Everything's Coming Up Roches
Stephen Simpson, CFA
Stephen Simpson, CFA
Stronger First Quarter Sales Help Roche, But ASCO Probably Matters More
Stephen Simpson, CFA
Stephen Simpson, CFA
Poor Pipeline Productivity Has Left Roche More Vulnerable
Stephen Simpson, CFA
Stephen Simpson, CFA
Today, 11:32 AM
- Long-term follow-up data from a 16-subject Phase 1/2 clinical trial assessing Roche's (OTCQX:RHHBY) investigational biologic emicizumab in patients with severe hemophilia A show encouraging safety and prophylactic efficacy regardless of the presence of factor VIII inhibitors. The results were presented at the World Federation of Hemophilia 2016 World Congress in Orlando, FL.
- The data show patients who received once-weekly subcutaneous injections of either 0.3,1.0 or 3.0 mg/kg/week of emicizumab with median follow-up periods of 32.6 months, 27.0 months and 21.4 months, respectively, experienced a sustained decrease of 95% in annualized bleeding rate (ABR), irrespective of their inhibitor status and prior treatment regimen. The ABRs for the three cohorts were 1.4, 0.2 and 0.0, respectively.
- The product candidate's safety profile was consistent with what was previously reported in the Phase 1 study. No thromboembolic (blood clot that breaks loose and clogs another vessel) adverse events or clinically significant laboratory abnormalities were observed.
- Emicizumab is an bispecific antibody engineered to bind to both factors IXa and X, replacing the function of the missing factor VIII, thereby improving clotting function and preventing spontaneous bleeding. It was created by Chugai Pharmaceutical Co. and is being co-developed by Roche. Future clinical trials will explore less frequent dosing schedules.
- Related tickers: (OTC:BIOVF)(NASDAQ:BIIB)(BXLT)(OTCPK:BAYRY)(NASDAQ:OPK)(NYSE:SNY)(NASDAQ:ALNY)(NASDAQ:SGMO)(NASDAQ:CBIO)(NASDAQ:BMRN)
Thu, Jul. 21, 7:27 PM
- Puma Biotechnology (NYSE:PBYI) files its New Drug Application (NDA) with the FDA seeking approval of lead product candidate neratinib (PB272) for the extended adjuvant treatment of patients with HER2-overexpressed/amplified breast cancer who received prior adjuvant treatment with Roche's (OTCQX:RHHBY) Herceptin (trastuzumab).
- The data supporting the application was generated in the Phase 3 ExteNET study that showed treatment with neratinib reduced the risk of invasive disease recurrence or death 33% compared to placebo (p=0.009). The two-year invasive disease-free survival (DFS) rate for the neratinib group was 93.9% versus 91.6% for placebo. In patients with hormone receptor-positive breast cancer, the invasive DFS rates were 95.4% and 91.2%, respectively.
- The company filed its Marketing Authorization Application (MAA) in Europe last month.
- Shares are up 18% after hours on increased volume.
Thu, Jul. 21, 9:46 AM
- Results from a randomized 725-subject Phase 3 study assessing the safety and efficacy of Amgen (AMGN +0.4%) and collaboration partner Allergan's (AGN +0.5%) biosimilar candidate ABP 980 compared with Roche's (OTCQX:RHHBY) Herceptin (trastuzumab) demonstrated ABP 980's non-inferiority (no worse than) to the branded product. The data failed to show, however, that Herceptin was not superior to ABP 980 as measured by the primary endpoint of the difference in the percentage of patients with a pathologic complete response. The prespecified equivalence margin was plus/minus 13% and the observed upper end of the confidence interval was slightly higher at 13.4%. Adverse events were comparable.
- Despite the modest miss, the companies believe the data will be sufficient for regulatory approval.
- Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars under an agreement inked in December 2011 between Amgen and Watson Pharmaceuticals. Under the terms of the partnership, Amgen has primary responsibility for development, manufacturing and initial commercialization.
