Global Briefs: BI, Daiichi, Seagen, Biogen & More 

A roundup of news from Boehringer Ingelheim (BI), Daiichi Sankyo/Seagen, Biogen/Acorda Therapeutics. Highlights below.  

* BI To Expand Greek Mfg Plant with $131-M Investment 
* Daiichi Sankyo Gets Favorable Ruling on ADC Patent Dispute with Pfizer’s Seagen 
* Biogen Returns Rights to MS Drug to Acorda 

BI To Expand Greek Mfg Plant with $131-M Investment 
Boehringer Ingelheim (BI) has announced a EUR 120 million ($131 million) expansion and upgrade of its plant in Koropi, Greece.  

The company will increase the manufacturing capacity of new and existing medications, some of them in late-stage development. The expansion includes increasing capacity for Jardiance (empagliflozin), used to treat Type 2 diabetes, chronic heart failure, and chronic kidney disease, 

The expansion will create 110 additional jobs  

Source: Boehringer Ingelheim 

Daiichi Sankyo Gets Favorable Ruling on ADC Patent Dispute with Pfizer’s Seagen 
Daiichi Sankyo reports that the US Patent and Trademark Office (US PTO) has rendered a final written decision regarding Daiichi Sankyo’s patent-dispute with Pfizer’s Seagen over Daiichi’s Enhertu (trastuzumab deruxtecan), an antibody drug conjugate (ADC) for treating breast cancer, gastric or gastroesophageal  adenocarcinoma (i.e., stomach cancer or cancer of the esophagus). Pfizer acquired Seagen in 2023 for $43 billion.  

Daiichi Sanyko reports that the US PTO invalidated all claims by Seagen against Daiichi over Seagen’s US patent 10,808,039 (the ’039 patent) relating to linker technology that were challenged by Daiichi Sankyo in a post-grant review  proceeding (PGR). 

In December 2020, Daiichi Sankyo filed a PGR petition with the US PTO contesting the patentability of certain claims of the ’039 patent. In April 2022, the US PTO granted Daiichi Sankyo’s request to institute the PGR. The ’039 patent was the sole patent-in-suit in the infringement litigation between the parties in a federal district court in Texas, an appeal of which is now pending in a US court of appeals.  

The US PTO ruled that Daiichi Sankyo did not have to pay any royalties to Seagen regarding Enhertu. Prior to the recent ruling, Seagen had obtained a $42-million payment as well as royalty sales on Enhertu due to a claim that Daiichi Sankyo used technology obtained during a partnership with Seagen in the development of Enhertu. In 2019, Daiichi Sanyko and AstraZeneca entered into a global collaboration to jointly develop and commercialize Enhertu worldwide, except in Japan, where Daiichi Sankyo maintains exclusive rights. The drug received approval from the US Food and Drug Administration in December 2019.  

Source: Daiichi Sankyo 

Biogen Returns Rights to MS Drug to Acorda 
Biogen has chosen to return the commercialization rights of Fampyra (fampridine), a multiple sclerosis (MS) drug, to Acorda Therapeutics, a Pearl River, New York-based bio/pharmaceutical company, by terminating the licensing and collaboration agreement between the companies, effective January 1, 2025. Acorda markets the medication as Ampyra (dalfampridine) in the US. 

Acorda and Biogen are working together toward a transition for Acorda to commercialize and supply Fampyra for the great majority of people with MS outside the US currently being served. Acorda says it plans to assume commercialization responsibilities as soon as possible during 2024 as marketing authorization transfers and distribution arrangements are finalized for each territory. 

Source: Acorda Therapeutics