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June 16, 2014
07:33 EDTBIIB, ABBVBiogen, AbbVie announce results from Phase 3 DECIDE clinical trial
Biogen (BIIB) and AbbVie (ABBV) announced positive top-line results from the Phase 3 DECIDE clinical trial, designed to evaluate the superiority of once-monthly, subcutaneous daclizumab high-yield process when compared to intramuscular interferon beta-1a as a potential treatment for relapsing-remitting multiple sclerosis. Results showed that DAC HYP was superior on the study’s primary endpoint, demonstrating a statistically significant 45% reduction in annualized relapse rate compared to IFN beta-1a. AbbVie Chief Scientific Officer Michael Severino said, "The positive results in the DECIDE study represent achievement of an important milestone in the development of DAC HYP as a potential new treatment option for MS patients. Together, the companies are committed to working with regulatory agencies on filing plans for DAC HYP.” Biogen Idec and AbbVie plan to work with regulatory agencies to determine appropriate timelines for filing.
News For BIIB;ABBV From The Last 14 Days
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September 15, 2014
08:01 EDTBIIBAlnylam names Karen Anderson as SVP, Chief Human Resources Officer
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September 12, 2014
07:32 EDTBIIB, ABBVBiogen, AbbVie announce ZINBRYTA DECIDE Phase 3 study results
Biogen (BIIB) and AbbVie (ABBV) announced the full results from the Phase 3 DECIDE clinical trial, which show ZINBRYTA, dosed subcutaneously once a month, demonstrated a statistically significant improvement in reducing disease activity in people with relapsing-remitting multiple sclerosis compared to AVONEX. These results are being presented at the Sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis. Patients on ZINBRYTA demonstrated a statistically significant 45% reduction in annualized relapse rate compared to patients treated with AVONEX. Based on the efficacy and safety data from the ZINBRYTA clinical development program, Biogen Idec and AbbVie plan to file marketing applications for ZINBRYTA with regulatory authorities during 1H15.
September 11, 2014
07:31 EDTBIIBBiogen announces 5-year results from TECFIDERA ENDORSE Phase 3 study
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07:31 EDTBIIBBiogen announces new data from Plegridy Phase 3 ADVANCE trial
Biogen Idec announced new data from the second year of its Phase 3 ADVANCE clinical trial that show the positive treatment effects of PLEGRIDY were maintained in people with relapsing forms of multiple sclerosis beyond the first year of the study. These results were presented at the sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis in Boston. Post-hoc analyses from the two-year, Phase 3 ADVANCE clinical trial confirm that PLEGRIDY’s positive effects on reducing disease activity and disability progression were maintained in year two of the study. A significantly higher proportion of patients taking PLEGRIDY during both years of the study experienced no evidence of disease activity – defined as the absence of clinical and MRI disease activity over two years of treatment – compared to those who switched to PLEGRIDY from placebo. Also, those treated with PLEGRIDY for both years of the study had significant reductions in the risk of 24-week confirmed disability progression compared to patients treated with placebo during the first year. In addition, new data from the second year of ADVANCE show that patients who took PLEGRIDY throughout the study experienced statistically significant improvements in clinical and MRI outcomes – including annualized relapse rate, risk of relapse, risk of 24-week confirmed disability progression, and number of brain lesions – when compared to those who switched to PLEGRIDY after taking placebo for the first year. This new data also showed that the safety profile of PLEGRIDY was consistent between years one and two of the study.
05:34 EDTABBVAbbVie reports Humira Phase 3 trial meets primary endpoint
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September 10, 2014
10:24 EDTABBVEnanta announces AbbVie initiated Phase 2b trial with ABT-493
Enanta (ENTA) announced that AbbVie (ABBV) initiated a phase 2b clinical study with ABT-493, Enanta’s next-generation protease inhibitor. ABT-493 is the second clinical-stage protease inhibitor candidate developed within the Enanta-AbbVie collaboration. The phase 2b study being conducted by AbbVie will evaluate the safety and efficacy of ABT-493 co-administered with ABT-530 in HCV patients. AbbVie has informed Enanta that results from this trial are expected in 2015 and AbbVie plans to start phase 3 development of the combination next year.
