IamA Pharma company CEO whose drug just helped save the life of the 4th person in America to ever Survive the Brain Eating Amoeba- a 97% fatal disease. AMA!

Do you plan on jacking up the price so only rich people can survive it?

Absolutely not! Our drug has been covered almost entirely by insurance companies. On average the most out of pocket anyone has paid is around $40. Because it is such a rare disease and indication (even for leishmaniasis) insurance companies pay for it. On two occassions for Leishmaniasis patients who did not have insurance, I have waived the fee entirely. I can't promise that will happen everytime, but I do what I can. I truly care about patients and their lives which is why I am offering the drug to be stored in hospitals nationwide for free.

How do you break even on research of a drug for such a rare condition, especially at that level of patient-affordability?

It's difficult. However, our business plan involves more than just one product such as our Rhinase nasal products and marketing costs are kept at a minimum.

Don't be tempted by the dark side or reddit will...idk write some mean stuff about you or something

Sorry, I'm Canadian so we are supposed to just naturally be nice right?

I think you mean "eh?"

in true Canadian fashion, Sorry.. Again..

How much is the cash price of your medication?

There is no such thing as a cash price given the multiple number of people and companies who touch the product along the way. Our direct price per pack of Impavido is $16,000. However, you need to consider the alternative treatment and costs that will be required if they don't use Impavido.

One of the patients I donated to had previously been on 4 treatments of IV therapy of amphotercin each lasting 28 days. The patient was in his 80's and was becoming severely depressed about having to go through more treatments that seemed to be ineffective. The healthcare cost of treating a patient 4 times in a hospital bed exceeds $250,000 in total costs, not to mention the loss of time and pain as well as managing the side effects of the alternative treatment.

Again, insurance covers most of Impavido costs.

We recently had a 10 year old girl die of this horrible infection here in SC. According to our local newspapers she was given the medication you speak of. Is that true?

Yes it is. We got the call at 10pm, there were no flights available until the next morning. We had to wait, about an hour, for a courier to come pick up the drug and then it took about 7 hours to drive to South Carolina. Unfortunately by the time the drug made it, it was too late. I was personally devastated. That hospital now carries Impavido with our consignment program.

I actually did a pharma group project in college where we developed a plan for a drug that treated PAM.

Do you mind giving a high-level overview of the drug's mechanism of action? I'm curious to see how close we got. I'll also share the presentation if I can dig it up...

I would love to see the presentation!

While there are many theories on the mechanism of action, the true mechanism of action is still unknown actually. Lipid metabolism and cell wall maintenance have been indicated as possibilities.

You said 6 hospitals took you up on your offer, which ones?

There are actually 7 now, I should update that! 2 in Texas, 2 in Florida, 2 in South Carolina, and 1 in North Carolina. We are working on several others. A lot of hospitals have chosen to do press releases that they have the product and we plan to post and update a list on our website soon.

What a great contribution to medical science. Thanks for you and your company's hard work. Not to derail the conversation at hand, but there certainly is a stigma about "big pharma" in today's politics, especially in American politics. What are your thoughts on that issue?

I have worked for big pharma and generally speaking, most people are in it for the right reason. However, the mega mergers of pharmaceutical companies has created abnormal market conditions around competitiveness. While not big pharma, Martin Shkreli for example took advantage of a system for personal gain, which I don't believe is ethical.

Hello. I work on the packaging side of the industry and I'm curious about what type of packaging you decided to use for your product and why. So, after the drug is manufactured what did you and your team use as a packaging solution? Why? I see you use LDPE dropping bottles for your nasal sprays.

We use Aluminum foil blister packs for this product, it is the industry standard for this drug worldwide and we saw no reason to change it. If you know our bottle and pump, you already know we use high quality materials and know we don't cut corners.

Also, me and my daughter worked together to design the box!

Is there a plan for Profounda, Inc. to expand into other products, like an affordable epi-pen?

we are always looking for opportunities, especially when it comes to helping people but we are not currently looking at any Epi-pen opportunities unfortunately. If you know of any, let us know! my belief is that with such price gauging going on, it will encourage other people to develop and introduce other products at a lower price.

What is your response to: Drug companies don't want to find a cure to diseases. If they sold the cure, the person wouldn't need to take the medication for the rest of their life?

