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Drug Pipeline Monthly Update June 2021

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Drug Pipeline Monthly Update June 2021 Drug Pipeline MONTHLY UPDATE Critical updates in an ever changing environment June 2021 NEW DRUG INFORMATION ™ ● Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg): The U.S. Food and Drug Administration (FDA) has approved Pfizer’s Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg), as a once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. Uterine fibroids are the most common benign tumors in women of reproductive age and are estimated to affect 20 to 60% of women by the time they reach menopause. The approval of Myfembree is supported by efficacy and safety data from two Phase 3 clinical trials, LIBERTY 1 and LIBERTY 2 which demonstrated a 72.1% and 71.2% response rate respectively in menstrual blood loss at week 24. Additionally, the combination therapy preserved bone mass density in the women enrolled in the clinical trials. Myfembree has launched with a wholesale acquisition cost (WAC) of $974.54 for a 28-day supply.1 ™ ● Lybalvi (olanzapine and samidorphan): The FDA has approved Alkermes’ Lybalvi for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate. Lybalvi is a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity that is designed to mitigate weight gain associated with olanzapine. Lybalvi was approved based on Phase 3 ENLIGHTEN-2 study which demonstrated a lower mean percent weight gain from baseline compared to the olanzapine group and a lower proportion of patients who gained 10% or more of their baseline body weight at six months compared to the olanzapine group.2 FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee met October 2020 to discuss Lybalvi, they voted 15–1, with one abstention, that the drug was effective and prevented weight gain. Weight gain remains a side effect of Lybalvi, and the weight gain profile is inferior to that of risperidone. The FDA panel was divided on whether a label warning would sufficiently capture Lybalvi’s risks voting 11–6. Additional risks will be addressed in the warning label for patients with opioid withdrawal symptoms and opioid overdose due to how samidorphan works as an opioid antagonist. Alkermes expects to make Lybalvi available for patients in the fourth quarter of 2021 with pricing to follow. 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: June 2021 Page 2 ® ● Brexafemme (ibrexafungerp tablets): The FDA has approved Scynexis’ Brexafemme for oral use in patients with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. Brexafemme is the first in class triterpenoid which are structurally distinct glucan synthase inhibitors. It has shown activity against Aspergillus and Candida as well as activity against multidrug-resistant (MDR) species Candida auris as well as Pneumocystis. Brexafemme’s approval was based on two Phase 3 studies that demonstrated efficacy and favorable tolerability compared to placebo.3 Brexafemme is planning on launching in the second half of this year with pricing to follow. ® ● Wegovy (semaglutide 2.4mg): The FDA approved Novo Nordisk’s Wegovy for chronic weight management. Wegovy is indicated as an adjunct to diet and exercise for chronic weight management in adults with obesity (initial BMI≥30 kg/m2) or overweight (initial BMI≥27 kg/m2) with at least one weight-related comorbidity. Wegovy is a once-weekly subcutaneous injection. The approval is based on the results from the STEP Phase 3a clinical trial that demonstrated patients treated with Wegovy that did not have type 2 diabetes, lost an average weight loss of 17–18% of their weight (average of 34 pounds) which was sustained over 68 weeks. Compared to the placebo group where the average weight loss was about 2.5% or just under six pounds.4 In a trial of type 2 diabetes patients, the Wegovy arm lost 6.2% of initial body weight compared to placebo. Wegovy has launched with a WAC of $1,297 a month, equivalent to Novo Nordisk’s daily obesity drug Saxenda™ (liraglutide 3mg). ® ● Tembexa (brincidofovir): The FDA has granted approval of Chimerix’s Tembexa (brincidofovir) tablets and oral suspension approval for the treatment of smallpox for adult and pediatric patients, including neonates. Tembexa