Thu, Jul. 21, 7:21 AM
- Roche (OTCQX:RHHBY) Q2 results (CHF Millions): Total Revenues: 12,608 (+7.3%); Pharmaceuticals: 9,660 (+7.0%); Diagnostics: 2,948 (+8.2%).
- Pharmaceuticals: U.S.: 4,557 (+8.7%); Europe: 2,320 (+9.8%); Japan: 903 (+16.2%); International: 1,880 (-3.3%).
- Net Income (6 mo.): 5,467; EPS: 6.24 (+5.2%), CF Ops: 5,670 (-13.7%).
- Key Product Sales: MabThera/Rituxan: 1,877 (7.1%); Herceptin: 1,709 (+6.0%); Avastin: 1,724 (+4.9%); Perjeta: 467 (+38.6%); Actemra/RoActemra: 428 (+25.5%).
- 2016 Guidance: Revenue Growth: low- to mid-single-digit (unch); Core EPS growth: ahead of sales (unch).
Thu, Jul. 21, 6:23 AM
Thu, Jul. 21, 4:18 AM
- Helped by cost-control measures, Unilever (NYSE:UL) posted a profit rise and said it's ready for challenges ahead.
- Swatch (OTCPK:SWGAY) expects a recovery in the second half after net profit plunged 52% in H1.
- Roche (OTCQX:RHHBY) confirmed its outlook for 2016 and reported results that exceeded expectations.
- Driven by price and mix realization, SABMiller's (OTCPK:SBMRY) group net producer revenue grew 2% in Q1.
- Lufthansa (OTCQX:DLAKY) cut its full-year profit target, saying "terrorist attacks in Europe" weighed on its bookings.
- The fears also hit Easyjet (OTCQX:ESYJY), with shares under pressure after weak Q3 revenues.
Tue, Jul. 19, 10:50 AM
- Prompted by moderating growth from traditional drug sales, large cap drug/biotech firms have their sights set on developers of cancer therapies, in particular immunotherapies, to boost both their top and bottom lines. Roche (OTCQX:RHHBY -1.5%), Amgen (AMGN +0.1%), Sanofi (SNY -1.3%) and Gilead Sciences (GILD -1.2%) are all actively on the prowl for acquisitions.
- Medivation (MDVN +0.1%), with its prostate cancer drug Xtandi (enzalutamide), is currently in play. Sanofi has been the most aggressive with two unsuccessful bids, but Pfizer (PFE) and Celgene (CELG -0.6%) are supposedly interested.
- Analysts say Incyte (INCY -0.4%), with polycythemia vera and myelofibrosis drug Jakafi (ruxolitinib), and Seattle Genetics (SGEN -0.8%), with lymphoma drug Adcetris (brentuximab vedotin), are the most attractive takeover targets.
- Recent transactions include AbbVie's (ABBV -0.3%) buyout of Stemcentryx, Jazz Pharmaceuticals' (JAZZ -0.8%) takeout of Celator Pharmaceuticals and Bristol-Myers Squibb's (BMY -0.2%) acquisition of Cormorant Pharmaceuticals.
Mon, Jul. 18, 7:04 AM
- A Phase 3 clinical trial, GOYA, assessing Roche's (OTCQX:RHHBY) Gazyva/Gazyvaro (obinutuzumab) plus CHOP chemotherapy in treatment-naive patients with diffuse large B-cell lymphoma (DLBCL) failed to meet its primary endpoint of a statistically valid increase in progression-free survival (PFS) compared to MabThera/Rituxan (rituximab) plus CHOP chemo.
- Full results from GOYA will be presented at a future medical conference.
- Gazyva (branded as Gazyvaro ex-U.S.), developed with collaboration partner Biogen (NASDAQ:BIIB), is an engineered monoclonal antibody that binds to CD20, a protein expressed on certain types of B cells. It is believed to work by attacking targeted cells both directly and together with the immune system.
