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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.
Thu, Jan. 28, 4:15 AM
- Deutsche Bank (NYSE:DB) -1% premarket after posting a full-year loss of €6.8B, as writedowns, litigation charges and restructuring costs took their toll.
- Electrolux (OTCPK:ELUXY) slumped to a Q4 loss after costs from its failed GE deal weighed on results.
- A strong dollar hit purchasing costs at H&M (OTCPK:HNNMY), resulting in a set of relatively lackluster earnings.
- Roche (OTCQX:RHHBY) reported 5% fall in full-year net income as the strong Swiss franc countered gains from the company’s diagnostics and cancer treatment units.
Wed, Jan. 27, 11:25 AM
- Eli Lilly (LLY -0.2%) inks a non-exclusive agreement with Roche (OTCQX:RHHBY) under which it will sponsor the latter's development of a commercially scalable cerebrospinal fluid assay for amyloid-beta 1-42, a biomarker for Alzheimer's disease.
- Under the terms of the agreement, Lilly is responsible for certain development milestone payments and Roche is responsible for the development, registration and commercialization of the test.
- Currently, clinicians use two methods to detect amyloid in the brain: a cerebrospinal test and a positron emission tomography (PET) scan.
Wed, Jan. 27, 10:27 AM
- Clovis Oncology (CLVS -1.8%) commences a Phase 1b/2 clinical trial assessing the combination of Roche's (OTCQX:RHHBY +0.3%) atezolizumab (MPDL3280A) and rociletinib for the treatment of advanced EGFR-positive non-small cell lung cancer (NSCLC).
- The Phase 1b portion of the Clovis-sponsored study will evaluate the safety, tolerability and pharmacokinetics of the combination and the Phase 2 portion will assess the efficacy in two subgroups of EGFR+ NSCLC patients: those who have not previously received an EGFR tyrosine kinase inhibitor (TKI) or chemotherapy and those who have progressed on treatment with an EGFR TKI. T790M-negative and T790M-positive patients will be included in the Phase 1b and in the Phase 2 subgroup who have progressed on a prior EGFR TKI. Patients will not be required to be PD-L1-positive, although it will be assessed as part of the study.
- Rociletinib (CO-1686) is a mutant-selective inhibitor of epidermal growth factor receptor (EGFR). It is currently under regulatory review in the U.S. and Europe.
- Atezolizumab is a PD-L1 antagonist that is designed to block inhibitory T-cell checkpoints thereby allowing cytotoxic T cells to reach the tumor. It is under development for lung cancer, soft tissue sarcoma, breast cancer and colorectal cancer. Its rolling NDA submission in the U.S. for bladder cancer and lung cancer should be completed this quarter.
- Previously: FDA sets new PDUFA date for Clovis Oncology's rociletinib (Dec. 15, 2015)
Wed, Jan. 20, 12:03 PM
- Even critics of Roche's (OTCQX:RHHBY -2.1%) consistent opposition to the off-label use of cancer med Avastin (bevacizumab) for wet age-related macular degeneration (wet AMD) instead of the pricier Lucentis (ranibizumab) now must concede that its view is credible as it relates to patient safety.
- In cost conscious India, two states have suspended sales of Avastin after 15 wet AMD patients experienced pain and swelling in their eyes after receiving the medication. The company's India unit stands behind the drug while emphasizing that it does not promote Avastin for unapproved uses which, of course, have not been satisfactorily vetted via clinical trials.
- A number of countries in Europe have been receptive to the off-label use of Avastin for wet AMD considering Lucentis is 30x more expensive. France, for example, would save the equivalent of $273M each year by switching.
- Manufacturers have fought back. In September, an industry group filed a complaint with the European Commission arguing that French regulators' approval of Avastin for wet AMD is contrary to the EU approval process for medicines and "puts patients' health at risk."
- The differing cost/benefit viewpoints will, no doubt, persist indefinitely as more and more expensive biologics reach the market.
- ETFs: BIB, GRX, IRY, BIS, IXJ, BME, CNCR, THW
Wed, Jan. 20, 9:18 AM
- The FDA designates venetoclax, in combination with RITUXAN (rituximab), a Breakthrough Therapy for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL).
