Dasabuvir Sodium Hydrate

June 24, 2015 By Mark Terry , BioSpace.com Breaking News Staff Chicago-based AbbVie adds another arrow to its quiver in its arsenal of weapons against hepatitis C. The company announced today that its Phase IIIb TURQUOISE-III study showed a 100 percent clearance response with Viekirax and Exviera without ribavirin in genotype 1b (GT1b) chronic hepatitis C virus (HCV). “Genotype 1b represents a large portion of HCV patients globally, as it is the most prevalent sub-genotype, and there is a need to continue to explore additional treatment regimens,” said Jordan Field, research director and clinician scientist at the Toronto Center for Liver Disease in a statement. “The results of TURQUOISE-III are promising, demonstrating that genotype 1b HCV patients with compensated liver cirrhosis have the potential to achieve high response rates with an interferon and ribavirin-free treatment in 12 weeks.” The combination if Viekirax and Exviera is otherwise marketed by AbbVie as Viekira Pak, but the current study suggests that it is effective whether it is prescribed in combination with ribavirin or not. AbbVie has been in an ongoing price and distribution war with competitor Gilead Sciences, Inc. , which markets competitive hepatitis C treatments, Harvoni and Sovaldi. In January 2015, Gilead inked a definitive distribution agreement with health insurance company Anthem, Inc. , which makes Harvoni the primary treatment for genotype 1 hepatitis C, citing better pricing compared to AbbVie ’s Viekira Pak. Earlier in that month, on Jan. 7, Gilead had signed an exclusive deal with CVS Health Corp. to exclusively sell Harvoni and Sovaldi. These deals were in response to AbbVie signing a deal on Dec. 22, 2014, with pharmacy benefit manager Express Scripts Inc. for Express Scripts to only cover Viekira Pak and no longer cover Sovaldi and Harvoni. At that time, Geoffrey Porges , an analyst with Sanford Bernstein wrote in a note, “We have said before that a price war in the HCV market, with only two major competitors, Gilead and AbbVie , does not make sense for either competitor or for the future market potential of the category. However, it appears that AbbVie has chosen to start a price battle. AbbVie is likely to have had to pay dearly for the privilege of exclusive access plus no restrictions based on fibrosis scores.” All of the drugs are very expensive A round of Sovaldi treatment runs about $84,000, or about $1,000 per pill. Harvoni’s 12-week course costs about $94,500. Viekira Pak’s 12-week course of treatment runs about $83,319. Another drug for HCV in the marketplace is Johnson & Johnson ’s Olysio. Olysio was in the news in April when the U.S. Food and Drug Administration (FDA) approved a new Warnings and Precautions label for the drug, which included serious bradycardia when the drug was co-administered with sofosbuvir and amiodarone, as well as liver problems. The new drug study for AbbVie will probably bolster any efforts the company will make to expand its market or hold ground for HCV. The company was also recently was dubbed the “favorite large-cap pharma name” by two analysts, March Goodman and Ami Fadia , with UBS . Despite the fact AbbVie ’s Humira will lose U.S. patent protection in December 2016 and European patent protection in April 2018, they indicated that AbbVie ’s pipeline is “even more underappreciated than we had even thought.” As Rumors Swirl About GlaxoSmithKline Bid, Who Could Suitors Be? Rumors are swirling that Swiss-based Roche and U.S.-based Johnson & Johnson are eying the U.K. company for approximately $143 billion. But Roche and J&J aren’t the only companies though who have been thought could go after the elephant that is Glaxo. Last month there was buzz that Pfizer Inc. was considering acquiring Glaxo , a year after it failed to acquire AstraZeneca PLC . Just this month over a third of respondents in a poll conducted by BioSpace believe that AstraZeneca PLC could be in the running to acquire struggling GlaxoSmithKline (GSK) . So BioSpace wants to ask our readers again what they predict for this new dealmaking bonanza. Will Glaxo go—and if so, to whom? var _polldaddy = [] || _polldaddy; _polldaddy.push( { type: "iframe", auto: "1", domain: "biospace.polldaddy.com/s/", id: "as-rumors-swirl-about-glaxo-bid-who-could-suitors-be", placeholder: "pd_1434950261" } ); (function(d,c,j){if(!document.getElementById(j)){var pd=d.createElement(c),s;pd.id=j;pd.src=(' '==document.location.protocol)?' ':' ';s=document.getElementsByTagName(c)[0];s.parentNode.insertBefore(pd,s);}}(document,'script','pd-embed'));

