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Roche: A Leader In Biotech And Diagnostics, Part 2
Roche: A Leader In Biotech And Diagnostics, Part I
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
Thursday, Mar 137:25 AM
Thursday, Mar 137:25 AM| Comment!
- An FDA federal advisory committee has unanimously recommended the approval of a DNA test developed by Roche (RHHBF) as the primary screening tool for cervical cancer in women.
- The product would be used alone on women aged 25 and older, and could eventually supersede the PAP test, which has been around for 60 years.
- The market for Roche's test and those of other companies is worth over $200M.
Wednesday, Mar 127:51 AM
Wednesday, Mar 127:51 AM| Comment!
- France's competition authority is investigating Novartis (NVS) and Roche over whether they conspired to prevent the use of Roche's (RHHBY) Avastin to treat vision problems in favor of the more expensive drug Lucentis, which the companies co-promote.
- The news comes after Italy last week fined the firms a combined €182.5M over similar accusations.
Tuesday, Mar 119:23 AM
Tuesday, Mar 119:23 AM| Comment!
- Bayer (BAYRY) signs multi-year extension with Roche's (RHHBY) Ventana Medical Systems to develop companion diagnostics focused on immunohistochemistry.
- The agreement focuses on the development of diagnostic tests for Bayer's biomarker-targeted therapeutics.
- Ventana will create an expert team with resources exclusively designated for Bayer.
- Financial terms are undisclosed.
Monday, Mar 1010:00 AM
Monday, Mar 1010:00 AM| 1 Comment
- The WSJ profiles "pharmaceutical scouts," who, like talent-spotters in baseball "trying to pick tomorrow's big-leaguers from farm teams," search outside their companies to find drug candidates that have the potential to become blockbusters.
- In 2011, for instance, Johnson & Johnson's (JNJ) Peter Lebowitz helped his company beat competitors such as Novartis (NVS) to buy the rights to a blood-cancer drug from Pharmacyclics (PCYC) called Imbruvica.
- The treatment was eventually approved in November for a rare lymphoma and for chronic lymphocytic leukemia in February. J.P. Morgan forecasts Imbruvica will generate $1.3B in revenue for J&J in 2017.
- Half of J&J's drug pipeline is from outside the company, up from 20% in 2002.
- Other related tickers: MRK, RHHBY, BMY, SNY, CELG, GSK
Wednesday, Mar 59:40 AM
Wednesday, Mar 59:40 AM| Comment!
- Roche's (RHHBY) Lebrikizumab injection significantly lowered the rate of asthma attacks and improved lung function in a Phase IIb trial of patients with a severe form of the condition.
- In subjects with high levels of periostin, a protein that indicates a certain type of asthma and can be detected with a simple blood test, Lebrikizumab cut asthma attacks by 60% vs 5% for patients with a low level of the biomarker.
- Roche has already started two Phase III studies of Lebrikizumab and plans to file for authorization in 2016. The company has identified it as a potential blockbuster. (PR)
Wednesday, Mar 57:26 AM
Wednesday, Mar 57:26 AM| 1 Comment
- The Italian Competition Authority has fined Novartis (NVS) €92M and Roche (RHHBY) €90.5M for forming a cartel to push doctors to prescribe their jointly marketed and more expensive Lucentis therapy to treat vision problems instead of Roche's Avastin, which is older and far cheaper.
- The agency accused the companies of portraying Avastin as riskier than Lucentis in order to influence prescriptions.
- Both firms said they would appeal.
- Novartis and Roche could face further problems if the EU looks into the case and finds that the collusion extended beyond Italy.
Tuesday, Mar 48:21 AM
Tuesday, Mar 48:21 AM| Comment!
- New Roche (RHHBF) Chairman Christoph Franz promises continuity after shareholders overwhelmingly approve his appointment.
- "This company is on track and therefore continuity is the order of the day," Franz says.
- Roche has a number of high-margin new cancer drugs and healthy profits, although it's struggling to reduce its reliance on oncology following setbacks with treatments for diabetes, "good" cholesterol and schizophrenia.
- Former CEO and outgoing Chairman Franz Humer says the firm will look at acquisitions, with the company having more strategic flexibility after accumulating cash - it generated 16.4B Swiss francs ($18.6B) in free-cash flow last year.
Monday, Mar 33:30 AM
Monday, Mar 33:30 AM| Comment!
- An independent committee has recommended that Roche (RHHBY) end a Phase III trial of its MetMab (Onartuzumab) lung-cancer treatment, as the drug didn't show "clinically meaningful efficacy."
- The aim of the study was to assess whether Onartuzumab, when given with the oral therapy Tarceva, helped previously treated patients live longer compared with those who just received Tarceva.
- Analysts had viewed MetMab as a potential blockbuster and Roche is analyzing what the setback means for the drug's development.
- Shares are -1.7% in Zurich. (PR)
Thursday, Feb 2010:03 AM
Thursday, Feb 2010:03 AM| 1 Comment
- Roche (RHHBF) and a group of external investigators could share raw data from two trial's of the company's Avastin drug that provide conflicting evidence about how beneficial it is for patients with a brain cancer called glioblastoma.
