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Global Briefs: Ferring, Lilly, Astellas, Menarini & More 

A roundup of news from the large and mid-sized bio/pharmaceutical companies featuring Ferring Pharma, Eli Lilly and Company, Astellas, Menarini, Roche, Celltrion, Regeneron Pharmaceuticals and Teva. Highlights below.  

For the latest news roundup on small and Emerging Pharma companies, see Biotech Briefs. 

M&A News 
* Ferring Pharma To Acquire Gameto for $1.4 Bn 
* Teva Acquires BioXCel’s Neuroscience Drugs in $125-M Deal
Partnering News 
* Astellas, Audaxs in $1.3-Bn Deal for Preclinical Immuno-Oncology Fusion Molecule
* Menarini, Georgiamune in $1.1-Bn Pact for Small-Molecule Autoimmune Drug 
* Roche, Zymeworks in $813-M Pact for Trispecific T Cell Engager for Cancer 
* Celltrion, Kaigene in $580-M Pact for mAb for Autoimmune Diseases 
* US Gov’t, Regeneron Extend Supply Pact for Ebola Drug for $270 M 
Appointments 
* Lilly Announces Leadership Changes

M&A News 

Ferring Pharma To Acquire Gameto for $1.4 Bn 
Ferring Pharmaceuticals, a Saint-Prex, Switzerland-based bio/pharmaceutical company, has agreed to acquire Gameto, a bio/pharmaceutical company focused on women’s reproductive health, in a deal worth up to $1.38 billion. 

Gameto is applying cell engineering to develop treatments for women’s reproductive health, starting with infertility. The company’s proprietary in vitro maturation platform, Fertilo, uses bioengineered ovarian support cells derived from induced pluripotent stem cells to mature immature eggs outside the body. Gameto’s in vitro maturation platform is investigational in the US and has not been approved by the US Food and Drug Administration. 

The transaction is subject to customary closing conditions. 

Source: Ferring Pharmaceuticals  

Teva Acquires BioXCel’s Neuroscience Drugs in $125-M Deal 
Teva Pharmaceuticals has acquired late-stage neuroscience investigational assets from BioXcel Therapeutics, a New Haven, Connecticut-based bio/pharmaceutical company, including worldwide rights to BXCL501, a schizophrenia or bipolar I or II disorder drug candidate for at home use, in a deal worth up to $125 million ($57.5 million upfront and $67.5 million in milestone payments).  

BXCL501 is an investigational dexmedetomidine sublingual film under review by the US Food and Drug Administration (FDA) for at-home use in the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. Teva also acquired Igalmi (dexmedetomidine), an FDA-approved dexmedetomidine sublingual film for the treatment of agitation associated with schizophrenia or bipolar I or II disorder in a hospital setting. The application for the approval of BXCL501 has been submitted as a supplemental new drug application (NDA) to the Igalmi NDA. 

Teva acquired the assets for $57.5 million upfront and up to $67.5 million in contingent payments. These include a range of time-based payments linked to regulatory approval, including potential delays in approval, as well as payments tied to the achievement of specified sales milestones. Teva acquired the assets in being the successor bidder for them as part of US bankruptcy proceedings of BioXcel.  

Source: Teva Pharmaceuticals 

Partnering News 

Astellas, Audax in $1.3-Bn Deal for Preclinical Immuno-Oncology Fusion Molecule
Astellas Pharma and Audax Biosciences, a Melbourne, Australia-based bio/pharmaceutical company, have entered into an exclusive option and license agreement for DAX-044, Audax’s lead immuno-oncology drug candidate, in a deal worth up to $1.3 billion ($285 million upfront and $1.05 billion in milestone payments).  

Under the agreement, Astellas receives an exclusive option which, on exercise, will grant Astellas a worldwide license to develop, manufacture, and commercialize DAX-044. Audax has the option to co-fund and co-promote DAX-044 in Australia and New Zealand.  

DAX-044 is an investigational, immune-targeted interleukin-12 (IL-12) antibody-cytokine fusion molecule to concentrate IL-12’s immune-activating activity within the tumor microenvironment while limiting the systemic toxicity that has historically constrained IL-12-based therapy. DAX-044 has demonstrated a potential best-in-class therapeutic index for an IL-12 agent in preclinical studies and is currently in IND/CTN-enabling development, according to information from Astellas. 

Under the agreement, Audax will receive upfront and a potential future option-exercise payment totaling $285 million and continue development of DAX-044 into a Phase I study, which is expected to commence in 2027. Upon exercising its option, Astellas will assume sole responsibility for global development, manufacturing, and commercialization, with Audax having the option to co-fund and co-promote DAX-044 in Australia and New Zealand. In addition, Audax will be eligible to receive development and commercial milestone payments of up to $1.05 billion, as well as tiered double-digit royalties on worldwide net sales of DAX-044, if approved. Exercise of the option is subject to customary conditions, including receipt of applicable antitrust clearances. 

Source: Astellas 

Menarini, Georgiamune in $1.1-Bn Pact for Small-Molecule Autoimmune Drug
Menarini, a Florence, Italy-based bio/pharmaceutical company, a Gaithersburg, Maryland-based clinical-stage bio/pharmaceutical company focused on cancer and autoimmune diseases, have announced an exclusive worldwide license and collaboration agreement for GIM-621, an oral drug for treating solid tumors, in a deal worth up to $1.1 billion. 

