SA News • Mon, Jan. 19
- Switzerland-based pharmaceutical company Roche Holding Limited (RHHBY) has had a topsy-turvy year so far.
- During the first half of 2014, Roche’s net incomes fell almost 7% as compared to the first six months of 2014.
- Over the course of the year, Roche has expanded its portfolio and has branched out towards newer markets in order to seek further avenues for growth.
- Roche faced failures in the clinical trial stages for not one but two of its drugs. The company was seeking treatments for Alzheimer’s as well as breast cancer.
- It will be in the investors’ best interests to currently steer clear from buying into Roche’s stock as future revenue generation and earnings growth is not visible at the moment.
- The Phase III MARIANNE study of Kadcyla delivered a major disappointment as this would-be successor to Herceptin failed to show superior efficacy alone or in combination with Perjeta.
- Roche also announced the end of another Alzheimer's program, casting further doubt on the company's ability to develop new drugs outside of its oncology franchise.
- Loss of Kadcyla upside suggests Roche is fairly valued today; a decent hold for investors looking for long-term exposure to oncology, but perhaps not as compelling for new investments.
Roche's Avastin Should Get The Nod From The FDA On November 19
- Avastin in combination with chemotherapy is approved in Europe for treating platinum-sensitive, platinum-resistant, as well as newly-diagnosed ovarian cancer, but is only used off-label in the U.S.
- FDA approval will be based on the AURELIA trial, where Avastin showed a significant improvement in the primary endpoint, progression-free survival (PFS), but no marked difference in overall survival.
- Avastin showed lower incidence of serious adverse effects than in previous trials; similarly, patients were significantly more satisfied, according to quality-of-life surveys, which supports the PFS benefits.
- Barring some serious safety information that hasn't become public, Avastin should be granted approval based on comments and recommendations formulated by the FDA workshop panel on cancer endpoints.
- If approved, Avastin can capture much of a $2 billion market of patients who relapse after first-line chemotherapy in ovarian cancer.
Roche's Cancer Drug Sales Continue To Grow, May Face Competition In The Medium TermLucrative Advice • Oct. 29, 2014
- Roche showed impressive performance as sales grew on the back of their growth in cancer drug sales. Revenue was spread across pharmaceuticals division as well as its diagnostics division.
- Growth in Roche’s pharmaceutical division was broad based as it wasn’t only the breast cancer treatment drugs that performed well.
- There are expectations of future competition in the market but Roche has strategized smartly in order to deal with the market saturation.
- Roche is aiming to grow its portfolio beyond oncology to immunology and ophthalmology.
- Investment in Roche is definitely rewarding and safe, and any future drop in prices should be considered an ideal entry point.
- Roche has seen Art Levinson, former CEO of Genentech, leave the board as his company Calico signs a major partnership with AbbVie.
- Roche has been making some odd M&A decisions of late (including a seeming lack of conviction about abandoning or doubling down in sequencing) and has seen top-notch talent go elsewhere.
- In a generally expensive sector, Roche screens as a decent investment option but the company needs to add more pharma experience to its board and strengthen its non-oncology business.
With An Iffy Non-Oncology Pipeline, Roche Pays Up For InterMune
- Roche comes out on top in what was rumored to be a multi-party bidding process for InterMune, agreeing to pay over $8 billion for the developer of Esbriet (for IPF).
- Even with incremental free cash flow margins above 50%, Roche has to generate more than $2 billion/year in U.S. sales to justify the price paid for InterMune.
- Roche's past failures in developing drugs outside of oncology likely pushed management toward this deal, but the shares still look modestly undervalued on mid-single digit growth expectations.
- The company is hopeful that by leveraging Genia's technology, it will be able to bring the cost of DNA sequencing down and at the same time improve its speed and sensitivity.
- If DNA sequencing helps Roche in developing 1-2 targeted drugs for cancer and other serious illnesses, the incremental sales could be significant.
- The broader attempt appears to be toward strengthening the diagnostics business and gain share as Johnson & Johnson falters in this market.
Roche Hikes Dividend By 6%, Remains A Safe Yield Play
Roche: Impact Of Rituxan Patent Expiration In EuropePharma Reports • Oct. 21, 2013
Will Lost Patents Force Roche Into Acquisition Mode?
Roche Holdings: New Drugs Drive Oncology Unit's GrowthTrefis • Mar. 15, 2013
Mon, Jan. 19, 5:26 PM
- As expected, the European Commission approves Boehringer Ingelheim's OFEV (nintedanib) for the treatment of patients with idiopathic pulmonary fibrosis (IPF). The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion in November backing approval.
