Tue, Mar. 31, 12:37 PM
- Former Nomura analyst Amit Roy says the market for cancer immunotherapies called PD-1 inhibitors will only be ~$10B, far below the $20B - 30B forecasts being circulated today. He cites two main factors that could hamper growth: they only work for certain groups of cancer patients plus several layers of selection will be required for some cancers such as breast and colorectal, and there is a growing evidence that shorter therapy, cutting the treatment period to eight from 16 weeks, may be sufficient. If this comes to fruition, it would shrink the market by almost half (although a price increase could mitigate some of the shrinkage).
- PD-1 (programmed cell death protein 1) is found on the surface of cancer cells. It is used by tumors to evade the immune system so blocking its action enables the body to attack and kill cancer.
- Current FDA-approved PD-1 inhibitors are Bristol-Myers Squibb's (BMY -1.2%) Opdivo (nivolumab) and Merck's (MRK -0.7%) Keytruda (pembrolizumab).
- PD-1-related tickers: (MDVN -2.4%)(FPRX -1.2%)(CELG -3.1%)(OTCQX:RHHBY +0.6%)(AZN -1.7%)(SRNE +3.4%)
Mon, Mar. 30, 10:45 AM
- ImmunoGen (IMGN +2.3%) raises net $194M via a non-dilutive royalty deal with TPG Special Situations Partners (TSSP). In exchange for a gross payment of $200M, TSSP will have the right to receive 100% of the royalty revenue on Kadcyla (ado-trastuzumab emtansine) sales by Genentech (OTCQX:RHHBY +0.3%) until TSSP has received a total of either $235M or $260M, depending on the timing. Afterward, TSSP will receive 15% of Kadcyla royalties while ImmunoGen will receive 85%. The transaction should close in early April.
Mon, Mar. 23, 12:38 PM
- The Federal Trade Commission grants early termination under the HSR Act of the waiting period of Pfenex's (PFNX -1.4%) exclusive collaboration deal with Hospira (PFE +3.2%) to develop and commercialize PF582, a biosimilar to Roche's (OTCQX:RHHBY +0.7%) Lucentis (ranibizumab). The action clears the way for Hospira's initial payment of $51M to Pfenex.
- Previously: Pfenex up on Hospira biosimilar deal (Feb. 10)
Thu, Mar. 19, 4:37 PMPhase 1 study shows safety of Prothena Parkinson's disease drug candidate plus significant reduction in key PD-related protein
- A 40-subject Phase 1 single ascending dose study evaluating the safety of Prothena's (NASDAQ:PRTA) investigational monoclonal antibody for the treatment of Parkinson's disease (PD), PRX002, met its primary endpoint of safety and tolerability. All PRX002-related adverse events were mild and no dose-limiting toxicities were seen.
- Results from the study also showed that treatment with PRX002 reduced mean free serum alpha-synuclein levels, a protein involved in the onset and progression of PD, up to 96%, with a strong, rapid, dose-dependent response after a single dose.
- A multiple ascending dose trial assessing the safety and tolerability of PRX002 is ongoing. The product candidate is being jointly developed with Roche (OTCQX:RHHBY).
- Alpha-synuclein is a protein found in neurons. Its normal function is not well understood, but in synucleinopathies (e.g. PD, Lewy body dementia, multiple system atrophy) the protein can misfold and aggregate to form soluble aggregates and insoluble fibrils that contribute to the pathology of the disease. There is also increasing evidence that disease-causing synuclein can be propagated and transmitted from neuron to neuron, resulting is an infection-like spread of neuronal death.
- PRX002 is designed to slow or reduce the progressive degradation of neurons associated with synuclein misfolding and/or the cell-to-cell transmission of pathogenic synuclein.
- Previously: Prothena +5.3% AH, inks collaboration deal with Roche for Parkinson's antibodies (Dec. 11, 2013)
Thu, Mar. 19, 8:57 AM
- Biochemical supplier Sigma-Aldrich (NASDAQ:SIAL) closes a worldwide distribution agreement with Roche (OTCQX:RHHBY) for its Biochemical Reagents product portfolio, which includes kits and enzymes for cellular analysis, proteomics and PCR applications.
- The transition of the products from Roche to Sigma-Aldrich will occur this year. Financial terms are not disclosed.
Wed, Mar. 18, 7:45 AM
- Two 24-week Phase 3 trials (PINNACLE 1 & 2) evaluating AstraZeneca's (NYSE:AZN) PT003 in patients with chronic obstructive pulmonary disease (COPD) achieved their primary efficacy endpoints of statistically significant improvement in lung function compared to placebo.
- PT003 is a twice-daily fixed-dose combination of glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-2 agonist (LABA). It is the first LAMA/LABA combination to be delivered in a pressurized metered dose inhaler using the porous particle co-suspension technology developed by Pearl Therapeutics, which AZN acquired in 2013. The successful outcomes of the PINNACLE studies are the first from a series of pipeline candidates using Pearl's technology.
- PT003 was assessed in over 3,700 patients in over 275 study sites. The primary efficacy endpoint was trough forced expiratory volume in one second (FEV1). PT003 demonstrated statistically significant improvements in FEV1 versus placebo and the individual components glycopyrronium (PT001) and formoterol fumarate (PT005). PT001 and PT005 also showed statistically significant improvements in FEV1 compared to placebo.
- The company plans to file regulatory applications beginning this year. It will present the study results at a scientific meeting later this year.
- Related tickers: (NYSE:GSK) (NASDAQ:THRX) (NYSE:NVS) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
Tue, Mar. 17, 12:13 PM
- Celldex Therapeutics (CLDX -3.3%) and Roche (OTCQX:RHHBY +0.3%) enter into a clinical trial collaboration to evaluate the combination of Celldex's varlilumab and Roche's MPDL3280A in renal cell carcinoma. Under the terms of the agreement, Roche will provide its drug for the Phase 1/2 study while Celldex will fund and conduct the trial, expected to commence this year.
- Varlilumab (CDX-1127) is a fully human monoclonal antibody that targets CD27, a member of the tumor necrosis factor receptor class. It plays a key role in the activation pathway of lymphocytes and can be effectively manipulated with activating antibodies to induce potent anti-tumor effects while being less toxic due to its restricted expression and regulation.
- MPDL3280A is a monoclonal antibody that inhibits PD-L1 (programmed death-ligand 1), a transmembrane protein that is believed to play a key role in suppressing the immune system by hindering the proliferation of CD8+ T cells, the body's front-line attackers of foreign antigens. Binding to PD-L1 enables the activation of T cells so they can attack and kill cancer cells. The FDA recently designated MPDL3280A a Breakthrough Therapy for PD-L1-positive non-small cell lung cancer.
- Previously: Roche's MPDL3280A a Breakthrough Therapy for NSCLC (Feb. 2)
Mon, Mar. 2, 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.
Mon, Mar. 2, 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.
Mon, Mar. 2, 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.
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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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