3%)(TBIO +9.6%)(SQNM +1.8%)(BIOC +2.8%)(OTCQX:RHHBY +2.2%)(CHEK +20.8%)(TROV +0.6%)
    | Mon, May 9, 9:56 AM | 7 Comments
  • Fri, Apr. 29, 4:54 PM
    • Cranbury, NJ-based Oncobiologics (Pending:ONS) is set for its IPO of 5M shares of common stock at $11 - 13.
    • The clinical-stage biopharmaceutical firm develops biosimilars in immunology and oncology based on its proprietary BioSymphony Platform. Its most advanced candidates are ONS-3010, a biosimilar of AbbVie's (NYSE:ABBV) Humira (adalimumab) and ONS-1045, a biosimilar of Roche's (OTCQX:RHHBY) Avastin (bevacizumab). According to the company, both are Phase 3-ready.
    • Other pipeline candidates are ONS-4010 [biosimilar of Amgen's (NASDAQ:AMGN) Prolia/Xgeva (denosumab)], ONS-1055 [biosimilar of Eli Lilly's (NYSE:LLY) Erbitux (cetuximab)] and ONS-3030 [biosimilar of Roche's Actemra/Roactemra (tocilizumab)].
    • 2015 Financials ($M): Collaboration Revenue: 5.2 (-42.9%); Operating Expenses: 51.8 (+142.1%); Net Loss: (53.0) (-156.0%); Cash Burn: (27.5) (-292.9%).
    | Fri, Apr. 29, 4:54 PM | 6 Comments
  • Fri, Apr. 29, 12:35 PM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts positive opinions recommending approval of new indications for Roche's (OTCQX:RHHBY -0.4%) Gazyvaro (obinutuzumab) and Avastin (bevacizumab).
    • The thumbs up for Gazyvaro is the treatment of follicular lymphoma, in combination with bendamustine chemo, followed by maintenance therapy with Gazyvaro in patients who failed to respond to or progressed during or up to six months after treatment with MabThera (rituximab) or a MabThera-containing regimen, an indication already approved in the U.S.
    • CHMP's positive recommendation was based on results from the Phase 3 GADOLIN study which showed treatment with Gazyvaro reduced the risk of cancer worsening or death by 52%.
    • Gayzvaro/Gazyva, a CD20-directed monoclonal antibody, is currently approved for the treatment of chronic lymphocytic leukemia.
    • The thumbs up for Avastin is the first-line treatment, in combination with Tarceva (erlotinib), of adults with EGFR-positive, unresectable, advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). A mid-stage study, JO25567, showed treatment with Avastin extended progression-free survival by a median of 6.3 months. Avastin is currently approved for a range of cancers, including non-squamous NSCLC (in combination with carboplatin and paclitaxel).
    • Final decisions by the European Commission usually take ~60 days.
    • Related ticker: (BIIB -2.5%)
    | Fri, Apr. 29, 12:35 PM
  • Thu, Apr. 28, 11:37 AM
    • Credit Suisse claims Medivation (MDVN +8%) is worth $55 a share, ~5% above Sanofi's (SNY -1.1%) unsolicited bid of $52.50. It says much of the attention has focused on the prospects of prostate cancer drug XTANDI (enzalutamide), approved by the FDA in August 2012, which generated $1.15B in the U.S. last year as reported by development and commercialization partner Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY). What appears to be underrepresented is the value of the company's pipeline, led by late-stage PARP inhibitor talazoparib.
    • According to the analyst, other potential bidders include AstraZeneca (AZN -0.5%), Roche (OTCQX:RHHBY -0.5%) and Celgene (CELG +0.9%).
    • AstraZeneca reportedly has held internal talks about an offer. Medivation rejected Sanofi's first approach several weeks ago, so the bidding could turn hostile if the board rejects $52.50, a likely scenario.
    • Citi says Sanofi's offer is a bit light considering MDVN's 52-week high of $66.39, hit in June of last year. The board might reject the offer based purely on technical grounds.
    • Previously: Medivation +9% AH on reported Sanofi takeover effort (April 12)
    • Previously: Report: AstraZeneca held talks for Medivation bid (April 18)
    | Thu, Apr. 28, 11:37 AM | 7 Comments
  • Wed, Apr. 27, 4:18 PM
    • Looking in the rear view mirror, author and New York Time columnist Randall Stross says the red flags were numerous surrounding discredited diagnostics firm Theranos and its relentlessly self-promoting chief Elizabeth Holmes.
