A roundup of news from Merck & Co. Inc./Curon Biopharmaceutical, Lilly/Organon, BioMarin Pharmaceutical. Lexicon Pharmaceuticals, and Crown Laboratories/Revance. Highlights below. 

Mergers & Acquisitions 
* Merck & Co. To Acquire Bispecific Antibody from Curon Bio in $1.3-Bn Deal
* Skincare Company Crown Laboratories To Acquire Bio/Pharma Company Revance for $924 M 
Partnering 
* Lilly, Organon Expand Commercialization Pact for Lilly’s Migraine Drug 
Restructuring 
* BioMarin Restructuring Ops Relating to Gene Therapy Roctavian 
* Lexicon Pharmaceuticals Announces Restructuring Plan 

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Mergers & Acquisitions 

Merck & Co. To Acquire Bispecific Antibody from Curon in $1.3-Bn Deal 
Merck & Co. and Curon Biopharmaceutical, a Shanghai-based bio/pharmaceutical company, have entered into an agreement under which Merck, through a subsidiary, has agreed to acquire Curon’s CN201, a clinical-stage bispecific antibody for treating B-cell associated diseases, in a deal worth up to $1.3 billion ($700 million upfront and $600 million in milestone payments). 

CN201 is a CD3xCD19-targeting T-cell-engager bispecific antibody, designed to target B cells for elimination by T cells. CN201 is currently being evaluated in Phase I and Phase Ib/II clinical trials for the treatment of relapsed or refractory non-Hodgkin’s lymphoma and relapsed or refractory acute lymphocytic leukemia, respectively. 

Under the agreement, Merck will acquire full global rights to CN201 for an upfront payment of $700 million in cash. Curon is also eligible to receive up to $600 million in milestone payments associated with the development and regulatory approval of CN201. Closing of the proposed transaction is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in the third quarter of 2024.  

Source: Merck & Co. 

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Skincare Company Crown Laboratories To Acquire Bio/Pharma Company Revance for $924 M 
Crown Laboratories, a Johnson City, Tennessee-based skincare company, and Revance Therapeutics, a Nashville, Tennessee-based bio/pharmaceutical company, have agreed to merge in a $924-million deal.  

The combined company’s flagship brands include: Daxxify (toxin), the RHA Collection (filler), SkinPen (microneedling), PanOxyl (acne), Blue Lizard (sunscreen), and StriVectin (anti-aging). 

Under the agreement, which has been unanimously approved by Revance’s Board of Directors, Crown will commence a tender offer to acquire all outstanding shares of Revance’s common stock for $6.66 per share in cash, representing a total enterprise value of $924 million.  

Source: Crown Laboratories 

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Partnering 

Lilly, Organon Expand Commercialization Pact for Lilly’s Migraine Drug  
Eli Lilly and Company and Organon, the former biosimilars, women’s health and certain legacy established brands from Merck & Co, which were spun off in a separate company in 2021, have entered an agreement under which Organon will become the sole distributor and promoter for Lilly’s migraine medicine, Emgality (galcanezumab), in certain additional markets: Canada, Colombia, Israel, South Korea, Kuwait, Mexico, Qatar, Saudi Arabia, Taiwan, Turkey and the United Arab Emirates. This expanded partnership builds on Organon’s role as sole distributor and promoter of Emgality in Europe since February 2024. 

Emgality, a humanized monoclonal antibody calcitonin gene-related peptide (CGRP) antagonist, is indicated for the preventive treatment of migraine in adults, and in some markets, the indication specifies prophylaxis for those with at least four migraine days per month. Emgality is also indicated in some markets for the treatment of episodic cluster headache in adults. 

Lilly will remain the marketing authorization holder and will manufacture the product for sale. Total consideration to be paid to Lilly for the expansion of territory includes an upfront payment of $22.5 million as well as sales-based milestone payments. 

Source: Organon 

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Restructuring 

BioMarin Restructuring Ops Relating to Gene Therapy Roctavian 
BioMarin Pharmaceutical, a Dublin, Ireland-based bio/pharmaceutical company, has announced a restructuring relating to Roctavian (valoctocogene roxaparvovec-rvox), an adeno-associated virus vector-based gene therapy for treating certain forms of severe hemophilia A. 

The company says it will focus commercial operations on three markets, the US, Germany, and Italy, where the medicine is approved and reimbursed as a treatment for severe hemophilia A. With ample commercial supply of Roctavian on hand to serve anticipated demand, the company has placed its gene-therapy manufacturing facility in an idle state until such time when additional production is necessary.    

By focusing commercial, research and manufacturing programs, BioMarin anticipates reducing annual direct Roctavian expenses to approximately $60 million, beginning in 2025. The company has already begun to operationalize the reduction of Roctavian expenses this year to achieve $60 million in expenses beginning in full-year 2025. As a result of these changes, the company expects Roctavian to be profitable by the end of 2025. Roctavian had first-half 2024 revenues of $7 million 

Source: BioMarin Pharmaceutical 

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Lexicon Pharmaceuticals Announces Restructuring Plan 
Lexicon Pharmaceuticals, a The Woodlands, Texas-based bio/pharmaceutical company, has announced a new restructuring plan. 

Under the plan, the company will optimize its promotional efforts for Inpefa (sotagliflozin) in heart failure and reallocate resources to support the potential commercial launch of Zynquista (sotagliflozin) for improvement of glycemic control in adults with Type 1 diabetes and chronic kidney disease. The company expects these efforts to result in cost savings of approximately $40 million for 2025 while ensuring all R&D programs, including the Phase III study of sotagliflozin in hypertophic cardiomyopathy and the ongoing Phase IIb dose-optimization study of LX9211 in diabetic neuropathic pain are fully funded. 

Additionally, Lexicon is reducing its headcount by more than 75, or approximately 50% of its current field force, by the end of the third quarter of 2024. 

Source: Lexicon Pharmaceuticals