Page 149 - CW E-Magazine (8-10-2024)

Pharmaceuticals Pharmaceuticals

GROWING PRESENCE Nicotinell and related brands by way of defi nitive agreement, Dr. Reddy’s said sists of Nicotinell, a global leader in the
Piramal Pharma Solutions to expand sterile injectables acquisition of all of the quotas of Haleon the total consideration for the acquisition NRT category with a footprint in over
Group fi rm Northstar Switzerland will consist of an upfront cash payment 30 countries spanning Europe, Asia,
facility in US SARL incorporated in Switzerland, of GBP 458-mn and performance-based including Japan, and Latin America
Dr. Reddy’s said in a regulatory fi ling.
contingent payments of up to GBP 42-mn, and local market–leading brand names
payable in 2025 and 2026. It expected of the product – Nicabate in Australia,
Piramal Pharma Solutions (PPS), The Hyderabad-based fi rm’s board, the transaction to close in early Q4 of Thrive in Canada, and Habitrol in New
a leading global Contract Develop- on July 27, had approved fund infusion calendar year 2024, subject to comple- Zealand and Canada. The acquisition
ment and Manufacturing Organisa- of up to GBP 500-mn ($640-mn) in tion of customary conditions, including will be inclusive of all formats such as
tion (CDMO) and part of Piramal DRL SA towards the acquisition. regulatory approvals. lozenge, patch, gum as well as pipeline
Pharma Ltd., has unveiled an $80-mn products, in all applicable global mar-
investment plan to expand its In June, announcing the signing of a The portfolio to be acquired con- kets outside of the US, it had said.
Lexington, Kentucky (USA) facility.
REGULATORY ACTION
The site specialises in sterile Biocon gets four USFDA observations for Bengaluru
compounding, liquid filling, and
lyophilisation for sterile injectable API facility
drug products, playing a vital role in
PPS integrated antibody – drug conju- Biocon informed that the US health within the stipulated time,” it added. duct unit, a medical device assembly
gate (ADC) development and manu- regulator has issued four observations Biocon clarifi ed that it does not antici- unit, an analytical quality control labora-
facturing programme, ADCelerate. after inspecting its Bengaluru-based pate any material impact on its business tory, two microbiological control labo-
API (active pharmaceutical ingredient) operations due to these observations. ratories, and two warehouses.
The investment, financed by bank manufacture 104 product batches driven rapid growth in the injectables facility. In a separate development, the USFDA
loans and internal accruals, aims to per year (utilisation at peak levels). market, with an expected market value also conducted a current Good Manu- The inspection concluded with the
enhance the site’s existing capacity Upon completion of the expansion exceeding $20-bn by 2028. This The US Food and Drug Administra- facturing Practice (cGMP) inspection issuance of a Form 483, which out-
and capabilities to meet the demands in Q1 of 2027, this capacity will growth underscores the necessity for tion (USFDA) conducted a surveillance of Biocon Biologics’ insulin manu- lined: fi ve observations across the drug
of a rapidly growing market. increase to over 240 annual batches. robust commercial – scale manufac- inspection of the API facility (Site 2), facturing facility in Malaysia between substance and drug product facilities;
turing capabilities. As the efficiency located at Bengaluru from September September 17 and September 27, 2024. zero observations at the medical device
The expansion will equip the “This expansion represents a stra- and efficacy of injectable treatment 23- 27, 2024, the company said in a assembly unit; three observations related
Lexington site with an additional tegic investment in the future of Pira- options improve, more patients will regulatory fi ling. “Four observations The inspection covered several to the analytical and microbiological
24,000 square feet of manufacturing mal Pharma Ltd. Filling the commer- benefit from these advanced thera- were cited at the end of the inspection, biologics manufacturing units, including quality control laboratories; and none
space, a new laboratory, and state- cial manufacturing gap enables the pies. which the company will be addressing one drug substance and one drug pro- for the warehouse operations.
of-the-art machinery to scale clients’ Lexington site to access the rapidly
products effectively. Key additions expanding injectables market and esta- “The injectables market has steadily ANIMAL HEALTHCARE
include a new filling line, two com- blish itself as a key player in the increased in recent years and there Sequent Scientifi c and Viyash Lifesciences to merge
mercial-size lyophilisers, a special segment,” said Ms. Nandini Piramal, is currently insuffi cient supply. We
capping machine, and an external Chairperson, Piramal Pharma Ltd. are committed to adapting to meet Sequent Scientifi c and Viyash Life- Calling it a transformative step to- with Viyash Lifesciences.” Mr. Hari-
vial washer. this rising demand,” said Mr. Peter sciences are looking to merge, with the wards creating a company with integrated babu Bodepudi, Chairman and CEO,
Significant research, develop- DeYoung, Chief Executive Offi cer, aim of creating a differentiated animal capabilities in animal health, Mr. Raja- Viyash, said, “With our combined re-
Currently, the Lexington site can ment, and scientific innovation have Global Pharma. healthcare company with end-to-end ram Narayanan, Managing Director sources, R&D capabilities, manufactur-
ACQUISITION capabilities, the two companies said, and Chief Executive of Sequent said: ing capacities, and streamlined supply
without divulging fi nancial details.
chain, we are well-positioned to acce-
“In order to continue to deliver diffe-
Dr. Reddy’s invests $620-mn in Swiss arm to acquire rentiated value to our customers in times lerate growth and offer a wider range of
With Viyash’s operating capabili-
Haleon’s Nicotinell portfolio ties, this merger will enhance the com- to come, it is imperative to scale up our high-quality products.”
product development and R&D capabi-
bined entity’s scale, deepen its R&D lities to capture the market opportunity The proposed merger is subject to
Dr. Reddy’s Laboratories, as part gory outside of the US, has invested the subsidiary, allotted 62,00,000 capabilities, strengthen its supply chain, we are seeing and to build on our leader- regulatory approvals, including from
of its proposed acquisition of British $620-mn in a Swiss subsidiary. non-convertible preference shares and position the combined entity to ship in the animal health market. To shareholders, stock exchanges, Com-
fi rm Haleon’s global portfolio of con- each with a nominal value of $100 become a key player in the pharma- strengthen our end-to-end capabilities, petition Commission of India and the
sumer healthcare brands in the nico- Consequently, Dr. Reddy’s Labo- on September 27. The funds infused ceutical market, a note on the proposed we have decided to pursue an inorganic National Company Law Tribunal, the
tine replacement therapy (NRT) cate- ratories SA (DRL SA), Switzerland, into DRL SA will be used to acquire merger said. route, and we propose a potential merger note said.

148 Chemical Weekly October 8, 2024 Chemical Weekly October 8, 2024 149

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