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Sep. 24, 2015, 3:50 PM
- The U.S. Court of Appeals of the Federal Circuit upholds the ruling by the U.S. District Court for the District of New Jersey that 18 claims from four Shire (SHPG +0.5%) patents covering Vyvanse (lisdexamfetamine dimesylate) are valid. The patent claims cover the lisdexamfetamine dimesylate compound and a method of using the compound for the treatment of attention deficit hyperactivity disorder (ADHD).
- The ruling means that Shire's patents will be valid until 2023 which is, obviously, bad news to the five would-be generic competitors who filed Abbreviated New Drug Applications (ANDAs): Actavis (AGN +1.4%), Amneal Pharmaceuticals, Mylan (MYL +0.7%), Roxane Laboratories and Sandoz (NVS -0.6%).
Sep. 23, 2015, 9:32 AM
- A Phase 3 clinical trial comparing Amgen's (NASDAQ:AMGN) biosimilar candidate ABP 215 to Roche's (OTCQX:RHHBY) Avastin (bevacizumab) successfully achieved its primary endpoint of demonstrating clinical equivalence to Avastin in lung cancer patients.
- The 642-subject, randomized, double-blind, active-controlled study assessed the objective response rates of ABP 215 and bevacizumab in patients with advanced non-squamous non-small cell lung cancer receiving first-line chemotherapy with carboplatin and paclitaxel. The duration of treatment included a screening period of up to four weeks followed by up to six treatment cycles (IV infusion of 15 mg/kg every three weeks) and an end-of-treatment visit 21 days after the last dose of either ABP 215 or bevacizumab.
- ABP 215 is one of four oncology biosimilars being developed under a collaboration with Allergan (NYSE:AGN). Amgen has a total of nine biosimilars in development.
Sep. 17, 2015, 4:06 PM
- The FDA approves Allergan's (AGN -0.7%) VRAYLAR (cariprazine) for the acute treatment of adult patients with experiencing manic or mixed episodes associated with bipolar I disorder and adults with schizophrenia.
- Cariprazine, discovered by Budapest, Hungary-based Gedeon Richter and licensed to Forest Labs (then Actavis, then Allergan) in the U.S. and Canada, is a once-daily atypical antipsychotic. Its specific mechanism of action is unknown, but it acts as a partial agonist at the dopamine D3 and D2 receptors with high affinity and as an antagonist at serotonin 5-HT1A receptors.
- Bipolar disorder affects ~2.6M American adults.
Sep. 14, 2015, 11:15 AM
- With market eyes on a Fed rate-hike decision considered to be a bit of a toss-up amid differing opinions, Goldman Sachs is banking on the (slightly) more dovish position that the agency will wait until December. The bank is still laying out how to play the hike when it invariably comes.
- Strength in balance sheets is what you need, it says, noting that those companies outperform (by an average 5%) in the three months after a rate-boosting cycle begins. In Goldman's "High Quality Stock" basket: CMG, DLTR, PEP, KMI, BLK, GOOG, AAPL, PCLN, ORCL, WFC.
- Meanwhile, it suggests avoiding companies with high floating-rate debt as they bear the brunt of a move away from near-zero interest rate policy. "When the tightening cycle finally starts, the immediate impact will be felt by firms with high proportions of variable rate borrowing."
- Included in that "avoid" list: CL, COL, JNJ, AAPL, EBAY, MET, KO, GIS, F, MCD, GM, TWX, CVX, AGN, MON.
- (Yes, cash-rich Apple made both lists, having a strong balance sheet along with floating debt.)
Sep. 10, 2015, 1:05 PM
- Thinly traded ZS Pharma (ZSPH +11.7%) is up on a 5x surge in volume as traders take positions hoping for good news, like being acquired. The bullishness was stoked when the company canceled its presentation and one-on-one meetings at a Citi investor conference and has not returned calls regarding the reason.
- Bulls cite the similarity to Kythera, which canceled an appearance at a conference several months ago and announced its takeover by Allergan (AGN) shortly thereafter.
Sep. 10, 2015, 7:26 AM
- Apricus Biosciences (NASDAQ:APRI) licenses the U.S. development and commercialization rights to Vitaros from Allergan (NYSE:AGN). Under the terms of the agreement, Apricus has exclusive rights to develop and commercialize the product in the U.S. in exchange for a $1M upfront payment and a future $1.5M milestone payment.
- Upon the FDA's acceptance of the NDA, Allergan has a one-time opt-in right to take over the commercialization of Vitaros. If it elects to do so, Apricus will receive a total of $25M in upfront and milestone payments and double-digit royalties on net sales. If Allergan elects not to exercise its opt-in right, Apricus will commercialize Vitaros and pay Allergan double-digit royalties on net sales. Allergan retains the right to launch a generic version of Vitaros in the future.
- Apricus licensed the U.S. rights to Vitaros to Warner Chilcott on February 3, 2009. Actavis completed its acquisition of Warner on October 1, 2013 and its acquisition of Allergan on March 17 of this year.
- Vitaros, currently cleared in the EU and Canada, is a topical cream for the treatment of erectile dysfunction (ED). The U.S. is the largest ED market at over $3B per year. About 150M men worldwide suffer from ED.
- APRI is up 28% premarket on increased volume.