- Venetoclax, an inhibitor of a protein called B-cell lymphoma-2, is being co-developed by AbbVie (NYSE:ABBV) and Roche (OTCQX:RHHBY). It is also tagged a Breakthrough Therapy for Priority Review as a single agent for the treatment of CLL in relapsed/refractory patients with a genetic mutation known as a 17p deletion, the marketing applications for which are currently under review in the U.S. and Europe.
- Breakthrough Therapy status provides for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
- Previously: FDA grants Priority Review for AbbVie's venetoclax NDA (Jan. 12)
Wed, Jan. 13, 7:49 AM
- Catalent (NYSE:CTLT), through its wholly owned subsidiary Redwood Bioscience, enters into a research collaboration with Roche (OTCQX:RHHBY) to develop next-generation molecules coupling different therapeutics modalities using Catalent's SMARTag technology, an antibody-drug conjugate platform.
- Under the terms of the agreement, Roche will pay Catalent an upfront fee of $1M, initial phase research funding, up to $618M in milestones and royalties on net sales. In exchange, Roche will have non-exclusive access to the SMARTag platform and an option to acquire commercial licenses to develop molecules directed to a defined number of targets.
Tue, Jan. 12, 9:15 AM
- The FDA will review AbbVie's (NYSE:ABBV) New Drug Application (NDA) for venetoclax under its Priority Review designation, shortening the review clock to six months from the standard 10 months. The marketing application seeks clearance of venetoclax for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior line of therapy, including patients with a 17p deletion.
- Breakthrough Therapy-tagged venetoclax, co-developed with Roche (OTCQX:RHHBY), is a small molecule inhibitor of the BCL-2 protein, 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.
- AbbVie's Marketing Authorization Application (MAA) seeking clearance in the EU is currently under review by the European Medicines Agency.
- Previously: AbbVie's venetoclax successful in mid-stage study in hard-to-treat blood cancer; regulatory submissions expected before end of year (Aug. 12, 2015)
- Previously: Venetoclax a Breakthrough Therapy for blood cancer (May 7, 2015)
Mon, Jan. 11, 7:28 AM
- Roche (OTCQX:RHHBY) acquires Tensha Therapeutics for an upfront cash payment of $115M plus up to $420M in milestones. The Cambridge, MA-based firm develops cancer therapies based on innovative epigenetic technology that disrupts proteins called BET (bromodomain and extra terminal). Its lead product candidate is TEN-010, a small molecule BET inhibitor currently in Phase 1b development.
- BET proteins play a key role in mediating gene control and cellular memory. In cancer, they activate growth and survival genes. They also contribute to cancer cell memory by binding to the genome as molecular bookmarks.
Fri, Jan. 8, 7:31 AM
- Updated results from a Phase 2 study, IMvigor 210, assessing Roche's (OTCQX:RHHBY) Breakthrough Therapy-tagged atezolizumab (MPDL3280A) in patients with locally advanced or metastatic urothelial carcinoma (mUC) showed that the median overall survival of patients with higher levels of PD-L1 expression was 11.4 months and 7.9 months in the overall study population. Also, 84% of patients who responded to atezolizumab continued to respond regardless of their PD-L1 status when the results were evaluated with longer median follow-up of 11.7 months. Median duration of response has not been reached. Atezolizumab was well-tolerated and adverse events were consistent with prior studies. The data were presented at the 2016 Genitourinary Cancers Symposium in San Francisco.
- The company intends to submit the data promptly to global regulatory authorities with the aim of accelerating review. Its rolling NDA submission with the FDA is already underway for certain types of metastatic bladder cancer and lung cancer.
- Results from IMvigor 210 were initially reported in September. A Phase 3 study, IMvigor 211, comparing atezolizumab to standard-of-care chemotherapy in mUC patients who worsened after initial treatment in ongoing. According to clinicaltrials.gov, the estimated study completion date is January 2017.
- Atezolizumab is a PD-L1 antagonist that is designed to block inhibitory T-cell checkpoints thereby allowing cytotoxic T cells to reach the tumor. It is also under development for lung cancer, soft tissue sarcoma, breast cancer and colorectal cancer.
