Contact Us

FAQs

Madera Data Room FAQs

Madera is a patented gel cream formulated to be applied to the surface of the penis and cause an erection in less than 5 minutes.

Madera enhances blood flow using an FDA approved drug. The drug is Alprostadil, and it is FDA approved for erectile dysfunction (ED) as an injection or suppository.

Madera has patented a method of administering Alprostadil topically and we are working to get FDA approval for our method of application. There is an accelerated regulatory pathway with the FDA when you apply for a new administration of an existing approved drug. This is called the 505(b)(2) pathway, so named after the guiding regulation around this approval process.

Alprostadil, also known as Prostaglandin E1 or PGE1, is a hormone produced in the male prostate that is a robust vasodilator. Alprostadil is FDA approved as safe and effective to treat erectile dysfunction (ED). At present, it is self-administered as an injection deep into the penis each time you want to have sex.

Madera is the same drug, but it is applied by rubbing a gel onto the side of the penis. In animal studies, it worked within 2 minutes.

Alprostadil has other current applications, all delivered by injection or suppository form. Applied instead with our method as an external topical drug, we see large potential therapeutic applications, for not just ED, but also Raynaud’s Syndrome, arthritis, women’s sexual health, and baldness.

In August 2024, Madera was awarded a US patent for a method of administering Alprostadil topically. We have filed the patent world-wide. Other patents building on our findings are pending.

Madera is focusing on the erectile dysfunction application first because it has a faster FDA regulatory pathway and a large $4B+ target market with a significant unmet treatment need.

Not yet. Madera needs FDA approval before it can share the product with you. We will let investors know when we meet this hurdle.

PDE-5 inhibitors like Viagra and the vasodilator Alprostadil are very different types of drugs. The method of action for each is different.

Viagra is taken orally and affects one’s entire body. It has many unwanted side effects, including hearing loss, blindness and even death. It cannot be taken by men with heart conditions and does not work if the man has nerve damage. It also requires sexual arousal.

Alprostadil, in contrast, acts locally with minimal side effects and is effective in minutes. It is a naturally occurring hormone created in the male prostate and dissipates rapidly once the patient has sex.

In clinical studies, PDE-5 inhibitors are about 60% effective, Alprostadil injection is 96% effective.

Viagra takes up to an hour to be effective, Cialis can take much longer. Alprostadil acts immediately. In our animal study it worked within 2 minutes.

Yes, the data room includes a number of overviews and detailed reports on the ED and Raynaud’s Syndrome markets.

Our work to date has focused on producing a stable product, proving the concept in the lab and on animals, and obtaining patent protection. We’ve spent more than $1 million to date. The next tranche of funds will help us to: (a) optimize the formulation and (b) prepare documents for the FDA submittal.

  • Optimizing the formula includes:
  • finding the optimal ratio of ingredients to maximize permeation and stability, and reduce product costs, and
  • finalizing packaging.
  • The FDA submittal requires:
  • several non-clinical studies,
  • documentation of our methods, and
  • details about how Madera will produce the product. This part of the FDA submittal is called the CMC package (Chemistry, Manufacturing and Controls). This is an important set of procedures used in the pharmaceutical industry to ensure the quality and consistency of drug products.

The clinical trials start after submitting our application to the FDA. This will be about a year away. Our clinical plan will take up to a year, and includes

  • Phase 1 Clinical Safety Study, budget $1,500,000, to start 30 days after IND submission. Dosing of injected Alprostadil is well established, we believe this can be a study with a well anticipated outcome.
  • Phase 2/3 Clinical Efficacy Study - 120 Person Dosing and Efficacy Study, budget $2,750,000. No less than 2 centers, as many as 6 centers with 20 persons each.

On the non-clinical studies, we have budgeted for toxicology studies, bridging studies and several irritation studies - vaginal, anal, skin, buccal and eye.

Our clinical trials development plan has been aided and guided by the FDA required trials for this drug, Alprostadil, that is already approved.

As an overview:

  • The entire project is projected to cost $18 million to get through FDA approval.
  • We will raise the funds in tranches, raising the valuation as we go forward.
  • The first $6 million will get us through remaining formulation and preparation of the filing with the FDA. $1.1 million of this has been spent as of October 31, 2024.
  • The next $7 million will complete the clinical studies.
  • The remaining $5 million will cover post-filing and pre-manufacturing work, including transferring the product from the lab to the factory and marketing. It also includes a contingency, particularly for additional studies the FDA may require.

The detailed plan is in the data room and available to interested investors who sign a non-disclosure agreement.

Yes. we’ve received bids on many of the items, and estimates from many different sources, vendors, and experts.

First, any exposure to Madera by the partner will be incidental. The drug absorbs quickly and there will be little residue.

Second, the potential amount of exposure will be very small. Alprostadil is a hormone produced by the prostate, and during normal sex a woman is exposed to more Alprostadil than she would be exposed to by use of Madera.

As part of the normal FDA application process, we have budgeted for irritancy studies for skin irritancy, including vaginal, anal, mouth and eyes.

Notably, Alprostadil and the other ingredients in Madera are proven safe. One advising gynecologist has informed us that it may be beneficial for woman’s health by increasing circulation and we plan to pursue that as another potential therapeutic market.

