Page 145 - CW E-Magazine (22-7-2025)

Pharmaceuticals Pharmaceuticals

NOVEL TREATMENT mum sales price and to allocate quotas, Transo-Pharm a total of €13.4-mn for and in line with its usual practice, the
adding that it may also have exchanged their involvement in the cartel. C2 investigation against Alchem continued
Sun Pharma launches baldness drug in US after commercially sensitive information Pharma escaped a fi ne because it had under the standard cartel procedure.
with competitors. alerted the regulator about the cartel.
settling patent dispute This is the fi rst cartel that the Com-
In October 2023, the Commission Alchem decided not to settle this mission sanctioned in the pharmaceuti-
Sun Pharma has launched its novel attacks hair follicles, resulting in were raised or could have been raised fi ned Alkaloids of Australia, Alkaloids cartel case with the Commission, un- cal sector and in relation to an active
alopecia or anti-baldness drug ‘Leqselvi’ partial or complete loss of hair on the in that litigation. The launch of the drug Corporation, Boehringer, Linnea and like the other participants. As a result, pharmaceutical ingredient.
in the US following an out-of-court scalp and body. has been delayed by almost a year due
settlement of a patent dispute with US- to the ongoing patent litigation. COLLABORATION
based Incyte Corp. Sun had acquired Sun will pay Incyte an upfront
the drug as part of Concert Pharma amount, plus ongoing royalty payments The drug demonstrated rapid results Glenmark arm, AbbVie ink $700-mn cancer drug
which it bought for $576-mn or until the expiry of the patents, in ex- in clinical trials with one third of pati-
Rs. 4,600-crore. change for the settlement and license. ents regaining almost all hair by week licensing deal
The details of settlement were not 24. Some patients (3%) achieved 80%
“Leqselvi (deuruxolitinib) 8-mg disclosed. or more scalp coverage within just Ichnos Glenmark Innovation (IGI), in emerging markets including the rest developed using IGI’s proprietary
tablets are now available to healthcare eight weeks. However, the drug may an alliance between New York-based of Asia, Latin America, the Russia/CIS BEAT protein platform, for oncology
scientifi c research group Ichnos Sciences region, the Middle East, Africa, Aus-
and autoimmune diseases.
providers and people living with severe Under the terms of agreement, the cause serious side effects including and Mumbai-based Glenmark Pharma- tralia, New Zealand and South Korea.
alopecia areata in the US,” the company parties will seek dismissal of the pend- infections, malignancies, thrombosis, ceuticals, has signed an exclusive AbbVie will get these rights exclusively The drug candidate can change the
said in a notice to the stock exchanges. ing ‘Leqselvi’ litigation in the United gastrointestinal perforations, and cer- global licensing pact with US-based for North America, Europe, Japan, and treatment landscape in multiple myeloma,
States District Court for the District of tain laboratory abnormalities. There
Alopecia areata is an autoimmune New Jersey. Sun and Incyte will mutu- also may be an increased risk of mor- AbbVie to develop and commercialise Greater China. said Mr. Saldanha. Sales of drugs in
disease in which the immune system ally release each other of all claims that tality and major cardiovascular events. IGI’s innovative drug ‘ISB 2001’ used this segment are projected at $50-bn
for treating a rare form of blood cancer. “Multiple myeloma is a very com- in 2030, by when this drug is expected
petitive space and there are a lot of to be in the market. “We need more
Lupin and Zentiva ink biosimilar license and supply IGI, a clinical stage biotechnology assets being developed but AbbVie is successes, every success will bring

fi rm focused on oncology, will receive super confi dent about this asset and that’s more attention to innovation in India. A
agreement an upfront payment of $700-mn (about why they are paying $700-mn upfront deal of this magnitude should bring that
Rs. 6,000-crore) from AbbVie. It is also which is among the top 3-5 licensing attention,” he pointed out.
Lupin and Czech Republic’s Zen- mercialisation activities outside USA milestone payments up to $50-mn. The
tiva Group have entered into a license and Canada, predominantly in Europe profi ts from the defi ned markets will be eligible to receive up to $1.2-bn in deve- deals in the last two years,” said On the R&D spending on the mole-
lopment, regulatory, and commercial mile-
Mr. Glenn Saldanha, Managing Director,
and supply agreement for commerciali- and CIS markets. Lupin will undertake shared between the two companies. stone payments, along with tiered, dou- Glenmark Pharmaceuticals. cule, Mr. Saldanha said, “We have
sation of Lupin’s biosimilar Certoli- commercialisation in the remaining ble-digit royalties on net sales of the asset. spent about $70-mn a year and that will
zumab Pegol, across multiple markets regions, including USA and Canada. Certolizumab Pegol is indicated The drug candidate is in Phase-I be the ongoing spend and they (IGI)
globally. for the treatment of patients with rheu- In a regulatory fi ling, Glenmark said clinical trials and has shown promising will now start using that capital for
Both parties will invest in the deve- matoid arthritis, polyarticular juvenile
Lupin will be responsible for the lopment of the new biosimilar. Lupin idiopathic arthritis, psoriatic arthritis, it will develop, manufacture, and lead outcomes in patients with relapsed/re- developing the rest of the multi-specifi c
development, manufacturing and sup- will receive an initial payment of non-radiographic axial spondyloarthri- commercialisation efforts of ‘ISB 2001’ fractory multiple myeloma. It was assets in their portfolio.”
ply of the product within the agreed $10-mn upon execution of the agreement tis, moderate-to-severe plaque psoriasis Biosimilars could help push India’s drug exports to $1 trillion by 2030
territories. Zentiva will oversee com- and total development and regulatory and Crohn’s disease.

TRADING TROUBLES Biosimilars are poised to drive he was quoted as saying in an Economic Europe,” Mr. Joshi said. “These fi rms
the next wave of growth in the Indian Times report. That would be about half have the fi nancial muscle, global regu-
EU Commission fi nes Alchem for participating pharmaceutical industry and help the of the whole pharma exports, which is latory experience, and technological
country achieve its ambitious goal of expected to grow to $120-130-billion by infrastructure to navigate the complexi-
in API price fi xing cartel $1-trillion in drug exports by 2030, accor- 2030 from $50-$55-billion at present. ties involved in the development and
ding to Mr. Namit Joshi, Chairman approval of such products.” According
The European Commission has The Commission said Alchem antispasmodic drug Buscopan and its of Pharmexcil, the export promotion “Large Indian pharmaceutical to him, biologics, biosimilars, digital
fined Haryana-based pharma firm, breached EU antitrust rules by partici- generic version. agency under the commerce and industry companies such as Biocon, Dr. Reddy’s, therapeutics and other high-value, inno-
Alchem International Pvt. Ltd. and its pating in a cartel with other drugmakers ministry. and Cipla have already begun to make vation-driven categories represent the
subsidiary Alchem International (H.K.) involving the ingredient N-Butylbro- The watchdog found that, for more considerable strides in biologics and next phase of growth beyond traditional
Ltd. €489,000 (almost Rs. 5-crore) for mide Scopolamine/Hyoscine (SNBB), than 12 years, Alchem and other cartel The country’s biosimilars market has biosimilars, with product launches generics, offering opportunities to
breaching EU antitrust rules. which is used to make the abdominal members coordinated to fi x the mini- the potential to exceed $60-bn by 2030, in advanced markets like the US and move up the global value chain.

144 Chemical Weekly July 22, 2025 Chemical Weekly July 22, 2025 145

Contents Index to Advertisers Index to Products Advertised