- It is currently approved in the U.S. for the treatment of chronic lymphocytic leukemia and follicular lymphoma, both in combination with certain types of chemo.
Thu, Jul. 14, 6:50 AM
- Amgen (NASDAQ:AMGN) inks an exclusive deal with Tokyo-based Daiichi Sankyo (OTCPK:DSKYF)(OTCPK:DSNKY) to commercialize nine biosimilars in Japan, including adalimumab [AbbVie's (NYSE:ABBV) Humira], bevacizumab [Roche's (OTCQX:RHHBY) Avastin] and trastuzumab (Roche's Herceptin).
- Under the terms of the agreement, Amgen will be responsible for development and manufacturing and Daiichi will manage regulatory submissions and handle distribution and commercialization while Amgen will have a limited rights to co-promote the products.
- Amgen will retain all distribution and commercialization rights outside of Japan. Financial terms are not disclosed.
Mon, Jul. 11, 8:51 AM
- Micro cap Organovo (NYSEMKT:ONVO) is up 10% premarket on increased volume in response to is announcement of positive preclinical results generated with its 3D bioprinted human liver tissues.
- The data, published in the journal PLOS One, showed Organovo's product was able to detect significant dose-dependent toxicity of trovafloxacin at clinically relevant doses compared to levofloxacin, a structurally similar but non-toxic compound. The hepatotoxicity of trovafloxacin, a broad based antibiotic launched by Pfizer (NYSE:PFE) but later withdrawn from the market because of the risk of serious liver damage, was not originally identified by traditional preclinical tests, including animal studies.
- The study was funded by Organovo and Roche Pharmaceuticals (OTCQX:RHHBY).
Thu, Jul. 7, 6:12 PM
- Nano cap Eleven Biotherapeutics (NASDAQ:EBIO) is up 44% after hours on robust volume in response to its announcement that the FDA has approved its Investigational New Drug (IND) application for EBI-031 for the treatment of ocular diseases. The company is now entitled to a $22.5M milestone payment from licensee Roche (OTCQX:RHHBY). The company filed the IND last month with the aim of conducting clinical trials in diabetic macular edema and uveitis.
- EBI-031 is a humanized monoclonal antibody that potentially binds to interleukin-6, a pro-inflammatory cytokine. It was designed and engineered for intravitreal (injected into the eye) delivery using Eleven's AMP-Rx platform.
- Previously: Eleven Bio inks development deal with Roche; shares up 61% premarket (June 13)
Thu, Jul. 7, 4:16 PM
- The FDA approves Roche Molecular Systems' (OTCQX:RHHBY) cobas HPV test for use with cervical cells obtained for a Pap test and collected in SurePath Preservative Fluid, the first test to be so approved. SurePath is one of two fluids commonly used for Pap tests.
- The cobas HPV Test with SurePath Preservation Fluid is approved for use with cervical cell samples obtained for a Pap test to screen women at least 30 years old to determine if additional follow-up and diagnostic procedures are needed. It is also approved for women at least 21 years old who already had an abnormal Pap test result in order to determine if follow-up is needed. It is not approved as a first-line HPV screening test.
- The Roche test can be performed on its cobas line of automated analyzers. SurePath is manufactured by Becton Dickinson and Company (NYSE:BDX).
Thu, Jul. 7, 11:32 AM
- Ghent, Belgium-based Ablynx (OTC:ABLYF) announces positive top-line results from a Phase 2b clinical trial assessing vobarilizumab (ALX-0061) in 251 patients with moderately to severely active rheumatoid arthritis (RA) who are intolerant to methotrexate or for whom methotrexate is inappropriate. The primary objective of the study was to investigate the safety and efficacy of various dose regimens for vobarilizumab monotherapy to guide further clinical development. The primary endpoint of the study was the proportion of subjects achieving ACR20 (20% improvement in RA symptoms) at week 12.
