FDA approval for NZ-made acne treatment
Auckland-based Douglas Pharmaceuticals gained Food and Drug Administration (FDA) approval to sell its prescription acne medication isotretinoin in the United States in 2012.
Jeff Douglas
Douglas Pharmaceuticals director Jeff Douglas.
Reduces sebum production
The drug, sold here as Oratane, markedly reduces sebum (oil) production and shrinks the skin’s sebaceous glands. It has a range of usually short-term side effects but is touted as an effective treatment for those suffering from acne and several other skin conditions. While the company enjoys a healthy export market to 35 countries, Douglas Pharmaceuticals has been trying for 10 years to break into the US acne medication market that is currently worth around US$400 million (NZ$494 million).
First New Zealand-developed human medicine to be US approved
“This is a huge breakthrough for us and for New Zealand, which will benefit from the increased export earnings,” says Douglas Pharmaceuticals director Jeff Douglas.
“We believe our isotretinoin is the first New Zealand-developed human medicine to be approved for use in the US. It’s our biggest export product and is the market leader in Spain, Austria, Germany and Mexico. The US market has, however, taken a little longer to get approval, but as the US is the largest pharmaceutical market in the world, the potential for us is very exciting.”
Douglas says the company recently conducted clinical research to extend the product’s use to other indications.
“Although the product has been around for about 30 years, we’ve been coming up with new ways to use it. It’s normally indicated for the treatment of moderate to severe acne.”
Effective against other conditions
Other conditions the drug has been found effective against, as listed by the New Zealand Dermatological Society, include gram-negative folliculitis, hidradenitis suppurativa, oil folliculitis, pityrosporum folliculitis, pseudofolliculitis barbae, pyoderma faciale, rosacea and rhinophyma, scalp folliculitis and acne necrotica, sebaceous hyperplasia and seborrhoea.
Mr Douglas says the first United States orders will be despatched in February 2012 and a consumer launch is likely around April or May 2012.
The company, which specialises in products in the areas of immuno-suppression, the central nervous system, oncology and dermatology, currently has another three New Zealand-developed products under review by the FDA.
Oratane
Acne treatment Oratane, now approved for release in the US.
Other export expansions
The company says it is also working with an international pharmaceutical firm to begin exporting to areas where it has no infrastructure, such as Africa, South America, Central America and Eastern Europe.
‘‘We have formed a close relationship with a major pharmaceutical company who will have to remain anonymous at this stage until we make a public announcement. To establish infrastructure in those countries is not easy, unless of course you are very well financed and structured,’’ says founder Sir Graeme Douglas.
In mid-January 2012, Sir Graeme, who began working as a pharmacist in the 1950s, was announced as a finalist for Outstanding International Business Leader in the 2012 New Zealand International Business Awards.
Douglas Pharmaceuticals, founded in 1967, is one of New Zealand’s most successful drug manufacturers and distributers, with factories in Auckland and Fiji. The company’s export turnover has grown to over $85 million dollars from 15 different generic products that are sold to 60 companies around the world. It earns over $57 million of domestic revenue and employs around 470 people.
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Read about the work that another New Zealand company, Qunatec, is doing on acne treatments:
