Page 146 - CW E-Magazine (19-12-2023)

Pharmaceuticals Pharmaceuticals

CANCER DRUG COLLABORATION
Zydus Lifesciences inks licensing pact with Daewoong Dr. Reddy’s arm, Coya Therapeutics team up

Pharmaceutical for sclerosis drug development

Zydus Lifesciences Ltd. has an- to co-develop and commercialise the commercialisation milestone payments Dr. Reddy’s Laboratories SA, a the US, Dr. Reddy’s will pay Coya an
nounced a licensing pact with South drug in six dosage strengths for the US based on the successful outcome. wholly-owned subsidiary of Hydera- additional $4.2-mn. Coya anticipates
Korea’s Daewoong Pharmaceutical Co. market. bad-based Dr. Reddy’s Laboratories, that the IND fi ling will be made in the
Ltd., to co-develop and commercialise “We aim to be the fi rst company in has entered into an agreement for the fi rst half of 2024.
a generic version of Leuprolide Acetate While Zydus will take care of clini- manufacturing the generic version of development and commercialisation of
for depot suspension to treat advanced cal development and commercialisation this complex, long-acting injectable,” ‘COYA 302’, an investigational combi- The agreement includes develop-
prostatic cancer, endometriosis and in the US market, Daewoong will be Daewoong Pharma CEO, Mr. Sengho nation therapy for the treatment of ment and regulatory milestones of up
uterine leiomyomata (fi broids). responsible for pre-clinical studies, pro- Jeon said. Amyotrophic Lateral Sclerosis (ALS). to $40 million should all such deve-
duction and supply from its manufactur- lopment and regulatory milestones be
Zydus Worldwide DMCC, a wholly- ing facilities in Osong, South Korea. The drug had annual sales of ap- Under the terms of the agreement, achieved. Additionally, Coya is eligible
owned subsidiary Zydus Lifesciences, proximately $671-mn in the US, with Coya has granted Dr. Reddy’s an exclu- to receive sales-based milestone pay-
and Daewoong Pharma have entered The exclusive agreement also in- a growth rate of 10 %, according to sive licence to commercialise ‘COYA ments of up to $677.25-mn linked to
into an exclusive licensing agreement cludes development, regulatory and IQVIA MAT October 2023 data. 302’, a proprietary co-pack kit contain- America. Coya will be responsible for tiers of cumulative net sales being
ing a combination of low-dose IL-2 the clinical development of COYA 302 achieved over several years (over the
AMALGAMATION PLANS and CTLA-4 Ig (abatacept) in the US, and for seeking regulatory approval. term of the agreement subject to pro-
Orchid Pharma board okays Dhanuka Laboratories merger Canada, the European Union and the UK. Dr. Reddy’s will make a $7.5-mn duct commercial exclusivity).
This agreement is in addition to the in-
The Board of Directors Orchid Pharma into Orchid Pharma as per the scheme, Pharma manufactures and exports active licensing agreement with Dr. Reddy’s, upfront payment to Coya. Upon the fi rst In addition, Dr. Reddy’s will pay
Ltd. has approved a draft scheme of Orchid Pharma’s post scheme share- pharmaceutical ingredients (APIs) and signed in early 2023. FDA acceptance of an investigational Coya royalties based on a percentage of
amalgamation with Dhanuka Labora- holding will be 74.45% for the promoter fi nished dosage forms, but about 68% new drug (IND) application for ‘COYA net sales of ‘COYA 302’, ranging from
tories Ltd. (DLL), subject to approvals and promoter group and 25.5 5% for the of its Rs. 670-crore revenues come from Coya retains the right to commercia- 302’, Dr. Reddy’s will pay Coya an the low to middle teens. Coya is not
from shareholders, creditors, NCLT, BSE, public, compared with the pre-scheme three products – Cefi xime, Cefuroxime lise ‘COYA 302’ for patients with ALS additional $4.2-mn. Upon dosing of the a related party to Dr. Reddy’s or its
NSE, and other regulatory authorities. shareholding of 69.84% and 30.16%, and Ceftriaxone. in Japan, Mexico, and countries in South fi rst patient in the fi rst Phase-2 trial in promoters/promoter group.
respectively.
“There will be a change in the share- The company was started in 1992 REGULATORY CHALLENGES
holding pattern of Orchid Pharma pursu- The proposed amalgamation aligns by an entrepreneur, Mr. K. Raghavendra Dr. Reddy’s slumps on US FDA’s ‘severe’ observations
ant to the scheme, in accordance with the with a resolution plan from May 16, Rao, and was acquired by DLL through a
share exchange ratio,” said the company 2019, aiming to create a larger com- Corporate Insolvency Resolution Process for Bachupally unit
statement. pany with a potential sales turnover of in March 2020. Orchid recently raised
Rs. 1,400-1,500 crore and an EBITDA of Rs. 400-crore through a Qualifi ed Institu- Shares of Dr. Reddy’s Laborato- some of the observations can lead to a mination, data integrity and market
Following the amalgamation of DLL Rs. 200-250 crore. Chennai-based Orchid tional Placement issue. ries (DRL) fell nearly 11% on warning letter for the Bachupally faci- complaints. The Bachupally unit con-
Intas Pharma pulled up for manufacturing lapses December 11 after the US Food & lity. It further said observations 1, 2, tributes to 30% of Dr. Reddy’s overall
Drug Administration (USFDA) made 4, 5, 6, 8 and 9 highlight issues such as revenue from the US and manufac-
at Ahmedabad plant observations on the company’s Bach- out-of-specifi cation microbial conta- tures four out of the top 10 products.
upally, Hyderabad, facility following
its inspection between December 4 Vibcare Healthcare opens pharma
The USFDA has pulled up Intas Chudgar, the USFDA has pointed July 22 to August 2, 2019, it had cited and 8.
Pharmaceuticals Ltd. for manufacturing out various manufacturing lapses at similar CGMP observations. “Repeated facility in Panchkula
lapses, including violation of current the Matoda-Sanand, Ahmedabad-based failures demonstrate that executive man- In a fi ling to the exchanges,
good manufacturing practice (CGMP) facility, which were discovered when agement oversight and control over the Dr. Reddy’s informed about the deve- Vibcare Healthcare has inaugura- lity comprises four specialised produc-
regulation, at its Ahmedabad-based the regulator inspected the facility from manufacture of drugs is inadequate,” it lopment and added that it will address ted a manufacturing facility in Panch- tion units for general tablets, liquids,
plant. May 1-12, 2023. added. FDA may withhold approval of the issues raised by USFDA within a kula, Haryana, at an investment of capsules, and ointments, and is aligned
new applications or supplements listing stipulated timeline. Rs. 40-crore. with global quality standards includ-
In a warning letter to the company’s The USFDA noted that in a previous the fi rm as a drug manufacturer until ing EU GMP, PIC/S, and UKMHRA
CEO and Managing Director, Mr. Nimish inspection, including the inspection of violations are completely addressed. Brokerage fi rm Antique noted that Spanning over fi ve acres, the faci- GMP.

146 Chemical Weekly December 19, 2023 Chemical Weekly December 19, 2023 147

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