Wed, Jul 05, 2017 - Page 12 News List

PharmaEssentia renegotiates terms

By Ted Chen  /  Staff reporter

PharmaEssentia Corp (藥華醫藥) yesterday said it has renegotiated contract terms with a European distribution partner as prospects for its new orphan drug brighten.

The company said that its terms with Austria’s AOP Orphan Pharmaceuticals AG have changed and that it might receive as much as 20 percent of sales of P1101, its polycythemia vera drug, up from 16 percent of sales under a previous agreement.

The change came after jakafi, a treatment for myeloproliferative neoplasm developed by US-based Incyte Corp, began making headway in the global market, netting aggregate sales of more than US$1 billion since it was approved for sale, PharmaEssentia said.

Despite the rarity of the blood-related disorder, jakafi had sales of about US$1.43 billion throughout Europe, the Middle East and the US from 2011 to last year, PharmaEssentia said.

Specifically, jakafi first gained approval to be used as a first-line treatment for mycosis fungoides by the US Food and Drug Administration (FDA) in 2011, followed by approval by the European Medicines Agency in 2012, the company said.

Later, jakafi’s indications were expanded to include polycythemia vera as a second-line treatment in 2015 by the FDA, while the expanded indication was approved by the European agency last year, PharmaEssentia said.

Sales of jakafi in the US last year surged 45 percent to US$581 million, it said.

Alongside polycythemia vera, P1101 also treats myeloproliferative neoplasm, mycosis fungoides and essential thrombocythemia, the company said.

PharmaEssentia is upbeat on the improved market outlook for treatments for the rare blood disorder and in light of favorable clinical trial outcomes, P1101 could become one of the major offerings with the orphan drug designation.

In addition, PharmaEssentia has set its sights on tapping the European market and expects to gain regulatory approval for sales to begin there following the precedents set by jakafi, it said.

The company was also optimistic that AOP would be able to secure approval from the European agency.

PharmaEssentia and AOP presented results of three clinical studies on P1101 at a European Hematology Association meeting in Madrid last month.

The results the clinical and molecular data demonstrated P1101’s disease modifying capability and support the delay of disease progression, the two companies said.

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