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Yesterday, 3:26 PM
- Supernus Pharmaceuticals (SUPN +19.5%) heads north on more than triple normal volume in response to the news of a favorable court ruling in a patent infringement case against Actavis [now Allergan (AGN +0.5%)] involving Supernus' epilepsy drug Oxtellar XR (oxcarbazepine) extended-release tablets.
- The court ruled in favor of Supernus on two patents ('898 and '131), but favored Actavis on a third ('600).
- The company sued Actavis in August 2013.
Wed, Feb. 3, 4:35 AM
- Pfizer (NYSE:PFE) is insisting that its $160B takeover of Allergan (NYSE:AGN) will not be thwarted by political opposition, amid criticism that the so called tax-inversion would cost the U.S. Treasury billions of dollars in future revenues.
- "Under current law, I do not believe there is any reason why the deal will not close - full stop," Pfizer CEO Ian Read declared.
- He also reiterated a plan to delay until 2018 a decision on whether to break the enlarged Pfizer-Allergan into two or three smaller companies, but said he would be open to offers for its generics business.
Fri, Jan. 29, 7:51 AM
- The FDA designates Allergan's (NYSE:AGN) Fast Track-tagged rapastinel (GLYX-13) a Breakthrough Therapy for the treatment of major depressive disorder (MDD).
- Phase 3-stage rapastinel is an intravenously administered inhibitor of N-methyl-D-aspartate ((NMDA)) receptor, an ion channel protein found in nerve cells. In a mid-stage study, a single dose produced antidepressant efficacy after one day in MDD patients who had not responded to other medications.
- The company intends to initiate a series of Phase 3 studies this year.
- About 16M Americans live with MDD. As many as 70% fail to respond adequately to first-line therapies.
- Breakthrough Therapy status provides for more intensive guidance from the FDA review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
Fri, Jan. 29, 7:34 AM
- Allergan plc (NYSE:AGN) and AstraZeneca (NYSE:AZN) ink a global agreement to develop and commercialize ATM-AVI, an investigational fixed-dosed combination antibiotic, aztreonam and avibactam, for the treatment of serious infections caused by metallo-beta-lactamase (MBL)-producing Gram-negative bacteria, a difficult-to-treat subtype of carbapenem-resistant Enterobacteriaceae for which there are limited treatment options.
- Under the terms of the agreement, Allergan owns commercialization rights in the U.S. and Canada and AstraZeneca owns commercialization rights elsewhere.
- ATM-AVI is the first drug candidate developed under a September 2015 public-private partnership between AZN and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response. The aim of the alliance is to develop drugs to treat illnesses caused by bioterrorism agents and antibiotic-resistant infections.
Fri, Jan. 22, 9:03 AM
- The FDA approves Allergan's (NYSE:AGN) BOTOX (onabotulinumtoxinA) for the treatment of adults with lower limb spasticity (LLS) to decrease the severity of increased muscle stiffness in ankle and toe muscles. It was cleared for the treatment of upper limb spasticity in March 2010.
- Spasticity, affecting ~1M Americans, is characterized by an abnormal increase in muscle tone or stiffness that may interfere with movement. The discomforting condition is typically caused by brain or spinal cord injury but may also be caused by stroke, cerebral palsy, multiple sclerosis, physical trauma or infection.
- In clinical LLS studies, treatment with BOTOX showed statistically significant improvements in two measurements: the Modified Ashworth Scale ankle score and the Clinical Global Impression of Change by Physician scale. The safety profile was consistent with the known profile of BOTOX.
Thu, Jan. 21, 10:40 AM
- The FDA approves an expanded label for Allergan's (AGN +1%) antibiotic DALVANCE (dalbavancin) that allows for a single 30-minute 1500 mg IV infusion for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by Gram-positive bacteria. It is the only IV antibiotic cleared to be administered this way. The original dosing regimen specifies two doses: 1000 mg followed by 500 mg a week later.
- DALVANCE was first approved in the U.S. in May 2014.
