- 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
Nov. 10, 2014, 12:31 PM
- At the Biennial Meeting of the International Gynecologic Cancer Society in Melbourne, Australia, investigators presented Phase 2 data for OxiGene's (OXGN -7.4%) fosbretabulin combined with Roche's (OTCQX:RHHBY +0.5%) Avastin (bevacizumab) for the treatment of recurrent ovarian, tubal and peritoneal carcinoma.
- The study achieved its primary endpoint of a statistically significant increase in progression-free survival (PFS) for the combination compared to bevacizumab alone (p=0.049). Mean PFS for the combo was 7.3 months (n=54) versus 4.8 months for bevacizumab (n=53).
- In a post hoc subgroup analysis, there was also a statistically significant improvement in PFS in patients who were platinum-resistant (n=27). Median PFS for the combo group was 6.7 months compared to 3.4 months for bevacizumab alone (p=0.01).
- Patients receiving the combo also showed a higher objective response rate (ORR) but the results were not statistically significant.
Nov. 6, 2014, 8:03 AM
- In a setback for India's generic drug firm Ranbaxy Laboratories Ltd., the FDA revokes its previously granted tentative approvals for its lower cost versions of AstraZeneca's (NYSE:AZN) heartburn med Nexium and Roche's (OTCQX:RHHBY) antiviral Valcyte.
- The agency informed the company that while there were no data integrity issues related to its filings, its decisions granting the approvals were "in error."
- The revocation also terminates its six-month first-to-file market exclusivity.
- Management says in a statement, "Ranbaxy is disappointed with this development and is actively evaluating all available options to preserve its rights."
Nov. 5, 2014, 7:34 AM| Comment!
Nov. 3, 2014, 1:06 PM
- The FDA accepts Boehringer Ingelheim's NDA for Spiriva Respimat (tiotropium bromide) for the maintenance treatment of asthma in patients at least 12 years old who remain symptomatic on at least inhaled corticosteroids.
- Spiriva is currently cleared for the maintenance treatment of bronchospasm (HandiHaler) associated with chronic obstructive pulmonary disease (COPD) and to reduce COPD exacerbations.
- The Respimat inhaler provides a pre-measured amount of medicine in a slow moving mist that helps the patient inhale the drug. It is designed to deliver the medication in a way that does not depend on how fast air is breathed in from the inhaler.
- Asthma and COPD-related tickers: (THRX -3%)(GSK -0.3%)(AZN -0.8%)(NVS -1.3%)(REGN +0.6%)(SNY -1.5%)(TEVA +1.5%)(OTCQX:RHHBY -1.3%)
Oct. 28, 2014, 12:44 PM
- Roche's (OTCQX:RHHBY +0.5%) Ventana Medical Systems enters into an agreement with ImmunoGen (IMGN +2.2%) to develop biomarker assays and a companion immunohistochemistry diagnostic test for one or more of ImmunoGen's product candidates. The initial test in the partnership is for folate receptor alpha (FRa) that is being used in the trials of ImmunoGen's FRa-targeting antibody-drug conjugate, IMGN853. Certain cancers such as epithelial ovarian and endometrial, highly express FRa.
- Specific financial terms are not disclosed.
Oct. 20, 2014, 10:40 AM
- Laboratory Corporation of America (LH -0.2%) launches its HIV GenoSure Archive, the first laboratory test that helps clinicians optimize antiretroviral (ARV) drug regimens for virally suppressed HIV patients. The test was developed using the Next Generation Sequencing Platform (NGS).
- Previous lab testing to guide ARV drug selection required higher viral loads than many HIV patients have. GenoSure Archive is performed by amplifying cell-associated HIV-1 DNA from infected cells in whole blood samples and then analyzing the polymerase region using NGS methods. The assay is analytically validated to identify mutations associated with resistance to all members of the most widely used ARV drug classes.
- HIV-related tickers: (ABBV +1.2%)(GILD +1.6%)(BMY +0.1%)(PFE -0.2%)(GSK -0.3%)(ABT +0.2%)(JNJ +0.1%)(PGNX +3%)(MRK +0.1%)(OTCQX:RHHBY +0.6%)
Oct. 20, 2014, 7:51 AM
- New Link Genetics (NASDAQ:NLNK) and Roche's Genentech (OTCQX:RHHBY) enter into an exclusive worldwide license agreement for the development of New Link's IDO pathway inhibitor, NLG919.
- Under the terms of the agreement, New Link will receive an upfront payment of $150M and will be eligible to receive more than $1B in milestones plus escalating double-digit royalties on commercial sales of multiple products by Genentech. The latter will fund R&D, manufacturing and commercialization costs and will provide research funding to New Link which will continue to pursue development activities associated with NLG919 in combination with its HyperAcute vaccine platform. New Link will retain the option for co-promotion rights for NLG919 and potential next generation IDO/TDO compounds in the U.S.
- NLNK is up 30% premarket on increased volume.
Oct. 17, 2014, 8:12 AM
- Roche (OTCQX:RHHBY) and Merck (NYSE:MRK) are set to present data from their respective immunotherapy drugs for the treatment of triple negative breast cancer (TNBC) at December's San Antonio Breast Cancer Symposium. TNBC does not respond to either of two types of hormonal therapy or drugs that target HER2 receptors, such as Roche's Herceptin.
