Page 186 - CW E-Magazine (2-1-2024)

Special Report Special Report

The CDMO/CMO report: The market for high-potency cial success, according to the IQVIA evaluated in a fi rst-in-human Phase II of $1-bn ($500-mn each for patritumab
clinical trial.
analysis.
deruxtecan and ifi natamab deruxtecan),
a pro-rated portion of which may be
manufacturing ADCs draw interest from Big Designed using Daiichi Sankyo’s refundable in the event of early termi-
trong growth in the global onco- volume, and offset by losses of exclu- Pharma proprietary DXd ADC technology to nation of development with respect to
logy market continues to drive sivity, including biosimilar impact. PATRICIA VAN ARNUM A recent and high-profi le deal in target and deliver a cytotoxic payload each program. For raludotatug deruxte-
Sgrowth for high-potency manufac- Editorial Director the ADC market is Merck & Co.’s and inside cancer cells that express a spe- can, Merck will be responsible for 75%
turing and opportunities for CDMOs/ Spending on oncology medicines is Drug, Chemical & Associated Daiichi Sankyo’s $22-bn ADC pact. In cifi c cell surface antigen, each ADC of the fi rst $2-bn of R&D expenses. Ex-
CMOs providing this specialized manu- expected to reach $375-bn by 2027, ac- Technologies Association,Inc. (DCAT) October 2023, the companies entered consists of a monoclonal antibody at- cept with respect to R&D expenses, the
facturing. What do the market numbers cording to the IQVIA Institute analysis. into a global development and commer- tached to a number of topoisomerase companies will equally share expenses
show now and in the near term? The US spending on oncology medi- 2021, according to the IQVIA analysis. cialization agreement for three of Dai- I inhibitor payloads (an exatecan de- as well as profi ts worldwide, except for
cines has risen from $58-bn. in 2018 Since 2013, 27% of US oncology new ichi Sankyo’s DXd ADC candidates: rivative, DXd) via tetrapeptide-based Japan where Daiichi Sankyo retains
Oncology drugs: a major growth driver to $88-bn in 2022, representing 45% active substances have not launched patritumab deruxtecan (HER3-DXd), cleavable linkers. In aggregate, the exclusive rights and Merck receives a
Oncology drugs, the largest thera- of global spending. Growth in the US in Europe, and 2% of Europe launch- ifi natamab deruxtecan (I-DXd) and three programs have multi-billion dol- royalty based on sales revenue.
peutic sector globally and in the US, is expected to increase to the 12-15% es have not reached the US, accord- raludotatug deruxtecan (R-DXd), in a lar worldwide commercial revenue po-
continues to be a major driver of growth range as more than 100 new drugs are ing to the IQVIA Institute analysis. In deal worth up to $22-bn ($4-bn upfront, tential for each company approaching Emerging bio/pharma companies: key
for high-potency manufacturing, both anticipated to launch across novel mo- China, 121 new active substances were $1.5-bn in continuation payments, and the mid-2030s, according to Merck & customer base for CDMOs/CMOs
for commercial products and drugs in dalities and frequently moving to ear- launched in oncology in the period $16.5-bn in milestone payments). The Co., which outlined the deal in an Octo- While the Merck–Daichi Sankyo
development. Biologics and newer ap- lier lines of therapy; increases in spend- from 2003 to 2022; 75 of these were companies will jointly develop and ber 18, 2023, press announcement. deal is an example of a Big Pharma play
proaches, such as immunotherapies, ing will be offset by patent expiries for launched in the last fi ve years. potentially commercialize these ADC in ADCs, in general, emerging biophar-
constitute the oncology-drug market, small molecules and biologics, accord- candidates worldwide, except in Japan Under the terms of the pact, Merck ma companies are leading innovation
but small molecules, including cytotox- ing to the IQVIA Institute’s analysis. The strength of the global oncology where Daiichi Sankyo will maintain ex- will pay Daiichi Sankyo upfront pay- in the oncology market. Emerging bio/
ics, and hybrid approaches, such as an- market is also evident through the in- clusive rights. Daiichi Sankyo will be ments of $1.5-bn for ifi natamab deruxte- pharma companies, defi ned as those
tibody-drug conjugates (ADCs), which A total of 115 oncology novel ac- dustry’s pipeline. The number of prod- solely responsible for manufacturing can due upon execution; $1.5-bn for pa- with less than $500-mn in annual sales
consists of a monoclonal antibody tive substances (NASs) have launched ucts under development in oncology and supply. tritumab deruxtecan, where $750-mn is and R&D spending less than $200-mn
linked to a cytotoxic small molecule, globally in the past fi ve years and 237 has grown signifi cantly over the last due upon execution and $750-mn is due per year, originated 70% of new US
