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The little cancer drug that big pharma forgot

Betadine is the largest selling sore throat treatment in Australia.

But it almost never made it to the shelves of our pharmacies and supermarkets.

The active ingredient was developed by an American pharmaceutical company that wanted to keep Betadine purely for hospital use.

It took an Australian microbiologist and biochemist, working for the small Adelaide pharmaceutical company Faulding to realise the drug’s potential as an over-the-counter sore throat treatment.

More than 30 years since making Betadine available to Aussies suffering from sore throats, it’s again time to challenge Big Pharma thinking, as the CEO of a small ASX-listed startup called Race Oncology.

At Race Oncology it’s our vision to bring drugs to market that were either overlooked by Big Pharma, or simply deemed unprofitable because they treat rare illnesses that represent small markets.

One such illness is Acute Myeloid Leukemia (AML). It’s a condition that affects less than 1000 people in Australia and only around 40,000 people worldwide.

A drug that showed significant promise in treating AML was developed three decades ago, but was shelved by Big Pharma in the US.

It disappeared after a series of Big Pharma mergers saw it slip through the cracks as R&D portfolios were rationalised.

Race Oncology in the race to fight cancer

The drug is called Bisantrene and it’s a cancer drug that tested in more than 40 clinical trials.

By today’s standards more than $100 million was spent on Bisantrene before it was cast aside in a series of mergers. Lederle Pharmaceuticals, which developed the drug, taken over by Wyeth, which was then overtaken by Pfizer, all in the space of a few years in the 1990s.

Like most big companies, the biggest weakness Big Pharma companies have is the expectation from their shareholders that they must deliver growing profits each year.

Against that, investing in new drugs is phenomenally expensive. The cost of bringing a single new drug to market is now estimated at more than $2 billion.

So, Big Pharma tends to focus on those drugs that can warrant that investment. Mergers also help, because they generate huge cost savings through rationalizing duplicate marketing and R&D operations.

But here’s the rub. Rationalizing R&D means cutting the ‘tail’ off the development pipeline. Put simply, it’s a numbers game. You chase the opportunities that look like delivering blockbuster returns and you shelve the smaller drug programs.

For a small pharma company like Race Oncology, this presents a unique opportunity. The merger mania that has taken place in the pharma industry over the last 30 years has left a lot of gems lying on the ground.

We found one of those gems in a drug called Bisantrene.

Bisantrene gives new hope for people with AML

AML or ‘acute myeloid leukemia’ is a rare but deadly blood cancer that strikes nearly 1,000 people each year in Australia.

The mainstay of treatment has always been chemotherapy with drugs called anthracyclines. Often they work at first, but typically the cancer returns or ‘relapses’. Then the patient is left with little real hope.

Bisantrene offers hope.

Before Lederle was sold off, they had spent probably more than $100m in development on Bisantrene, at least by today’s standards. This included 5 clinical studies that showed that it was effective in driving AML into remission, even after patients had relapsed.

The other major benefit of the drug is that it lacks cardiotoxicity, a big problem with the anthracyclines, which can cause heart failure.

We were so impressed we set up Race Oncology a year ago with the mission to get the drug to market and into the hands of doctors, so AML patients can have new hope. ‘Race’ seemed like a good name for such a company.

We’re already manufacturing the drug and are in the process of finishing off the development work that’s needed to get the drug approved. In the meantime, we are making it available as an experimental drug for use with AML patients who have exhausted other treatment options or can’t tolerate anthracycline therapy because of heart problems.

Our focus for this ‘compassionate use’ of Bisantrene will be those countries that allow drugs to be sold under what’s called a ‘named patient program’. This allows us to make modest sales and help offset our manufacturing and distribution costs for the drug.

Targeted cancer therapy

Bisantrene hasn’t gone unnoticed. One of the most interesting things about a chemotherapy drug with low cardiotoxicity is its potential to be used synergistically with newer cancer treatments, including immune therapies.

We are currently forming a joint venture with a Swiss-based company called TargImmune that has developed a unique targeted immune therapy technology.

The low cardiotoxicity of Bisantrene makes it an ideal broad-spectrum chemotherapy drug to use alongside TargImmune’s targeted approach.

It’s hoped that this combination strategy will open up the potential for Bisantrene to be used in treating all the major cancers including breast, lung and prostate cancer.

Another example of how a small pharma company can challenge and disrupt the thinking and attitude of Big Pharma. That’s really what Race Oncology is doing.

Just like Betadine, Big Pharma might have been focused on the dollars, not the sense.

Peter Molloy

Peter Molloy is the CEO of Race Oncology. He’s a microbiologist and biochemist with a career spanning almost three decades in the pharmaceutical and biotech industry. While at the Australian pharmaceutical company Faulding, he commercialised Betadine throat medication in Australia.

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