Page 148 - CW E-Magazine (11-6-2024)

Pharmaceuticals Pharmaceuticals

EXPANDED OFFERINGS COLLABORATION
Dr. Reddy’s CRDMO arm, Aurigene, opens new Canada’s Willow and Laurus Labs ink API development

biologics facility in Hyderabad and licensing partnership

Dr. Reddy’s Laboratories’ contract re- Canadian biotech fi rm, Willow Bio- guaranteed R&D payments in year one. Willow’s BioOxi biological hydroxy-
search, development and manufacturing sciences, has announces a multi-product Upon commercialisation of the APIs, lation platform solves for selective
organisation (CRDMO) arm, Aurigene development and licensing partnership Willow will receive an annual royalty C-H hydroxylation at industrial scale –
Pharmaceutical Services Ltd., has opened with Hyderabad-based Laurus Labs. based on worldwide sales. often referred to as one of the “Holy
a new biologics facility spread over 70,000 Grails” of chemistry. BioOxi-enabled
sq ft in Genome Valley, Hyderabad. Through this partnership, Willow Laurus has commercialised more biomanufacturing of ingredients can
will leverage its AI-driven technology than 80 products since its inception. remove multiple chemical steps and
The facility is designed to serve platform and experience in enzyme, Laurus has nine manufacturing facili- signifi cantly reduce cost and resources.
customers with process & analytical strain, and process engineering to deli- ties including fermentation capabilities. Commenting on the collaboration,
development and small scale manufac- ver biobased processes for high-value CEO of Laurus Labs Dr. Satyanarayana
turing of antibodies and other recombi- Active Pharmaceutical Ingredients Laurus said it recognised the need Chava said, “Willow has demonstrated
nant proteins for preclinical and early (APIs) with existing markets, including to employ more sustainable methods through its bioengineering technology
phase clinical requirements. The pro- mers seeking to rapidly enter and progress Global Commercial Head – Biologics, Willow’s BioOxi-based corticosteroid to manufacture its APIs with reduced platform a unique capability to signi-
cess and analytical development labo- through clinical development. The open- Aurigene, added, “There are very few processes, for large scale manufactur- cost and less waste and thus, identifi ed fi cantly reduce the cost of API pro-
ratories are now operational while the ing of this facility is one of multiple stra- global CDMOs that can truly support ing, sales, and distribution at Laurus. Willow’s expertise and, specifi cally, its duction while enabling greater product
commissioning of manufacturing capa- tegic initiatives that Aurigene is imple- customers ‘end-to-end’ from discovery Willow and Laurus expect these fi rst AI-driven BioOxi platform, for deve- availability.”
city will be completed later in 2024, menting to support rapid growth in both services to large scale commercial manu- programmes to reach commercial manu- loping bioprocesses to key APIs. This
the company informed in a press note. the small molecule and biologics spaces, facture of both drug substance and drug facture in 2025. new partnership will start with the con- “This strategic partnership is the
The facility is expected to ensure seam- as illustrated by recent announcements product. Our new facility further streng- tinued optimisation and scaling of Wil- culmination of Willow’s new focus on
less transfer to large-scale commercial related to AI/ML-led drug discovery in thens Aurigene’s capabilities and builds on Under the terms of the collabora- low’s BioOxi platform, along with deve- pharmaceutical ingredients and invest-
CGMP manufacturing facilities. It is small molecules and a collaboration with our technical excellence, demonstrated tion, Willow expects to earn signifi cant lopment of new processes for targets ment over the past two years,” said
complementary to the company’s cur- Vipergen, a DNA-encoded library (DEL) global compliance and state-of-the-art annual revenues in research & develop- within Laurus’ API and other ingredient Dr. Chris Savile, Willow’s President &
rent discovery capabilities and infra- technologies service provider,” the press facilities as companies from start-up bio- ment and royalties, including $4-mn in portfolios. CEO.
structure, which primarily focuses on note stated. Mr. Akhil Ravi, CEO, Auri- techs to global multinationals continue to
recombinant proteins including mAbs, gene, said that the addition of this capa- strengthen their supply chains and seek MARKETING NOD
bi- and multi-specifi cs, immune-fusion city and capabilities shows the company’s economically viable support for both
molecules, antibody drug conjugates commitment to the continued expansion their development portfolios and marketed Aurobindo Pharma secures marketing authorisation
and other complex proteins. of its biologics business. Dr. Roger Lias, products.” for trastuzumab biosimilar in India

With the new facility, Aurigene’s ‘India’s pharma export sales to
end-to-end service offering now deli- Aurobindo Pharma said it has The product, which is used in treat- requirements, a decision may be made
vers solutions from, discovery through grow faster this year’ received its fi rst marketing authorisation ing some types of early and metastatic towards the end of Q3 or early Q4
large-scale commercial manufacturing for the biosimilar drug trastuzumab, breast cancers, is also fi led with the of FY25.
from three proximally located campuses India’s pharmaceutical export sales Mr. Udaya Bhaskar, Director General of which is used for breast cancer treat- European Medicines Agency by the
(discovery, process development/ growth is expected to pick up to nearly Pharmexcil, told Reuters on the sidelines ment, in the Indian market in the Hyderabad-based Aurobindo, and the In July last year, Aurobindo Pharma
clinical manufacture and large scale 11% this fi scal year, from a roughly 10% of an event in Hyderabad. Among them current fi nancial year. review procedure has already started. announced that the breast cancer bio-
commercial manufacture) thus ensuring increase last year, according to Pharma- the US is a key market – it accounts for The fi ling for the US is in progress, and similar product, BP02 (trastuzumab or
seamless delivery from “concept to ceuticals Export Promotion Council of about 30% of India’s annual pharma “We have promptly applied for a the company is expecting to complete biosimilar to Herceptin), developed by
commercial”, Dr. Reddy’s informed. India (Pharmexcil). Exports are expected exports after a nearly 16% increase in manufacturing license, which we ex- the USFDA fi ling also in the next three its wholly owned subsidiary company,
to cross $31-bn in the year ending March fi scal 2024, according to Pharmexcil. The pect to obtain very soon. So, the plan is months. CuraTeq Biologics Pvt. Ltd., has met
“The newly opened Genome Valley 31, compared with exports of nearly country’s drug shortages as well as the to manufacture the batches and launch its primary endpoint in phase 3 clinical
facility will deliver robust, compliant and $28-bn in fi scal 2024. increased use of drugs for lifestyle dis- the product in the second half of this According to Dr. Makkapati, if the trial and shown equivalent effi cacy to
economically viable cell lines, process eases such as diabetes, hypertension and year (FY25) in the domestic market,” procedure unfolds well with the Euro- Herceptin in regard to its clinical res-
development solutions and supporting The growth markets will be the United depression will aid demand for India’s said Dr. Satakarni Makkapati, CEO- pean Medicines Agency without any ponse, in addition to demonstrating a
analytical methods in support of custo- States, UK, Latin America and Africa, affordably priced drugs, Mr. Bhaskar said. Biosmilars, Aurobindo Pharma. glitches or without any additional data comparable safety profi le.

148 Chemical Weekly June 11, 2024 Chemical Weekly June 11, 2024 149

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