Acalabrutinib

CALQUENCE®

Oncology

How many ANDA filers with paragraph IV certification will file later this year?

About CALQUENCE®

  1. Patented by AstraZeneca
  2. Inhibitor of Bruton’s tyrosine kinase (BTK) with potential antineoplastic activity to treat CLL, SLL and previously treated MCL

Approvals

  1. First U.S. approval date: October 31, 2017
  2. First E.U. approval date: November 5, 2020
  3. U.S. new chemical entity (NCE) expiry: 2022
  4. First U.S. Paragraph IV certifications anticipated: October 2021

About CALQUENCE® in the market

  1. Global 2020 sales: More than $500 million, up from $164 million in 2019
    • Global sales: $11.6 billion
    • Highest U.S. sales of all LOE products reviewed: $6.5 billion
  2. In the United States, increase in market share by 115% from 2018 to 2019

U.S. market share

Source: Cortellis Generics Intelligence

About AstraZeneca

  1. Main focus: oncology, cardiovascular, renal and metabolism, and respiratory and immunology
  2. Except for a bevacizumab biosimilar and legacy products such as ZOLADEX® (goserelin acetate), almost all their oncology portfolio (accounting for 42% of their revenue) are recently approved drugs that will lose exclusivity within the next 15 years

Patient impact

Approximately 70% of MCL cases are diagnosed with advanced disease, and most patients receive treatment regardless of disease stage. Because of the aggressive nature of MCL, few patients experience an extremely durable remission, while most patients will require second or third-line treatment.

Although patients with CLL or SLL do not necessarily receive pharmacologic treatment initially, 75% of patients eventually require drug treatment.

~50,000
people have MCL, CLL or SLL in the key markets

Based on Cortellis data, there are few confirmed sources of API, although there are companies in India (all with an “Established” Corporate API Rating*) developing on the API: MSN Laboratories Private Limited, NATCO Pharma Limited, Sun Pharmaceutical Industries Ltd. and Sionc Pharmaceuticals Pvt.Ltd.Although there is minimal API manufacturing, Cortellis Generics Intelligence data show a variety of patents on manufacturing process, intermediates and product derivatives from the following companies indicating numerous generic companies evaluating the product:

  • Apotex Inc.
  • Alembic Pharmaceuticals Limited Cipla Limited
  • Reddy’s Laboratories
  • Fresenius SE & Co. KGaA
  • Teva Pharmaceutical Industries Ltd.
  • Zentiva Group, a.s.

Source: Cortellis Generics Intelligence

*Corporate API Rating: proprietary Cortellis Generics Intelligence analytic that indicates how capable the corporate group is of supplying bulk to regulated markets like Europe and North America.

Source: Cortellis Generics Intelligence

Data current as of April 21, 2021

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