    • First, the company failed to elicit investments from the major Silicon Valley venture capital players despite numerous pitches/presentations. Professor Stross says it was turned down twice by GV (formerly Google Ventures) due to the apparent lack of substance (technical data) backing up its claims.
    • Second, the company refused to publish in peer-reviewed journals, a tried-and-true way to credential the technology.
    • Third, the make-up of the board was puzzling, since no member had experience in the diagnostics industry. Celebrity members, in this case former Secretary of State George Schultz and former National Security Advisor and Secretary of State Henry Kissinger, reinforced the perception that the constituency was for show instead of advancing the business.
    • At least Ms. Holmes is famous, sporting the covers of Fortune, Forbes, Inc., and T: The New York Times Style Magazine. Maybe Rolling Stone is next.
    • Diagnostics-related tickers: (NYSE:ABT)(OTCQX:RHHBY)(NYSE:TMO)
    | Wed, Apr. 27, 4:18 PM | 7 Comments
  • Tue, Apr. 19, 7:13 AM
    • Roche (OTCQX:RHHBY) Q1 results (CHF Millions): Total Revenues: 12,414 (+4.9%); Pharmaceuticals: 9,800 (+5.1%); Diagnostics: 2,614 (+4.1%).
    • Pharmaceuticals: U.S.: 4,716 (+7.4%); Europe: 2,319 (+6.5%); Japan: 853 (+11.8%); International: 1,912 (-3.9%).
    • Key Product Sales: MabThera/Rituxan: 1,825 (+4.6%); Herceptin: 1,725 (+4.4%); Avastin: 1,706 (+5.4%); Perjeta: 439 (+36.3%); Actemra/RoActemra: 386 (+15.6%); Tamiflu: 367 (-2.4%); Xolair: 356 (+26.7%); Lucentis: 355 (-9.9%); Activase/TNKase: 276 (+24.9%); Tarceva: 258 (-12.5%).
    • 2016 Guidance: Revenue growth: low-to mid-single digit; Core earnings per share growth: ahead of sales.
    | Tue, Apr. 19, 7:13 AM
  • Mon, Apr. 18, 11:56 AM
    • Chinese biotech BeiGene (BGNE -2.9%) reports positive data from an ongoing Phase 1 clinical trial assessing product candidate BGB-283 in patients with BRAF or KRAS/NRAS-mutated cancers who have not responded adequately to prior treatments (one to six prior lines of therapies). The data were presented at the 2016 American Association for Cancer Research Annual Meeting in New Orleans, LA.
    • At the time of the data cutoff, there were 29 evaluable patients. One receiving a 40 mg starting dose had a confirmed complete response, two patients receiving a 20 mg or 30 mg starting dose had confirmed partial responses and 15 patients had stable disease (no progression), implying a disease control rate of 79% (n=23/29).
    • The most frequent mild-to-moderate (grade 1 or 2) treatment-related adverse events were fatigue (52%), thrombocytopenia (low blood platelets)(39%), decreased appetite (39%), hand-foot syndrome (redness/swelling in hands and/or feet)(35%), acne (32%) and hypertension (32%). Serious treatment-related adverse events (grade 3 or 4) observed were thrombocytopenia (13%), fatigue (10%) and liver enzyme (ALT) elevation (10%).
    • BGB-283 is called a RAF dimer inhibitor which has shown activity against the RAF family of kinases, including ARAF, BRAF, CRAF and BRAF V600E. It can potentially address resistance to first-generation BRAF inhibitors. For example, vemurafenib, discovered b Daiichi Sankyo (OTCPK:DSKYF)(OTCPK:DSNKY) and marketed by Roche (OTCQX:RHHBY +1.4%) under the brand name Zelboraf, achieves only a 5% response rate in BRAF V600E-positive colorectal cancer.
    • BeiGene is currently conducting all clinical development for BGB-283. It retains all rights to the candidate in China while Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) has exclusive rights ex-China.
    • Previously: BeiGene on deck for IPO (Jan. 20)
    | Mon, Apr. 18, 11:56 AM | 1 Comment
  • Mon, Apr. 11, 2:28 PM
    • The FDA approves AbbVie's (ABBV +0.5%) Breakthrough Therapy- and Priority Review-tagged Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called a 17p deletion and who have been treated with at least one prior line of therapy.
    • In clinical studies, 80% of 17p deletion-positive CLL patients who received Venclexta experienced a complete or partial remission of their cancer.