Dec. 22, 2015, 6:41 PM
- Celgene (NASDAQ:CELG) is up 6.9% after hours following a patent settlement concerning its top-selling drug, Revlimid.
- The drugmaker's deal with India's Natco Pharma and its U.S. partner Arrow International (part of AGN) means Natco and Arrow get a license to make an unlimited quantity of generic Revlimid starting Jan. 31, 2026 -- more than a year before patents on the drug expire (April 2027).
- Natco will also get a limited license to sell the multiple myeloma drug -- which made up 63% of Celgene's $2.3B in revenues last quarter -- in the U.S. starting March 2022.
- Jefferies on the deal: "Though this represents a compromise, overall we view the settlement as a positive, removing a major overhang on shares and enabling a clearer road towards lower-risk long-term growth."
Dec. 14, 2015, 10:44 AM
- Allergan (AGN +0.1%) announces that its VIBERZI (eluxadoline) is now available by prescription in the U.S. for the treatment of patients with irritable bowel syndrome with diarrhea. It was cleared by the FDA in May.
- The U.S. DEA completed its review of the drug and classified it as Schedule IV (low potential for abuse and low risk of dependence).
- Eluxadoline is a combination of mu opioid receptor agonist and delta opioid receptor agonist. It is designed to treat the symptoms of IBS while reducing the incidence of constipation that can occur with unopposed mu opioid receptor agonists. Allergan (Actavis) acquired the rights to eluxadoline on the basis of subsidiary Forest Laboratories' acquisition of Furiex Pharmaceuticals.
- Previously: Ironwood Pharma to co-promote VIBERZI with Allergan in U.S. (Aug. 5)
Dec. 3, 2015, 11:53 AM
- According to sources close to the matter, Teva Pharmaceutical Industries (TEVA +2.2%) is currently divesting $1B in assets in order to address antitrust concerns related to its intended $40.5B acquisition of Allergan's (AGN -0.2%) generics business, Actavis Generics. The move will help ensure that the deal goes through in Q1 as planned.
- Previously: Teva to buy Allergan Generics for $40.5B (July 27)
Dec. 3, 2015, 6:48 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) prices its public offering of 54M American Depositary Shares (ADSs), each representing one ordinary share, at $62.50 per ADS. It also prices its public offering of 3.375M 7.00% Mandatory Convertible Preferred Shares at $1,000 per share, each automatically converting to between 13.3333 and 16.0000 ADSs on December 15, 2018.
- Net proceeds of ~$3.29B each will help fund the cash portion of its previously announced acquisition of Allergan's (NYSE:AGN) generics business (Actavis Generics).
- Previously: Teva initiates equity offering in connection with Actavis Generics transaction (Nov. 30)
Nov. 30, 2015, 11:58 AM
- A Phase 2 clinical trial assessing Ironwood Pharmaceuticals' (IRWD -0.2%) linaclotide in adults with opioid-induced constipation (OIC) met its primary endpoint. The 254-subject, randomized, double-blind, placebo-controlled study was jointly conducted with a subsidiary of Allergan (AGN -1.9%), the company's co-development and co-commercialization partner in the U.S.
- Linaclotide-treated patients demonstrated a statistically significant improvement from baseline to week 8 in Spontaneous Bowel Movement (SBM) frequency rate for both doses evaluated (145 mcg and 290 mcg) compared to placebo.
- Ironwood and Allergan will make a decision on the advancement of the OIC program after they review the results from the linaclotide colonic release Phase 2b study in adults with IBS-C (irritable bowel syndrome with constipation), expected in H2 2016, and a complete analysis of the commercial opportunities (sounds like Allergan is going to bail). Linaclostide, branded as LINZESS in the U.S. and CONSTELLA in the EU, is currently cleared in the U.S. for the treatment of adults with IBS-C or CIC (chronic ideopathic constipation). LINZESS generated $117.5M in U.S. sales in Q3 (+47% yoy), with Ironwood's share coming in at $39.6M.
