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News Breaks
February 1, 2014
16:51 EDTABBV, LLYFDA probes risk of cardiovascular events from testosterone product use
FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. The FDA said, "We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. FDA is providing this alert while it continues to evaluate the information from these studies and other available data. FDA will communicate final conclusions and recommendations when the evaluation is complete." The Fly notes that products in this category include AndroGel from AbbVie (ABBV) and Axiron from Eli Lilly (LLY). Reference Link
News For ABBV;LLY From The Last 14 Days
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April 22, 2014
12:39 EDTLLYOn The Fly: Midday Wrap
Stocks on Wall Street were higher at midday amid a number of big deals and a much talked about proposed deal in the pharmaceutical industry, as well as another wave of earnings reports. The market opened quietly but on the positive side of the ledger as investors pored over the multitude of quarterly reports issued after the close last night and earlier today. Near noon the market stood near its session highs and is pointing toward its sixth consecutive positive close. ECONOMIC EVENTS: In the U.S., existing home sales slipped 0.2% to a 4.59M rate in March, versus expectation for them to have fallen 1% to a 4.56M rate. The Richmond Fed manufacturing survey for April had a reading of 7, beating the consensus forecast for a reading of 2. COMPANY NEWS: Valeant Pharmaceuticals (VRX) teamed with Bill Ackman's hedge fund Pershing Square to make a hostile takeover offer for Allergan (AGN), sending shares of both companies higher. Allergan confirmed it received the offer of $48.30 in cash and 0.83 shares of Valeant stock for each of its own shares, which it said it will evaluate with the help of its advisers. Analysts' opinion on the fallout varied, with one firm suggesting Allergan could pursue its own takeover of Shire (SHPG) or Jazz Pharmaceuticals (JAZZ) as a defense, and another saying a rival big pharma company, such as Johnson & Johnson (JNJ) or Merck (MRK), could launch a competing bid for Allergan. Shares of Allergan led all gainers on the S&P 500, rising 16%, while Valeant shares gained more than 6%... A number of other big drug makers made news with a string of deals, as Novartis (NVS) and GlaxoSmithKline (GSK) both reshaped their companies via a trio of agreements. Novartis will acquire GSK's oncology products for a $14.5B payment and up to $1.5B contingent future payments, Novartis will sells its Vaccines business, excluding flu, to GSK for $7.1B plus royalties, and the two agreed to tie-up their consumer healthcare businesses through a joint venture. In a separate transaction, Novartis agreed to divest its Animal Health Division to Eli Lilly (LLY) for about $5.4B. MAJOR MOVERS: Among the notable gainers following their earnings reports were streaming video service Netflix (NFLX), which advanced almost 6%, and motorcycle maker Harley-Davidson (HOG), which rose 8%. Companies that slid following their earnings reports included printer maker Lexmark (LXK), which fell over 11%, and Pentair (PNR), which dropped almost 6%. INDEXES: Near midday, the Dow was up 106.77, or 0.65%, to 16,556.02, the Nasdaq was up 45.95, or 1.11%, to 4,167.50, and the S&P 500 was up 11.59, or 0.62%, to 1,883.48.
10:36 EDTLLYEli Lilly sees Novartis deal as accretive on a cash basis by 2016
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08:56 EDTABBVEnanta announces ABT-450 NDA submission
Enanta (ENTA) announced that AbbVie (ABBV), Enanta’s collaboration partner for ABT-450, has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for an investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 hepatitis C virus infection. The three direct-acting antiviral regimen consists of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333. ABT-450 is the lead protease inhibitor developed through Enanta’s collaboration with AbbVie. The U.S. NDA filing triggers a $20M milestone payment to Enanta from AbbVie. AbbVie also plans to submit applications for regulatory approval of its regimen in the European Union in early May. Enanta is entitled to receive an additional $20M upon the first regulatory filing in the European Union for a regimen containing a collaboration compound.
08:49 EDTABBVAbbVie submits NDA to FDA for GT1 hepatitis C virus infection
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07:11 EDTLLYEli Lilly to host conference call
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05:38 EDTLLYEli Lilly acquires Novartis Animal Health for $5.4B in all-cash transaction
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05:35 EDTLLYNovartis says transactions 'represent a transformation' for the company
The elements of the transaction with GSK (GSK) are inter-conditional and subject to approval by GSK shareholders. The Novartis (NVS) board unanimously believes that the transactions with GSK and the transaction with Lilly (LLY) are in the best interests of Novartis and the Novartis Shareholders as a whole. The transaction with Lilly is expected to close by the end of 1Q15 and the transaction with GSK is expected to close during the first half of 2015. The terms of the divestment of the Vaccines business would maximize the value of its pipeline, including Bexsero. The divestment of Animal Health would recognize the full value of the business. The transactions are expected to improve Novartis' sales and core operating income growth rates, while improving margins. Each of the transactions is projected to be value creating. The company commented, "These transactions represent a transformation for Novartis. We have leading positions in our core businesses in high-growth segments of healthcare. This will enable us to continue to build the world's most respected and successful healthcare company. Our strategic focus on science-based innovation and our global scale position the company well to meet the changes in the healthcare industry for the coming decade and beyond."
05:29 EDTLLYNovartis divests Animal Health Division to Eli Lilly for about $5.4B
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05:10 EDTLLYEli Lilly announces FDA approval of Cyramza
Eli Lilly announced that the FDA has approved Cyramza as a single-agent treatment for patients with advanced or metastatic gastric cancer or gastroesophageal junction, or GEJ, adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. With this approval, CYRAMZA becomes the first FDA-approved treatment for patients in this setting.
