Page 152 - CW E-Magazine (18-3-2025)

Pharmaceuticals Pharmaceuticals

INORGANIC GROWTH solutions to prevent Chikungunya in Genome Valley, Hyderabad will be fi rst approval of the vaccine in the US
Sun Pharma to acquire US-based Checkpoint vulnerable populations in endemic augmented to make the Chikungunya as the fi rst Chikungunya vaccine for
regions”.
persons as young as 12 years and the
vaccine. The manufacturing of Chikun-
Therapeutics for $355-mn The initial technology transfer gunya vaccine at BE is expected to positive opinion from the European
generate up to 300 new jobs. Bavarian Medicines Agency’s Committee for
would be followed by regulatory ap- Nordic has been seeking to provide Medicinal Products for Human Use
Mumbai-based Sun Pharmaceutical tumour cancers, they said, adding that to receive up to an additional $0.70 in proval applications and commence- global access to its Chikungunya have demonstrated the viability to
Industries has entered into an agree- Checkpoint has an approval from the cash, without interest, if cosibelimab ment of commercial manufacturing vaccine via partners for markets outside expand regulatory approvals beyond
ment with Checkpoint Therapeutics US Food and Drug Administration is approved prior to certain deadlines thereafter. BE’s existing facilities in the US and Europe. The recent and these markets, the company said.
Inc., to acquire the immunotherapy for ‘Unloxcyt’ (cosibelimab-ipdl) for in the European Union, subject to the
and targeted-oncology company for the treatment of adults with metastatic centralised approval procedure; or in FACILITY INSPECTION
a consideration of up to $355-mn cutaneous squamous cell carcinoma Germany, France, Italy, Spain or the
(Rs. 3,088-crore). (cSCC) or locally advanced cSCC, who United Kingdom, subject to the terms USFDA raps Granules India for Telangana plant shortcomings
are not candidates for curative surgery and conditions in the contingent value The US Food and Drug Administra- adequate written procedures for main- repairs, adherence to appropriate pre-
This is Sun Pharma’s second large or curative radiation. rights agreement, the note said. tion (USFDA) has pulled up Granules taining equipment at the Medchal- ventive maintenance schedules, timely
transaction in two years, after it ac- India for failing to maintain buildings Malkajgiri-based manufacturing facility. technological upgrades to the facility
quired US-based Concert Pharmaceuti- Mr. Dilip Shanghvi, Sun Pharma’s The upfront cash payment of $4.10 for drug storage and avoiding adequate The USFDA inspected the facility from infrastructure, and improved systems for
cals for $576-mn (2023); besides being Chairman and Managing Director said, per share of common stock represents a procedures regarding cleaning and main- August 26 to September 6, 2024. ongoing management review,” it added.
among its large overseas transactions “The acquisition further bolsters our inno- premium of approximately 66 percent tenance of equipment at its Telangana-
after acquisition of Israeli drugmaker vative portfolio in onco-derm therapy.” to Checkpoint’s closing share price on based formulations plant. “In response to this letter, provide a The USFDA also pointed out that
Taro Pharma. March 7, 2025, it added. plan and timeline to implement routine, a large amount of torn CGMP records
Deal details In a warning letter to the company’s vigilant operations management over- were discovered in at least 15 plastic
Sun Pharma will make an upfront On completion of the transaction, Checkpoint, Sun Pharma and Chairman and Managing Director sight of facilities,” the USFDA said. waste bags during the inspection, in-
cash payment of $4.10 per share, or a Sun Pharma will acquire all outstand- Fortress Biotech Inc (Checkpoint’s Mr. Krishna Prasad Chigurupati, the “This plan should ensure, among other cluding analytical balance printouts
consideration of up to $355-mn, the ing shares of Checkpoint and its stock- controlling stockholder) have entered US health regulator, stated that the things, prompt detection of facility con- and worksheets containing manufactur-
companies said in a joint statement. holders will receive, for each share of into a royalty agreement, under which company failed to establish and follow tamination issues, effective execution of ing and testing data.
common stock they hold, an upfront following the closing of the transaction
Checkpoint is a commercial – stage cash payment of $4.10, without interest, Fortress would receive royalty payments PORTFOLIO EXPANSION
company focused on developing novel and a non-transferable contingent value based on future sales of cosibelimab
treatments for patients with solid right (CVR) – entitling the stockholder during a specifi ed term. Glenmark acquires acetylcysteine injection, launches

COLLABORATION in US market
Biological E partners with Bavarian Nordic to improve Glenmark Pharmaceuticals Inc., relates to Atomoxetine capsules manu-

access to Chikungunya vaccine USA, has announced the acquisition factured in India in multiple strengths.
and launch of acetylcysteine injection,
6 gm/30 mL (200 mg/mL) single-dose The company is recalling the
Hyderabad-based Biological E has countries. The scale of our manufac- vials in the US market. affected lot due to ‘CGMP Deviations’,
partnered with Bavarian Nordic to turing and successful track record in the US Food and Drug Administration
expand access to Denmark-based providing global access to vaccines is The company acquired the Abbre- (USFDA) said in its latest Enforcement
Bavarian Nordic’s Chikungunya vaccine synergistically aligned with Bavarian viated New Drug Application (ANDA) Report. The recall is due to “presence
in low- and middle-income countries Nordic via this strategic partnership,” for the product from Aspen Pharma of N-Nitroso Atomoxetine impurity
(LMIC). Ms. Mahima Datla, Managing Direc- USA Inc. The injection is therapeutically ble portfolio as the company continues to above the FDA recommended limit,” it
tor, Biological E, said in a release. equivalent to Cumberland Pharmaceuti- focus on growth in the hospital segment. added. The company initiated the Class
The partnership comprises a tech- Mr. Paul Chaplin, President & CEO of cals’ Acetadote Injection, which achieved II recall on January 29 this year. As per
nology transfer of the current drug to endemic low- and middle-income Bavarian Nordic, said, “We are pleased annual sales of approximately $15.2-mn Recall of ADHD medication the USFDA, a Class II recall is initiated
product manufacturing process for the countries. to announce our fi rst collaboration to for the 12-month period ending January In another development, Glenmark in a situation in which use of, or expo-
Chikungunya vaccine, with the option expand global access to our Chikun- 2025, according to IQVIA data. is recalling close to 15-lakh bottles of sure to, a violative product may cause
to transfer the drug substance process at “We are pleased to collaborate gunya vaccine and also our fi rst partner- a generic medication used in the treat- temporary or medically reversible
a later stage. To that end, the companies with Bavarian Nordic to help expand ship with Biological E. Expanding Mr. Marc Kikuchi, President & Busi- ment of attention defi cit hyperactivity adverse health consequences or where
have reached an agreement to expand the availability of their Chikungunya supply is a prerequisite for our ability ness Head, North America, said the ac- disorder in the US market, according the probability of serious adverse health
their capacity to provide future supplies vaccine in low and middle-income to address the increasing need for quisition strengthens Glenmark’s injecta- to the US health regulator. The recall consequences is remote.

152 Chemical Weekly March 18, 2025 Chemical Weekly March 18, 2025 153

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