The additional challenges to launching new drugs that emerged since COVID-19 upended the biopharma industry, and life as we knew it, will continue into 2021, according to the annual list of trends released December 21 by Seqens CDMO North America (formerly PCI Synthesis, a contract development and manufacturing organization focused on producing new chemical entities (NCEs), active pharmaceutical ingredients (APIs), and other specialty chemical products.
Those challenges, according to Seqens CDMO NA, include supply chain issues that require companies to find alternative sources for raw materials; and the potential for shortages of medicines due to biopharmas diverting raw materials and manufacturing capacity to producing COVID-19 drugs and vaccines. More than 300 such therapeutics are in development, according to GEN’s COVID-19 DRUG & VACCINE TRACKER.
And despite the demand by politicians across the political divide for lower prices, drug prices will likely rise, Seqens CDMO NA predicted. It offered reasons extending beyond possible drug shortages and the ongoing cost of developing new medicines, including the many layers of drug delivery partners that add costs without adding value.
“Companies and regulators need to make long-term systemic changes to ensure the U.S. and the world can be better positioned to handle potential disruption from a future pandemic,” Ed Price, founder of Seqens CDMO NA, said in a statement. “This will include finding new ways to protect supply chains and streamline processes to more easily work with regulators and get faster approvals while ensuring patient safety.”
Yet the challenging environment for drug development has not stopped companies from launching dozens of new treatments. The FDA, for example, approved no fewer than 52 novel drug approvals during 2020 as of December 21—already surpassing the 48 approvals issued in 2019, though just under the 59 approvals granted in 2018.
Below is GEN’s top 15 A-List of top-selling prescription drugs launched in 2020, based on sales data disclosed by the drugs’ developers through the first three quarters.
Top-selling drugs are ranked based on sales or revenue reported for the first through third quarters of 2020 by biopharma companies in press announcements, annual reports, investor materials, and/or conference calls. Each drug is listed by name, reported sales, sponsor(s), type, and diseases for which the treatment is indicated.
Ranking #20 through #16 in Q1-Q3 2020 were treatments that generated between CHF 7 million (about $7.9 million) and $11.875 million—Enspryng (satralizumab-mwge) and Evrysdi (risdiplam), both from Genentech, a Member of the Roche Group; Intra-Cellular Therapies’ Caplyta (lumateperone); GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf), and Incyte’s Pemazyre® (pemigatinib).
Nearly half (seven) of the top 15 drugs launched in 2020 as of deadline were indicated for various forms of cancer—with two of the therapeutics launched as treatments for gastrointestinal stromal tumors (GIST). Two top-selling newly launched drugs listed below are indicated for migraines (as was a third drug that generated too little in sales to make the list, Lundbeck’s Vyepti™ [eptinezumab-jjmr]), which made only DKK 42 million (about $6.9 million).
Another two top selling drugs were indicated for blood disorders. And as might be expected during the pandemic, another two of the top 15 best-selling newly launched drugs were indicated as treatments for COVID-19.
Not included on the list were drugs for which data was unavailable for any of several reasons: In some cases, a drug’s developer was privately held and did not disclose any sales information. In other cases, a publicly-traded developer of a newly-launched drug limited its sales disclosures to its top-selling therapeutics. Still in other cases, the launch of a drug came during the fourth quarter, with data to emerge only when the company reports fourth quarter results in 2021.
