Narhex boss sets out path to market

Sydney-based Narhex has begun recruiting for an early-stage trial of an HIV drug. Helen Schuller spoke with the company's MD, John Mills, about HIV drug development, working in China, and good management.

Since he took the reins at Sydney anti-viral drug developer Narhex Life Sciences (ASX:NLS), Prof John Mills has established a clear focus for the company following the resignation of former managing director and founder John Majewski last September.

"I definitely didn't put my hand up," Mills told Australian Biotechnology News -- he was thrown into the role of managing director, rather than volunteering. "It came up suddenly -- [Majewski's resignation] happened in a short period of time. I realised it would be difficult and time consuming. I had a full schedule but recognised the interesting opportunity I had -- but I certainly didn't put my hand up."

Although reluctant to take the helm, he concedes that he had a better-than-average grasp of what Narhex was about, and a strong vision for the company. "John has done a good job. The problem was he didn't have experience or contacts for a clinical research program -- he realised he wasn't the best person. Did I have to undo anything he did? No.

"The key issues I am focusing on are that of making sure the clinical trials get going as quickly as possible, with as few delays as possible -- making sure there is drug supply for the various proposed clinical trials, reviewing establishing sites and ensuring regulatory issues have been met.

"We have made some of the concrete steps to move forward we have updated the scientific advisory board and they are enthusiastic and targeted -- there is a clear path forward."

Mills added several new faces to the advisory board, which met for the first time at the end of October. "The scientific advisory board are all people that I know well and have worked with in the past. I am working with a sense of enthusiasm. I went into the role with ideas -- they have changed but changed for the better and we are unanimous in the direction we should be taking. We have experts who are say this is the correct clinical path."

HIV push

Narhex listed on the ASX last year, raising $8 million to fast-track clinical trials of its Nar DG 35 protease inhibitor for HIV. An early phase II clinical trial in Brazilian volunteers has already shown that the drug reduces HIV loads and improves counts of CD4-positive lymphocytes, the main marker of HIV infection. Narhex has also signed an agreement with the giant Chinese government trading company CMC Shaanx, which will pay the costs of phase III clinical trials, and registering the drug for clinical use in China.

"I am aiming to be in a position where we have a secure platform to do a phase IIb study in Q3 2006," Mills said. "There is not enough money to compete these trials and we plan to either partner or raise more money. The presumption is that if we successfully complete pharmacokinetic and proof-of-concept trials, it will lift the share price and the market will respond.

"We have enough money to conduct trials in China but not enough in the Western world. It depends on the clinical trial landscape in China. Doing deals in China is not something that happens with the snap of a finger and has taken longer than expected -- but it is progressing. We are very anxious to conclude a deal with China before the end of the year and it is in the front of our minds."

Mills said "the most sensible decision" for Nar DG 35 would be to develop it in parallel with China, or in China first and then in a Western country. "The intention is to complete trials in China in 2007 and move right into licensing," he said. "We hope to conduct Western phase II trials towards the end of 2006 -- depending how they are done, they could be completed in mid- to late 2007. Then phase III would be completed by the end of 2008-09."

'Different landscape'

Mills was director of the Burnet Institute in Melbourne, head of the Children's Virology Research Unit, and director of the National Centre in HIV Virology Research. He is currently a professor of microbiology at Monash University.

"I knew about [Nar DG 35] through pharmacokinetic studies at the Burnet Institute," he said. "I have known about the drug for a long time and knew it needed to be developed.

"HIV is a different landscape to other drug trials that are more likely to fall over at phase III. In a major trial there is only one HIV drug that has fallen over at the completion of phase IIb studies -- it is very unlikely it will happen."

Mills is currently a non-executive director of Phosphagenics and GBS Venture Partners, and has previously been a non-executive director on the board of Melbourne-based Amrad (Now Zenyth). He is also managing director of Advanced Diagnostic Concepts and its wholly-owned subsidiary, TissuPat.

When it came to management style, Mills said, he was definitely not a micro-manager. "But I like people to keep me aware of what's going on," he said. "I'm time-orientated and don't like sitting on my hands waiting for things to happen."

Mills also feels strongly about the importance of appointing the right advisors. "You are fool if you have experts and don't listen to them," he said. "At the moment we are a virtual company. Our next issue -- GMP manufacturing -- we will speak to consultants about."

Mills admits that his role as Narhex's managing director does have a limited timeframe. "I think the next 18-24 months are really critical," he said. "If the board felt it was necessary I would stand down at that point. I think in the longer term they are looking for someone else.

"The really critical thing that needs to be done now is to create a robust platform that will allow the company to move forward."