Drug Pipeline Monthly Update Critical updates in an ever changing environment September 2017 New drug information ● Zerviate™ (cetirizine ophthalmic solution): The U.S. Food and Drug Administration (FDA) approved Nicox Ophthalmic’s Zerviate for the twice daily treatment of ocular itching associated with allergic conjunctivitis. ● Benznidazole Tablets: The FDA granted accelerated approval to Chemo Research’s Benznidazole Tablets for the treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi in pediatric patients 2 to 12 years of age. Prior to approval, this drug was only available through the Centers for Disease Control and Prevention. The Chemo group worked with its U.S.-based pharmaceutical division Exeltis, as well as Mundo Sano and Drugs for Neglected Diseases initiative (DNDi) to complete the New Drug Application and notes that a substantial part of any revenue derived from the future sale of the neglected tropical disease priority review voucher they received will be directed towards enhancing access to treatment for Chagas patients and improving patient health in other disease areas.1 ● Zypitamag™ (pitavastatin magnesium): Zydus Pharmaceuticals received FDA approval for Zypitamag for high cholesterol. Zypitamag is an alternate salt product of Kowa Company Ltd’s Livalo® (pitastatin calcium). ● Admelog® (insulin lispro injection): The FDA granted tentative approval for Sanofi’s Admelog for the treatment of adults and children with diabetes mellitus. Tentative approval from the FDA means that Admelog met all necessary regulatory requirements for approval in the United States, pending any patent issues yet to be resolved. ● Adzenys™ ER (amphetamine): Neos Therapeutics received FDA approval of Adzenys ER, amphetamine extended-release oral suspension for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 years and older. Adzenys ER is considered bioequivalent to Shire’s Adderall® XR. ● Trelegy™ Ellipta® (fluticasone furoate, umeclidinium and vilanterol): GlaxoSmithKline and Innoviva received FDA approval of Trelegy Ellipta, a triple drug combination inhaler for the long-term, once-daily maintenance treatment of appropriate patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Trelegy Ellipta is the first inhaler to contain the combination of three drug classes in one inhaler: an inhaled corticosteroid, an anticholinergic, and a long-acting beta2-adrenergic agonist. While the information in this newsletter is from sources we believe to be reliable, we do not warrant that the information in this document is free from error. Use it only as a guide. Statements regarding drugs or manufacturers are not intended as promotion; those statements should not be used to make assumptions about formulary status. Each trademarked drug name is the property of its respective owner. Drug Pipeline Monthly Update: September 2017 Page 2 Generic Drug Information ● Sabril® (vigabatrin): Par Pharmaceuticals launched the first generic of Lundbeck’s Sabril, an adjunctive therapy for refractory complex partial seizures and a monotherapy for pediatric patients with infantile spasms. No patents or exclusivities remain. According to IMS, Sabril had approximately $329 million in U.S. sales over the past year. ● Fosrenol® (lanthanum): Natco Pharma/Lupin pharmaceuticals launched the first generic of Shire’s Fosrenol to reduce serum phosphate in patients with end stage renal disease (ESRD). Multiple manufacturers are awaiting FDA approval of their generic tablets. According to IMS, Fosrenol had $122.4 million in U.S. sales over the past year. Drug Pipeline Monthly Update: September 2017 Page 3 New molecular entity approvals in the past 12 months Generic name Brand name Manufacturer Indication(s) Date approved* benznidazole Benznidazole Chemo Research/ Chagas disease August 2017 Tablets DNDi/Mundo Sano betrixaban Bevyxxa™ Portola Prophylaxis of venous thromboembolism July 2017 delafloxacin Baxdela™ Melinta Skin infections June 2017 naldemedine Symproic® Shionogi Pain March 2017 safinamide Xadago® Newron Parkinson’s disease March 2017 Pharmaceuticals desmopressin nasal spray Noctiva™ Allergan and Serenity Nocturnal polyuria March 2017 house dust mite sublingual Odactra™ Merck, Sharp & House dust mite allergies March 2017 allergy immunotherapy Dohme plecanatide Trulance™ Synergy Chronic idiopathic constipation January 2017 crisaborole Eucrisa™ Pfizer/Anacor Mild to moderate atopic dermatitis December 2016 prasterone Intrarosa® Endoceutics Inc Pain during intercourse November 2016 *Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer. Drug Pipeline Monthly Update: September 2017 Page 4 Other new product approvals in