PharmaEssentia expects EU marketing approval

By Ted Chen  /  Staff reporter

Wed, Dec 20, 2017 - Page 12

PharmaEssentia Corp (藥華醫藥) yesterday said it expects to gain marketing approval in Europe before the end of the third quarter next year for its new P1101 polycythemia vera (PV) drug.

The company is also seeking approval from US authorities for the drug.

PharmaEssentia reported favorable outcomes of its 12-month and a 24-month phase III clinical studies for P1101 at this year’s American Society of Hematology annual meeting, with both demonstrating superiority over other treatment options.

The drug, which is to be marketed as Ropeginterferon-alfa-2b (Ropeg), is classified as an orphan drug for PV, a rare blood disease.

In light of favorable clinical study results, Ropeg could become the mainstream first-line treatment for PV, PharmaEssentia chief executive officer Lin Ko-Chung (林國鐘) said.

While the company has formed a partnership with Austria-based AOP Orphan Pharmaceuticals AG to oversee market approval and sales of Ropeg in Europe, it is confident it can handle the US market internally.

The company is familiar with the US market, as much of its senior management team has extensive experience at US pharmaceutical companies and at the US Food and Drug Administration, it said.

“We have a close-knit network of physicians and patients in the US,” PharmaEssentia general manager Jack Hwang (黃正谷) said at a news conference in Taipei, adding that in most cases, PV patients are referred to hematology specialists for treatment.

The US-based Myeloproliferative Neoplasms Research Foundation has also voiced its support for Ropeg, Hwang said.

Ropeg is an interferon with milder side effects than other treatment options, such as hydroxyurea, a first-line chemotherapy, and Pegasys (peginterferon alfa-2a), an interferon.

Patients who have exhausted first-line options usually move on to Jakafi (ruxolitinib).

The company has hired Marija Sebastian, a former Novartis AG executive who oversaw global sales of Jakavi, to lead its US sales operation, Hwang said.

Formulated with the company’s proprietary pegylation technology platform, Ropeg consists of a single isomer, compared with eight in Pegasys, and its improved purity takes a lesser toll on users, PharmaEssentia said.

An improved safety profile also enables users to tolerate higher doses, cutting down the required regiment from weekly injections to biweekly injections, it said.

Ropeg has also been found to reduce the likelihood of mutations in the JAK2 gene, a condition that is associated with PV, it added.

The drug is expected to be priced between US$60,000 and US$100,000, compared with US$130,000 for Jakavi, PharmaEssentia investor relations director Ku Shan-chi (古珊綺) said, adding that about 85,000 people have been diagnosed with PV in the US.

Meanwhile, the company also plans to expand Ropeg’s indications to include essential thrombocythemia, Ku said.