Yes - the Madera team are experts in this field that have extensive experience in drug development and regulatory approval. Together, the team has over 100 years of direct experience.

The CEO has successfully built and led four world-class healthcare companies, driving over $2 billion in shareholder value and delivering 15x returns on invested capital.

The technical and regulatory teams have developed and obtained approval on numerous drugs and are experts in their fields. We also have marketing expertise in bringing block-buster drugs to market.

The data room has CV’s on key team members.

Drug sales and mergers are common in the pharmaceutical industry. It is common for larger pharmaceutical companies to pay 3-4x expected sales for newly approved drugs. In the ED market there is a history of this and those historical comparative transactions are in the data room.

Madera is targeting multi-billion-dollar markets that have the potential for extraordinary returns. The sales of the injected Alprostadil for ED are estimated between $200 million to $300 million. We expect wider use of Madera, but even if Madera only takes this market share, the value of Madera would exceed $1 billion and the projected returns to investors would be more than 60x invested capital.

Our goal is to sell the ED application on FDA approval, which we project to be within 3 years.

They have tried unsuccessfully. Madera has discovered and patented a skin permeation method to administer the Alprostadil, that’s what makes this opportunity exciting.

Over the past 40 years there have been many attempts around this goal. Madera has benefited from public information disclosed in several expired patents and the many clinical studies performed by those who have come before us.

Our patented breakthrough is the discovery of a combination of reagents and solvents that greatly enhance skin permeation of the active drug, Alprostadil.

The potential therapeutic applications include erectile dysfunction, as well as other conditions that may benefit from greater blood flow, including Raynaud’s Syndrome, arthritis, women’s health, and baldness.

Eroxon is not a drug, it is a gel with alcohol in it that evaporates and feels cool. That product has no active drug ingredient and is only useful for males with “mild” ED. Similar products have been for sale in “sex shops” for many years.

Selling it in drug stores like CVS may offer them a new retail distribution channel, but they will not be a competitor to Madera.

There is more detailed information on Eroxon in the data room section 5. Market Information, where you can find two reports: Competitor Research & Analysis and the Eroxon Case Study.

The active ingredient is an effective FDA approved vasodilator that currently requires a prescription. We expect Madera to be a prescription drug.

Pricing will have to be a decision made as part of our marketing and commercialization, but there is room for a substantial profit in the cash pay and the insurance reimbursed markets.

TriMix, a widely used method of injecting Madera’s ingredients, costs $30-$60 per injected dose.

Viagra costs $65 to $145 per pill from Pfizer, $4 to $10 for generic (Hims https://www.hims.com/blog/how-much-viagra-cost ) [Note, Viagra is the most counterfeited drug on the planet and you can buy generics/fakes for $1 per pill, which may or may not contain sildenafil]

Our cost of goods is projected to be less than $4, including packaging and materials. Pricing is anticipated to be at 20x cost, at 90%+ margin. ) [Note, Viagra is the most counterfeited drug on the planet and you can buy generics/fakes for $1 per pill, which may or may not contain sildenafil]

For the ED application, we are applying through an accelerated regulatory pathway the FDA calls a 505(b)(2) review. It applies to a drug that is already approved in a different form. Madera is a novel administration (topical) for an existing (injected) drug.

The timing is based on the FDA’s stated time frames for a 505(b)(2) review.

For other applications, such as Raynaud’s Syndrome, there is a longer approval pathway because Alprostadil is not currently approved for Raynaud’s Syndrome – Madera will be the first way to administer it effectively. Madera will have to do dosing studies and other clinical work for this application. This will require additional funding. Our plan is to start work on the other therapies when we have the ED application submitted. ) [Note, Viagra is the most counterfeited drug on the planet and you can buy generics/fakes for $1 per pill, which may or may not contain sildenafil]

Our primary protection will be our patent, which will be in effect until August 2044.

From the FDA, Madera would get 3 years of market exclusivity if the FDA agrees that all the ingredients are known, safe and effective, and that we have met the criteria that the “route of administration or conditions of use may be granted exclusivity if clinical investigations were essential to approval of the application containing those changes.” That is directly what we are doing.

( https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-business-assistance-frequently-asked-questions-new-drug-product-exclusivity )

If the FDA decides that the drugs are new chemical entities (NCE), or that their combination is new, we may have to do more testing, but when successful, would get 5 years of exclusivity. It seems unlikely that they would deem these old drugs NCE’s, but given that TriMix isn’t approved, and contains papaverine, which predates the FDA (it was discovered in 1848 by Merk) but is no longer in the Orange Book, they may. [Side note: many sources online, including the Mayo Clinic, say papaverine is FDA approved and list its applications. It is not in the FDA Orange Book]. )

If the FDA does say that papaverine is an NCE, it could cost us time for more studies, but would give longer exclusivity and drive all other use of papaverine out of the market, except through us (we’d own the drug). We’ve considered this risk and benefit and factored it into our regulatory plan.

The patent, and expected additional patents, will give us much longer potential exclusivity.

Madera Pharmaceuticals is dedicated to providing high-quality healthcare products and services, ensuring the well-being of our customers with trusted pharmaceutical solutions.

© 2024 Madera Pharmaceuticals . All rights are reserved

Designed and Developed by WEBHEQ