I don't believe in that. I believe if you do whats best for the patients and be a good person that things will work out. For Impavido (miltefosine) we treat maybe 30-40 patients per year. we lucked out in finding a cure for both Leishmaniasis and potentially the Amoeba. For our other Rhinase Nasal products, with good customer service and a product that works- patients will keep coming back. The majority of people in this industry want to help people and make a difference- not make people dependent on drugs. Of course there are the Martin Shkreli's of the world, but I don't believe that he represents the majority.

Have you ever tried pepper jelly on crackers?

I have never tried pepper jelly at all, do you recommend it?

Hello Todd,thanks for doing this AMA. I will not ask you about the PAM,but i will do ask about the Leischmania. Since i am Vet Student,i want to ask is your medicine effective in treating leischmania(sorry if i have a typo) in dogs? Best wishes :)

Yes it is! We have actually sold to vets since we have acquired rights to this product earlier this year. I am a big animal lover and am so thankful that this works on humans and pets alike!

Bonus pic of my pups: http://imgur.com/zflaLAa

Two of them were on Miltefosine, our newly acquired drug (It’s FDA indication is for the treatment of Leishmaniasis- a rare tropical disease). Sebastian Deleon marks the 4th survivor and the 3rd on our medication.

So somebody managed to get their brain eaten by an amoeba and somehow survive without treatment?!

That case was in 1978 in California, and he wasn't diagnosed with the Amoeba until 2 years after he had recovered from it so we don't really have any information as to what happened there or how he was treated, but yeah survived and no brain damage which is remarkable!

How do you know you have the amoeba?

The Amoeba is confirmed through a spinal tap. However the symptoms are: A headache, stiff neck, fever, light sensitivity, touch sensitivity, nausea. Unfortunately, these symptoms are the same as both viral and bacterial meningitis. In the case of many patients, the initial tests for Amoebas were negative and were then found to be positive. If you have ANY of these symptoms and have been around water (including slip and slides, nasal flushing) seek URGENT medical care and tell them you have been around water.

If you have ANY of these symptoms and have been around water (including slip and slides, nasal flushing)

Is this also a risk for people who use tap water in C-PAP machines? Can distilled water carry a risk?

Distilled water is recommended because Tap water is clearly unsafe. However any water that is sitting around is susceptible to becoming affected with bacteria or amoebic parasites.

Though probably nothing compared to the high probability of death if the drugs aren't taken, what are the side effects or any long lasting heath effects from the 28 day regimen?

There are no long lasting side effects. There are minor side effects which are reversible, the major side effect being Nausea- which in most cases can be managed. more information can be found at www.Impavido.com

What prompted your company's focus on fighting such a rare affliction? A nasal spray seems like a more traditional/safe product to focus on, but why go for the amoeba?

First of all we didn't go for the Amoeba, we went for the drugs indication which was for Leishmaniasis (a rare tropical disease) because other companies were not willing to make the product available in the U.S due to the small patient population and therefore lack of significant profit. We became aware of the Amoeba effectiveness after discussing with the CDC and the Amoeba foundations. It became evident quickly that the current method of distribution was not an effective solution to helping patients survive this terrible disease. That's why I created the consignment program at no charge for the Hospitals- until the drug is used- to increase the odds of survival.

While nasal products appear to be safe there are still negative effects to steroid use. Our belief is that if a patient can get relief to their allergy and dry nose conditions without using a steroid, that's a better way to treat the patient. For us, its not always about numbers, it is about uniquely solving medical problems with unique solutions.

Thanks. As a follow-up, which is your favorite (and least favorite) of the amoeba foundations?

We work closely with both foundations Kyle Cares and Jordan Smelski foundation for Amoeba Awareness and they actually work with each other. It is really a group effort filled with wonderful people. It's not about favorites, it is about patients afflicted so we encourage anyone and everyone to be involved.

It seams you are having trouble stocking Hospitals can distrubution centers ie, Amazon, Walmart store the drug through out America?

The problem is not "how fast can you ship" it is "how fast can you dispense". We can ship anywhere over night. the CDC can ship anything within 9 hours, and neither of those are fast enough. Hospitals need to stock this product.

Hello

How long after being infected by the amoeba will the drug be effective?

Another question that might be hard to answer since you are in the US. I was travelling in New Zealand last winter and at many of the thermal rivers and pools there where warning signs saying not to put your nose/ears under water to avoid infection, is this a warning for Naegleria fowleri?