April 21, 2014
16:16 EDTLLYEli Lilly's Cyramza gets FDA approval
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April 15, 2014
09:22 EDTABBVAbbVie initiates Phase III clinical trial of veliparib in lung cancer
AbbVie announced the initiation of a global Phase III clinical trial evaluating the safety and efficacy of its investigational compound, veliparib or ABT-888, in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer. The trial will compare patients randomized to receive either the standard chemotherapies of carboplatin and paclitaxel with the addition of veliparib, versus patients receiving carboplatin and paclitaxel with the addition of placebo. The trial will recruit approximately 900 patients.
06:32 EDTLLYPatients paying much more for specialty drugs, NY Times says
The amount that patients with certain diseases must pay for specialty drugs has increased significantly, a research firm reported, according to The New York Times. Meanwhile, consumers' use of health care increased in 2013 for the firm time in three years, the newspaper quoted the firm, the IMS Institute for Healthcare Informatics, as saying. Publicly traded drug makers include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Publicly traded health insurers include AMERIGROUP (AGP), Aetna (AET), Centene (CNC), Cigna (CI), Health Net (HNT), Healthspring (HS), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH), WellCare (WCG) and WellPoint (WLP).Reference Link
April 14, 2014
17:31 EDTABBVAbbVie stock could reach $55, Barron's says
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10:02 EDTLLYOn The Fly: Analyst Upgrade Summary
Acorda Therapeutics (ACOR) upgraded to Outperform from Market Perform at FBR Capital... Allegheny Technologies (ATI) upgraded to Neutral from Underperform at Sterne Agee... BP (BP) upgraded to Buy from Hold at Canaccord... Bloomin' Brands (BLMN) upgraded to Buy from Hold at Deutsche Bank... Boardwalk Pipeline (BWP) upgraded to Neutral from Underperform at BofA/Merrill... Boston Scientific (BSX) upgraded at BofA/Merrill... Charles Schwab (SCHW) upgraded to Buy from Neutral at UBS... Citigroup (C) upgraded to Hold from Sell at Rafferty Capital... Community Health (CYH) upgraded to Outperform from Perform at Oppenheimer... Eaton Vance (EV) upgraded to Neutral from Sell at Citigroup... Eli Lilly (LLY) upgraded to Hold from Underperform at Jefferies... F5 Networks (FFIV) upgraded to Buy from Hold at Stifel... HeartWare (HTWR) upgraded to Buy from Neutral at BTIG... Heartland Payment (HPY) upgraded to Hold from Sell at Stifel... Hyatt Hotels (H) upgraded to Outperform from Market Perform at FBR Capital... MasterCard (MA) upgraded to Outperform from Neutral at RW Baird... McDermott (MDR) upgraded to Neutral from Underweight at HSBC... Palo Alto (PANW) upgraded to Overweight at Stephens... PetroChina (PTR) upgraded to Neutral from Underperform at Credit Suisse... Seagate (STX) upgraded to Buy from Hold at Argus... Sensata (ST) upgraded to Buy from Neutral at Citigroup... Stryker (SYK) upgraded to Neutral from Reduce at SunTrust... TD Ameritrade (AMTD) upgraded to Buy from Neutral at UBS... TTM Technologies (TTMI) upgraded to Buy from Hold at Stifel... Transocean (RIG) upgraded to Hold from Sell at Deutsche Bank... VMware (VMW) upgraded to Outperform from Underperform at CLSA... Visa (V) upgraded to Outperform from Neutral at RW Baird... Yahoo (YHOO) upgraded to Buy from Neutral at SunTrust... Zimmer (ZMH) upgraded to Neutral from Reduce at SunTrust... bebe stores (BEBE) upgraded to Buy from Neutral at Janney Capital.
09:04 EDTLLYEli Lilly and Boehringer Ingelheim's NDA accepted by FDA
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07:45 EDTABBVAbbVie defended at BMO Capital
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05:57 EDTLLYEli Lilly upgraded to Hold from Underperform at Jefferies
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April 12, 2014
19:23 EDTABBVEnanta reports detailed results from Turquoise ll study
Enanta Pharmaceuticals (ENTA) announced that detailed results from AbbVie’s (ABBV) pivotal phase 3 TURQUOISE-II study, will be presented as a late-breaking oral presentation at the International Liver Congress, ILC, which is the 49th Annual Meeting of the European Association for the Study of the Liver, EASL. Results from the TURQUOISE-II study were featured in the ILC press conference and were published on-line in the New England Journal of Medicine. The TURQUOISE-II study reports results from AbbVie’s investigational three direct-acting antiviral regimen containing ABT-450, Enanta’s lead protease inhibitor discovered through Enanta’s collaboration with AbbVie. The regimen consists of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333. TURQUOISE-II is a global, multi-center, randomized, open-label study evaluating the efficacy and safety of 12 weeks or 24 weeks of treatment with AbbVie's three direct-acting antiviral regimen with ribavirin, RBV, in adult patients with genotype 1, GT1, chronic hepatitis C virus, HCV, infection with compensated liver cirrhosis. Patients achieved sustained virologic response rates 12 weeks post-treatment, SVR12, of 91.8% and 95.9% in the 12-week and 24-week treatment arms, respectively. Patients in the study were either new to therapy or treatment-experienced, failed previous treatment with pegylated interferon and RBV.
April 11, 2014
05:27 EDTABBVEnanta announces results for partner AbbVie's HCV studies
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05:24 EDTABBVAbbVie announces 96% sustained virologic response rates in HCV study
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