March 30, 2015 By Riley McDermid , BioSpace.com Breaking News Sr. Editor Rumors that Irish biopharma Shire Pharmaceuticals may be buying up BioMarin Pharmaceutical Inc. have several Wall Street traders closely watching both companies this week for news of a deal, a source close to the news told BioSpace exclusively, as whispers continued from last week sent BioMarin ’s share price on a rollercoaster ride from a gain of 15 percent to a now-resting price of $129.14. That news didn’t surprise one market player, who asked not to be named because a deal may not be public yet. “ BioMarin has been at the top of my take out list,” said the source. “That’s one of the reasons I initiated earlier this year. The fit with Shire seems obvious.” The saga began with a Thursday evening blog post for blog Betaville, in which Ben Harrington said Morgan Stanley and Lazard are advising Shire on a $65 billion acquisition of San Rafael, Calif.-based BioMarin . So far, both companies refused to comment, saying they don’t speculate about market rumors, and sources on both the trading and corporate side say a deal is highly possible. Mark Schoenebaum , a biotech analyst and medical doctor with ISI Evercore , said in a note earlier this spring exactly why BioMarin would be such an attractive target for any larger company looking to get a toehold in the rare disease market. “Overall, we are bullish on the following pipeline products: PEG-PAL for PKU - potential to transform quality of life of PKU patients, and neurocog endpoint offers upside; BMN 111 for achondroplasia--one of BMRN’s largest markets, no dose-limiting toxicity so far, clinically significant anthropomorphic measurements would represent upside to numbers; BMN 190 for CLN2--strong initial data from open-label study, single Phase 1/2 trial likely sufficient for approval given disease severity; Drisapersen for DMD--first-in-class is key in US, IP likely prevents eteplirsen from marketing in EU, BMRN’s global network is an advantage Ex-US,” wrote Schoenebaum in a Jan. 28 note. “Whereas we are cautiously optimistic on: BMN 673 for BRCA cancers,” he said, “preclinically best-in-class but clinical efficacy and safety have yet to be verified in larger trials.” BioMarin Pharmaceutical Inc. (BMRN) ’s acquisition in late November 2014 of ProSensa Holding N.V. (RNA)for $680 million, plus up to $160 million in contingent milestones payments, is a solid deal for investors as long as ProSensa ’s drug candidates complete crucial trials, said Jeremiah Shepherd , a biotech analyst for Credit Suisse , Nov. 25. “Contingent Value Rights agreements appear achievable to us: We arrive at a premium to the offer price by probability adjusting the NPV of the anticipated CVRs by 80 percent,” wrote Shepherd in a note to investors. “We believe that both CVRs are achievable as RNA should have additional data to supplement the expected NDA and MAA filings ahead of the potential approvals.” Under the terms of the deal, BioMarin will buy all of Prosensa ’s issued and outstanding shares and all ordinary share equivalents with cash for $17.75 per share. There are then two built-in regulatory milestones that will have to be met before the Prosensa can cash in: The first for U.S. approval of drisapersen in the U.S. no later than May 15, 2016, and the second for approval in Europe no later than Feb. 15, 2017. Those milestones theoretically appear achievable, said Shepherd in his note. “Rolling NDA still on track for completion in first quarter of 2015. The final module is still expected to be submitted in the first quarter of 2015 and is likely to be evaluated under a priority review,” he said. “The CVR for U.S. accelerated approval has a deadline of May 15, 2016 which should provide sufficient breathing room to address any issues the FDA may have with the NDA filing.” Both companies look to be on track for approval from global regulators, said Shepherd, as BioMarin ’s massive size is likely to help ProSensa navigate what can sometimes be tricky international regulatory standards. “EU filing now sometime in 2015,” he said. “The MAA is now expected to be filed in 2015, which provides a broader window than previous guidance of the first quarter of 2015.” Speculation about who in Big Pharma could go shopping in 2015 is continuing to mount, after a record year for acquisitions in the biotech sector has industry players wondering if large companies like Pfizer Inc. and Actavis plc will be stepping up buying activity in the next few