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November 3, 2015 By Mark Terry , BioSpace.com Breaking News Staff Ahead of its investor presentation today, UK-based GlaxoSmithKline profiled a portfolio of about 40 potential new drugs and vaccines across six core areas. The six core areas include HIV and infectious diseases, oncology, immuno-inflammation, vaccines, respiratory and rare diseases. The portfolio is the result of GSK ’s research and development efforts along with more than 1,500 company and academic collaborations. GSK also indicates that about 80 percent of the pipeline are potentially “first-in-class” drugs with novel mechanisms of action. The company is under some pressure to improve growth and move away from a major China bribery scandal that cost the company $500 million in fines and a loss of goodwill with the Chinese government. The company has been encouraged to break up from one of its biggest investors, Neil Woodford , of Woodford Investment Management . Woodford argues that GSK ’s stock is underperforming, down about three percent over the last year and that investors are losing patience waiting for the new pipeline to come to fruition. Woodford owns about £35 million of GSK stock. It has also been confirmed that Pfizer Inc. did attempt to acquire GlaxoSmithKline , but GSK apparently rebuffed the offer and a price was never discussed. Analysts typically argue that the British government is fairly hostile to such a deal, which would make Pfizer Inc. ’s efforts at a tax inversion deal all that more difficult to pull off. Pfizer has turned its gaze toward Dublin-based Allergan . In today’s announcement, GSK indicated that it expects to submissions for up to 20 drugs before 2020. Some of them are in advanced late-stage development and could, if approved, launch prior to 2020. Others are in earlier development, particularly those in oncology, immuno-inflammation and respiratory disease It does indicate that in 2016 and 2017, it has the potential to begin Phase II development of approximately 30 new molecular entitles (NMEs) and product line extensions (PLEs) and start Phase III trials of about 20 NMEs and PLEs. “Earlier this year we set out our expectations for the Group to generate sustained sales and earnings performance over the next five years,” said Andrew Witty , chief executive officer of GSK in a statement. “With the recent transaction, we have significantly strengthened our Vaccines and Consumer Healthcare Businesses. Today, we have profiled around 40 innovative potential new medicines and vaccines which will support future growth in Pharmaceuticals and Vaccines businesses.” The company recently released two HIV drugs, Tivicay and Tirumeq, which, according to BloombergBusiness, have helped to offset sluggish sales of the company’s best-selling drug, Advair. GSK also announced several new upcoming collaborations. These include working with the National Institute of Allergy And Infectious Diseases (NIAID) on optimizing and developing broadly neutralizing antibodies (bnAbs) in HIV, a deal with Regulus Therapeutics, Inc. to study GSK ’s NS5B polymerase inhibitor, 2878175, currently in Phase I trials, with Regulus ’ miR-122 antagonist, RG-101, for hepatitis C. It is also continuing its collaboration with Isis Pharmaceuticals, Inc. on antisense technology in hepatitis B, with a Phase II trial expected in 2016. The company has also inked a deal with Merck & Co. to study GSK’s anti-OX40 monoclonal antibody with Merck ’s Keytruda. This is a Phase I trial. “The level of innovation in this portfolio is substantial,” Witty said in a statement. “We believe this is critical in today’s operating environment as payers look to balance pressures of pricing and demand. It also provides us with confidence that this portfolio can generate significant value for shareholders and deliver widespread benefits to patients and consumers.”

October 22, 2014 By Riley McDermid , BioSpace.com Breaking News Staff News that Regulus Therapeutics Inc has seen a breakthrough in its hepatitis C treatment sent shares of the stock skyrocketing more than 107 percent on Wednesday, as traders rushed in to get a piece of a promising biopharma market rally. Regulus was clocking in at $14.03 in early afternoon trading, up 107.24 percent from the previous trading session. Regulus announced earlier in the day that it “has demonstrated human proof-of-concept with a microRNA therapeutic from an ongoing clinical study evaluating RG-101, a wholly-owned, GalNac-conjugated anti-miR targeting microRNA-122 (“miR-122"), for the treatment of hepatitis C virus infection (“HCV”).” Interim results from the ongoing clinical study found that a single subcutaneous dose of 2 mg/kg of RG-101 as monotherapy resulted in “significant and sustained” reductions in HCV RNA in a varied group of patients, including difficult to treat genotypes and patients who experienced viral relapse after a prior IFN-containing regimen. The study also found that RG-101 is safe, well tolerated and has a demonstrably favorable pharmacokinetic pro date that could allow it to combine with oral direct-acting antiviral agents to treat HCV. “[The data] is a significant milestone in Regulus’ history, and represents a key achievement under our ‘Clinical Map Initiative’,” said Kleanthis Xanthopoulos , president and chief executive officer of Regulus , in a statement. “We believe these interim data are exceptional and provide strong evidence to support the rapid advancement of RG-101 into future clinical studies, while presenting a clear opportunity for a potentially disruptive therapy to the current HCV treatment paradigm,” he said. var switchTo5x=true; stLight.options({publisher: "0341611e-38a4-415d-9e18-75e093ff27e0", doNotHash: false, doNotCopy: false, hashAddressBar: false});