- Previously: Europe Ad Comm supports approval for BI pulmonary fibrosis drug (Nov. 21, 2014)
- IPF-related tickers: (NYSE:BMY) (OTCQX:RHHBY) (NASDAQ:FGEN) (NYSE:AZN) (OTCPK:ALPMF) (OTCPK:ALPMY)
Fri, Jan. 16, 6:14 AM
- Looking to gain access to an experimental drug to treat spinal muscular atrophy, Roche (OTCQX:RHHBY) has agreed to buy privately-held Trophos.
- The acquisition is the latest in a spate of deals by Roche, following its purchase of a $1B stake in Foundation Medicine and licensing agreement with Genome pioneer J. Craig Venter.
- Under the terms of the agreement with Trophos, the French firm's shareholders will receive an upfront payment of €120M ($140M), plus further payments based on predetermined milestones worth up to €350M.
- OTCQX:RHHBY -2.2% premarket
Thu, Jan. 15, 8:40 AM
- "Words fail me," says Swatch (OTCPK:SWGAY) CEO Nick Hayek. "Today's SNB action is a tsunami; for the export industry and for tourism, and finally for the entire country." Swatch is lower by 15.75% in European action.
- Previously: Swiss shares crater after SNB abandons cap on euro (Jan. 15)
- A sampling of others: Cement maker Holcim (OTCPK:HCMLY) is down 11.2%, Novartis (NYSE:NVS) is down 9%, Roche (OTCQX:RHHBY) is down 7.9%, Credit Suisse (NYSE:CS) is down 11.7%, and UBS (NYSE:OUBS) is down 10.8%.
- The good news for ADR players is that's all action in Switzerland. Thanks to the franc's now 13.5% gain, the ADRs trading in the U.S. are likely all to be higher.
Thu, Jan. 15, 7:50 AM
- Roche's (OTCQX:RHHBY) Genentech unit signs a multi-year deal with genome pioneer J. Craig Venter's Human Longevity start-up to sequence and analyze tens of thousands of human genomes. The data will be used to identify new drug targets and biomarkers.
- Human Longevity's goal is to sequence 1M genomes by 2020. The transaction will enable it to have access to both genomic and clinical information from patients enrolled in clinical trials. The DNA will be stripped of personal identifying details but will be linked to clinical information.
- Financial terms are undisclosed.
Wed, Jan. 14, 9:13 AM
- Express Scripts' (NASDAQ:ESRX) success in containing the prices of new HCV therapies by pitting Gilead Sciences (NASDAQ:GILD) against AbbVie (NYSE:ABBV) is sending shock waves through the biotech/pharma industry. Most of the big players slumped yesterday as investors fear that ESRX's tactics will spread to other high cost areas like cancer and cholesterol.
- At JPM15 yesterday, CEO George Paz said that the new cholesterol-lowering post-statin PCSK9 inhibitors will be the next big opportunity to pit drug firms against each other in order to drive costs down. FDA clearance of the first two therapies, one from Amgen (NASDAQ:AMGN) and the other from Regeneron Pharmaceuticals (NASDAQ:REGN) (NYSE:SNY), is expected to occur at about the same time.
- The prices of emerging cancer therapies will also be in payers' crosshairs. Amgen's Blincyto, for example, costs $178,000 per standard course of treatment while Merck's (NYSE:MRK) Keytruda is close behind at $150,000.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NYSE:LLY) (ABBV) (NYSE:PFE) (NASDAQ:BIIB) (NYSE:ABT) (NASDAQ:CELG) (NYSE:BMY) (OTCQX:RHHBY) (NYSE:JNJ) (NYSE:NVS) (OTCPK:BAYRY)
Tue, Jan. 13, 7:06 AM
- Roche (OTCQX:RHHBY) enters into a development and commercialization deal with Japan's Meiji Seika Pharma and Canada's Fedora for OP0595, a beta-lactamase inhibitor in Phase 1 development. Beta-lactamase inhibitors restore or potentiate the activity of beta-lactam antibiotics (e.g., penicillins, cephalosporins, monobactams) which is of keen interest from the medical community considering the ever-increasing threat of bacterial resistance.
- Under the terms of the agreement, Roche obtains worldwide rights to OP0595 except Japan where Meiji retains rights. Meiji and Fedora will receive upfront payments and various milestones potentially up to $750M plus tiered royalties on commercial sales.
Mon, Jan. 12, 2:14 AM
- Roche (OTCQX:RHHBY) is acquiring a majority of Foundation Medicine (NASDAQ:FMI) for more than $1B, by buying a combination of outstanding and newly issued shares for a 52.4%-56.3% stake on a fully diluted basis.
- Foundation is the leader in the growing area of sequencing the genes of tumor samples, looking for mutations that can help predict which drug will be most effective for a particular patient.
