Mon, May 11, 8:07 AM
- The FDA approves Roche's (OTCQX:RHHBY) real-time PCR test for the KRAS genetic mutation in tumor samples from patients with metastatic colorectal cancer (mCRC). The test, which detects mutations in codons 12 and 13 of the KRAS gene, is performed on the company's cobas 4800 analyzer.
- The new assay expand's the system's companion diagnostic menu to three: BRAF (melanoma), EGFR (lung cancer) and KRAS (mCRC).
Fri, May 8, 9:23 AM
- Nano cap Ohr Pharmaceuticals (NASDAQ:OHRP) presented results from the clinical trial that failed to show its eye drops for wet-AMD (wet form of age-related macular degeneration) were better than placebo at the Association for Research in Vision and Ophthalmology conference in Denver, CO. The company originally announced the data from the Phase 2 study, called IMPACT, in March. Shares plunged almost 70% on the news.
- Data presented at the meeting in the modified intent-to-treat (mITT) population with classic containing lesions showed that patients treated with the combination of OHR-102 (0.2% squalamine lactate ophthalmic solution) and Roche's (OTCQX:RHHBY) Lucentis (ranibizumab injection) (n=37) had mean gains in visual acuity at Month 9 of +11 letters compared to +5 letters in the Lucentis + placebo cohort (n=28). 44% of patients receiving the combination therapy achieved an e3 line vision gain at Month 9 compared to 29% in the Lucentis + placebo group.
- In the overall mITT population, patients with either classic containing or occult only lesions, the OHR-102 combination arm showed a less distinct benefit (+7.8 letters) compared to Lucentis + placebo (+5.3 letters).
- The company appears undeterred by the failure of IMPACT. It plans to proceed to Phase 3 development in H2 targeting, no doubt, wet-AMD patients with classic containing lesions (classic choroidal neovascularization).
- Previously: Ohr Pharma Phase 2 study of wet-AMD drug fails to hit primary endpoint; shares plummet 55% premarket (March 27)
Thu, May 7, 11:13 AM
- Spurred by the progress of a bill moving through Congress that will speed new drugs to market for conditions lacking cures, called The 21st Century Cures Act, the FDA has scheduled a public meeting this summer to address concerns by the drugs industry that regulatory restrictions on what they can say about the off-label use of their products violates their First Amendment right to free speech. Language in the bill is ratcheting up the pressure on the agency to relax its guidelines.
- Drug makers were emboldened on its prospects of changing the rules after an appeals court overturned the conviction of a pharmaceutical sales representative in 2012 who was convicted of promoting off-label uses of the narcolepsy drug Xyrem. The court ruling was based on First Amendment protection for truthful and non-misleading off-label speech.
- The American Medical Association supports the need for physicians to have access to accurate and unbiased information about off-label uses of drugs since it already accounts for as much as 20% of prescribing, with higher levels in oncology and pediatric rare diseases.
- Giving drug firms more leeway in this arena has its detractors, however. Rita Redberg, M.D., Professor of Medicine at the UC-San Francisco says, "At my own medical center we have banned pharmaceutical reps from coming because we don't think they are a good source of information. You don't ask the barber if you need a haircut."
- Pharma companies have a dubious history of breaking the rules governing off-label promotion. Over the past 10 years, 17 firms have paid more than $16B in settlements related to inappropriate off-label selling.
- Further complicating matters is the fact that up to 75% of published pre-clinical trial results cannot be reproduced in later studies.
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (MRK +0.4%)(LLY -0.1%)(PFE +0.3%)(BMY +0.7%)(GSK -4.1%)(OTCQX:RHHBY -1.1%)(SNY -0.6%)(OTCPK:BAYRY -0.5%)(NVS +0.1%)(AZN -0.3%)(JNJ +0.2%)(ABT -0.1%)(ABBV +0.1%)
Thu, May 7, 7:23 AM
- The FDA designates venetoclax (RG7601, GDC-0199/ABT-199) a Breakthrough Therapy for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who have genetic mutation known as a 17p deletion. Patients in this classification generally have poor prognoses.
- Venetoclax selectively binds to and inhibits Bcl-2 proteins which play a key role in apoptosis (cell death). Bcl-2s are highly expressed in blood cancers. The drug candidate is being jointly developed by Roche (OTCQX:RHHBY) and AbbVie (NYSE:ABBV).
- Breakthrough Therapy status allows for more intensive guidance from the FDA on the most efficient development path, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
Tue, May 5, 5:05 PM
- Pacific Biosciences (NASDAQ:PACB) achieves a second development milestone under its 2013 collaboration agreement with Roche (OTCQX:RHHBY), triggering a $10M payment. Pac Bio has now earned $20M of the $40M potential milestones specified in the contract.
- The agreement covers clinical diagnostic products, including sequencing systems and consumables based on Pac Bio's Single Molecule Real-Time (SMRT) technology. Under the terms of the agreement, Roche has the exclusive right to commercialize the products for clinical use, subject to certain terms and conditions.
Wed, Apr. 22, 7:30 AM
- Roche (OTCQX:RHHBY) Q1 results (CHFm): Total Revenues: 11,833 (+2.9%); Pharmaceuticals: 9,322 (+3.1%), U.S.: 4,392 (+13.4%), Europe: 2,178 (-10.2%), Japan: 763 (-9.7%), International: 1,989 (+4.8%); Diagnostics: 2,511 (+2.2%).
- Product sales leaders: MabThera/Rituxan: 1,744 (+4.6%); Herceptin: 1,652 (+8.3%); Avastin: 1,619 (+3.5%); Lucentis: 394 (-3.2%); Actemra/RoActemra: 334 (+22.3%); Perjeta: 322 (+80.9%); Xolair: 281 (+37.1%).
Tue, Apr. 21, 7:26 AM
- Inovio Pharmaceuticals (NASDAQ:INO) initiates a Phase 1 dose escalation study to evaluate the safety, tolerability and immunogenicity of its DNA immunotherapy, INO-1800, in patients with chronic hepatitis B infection. The action triggers a $3M milestone payment from co-developer Roche (OTCQX:RHHBY).
- The trial will assess INO-1800 alone or in combination with INO-9112, Inovio's IL-12-based immune activator. All patients will also be treated with standard-of-care antiviral therapies.
- In preclinical studies, INO-1800 generated strong T-cell and antibody responses that led to the elimination of targeted liver cells in mice. Investigators observed that hepatitis-B-specific T-cells exhibited a killing function and could migrate to and remain in the liver where they cause clearance of target cells without evidence of liver injury.
- About 240M people worldwide are infected with hepatitis B, contributing to 1M deaths per year. Liver cancer, a common progression of chronic hep B infection, strikes 600K people every year, killing most within five years.
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 PM
- 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.
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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