FDA approval in hand, Sarepta plans for future studies
- Sarepta Therapeutics, fresh off an approval decision for its Duchenne muscular dystrophy drug, on Wednesday announced a proposed public offering of $225 million in common stock to help fund further clinical trials, along with commercialization and manufacturing.
- In addition, the biotech company will soon open its manufacturing facility in Andover, Massachusetts, according to a report from the Boston Business Journal.
- Sarepta bought the 60,000 square foot facility in 2014, but regulatory setbacks and the much-delayed decision on eteplirsen's approval have meant the plant hasn't been utilized as planned.
As part of eteplirsen's approval, the Food and Drug Administration is requiring Sarepta complete a 2-year controlled trial of eteplirsen comparing the approved dosage of the drug with a significantly higher dose regimen, along with several other safety studies.
Coupled with its commercialization plans, Sarepta will be ramping up production of the drug to supply both the market and its continuing trial obligations.
Doing so will require additional funding, which the proposed stock offering is aimed at addressing. If sold, Sarepta said the money would be used for the "continuation and initiation of further clinical trials, commercialization, manufacturing," along with other business needs.
Along with the offering, Sarepta is shopping around the Priority Review Voucher that it received from the FDA. The company is hoping that it can sell the voucher to the highest bidder for some non-dilutive financing. PRVs are given out to help facilitate the development of pediatric rare disease drugs and can be used by other companies to expedite approval of any product.
Sarepta has also recently consolidated its footprint, closing a research manufacturing facility in Corvallis, Oregon and transitioning some employees to its Andover and Cambridge sites. Those changes are expected to wrap up be the end of this year.
"Commercially, our team is in place and our supply chain is ready to provide product to patients," said Bob Cumbo, head of global development on a call with analysts following eteplirsen's approval. The company also indicated it had sufficient quantities of the drug to supply patients for over a year.
Sarepta's cash stocks stood at nearly $112 million as of June 30. The company used up $104 million in operating activities through the first six months of the year.
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