Sep. 3, 2015, 5:34 PM
- Allergan (NYSE:AGN) is acquiring AqueSys, a clinical-stage developer of ocular implants that lower intraocular pressure related to glaucoma, for $300M up-front + "regulatory approval and commercialization milestone payments related to AqueSys' lead development programs." The deal is expected to close in Q4.
- Allergan: "The acquisition of AqueSys adds XEN45, a soft shunt that is implanted in the subconjunctival space in the eye through a minimally invasive procedure with a single use, pre-loaded proprietary injector. The proprietary XEN45 technology facilitates aqueous fluid flow to lower Intra-Ocular Pressure (IOP) while protecting against the potential for hypotony (IOP that is too low) that is associated with current subconjunctival procedures."
- XEN45 has been approved for use in the EU, Turkey, Canada, and Switzerland. FDA approval is expected by late 2016 or early 2017.
Aug. 28, 2015, 11:10 AM
- There's plenty of precedent for the recent market action, says Morgan Stanley's Adam Parker, noting the market has dropped more than 5% 16 times since March 2009, and each time has moved on to new highs.
- His half-glass view is that the economy is in the middle of its longest expansion ever, and a less-active Fed, a nervous consumer maybe saving more, a lower oil price, and a flattish dollar all argue for continued expansion.
- Morgan's top ideas to buy on the pullback: AGN, AMZN, AAPL, AVGO, BAC, BKU, DAL, GILD, GOOG, GOOGL, HLT, JPM, KR, LEN, LMCK, MGA, MBLY, NWL, QCOM, SABR, CRM, SBAC, SBUX, BX, TMO, VRSK, WWAV, XL.
Aug. 14, 2015, 3:45 PM
- The U.S. District Court for the Southern District of New York rules that Actavis, the U.S. generics business of Allergan (AGN -0.4%), infringed on two Endo International (ENDP +2%) patents with its generic version of Endo's OPANA ER (oxymorphone HCl), an opioid agonist for the treatment of pain severe enough to require daily, around-the-clock treatment with an opioid.
- As a result of the ruling, Allergan's generic product will be removed from the market and planned launches from other generic drug makers will be delayed indefinitely.
- Endo filed suit against Actavis in December 2012.
Aug. 6, 2015, 10:58 AM
- Allergan (AGN -1.2%) Q2 results: Revenues: $5,755M (+115.8%); COGS: $2,130.1M (+64.3%); R&D Expense: $454.9M (+187.9%); SG&A: $1,461.2M (+160.2%); Operating Loss: ($162.9M) (-179.0%); Net Loss: ($243.1M) (-599.2%); Loss Per Share: ($0.80) (-385.7%); Quick Assets: $1,526.4M (+508.1%).
- No guidance given.
Aug. 6, 2015, 7:04 AM
- Allergan (NYSE:AGN): Q2 EPS of $4.41 beats by $0.03.
- Revenue of $5.73B (+117.0% Y/Y) beats by $20M.
Aug. 5, 2015, 5:30 PM
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Aug. 5, 2015, 10:11 AM
- Ironwood Pharmaceuticals (IRWD +1.9%) will co-promote VIBERZI (eluxadoline) in the U.S. with Allergan (AGN +1.5%) as soon as the product receives its final scheduling designation by the U.S. Drug Enforcement Administration. The FDA recommended that it be classified as a controlled substance.
- Under the terms of the agreement, Ironwood's sales force will detail VIBERZI to the same 25,000 healthcare providers that it currently details LINZESS and Cologuard. Ironwood will be compensated based on the number of calls made by the sales group as well as unspecified performance metrics. Allergan will be responsible for all other commercialization costs related to VIBERZI.
- VIBERZI is a mu-opioid receptor agonist indicated for the treatment of adult patients with irritable bowel syndrome with diarrhea (IBS-D). In a drug discrimination study, intravenous administration of eluxadoline hydrochloride produced full generalization to the morphine cue. In a self-administration study in monkeys, eluxadoline hydrochloride was self-administered to a degree less than half for heroin but greater than saline. Two human abuse studies of oral and intranasal doses of showed a rate of euphoria of 14 - 28% compared to 44 - 76% for oxycodone.
Aug. 5, 2015, 8:31 AM
- In order to complete the transaction quicker, Allergan (NYSE:AGN) and Kythera (NASDAQ:KYTH) amend their merger agreement to provide for all-cash consideration in the former's $2.1B bid for the latter. The original bid specified an 80/20 split between cash and stock. The transaction should close this quarter.
- Previously: Allergan takes out Kythera Biopharmaceuticals for $2.1B; KYTH up 22% premarket (June 17)
Jul. 28, 2015, 2:38 AM
- So what's Allergan (NYSE:AGN) doing with all that cash from the Teva deal? CEO Brent Saunders plans to use the money to increase the size of the firm's existing drug business, expand into new therapy areas and pursue larger deals.
- When asked if Allergan planned to spend the cash within 18 months, Saunders replied that he would, as long as the company could maintain its investment-grade credit rating.
- Possible targets: Biogen (NASDAQ:BIIB), AbbVie (NYSE:ABBV) and Amgen (NASDAQ:AMGN).
- Previously: Teva to buy Allergan Generics for $40.5B (Jul. 27 2015)
Jul. 27, 2015, 9:14 AM
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