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TaiMed aiming to apply for US FDA authorization

Source: Taipei Times by Kao Shih-Ching

TaiMed Biologics Inc (中裕新藥) plans to apply within a month to the US Food and Drug Administration (FDA) for permission to license its Trogarzo “by intravenous push” treatment, as the company’s phase 3 clinical trial showed promising results, it said in a filing with the Taipei Exchange on Sunday.

On March 1, 2019, the HIV/AIDS drug developer began its last stage of human testing in the US to observe whether Trogarzo by intravenous push could produce the same effect as its Trogarzo “by intravenous infusion” treatment, which has already been launched.

Trogarzo by intravenous infusion needs to be diluted with saline solution and administration of the medication takes 15 minutes, while Trogarzo by intravenous push can be given to patients undiluted and takes only 30 seconds to administer, the company said.

Twenty-two people who were infected with HIV-1, but were in a stable condition and had already taken Trogarzo by intravenous infusion for at least three months, participated in the phase 3 trial, TaiMed said in the filing.

Participants initially took Trogarzo by intravenous infusion once every two weeks, but later took Trogarzo by intravenous push, also once every two weeks, the company said.

They did not report any severe adverse reactions, but some had mild or medium adverse reactions, it said.

The concentration of Trogarzo declined at similar rates in participants treated using the intravenous infusion and intravenous push methods, indicating that the different administration routes did not affect the rate of the drugs’ absorption, TaiMed said.

The different methods of administration did not lead to a change in participants’ viral loads, and no one reported viral loads of more than than 1,000 copies per milliliter twice consecutively, it said.

Meanwhile, no participants developed anti-Trogarzo antibodies, TaiMed said.

“Overall, the test results have reached our objectives. We will apply for a biologics license,” TaiMed said. “It is expected that we will obtain approval within a few months.”

TaiMed paid about US$2 million for the phase 3 clinical trail, which was carried out by a contract research organization, it said, adding that the payment excluded drug expenses and research costs.

The company said it expects to receive a milestone payment of US$3 million from its marketing and distribution partner, Theratechnologies Inc, if it gains approval from the FDA.

TaiMed has signed a 12-year contract with Theratechnologies, which would be in charge of sales of Trogarzo by intravenous push in the US, Canada, most European countries and Israel.

It has signed another contract with Meroven Ltd, which would market the medication in the Middle East and North Africa.


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