This patient recieved the mediaction around 30 hours after exposure. Between 48-72 hours the patient in this case, after receiving our medication (in conjunction with other medications and of course brilliant medical care)- testing showed that the Amoeba was completely absent.

The longest recorded time was 66 hours after exposure that someone survived without brain damage. But I wouldn't recommend waiting that long!

In regards to the sign you saw, I would say that it is very likely they were warning about the Amoeba. It is very common in warm waters and you get infected by infested waters traveling up your nose, but of course there can be a number of other infections the signs can be warning about- so i can't say for sure. For Naegleria Fowleri, it is recommended to keep your head out of the water, wear a nose plug, or stay out all together. While we may have hope for a cure now, it is still extremely dangerous to contract.

How long is a patient required to take Impavido to rid themselves of the amoeba?

It is a 28-day course of therapy, however the Amoeba seems to be killed within a 48-72 hour period.

Does your company hire recently graduated PhDs for research, or do you prefer people coming off a post-doc? I'm hoping to jump right into industry when I finish my doctorate in a year or two and avoid remaining in academia.

We are still at an evolving entrepreneurial stage and typically use consultants where needed. I suggest you target the top Biotech and Pharma Companies as the best entry point. Better yet, invent something new and start your own company.

What's the most frustrating component for you regarding Clinical Trials? How would you make that challenge less difficult?

The bureaucracy. The sheer amount of paper work, money, man hours and the hoops you have to jump through make it difficult for drugs that have the potential to really help unable to get their foot in the door.

What stops a company like your from undercutting another company says Mylan for instance, by flooding the market with a cheaper variant of their epipen auto injectors?

First of all Mylan is primarily a generic company and they understand as well as anyone how the generic market works. There is nothing other than technology, intellectual property and manufacturing capability to stop someone from coming up with a cheaper version. In the generic market, having a portfolio of generic products allows large generic companies to have the ability to price below cost on certain SKUs and therefore a small company with only one generic is vulnerable to losing market share and therefore profits.

I know you just sell the drug and aren't necessarily an expert on the amoeba, but maybe you are.

I used to really enjoy open water swimming for exercise (2-4 miles at a time) in FL lakes, but stopped a few years ago when I learned of the organism. I know you can protect yourself with nose clips, but that isn't conducive to elite swimming form. Is it safe to swim in the water considering you are only breathing out into the lake? Is there anything else you can do to protect yourself?

The Amoeba is found in most bodies of fresh water and water about 72 degrees F and above. While we may not be doctors we definitely have spent a lot of time researching PAM, I wouldn't recommend swimming in fresh body water. If you do go swimming, use a nose plug, and the most important thing is to watch out for and recognize the symptoms. Do not wait to go to the hospital and make sure you inform them you have been in fresh bodied water.

So is this why we've been hearing stories about this bug, or is global warming increasing the opportunity for this bug to thrive?

The Amoeba has always been present in fresh water, and we believe in the past it was under diagnosed as its symptoms are so closely aligned with that of bacterial meningitis. We believe awareness (through Kyle cares and the Jordan Smelski foundation) has launched this bug into the news and do believe that with global warming the risk is at an even greater threat.

What are your thoughts on the recent and not so recent price-hikes of lifesaving medicine?

I think it is unethical. plain and simple. I have answered this in a few ways throughout the thread if you want a more in depth answer.

Hi, Todd, thanks for doing this AMA! I have a couple of questions, if you don't mind answering.
* How many cases of PAM arise in the United States per year and is infection by negleria fowleri more likely in any particular climates or regions, e.g. warmer bodies of fresh water in southeastern states vs. colder bodies of water in, say, the Pacific Northwest?

*Regarding your proposed consignment program for Impavido, are there any examples of existing consignment programs in which drug companies stock hospitals with other life-saving drugs such as antivenin? Surely PAM isn't the only drug designed to treat illnesses in which time is such a serious factor. A consignment program like the one you propose seems like a no-brainer--hospitals get life-saving medicine for free and only have to pay for it when it's used.

Thank you for taking the time to do this AMA. In a world where most pharma CEOs seem to have gone to the Martin Shkreli school of business, it's nice to know there's at least one decent person like you out there in the pharmaceutical business.

On average 6 patients a year are confirmed by the CDC to have the Amoeba. I believe, along with other experts in the field that this number could be much higher as autopsy's are generally not done if they suspect bacterial meningitis due to family wishes. Just because a case has been confirmed to be bacterial, does not mean it is not also Amoebic, it could be both.

