Mark Rothera, President and CEO of Orchard Therapeutics

Orchard Therapeutics said it will build out a gene therapy manufacturing facility in Fremont, CA, that will employ 100 people and increase its manufacturing capabilities to support plans for an expanded pipeline.

The new facility, Orchard said, will enhance its capacity to develop and deliver lentiviral vector and gene-corrected hematopoietic stem cells for a wide range of diseases by providing additional CGMP manufacturing capacity for both lentiviral vector and cryopreserved cell therapy products.

“Orchard’s new California manufacturing facility will provide enhanced capacity and long-term supply in support of our extensive pipeline beyond the company’s most advanced clinical programs,” Orchard president and CEO Mark Rothera said yesterday in a statement. “We are pleased to continue our growth in the Bay Area and look forward to welcoming additional technical and management talent to join our mission of transforming patients’ lives through gene therapy.”

Orchard has signed a long-term lease for the 150,000-square-foot facility. It will be the gene therapy developer’s third site in California: the company leases 4,138 square feet of R&D labs and office space in Menlo Park, as well as 4,472 square feet of R&D laboratories and office space in Foster City. Those sites are focused on ongoing development and validation of the manufacture of Orchard’s ex vivo gene therapy product candidates.

“The expansion of our California operations to now include a manufacturing facility is a critical step in advancing Orchard’s capabilities to supply products for our ex vivo gene therapy programs,” added Stewart Craig, Ph.D., Orchard’s chief manufacturing officer. “We believe that this new facility, as an early investment in our own manufacturing, will not only drive efficiencies and scalability in terms of lentiviral vector and drug product development, it will also complement the capabilities of our existing vector and drug product manufacturing partners to support the potential launch of our gene therapy clinical product candidates.”

$80M to $90M Toward Facility

Responding to a GEN query today, Orchard said it “expects to use approximately $80–90 million in net proceeds from its recent IPO to fund the design and construction of its own manufacturing facility, including the necessary laboratory and manufacturing equipment, to support its long-term capacity needs for its product pipeline. These costs do not include costs to operate.”

That range is in line with Orchard’s prospectus for the initial public offering it completed on November 5, in which the company said it would use approximately $84.5 million in net proceeds for the facility.

Of the remaining proceeds, Orchard said it would use approximately $65.8 million toward ongoing development of its product candidates, including:

  • Completing registrational trials and submitting for regulatory approvals in the United States and Europe for OTL-101 for ADA-SCID, OTL-200 for metachromatic leukodystrophy, and OTL-103 for Wiskott-Aldrich syndrome
  • Establishing clinical proof of concept for X-linked chronic granulomatous disease (X-CGD) candidate OTL-102
  • Further advancing transfusion-dependent beta-thalassemia (TDBT) candidate OTL-300, MPS-IIIA (Sanfilippo type A) candidate OTL-201 and MPS-IIIB (Sanfilippo type B) candidate OTL-202, and advancing preclinical programs

Orchard also said it would use approximately $17.8 million of IPO net proceeds to fund ongoing commercialization of the gene therapy Strimvelis™ in the European Union and expand its marketing and sales infrastructure in key markets, including the U.S. and Europe, in preparation for potential commercial approval of OTL-101, OTL-200, and OTL-103.

Orchard earlier this year acquired Strimvelis as part of the rare disease gene therapy portfolio handed off by GSK, in return for the pharma giant taking a 19.9% stake, as well as undisclosed milestone payments and royalties, and a seat on Orchard’s board.

Orchard raised $225.5 million in gross proceeds through its IPO, in which the company sold 16,103,572 American Depositary Shares (ADSs), at $14 per share. The gross proceeds—which exclude deducting underwriting commissions and estimated offering expenses—included the partial exercise by the underwriters of their option to purchase up to 1,817,857 additional ADSs from Orchard at the IPO price, less underwriting discounts and commissions.

“We expect that development of our own manufacturing facility will provide us with enhanced control of material supply for both clinical trials and commercialization, enable the more rapid implementation of process changes, and allow for better long-term margins,” Orchard stated in the prospectus.

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