are also part of the market and repre- over the last 20 years, with large geo- decade, with more than 2,000 products All three potentially fi rst-in-class after 12 months; and $1.5-bn for raludo- oncology drugs in 2022 and launched
sent opportunities for CDMOs/CMOs graphic variations, according to the currently under development, accord- DXd ADCs are in various stages of tatug deruxtecan, where $750-mn is due 71% of their own products, according
providing high-potency manufacturing. IQVIA Institute analysis. There were ing to the IQVIA Institute study. Global clinical development for the treat- upon execution and $750-mn is due af- to the IQVIA analysis. Emerging bio-
10 new cancer medicines launched in research and development activity in ment of multiple solid tumours both ter 24 months. Merck also will pay Dai- pharma companies were also responsi-
Overall, on a global basis, spending the US in 2022, and nine were orphan oncology remained at historically high as monotherapy and/or in combina- ichi Sankyo up to an additional $5.5-bn ble for 71% of the oncology pipeline in
on cancer medicines rose to $196-bn designated. In the US, 53 unique new levels in 2022, up 22% from 2018, and tion with other treatments. Patritumab for each DXd ADC contingent upon the 2022, up from 45% a decade ago.
globally in 2022, growing at an average haematological cancer medicines have the global number of patients treated deruxtecan was granted Breakthrough achievement of certain sales milestones.
12% annually over the last fi ve years, been launched since 2013, with 89 to with approved medicines increased at Therapy Designation by the US Food When combined with the additional In comparison, large pharma compa-
according to a recent study, Global On- treat solid tumours. In 2022, the Euro- an average of 5% annually over the and Drug Administration in December refundable upfront payment of $1-bn, nies, those with greater than $10-bn in
cology Trends 2023: Outlook to 2027, pean Medicines Agency approved six same period, according to the IQVIA 2021 for the treatment of patients with total potential consideration across the annual sales, have seen a declining share
by the IQVIA Institute for Human Data small molecules and eight biologic new Institute study. In addition, oncology EGFR-mutated locally advanced or three programs is up to $22-bn. of the oncology pipeline, responsible for
Science. The growth in major markets active substances for oncology in 2022, clinical trial starts remained at histori- metastatic non-small cell lung cancer 21% of products currently under devel-
is driven by new products and brand compared to the 10 total approved in cally high levels in 2022, up 22% from (NSCLC) with disease progression on In addition, Merck may opt out of opment, down from 36% in 2017. Since
2018 and primarily focused on rare or after treatment with a third-genera- the collaboration for patritumab derux- 2020, overall oncology pipeline growth
cancers. Oncology development is fo- tion tyrosine kinase inhibitor (TKI) and tecan and raludotatug deruxtecan and has slowed, growing just 5% over the
cused on solid tumours, with next-gen- platinum-based therapies. The submis- elect not to pay the two continuation last two years, but with 15% growth
eration biotherapeutics growing across sion of a biologics license application payments of $750-mn each that are due in the Emerging Bio/Pharma pipeline
all cancers. Among the various classes (BLA) in the US is planned by the end after 12 months and 24 months, respec- compared to a 13% decline across larger
of oncology drugs, clinical trials started of March 2024 for patritumab derux- tively. If Merck opts out of patritumab companies. Of the emerging biopharma
for PD-1/PD-L1 inhibitors grew 54% tecan. Ifi natamab deruxtecan is cur- deruxtecan and/or raludotatug deruxte- companies working in oncology, 77%
over the last fi ve years, accounting for rently being evaluated as monotherapy can, the upfront payments already paid are solely focused on oncology drug re-
81% of ongoing single-country late- in a Phase II clinical trial in patients will be retained by Daiichi Sankyo and search and development and of those fo-
stage trials. ADCs are also emerging with previously treated extensive-stage rights related to such DXd ADCs will cused solely on oncology, 72% are only
with signifi cant effi cacy across a broad small cell lung cancer (SCLC). Ralu- be returned to Daiichi Sankyo. Merck developing a single drug, according to
range of targets, with varying commer- dotatug deruxtecan is currently being will pay an additional upfront payment the IQVIA Institute study.

186 Chemical Weekly January 2, 2024 Chemical Weekly January 2, 2024 187

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