September 8, 2014
12:40 EDTABBVFTC sues AbbVie over blocking of AndroGel generics
The Federal Trade Commission has filed a complaint in federal district court charging several pharmaceutical companies with "illegally blocking American consumers’ access to lower-cost versions of the blockbuster drug AndroGel." The FTC's complaint alleges that AbbVie (ABBV) and its partner Besins Healthcare filed baseless patent infringement lawsuits against potential generic competitors to delay the introduction of lower-priced versions of the testosterone replacement drug AndroGel. While the lawsuits were pending, AbbVie then entered into an anticompetitive pay-for-delay settlement agreement with Teva Pharmaceuticals (TEVA) to further delay generic drug competition, the FTC claims. Reference Link
09:27 EDTBIIBLeerink biotech analyst holds a luncheon meeting with a conference call
Biotech Analyst Schwartz provides an update on key trends and controversies for marketed MS therapies and discusses new data presented at ACTRIMS-ECTRIMS at a Luncheon Meeting with an Analyst/Industry conference call to be held in Boston on September 11 at 12:15 pm.
07:15 EDTBIIB, ABBVIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.
September 4, 2014
08:52 EDTABBVInfinity Pharmaceuticals upgraded at JMP Securities
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07:38 EDTABBVInfinity Pharmaceuticals price target raised to $21-$25 from $17-$20 at Wells Fargo
Wells Fargo increased its price target on Infinity (INFY) after the company announced a global development and commercialization oncology agreement with AbbVie (ABBV) for duvelisib. The firm thinks the financial terms of the deal are favorably for Infinity, and significantly lower the risk presented by Infinity's stock. It raised its estimate of the drug's chances of success to 75% from 65% and keeps an Outperform rating on Infinity.
September 3, 2014
16:20 EDTABBVOn The Fly: Closing Wrap
Stocks on Wall Street began the session in positive territory after Russian President Vladimir Putin said he had an outline for a cease-fire plan for eastern Ukraine and was closing in an agreement. The averages hit their highs shortly after the open and the Nasdaq was the first index to cross into negative territory as it was weighed down by Apple's (AAPL) decline. The market moved in a narrow range as investors anticipated the Fed’s Beige Book report, scheduled for release mid-afternoon. The report was fairly benign and the market limped into the close, with volume remaining light. ECONOMIC EVENTS: U.S. factory orders rose 10.5% in July, which was a bit below the forecast for 11.0% growth. The Fed's Beige Book stated that the pace of growth did not change significantly in any of the central bank's 12 regions during a six week period ended in August compared with the previous six week period. COMPANY NEWS: Shares of Apple retreated $4.36, or 4.22%, to $98.94 after research firm Pacific Crest advised investors to take some profits in the stock. Analyst Andy Hargreaves forecast the percentage of new iPhone users who buy the next version of the device beyond the iPhone 6 is likely to decline versus prior cycles. The stock likely has only limited room to increase, according to Hargreaves, who said he would probably downgrade Apple unless new products that can generate billions of dollars in new operating profit are launched at its September 9 event. MAJOR MOVERS: Among the notable gainers was Infinity Pharmaceuticals (INFI), which surged $4.81, or 44.05%, to $15.73 after the company announced a cancer drug collaboration with AbbVie (ABBV) and a master clinical supply agreement with Roche (RHHBY). Also higher was Mobileye (MBLY), which jumped $3.94, or 9.16%, to $46.97 ahead of its second quarter earnings report, which is due tomorrow morning. Among the noteworthy losers was Repros Therapeutics (RPRX), which fell $4.11, or 18.55%, to $18.05 after FDA briefing documents ahead of a panel on T-normalizing therapies prompted Piper Jaffray to downgrade the stock to Neutral from Overweight. Also lower after its earnings report was apparel company Vince Holding (VNCE), which fell $4.47, or 11.54%, to $34.27. Analysts at Piper Jaffray attributed the post-earnings weakness to investor concerns over heightened inventory levels, but the firm said it still sees Vince as one of the best small cap growth names in its space and would be "aggressive buyers" on the weakness. INDEXES: The Dow edged up 10.72, or 0.06%, to 17,078.28, the Nasdaq fell 25.62, or 0.56%, to 4,572.56, and the S&P 500 slipped 1.56, or 0.08%, to 2,000.72.
