There’s an endless parade of new pharmaceuticals to consider when it comes to getting them into the market.
The FDA’s proposed guidelines have been in the works for a couple of years now and now, a new pharmaceutical company has made it their number one priority to get a new drug onto the market as soon as possible.
That new drug, Merrimack Pharmaceuticals, is hoping to get approved this year, according to The Wall Street Journal.
The company plans to make the drug, which it says is a “nucleotide-targeted therapy” for the condition of Huntington’s disease, available in the U.S. for a few months in 2019.
But the company has a few more hurdles to overcome before the drug can be ready for the market in 2019, according the Journal.
First, Merris aims to make sure the drug will be safe and effective for patients with the disease.
Second, Merrris has to get approval from the FDA to market the drug in the United States.
Third, Merricks hope to reach out to drugmakers to make their drugs more affordable for the American public.
“There are many hurdles we’re going through right now to get this approved,” said Jeffery Felt, Merriam-Webster’s vice president of regulatory affairs.
“We’re going to continue to do everything we can to get the drug approved and to make it affordable for American patients.”
While the process may seem complex and expensive, Merrin hopes to make things easier by making it easy to get in on the action.
“It’s been extremely difficult and time consuming,” Felt told the Journal, “but we’re optimistic.”
So far, Merrs CEO and cofounder, Alex Molloy, says he’s received a number of offers for the company’s drugs.
The most recent one came last month, he said.
The drug, he noted, was developed by Merrimacks own company, but the process of developing the drug was not.
“A lot of these [new] drugs are developed and made in this country,” Molloys told the Wall Street Journa.
“When we see this [new drug], we’re not just going to say ‘hey, Meris made it in America’ or ‘Meris is doing something right’ or whatever, but we’re really going to look at the whole picture.
We’re going see what the value proposition is.”
And, Molloyd says, “we want to make this affordable for patients.”
The Merrimcks first drug, the drug that’s been dubbed the “bioengineered cure,” will be available to patients in 2019 and costs around $100,000.
But, the company says, the price will go up when it reaches the FDA’s list of approved drugs in 2019 to $130,000 and will be able to negotiate lower prices with the companies that manufacture the drugs.
For patients who can’t afford to pay that much, the treatment could be a good alternative.
“I don’t know of anyone who’s not going to be very interested in the treatment,” Molls said.
Merrimanks CEO, Alex W. Molloya, told the WSJ the company plans “to aggressively pursue” new pharmaceutical companies to produce and sell its drug in 2019 as it looks to “break even.”
“We have a good track record of success in the drug industry,” Mrolly said.
“Our approach is to continue making progress, and we have a lot of good prospects.
But it will be interesting to see what happens.”
Merrimakers first drug has been called a “biosciences drug” But the drug is still a bit of a departure for Merrimackers approach.
The bioengineered treatment for Huntington’s is not exactly a new idea, but it’s been a bit controversial since its first clinical trials began in the spring of 2017.
The disease is caused by a mutation in a gene that makes proteins that help cells function.
When the disease strikes, the protein-making cells that produce the proteins, called myelin sheaths, get destroyed and the myelin can no longer support the cell.
The loss of myelin makes the cells unable to move, but can also result in seizures, heart attacks, and strokes.
Molly said the company hopes to continue working with the FDA and other government agencies to determine how the treatment will be used in people who need it most, like people with Huntington’s who can no long hold a job.
“This is a very promising, very innovative, very interesting, innovative, new therapy,” Molly told the WJC.
“But I think we need to make that clear to patients, so they know exactly what they’re getting.”
But the problem with the drug and the process behind it is that it’s not yet a cure.
Molls says that while the drug has shown some early results in some patients, it’s still