Global Briefs: Samsung Bioepis, Roche, Daiichi, Novartis & More 

A roundup of news from Samsung Bioepis, Roche’s Genentech, Daiichi Sankyo, Novartis, Vertex Pharmaceuticals, bluebird bio, Lilly, AstraZeneca, Aspen, and Sandoz. Highlights below.  

* Samsung Bioepis Reaches Settlement for Biosimilar of J&J’s Blockbuster Drug Stelara
* Roche’s Genentech Appoints Interim CEO as Full-Time CEO 
* Daiichi Sankyo, Novartis Settle Patent Dispute for Cancer Drug   
* FDA Approves First CRISPR-Gene Therapy    
* Lilly To Open Innovation Accelerator Lab in San Diego 
* AstraZeneca Launches Digital Health Company Evinova 
* Aspen To Acquire Sandoz’s Chinese Biz and Sell Four Products to Sandoz in Europe 

Samsung Bioepis Reaches Settlement for Biosimilar of J&J’s Blockbuster Drug Stelara 
Samsung Bioepis, a developer of biosimilars, has entered an agreement with Johnson & Johnson to settle all pending US patent litigation between the two companies and clearing the way for commercialization in the US of Samsung Bioepis’ SB17, a proposed biosimilar of J&J’s Stelara (ustekinumab), a drug to treat moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis and active psoriatic arthritis. J&J posted 2022 global sales of $9.7 billion for the drug. 

Under the settlement agreement, the license period for Samsung Bioepis’ biosimilar in the US will begin on February 22, 2025. Samsung Bioepis’ biologics license application for SB17 is under review by the US Food and Drug Administration. SB17, if approved, will be commercialized in the US by Sandoz. Samsung Bioepis and Sandoz  entered into a development and commercialization agreement for SB17 in September 2023 for the US, Canada, European Economic Area (EEA), Switzerland, and the UK.  

Source: Samsung Bioepis 

Roche’s Genentech Appoints Interim CEO as Full-Time CEO 
Roche’s Genentech has appointed Ashley Magargee, currently interim CEO of Genentech and Head of the company’s US Commercial Portfolio, to CEO, effective January 1, 2024. In addition to her role as Head of US Commercial Portfolio, Magargee has been serving as interim CEO of Genentech since the departure of Alexander Hardy, Genentech CEO, on November 1, 2023. She will report to Teresa Graham, CEO of Roche Pharma, and become a member of Roche’s Pharma Leadership Team. 

Magargee joined Genentech in 2004 and has held senior management positions at Roche and Genentech in lifecycle management, digital customer experience, market access and was also the General Manager in Singapore. Most recently, she served as Head of Commercial Portfolio, Genentech. 

Source: Genentech 

Daiichi Sankyo, Novartis Settle Patent Dispute for Cancer Drug   
Daiichi Sankyo has announced that Plexxikon, a Daiichi Sankyo subsidiary, and Novartis have settled Plexxikon’s patent- infringement lawsuit against Novartis regarding the sale in the US of Novartis’ oncology drug, Tafinlar (dabrafenib).  

The US District Court for the Northern District of California previously issued an order sustaining a jury verdict in favor of Plexxikon, finding that Novartis’ Tafinlar infringes Plexxikon’s US patents. The court subsequently issued a judgment requiring Novartis to pay $177.8 million in damages, pre- and post-judgment interest, and a 9% royalty on US sales of Tafinlar until the expiration of the patents. Novartis commenced an appeal to the US Court of Appeals for the Federal Circuit on October 27, 2022, seeking review of that judgment.  

Pursuant to the settlement, Plexxikon will receive a lump-sum payment from Novartis of approximately $182 million. The settlement will result in the dismissal of Novartis’s appeal and full satisfaction of the judgment entered against Novartis. 

Source: Daiichi Sankyo 

FDA Approves First CRISPR-Gene Therapy   
The US Food and Drug Administration (FDA) has approved Vertex Pharmaceuticals’ Casgevy, the first FDA-approved treatment to use the genome-editing technology, CRISPR. Casgevy is a gene therapy for treating sickle-cell disease in patients 12 years and older. 

CRISPR/Cas9 is a type of genome-editing technology under which patients’ hematopoietic (blood) stem cells are modified by genome editing. CRISPR/Cas9 can be directed to cut DNA in targeted areas, enabling the ability to accurately edit DNA where it was cut. The modified blood stem cells are transplanted back into the patient, where they engraft (attach and multiply) within the bone marrow and increase the production of fetal hemoglobin (HbF), a type of hemoglobin that facilitates oxygen delivery. In patients with sickle-cell disease, increased levels of HbF prevent the sickling of red blood cells. 

FDA also approved bluebird bio’s Lyfgenia, another gene therapy for treating sickle-cell disease. Lyfgenia uses a lentiviral vector (gene delivery vehicle) for genetic modification and is approved for the treatment of patients 12 years of age and older with sickle-cell disease and a history of vaso-occlusive events. 

Source: The US Food and Drug Administration 

Lilly To Open Innovation Accelerator Lab in San Diego 
Eli Lilly and Company has announced plans to open a Lilly Gateway Labs location in San Diego, California in the first half of 2024. Gateway Labs is Lilly’s shared innovation accelerator that provides participating companies with lab space and access to Lilly scientists, researchers, and executives. This will be the company’s third Gateway Labs location, with additional sites located in San Francisco, California, and Boston, Massachusetts. 

The new site will offer nearly 62,000 square feet of rentable lab space, as well as open workstations. It is expected to accommodate 10 companies and more than 120 biotech and Lilly employees. 

Source: Eli Lilly and Company 

AstraZeneca Launches Digital Health Company Evinova 
AstraZeneca has launched Evinova, a new digital health company. With backing from AstraZeneca and strategic collaborations with Parexel, a CRO, and Fortrea, a CRO, Evinova offers digital products and services to the life-sciences and healthcare sector.  

Evinova will prioritize bringing to market digital technology solutions already being used globally by AstraZeneca to optimize clinical trial design and delivery. Evinova will also pursue opportunities in digital remote patient monitoring and digital therapeutics with a pipeline of digital innovations in these areas. 

Source: AstraZeneca 

Aspen To Acquire Sandoz’s Chinese Biz and Sell Four Products to Sandoz in Europe 
Aspen Global has agreed to acquire Sandoz’s Chinese business and sell to Sandoz four anesthetic products in Europe. 

Under the agreement, Aspen will acquire from Sandoz the entire share capital of its subsidiary, Sandoz (China) Pharmaceutical Co., together with the commercialization rights and related intellectual property for a portfolio of established products currently commercialized by the company, including Sandostatin (octreotide), Aclasta (zoledronic acid), and voriconazole, and a pipeline of products to be launched in the short-to-medium term, The deal also includes the sale to Sandoz of Aspen’s commercialization rights and related intellectual property for four anesthetic products, namely Nimbex (cisatracurium), Tracrium (atracurium), Carbocaine (mepivacaine), and Naropin (ropivacaine), currently sold by Aspen in the European Economic Area. 

Under the agreement, Aspen is paying up to EUR 92.6 million ($100 million), with EUR 18.5 million ($20 million) contingent upon the sales performance of the pipeline products. For the disposal, Aspen will receive a consideration of up to EUR 55.5 million ($60 million), with EUR 9.3 million ($10 million) contingent on the sales performance of the anesthetic products.  

Source: Aspen