- Previously: Roche's atezolizumab successful in mid-stage study in type of bladder cancer (Sept. 27, 2015)
Fri, Jan. 8, 5:12 AM
- Pacific Biosciences (NASDAQ:PACB) may get bought sooner than expected, William Blair says, noting recent chatter of a theoretical $20/share price in a potential deal with Glaxo (NYSE:GSK).
- Firm says Roche (OTCQX:RHHBY) is the "obvious buyer" for the company.
- A takeout price of $16/share (30% upside) would likely meet shareholder approval, and be reflective of the long-term revenue opportunity for the Sequel.
- Absent a buyout, Blair thinks PACB will need to raise more capital in 2016.
- Previously: Pacific Bio earnings up 120% in Q3 (Oct. 23, 2015)
- Related: Pacific Biosciences Has Taken Some Big Steps Forward (Dec. 17, 2015)
Mon, Jan. 4, 9:28 AM
- Halozyme (NASDAQ:HALO) enters into a $150M credit agreement with Roche (OTCQX:RHHBY) and Baxalta (NYSE:BXLT) secured by future royalties of ENHANZE under its collaborations with the two firms. The deal, expected to close this month, will be facilitated through investment funds managed by Pharmakon Advisors and Athyrium Capital Management. Under the financing structure, Halozyme will form a wholly owned subsidiary, Halozyme Royalty LLC, which will borrow $150M at an interest rate of 8.75% plus three-month LIBOR (0.70 - 1.50%).
- On the closing date, Halozyme will transfer to Halozyme Royalty the right to receive royalty payments from commercial sales of Herceptin SC and MabThera SC by Roche and Hyqvia sales by Baxalta. Halozyme will continue to record and report royalty revenues over the term of the loan, using the payments from its collaboration agreements to repay the principal and interest.
- Under the terms of the agreement, Halozyme Royalty will not be required to apply any of the royalty payments to repay the loan in 2016. All interest accrued this year will be capitalized and added to the outstanding balance. It will be required to apply 50% of the royalty payments in 2017 to the loan and 100% thereafter. The loan's final maturity date is December 31, 2050. The repayment is the sole obligation of Halozyme Royalty with no recourse to Halozyme Therapeutics or its subsidiaries.
- Proceeds will fund the initiation of its Phase 3 study in pancreatic cancer, ongoing studies in non-small cell lung cancer and gastric cancer and the start of its breast cancer trial with Eisai (OTC:ESALF)(OTCPK:ESALY).
Dec. 21, 2015, 7:07 AM
- The FDA approves Roche's (OTCQX:RHHBY) HIV-1 viral load test for use on its automated cobas 6800 and 8800 systems. The diagnostic assay simultaneously amplifies and detects two separate regions of the HIV-1 genome which are not subject to selective drug pressure. The test will inform doctors on the effectiveness of antiretroviral therapy for their HIV-1 patients.
Dec. 11, 2015, 1:43 PM
- In a superb example of the benefits of its Priority Review process, the FDA approves Roche's (OTCQX:RHHBY -0.1%) Breakthrough Therapy-tagged Alecensa (alectinib) for the treatment of patients with ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after or are intolerant to treatment with Pfizer's (PFE -0.9%) XALKORI (crizotinib). The agency's clearance is only ~three months after it accepted the NDA for review and three months before the March 4 PDUFA date.
- Anaplastic lymphoma kinase (ALK)-positive NSCLC, accounting for ~5% of NSCLC cases, typically occurs in younger people with a history of light or no smoking.
- Alectinib is an ALK inhibitor that Roche licensed from Chugai Pharmaceutical (OTC:CHGCF)(OTCPK:CHGCY) in 2012. It was cleared for sale in Japan in July 2014.
- Previously: FDA grants Priority Review for Roche's alectinib for second line treatment of lung cancer (Sept. 9)
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
- Micro cap Oncothyreon (NASDAQ:ONTY) sets a new standard in obfuscation today with an impossible-to-fully-decipher press release about updated data from two early-stage trials evaluating lead product candidate ONT-380 for the treatment of HER2-positive breast cancer. The data will be presented at the San Antonio Breast Cancer Symposium, December 8-12.
- 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)
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
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