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DIRECTORY OF SINGAPORE PROCESS & CHEMICALS INDUSTRIES 2021/2022
In the update, PwC said that “the large strategic players will continue shedding non- core business units, focusing instead on building specialty platforms and moving away from being pharma conglomerates”.
“As a result, we expect to see accelerating deal activity from the divestment of consumer- focused businesses (such as over-the-counter products) and the acquisition of specialty pharma developers, contract development and manufacturing, and contract research organisations,” it added.
But the high volume of transactions in recent years is coming under scrutiny by regulatory authorities. In March 2021, a multilateral working group led the US Federal Trade Commission (FTC) announced a probe of pharma M&As and their impact on competition.
Among the questions being asked were: What are the merger’s effects on innovation, price fixing, reverse payments and other regulatory abuses? What evidence would be needed to challenge a transaction based on any new or expanded theories of harm?
The review may also consider FTC’s past pharma merger reviews to assess whether errors were made.
New FDA drug approvals
The US FDA has stepped up its approval process of novel drugs. Fifty-three novel drugs were approved in 2020, up from 48 in the previous year, among them the Pfizer-BioNTech and Modena vaccines for Covid-19.
Of the 53 drugs approved, 60% were ‘orphan’ drugs for the treatment, prevention or diagnosis of a rare disease or condition. Among them were Zokinvy for Hutchinson- Gilford Progeria Syndrome and progeroid laminopathies, rare conditions caused by certain genetic mutations that lead to premature ageing, and a new drug to treat those with hereditary angioedema, a rare disorder which causes severe swelling in the limbs, face, intestinal tract and airway.
Almost a third were made through the fast- track designation, which “speeds new drug development and review by increasing the level of communication between the FDA and drug developers, and by enabling the Centre for Drug Evaluation and Research (CDER) to review portions of a drug application ahead of the submission of the complete application”.
For the January to August 2021 period CDER, a part of the FDA that regulates over-
the-counter and prescription drugs, approved a total of 33 new molecular entities and new therapeutic biological products. It said some of the newly approved products are innovative new products that never have been used in clinical practice, while others are the same as, or related to, previously approved products that will compete with those already in the market.
Research and
development on track
Notwithstanding the disruption caused by Covid-19, research and development (R&D) remained at historically high levels driven by new funding and strategic transactions, especially in oncology, according to a new research report “Global Trends in R&D: Overview Through 2020” by the IQVIATM Institute for Human Data Science.
Funding for early- and late-stage R&D increased significantly in 2020, reflecting a strong focus on innovative pathways and approaches to discover and develop novel therapeutics, and strategic transactions, while aggregate R&D spend for the top 15 companies “reached a record high”.
This sustained investment and efforts to discover and develop innovative medicines yielded a record 66 new drugs globally with success in oncology and treatments for rare diseases in addition to Covid-19 vaccines, the report noted.
“The growth in research and development driven by new oncology drugs, new funding and strategic investments is a testament to the resilience and strength of the innovative, global biopharmaceutical industry,” said the institute’s executive director Murray Aitken.
“Faced with significant disruption and the need to reprioritise research and development, the global life sciences industry has demonstrated its ability to meet and even exceed expectations for new and better lifesaving therapies and vaccines,” he added.
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