| 15 |
Ayvakit™ (avapritinib) |
Q1-Q3 2020 sales: $15.3 million
Sponsor(s): Blueprint Medicines Type: Tyrosine kinase inhibitor targeting PDGFRA and PDGFRA D842 mutants as well as multiple KIT exon 11, 11/17 and 17 mutants with half maximal inhibitory concentrations (IC50s) less than 25 nM Indication(s): Unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations, in adults FDA Approval Date: January 9, 2020 |
| 14 |
Retevmo™ (selpercatinib) |
Q1-Q3 2020 sales: $17.9 million
Sponsor(s): Eli Lilly Type: Kinase inhibitor targeting wild-type RET and multiple mutated RET isoforms as well as VEGFR1 and VEGFR3 with IC50 values ranging from 0.92 nM to 67.8 nM Indication(s): Forms of non-small cell lung cancer (adults); medullary thyroid cancer and other types of thyroid cancers (patients aged 12 years and older) whose tumors have a mutation or fusion in the RET (rearranged during transfection) gene FDA Approval Date: May 8, 2020 |
| 13 |
Tabrecta™ (capmatinib) |
Q1-Q3 2020 sales: $18 million
Sponsor(s): Novartis Type: Kinase inhibitor targeting MET, including the mutant variant produced by exon 14 skipping Indication(s): Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test FDA Approval Date: May 6, 2020 |
| 12 |
Qinlock® (ripretinib) |
Q1-Q3 2020 sales: $20.0 million
Sponsor(s): Deciphera Pharmaceuticals Type: Tyrosine kinase inhibitor targeting KIT proto-oncogene receptor tyrosine kinase (KIT) and platelet derived growth factor receptor A (PDGFRA) kinase, including wild type, primary, and secondary mutations Indication(s): Treatment of adults with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib FDA Approval Date: May 15, 2020 |
| 11 |
Sarclisa® (isatuximab-irfc) |
Q1-Q3 2020 sales: €18 million ($21.999 million)
Sponsor(s): Sanofi Type: CD38-directed cytolytic antibody Indication(s): Multiple myeloma in adults who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, in combination with pomalidomide and dexamethasone FDA Approval Date: March 2, 2020 |
| 10 |
Nurtec™ ODT (rimegepant) |
Q1-Q3 2020 sales: $28.513 million
Sponsor(s): Biohaven Pharmaceuticals Type: Calcitonin gene-related peptide receptor antagonist Indication(s): Acute treatment of migraine with or without aura in adults FDA Approval Date: February 27, 2020 |
| 9 |
Zepzelca™ (lurbinectedin) |
Q1-Q3 2020 sales: $36.9 million
Sponsor(s): Jazz Pharmaceuticals Type: Alkylating drug designed to bind guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix towards the major groove Indication(s): Treatment of adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy FDA Approval Date: June 15, 2020 |
| 8 |
REGEN-COV2 (casirivimab and imdevimab) |
Q1-Q3 2020 sales: $40.2 million
Sponsor(s): Regeneron Pharmaceuticals Type: Combination or “cocktail” of two monoclonal antibodies Indication(s): Treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization FDA Approval Date: November 21, 2020 |
| 7 |
Ubrelvy® (ubrogepant) |
Q1-Q3 2020 sales: $60 million
Sponsor(s): AbbVie 1 Type: Calcitonin gene-related peptide receptor antagonist Indication(s): Acute treatment of migraine with or without aura in adults FDA Approval Date: December 23, 2019 |
| 6 |
Adakveo® (crizanlizumab-tmca) |
Q1-Q3 2020 sales: $71 million
Sponsor(s): Novartis Type: Selectin blocker Indication(s): Reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease FDA Approval Date: November 15, 2019 |
| 5 |
Trodelvy™ (sacituzumab govitecan-hziy) |
Q1-Q3 2020 sales: $73.0 million
Sponsor(s): Immunomedics (Acquisition by Gilead Sciences completed on October 23) Type: Trop-2-directed antibody and topoisomerase inhibitor conjugate Indication(s): Treatment of adults with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease (Approved under accelerated approval) FDA Approval Date: April 22, 2020 |
| 4 |
Ruxience™ (rituximab-pvvr) |
Q1-Q3 2020 sales: $78 million
Sponsor(s): Pfizer Type: CD20-directed cytolytic antibody; biosimilar to Rituxan® (rituximab), co-marketed by Genentech and Biogen Indication(s): Non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener’s Granulomatosis), and microscopic polyangiitis when taken in combination with glucocorticoids (all in adults) FDA Approval Date: July 23, 2019 |
| 3 |
Reblozyl® (luspatercept-aamt) |
Q1-Q3 2020 sales: $159 million
Sponsor(s): Bristol-Myers Squibb (BMS) and Acceleron Pharma 2 Type: Erythroid maturation agent Indication(s): Anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions; Anemia failing an erythropoiesis stimulating agent and requiring 2 or more RBC units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) FDA Approval Date: November 8, 2019 |
| 2 |
Tepezza® (teprotumumab-trbw) |
Q1-Q3 2020 sales: $476.3 million
Sponsor(s): Horizon Therapeutics Type: Insulin-like growth factor-1 receptor inhibitor Indication(s): Thyroid Eye Disease FDA Approval Date: January 21, 2020 |
| 1 |
Veklury® (remdesivir) |
Q1-Q3 2020 sales: $873 million
Sponsor(s): Gilead Sciences Type: SARS-CoV-2 nucleotide analog RNA polymerase inhibitor Indication(s): Adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization 3 FDA Approval Date: October 22, 2020 |
References
1. Ubrelvy was developed by Allergan, which was acquired by AbbVie for $63 billion in a deal completed May 8, 2020.
2. Reblozyl was developed by Celgene and Acceleron. BMS acquired Celgene for $74 billion, in a deal completed November 20.
3. In its “Prescribing Information” label, Gilead states that Veklury “should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.”
