Global Briefs: GSK, Lilly, Amgen & More 

A roundup of news from GSK, Eli Lilly and Company, QurAlis, Amgen, Bristol-Myers Squibb, Neurocrine Biosciences, and Incyte. Highlights below.  

Partnering News 
* Lilly, Quralis in $622-Million Pact for Antisense Drug   
* Eli Lilly and Company Appoints Former BMS Executive as Head of Quality 
* Neurocrine Biosciences Names New CEO 
* Amgen Gets FDA OK for Interchangeable Biosimilar of Rare-Disease Blockbuster Drug
* Incyte Expanding HQ Site 
* BMS Announces New 10-Year Plan To Expand Medicines Access in Low- & Middle-Income Countries
M&A News 
* GSK Acquires Elsie Biotechnologies for $50 M 

Partnering News 

Lilly, Quralis in $622-Million Pact for Antisense Drug 
Eli Lilly and Company and QurAlis, a Cambridge, Massachusetts-based bio/pharmaceutical company, have entered into an exclusive license agreement under which QurAlis is granting Lilly global rights to develop and commercialize QRL-204, an antisense oligonucleotide (ASO) for treating certain neurodegenerative diseases, in a deal worth up to $622 million ($45 million upfront, an undisclosed equity investment by Lilly, and $577 million in milestone payments). 

QRL-204 is designed to restore UNC13A function in amyotrophic lateral sclerosis (ALS) (commonly referred to as Lou Gehrig’s disease), frontotemporal dementia (FTD), and other neurodegenerative diseases. UNC13A is a regulator of neurotransmitter release at synapses and is one of several pre-mRNAs that becomes mis-spliced due to loss of nuclear TAR DNA Binding Protein-43 (TDP-43). TDP-43 pathology is implicated in 90% of ALS cases and approximately 50% of FTD cases, according to information from QurAlis.  

Under the agreement, QurAlis granted Lilly an exclusive, worldwide license to develop and commercialize QRL-204 and other UNC13A-targeting compounds in exchange for an upfront payment of $45 million to QurAlis, plus an additional equity investment. QurAlis is also eligible for future milestone payments of up to $577 million and tiered royalties on net sales. 

The agreement includes a research and development collaboration to identify and develop additional candidates targeting UNC13A, using QurAlis’ FlexASO splice-modulator platform. The platform was developed to generate splice-switching ASOs with improved potency and increased therapeutic index.  

Source: QurAlis 


Eli Lilly and Company Appoints Former BMS Executive as Head of Quality 
Elli Lilly and Company has named Melissa Seymour, currently Chief Quality Officer for Bristol-Myers Squibb (BSM), as Lilly’s Executive Vice President of Global Quality and a member of the company’s Executive Committee, effective July 22, 2024. She will succeed Johna Norton, currently Lilly’s Executive Vice President of Global Quality, whose retirement after 34 years of service was announced earlier this year (2024). 

In addition to BMS, Seymour has held senior leadership roles at global pharmaceutical companies, including Biogen as well as with extended experience at Novo Nordisk and GlaxoSmithKline. She has led the development of quality compliance strategies, implemented quality processes and systems, and developed talent to ensure quality and compliance.  

Source: Eli Lilly and Company 

Neurocrine Biosciences Names New CEO 
Neurocrine Biosciences, a San Diego, California-based bio/pharmaceutical company, has announced that Kevin Gorman, Ph.D., will retire as Chief Executive Officer of Neurocrine on October 11, 2024. Kyle Gano, Ph.D., currently Neurocrine’s Chief Business Development and Strategy Officer, will succeed him in the CEO role. Dr. Gano will also join the Company’s Board of Directors at that time, and Dr. Gorman will continue to serve on the Neurocrine Board. 

Gano joined Neurocrine Biosciences more than 23 years ago. After beginning his career at Neurocrine in a market research and analytics role, Dr. Gano assumed the position of Chief Business Development Officer in 2011 and Chief Business Development and Strategy Officer in 2020.  

