Global Briefs: BioMarin Pharma, Lilly, BI, DSM & More 

A roundup of news from BioMarin Pharmaceutica, Eli Lilly and Company/Amphastar Pharmaceuticals, Boehringer Ingelheim, DSM/Adare Biome, and Moderna/Merck & Co., Highlights below.  

* BioMarin Opens New $42-M Aseptic Mfg Facility 
* Lilly To Divest Diabetes Drug To Amphastar for $1.07 Bn 
* BI Opens $384-M Biologics Development Center 
* DSM To Acquire Postbiotics Company Adare Biome for $303 M 
* Moderna Reports Positive Results for Personalized Cancer Vaccine in Combination with Merck & Co.’s Immuno-oncology Drug Keytruda 

BioMarin Opens New $42-M Aseptic Mfg Facility 
BioMarin Pharmaceutical, a Dublin, Ireland-based bio/pharmaceutical company, has expanded its site in Shanbally, County Cork, Ireland, through the opening of a new EUR 38 million ($42 million) aseptic production facility. The EUR 38 million ($42 million) investment, made over four years, expands manufacturing, packaging and labelling for BioMarin therapies for global distribution.  

With the expansion, BioMarin will begin end-to-end manufacturing for a number of the company’s commercial products. The new facility has the capacity to produce additional clinical and commercial products, including gene therapies.   

In addition, BioMarin is investing more than EUR 30 million ($33 million) to expand its packaging operations at its site in Shanbally and plans to recruit more than 40 roles across its operations at the site over the coming years (as reported on April 24, 2023). The company now employs more than 500 people across two locations in Ireland: the Shanbally manufacturing site and Earlsfort Terrace in Dublin. 

Source: IDA Ireland 

Lilly To Divest Diabetes Drug To Amphastar for $1.07 Bn   
Eli Lilly and Company has agreed to divest to Amphastar Pharmaceuticals, a Rancho Cucamonga, California-based specialty and generics company, Lilly’s Baqsimi (glucagon), a nasally administered drug for treating severe hypoglycemia in people with diabetes, in a deal worth up to $1.075 billion ($500 million upfront, an additional $125 million after one year from closing, and $450 million in milestone payments).  

Lilly launched Baqsimi in 2019, and it is currently available in 27 international markets. Worldwide 2022 sales for Baqsimi were $139.3 million.  

Under the agreement, Amphastar will pay Lilly $500 million in cash at closing and an additional $125 million in cash upon the one-year anniversary of closing. Lilly is also eligible to receive sales-based milestone payments of up to $450 million in aggregate. The transaction has been approved by the Boards of Directors of both companies. The transaction is expected to close in the second or third quarter of 2023, subject to customary closing conditions. 

Source: Eli Lilly and Company and Amphastar Pharmaceuticals 

BI Opens $384-M Biologics Development Center 
Boehringer Ingelheim (BI) has inaugurated a new EUR 350 million ($384 million) biologics development center in Biberach, Germany.  

The new center, which offers workplaces for more than 500 employees, has gross floor space of 34,500 square meters. Biberach is the company’s largest R&D and bio/pharmaceuticals site with more than 7,000 employees. 

Source: Boehringer Ingelheim 

DSM To Acquire Postbiotics Company Adare Biome for $303 M 
DSM has entered into exclusive negotiations to acquire Adare Biome, a developer and manufacturer of postbiotics and part of Adare Pharma Solutions, a CDMO of drug products and drug-delivery services, for EUR 275 million ($303 million).  

Postbiotics is an emerging segment of the gut health market. Unlike the live bacteria in probiotics, postbiotics consist of inanimate microorganisms and/or their cellular components and metabolites that confer a health benefit to the host. A growing body of scientific evidence shows that postbiotics deliver comparable health benefits and are more stable with a longer shelf-life and can be used in a wider range of applications and in new ingredient combinations, according to information from DSM.  

Adare Biome’s key product is Lactéol, a branded supplement for relieving gut upsets. With the acquisition, DSM anticipates being able to extend the availability of Lactéol for people through its i-Health business unit. Additionally, further development of the postbiotic ingredient will include further science development and development in dietary supplements, early-life nutrition, medical nutrition, and nutritional improvement for the under-nourished. The pending acquisition of Adare Biome also helps establish DSM in the microbiome management market for pets and expands its animal health range, where the stability of postbiotics means they can be incorporated into DSM’s premix feed solutions. 

The transaction is subject to consultation by workers’ councils and customary regulatory conditions. 

Source: DSM 

Moderna Reports Positive Results for Personalized Cancer Vaccine in Combination with Merck & Co.’s Immuno-oncology Drug Keytruda  
Merck & Co. and Moderna, a Cambridge, Massachusetts bio/pharmaceutical company specializing in mRNA vaccine and drug development, reported positive results from a Phase IIb study evaluating Moderna’s mRNA-4157, an investigational mRNA individualized neoantigen therapy (i.e., personalized cancer vaccine) in combination with Merck’s Keytruda (pembrolizumab) a cancer immunotherapy, in patients with resected high-risk melanoma (Stage III/IV). The companies reported that combination therapy reduced the risk of recurrence or death by 44%.  

Individualized neoantigen therapies are designed to prime the immune system so that a patient can generate a tailored antitumor response specific to their tumor mutation signature. mRNA-4157 is designed to stimulate an immune response by generating specific T cell responses based on the unique mutational signature of a patient’s tumor. Keytruda is an immunotherapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Based on early clinical studies, combining mRNA-4157 with Keytruda may potentially provide an additive benefit and enhance T cell-mediated destruction of tumor cells.   

The companies say that they will begin Phase III testing soon (as reported on April 16, 2023) and will evaluate the combination therapy in other indications, beginning with lung cancer.   

Source: Merck & Co. and Moderna