Nov. 30, 2015, 10:10 AM
- Teva Pharmaceutical Industries (TEVA -2.2%) commences concurrent offerings of $3.375B of American Depositary Shares (ADSs), each representing on Teva ordinary share, and $3.375B of Mandatory Convertible Preferred Shares. Final amounts of the securities will be determined based on market (and other) conditions. Terms of the convertibles are not disclosed.
- Net proceeds will help fund its previously announced $40.5B acquisition of Allergan's (AGN -1.7%) generics business.
Nov. 25, 2015, 8:40 AM
- Allergan (NYSE:AGN) and start-up Rugen Therapeutics enter into an exclusive collaboration to discover and develop novel therapies for Autism Spectrum Disorders and Obsessive Compulsive Disorders, focusing on small molecule candidates.
- Under the terms of the agreement, Rugen will receive an upfront payment and milestones. Allergan will have the exclusive option to acquire all rights, including global IP, to the compounds following clinical proof-of-concept studies. Specific financial terms are not disclosed.
Nov. 24, 2015, 4:58 AM
- U.S. politicians are heavily condemning Pfizer's (NYSE:PFE) deal with Allergan (NYSE:AGN) as a tax dodge, surfacing another round of corporate tax concerns in Washington, though legislative action before 2017 is unlikely.
- Prime Democratic nominee Hillary Clinton accused the company of avoiding its "fair share" of taxes that "will leave U.S. taxpayers holding the bag," while Republican front-runner Donald Trump called the deal "disgusting" and said "our politicians should be ashamed."
- The $160B transaction will move Pfizer's tax address from the U.S. to Ireland, marking the largest inversion deal of all time.
- Previously: Pfizer and Allergan agree to merge (Nov. 23 2015)
Nov. 23, 2015, 2:47 PM
- Goldman Sachs' Hedge Fund VIP list of the 50 most-heavily-owned stocks have trailed the S&P 500 by about 500 basis points (down 2% vs. the S&P's 3% gain) year-to-date, including 720 basis points of underperformance since the start of October (down about 8% vs. down about 1%).
- Call it the Valeant effect: Health-care stocks have accounted for about 70% of the year-to-date 2% decline.
- Based on the most recent filing, hedge funds are bailing on some of their poorer performers, including Valeant (NYSE:VRX), HCA Holdings (NYSE:HCA), Endo (NASDAQ:ENDP), Ally Financial (NYSE:ALLY), and NorthStar Realty (NYSE:NRF), and have instead placed bets on Baidu (NASDAQ:BIDU), Mylan (NASDAQ:MYL), MGM Resorts (NYSE:MGM), and GE.
- After the shakeup, the top five hedge fund hotels: Allergan (NYSE:AGN), Facebook (NASDAQ:FB), Alphabet (GOOG, GOOGL), Time Warner Cable (NYSE:TWC), and Amazon (NASDAQ:AMZN).
Nov. 23, 2015, 7:48 AM
- It's official. Pfizer (NYSE:PFE) and Allergan (NYSE:AGN) agree to merge in a $160B deal, the largest inversion transaction on record. AGN shareholders will receive 11.3 shares of the combined company for each AGN share while PFE shareholders will receive one share of the combined firm for each PFE share. The deal should close in H2 2016. After the merger, the company will do business as "Pfizer plc" and trade under the "PFE" symbol. It will be domiciled in Ireland (pro forma adjusted effective tax rate expected to be 17 - 18%).
- Pfizer shareholders will own ~56% of the combined firm while Allergan shareholders will own ~44%. Pfizer chief Ian Read will be Chairman & CEO while Allergan chief Brent Saunders will be President & COO.
- The merger should be neutral to Pfizer's non-GAAP EPS in 2017, accretive in 2018, more than 10% accretive in 2019 and accretive in the high teens in 2020. Operating cash flow should exceed $25B beginning in 2018.
- The company will make a decision on splitting its innovative and established businesses no later than the end of 2018.
- Separately, Pfizer will execute a $5B share repurchase program in H1 2016. It has ~$5.4B remaining on its previously announced buyback plan.
- Pfizer will host a conference call this morning at 8:30 am ET to discuss the transaction.
- Slide presentation
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