Today, 10:24 AM
- Roche (OTCQX:RHHBY) announces the commercial availability of the cobas HBV quantitative nucleic acid test for use on its fully automated cobas 6800/8800 Systems in countries that recognize CE Mark. The test covers all known hepatitis B (HBV) genotypes (A-H).
- The 6800/8800 systems can process up to 384 and 960 PCR-based results, respectively, in an eight-hour shift.
- The products are not currently available in the U.S.
Today, 10:10 AM
- Since it is only about half way there in its effort to establish a majority stake in Foundation Medicine (FMI +0.4%), Roche (OTCQX:RHHBY -0.1%) extends the expiration date to April 6 to acquire 15,604,288 common shares. So far it only 7,739,202 shares have been tendered. After acquiring the 15.6M shares it intends to buy another 5M that Foundation will issue.
- The Cambridge, MA-based firm uses genetics to help select drugs for cancer patients. Its IPO was in September 2013.
Today, 8:48 AM
- Micro cap Athersys (NASDAQ:ATHX) jumps 20% premarket on robust volume in response to its announcement of an exclusive partnership and license agreement with Chugai Pharmaceutical Co. (OTCQX:RHHBY) to develop and commercialize MultiStem cell therapy for ischemic stroke in Japan.
- Under the terms of the agreement, Chugai is responsible for the development and commercialization of MultiStem for the indication in Japan. Athersys will receive an upfront cash payment of $10M, development and regulatory milestones of up to $45M, sales milestones of up to $150M and tiered double-digit royalties on net sales.
- MultiStem is currently in Phase 2 development for ischemic stroke in the U.S. and Europe.
Fri, Feb. 27, 1:28 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting the use of Roche's (OTCQX:RHHBY +0.5%) Avastin (bevacizumab), in combination with standard chemotherapy, for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer. Cancer of the cervix strikes over 30K European women each year.
- Avastin is currently approved in the E.U. for the treatment of breast, colorectal, non-small cell lung, kidney and ovarian cancers.
- The U.S. FDA cleared Avastin for cervical cancer in August of last year.
- Avastin is Roche's second best seller, generating $6.4B in sales last year.
Thu, Feb. 26, 10:23 AM
- The European Commission approves Xadago (safinamide) for the treatment of idiopathic Parkinson's disease (PD). The drug was developed by Newron Pharmaceuticals S.p.A. and will be commercialized by privately-held Zambon S.p.A., both based in Italy.
- Xadago's specific indication is for the treatment of mid-to-late stage fluctuating patients as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicines.
- Safinamide is a new chemical entity, the first approved in Europe in 10 years for PD, with a unique mode of action including selective and reversible MAO-B (monoamine oxidase) inhibition, use-dependent Na (sodium) channels blockade and Ca (calcium) channels modulation which enables it to modulate abnormal glutamate release. Glutamate is an important neurotransmitter that plays a key role in neural activation.
- PD-related tickers: (SNY -2.9%)(ABBV -0.2%)(IPXL -0.5%)(NDRM +1.2%)(XNPT)(OTCPK:BIOZF)(ACOR -1.6%)(OTCQX:RHHBY -0.4%)(PRTA -3.4%)(ADMS -2.5%)(TEVA)(OTCQX:CYNAF -0.9%)(OTCQB:TTNP +2.9%)
Tue, Feb. 24, 8:14 AM
- Merck (NYSE:MRK) extends a royalty-free license to the Medicines Patent Pool (MPP) for its pediatric formulations of raltegravir (marketed as Isentress in the U.S.) for the treatment of HIV-1 infection in infants and children from four weeks to under 12 years of age in developing countries. This is the MPP's first agreement that provides access to an HIV integrase inhibitor for use in combination HIV therapy for patients in this age range.
- Raltegravir is the only integrase inhibitor cleared for use in infants and children as young as four weeks in the U.S. and European Union. Pediatric formulations are available as chewable tablets (25 mg and 100 mg) and granules for oral suspension (single-use 100 mg packets).
- There are ~3.2M children infected with HIV worldwide.
- The MPP, founded in 2010, is a United Nations-backed organization that aims to increase access to HIV medicines and technologies to people in developing countries. It has agreements with AbbVie (NYSE:ABBV), Bristol-Myers Squibb (NYSE:BMY), Gilead Sciences (NASDAQ:GILD), Roche (OTCQX:RHHBY), NIH and ViiV Healthcare (NYSE:PFE) (NYSE:GSK).
