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Australian not-for-profit group wins unprecedented FDA approval for blindness drug

Sunday, July 22nd, 2018

London: An Australian company has won unprecedented US approval for a new drug to treat the second most common preventable cause of blindness in the world.

In the process, Medicines Development for Global Health, based in Melbourne, became the first not-for-profit company in the world to register a medicine with the US Food and Drug Administration.

Mark Sullivan, managing director of Medicines Development for Global Health.

Photo: Supplied

The World Health Organisation has been calling for better treatments for river blindness for more than a decade, but because the medicine would be mostly used by those in poverty-stricken countries, there has been no financial incentive for drug companies to develop new treatments. The current treatment is 20 years old.

River blindness is caused by parasitic worms and spread by black flies. It affects the skin and eyes and is prevalent in sub-Saharan Africa.

In a double-win for Medicines Development for Global Health, it has also won a highly sought after voucher designed to financially reward companies that develop drugs for neglected diseases.

Managing director Mark Sullivan said while FDA approval for the company’s drug, moxidectin, was a “momentous achievement” for any pharma company, it was “a particularly rare and exciting event” for those trying to treat neglected diseases.

The FDA gave its approval for the treatment, which is swallowed as a tablet, in June after the application was submitted in October 2017.

Mr Sullivan established the Melbourne-based not-for-profit company in 2005 with the sole purpose of filling the gap left by the big pharmaceutical companies by developing medicines that were based on need for treatment rather than the patients’ ability to afford them.

Medicines Development for Global Health has been working for five years on the development of the drug and is now planning to develop moxidectin as a new treatment for scabies, a common problem in Indigenous communities.

Priority review voucher

The company has also won a priority review voucher under a scheme set up in 2007 to create a financial incentive to reward drug makers willing to spend the time and money developing treatments for the some of the world’s most neglected diseases. The scheme creates a market for making new drugs that the private market was not filling itself.

Under the scheme, a company that wins a voucher gets a fast track through the FDA for consideration of its  next new drug,  even if it’s a treatment that would have a commercial return. This gives it a head-start over its rivals.

Crucially, a company can also on-sell the voucher to a bigger company willing to pay anywhere between $US100 million and $300 million for the right to almost halve the approval time.

Because Medicines Development for Global Health is a not-for-profit, its proceeds from drug sales and the voucher will be reinvested in the company to develop new drugs & medications for other neglected diseases.

“Our plan is to sell the voucher and use the funds to support further development of moxidectin for other neglected diseases but also to expand our portfolio into other medicines and vaccines,” Mr Sullivan said.

Professor David Ridely from Duke University authored the scheme and said Medicines Development for Global Health was a textbook example of how he envisaged the program would work.

“I’m delighted that the voucher program is playing a role in treating patients with river blindness, and one day eliminating the disease,” he said.

Mr Sullivan said the development of moxidectin could not have been possible without a $US13 million co-investment from the Global Health Investment Fund, which is the social impact investment fund initially put together by the Bill and Melinda Gates Foundation.

”We believe moxidectin may play a pivotal role in eventually eradicating river blindness, and look forward to working with MDGH and others in making this happen,” Curt LaBelle, managing partner at the investment fund, said.

Color-enhanced Scanning Electron Micrograph (SEM) of Onchocerca volvulus, image of a female worm with microfilaria. O. volvulus is a nematode that causes onchocerciasis, or “river blindness,” mostly in Africa. Long-term corneal inflammation, or keratitis, leads to thickening of the corneal stroma which ultimately leads to blindness.

The Food and Drug Administration (FDA) has approved moxidectin for the treatment of onchocerciasis (river blindness) due to Onchocerca volvulus in patients ≥12 years of age.

Moxidectin, a macrocyclic lactone, is an anthelmintic drug that selectively binds to the parasite’s glutamate-gated chloride ion channels. It is active against O. volvulus microfilariae but it does not kill adult O. volvulus parasites. The tropical disease spreads from person to person via black flies that breed near rivers in South and Central America, sub-Saharan Africa and Yemen

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BEST HOME REMEDIES FOR HEAD & BODY LICE

Monday, March 14th, 2011

Head Lice –

Louse Home Remedies   –

Suggested remedies for Head Lice

Drown the  lice by covering your skin in olive oil for several hours.

Head Lice Remedies

For head lice problems rinse your hair with vinegar. Vinegar  helps in killing all the lice nits in a matter of days.

Coconut oil for massaging hair scalp after helps.

For head lice use Listerine (original flavor): Another remedy for treating head lice is rubbing listerine mouth wash on your head. This will kill all the lice.

Massage your head with mayonnaise and comb it after 2 hours. This will kill all the lice and their eggs. Apply a mixture of lemon and butter on your head, wait for 15 seconds and then rinse your head.

An anti-lice oil can be mixed with coconut (or mustard) oil and 0.2 per cent lindane (BHC) or 0.1 per cent pyrethrum essence. This oil can be rubbed well into the scalp to kill lice. (Ingredients can be purchased from a chemical dealer).

Mix talcum powder with 0.2 per cent prethrum dust in it (or add 10 per cent DDT). Sprinkle this powder on the hair before going to bed and rub it vigorously so that it reaches the roots. Cover your mouth, nose and eyes to protect them from the powder.

Anti-louse lotion, either gammabenzene hexachloride lotion or cream (Lorexane, Gammaexane) or Malathion (Prioderma) will kill the eggs which can be removed by a comb with very fine teeth. One treatment is enough but all the family who are infested should be treated and the hair examined regularly for a while. You may consult a doctor for the treatment.

To remove head lice and their nits. put any common lotion on your  skin generously and then comb your hair out with a regular comb to get any knots out then comb out with a fine tooth comb.

Some people swear by using a common cheap hair gel put on generously & left on under a shower cap for several hours or overnight to smother the bugs etc

Sourced & published by Henry Sapiecha