The Amoeba is found in most bodies of fresh water and water about 72 degrees F and above. Most cases have been in Florida and Texas, but not all States require cases to be reported. Cases have been found as far North As Minnesota.

There are other consignment programs, however, usually they charge 10% of the value of the drug to have it stocked. I am unaware of any specific drugs that charge nothing.

Snake bites are actually more common than this Amoeba, therefore it is easier to convince a hospital to stock the product. Though, not every Hospital stocks anti-venom. For example, I believe for me, who is in Orlando, the closest hospital with anti-venom is in Miami- 4 hours away. In our case, minutes matter which is why we are hoping to get it in as many hospitals as possible.

As a person who has 30 years of Pharmaceutical industry experience, what is your opinion on medical marijuana? Specifically, marijuana's proven ability to "cure cancer".

I think Medical Maijuana has it's place, but it is also being over used and abused. However, I don't think Marijuana should be illegal in the first place.

Semi-serious question here. Given your experience with the disease, would you say the House episode (if you've seen it, the one with the laughing cop at the end of Season 2) was an accurate depiction of its progression, symptoms and cure? I know that House takes a lot of liberties when it comes to portraying actual medical conditions but I've always wondered about this one.

I haven't seen the episode but I definitely have an interest to watch it. If I remember to, I will report back and let you know!

I'm probably too late, but it's worth a shot:

Are you good friends with the 4 people you have saved so far?

And on another hand, how well do you think Profounda Inc will do in the near future?

We have just recently met the parents of Sebastian Deleon, it was a very emotional meeting with lots of hugs. We do not know the families of the other survivors as we have only just acquired the rights to the drug earlier this year. However, we have established friendships with both Jeremy Lewis and Steve Smelski who have lost their children to this horrible disease and we will continue to work with them to raise awareness.

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I did send my son! He actually works for my company as an Operations Manager, but it was on a Sunday and I was out of town. He had just gotten back from visiting Tampa and was still in his Pajamas when he raced out the door!

Are you relying on recent court rulings to promote this drug off-label? Won't you face backlash from the FDA since your indication is for a different disease?

Thanks!

Its possible. Currently the CDC has been recommending the use of miltefosine for the treatment of the Amoeba.

What color is the liquid in your nasal spray? Would you consider changing it to an ecto-green hue? Hilarity would ensue.

Rhinase is colorless- there are no Dyes added. I always consider funny options however.

What are your plans to make this more attainable for people that may get this amoeba?

We have created a consignment program with Hospitals so that they can have our drug on hand at no charge until the drug is used. Timing is key and we want to make sure that everyone has access as soon as possible.

What is Rhinase and does it work on hair?

Haha Hi Anthony :)

Tipping my hat to you sir.

I'd love to hear more about what you have in store next. Have you targeted your next disease/infection?

We are always look for new opportunities! Right now we are focusing mainly on Impavio and our Rhinase nasal products. Please check them out!

What's your opinion on the prescription drug abuse epidemic affecting the US? What can be done to mitigate how easy it is to obtain narcotics?

I think that no matter what kind of drug, there will always be people out there abusing them in some way. I think, as a drug manufacturer, it is important to create drugs that help people and make them accessible to those who need them. However, there is always potential for abuse. I believe you should focus on treatment for those people that abuse the drugs and not on restricting the drugs which may affect those who really need it.

As a Florida native and resident, I just wanted to say thank you! Every year we hear about these amoebas and the deaths they cause. We stay out of any "warm" water mainly because of the risk from the amoebas and secondarily, the alligators!

My question is- What can be done to get your drug into more hospitals?

Awareness is key. We are working with talking to Hospitals one by one about the importance of having this drug and hopefully with awareness they will be more receptive to wanting to store this drug onsite.

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Naegleria fowleri Amoeba is actually fairly common, getting the disease it causes itself however is more rare. It has been found in hot springs and swimming holes, freshwater lakes, untreated pools and spas, mud puddles, Slip in slides from backyard hoses, and even neti pots used to clean out sinuses. You get the infection from having Amoeba infested water thrust up your nasal passageways. Symptoms start usually within 2 days of exposure and patients usually die within 3-7 days after the symptoms start which is why its so important to act quickly in every case where Naegleria fowleri is suspected.

Would you say that most of your money is made through boner pills, or all of it?

I would say zero dollars, as we do not sell erectile dysfunction pills. though, that would really be a pick me up.