Source: Neurocrine Biosciences 


Amgen Gets FDA OK for Interchangeable Biosimilar of Rare-Disease Blockbuster Drug 
The US Food and Drug Administration (FDA) has approved Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to AstraZeneca’s Soliris (eculizumab), a blockbuster rare-disease drug. Soliris had 2023 sales of $3.1 billion. AstraZeneca acquired the drug with its $13.3-billion acquisition of Alexion Pharmaceuticals, a Boston, Massachusetts-based bio/pharmaceutical company, in 2021.   

An interchangeable biosimilar is a biosimilar that has been shown to meet other requirements under the law and may be substituted for the reference product without consulting the prescriber. The substitution may occur at the pharmacy, subject to state pharmacy laws, which vary by state, a practice commonly called “pharmacy-level substitution,” similar to generic-drug substitution for brand name drugs. 

Amgen’s Bkemv was approved for treating paroxysmal nocturnal hemoglobinuria, a rare blood disorder, to reduce hemolysis, and for treating atypical hemolytic uremic syndrome, a very rare genetic disease that causes tiny blood clots to form in blood vessels, to inhibit complement-mediated thrombotic microangiopathy. 

Source: The US Food and Drug Administration 

BMS Announces New 10-Year Plan To Expand Medicines Access in Low- & Middle-Income Countries 
Bristol Myers Squibb (BMS) has announced its ASPIRE (Accessibility, Sustainability, Patient-centric, Impact, Responsibility and Equity) plan, a 10-year strategy to advance access to its treatments in low- and middle-income countries (LMICs).  

As part of ASPIRE, BMS is developing tailored strategies to increase affordability and availability of its medicines in LMICs, with 100%  of the company’s marketed products to be supported by access plans.  

In LMICS, the company has introduced local brands of many of its innovative medicines to address affordability issues, expand access, and help reduce the time lag between the availability of its medicines in higher-income countries and lower-income countries.  

BMS is also making its medicines available where it doesn’t have a commercial presence through the Direct Import and the Direct-to-Institution pathways. Through the Direct Import pathway, BMS is providing access to 12 medicines in more than 80 LMICs, using tiered pricing commensurate with affordability. The Direct-to-Institution (DTI) pathway is a scalable and sustainable channel that provides access to BMS’ innovative medicines to multiple patients through collaboration with local institutions. The company’s initial DTI efforts are in five LMICs in East Africa and Pakistan and West Africa in 2025, with the goal of scaling to more than 15 LMICs by 2026. 

Source: Bristol Myers Squibb 

Incyte Expanding HQ Site 
Incyte, a Wilmington, Delaware-based bio/pharmaceutical company, has announced the expansion of its presence in Delaware with the acquisition of two buildings in downtown Wilmington. The new buildings will allow the company’s US-based teams to be located together. This marks Incyte’s fourth expansion in Delaware since establishing operations in Alapocas in 2014.  

The new building on King Street is expected to open in 2026. It will initially house 400-plus employees, including the company’s US Oncology and Dermatology teams that are currently located in Chadds Ford, Pennsylvania, as well as global corporate employees currently located at its Augustine Cut-off campus. The company’s Research and Development and Technical Operations teams will remain at their current location on Augustine Cut-off in Alapocas. The North French Street building will be used for future expansion.

Source: Incyte 

M&A News 

GSK Acquires Oligo Company Elsie Biotechnologies for $50 M 
GSK has acquired Elsie Biotechnologies, a San Diego, California-based bio/pharmaceutical company, for up to $50 million. 

This acquisition allows GSK to integrate Elsie’s oligonucleotide discovery, synthesis, and delivery technologies to enhance GSK’s platform R&D capabilities. This follows a successful research collaboration with Elsie, announced in July 2023, in which GSK was able to explore and validate the technology. 

Source: GSK