The Phase II results of FMX101 in my estimate are better than any other approved acne treatment with no side effects.
Topical spume. spray medication is going to grab place of traffic share from both oral and other consisting of topics medications because of its superior qualities.
The novel secondary offering was six times oversubscribed, showing firm institutional demand for shares.
Bull place of traffic in Biotech
It is five years into a stimulator of the stock-market market and time to be a bit more careful investing in stocks. In blunder markets, most stocks are going up and it’s without anxiety to confuse stock picking prowess with a general positive momentum for whole stocks. I need an edge to besiege profitably, especially in the biotech battle-field where many companies have yet to cause to be a profit.
I am fond of in good season stage, innovative pharmaceutical companies that confess proprietary drug development platforms. Companies through a strong possibility of getting a fruit approved. It must have proprietary physic discovery platforms and/or novel drug delivery systems. Even better if the matter is in the early stages and has been more or less de-risked. That gives the revelation platform commercial value and makes it of profit to competitors as a buyout mark.
I have written articles on Pfenex Inc. (NYSEMKT:PFNX) and Insys Therapeutics (NASDAQ:INSY) that have their own proprietary platforms edifice the pipeline. The theory behind these investments is a simpler essay than most high risk, make it or delinquency biotech companies. These companies are seizure existing approved drugs and making them either similar and/or better acting than the current unsalable article on the market. The FDA allows the treatment of prior drug trials to protect a new drug application (with a repaired formulation) so the expense of trials and the time to approval are lessened. The put in peril of FDA failure is diminished because the drug has been previously approved in a divergent form.
I wrote several articles (in March and April) touching Pfenex Inc. and their discovery platform enabling faster ascertainment and a lower cost model conducive to biosimilar drugs. And as it turns audibly, PFNX has a few things in habitual with Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX); the couple just went public, they both had to divide their IPO offering price in moiety (to $6 per share) and one as well as the other completed secondary offerings at higher prices. These companies are after this flush with cash and own true valuable platforms for drug discovery.
FOMX has ~t one approved drugs. That should change later this year which time a FOMX partner Bayer is expected to admit FDA approval for a foam consequence to treat Rosacea. Bayer is relating to to de-risk the FOMX platform through its pending FDA approval.
Foamix Pharmaceuticals is a small Israeli troop that has a vision. It began to take appearance after seeing clinical results from couple products under development. They were efficient to stabilize two antibiotic drugs, minocycline and doxycycline, into a local foam treatment. FOMX was a technology function and that day they changed into a specialty pharmaceutical body. The CEO stated recently that they be persuaded FOMX is the only company clever to achieve stable topical formulations of minocycline and doxycycline, two highly unstable antibiotic drugs.
A bit of luck happened last year as far as concerns FOMX. After Warner Chilcott was sold to Actavis and the elder team at Warner Chilcott sought to replace up a new dermatology company. They approached FOMX CEO Dov Tamarkin by an offer to buy projects from the FOMX pipeline. FOMX took the opportunity in a different direction. They asked the maker marketing, regulation and development managers at Warner Chilcott to adorn up FOMX in the U.S. They accepted the present itself and FOMX launched an IPO in the U.S. to fund development (link to article).
FOMX has 9 mix with ~s delivery platforms and can administer drugs, including corticosteroids, retinoids, antibiotics, antifungal and antiviral agents, NSAIDs, and hormones; and be possible to be used to treat skin disorders, e.g., psoriasis, acne, rosacea, fungal and bacterial infections, to the degree that well as conditions that require transdermal giving of drugs.
Source from investor presentation.
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They describe their spume platform on the company website:
“The patented platforms take in several water-containing compositions, such for the re~on that emulsion or emollient foams, nano-emulsion foams and hydro-ethanolic foams; wet-free compositions such as oil foams, petrolatum-based or unguent foams; and waterless hydrophilic foams, among others. These proprietary platforms are indestructible and can carry and deliver a multifariousness of drug types and combination products, some of which may be unusable in other limited forms or have considerably limited durability when delivered orally or via other local platforms, such as ointments, creams, lotions, or gels.”
Right after this the two platforms of interest are the oil foams and the nano-emulsion foams. Here is one excerpt from the 2013 press release regarding their discovery platform.
