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%)
Oct. 3, 2014, 11:55 AM
- Britain's National Institute for Health and Care Excellence (NICE), the group that advises the National Health Service on the cost-benefit profiles of medicines and care services, determines that Roche's (OTCQX:RHHBY -1.1%) Gazyvaro (obinutuzumab) does not qualify for inclusion in the government-run health program despite being approved for sale by the EC. NICE Chief Andrew Dillon says, "Although obinutuzumab is a clinically effective treatment, there were too many uncertainties in the company's submission and we cannot be confident that it is an effective use of NHS resources. With limited resources we need to ensure that each treatment we recommend gives patients not only the best care but is also of the best value to the NHS."
- Gazyvaro's full-regimen price is ₤26,496. It plans to work with the agency to address the situation.
- In August, NICE rejected Kadcyla (ado-trastuzumab emtansine) for the treatment of an aggressive form of breast cancer. Roche had extended a discount to the NHS off the list price of ₤90,000.
- Unsurprisingly, Roche takes a dim view of NICE referring to the agency as "not fit for purpose."
Oct. 1, 2014, 10:05 AM
- In response to the ever-increasing risk of security breaches, the FDA issues final guidance for device makers entitled, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." The agency recommends that device manufacturers consider cybersecurity risks at part of the design and development of their products and submit documentation to the FDA about the risks identified and the controls in place to mitigate them. The agency also recommends that companies submit their plans for patches and upgrades to device operating systems and medical software.
- The agency will hold a public workshop on October 21, 2014 to discuss how all the constituency groups can work together to improve cybersecurity in medical devices and protect the public health.
- ETFs: IBB, BIB, IRY, IXJ, BIS, DRGS
- Some related tickers: (MDT -0.2%)(BSX -0.9%)(STJ -0.3%)(ABT -0.6%)(JNJ -1.4%)(OTCQX:RHHBY +0.1%)
Oct. 1, 2014, 8:21 AM
- Yesterday, the U.S. Government released the first comprehensive disclosure of payments made by medical companies to doctors. Over the first five months of 2013, med firms paid $3.5B to doctors to fund items such as research, consulting, royalties to hospitals to help develop products and fees for speaking engagements. The monies were disbursed in two broad categories: research funding and fees to doctors for consulting and other non-research services.
- Roche's (OTCQX:RHHBY) Genentech unit led the way in the non-research category with $135M. Most of this (90%) went to a Southern California hospital network for royalties.
- Bristol-Myers Squibb (NYSE:BMY) was #1 in the research category with $329M which, according to the company, was largely the value of experimental medicines used in studies.
- Medtronic (NYSE:MDT) paid one unidentified doctor ~$3M who was among a group of six physicians paid at least $500K by the device maker. The company's total outlay for the period was $30.1M.
- Johnson & Johnson (NYSE:JNJ) paid $68M for non-research expenses.
- The disclosures, mandated by Obamacare, cover 4.4M payments to ~550K doctors and 1,360 teaching hospitals from August to December 2013.
- The disclosures are a bit controversial. Physicians complained that the government did not give them enough time to review the data to correct mistakes.
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
Sep. 29, 2014, 7:38 AM
- Shares of micro cap Exelixis (NASDAQ:EXEL) are up 26% premaket on healthy volume in response to positive Phase 3 results for cobimetinib announced today by Roche. Exelixis discovered the drug internally. It entered into a global co-development agreement with Genentech (OTCQX:RHHBY) in late 2006. In November 2013, Exelixis exercised its option to co-promote cobimetinib, if approved, in the U.S. It is entitled to an equal share of U.S. profits and losses which will decrease as sales increase and will share equally in U.S. marketing and commercialization costs. It is eligible to receive royalties on ex-U.S. sales.
Sep. 29, 2014, 7:28 AM
- At the European Society of Medical Oncology (ESMO) Congress today, Roche (OTCQX:RHHBY) announced positive from a Phase 3 clinical trial evaluating the safety and efficacy of the combination of cobimetinib plus Zelboraf (vemurafenib) compared to Zelboraf alone in patients with advanced melanoma.
- The results showed that patients with previously-untreated BRAF V600 mutation-positive advanced melanoma who received the combination lived significantly longer that those who received Zelboraf alone. Median progression-free survival in the combination therapy cohort was 9.9 months compared to 6.2 months in the monotherapy cohort.
