Lupin, Inc.

A partial clinical hold on BioNTech's ADC candidate, Takeda's option deal with Ascentage, and a senior leadership meeting between Chinese and U.S. drug regulators made our news this week. BioNTech and MediLink's HER3 ADC has been put on a partial clinical hold by the FDA. Takeda has identified a potential challenger to Novartis' Scemblix. Senior officials from China and U.S. drug authorities met at the FDA's headquarters for the first time since 2017. And more. 1. FDA halts trial of BioNTech-MediLink ADC over 'significant risk of illness' The FDA has put a partial hold on a phase 1 trial of MediLink Therapeutics’ BioNTech-partnered HER3-targeted antibody-drug conjugate. A BioNTech presentation recently showed that as of Feb. 4, two patients from the fifth dose cohort and one in the seventh dose group had died in the study. In the slides, BioNTech said it will focus further clinical development on lower dose levels. 2. Takeda circles leukemia rival to Novartis' Scemblix in up to $1.3B deal with Ascentage Takeda is paying $100 million for an option to license a third-generation BCR-ABL tyrosine kinase inhibitor from China’s Ascentage Pharma. The drug, called olverembatinib and already approved in China, is a competitor to Novartis’ Scemblix in chronic myeloid leukemia. Takeda is also making a $75 million investment in Ascentage, which is in line for up to about $1.2 billion in milestones if everything plays out positively. 3. China’s NMPA visits US in first senior-level meeting at FDA HQ since 2017 (tweets) Deputy Commissioner Zhao Junning of China’s National Medical Products Administration met with FDA Deputy Commissioner Kim Trzeciak Tuesday in the first senior-level meeting between the two agencies at FDA’s headquarters since 2017. The two agencies discussed the 2007 FDA-SFDA China Agreement on the Safety of Drugs and Medical Devices, including their 2024 work plan, according to the FDA. 4. Day One inks $1.2B biobucks pact for MabCare’s solid tumor ADC Day One Biopharmaceuticals paid $55 million up front to get its hands on ex-China rights to MabCare Therapeutics’ antibody-drug conjugate targeting PTK7, which is overexpressed in esophageal, ovarian, lung and endometrial cancers among adults, as well as in neuroblastoma, rhabdomyosarcoma and osteosarcoma in children. The Chinese biotech may get up to $1.15 billion in potential milestones. 5. Takeda flunks pivotal epilepsy tests but mulls path to market for Ovid-partnered prospect Takeda’s soticlestat, for which it paid Ovid Therapeutics $196 million to partner on, missed the primary endpoints in two phase 3 trials in two forms of epilepsy, refractory Lennox-Gastaut syndrome and Dravet syndrome, respectively. Still, arguing that the cholesterol 24 hydroxylase inhibitor showed some treatment effects, Takeda said it will discuss the totality of the data with the FDA. 6. India's Lupin announces CEO pick for new subsidiary as it moves into the CDMO arena Lupin is venturing into the CDMO space with its new subsidiary Lupin Manufacturing Solutions, which will work on the development, production and sale of active pharmaceutical ingredients. The unit will be led by Abdelaziz Toumi, who previously worked at Bayer, Catalent, Lonza and other companies. Lupin has in the past dealt with drug recalls and FDA citations.   7. Emergent, pivoting away from CDMO business, sells Baltimore plant to acquisitive Bora for $30M Emergent BioSolutions has agreed to sell its fill-finish drug product facility in Baltimore-Camden to Taiwanese CDMO Bora Pharmaceuticals for $30 million. Bora intends to keep about 350 Emergent employees currently stationed at the 87,000-square-foot facility. The deal follows Bora’s $210 million acquisition of Minnesota generic manufacturer Upsher-Smith Laboratories earlier this year. Other News of Note:  8. Innovent braves bruising cytokine space, linking fusion protein to tumor responses in small study 9. Samsung Biologics upgrades another production pact, this time with Baxter for $223M 10. Mission Based Media unveils ad-free model for health podcasts, including Eisai-backed Alzheimer’s series 11. Biocon looks for partner to trial generic to Novo’s Wegovy, Ozempic in China