16:09 EDTABBVAbbVie backs Q3 adjusted EPS view 77c-79c, consensus 77c
16:09 EDTABBVAbbVie confirms FY14 adjusted EPS view $3.06-$3.16, consensus $3.16
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13:02 EDTABBVAbbVie, Calico announce collaboration
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12:33 EDTABBVOn The Fly: Midday Wrap
Stocks on Wall Street were higher to begin the day, as reports spurred optimism that a ceasefire agreement between Russia and the Ukraine may soon be reached. The move was short lived, as the averages turned mixed during the second hour of trading. Shares of Apple (AAPL) are weighing down the Nasdaq after an analyst recommended investors take some profits in the stock. ECONOMIC EVENTS: In the U.S., factory orders rose 10.5% in July, which was a bit below the forecast for 11.0% growth. The Fed's Beige Book is scheduled to be released at 2:00 pm ET. In Europe, the final reading of Eurozone services PMI was knocked down to 53.1 from a preliminary 53.5 reading, mirroring the lowering of the Eurozone manufacturing PMI reading yesterday. COMPANY NEWS: Shares of Apple retreated 4% after research firm Pacific Crest advised investors to take some profits in the stock. Pacific Crest analyst Andy Hargreaves forecast the percentage of new iPhone users who buy the next version of the device beyond the iPhone 6 is likely to decline versus prior cycles. The stock likely has only limited room to increase, according to Hargreaves, who said he would probably downgrade Apple unless new products that can generate billions of dollars in new operating profit are launched at its September 9 event... Carmakers reported on August vehicle sales in the U.S., with Chrysler (FIATY) reporting a 20% increase, Ford stating that sales rose slightly compared to the prior year and General Motors (GM) posting a 1.2% decline in sales. MAJOR MOVERS: Among the notable gainers was Infinity Pharmaceuticals (INFI), which jumped 46% after the company announced a cancer drug collaboration with AbbVie (ABBV) and a master clinical supply agreement with Roche (RHHBY). Also higher was Mobileye (MBLY), which gained nearly 10% after Morgan Stanley wrote that the stock could rise "towards $100" if the company maintains its current market, gross margins and earnings position. Mobileye is scheduled to report on its second quarter results tomorrow morning, which will be its first quarterly report since its August IPO. Among the noteworthy losers was Repros Therapeutics (RPRX), which dropped 15% after newly posted FDA briefing documents regarding a panel on T-normalizing therapies prompted Piper Jaffray to downgrade the stock to Neutral from Overweight. Also lower following its earnings report was apparel company Vince Holding (VNCE), which fell 11%. INDEXES: Near midday, the Dow was up 33.71, or 0.2%, to 17,101.27, the Nasdaq was down 23.24, or 0.51%, to 4,574.95, and the S&P 500 was down 0.64, or 0.03%, to 2,001.64.
09:15 EDTABBVOn The Fly: Pre-market Movers
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07:59 EDTABBVInfinity Pharmaceuticals to host conference call
Conference call to discuss the strategic collaboration with AbbVie Inc to develop and commercialize duvelisib will be held on September 3 at 8:30 am. Webcast Link
06:48 EDTABBVInfinity, AbbVie announce global strategic collaboration to develop duvelisib
Infinity Pharmaceuticals (INFI) and AbbVie (ABBV) announced that they have entered into a global collaboration to develop and commercialize duvelisib, Infinity’s oral inhibitor of phosphoinositide-3-kinase-delta and PI3K-gamma, for the treatment of patients with cancer. Duvelisib has shown clinical activity across a broad range of blood cancers, including indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia. Infinity is conducting registration-focused trials evaluating the safety and efficacy of duvelisib, including DYNAMOTM, a Phase 2 study in patients with iNHL, and DUOTM, a Phase 3 study in patients with CLL. Under the terms of the agreement, Infinity will receive an upfront payment of $275M and is eligible to receive up to $530M in additional payments for the achievement of development, regulatory and commercial milestones, including up to $405M for the achievement of milestones through the first commercial sale of duvelisib. In the U.S., the companies will jointly commercialize duvelisib and will share equally in any potential profits. Outside the U.S., AbbVie will be responsible for the conduct and funding of commercialization of duvelisib, and Infinity is eligible to receive tiered double-digit royalties on net product sales. Development and commercialization activities under the collaboration will be managed through a shared governance structure. In the U.S., Infinity and AbbVie will jointly commercialize duvelisib, assuming regulatory approval, with Infinity booking sales, and will share equally in any potential profits or losses. Outside the U.S., AbbVie will be responsible for conducting and funding of any commercialization of duvelisib, and Infinity is eligible to receive tiered royalties on net product sales, with percentages ranging from 23.5%-30.5%. For sales of duvelisib in the U.S., AbbVie and Infinity will share equally the existing royalty obligations to Mundipharma International Corporation Limited/Purdue Pharmaceutical Products L.P., and Infinity will be responsible for these royalty obligations outside of the U.S. Infinity will also be responsible for the existing royalty obligations to Millennium: The Takeda Oncology Company for sales of duvelisib worldwide. As part of the strategic collaboration, the companies will share responsibility for the conduct of specific trials specified within an agreed-upon global development plan, with each company leading the development of certain trials within the plan. For the initial global development plan agreed to by the companies, Infinity will fund the trials it conducts and the companies will share equally the funding of trials conducted by AbbVie. The agreement includes plans to launch multiple Phase 2 and Phase 3 studies of duvelisib in hematologic malignancies over the next several years.
06:48 EDTABBVInfinity Pharmaceuticals, AbbVie announce global strategic collaboration
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