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This article first appeared in Corporate, The Edge Malaysia Weekly, on August 8 - 14, 2016.


TauRx Pharmaceuticals Ltd will be entering into dialogue this year with regulatory authorities European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for its experimental Alzheimer’s drug LMTX, says co-founder and executive chairman Claude Wischik.

Genting Bhd has a 20.7% stake in TauRx.

“The dialogue will start this year but we don’t know how long it will take and where it will go. We will file meeting requests in the near future,” Wischik tells The Edge over the phone from Canada.

He says he cannot put a timeframe on the dialogue. “This is quite a formalised and lengthy procedure, which only begins with an initial dialogue,” he adds.

“When considered together, these trials are not negative. It is an important discovery — that the drug does not work in combination with other drugs already approved for Alzheimer’s disease but seems to work well as a monotherapy.”

Now, the most important thing is for TauRx to complete the data analysis and compile the overall conclusions from the two Alzheimer’s studies of Phase 3, says Wischik.

“There is still a lot of work to be done. That data needs to be put together into one or more papers to be submitted for publication in peer-reviewed journals in the autumn. It will take time. We will prepare dossiers for the initial dialogues with the two key regulatory authorities here — the EMA and FDA,” he explains.

So, what this means is that the research findings are unlikely to be a fluke, says Wischik.

Over a week ago, TauRx released the results of the first study of Phase 3 on LMTX, which showed that it had failed to meet its “co-primary endpoints”. But the drug did benefit a small group of patients who were on the drug alone, according to the findings released recently at the Alzheimer’s Association International Conference in Toronto, Canada.

“The key findings in our first study with 891 patients are now confirmed in a second separate study in a further 800 patients. This is hopeful for patients. We have opened up a new potential avenue of treatment that hasn’t been explored in such detail before by anyone,” says Wischik.

“The preliminary data from the second study confirmed what we saw in the first study. As such, the chances of the second trial achieving its revised primary analysis outcomes are 100%. It is not speculative. It is the case. We already know that, for the second trial, the primary analyses have confirmed the monotherapy findings from the first study. It then depends on how the regulatory authorities respond to the second study and to an analysis of pooled data from both studies. We are not sure if they will require us to do another study,” he adds.

When asked if more investment will be needed, Wischik says it depends on the outcome of the dialogue with the regulatory authorities.

Genting did not respond to questions on whether the group is willing to invest further if the need arises.

That TauRx is planning to have a dialogue with the EMA and FDA this year is a step forward, say analysts.

“It seems like things are still moving despite the company not meeting the end points of the first study of Phase 3. There are people who were hoping for a home run straight away, but it is not the case … these things take time,” says a local gaming analyst who tracks the developments closely as he covers Genting.

“I guess now we have to wait for the outcome of this dialogue with the authorities and to see what is next — whether another study and more investments are needed, or perhaps even the possibility of starting the process of commercialisation,” the analyst says, adding that the market is also waiting to see the outcome of TauRx’s findings from its trial in frontotemporal dementia.

UOB Kay Hian head of research Vincent Khoo says, “The present valuation of Genting has not factored in any option value of TauRx’s potential commercialisation.”

On the trial for frontotemporal dementia, Wischik reveals that the company is still analysing and filing the patent. “I can’t say at this stage what the results will be,” he says, adding that the drug was administered both as a monotherapy and with other drugs more often used for treating Alzheimer’s disease as there are no drugs approved specifically for the treatment of frontotemporal dementia.

TauRx is expected to release its findings on the outcome of the third Phase III trial in frontotemporal dementia, which will be presented at the 10th International Conference on Frontotemporal Dementias in Munich, Germany, later this month.

Nearly 14 years ago, in November 2002, Genting announced a total investment of US$111.8 million in TauRx in exchange for a 20% stake. Singapore’s sovereign state fund Temasek is also a substantial shareholder of the pharmaceutical company.

According to news reports, TauRx is still loss-making as it is at the clinical development phase. Genting’s total investment cost in TauRx stands at over RM480 million. 


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