Insulin

 In Sub-Saharan Africa lack of insulin access results in a life expectancy of less than a year for a child with type 1 diabetes, compared to almost normal life expectancy in high-income settings.

source: WHO

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Cole (center) was diagnosed with Type 1 diabetes when he was 10. Because of a high-deductible health insurance policy, his mom is forced to pay $1500.00 out of pocket for short term insulin supplies...after applying a $350 coupon.

Source: Business Insider

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A former English teacher, Dolores Suvak, 68, is diabetic, one of an estimated 11.2 million seniors — 25.9 percent of Americans 65 or older, according to the American Diabetes Association. Medicare Part D’s prescription drug “doughnut hole” coverage gap caused her insulin price to double in the first year.

source: Pittsburgh post-gazette

 

 

Our goal is to bring affordable insulin to those in need.

Fair Access Medicines initiated a program to develop and manufacture Human Insulin. We are currently using a method that is capable of producing Human Insulin at high levels. This will allow us to make large amounts of insulin at low cost. We will then seek approval from the US Food and Drug Administration (FDA) to market insulin in the United States and worldwide.

Recently, we obtained free access to incubator laboratory space that will allow us to develop the insulin manufacturing process at Bayer’s CoLaborator facility in Mission Bay, San Francisco. This is a very important milestone and strong recognition of the importance of our effort.

In conjunction with this gracious offer, we urgently seek funding to support this effort. These funds will support development including personnel, supplies, testing, contract analytical, molecular biology and manufacturing support and regulatory compliance activities leading to a “Pre-IND” meeting with the US Food and Drug Administration (FDA).

 

Diabetes Worldwide

 
 
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Insulin matters.

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542,000 children have type 1 diabetes

Three quarters of people with diabetes live in low and middle income countries.

 source: International Diabetes Federation

source: International Diabetes Federation

Every 6 seconds a person dies from diabetes (5.0 million deaths)

 
 

Insulin prices have skyrocketed in recent years.

The prices of two popular forms of insulin (Lantus and Levemir) are plotted on this graph. The graph shows that these prices have gone up almost 500% over a ten year period.

 
 

Daraprim

"What happened to the $750 pill that catapulted Martin Shkreli to infamy".... 

The Washington Post reported in its August 1, 2017 issue that "That drug, called Daraprim, went from $13.50 a pill to $750 a pill in the summer of 2015. Now that the outrage over access to that lifesaving medicine has died down, guess how much the pill costs? $750. There is still no generic version."

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Our goal is to bring Daraprim (pyrimethamine) to those in need in the U.S.

Fair Access Medicines, a California registered 501(c)(3) nonprofit organization, has initiated a program to develop and manufacture generic pyrimethamine (sold under the trade name  Daraprim®) in the U.S. To accomplish this goal, we will use North American based partners to make, formulate, and gain FDA allowance for a generic version of Daraprim®.
Daraprim® is an old drug (available since 1953). Daraprim® is sold in the U.S. by Turing Pharmaceuticals AG. In 2015, under the auspices of Martin Shkreli, Turing raised the price of Daraprim from $13.50 to $750 per tablet.  This instant price hike put the drug out of reach for many patients, and earned Shkreli the title of “the most hated man in America.”
Using our expertise small molecule synthesis, formulation, and FDA regulatory pathways, and working with partners in North America, we will manufacture, gain FDA allowance for, and sell a generic version of Daraprim® in the U.S. at a significantly reduced cost.  
Not everyone needs pyrimethamine, but for those individuals with a parasitic infection called toxoplasmosis, it is not only important, but can be lifesaving. For newborn babies born with toxoplasmosis, it can prevent severe brain damage, liver disease, blindness and death. The prompt treatment of these babies is so important that most states in the U.S. now include testing for toxoplasmosis on the newborn screen that is collected on every baby in the country. For pregnant women with this parasitic infection, it can prevent many of the sequellae of the disease, in addition to the prevention of spread via the placenta to their newborns. For immunocompromised individuals, latent infection can persist, even after initial treatment, and reactivation can occur at any time.  The lifelong use of daily pyrimethamine for these patients can prevent this reactivation which often is associated with lesions in the brain , seizures and  permanent central nervous system damage.
 The sharp increase in price for this drug literally has meant life and death for the most vulnerable in our society.  The effect of this increase has a “trickle down effect” as well. For those without insurance, the cost is prohibitory for many. But even for those who enjoy insurance coverage, drug cost increases such as this drive up the cost of individual policies as well as healthcare cost in general.


HELP US TAKE GREED OUT OF THE PHARMACEUTICAL FORMULA…

 

By helping us, you're helping your neighbors and millions worldwide.

We're going to make Human Insulin and Daraprim affordable for the millions of people in need .