Fri, Feb. 20, 7:15 AM
- The World Health Organization (WHO) approves the use of a 15-minute point-of-care test developed by Corgenix Medical (OTCQB:CONX) to detect the presence of the Ebola virus. The company developed the assay with funding assistance of the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation.
- Procurement and roll-out in Africa will begin in a few weeks pending the completion of administrative procedures with the U.S. FDA.
- Ebola-related tickers: (NYSE:MRK) (NASDAQ:NLNK) (NYSEMKT:IBIO) (NASDAQ:NVAX) (NYSE:GSK) (NYSE:JNJ) (NASDAQ:TKMR) (NYSEMKT:HEB) (NASDAQ:BCRX) (NASDAQ:SRPT) (NASDAQ:CMRX) (NASDAQ:ABIO) (OTCQB:AEMD) (OTCPK:BVNRY) (NASDAQ:INO) (OTCQX:RHHBY)
Thu, Feb. 19, 10:10 AM
- Facing ever-increasing pushback from payers over the high price of new treatments, some biotech firms are working on a new payment model that rewards them for the long-term performance of their drugs. Gene therapy developers, including BioMarin Pharmaceuticals (BMRN +0.4%) and Sangamo BioSciences (SGMO -0.1%), are leading the effort.
- The industry says that a one-time cure, even if priced greater than $1M, saves money over the long term but acknowledges that payers will balk at paying the cost upfront. The general consensus is that an upfront payment over $1M will be unacceptable.
- Under a pay-for-performance scheme, the annuity-like payments would cease if medical testing showed that the therapy was not working. Much work remains to be done, though, before this approach could be implemented. For example, legislation may be required to force insurers to pick up the tab for patients that switch coverage.
- Some proponents of the new scheme say that the payment streams could be securitized and sold to investors, like consumer debt.
- Gene therapies represent the highest priced treatments. Only one has cleared the regulatory hurdle to date, UniQure's (QURE +1.5%) Glybera, which costs 850K euros ($1M) in Germany. It will be sold for a one-time payment because it is too difficult to measure how well it works (this reasoning will undoubtedly pop up again).
- Previously: UniQure sets price record with Glybera (Nov. 26, 2014)
- Related tickers: (CELG +1.3%)(AMGN -0.2%)(BIIB +0.5%)(GILD +0.1%)(MRK -0.3%)(GSK -0.2%)(AZN +0.9%)(LLY +0.3%)(NVS +0.1%)(PFE -0.5%)(JNJ -0.3%)(OTCQX:RHHBY +1.4%)(BMY -0.4%)(ABT)(BAX -1.1%)
Thu, Feb. 19, 7:28 AM
- The FDA grants Priority Review for Roche's (OTCQX:RHHBY) New Drug Application (NDA) for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of patients with BRAF V600-positive advanced melanoma. The PDUFA date is August 11.
- The Priority Review designation applies to medicines that the FDA determines have the potential to deliver significant improvements in the treatment, prevention or diagnosis of a disease. The major benefit to the product developer is a shorter review clock: six months versus ten months.
- Cobimetinib, being co-developed by Exelixis (NASDAQ:EXEL) and Genentech, is a selective inhibitor of MEK (mitogen-activated protein kinase), a component of a pathway that mediates downstream signaling of growth factor receptors that are prominently activated in a variety of human tumors. It has demonstrated particular efficacy in BRAF-mutant tumors.
- Zelboraf, approved in the U.S. in 2011, is indicated for the treatment of BRAF V600E-positive unresectable or metastatic melanoma.
- Previously: Roche submits NDA for skin cancer med (Dec. 15, 2014)
- EXEL is up 8% premarket on high volume.
Wed, Feb. 18, 5:41 PM
- In an NIH-sponsored Diabetic Retinopathy Clinical Research Network comparative effectiveness study published in the New England Journal of Medicine, Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea (aflibercept) was more effective than Genentech's (OTCQX:RHHBY) Avastin (bevacizumab) and Lucentis (ranibizumab). The 660-patient study was designed to compare three anti-VEGF therapies for the treatment of diabetic macular edema.
- Eylea demonstrated significantly greater improvement in mean visual acuity letter score at one year, the primary efficacy endpoint, than the comparators. Eylea's score was +13 letters from baseline versus +11 for Lucentis and +10 for Avastin.
- In patients with moderate or worse vision loss at the start of the trial, Eylea showed a statistically significant seven-letter (~1.5 lines on an eye chart) improvement over Avastin and a five-letter improvement over Lucentis (Eylea: +19 letters from baseline; Lucentis: +14; Avastin: +12).