Sun, Jan. 11, 10:29 PM
- Based on an assessment by the independent Data Monitoring Committee, Bristol-Myers Squibb (NYSE:BMY) stops its Phase 3 trial, CheckMate-017, evaluating Opdivo (nivolumab) versus docetaxel in previously treated patients with advanced squamous cell non-small cell lung cancer (NSCLC). The committee concluded that the study met its primary endpoint of demonstrating superior overall survival (OS) compared to docetaxel. This is the first time a PD-1 inhibitor has shown a survival advantage in lung cancer.
- Eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension.
- The company will complete a full analysis of the data and work with investigators on the future presentation and publication of the results.
- PD-1-related tickers: (NASDAQ:MDVN) (NYSE:MRK) (NASDAQ:FPRX) (NASDAQ:CELG) (OTCQX:RHHBY) (NYSE:AZN)
Fri, Jan. 9, 8:01 AM
- The FDA approves Roche's (OTCQX:RHHBY) cobas TaqScreen MPX Test, v2.0 for the detection and identification of HIV, HCV and HBV in donations of human whole blood and blood components including source plasma. The test, which delivers increase sensitivity, is the only FDA-approved diagnostic that simultaneously detects and identifies the three viruses in one assay.
- The assay can be performed on a fully automated system which saves time and labor by eliminating the need for consecutive rounds of testing.
Wed, Jan. 7, 10:41 AM
- Arena Pharmaceuticals (ARNA +33.4%) jumps on higher volume in early trading in response to its report of a dose-dependent effect on lymphocyte count lowering for APD334 in a Phase 1b trial.
- Mean decreases in lymphocyte count in blood from baseline were as high as 69%. Counts recovered from baseline, on average, within one week of cessation of dosing. Lymphocyte lowering has been shown to correlate with clinical efficacy in Phase 2 and 3 trials of other S1P1 modulators in multiple sclerosis, psoriasis and ulcerative colitis.
- APD334 is an oral drug that targets the sphingosine 1-phosphate subtype 1 (S1P1) receptor for the potential treatment of autoimmune diseases. The company plans to proceed to Phase 2 development.
- Related tickers: (OTCPK:ALIOF) (OTC:ALIOY) (NYSE:GSK) (OTCQX:RHHBY)
Dec. 29, 2014, 7:01 AM
Dec. 29, 2014, 5:47 AM
- The FDA has given emergency approval for Roche's (OTCQX:RHHBY) LightMix Ebola Zaire rRT-PCR Test, helping health care authorities fight the current outbreak of the deadly disease.
- The test can generate results in about three hours and would allow "health-care professionals to quickly detect the virus and start patient treatment as early as possible," said Roland Diggelman, chief operating officer at Roche’s diagnostics division.
Dec. 19, 2014, 8:44 AM
- ImmunoGen (NASDAQ:IMGN) plummets 40% premarket on robust volume in response to Roche's (OTCQX:RHHBY) announcement that its Phase 3 trial evaluating Kadcyla (trastuzumab emtansine) failed to significantly improve progression-free survival as a first-line therapy in breast cancer patients.
- Kadcyla was developed based on ImmunoGen's ADC technology which uses tumor-targeting antibodies to deliver an ImmonGen cell-killing agent to cancer cells.
- Previously: Roche cancer drug fails label expansion trial (Dec. 19, 2014)
Dec. 19, 2014, 7:27 AM
- Roche's (OTCQX:RHHBY) Kadcyla (trastuzumab emtansine) alone or in combination with Perjeta (pertuzumab) fails to significantly improve progression-free survival (PFS) compared to a regimen of Herceptin (trastuzumab) plus taxane chemotherapy in a Phase 3 clinical trial assessing Kadcyla as a first-line therapy in HER2-positive breast cancer. Kadcyla is currently approved as a second-line (or later) therapy after treatment with Herceptin and a taxane.
- The study met its non-inferiority endpoint by demonstrating that all three regimens helped patients live without their disease worsening (PFS) for a similar amount of time.
- Data from the trial will be discussed with health authorities and presented at a future medical meeting.
Dec. 19, 2014, 7:09 AM
- Roche (OTCQX:RHHBY) terminates the development of its anti-amyloid candidate, gantenerumab, for the treatment of prodromal (pre-dementia) Alzheimer's disease after a pre-planned futility analysis and recommendation by the independent Data Monitoring Committee. Clearly, the DMC's analysis showed that the Phase 3 trial would be unlikely to achieve its primary efficacy endpoint.
- The company will share the data with the medical community after a full review and analysis.
Dec. 16, 2014, 9:49 AM
- Roche (OTCQX:RHHBY -0.3%) launches the cobas Liat System for molecular diagnostics testing in the on-demand environments of physician offices, pharmacies and hospital laboratories. The fully automated system utilizes the company's polymerase chain reaction (PCR) technology and can generate results in 20 minutes or less. Its two initial tests are for Influenza A/B and Strep A.
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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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