is a nucleotide analog lipid-conjugate designed to mimic a natural monoacyl phospholipid to achieve effective intracellular concentrations of the active antiviral metabolite, cidofovir diphosphate. Tembexa was approved under the FDA’s animal rule using efficacy data in two lethal orthopoxvirus animal models of human smallpox disease. The rabbitpox model demonstrated Tembexa treatment resulted in statistically significant survival benefit versus placebo following delayed treatment after animals were infected with a lethal viral dose.5 Although smallpox was certified as eradicated in 1980 by the World Health Organization, it continues to be a potential global threat in today’s interconnected world. Smallpox outbreaks killed several hundred million people throughout several centuries.6 Tembexa launch and pricing are pending. ® ● Rezipres (ephedrine hydrochloride injection): The FDA approved Eton Pharmaceuticals’ Rezipres for the treatment of clinically important hypotension occurring in the setting of anesthesia. Rezipres is a ready-to-use hospital injectable. Rezipres was approved via the 505(b)2 pathway using Exela Pharma’s Akovaz as its reference product.7 Rezipres launch and pricing are pending. Drug Pipeline Monthly Update: June 2021 Page 3 GENERIC DRUG INFORMATION ® ● Thiola (tiopronin): Teva launched their generic version of Travere Therapeutics’ Thiola indicated in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone. Thiola generated less than $10 million in U.S. annual sales in 2020. ® ● Bepreve (bepotastine besilate): Mylan launched their generic version of Bausch Health’s Bepreve for the treatment of conjunctivitis. Multiple manufacturers are set to launch in 2021. Bepreve generated $38 million in U.S. annual sales in 2020. ® ● Banzel (rufinamide tablet): Multiple manufacturers have launched their generic version of Eisai’s Banzel for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and adults. Banzel generated $302 million in U.S. annual sales in 2020. ® ● Kaletra (lopinavir-ritonavir): Hetero launched their generic version of Abbvie’s Kaletra for the treatment of HIV-1 infection in adults and pediatric patients (14 days and older). Kaletra generated $36 million in U.S. annual sales in 2020. + Specialty medication Drug Pipeline Monthly Update: June 2021 Page 4 NEW MOLECULAR ENTITY APPROVALS IN THE PAST TWELVE MONTHS DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* brincidofovir Tembexa® Chimerix Smallpox June 2021 ibrexafungerp Brexafemme® Scynexis Antifungal June 2021 olanzapine and samidorphan Lybalvi® Alkermes Schizophrenia or bipolar I disorder June 2021 estetrol and drospirenone Nextstellis™ Mayne Pharma, Pregnancy prevention April 2021 (E4/DRSP) Mithra Pharmaceuticals viloxazine hydrochloride Qelbree™ Supernus ADHD April 2021 Pharmaceuticals oritavancin Kimyrsa™ Melinta Therapeutics Acute bacterial skin and skin structure March 2021 infections (ABSSSI) serdexmethylphenidate and Azstarys™ KemPharm ADHD March 2021 dexmethylphenidate cabotegravir Vocabria™ VIIV Healthcare HIV-1 infection January 2021 cabotegravir and rilpivirine Cabenuva™ VIIV Healthcare HIV-1 infection January 2021 vericiguat Verquvo™ Merck Heart failure January 2021 vibegron Gemtesa™ Sumitomo Overactive bladder December 2020 Pharmaceuticals Co. tirbanibulin Klisyri® Athenex and Almirall Actinic keratosis December 2020 clascoterone Winlevi™ Cassiopea SPA Acne August 2020 fostemsavir Rukobia™ Viiv Healthcare HIV August 2020 oliceridine Olinvyk™ Trevena Pain August 2020 nifurtimox Lampit™ Bayer Pediatric Chagas disease August 2020 abametapir Xeglyze™ Hatchtech Head lice treatment July 2020 remimazolam Byfavo™ Acacia Pharma Procedure sedation July 2020 *Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer. Drug Pipeline Monthly Update: June 2021 Page 5 OTHER NEW PRODUCT APPROVALS IN THE PAST TWELVE MONTHS DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* ephedrine injection Rezipres® Eton Pharmaceuticals Hypotension June 2021 semaglutide Wegovy™ Novo Nordisk Chronic weight management June 2021 relugolix, estradiol and Myfembree™ Myovant (Sumitomo Heavy menstrual bleeding June 2021 norethindrone Dainippon) bupivacaine and meloxicam Zynrelef™ Heron Therapeutics Postoperative
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