Zydus Lifescience arm signs exclusive licensing pact with Synthon for Ozanimod capsules in the US market

Zydus Lifescience on Thursday, September 4, announced that its wholly-owned subsidiary Zydus Lifesciences Global FZE inked an exclusive pact with Synthon BV for Ozanimod capsule, a generic version of Zeposia, in the US market.

Netherlands-based pharmaceutical Synthon has a pending abbreviated new drug application in the United States, seeking approval for Ozanimod Capsules, used for relapsing forms of multiple sclerosis, Zydus said in a regulatory filing.

Under the license and supply agreement, Synthon will be responsible for obtaining regulatory approval for Ozanimod Capsules. Post that, it will also be responsible for manufacturing and supplying the drug.

Furthermore, Zydus will be responsible for the commercialisation of the capsules in the US, it added.

Synthon received tentative approval within 30 months from the USFDA (US Food and Drug Administration), as the company is one of the first filers. This makes the capsules eligible for a shared 180-day exclusivity upon market entry.

“Zeporsia (Ozanimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults,” the filing added.

The drug is also approved for moderately to severely active ulcerative colitis (UC) in adults.

Commenting on the development, Punit Patel, President and Chief Executive Officer of Zydus Pharmaceuticals, said: “This collaboration with Synthon enables us to bring this important treatment to the U.S. market. This collaboration reinforces our strategic focus on advancing care in therapeutic areas and reflects our commitment to making essential medicines more accessible to patients.”

Zeprosia is a trademark of Receptos, a Bristol Myers Squibb company, the filing stated.

“This collaboration with Zydus for Ozanimod capsules continues to underscore our proven expertise in developing first-to-market, complex generic products. We are pleased to strengthen our partnership with Zydus as we continue advancing our strategic commitment to expanding access to essential medicines,” said Anish Mehta, the Chief Executive Officer of Synthon BV.

Shares of Zydus closed 0.50% higher at ₹1,013.25 apiece on the National Stock Exchange. However, the announcement was made after the market closed.