Winning one part of the drug development process

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Dr James Garner joined Sydney-based oncology-focussed biotechnology company Novogen (ASX:NRT) early 2016 after an extensive career with multinational life sciences companies in development and commercialisation roles.

He was appointed with a mandate to lead the transformation of the company into a more operationally focussed organisation.

"This is a company that has been known to investors for around 25 years," Dr Garner told PharmaDispatch. "It has worked on its in-house portfolio, which is the long journey, but has always been some way off commercialisation.

"This is the traditional biotech model, with companies taking internally discovered intellectual property through the development process. The obvious examples are Amgen and Genentech."

Dr Garner says his focus has been to evolve the company away from this traditional model.

"The challenge is that it's a 12 to 15 year process, very high cost, with the high likelihood of something going wrong at some point. The reality is that this is a very high-risk industry.

"Taking a drug through the entire process is very tough because as smaller scale companies we simply can't be good at everything. Some can be good at different parts of the process, development or commercialisation, but how many are good at everything?"

He says Novogen has tried to think about its business in a different way, looking to 'win' one part of the process, such as late stage clinical development to early phase 2.

"We want to identify drugs in large pharmaceutical companies where some investment has already been made. We can take it into the next stage and then partner to commercialise. I suppose we're really looking to own the drug for 3 to 6 years. The opportunity exists because these large companies tend to produce more intellectual property than they can actually commercialise."

The company's evolution has been headlined by the acquisition of GDC-0084 from Genentech in November last year.

Rights to the small molecule inhibitor of the phosphoinositide-3-kinase (PI3K) pathway were acquired for an upfront payment of US$5 million plus performance-related payment linked to regulatory and commercial milestones.

The lead indication for GDC-0084 is glioblastoma multiforme (GBM), the most aggressive form of brain cancer, with median overall survival of around 12 to 15 months from diagnosis.

At the time of acquisition, Genentech had completed a phase 1 study with positive data presented at the American Society of Clinical Oncology annual meeting in Chicago last year.

Dr Garner says Novogen's interest in GDC-0084 did result in Genentech taking another look at the molecule. He says it is even possible the company, which is wholly-owned by Roche, could license it back in the future.

"There is no obligation to deal with Genentech but we could, or we could license it to another company."

He says Novogen will be looking to grow its portfolio of in-licensed products to 3 to 5, to diversify and help mitigate risk, does reach out pro-actively to companies.

"Getting access has been ok and we reviewed around 30 products in the past year. We're still reviewing a couple in detail."

The company also has another oncology product in development, Cantrixil in phase 1 for ovarian cancer, and has significantly reduced costs under Dr Garner's leadership.

"We're a focussed organisation with around 15 employees," he said, adding the immediate plan is to direct its resources into development its two lead products including a phase 2 study for GDC-0084.