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Week in Review: Samsung Biologics Signs $1 Billion Manufacturing Contract with US Biopharma

publication date: Jul 6, 2024
 | 
author/source: Richard Daverman, PhD

Deals and Financings

Samsung Biologics, a Korean CDMO, signed a $1.06 billion agreement to provide manufacturing services for an unnamed US pharma (see story). The agreement is the largest that Samsung Bio has made since it was founded in 2011. So far this year, the CDMO has signed seven new agreements, totaling $1.8 billion. Six of these are additions to previous contracts. In 2023, Samsung Bio booked $2.7 billion in revenue, a figure that emphasizes how important the new $1 billion deal is to the company. As part of the agreement, Samsung Bio signed a non-disclosure clause protecting the name of the client. 

Takeda (TSE: 4502; NYSE: TAK) has made the initial $100 million payment to option global rights (ex-China) for olverembatinib from Ascentage Pharma (HK: 6855) (see story). Takeda added that the deal, initially announced three weeks ago, includes an option exercise fee and up to $1.2 billion in milestone payments and double-digit royalties on annual sales, along with an unspecified investment in Ascentage. Olverembatinib, a third-gen BCR-ABL inhibitor, is already launched in China for three chronic myeloid leukemia (CML) indications. When the agreement was originally announced, Takeda did not disclose that the milestones could total $1.2 billion. 

Japan’s Eisai regained global rights to farletuzumab ecteribulin, its antibody-drug conjugate targeting the FRα protein, after BMS dropped out of their partnership (see story). In 2021, BMS paid $450 million upfront and agreed to pay $200 million in development costs and up to $2.45 billion in milestones for the candidate. Eisai will keep the $450 million, but will return whatever is left of the $200 million of support. The Japanese multinational said it would speed up development of the drug, which is now in a Phase I/II study in solid tumors, a Phase II trial for ovarian, peritoneal and fallopian tube cancers and a mid-stage study for non-small cell lung cancer.

IASO Bio announced a plan to acquire Innovent’s share of the rights to their jointly developed BCMA CAR-T therapy in exchange for an 18% share of IASO (see story). One year ago, China approved Fucaso® (Equecabtagene Autoleucel) as a fourth-line therapy for relapsed/refractory multiple myeloma (RRMM) patients. IASO will have all global commercial rights to Fucaso®, including intellectual property rights, and will responsible for developing, manufacturing and commercializing the CAR-T, while Innovent will become a strategic shareholder of IASO Bio. Innovent said the agreement will lead to other cooperative projects between the companies. 

Harvest Integrated Research Organization (HiRO), a boutique US-China clinical stage CRO, acquired DeltaMed Solutions, a New Jersey CRO that offers end-to-end services for large to mid-sized biopharmas (see story). HiRO was originally formed in 2020 in Shanghai to serve China biopharmas that wanted to conduct clinical trials in the US and Europe. DeltaMed is HiRO's third CRO acquisition following Australia-New Zeeland based PharmaSols in 2021 and Courante Oncology of the US last year. HiRO now has a footprint in the US, Ireland, Mainland China, Taiwan, Australia, New Zealand, Japan, South Korea, Malaysia and the Philippines. 

Shanghai Hasten Biopharma has acquired rights in eight Asia countries (outside Mainland China) to 14 branded products developed by Celltrion of Korea (see story). Hasten focuses on products for chronic diseases and critical care, and the 14 in-licensed products include treatments in hypertension and diabetes. Financial details of the agreement were not disclosed. Hasten is supported by Singapore’s CBC Group, which also assisted the company in completing the deal with Celltrion. Last September, Hasten signed a $325 million agreement for greater China rights to a PCSK9 inhibitor aimed at lowering cholesterol from US-based LIB Therapeutics.

Trials and Approvals

Taiwan’s Tanvex BioPharma was approved to launch a filgrastim biosimilar in the US to treat neutropenia induced by cancer chemotherapy (see story). The originator drug is Amgen’s neupogen (filgrastim). TX01 is a recombinant human granulocyte colony-stimulating factor biologic that stimulates white blood cell production. The candidate, marketed as Nypozi, is the first Tanvex biosimilar approved for use in the US and the first biosimilar for any Taiwan biopharma. However, Nypozi is the fourth filgrastim biosimilar approved for US use, a market estimated to total $400 million per year. Tanvex was previously approved to sell the drug in Canada. 

 


 

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