Sarepta Therapeutics today is formally opening its Research and Manufacturing Center in Andover, MA, with plans to double its workforce there over the next year to year-and-a-half—less than a year after winning a controversial first-ever FDA approval for a Duchenne muscular dystrophy (DMD) treatment.
Sarepta plans a grand opening for the facility, whose cost was not disclosed, and where approximately 50 employees are now based. That number will grow by 100% over the next 12 to 18 months, the company said.
The facility’s initial focus, Sarepta said, will be to advance its pipeline R&D programs. The company said it could have up to seven investigational DMD treatments into clinical phases by year’s end.
According to its website, Sarepta’s pipeline includes separate Phase III DMD treatments that skip exon 53 and exon 45, as well as a preclinical candidate designed to skip exon 52, and discovery-phase candidates designed to skip exons 8, 35, 43, 44, 50, and 55. Sarepta’s DMD candidates are designed to skip an exon in the dystrophin pre-mRNA to enable the synthesis of a shortened, functional form of the dystrophin protein.
Sarepta has been based in Massachusetts since 2013 and moved into its current Cambridge, MA, headquarters the following year. Also in 2014, Sarepta disclosed plans to expand its operations in the Commonwealth, shelling out $15 million to acquire from Eisai the 26-acre Andover site, at 100 Federal Street, which the Japanese pharma giant shut down the previous year.
Last year, Sarepta shifted to Andover and Cambridge operations that were based in Corvallis, OR, in a consolidation and restructuring that shrunk the company’s workforce 19%.
“Sarepta has benefited enormously from the Commonwealth’s talented and highly educated workforce. This expansion underscores our ongoing commitment to patients with Duchenne and investment in the vibrant Massachusetts economy,” Edward M. Kaye, M.D., a director on Sarepta’s board and a special regulatory and scientific advisor to the company, said in a statement.
Kaye resigned as president and CEO in April, seven months after Sarepta won FDA approval for its exon 51-skipping DMD treatment Exondys 51™ (eteplirsen) despite recommendations by two advisory committees against approving the treatment and over objections from some administrators. Those administrators included the then-director of the FDA’s Office of New Drugs (OND) John K. Jenkins, M.D., subsequently retired from the federal government.
After winning approval for Exondys 51, Sarepta obtained a Rare Pediatric Disease Priority Review Voucher (PRV) that it sold to Gilead Sciences in February for $125 million upfront.
Massachusetts Gov. Charles D. Baker will head a group of dignitaries set to speak at the grand opening, along with Robert K. Coughlin, president and CEO of the state’s biopharma industry group MassBio, and Travis A. McCready, president and CEO of the Massachusetts Life Sciences Center’s (MLSC).
Last week, Baker announced plans to provide up to $500 million over five years for strategic investments in public infrastructure, R&D, workforce training, and education, including up to $295 million in capital authorization and up to $150 million in tax incentives tied to job creation. The program is intended to continue the Commonwealth’s life sciences effort spearheaded by MLSC, the quasi-public agency that oversees the commonwealth's $1 billion, 10-year Life Sciences Initiative, set to end next year.