Page 142 - CW E-Magazine (31-12-2024)

Pharmaceuticals

WIDER ACCESS
Valneva licenses chikungunya vaccine to Serum Institute

Valneva SE, a speciality vaccine SII will also make available a stock- potential use when responding to a future
company, and Pune-based Serum Insti- pile of 100,000 doses of the drug pro- chikungunya outbreak in the region.
tute of India (SII), the world’s largest duct to CEPI as an ‘investigational ready
manufacturer of vaccines by number reserve’ that could be used in clinical Valneva’s chikungunya vaccine
of doses, have announced an exclusive trials in the region. Such research could is the world’s fi rst and only licensed
license agreement for Valneva’s sin- provide additional data on the perfor- chikungunya vaccine, currently approved
gle-shot chikungunya vaccine that ena- mance of the vaccine among local in the US, Europe, and Canada for the
bles supply of the vaccine in Asia. The populations. prevention of disease caused by the
collaboration to support broader access chikungunya virus in individuals 18 years
to the vaccine in low-and-middle-in- A safety stock of up to 100,000 doses of age and older. Regulatory reviews
come countries (LMICs) in the region of the chikungunya vaccine will also be to expand the age range to individuals
falls within the framework of the $41.3-mn made available and directly accessible 12 years of age and older are currently
funding agreement Valneva signed with to CEPI, at costs incurred by CEPI, for ongoing.
the Coalition for Epidemic Prepared- Omexa Formulary to invest in a new unit for mono-
ness Innovations (CEPI) in July 2024
with co-funding from the European clonal antibodies
Union. Chennai-based Omexa Formulary will have an annual production capacity
Pvt. Ltd. plans to set up a new manu- of 520-kg of monoclonal antibodies
The companies will work urgently facturing unit for monoclonal antibo- and 164,000 units per month of formu-
to bring the vaccine to the Indian mar- dies and formulation products with an lation products.
ket, and certain other Asian countries, investment of Rs. 95-crore on a 4-acre
subject to local regulatory approvals, site within TANSIDCO Industrial Omexa plans to produce 30 monoc-
as India is currently enduring one of its Park in Tindivanam Taluk, Villupuram lonal antibody products, along with two
worst chikungunya outbreaks. Nearly District, Tamil Nadu. formulation products – prefi lled syringes
370,000 cases were confi rmed in India and vials, as well as lyophilised vials.
between January 2019 and July 2024. According to documents fi led for The project is expected to generate
environmental clearance, the facility employment for about 120 people.
Under the agreement, the compa- Supriya Lifescience inaugurates new API
nies will conduct a technology transfer
of the current drug product manufac- production block
turing process. Valneva will supply its Supriya Lifescience Ltd. has inau- with an investment of approximately
chikungunya vaccine drug substance gurated its new multipurpose Active Rs. 125-crore, adds a substantial capa-
to SII, which will complete manufactur- Pharmaceutical Ingredients (APIs) pro- city of 335-klpd (kilolitres per day) to
ing and be responsible for seeking and duction block, Module E, at the Lote the company’s operations, taking total
maintaining regulatory approval of the Parshuram site. The facility, developed capacity to 932-klpd.
vaccine in India and other countries in Aurobindo Pharma’s API unit in Telangana gets
Asia. Future commercialisation will be
based on a profi t-sharing model along two US-FDA observations
with single-digit million milestone Aurobindo Pharma has announced Mandal, Sanga Reddy District, Telangana,
payments towards technology transfer that the United States Food and Drug was conducted from December 9-17,
and regulatory approvals to Valneva. Administration (FDA) completed an 2024, the company said in a regulatory
inspection of Unit-V, an active pharma- fi ling. The US FDA closed the inspec-
Under the terms of the agreement, ceutical ingredient (API) manufac- tion with two observations, which are
SII has committed to priority supply of turing facility of its wholly-owned subsi- described as procedural in nature. Auro-
the chikungunya vaccine at an afforda- diary, Apitoria Pharma Pvt. Ltd. The bindo Pharma said the company will
ble price to public health markets in inspection of the facility situated respond to these observations within
LMICs. at Pashamylaram Village, Patancheru the stipulated time frame.

142 Chemical Weekly December 31, 2024

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