- Avastin didn't help patients live longer in either study, but in one of them, it does seem to have improved or maintained quality of life and brain function. That wasn't the case in the other trial.
- If Avastin can improve quality of life and brain function, says Howard Fine of the New York University Cancer Institute, "a strong argument can be made for its use as part of the initial treatment of glioblastoma, regardless of its effect on survival."
- However, such considerations would be new ground for the FDA, says Fine.
Tuesday, Feb 48:28 AM
Tuesday, Feb 48:28 AM| 4 Comments
- Ten major pharmaceuticals companies are getting together with the National Institutes of Health and other organizations in a five-year partnership that will look to understand the science behind Alzheimer's, Type 2 diabetes, rheumatoid arthritis and lupus.
- In an unusual move, the normally secretive participants will share scientists, tissue, blood samples and data, with the aim being to identify targets for new drugs.
- The firms involved include Bristol-Myers Squibb (BMY), Johnson & Johnson (JNJ), GlaxoSmithKline (GSK), Takeda (TKPHF) and Sanofi (SNY).
- Those that haven't joined include Amgen (AMGN), Roche (RHHBY) and AstraZeneca (AZN).
Monday, Feb 311:59 AM
Monday, Feb 311:59 AM| 3 Comments
- PDL BioPharma (PDLI -1.9%) says it reached agreement with Genentech and Roche (RHHBF, RHHBY) which resolves all outstanding legal disputes between the parties, including Nevada litigation and arbitration proceedings related to the audit of royalties on sales.
- Genentech will pay a fixed royalty rate of 2.125% on worldwide sales of Avastin, Herceptin, Lucentis Xolair, Kadcyla and Perjeta, rather than the previous tiered royalty rate in the U.S and the fixed rate on all ex-U.S. based manufactured and sold licensed products.
Thursday, Jan 302:17 AM
Thursday, Jan 302:17 AM| Comment!
- Roche's (RHHBF) 2013 net profit rose 18% to 11.4B Swiss francs ($12.7B), missing expectations of 11.62B francs.
- Core EPS +10% to 14.27 francs, falling short of consensus of 14.78 francs.
- Sales +3% to 46.8B francs topping estimates of 46.7B francs.
- Earnings were boosted by sales of Roche's oncology, immunology and ophthalmology products, as well as of its diagnostic offerings.
- Roche plans to increase its dividend by 6% to 7.80 francs a share.
- Roche forecasts that 2014 revenue will rise by a low- to mid-single-digit percentage at constant currencies and that core EPS will grow at a faster rate, with earnings boosted by sales of its biggest cancer drugs and new products. Kadcyla (breast cancer) and Gazyva (leukemia) were authorized in the U.S. last year. (PR)
Tuesday, Jan 217:00 AM
Tuesday, Jan 217:00 AM| Comment!
- Roche's (RHHBY) Bitopertin treatment for schizophrenia fell short of its main targets in two Phase III studies
- In combination with antipsychotic therapy, Bitopertin didn't significantly improve the negative symptoms of schizophrenia after 24 weeks of treatment compared with a placebo.
- Roche is continuing to carry out another Phase III study of Bitopertin for schizophrenia, and late-stage trials to assess its effect on symptoms such as hallucinations and delusions.
- The results are a particular blow, as Roche has increased its investment in neuroscience in recent years as it looks to expand beyond it core expertise of oncology.
- Shares are +0.1% in Zurich. (PR)
Monday, Dec 232013, 6:05 PM
Monday, Dec 232013, 6:05 PM| Comment!
- Carlyle Group (CG) appears to be the leader to acquire Johnson & Johnson's (JNJ) clinical diagnostics unit, beating out P-E peer Blackstone (BX) and its partner Danaher (DHR), Reuters reports.
- The exact price of CG's offer is not known, but a deal likely would fetch ~$4B and could be completed within the next two weeks.
- JNJ's ortho clinical diagnostics unit makes blood-screening equipment and laboratory blood tests; it's a small player in a market led by Roche (RHHBY, RHHBF), Siemens (SI), Abbott Labs (ABT) and DHR.
Monday, Dec 92013, 12:22 PM
Monday, Dec 92013, 12:22 PM| Comment!
- Roche (RHHBY -0.8%) says Phase 3 data from a study of GA101 in CLL show patients "experienced nearly a year of extra remission time when treated with GA101 in combination with chlorambucil, compared with MabThera and chlorambucil."
- Median PFS: 26.7 months versus 15.2 months; HR=0.39.
- CR rate: 21% for GA101/chlorambucil versus 7% for MabThera/chlorambucil.
- The company calls the results "unprecedented": "For the first time in a first-line Phase 3 CLL study, we have seen a therapy that shows superior efficacy over MabThera," Roche says. (PR)
Friday, Dec 62013, 4:34 AM
Friday, Dec 62013, 4:34 AM| Comment!
- The annual American Society of Hematology meeting is due to start today in New Orleans, where new treatments for chronic lymphocytic leukemia from Gilead Sciences (GILD), Pharmacyclics Inc. (PCYC), Infinity Pharmaceuticals (INFI), Roche (RHHBY) and others will be a focus.
- Analysts forecast that the drugs will collectively generate up to $9B a year in annual revenue by 2020.