- 42% of patients receiving Eylea gained at least 15 letters in best corrected visual acuity (BCVA) from baseline compared to 32% for Lucentis and 29% for Avastin.
- Eylea accounts for almost all of Regeneron's product revenue, posting $1.7B in sales last year.
- Investigators intend to present the results at next week's Annual Macula Society Meeting in Scottsdale, AZ.
Tue, Feb. 10, 10:05 AM
- Pfenex (PFNX +25.9%) and Hospira (HSP +0.1%) team up to develop and commercialize PF582, Pfenex's lead biosimilar candidate to Genentech's (OTCQX:RHHBY +0.8%) Lucentis (ranibizumab), which logged ~$4B in sales last year.
- Under the terms of the collaboration, Pfenex will receive an upfront payment of $51M, once the agreement clears antitrust review, and up to $291M in development and sales milestones plus tiered double-digit royalties on commercial sales.
- The companies will share the Phase 3 equivalence clinical trial costs. Hospira will be responsible for manufacturing and commercializing PF582 worldwide.
Mon, Feb. 9, 4:01 PM
- Roche (OTCQX:RHHBY -2.5%) acquires Potsdam, Germany-based Signature Diagnostics AG, a translational oncology and genomics company that develops large blood plasma and tissue biobanks in multiple cancers that are constructed from multicenter prospective clinical studies. Signature uses its biobank samples with clinical progression and genetic data to develop and validate circulating cell-free DNA (cfDNA) tests, which show promise in non-invasive treatment response monitoring.
- Roche intends to leverage Signature's expertise in cancer biobanks and next generation sequencing (NGS) assay development to accelerate the development of targeted NGS-based diagnostics.
- Specific terms of the deal are undisclosed.
Sat, Feb. 7, 11:53 AM
- The FDA approves Genentech's (OTCQX:RHHBY) Breakthrough Therapy-tagged Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy in patients with diabetic macular edema. It is administered by a physician as a once-monthly injection into the eye.
- Previously: Decision today for FDA review of Lucentis expanded label (Feb. 6)
Fri, Feb. 6, 10:30 AM
- Today is the PDUFA date for the FDA's review of Genentech's (OTCQX:RHHBY) supplemental Biologics License Application (sBLA) submitted on August 7 for the use of Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy, an eye disease affecting nearly 8M Americans.
- Lucentis is currently cleared for the treatment of wet age-related macular degeneration, macular edema following retinal vein occlusion and diabetic macular edema.
- Previously: FDA accepts sBLA for Lucentis label expansion (Oct. 8, 2014)
Wed, Feb. 4, 7:23 AM
- On the basis of an pre-planned interim analysis by an independent data monitoring committee, a Phase 3 clinical trial assessing Roche's (OTCQX:RHHBY) Gazyva (obinutuzumab) in patients with refractory indolent non-Hodgkin's lymphoma was ended early after it was determined that it met its primary endpoint. The results showed that patients treated with Gazyva plus bendamustine followed by Gazyva alone lived significantly longer without disease worsening or death (progression-free survival or PFS) that those treated with bendamustine alone. The study was stopped because the benefit was profound with no unexpected adverse events.
- The data will be presented at a future medical conference and will be used in regulatory applications in the U.S. and E.U.
- Gazyva/Gazyvaro is a monoclonal antibody designed to attach to a B-cell surface protein called CD20. Along with the body's immune system, it attacks and kills targeted cells. It is approved in more than 40 countries, in combination with chlorambucil, for the treatment of treatment-naive chronic lymphocytic leukemia.
Mon, Feb. 2, 7:05 AM
- The FDA designates Roche's (OTCQX:RHHBY) investigational cancer immunotherapy, MPDL3280A, a Breakthrough Therapy for the treatment of patients with PD-L1-positive non-small cell lung cancer (NSCLC) whose disease has progressed or after platinum-based chemotherapy (and appropriate targeted therapy for those with an EGFR mutation-positive or ALK-positive tumor).
- This is the second BTD tag for the product candidate. The first, for metastatic bladder cancer, was granted in 2014.
- Breakthrough Therapy status allows a more rapid review of the New Drug Application (NDA) or Biologics License Application (BLA), including allowing the submission after a Phase 2 trial, in certain cases.
- Roche intends to initiate new Phase 3 studies this year evaluating MPDL3280A in additional tumor types.
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