Mon, Apr. 13, 1:02 PM
- Nico Andre, Roche's (OTCQX:RHHBY -0.1%) head of medical affairs for oncology, says the company expects to have 11 immunotherapy cancer drug candidates in late-stage trials by the end of this year. The furthest along, MPDL3280A, is a monoclonal antibody that inhibits PD-L1, a protein on the surface of cancer cells that plays 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. The company plans to submit regulatory applications in the U.S. and Europe for MPDL3280A later this year.
- Some analysts project that cancer immunotherapies will be greater than a $30B market by 2025.
Wed, Apr. 8, 7:15 AM
- The European Commission approves Roche's (OTCQX:RHHBY) Avastin (bevacizumab), in combination with standard chemotherapy, for the treatment of adult patients with cervical cancer. The clinical trial data supporting clearance showed that treatment with Avastin reduced the risk of death by 26%, representing a median improvement in survival of almost four months compared to women who received chemo alone (median overall survival: 16.8 months vs. 12.9 months; p=0.0132).
- About 33K women are diagnosed with cervical cancer in the EU each year and ~13K will die from the disease.
- Avastin is also cleared in Europe for the treatment of advanced stages of breast, colorectal, non-small cell lung, ovarian and kidney cancers. It is also approved in the U.S. and over 60 countries worldwide for the treatment of progressive glioblastoma following therapy.
Thu, Apr. 2, 12:45 PM
- At a special meeting of Foundation Medicine (FMI +0.2%) stockholders, almost all of the 78% of the total number of outstanding shares eligible voted in favor of Roche's (OTCQX:RHHBY +0.6%) plan to acquire a majority stake in the firm. The successful vote satisfies one of the remaining closing conditions of the proposed deal.
- The transaction will include Roche's pending tender offer, which expires on April 6, to buy up to 15.6M shares of FMI common stock at $50 per share and the purchase of 5M newly issued shares of common also at $50.
- Previously: Roche to purchase majority stake in Foundation Medicine (Jan. 12)
Wed, Apr. 1, 8:14 AM
- Racing rivals Bristol-Myers Squibb (NYSE:BMY), Merck (NYSE:MRK) and AstraZeneca (NYSE:AZN) for a leadership position in immuno-oncology, Roche (OTCQX:RHHBY) says that finding combination therapies that attack cancer on different fronts would be "extremely important." CEO Severin Schwan confirms that his organization is ready to collaborate with competitors to develop these new treatments. "Partnering is absolutely fundamental," he says.
- Roche, with its robust internal product development capabilities, has not collaborated with other firms as readily as its rivals, choosing instead to acquire. Its most recent deal was buying a majority stake in Foundation Medicine, for example. Its collaboration with Exelixis (NASDAQ:EXEL) is bearing fruit, though. Last month, the FDA accepted their New Drug Application (NDA) under Priority Review for the combination of cobimetinib and Zelboraf (vemurafenib) for the treatment of advanced melanoma.
- Previously: Roche extends expiration of tender offer for Foundation Med shares (March 2)
- Previously: Roche's melanoma combo NDA gets Priority Review (Feb. 19)
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%)
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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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