- Both companies' products are PD-1 inhibitors. Roche is also testing its candidate, called MPDL3280A, for the treatment of melanoma and lung, bladder, kidney, bowel and blood cancers. Merck's product, Keytruda (pembrolizumab) injection, is currently cleared for the treatment of melanoma.
- Bristol-Myers Squibb (NYSE:BMY) and AstraZeneca (NYSE:AZN) are also players in the space.
Oct. 17, 2014, 7:40 AM
- In a comparative study sponsored by the National Institutes of Health and run by the Diabetic Retinopathy Clinical Research Network (DRCR.net), Regeneron's (NASDAQ:REGN) Eylea (aflibercept) injection demonstrated a significantly greater improvement in mean change in best-corrected visual acuity from baseline at week 52 compared to both Genentech's (OTCQX:RHHBY) Avastin (bevacizumab) and Lucentis (ranibizumab) injection. The was the study's primary endpoint.
- The mean number of injections using the protocol-specified retreatment regimen was one fewer in the Eylea cohort compared to Avastin and Lucentis and fewer patients in the Eylea group received criteria-based macular laser treatments.
- DRCR.net is finalizing and verifying the data before submitting it for publication.
Oct. 16, 2014, 10:43 AM| 1 Comment
Oct. 16, 2014, 9:29 AM
- Roche (OTCQX:RHHBY) financial results ytd through Q3 (Millions of CHF): Group Sales: 34,757 (-0.3%); Pharmaceuticals: 26,965 (-0.8%), U.S. Pharma: 11,528 (+0.9%), Europe Pharma: 7,070 (+1.7%), Japan Pharma: 2,406 (-3.5%), International Pharma: 5,961 (-5.6%); Diagnostics: 7,792 (+1.5%).
- 2014 Guidance: Group sales growth: low-to-mid-single digit; Core EPS growth: >Group sales growth; Dividend outlook: further increase.
Oct. 15, 2014, 3:59 PM
- U.S. patients saddled with idiopathic pulmonary fibrosis have reason to cheer today. The FDA approves two new drugs to treat the disease.
- The agency approves Roche's (OTCQX:RHHBY -0.5%) Esbriet (pirfenidone) ahead of its November 23, 2014 PDUFA date under its Fast Track, Breakthrough Therapy and Orphan Drug designations.
- It approves privately-held Boehringer Engelheim's Ofev (nintedanib) ahead of its January 2, 2015 PDUFA date also under the same designations.
Oct. 9, 2014, 11:31 AM
Oct. 8, 2014, 12:35 PM
- The FDA accepts and grants priority review of Roche unit Genentech's (OTCQX:RHHBY +0.1%) supplemental Biologics License Application (sBLA) of Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy. The PDUFA date is February 6, 2015.
- Lucentis is currently cleared for the treatment of wet age-related macular degeneration, macular edema following retinal vein occlusion and diabetic macular edema.
- Related tickers: (REGN -0.4%)(AGN +1.1%)(ALIM +1%)(OTCPK:BAYRY +0.2%)(OTCPK:BAYZF)(PSDV -4.8%)
Oct. 7, 2014, 11:57 AM
- BC, Canada-based Xenon Pharmaceuticals (XENE) is set for its IPO of 4M shares at $10 -12.
- The clinical-stage biopharmaceutical firm discovers and develops differentiated therapeutics for orphan indications based on its Extreme Genetics platform. It focuses its discovery efforts on rare human diseases with extreme traits, including diseases caused by mutations in ion channels.
- The Extreme Genetics platform yielded the first gene therapy product approved in the EU, uniQure's (QURE +1.5%) Glybera (alipogene tiparvovec) for the treatment of adult patients with familial lipoprotein lipase deficiency.
- Its pharma partners include (TEVA -0.3%), Genentech (OTCQX:RHHBY -2.5%) and Merck (MRK -1.2%). Collaborations have generated over $140M in revenue to Xenon so far. Future milestone payments could potentially surpass $1B.
- The company's lead product is TV-45070 for the treatment of osteoarthritis of the knee. A 300-patient Phase 2b clinical trail run by Teva subsidiary Ivax International GmbH is underway.
- A second product candidate, GDC-0276, for the treatment of pain is being developed in collaboration with Genentech. A Phase 1 study commenced in September 2014.
- Osteoarthritis of the knee-related tickers: (AMPE +0.3%)(FLXN -4.6%)(ANIK -1.2%)(ZMH -0.7%)
Oct. 6, 2014, 10:44 AM
- Privately-held Sunnyvale-CA-based Icon Bioscience announces that the last patient has completed treatment in its pivotal Phase 3 clinical trial of IBI-10090. The firm expects to report top-line data this quarter.
- IBI-10090 is a controlled sustained-release formulation of dexamethasone based on the company's Verisome drug delivery platform. It is administered via a single injection into the anterior chamber of the eye immediately following cataract surgery.
- Some eye therapy-related tickers: (NASDAQ:EYEG)(ALIM)(OTCQX:RHHBY +0.5%)(ABT +1.3%)(OHRP -0.3%)(AKRX +1.1%)(OCUL +1.4%)(NVS +0.2%)(AERI +0.7%)(AGN -0.2%)(REGN)(AAVL +0.4%)
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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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