months. Analysts, bankers, venture capitalists and much of Wall Street is continuing to vet possible acquisition scenarios, with one of the primary topics snap-on buying, said some sources Wednesday. “The only real place they can find growth is through acquisition,” said Jeff Stute , head of health-care investment banking at JP Morgan Chase & Co. Bloomberg has reported that drugmakers saw a record $234 billion of acquisitions in 2014, three times the number completed in 2013 “2014 was clearly the year of the big deal,” Rich Jeanneret , Americas vice chair of transaction advisory services at EY in New York, told the news service. “I think that’s going to persist in 2015 because there’s much more confidence in the M&A ecosystem.” Large companies will continue to look for ways to buy snap-on targets that have existing pipelines and technologies, said market watchers, including the always-hot oncology sector, where Pfizer paid $850 million in 2014 for the rights to Merck KgaA ’s immunotherapy cancer drug. “There’s a new norm in the larger companies in the industry of outsourcing innovation,” said Kevin Starr , co-founder and partner at Boston-based Third Rock Ventures , told Bloomberg . “Oncology’s still the king of the hill and commands the broadest and deepest interest among buyers,” added Stute. The question of how to pay the least tax possible, particularly after a bruising year when American lawmakers tightened efforts to move abroad to avoid taxation, will also come into play. “Funds which have a lot of money are looking for more opportunities, and they’re going to look at the biotech and specialty pharma space,” Myles Clouston , Nasdaq ’s senior director of advisory services, told Bloomberg . The Nasdaq Biotechnology Index was up 34 percent at the end of 2014, a huge leap compared to the S&P 500 Index ’s gain of only 11 percent. It has since trimmed those gains but remains up 40.15 percent year-over-year. “We are not hearing anything that would suggest a decrease in acquirers’ M&A appetites heading into 2015,” Joe Rosenberg , a Nasdaq biotech and health-care specialist, told Bloomberg . The billion dollar question of the moment appears to be whether Pfizer Inc. will take another run at acquiring Chicago-based AbbVie now that it’s “cooling off” period has ended. Ever since Pfizer ’s May 2014 bid worth $119 billion for British company AstraZeneca PLC fell apart, rumors have swirled over a possible replacement target. Pfizer ’s interest in AstraZeneca was at least partly due to its tax domicile in the U.K., which would have cut Pfizer ’s tax load. But changes in U.S. tax policy regarding so-called “tax inversion deals” have made these types of acquisitions less worthwhile. In October Pfizer announced a stock repurchase plan of $11 billion in conjunction with a previous $1.3 billion share repurchase program. Analysts suggested that this was an attempt to strengthen the company’s stock value. Pfizer also has a number of patents ending, which will make the company more vulnerable to inexpensive generics. Other possible acquisition targets for Pfizer have been UK-based GlaxoSmithKline , Dublin-based Actavis plc and New York-based Bristol-Myers Squibb Company . Bristol-Myers is valued at $81 billion. Neither a Bristol-Myers or AbbVie deal would offer Pfizer any tax-inversion benefits, with primary headquarters in the U.S. A deal with Bristol-Myers Squibb would help Pfizer in the oncology market, in which the company has expressed interest. AbbVie ’s strongest product is the rheumatoid arthritis medication Humira, with sales projected to rise by 20 percent by 2020. AbbVie has also recently received promising news for its hepatitis C virus treatment, VIEKIRAX + EXVIERA. The compound was granted positive opinions by the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) . A final decision is expected in the first quarter of this year. AbbVie also had plans for acquiring Dublin-based Shire PLC for $54 billion, but killed the deal after the U.S. Treasury Department changed its tax-inversion regulations. Analysts have speculated that potential alternate targets could include Cubist Pharmaceuticals, Inc. and NPS Pharmaceuticals, Inc. . Shire acquired a $1.64 billion break-up fee from AbbVie and recently arranged a $2.1 billion loan facility. Analysts have speculated that Shire may also be interested in Bedminster, N.J.-based NPS Pharmaceuticals, Inc. Shire focuses on neuroscience, rare diseases, GI and internal medicine. They are best known for ADHD medications and ulcerative colitis drugs.