    • Venetoclax, co-developed with Roche (OTCQX:RHHBY +0.1%), 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.
    • Read now Purchase AbbVie: Doctor's Orders
    | Mon, Apr. 11, 2:28 PM | 5 Comments
  • Mon, Apr. 11, 6:53 AM
    • Genentech's (OTCQX:RHHBY) Breakthrough Therapy-tagged atezolizumab (MPDL3280A) receives another accelerated review indication, this time for patients with locally advanced or metastatic PD-L1-positive non-small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemo. The FDA's action date is October 19. Last month, it was designated for Priority Review for urothelial cancer.
    • Atezolizumab is a PD-L1 antagonist that is designed to block inhibitory T-cell checkpoints thereby allowing cytotoxic T cells to reach the tumor.
    • Priority Review status shortens the review clock to six months from the standard 10 months.
    • Previously: Roche's atezolizumab BLA to get Priority Review in U.S. for bladder cancer (March 15)
    | Mon, Apr. 11, 6:53 AM
  • Thu, Apr. 7, 4:39 PM
    • Rumors doubting upstart blood tester Theranos' technology may be bit premature. The company recently hosted three scientific review sessions with leading experts who were invited to review its proprietary technologies with full access to its systems, devices and data. The group reviewed development and validation reports for tests performed on small volume samples, including finger-sticks, using Theranos' gear for a range of assays, including those chosen by the experts. They appear to have been favorably impressed.
    • Co-chair of the company's Scientific and Medical Advisory Board David Helfet, M.D., director of the Orthopedic Trauma Service, Hospital for Special Surgery and New York-Presbyterian Hospital says, "It is clear that Theranos has done what people thought was impossible. Theranos invited groups of independent experts in the fields of pathology and laboratory medicine and literally took the lid off of the box. Experts were shown Theranos' technology, met with Theranos scientists and had access to any data. Theranos' technology is a ground-breaking feat of science and engineering, making it possible to accurately analyze micro amounts of blood for the same tests routinely done today with traditional venipuncture."
    • After the three sessions, the company added eight prominent laboratory and medical experts to its Scientific and Medical Advisory Board. The group will advise company management and internal teams regarding the full integration of its technology into routine clinical practice. Those with laboratory management expertise will assist the company in inspecting its own labs and will help clinical lab directors implement best practices in their operations.
    • Say what you will about the company and its "black box" technology, but it would not be possible to engage a large group of experts without technical credibility.
    • Clinical diagnostics-related tickers: (NYSE:ABT)(OTCQX:RHHBY)(NYSE:TMO)
    | Thu, Apr. 7, 4:39 PM | 2 Comments
  • Thu, Apr. 7, 7:04 AM
    • The European Commission approves Boehringer Ingelheim's Giotrif (afatinib) for the treatment of advanced squamous cell carcinoma of the lung (SqCC) whose disease has progressed on or after platinum-based chemo. SqCC, the largest sub-type of non-small cell lung cancer (20-30% of cases), is associated with a poor prognosis. Median overall survival (OS) is only about one year.
    • The data supporting the marketing application was generated in the LUX-Lung 8 trial which showed patients treated with Giotrif experienced a 19% improvement in OS, a 19% reduction is the risk of cancer progression and an 11% improvement in disease control rate.
    • The most frequent serious adverse events were grade 3 diarrhea (10%) and grade 3 stomatitis (mouth sores)(4%).
    • Giotrif was previously cleared for the treatment of EGFR mutation-positive non-small cell lung cancer (NSCLC).
    | Thu, Apr. 7, 7:04 AM
  • Wed, Mar. 30, 11:26 AM
    • With the aim of maintaining the safety of the nation's blood supply, the FDA allows the use of Roche's (OTCQX:RHHBY) investigational test for the Zika virus to be used to screen donated blood in areas with active mosquito-borne transmission. The agency's decision should reduce the pressure on Puerto Rico, which has been importing blood from the continental U.S. after suspending local collections to reduce the risk of transmitting the virus to local patients.
    • Per FDA guidance, local blood collections may resume if a licensed or investigational test for the Zika virus is available. The FDA's recommendations for Zika blood donor referrals remain in place.
    • Related ticker: (ABT +0.5%)
    • Update: Roche will roll out the test, performed on its automated cobas 6800/8800 systems, in Puerto Rico first, followed by sites in the southern U.S.
    | Wed, Mar. 30, 11:26 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
Industry: Drug Related Products
Country: Switzerland