- The data is currently under European Medicines Agency review. Roche plans to submit an NDA to the FDA later this year.
Sep. 25, 2014, 7:27 AM
- Roche's (OTCQX:RHHBY) Avastin (bevacizumab) and Xeloda (capecitabine) achieve their primary endpoints in two Phase 3 clinical trials in HER2-negative metastatic breast cancer.
- In the 185-patient IMELDA study, the safety and efficacy of maintenance treatment with Avastin plus Xeloda chemotherapy was compared to Avastin alone in patients with HER2-negative metastatic breast cancer that had not progressed during first-line induction treatment with Avastin plus docetaxel chemotherapy. The trial met its primary endpoint of improving progression-free survival (PFS) with a statistically significant 62% reduction in the risk of tumor progression in the Avastin plus Xeloda cohort compared the Avastin alone group (median PFS after induction: 11.9 months vs. 4.3 months). The study also hit its secondary endpoint of an improvement in overall survival (OS) with a statistically significant 57% reduction in the risk of death in the the Avastin plus Xeloda group compared to Avastin alone (median OS after induction: 39.0 months vs. 23.7 months).
- The 494-patient TANIA study evaluated the safety and efficacy of Avastin as a second-line therapy in HER2-negative metastatic breast cancer patients treated with Avastin plus chemo as a first-line treatment. The trial met its primary endpoint of improving PFS in the second-line, significantly reducing the risk of tumor progression by 25% (median PFS: 6.3 months vs. 4.2 months).
- The safety profiles in both trials were consistent with earlier studies.
Sep. 17, 2014, 4:29 PM| Comment!
Sep. 15, 2014, 7:46 AM
- Roche (OTCQX:RHHBY) commences a Phase 3 clinical trial to evaluate the safety and efficacy of lampalizumab for the treatment of patients with geographic atrophy (GA), the advanced form of age-related macular degeneration (AMD). The primary endpoint of the 936-patient placebo-controlled study is the reduction in the rate of GA progression evaluated at week 48 from baseline.
- In a Phase 2 trial, the lampalizumab-treated group demonstrated a 20% reduction in GA lesion progression versus placebo. Lampalizumab-treated patients with the complement factor I biomarker demonstrated a 44% decrease in the rate of disease progression.
- No regulatory-approved therapies for GA currently exist.
Sep. 8, 2014, 7:22 AM
- The European Commission approves Roche's (OTCQX:RHHBY) RoActemra (tocilizumab) for the treatment of patients with severe, active and progressive rheumatoid arthritis (RA) who have not been treated with methotrexate. It is the first interleukin-6 (IL-6) receptor antagonist approved in Europe for early RA.
- The early RA indication is the fifth update and expansion to RoActemra's European label in three years.
Sep. 3, 2014, 11:56 AM
- The two firms sign a master clinical supply agreement whereby Roche (OTCQX:RHHBY +0.7%) will supply Gazyva (obinutuzumab) to Infiniti Pharmaceuticals (INFI +46.2%) for use in planned clinical studies to evaluate the combination of Gazyva and IPI-145 (duvelisib) as a treatment for patients with blood cancers.
- The companies also consummate a material transfer agreement whereby Infiniti will supply IPI-145 to Roche to use in its preclinical and translational research to evaluate the combination of duvelisib and Gazyva.
Sep. 2, 2014, 10:40 AM
- Roche (OTCQX:RHHBY -0.3%) debuts the molecular testing systems cobas 6800/8800 for blood and plasma donor screening in markets accepting the CE mark. The fully automated high throughput PCR analyzers can generate 96 results in less than 3.5 hours and up to 960 results in an eight-hour shift (8800) with substantial "walk-away" time and minimal operator interaction.
Aug. 28, 2014, 7:49 AM
- Pacific Biosciences of California (NASDAQ:PACB) achieves a development milestone under its agreement with Roche (OTCQX:RHHBY) triggering a $10M milestone payment. The companies signed a Development, Commercialization and License Agreement on September 23, 2013 whereby Pac Bio will develop diagnostic products for exclusive commercialization by Roche based its Single Molecule Real-Time (SMRT) technology. The agreement's initial term is 13 years. Roche may renew for 5-year periods. Pac Bio may earn up to an additional $30M in development milestones.
Aug. 25, 2014, 11:21 AM
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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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