Lupin got its start back in 1968 as an Indian vitamin manufacturer, thanks to 5,000 rupees founder Desh Bandhu Gupta borrowed from his wife. From vitamin maker to pharmaceutical specialist and now contract manufacturer, India’s Lupin is embarking on a new phase of its corporate journey. Lupin on Monday unveiled its new subsidiary, Lupin Manufacturing Solutions, which is poised to work on the development, production and sale of active pharmaceutical ingredients. The company is now starting to build out its contract development and manufacturing operations business, Lupin explained in a press release. At the same time, Lupin announced Abdelaziz Toumi will take the reins as CEO of the newly formed unit. Toumi’s track record includes stints at Bayer, Merck, Catalent, Lonza and KBI Biopharma. He will be based in Switzerland and spend a considerable amount of time in India, Lupin said. “We are delighted to welcome Abdel to our team,” Lupin’s managing director, Nilesh Gupta, said in a statement. “He brings a wealth of knowledge and experience in the API CDMO space and will be instrumental in establishing LMS as a trusted and preferred partner for our global customers.” Lupin got its start back in 1968 as an Indian vitamin manufacturer, thanks to 5,000 rupees founder Desh Bandhu Gupta borrowed from his wife. The company’s first manufacturing plant churned out iron and folic acid tablets for India’s government as part of a countrywide program aimed at improving maternal and childhood health. Soon after, Lupin started producing drugs for tuberculosis, according to its website. Meanwhile, Lupin has made headlines in recent years courtesy of recalls and FDA citations. That said, the company recently cleared an FDA inspection of its plant in Nagpur, India, with zero observations. Prior to that, Lupin revealed it had signed a license and supply agreement with Thailand’s OLIC to market Fuji Pharma’s pregnancy prevention drug Nextstellis in Vietnam and the Philippines. And, last summer, Lupin became the first company to score approval in the U.S. for its generic version of Boehringer Ingelheim’s blockbuster chronic obstructive pulmonary disease treatment Spiriva HandiHaler. The approval marked the first in the U.S. for a dry powder inhaler from India, Lupin’s CEO, Vinita Gupta, said at the time. Lupin’s manufacturing footprint spans 15 facilities across India, the U.S., Brazil and Mexico, with the company claiming its “pe-eminence as a leader in formulations and APIs.” Nevertheless, the company has run into production shortfalls before. Last summer, the company recalled two batches of birth control pills on the fact that they may not have been effective at preventing pregnancy. At the time, Lupin said testing on one of the lots of Tydemy tablets found low levels of ascorbic acid and high levels of a “known impurity.” Prior to that, Lupin in Nov. of 2022 received another in a series of Form 483 citations from the FDA, with the regulatory wrist slap focusing on the company’s API plant in Manideep, India.  Editor's note: This story has been updated with additional information on Lupin's manufacturing. 

Last month, Baxter announced plans to spin off its renal care and acute therapies units. That includes a restructuring plan that saw layoffs of up to 5% of the company’s global workforce last week. In connection with its new operating model, the company yesterday announced three new presidents for its vertically integrated global business units. Baxter intends to make each appointment effective on March 1, 2023. The company appointed Heather Knight as EVP and group president for medical products and therapies. She originally joined the company from Medtronic in 2019. Knight just last week resigned from Titan Medical’s board. The surgical robot maker has its own cost-cutting efforts in progress. Baxter also named Reaz Rasul as EVP and group president for healthcare systems and technologies. Rasul served as president of front line care, having joined the company in 2017. It appointed Alok Sonig as EVP and group president for pharmaceuticals. Sonig joined Baxter from Lupin, Inc. last year. The company said SVP and President of EMEA, Cristiano Franzi, will serve as interim head of its kidney care global business unit. A search for a new president of that business remains underway, Baxter said. Franzi is set to continue leading the EMEA operations during the search. Baxter plans to complete the design of its new operating model by early in the second quarter of 2023. It expects to implement an updated reporting framework in the second half of the year. Baxter’s board of directors gets a revamp In addition to its executive changes, Baxter’s board of directors is set for a new look, too. Thomas Chen notified the company of his decision to retire from the board, effective April 28, 2023. Baxter expects Cathy Smith to become chair of the board’s nominating, corporate governance & public policy committee immediately after Chen’s retirement. Baxter also decided not to nominate Albert Stroucken for reelection to the board at its 2023 annual stockholder meeting. This falls in accordance with the mandatory retirement age set forth in the company’s governance guidelines. Stroucken’s term expires on April 28, 2023. Baxter plans for Peter Wilver to serve on and become chair of the board’s audit committee following Stroucken’s departure. Following the departure of Chen and Stroucken, Baxter’s director headcount automatically decreases from 12 to 10. The board also appointed D. Brent Shafer as its lead independent director. Shafer served on the board, audit committee and compensation committee since May 2022.