- Participants were randomized to receive one of three subcutaneous regimens of vobarilizumab (150 mg every four weeks, 150 mg every two weeks or 225 mg every two weeks) or open-label tocilizumab [Roche's (OTCQX:RHHBY) Actemra] every one or two weeks (the comparator drug).
- Subjects in the vobarilizumab 225 mg (n=63) responded the best with 81% achieving ACR20, 49% ACR50 and 21% ACR70. The corresponding results in the Actemra arm were 78%, 45% and 23%. The proportion of the subjects in the 225 mg group who achieved remission as measured by an RA activity score called DAS28 was 41% compared to 27% for Actemra. The proportion achieving low disease activity or remission, determined by DAS28, also favored vobarilizumab 225 mg (60% versus 44%).
- Top-line results from a Phase 2b study of vobarilizumab combined with methotrexate should be available in Q3.
- Vobarilizumab inhibits the activity of the proinflammatory cytokine interleukin-6 (IL-6) by binding to the IL-6 receptor (IL-6R). It is comprised of an anti-IL-6R Nanobody linked to an anti-human serum albumin Nanobody which increases the half-life of the molecule. According to the company, its small size may enable it to penetrate more effectively into tissues.
- Ablynx inked a collaboration deal with AbbVie (ABBV) in 2013 to develop vobarilizumab for the treatment of inflammatory diseases.
- Previously: Abbvie in $840M deal to license arthritis, lupus drug (Sept. 23, 2013)
Thu, Jul. 7, 10:38 AM
- The first patient has been dosed in a Phase 2 clinical trial assessing Protalix BioTherapeutics' (PLX +1.6%) AIR DNase (formerly PRX-110) for the treatment of cystic fibrosis (CF). The 28-day switch-over study involves 15 CF patients previously treated with Roche's (OTCQX:RHHBY) Pulmozyme (dornase alfa). The primary endpoint is the change from baseline in lung function as measured by forced expiratory volume in one second (FEV1) and forced vital capacity (FVC). Top-line data should be available around year end.
- According to the company, AIR DNase is a proprietary plant cell-expressed recombinant form of a human enzyme called deoxyribonuclease 1 (DNase 1) that cleaves extracellular DNA and thins the thick mucus that accumulates in the lungs of CF sufferers. It is designed to be more effective than Pulmozyme by being more resistant to actin inhibition, which restricts DNase I activity. Actin is a protein that plays a role in a wide range of cellular processes.
Thu, Jul. 7, 8:28 AM
Tue, Jul. 5, 11:16 AM
- Thinly traded micro cap pSivida (PSDV +5.4%) bucks the market's bearishness. Shares are up on average volume (only ~23K shares so far) in response to its announcement of positive results from preclinical animal studies assessing the effectiveness of a sustained-release insert based on its Durasert technology to deliver a tyrosine kinase inhibitor (TKI) for the treatment of wet age-related macular degeneration (wet AMD).
- The data showed the TKI insert was similar in efficacy to an injection of an FDA-approved AMD biologic in preventing choroidal neovascularization (formation of new blood vessels) and reducing vascular leakage.
- Based on the encouraging results, the company intends to advance the Durasert TKI insert into clinical development.
- TKIs are currently used to treat cancer, but some inhibit a growth factor called PDGF (platelet-derived growth factor) which plays a key role in blood vessel formation. The TKI used by pSivida inhibits both PDGF and VEGF (vascular endothelial growth factor). AMD meds Lucentis (ranibizumab) and Eylea (aflibercept) are both VEGF inhibitors. In cancer, TKIs are taken orally because systemic administration is too toxic. PSivida's approach aims to deliver a TKI dose directly to the retina that is 1,000 times less that the dose used to treat cancer.
- Related tickers: (OTCQX:RHHBY -1.5%)(REGN -0.5%)
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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