Designer Drugs

Australian Custom Pharmaceuticals

Australian Custom Pharmaceuticals (ACP) has been gently reinventing that formula in principle, although so much has happened to health care in the 50-odd years since that system changed that it is hardly recognisable today.

ACP provides a bespoke alternative to mainstream off-the-shelf pharmaceuticals, has benefited from the spread of alternative and complementary medicine and the increased interests of the general public in health matters, and provides a more personalised service in terms of compounding even very small quantities of products to the very highest standards.

Pharmaceutical compounding is the practice of custom preparing ingredients to create medications that meet the needs of an individual patient at the request of a physician. Custom compounded medication is made specifically for the needs of the patient and is perfect for when a suitable over the counter alternative cannot be found. Some people are allergic or sensitive to preservatives and dyes, or are non-compliant to standard drug strengths; others have had a hard time swallowing a pill or react adversely to a medicine’s taste. Compounding also solves the problem of unavailable dosage strengths.

According to ACP’s Chief Executive Daryll Knowles, the company is no threat whatsoever to “Big Pharma”, as the major multinational drug companies are often known. Rather, ACP performs a service that the big boys simply cannot provide as they are geared only to massive worldwide distribution of mainstream products. Instead, ACP offers what would otherwise be unavailable in Australia – individual formulations that can take account of individual patients’ needs, sometimes cosmetic or wellness-related, but equally often life-enhancing or even life-saving. “Australia has the population of Los Angeles,” and the major drug companies don’t have an economic case for bringing many of their products here, he explains. “We miss out on a lot of medications.”

ACP doesn’t go anywhere near other companies’ patents. “I am concerned only that we do things correctly,” explains Daryll. He has trained pharmacists, lobbied for quality standards and even developed a software suite that removes the human error element from the compounding process. “With one-off compounding, you obviously cannot test every batch so we have a system where batches are computer-monitored,” with multiple checks, Bluetooth scales and barcodes. This system “rules out a mistake.”

Of course ACP does not copy registered drugs, but it can adapt them quite legally to the tolerances of individuals or groups of patients with particular symptoms. They may for example have a particular problem with delivery of the drug in question, in which case alternative delivery methods can be devised (such as where a patient has an allergy to a filler in a conventional big-company drug). In some cases, ACP (which has a full import-export licence) can bring in a specific drug from the US or Europe where it is on sale and adapt it to the needs of the local market.

Daryll cites a well-known company’s eye drop, used to treat glaucoma but also invaluable at a reduced strength for a particularly nasty paediatric eye disease that can blind the child. “I bought it from the US and used to dilute it to the correct dilution for the children – on prescription, of course. Some of those people are now in their 20s and 30s and still have their eyesight, which they otherwise would not have retained.”

At the turn of the century, says Daryll, there were perhaps 12 “modern compounders” and now there are close to 500, of which ACP is the largest, with turnover close to $10 million and an R&D budget just under one million dollars. While this latter figure is a much lower proportion of turnover than a GSK or Novartis, ACP’s marketing spend is also much lower than a multinational’s typical 30 per cent of revenue.

The company is also active in the veterinary field and also makes customised nutritionals – dietary products designed for individuals’ healthy lifestyles, including some serious athletes, and developed in conjunction with naturopaths. There are formulations for a number of conditions, including Asperger’s Syndrome and autism, which correct body chemistry imbalances.

With its experience, ACP is in a good position to advise and formulate. It has sterile suites and a full R&D lab in its pharmacy where it develops and tests formulations and does stability work on them. “We do much of the same work that a Big Pharma company does, but on a much smaller scale. To my knowledge we are the only pharmacy in Australia with this extra service.”

ACP maintains full awareness of dosages and side-effects. “We are kind of a gate-keeper on doctors trying to do new things. We are as close as we can get to GMP, except GMP calls for one product to be made at a time in the lab and we have many per day.

“We are a company that produces innovative products that are socially valuable and allow people to access medicine that is otherwise not available,” explains Daryll. The company is not working on leading edge research. “We are more interested in dose delivery than creating a new molecule – that is fraught with danger.” There is a misunderstanding among Big Pharma companies that operations such as ACP (and many have sprung up since Daryll started more than ten years ago, echoing the evident demand) are in some ways competitive and a threat to them. “They see us as a competitor that can be squashed, but they don’t understand what we do. We are not in their battlefield, we have moved on to the next one.” Among ACP’s product categories are pre- and post-menopause in women, depression, androgynous and erectile dysfunction in men, and tailoring dosages to infants and children or providing pleasantly flavoured versions of medicines that are acceptable to kids.

“We tend to get the ‘white rabbits’, the people who react to everything and for whom the mainstream is not working, where the doctors are throwing their hands in the air. We work closely with universities, for example with Melbourne University on drug and alcohol programmes, and on eczema and dermatitis solutions with Griffith University. We are an extra set of hands for them. I see us as a ‘viaduct’ taking the intellectual property to market.”

There are, of course, questions of regulation and issues of quality in this sector. A compounder might be mixing in his back kitchen or in a multi-million dollar lab, but “none of them are breaking the rules. I invite the TGA [Therapeutic Goods Administration, Australia’s regulatory authority for therapeutic goods] to my plant to show them what we do, but they don’t have any guidelines. I am producing socially valuable products for people, but for a very small percentage of people. I believe further regulation is required – there should be something written down.”

A complication is the suggestion that at a certain size (in terms of the number of scrips per month), a full TGA licence should be required, but “we all know that you can’t be a compounder and get a full TGA licence. The bigger compounders would be wiped out by that legislation and there are not enough small compounders to do the work so the public would miss out.”

Despite the restraints of regulations (including the fact that companies such as ACP are not able to advertise their wares and must rely on establishing contacts with clinicians to boost awareness of the advantages of the compounding service), Daryll is very confident of the future and accelerating toward it with more innovation. “We are getting involved now with genetic testing. I believe that for personalised medicine to realise its full potential, a genetic test first is needed.” He does not mean a full genome test at a cost of thousands of dollars but explains, “we are working with genetic testing companies on a small batch of tests to work out how an individual might metabolise 90 per cent of the medicines. This will enable doctors to truly dose correctly for their patients.”

Blood anticoagulants or anti-depressants depend for their efficacy on dosing according to metabolism (fast or slow, for example) and not – as often supposed – on sex, weight or ethnicity. The dosing of oncological drugs is likewise critically dependent on metabolism. “Chemotherapy is a highly personalised medication and doctors often don’t get it right – overdosing and making the person ill or under-dosing and failing to kill the tumour – because they dose per kilo [of body weight]. The big guys can’t do this although they are working feverishly with massive investment in personalised medicine.” It will, he forecasts, “save so many hospitalisations.”

Stem Cells

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October 20, 2018, 12:03 PM AEDT

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