Helixmith, which works on DNA and protein-based therapeutics, has launched its U.S. subsidiary, Genopis, for the full good manufacturing practice (GMP) production of Engensis, a plasmid DNA gene therapy codenamed VM202, in 2018. GMP is required to meet guidelines recommended by agencies that control the authorization and licensing of a manufacture and product sales.
Helixmith said that it would be given access to Wacker's global network of biologics expertise and an experienced partner. "A partnership with Wacker, one of the world`s leading microbial drug CDMOs, provides a significant boost to Helixmith," Helixmith CEO Yu Seung-shin said in a statement on February 3. The market for contract development and manufacturing organization (CDMO) is growing rapidly.
Of $120 million, Helixmith said it would receive $39 million upon closing the deal. The remaining amount may be received as milestone payments based on revenue and profit-sharing over the next five years.
The two companies will work together in preparation of milestones, while Genopis could produce future plasmid gene therapy products developed by Helixmith. The German company can use Genopis as a springboard to become a global player in gene therapy as a leap forward.
"With the growth of the gene therapy industry, demand for plasmid DNA has soared," said Wacker CEO Rudolf Staudigl. "Genopis' expertise in plasmid DNA technology expands our portfolio as a pharmaceutical-sector contract manufacturer." Wacker will operate Genopis when the transaction is closed in the first quarter of this year.
The two companies would prepare production data related to VM202's marketing permit and secure a partner in charge of commercial production. Helixmith is conducting clinical trials for Engensis, saying indications for clinical trials include diabetic peripheral neuropathy and amyotrophic lateral sclerosis (ALS).
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