Helixmith Signs Strategic Partnership Deal

with Global Chemical-Bio Company WACKER

 

- Helixmith sells US subsidiary, Genopis, to Wacker

- Total value of transaction may reach $120 million based on earn-out milestones

- Secured partner to support commercial production and BLA submission of Engensis

 

Helixmith Co., Ltd. established a strategic partnership with Wacker, a Munich-based chemical-biotech company and global leader in biopharmaceutical production. Helixmith will sell shares of Genopis, Helixmith's San Diego-based DNA manufacturing company, to Wacker. The total value of the deal may come in at up to at $120 million, of which $39 million is to be received upon closing. The remaining amount may be received as milestone payments based on revenue and profit sharing over the next five years.

 

This partnership creates a synergistic relationship between Helixmith, a global leader in gene therapy research and development, and Wacker, a globally active chemical group. Wacker’s portfolio comprises specialty products for numerous industries, including state-of-the-art solutions for the production of biologics.

 

Helixmith is conducting multiple late phase clinical trials in the US for its flagship plasmid DNA product, Engensis (VM202). Indications for current clinical trials include diabetic peripheral neuropathy (DPN) and Amyotrophic Lateral Sclerosis (ALS), for which Engensis has been granted RMAT status. The sale of Genopis to Wacker provides Helixmith with access to Wacker’s global network of biologics expertise and an experienced partner with which to pursue commercial production after biologics license application (BLA) approval of Engensis. The two companies intend to work closely together in preparation of these milestones. In addition, Genopis could also produce future plasmid gene therapy products developed by Helixmith.

 

"With the growth of the gene therapy industry, demand for plasmid DNA has soared," said Dr. Rudolf Staudigl, CEO of Wacker. “Genopis’ expertise in plasmid DNA technology expands our portfolio as a pharmaceutical-sector contract manufacturer. By leveraging our comprehensive microbial CDMO experience, we hope to make substantial contributions as Helixmith moves forward with its gene therapy platform," he added.

 

“A partnership with Wacker, one of the world`s leading microbial drug CDMOs, provides a significant boost to Helixmith,” said Dr. Seungshin Yu, CEO of Helixmith. “In particular, considerable investment and expertise are required on the production side in order to succeed in a BLA, and stable commercial production is essential after a successful BLA. Having a strong partner like Wacker provides us with additional confidence as we pursue our global blockbuster pipeline” she commented.

 

Helixmith launched Genopis in 2018 as a subsidiary to serve a burgeoning gene therapy industry undergoing rapid global growth. Wacker will assume operation of Genopis with the close of the transaction, expected Q1 2021. 

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Genopis:
Genopis is a full GMP plasmid DNA production facility in San Diego established by Helixmith in 2018. Its GMP facilities and mass production technologies follow US market standards, which lead global market norms and criteria. In 2019, Genopis obtained a license to manufacture medicine from the Food and Drug Branch (FDB) of the California Public Health Department (CDPH) and was granted approval by the City of San Diego for a new small and medium-sized GMP fermentation facility built for CDMO business. Since 2019, Genopis has successfully carried out full GMP production of Helixmith’s Engensis (VM202) drug substance, affirmed the reproducibility of its process and quality, and has recently expanded its CDMO services. In 2020, Helixmith secured additional funding via a capital increase to expand Genopis’ production capabilities.

Wacker Chemie AG:
Wacker Chemie AG (www.wacker.com) is a globally operating chemical company headquartered in Munich, Germany. With a wide range of state-of-the-art specialty products, WACKER is a leader in numerous industrial sectors. Its products support countless high-growth end-user sectors such as photovoltaics, electronics, pharmaceuticals and household/personal care products. In 2019, the Group generated sales of some €4.93 billion and had about 14,700 employees on December 31, 2019. Wacker Chemie AG is listed at the Frankfurt (Germany) Stock Exchange (ISIN: DE000WCH8881). Wacker Biotech, a subsidiary of Wacker Group, is a full-service contract manufacturer of therapeutic proteins, live microbial products (LMPs) and vaccines based on microbial systems.