GIM-621 is a preclinical-stage oral small-molecule immunotherapy with potential application across multiple solid tumors. It is one of multiple therapeutic candidates generated from Georgiamune’s research into mechanisms governing immune activation, suppression, and homeostasis. 

Under the agreement, Stemline receives an exclusive, worldwide license to develop, manufacture and commercialize GIM-621. Georgiamune will receive $45 million in upfront and near-term payments. Georgiamune is also eligible for preclinical, development, regulatory, and commercial milestone payments, for a total potential deal value of up to $1.1 billion, plus royalties. 

Source: Menarini 

Roche, Zymeworks in $813-M Pact for Trispecific T Cell Engager for Cancer 
Roche and Zymeworks, a British Columbia, Vancouver, Canada-based bio/pharmaceutical company, have entered into a global license and collaboration agreement for the research, development, and commercialization of ZW209, a trispecific T cell engager, in a deal worth up to $813 million ($55 million upfront and $758 million in milestone payments). 

ZW209 is a trispecific T cell engager developed to target DLL3-expressing tumor cells while simultaneously engaging T cells via binding to CD3 and CD28. ZW209 is structured to prevent unintended T cell activation while enabling tumor-targeted cytotoxicity. Preclinically, ZW209 has demonstrated differentiated long-term cytotoxicity in vitro, with enhanced T cell proliferation and survival. 

Under the agreement, Zymeworks is eligible to receive an upfront payment of $55 million, a $40-million payment upon initiation of the Phase Ib trial, and additional development, commercial, and sales-based milestone payments of up to $718 million, and tiered high-single digit to mid-teen royalties on future net sales of any approved medicines resulting from the collaboration. 

Source: Zymeworks 

Celltrion, Kaigene in $580-M Pact for mAb for Autoimmune Diseases 
Celltrion, an Incheon, South Korea-based bio/pharmaceutical company, and Kaigene, a Rockville, Maryland-based bio/pharmaceutical company focused on autoimmune diseases, have announced an exclusive worldwide licensing agreement for KG013, a monoclonal antibody for IgA nephropathy, an autoimmune kidney condition, in a deal worth up to $580 million. 

Under the agreement, Kaigene grants Celltrion exclusive worldwide rights to develop and commercialize KG013. Kaigene is eligible to receive up to $580.5 million in total consideration comprising an upfront payment and development, regulatory, and commercialization milestone payments, with milestone payments contingent on achieving the relevant objectives. Royalties on net sales are payable separately. Kaigene retains the option to participate in co-marketing in South Korea, subject to the terms of the agreement. 

KG013 is a half-life-extended, fully human Anti-a Proliferation-Inducing Ligand (APRIL) monoclonal antibody with femtomolar binding affinity, being developed for long-acting subcutaneous administration. APRIL is a signaling protein that supports plasma cell survival and immunoglobulin production. By inhibiting this pathway, KG013 is intended to suppress the production of pathogenic IgA and IgM antibodies. Its development aims to deliver sustained target inhibition while reducing treatment burden for patients who may require long-term therapy.  

Source: Kaigene 

US Gov’t, Regeneron Extend Supply Pact for Ebola Drug for $270 M 
Regeneron Pharmaceuticals, a Tarrytown, New York-based bio/pharmaceutical company, has extended its agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services to provide additional supply of Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a treatment for Ebola disease, in a deal worth up to $270 million.  

Inmazeb was approved by the US Food and Drug Administration (FDA), indicated specifically for infection caused by Orthoebolavirus zairense in adult and pediatric patients. The agreement continues a partnership that began with BARDA’s original procurement of the treatment in 2020. Under the new agreement, Regeneron expects to deliver additional treatment doses of Inmazeb to the US government through 2031 and receive payment of approximately $270 million. 

Source: Regeneron Pharmaceuticals 

Appointments 

Lilly Announces Leadership Changes  
Eli Lilly and Company has announced that Patrik Jonsson, Executive Vice President and President, Lilly International, has decided to retire at the end of 2026 after a 36-year career at the company. Effective January 1, 2027, Lilly’s US and international businesses will come together as Lilly Global Markets, led by Ilya Yuffa, currently Executive Vice President and President, Lilly USA and Global Customer Capabilities, who will become Executive Vice President and President, Lilly Global Markets. 

Yuffa joined Lilly in 1996 as a financial analyst and has held leadership roles in finance, business development, sales, and general management, including President and General Manager of Lilly’s Italy Hub, which covered more than 25 countries, President of Lilly Bio-Medicines, President of Lilly International and currently Executive Vice President and President, Lilly USA and Global Customer Capabilities. 

With the change in organizational structure and leadership, the following executives will lead the company’s six geographic hubs and report to Yuffa: 

  • Laura Steele, currently Group Vice President, US Cardiometabolic Health, will be promoted to President, Lilly USA. In 23 years at Lilly, Steele has held leadership roles in marketing, value and access, and commercial operations inside and outside the US, including Lilly’s U.S. neuroscience business. 
  • Elias Khalil, currently President and General Manager of Lilly’s Italy Hub, will be promoted to Group Vice President and President, Lilly Europe and Canada. In 18 years at Lilly, Khalil has held leadership roles across the Gulf region, Saudi Arabia and the US neuroscience business. 
  • Nabil Daoud will continue in his role as Group Vice President and President, Lilly InterContinental. 
  • Karla Alcazar, Huzur Devletsah and Winselow Tucker will continue in their roles as President and General Manager of Lilly Japan, Lilly China, and Lilly India, respectively. 

Source: Eli Lilly and Company