the past twelve months Generic name Brand name Manufacturer Indication(s) Date approved* fluticasone furoate, Trelegy™ Ellipta® GSK/Innoviva COPD September 2017 umeclidinium, vilanterol amphetamine extended release Adzenys™ ER Neos Therapeutics ADHD September 2017 suspension insulin lispro Admelog® Sanofi Diabetes August 2017 lesinurad/allopurinol Duzallo™ Ironwood Uncontrolled gout August 2017 Pharmaceuticals pitavastatin sodium Nikita™ Lupin High cholesterol August 2017 beclomethasone dipropionate Qvar® RediHaler™ Teva Teva August 2017 insulin glargine Lusduna® Nexvue™ Merck Diabetes August 2017 methylphenidate extended- Cotempla™ XR-ODT Neos Therapeutics ADHD July 2017 release orally disintegrating tablets mixed salts of a single-entity Mydayis™ Shire ADHD July 2017 amphetamine products pitavastatin Zipitamag Zydus High cholesterol July 2017 epinephrine injection Symjepi™ Adamis Allergic reactions June 2017 Pharmaceuticals Corporation cetirizine ophthalmic solution Zerviate™ Nicox Ophthalmic Eye itching May 2017 methotrexate solution Xatmep™ Silvergate ALL and arthritis in pediatric patients April 2017 Pharmaceuticals oxycodone, immediate-release RoxyBond™ Inspirion/ Pain, abuse deterrent April 2017 Daiichi Sankyo dapagliflozin/saxagliptin Qtern™ AstraZeneca Diabetes February 2016 lisdexamfetamine (chew tab) Vyvanse® Shire ADHD February 2017 naloxone nasal spray, 2 mg Narcan® Adapt Pharma Inc Opioid overdose January 2016 fluticasone propionate ArmonAir™ Teva Asthma January 2016 RespiClick® fluticasone AirDuo™ Teva Asthma January 2016 propionate/salmeterol RespiClick® oxymetazoline Rhofade™ Allergan Rosacea January 2016 hydrocodone extended release Vantrela™ ER Teva Pain, abuse deterrent January 2016 morphine extended release Arymo™ ER Egalet Pain, abuse deterrent January 2016 insulin glargine Basaglar™ Eli Lilly Diabetes December 2015, launched in December 2016 empagliflozin/metformin Synjardy® XR Eli Lilly Diabetes December 2016 extended release Lantus® (insulin glargine)/ Soliqua™ Sanofi Diabetes November 2016 Adlyxin™ (lixisenatide) Tresiba® (insulin degludec/ Xultophy® Novo Nordisk Diabetes November 2016 Victoza® (liraglutide) Drug Pipeline Monthly Update: September 2017 Page 5 Other new product approvals in the past twelve months contined Generic name Brand name Manufacturer Indication(s) Date approved* doxylamine/pyridoxine XR Bonjesta® Duchesnay Pregnancy-related nausea and vomiting November 2016 tenofovir alafenamide Vemlidy® Gilead Hepatitis B November 2016 mebendazole Vermox® Johnson & Johnson/ Parasitic disease November 2016 Janssen norethindrone/estradiol fe Taytulla™ Apil Pregnancy prevention October 2016 sumatriptan/naproxen Treximet® Permix Migraine October 2016 *Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer. Pipeline watch Anticipated FDA Generic name Brand name Manufacturer Indication(s) decision date ITCA 650 (exenatide mini-pump) N/A Intarcia Diabetes September 2017 secnidazole Solosec™ Symbiomix Bacterial vaginosis September 2017 insulin aspart FIAsp™ Novo Nordisk Diabetes September 2017 tadalafil PharmFilm® N/A MonoSol RX ED September 2017 aripiprazole, digital tablet Abilify® Otsuka, Proteus Health Drug/device combo for schizophrenia, 4th Quarter 2017 bipolar disorder and major depression testosterone enanthate Xyosted™ Antares Testosterone replacement October 2017 auto-injector QuickShot™ Pharmaceuticals rolapitant N/A Tesaro, Opko Health Chemotherapy-induced nausea and October 2017 vomiting aprepitant Cinvanti™ Heron Therapeutics Chemotherapy-induced nausea and November 2017 vomiting buprenorphine monthly depot N/A Indivior Opioid use disorder November 2017 semaglutide N/A Novo Nordisk Diabetes December 2017 ertugliflozin N/A Merck/Pfizer Diabetes December 2017 ertugliflozin/metformin N/A Merck/Pfizer Diabetes December 2017 ertugliflozin/sitagliptin N/A Merck/Pfizer Diabetes December 2017 acetaminophen/ibuprofen Maxigesic® AFT Pharmaceuticals Pain December 2017 SUN-101/eFlow (glycopyrrolate) N/A Sunovion COPD December 2017 Pharmaceuticals Inc dolutegravir/rilpivirine N/A Viiv Healthcare HIV-1 infection December 2017 ethinyl estradiol/ Twirla™ Agile Therapeutics Pregnancy prevention December 2017 levonorgestrel transdermal Drug Pipeline Monthly Update: September 2017 Page 6 Pipeline watch contined Anticipated FDA Generic name Brand name Manufacturer Indication(s) decision date testosterone undecanoate Jatenzo™ Clarus Therapeutics Testosterone replacement December 2017 mometasone furoate sinus Sinuva™ Intersect ENT Chronic sinusitis January 2017 implant buprenorphine FluidCrystal® N/A Braeburn Opioid use disorder January 2018 Pharmaceuticals polyethylene