Wed, May 20, 1:14 PM
- Thinly traded nano cap Lpath (LPTN -79.5%) craters on a massive 78x surge in volume in response to its announcement that its lead product candidate, iSONEP, failed to achieve its primary and key secondary efficacy endpoints in a Phase 2 trial in patients with wet age-related macular degeneration (wet AMD) who had not responded adequately to anti-vascular endothelial growth factor (VEGF) therapies such as Roche's (OTCQX:RHHBY -0.4%) Lucentis (ranibuzumab) or Avastin (bevacizumab) or Regeneron's (REGN +1.4%) Eylea (aflibercept).
- Patients treated with iSONEP, either alone or as an adjunct, did not show any statistically significant improvement in visual acuity.
- SVP and Chief Development Officer Dario Paggiarino, M.D., says, "This trial was designed to evaluate the activity of iSONEP in wet AMD patients that had previously received at least three prior injections of an anti-VEGF agent and had not responded well. While the primary endpoint of the trial was not met, we will be conducting a complete analysis of the data, including additional anatomical endpoints, to better understand the results from each arm of the trial."
- iSONEP is a monoclonal antibody that binds to a bioactive lipid called sphingosine-1-phosphate, a major regulator of vascular systems.
- Final results will be presented in November at the American Academy of Ophthalmology meeting in Las Vegas, NV.
- Related ticker: (PFE +0.4%)
Mon, May 18, 4:23 PM
- Ilumina (NASDAQ:ILMN) files a lawsuit in the U.S. District Court for the Northern District of California against Roche (OTCQX:RHHBY) subsidiary Ariosa Diagnostics accusing it of infringing on U.S. Patent No. 7,955,794 entitled "Multiplex Nucleic Acid Reactions." The action is focused on Ariosa's Microarray-based version of its Harmony Prenatal Test.
- Previously, Ilumina and its subsidiary Verinata Health filed suits in the same court accusing Ariosa of infringing the '794 patent as well as Patent Nos. 8,296,076 and 8,318,430 with the sequencing-based version of its Harmony Prenatal Test.
Thu, May 14, 10:17 AM
- Interim data from a Phase 2 trial, called POPLAR, evaluating Roche's (OTCQX:RHHBY +2.6%) investigational cancer immunotherapy, MPDL3280A, in treatment-experienced non-small cell lung cancer (NSCLC) patients showed a doubling of overall survival (OS) in those whose cancer expressed the highest levels of PD-L1 (programmed death ligand-1) compared to docetaxel chemotherapy. A less-profound improvement was observed in patients with medium/high PD-L1 expression.
- 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.
- Complete interim results from POPLAR (Abstract #8010) will be presented on the afternoon of May 31 at the American Society of Clinical Oncology meeting in Chicago, May 29 - June 2.
- Previously: Roche's MPDL3280A a Breakthrough Therapy for NSCLC (Feb. 2)
Thu, May 14, 10:00 AM
- In separate Phase 1/2 studies, patients treated with Roche's (OTCQX:RHHBY +2.1%) alectinib demonstrated response rates as high as 68.8%. Patients with ALK-positive non-small cell lung cancer whose disease had progressed following treatment with crizotinib (Pfizer's Xalkori) showed an overall response rate (ORR) of 50% in Study NP28673 and 47.8% in Study NP28761. In patients whose cancer has spread to the central nervous system, the ORRs were 57.1% and 68.8%, respectively.
- Alectinib is an anaplastic lymphoma kinase (ALK) inhibitor created at Chugai Kamakura Research Labs.
- Complete results will be presented at the American Society of Clinical Oncology meeting in Chicago, May 29 - June 2. Study NP28673 (Abstact #8008) will be presented on the morning of May 31 and Study NP28761 (Abstract #8019) will be presented on the morning of June 1.
Mon, May 11, 5:22 PM
- Ophthotech (NASDAQ:OPHT) completes enrollment in its first Phase 3 trial assessing Fovista (anti-PDGF BB pegylated aptamer) in combination with Roche's (OTCQX:RHHBY) Lucentis (ranibizumab) compared to Lucentis alone as monotherapy in patients with wet age-related macular degeneration (wet-AMD).
- Patient enrollment in a second Phase 3 study assessing Fovista + Lucentis compared to Lucentis alone should be completed by the end of Q3. Data readout from the first two studies should happen in 2016.
- A third Phase 3 study evaluating Fovista in combination with Regeneron's (NASDAQ:REGN) Eylea (aflibercept) or Roche's Avastin (bevacizumab) compared to Eylea or Avastin alone should reach its enrollment target in the same time frame as the other two studies, although the expected time from today is unclear.
- Total enrollment in the three trials will be ~1,866 across 225 sites worldwide.
- The company's objective with Fovista is to be agnostic relative to the choice of anti-VEGF agent co-administered with it.
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)
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