“Nano-emulsions are submicron sized emulsions that are below extensive investigation as drug carriers as antidote to improving the delivery of therapeutic agents. They enter into the composition of, by far, the most advanced nanoparticle systems toward the dermal and systemic delivery of pharmaceutical actives against controlled drug delivery and targeting.”
FOMX proprietary foams are generally better transporters of drugs, acquire enhanced bioavailability, better skin penetration (into and end the skin), and improved stability, becoming for any drug and safe. This adduce was taken from the recent 20-F filing of FOMX:
“Our proprietary technology enables us to formulate and stabilize a distant variety of drugs, including extremely impressible drugs that readily disintegrate when combined by most commonly-used topical compounds, enabling us to bring out topical formulations of existing therapies that were antecedently unavailable. By making these drugs useful for topical application, our foam platforms be possible to enhance their potency, clinical effectiveness and easiness-of-use while minimizing side goods. Our foam platforms are generally designed to have existence suitable for dermal, vaginal, nasal and other applications and be able to be tailored to treat a kind of diseases and disorders. We put confidence in that the diversity of our spume. spray platforms and their numerous possible combinations with other drugs will allow us to fix upon the best candidates for further progression in a continuously ascending gradation based on market need and the suitable regulatory pathway.”
FOMX has been exceedingly diligent regarding patent protection. CEO Dov Tamarkin announced for the period of the conference call (link):
“In March, the U.S. obvious office granted out our fifth plain surrounding our proprietary minocycline and doxycycline product line. This patent will be in constrain until 2030. This further supports the worth of our proprietary – the proprietary mind of our various foam platforms and limited product compositions, and extends our security of this unique product. As of March 31, we had a gross portfolio of more than 110 granted patents and again than 95 patent applications worldwide, including 39 granted patents in the United States.…”
The put in peril is that other companies can try to make ready competing products and the patent’s life compass is not as assured as a bolt new drug. On a positive draw out, companies that are about to confuse patent protection for existing drugs be able to extend the patent life by creating just discovered methods of delivery and formulation. This is the kind of Bayer is attempting to do by a product I will discuss later. This take is from the 20-F filed with the SEC.
“We have several granted patents allied to FMX101, FMX102, FMX103 and FDX104 in the U.S., which are expected to remain in force until 2030. These patents claim a formulation of a tetracycline antibiotic what one. can include minocycline or doxycycline, and for that may be less protective than patents that claim a recent drug. We also have patent applications claiming formulations what one. relate to FMX101, FMX102, FMX103 and FDX104 de~ in various global markets including the U.S., Australia, Brazil, Canada, China, the European Union, India, Israel and Mexico. As of March 31, 2015, we had a apparent portfolio of over 110 granted patents and in addition 95 patent applications worldwide, including 39 granted patents in the U.S., belonging to our foam-based platforms and other technology.”
There are four products in converging-point and the lead product is FMX101 in opposition to acne. They expect beginning Phase III trials in the third part quarter with results expected in 2016. FMX103 is planned to come in Phase II clinical trials for handling of Rosacea by the end of this district. FMX102 will be entering safety trials in favor of impetigo and a Phase III struggle in 2015 pending FDA reviews. Lastly, FMX104 desire report results from clinical trials in opposition to treatment of chemotherapy-induced rash in the third part quarter. They plan to submit a novel drug application, or NDA, submission on the side of each of these applications under the FDA’s 505(b)(2) regulatory course of life. That supports shorter trial times and depress costs.
FOMX also has a pre-clinical pipeline by many drugs under clinical development.
The conduce product
Imagine a new way of acquisition rid of acne by lightly abrasion foam on the sores and going to vein. That is what Foamix Pharmaceuticals is grievous to do with its lead performance FMX101. It will start two Phase III trials this year, by results expected in 2016 and order seek FDA approval in 2017. Acne affects millions of commonalty worldwide and as of January 31, 2015 is a $3.0 billion mart in the U.S. branded usage market. The market is split betwixt oral antibiotics ($1.7 billion in sales) or lotions, creams and ointments ($1.3 billion in sales). The acne mart is so fragmented that numerous companies are selling hundreds of millions integrity of drug treatments. This chart is from the company presentation.
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The truth about acne is that the carcass becomes immune to the drug used. It’s recommended to switch betwixt products to get better results. That is the one reason that there are so divers companies in the business of selling treatments.
There are drawbacks through oral treatment. Oral drugs must cross the body’s organs and may bring into being undesirable side effects. Oral drugs ~iness also be taken in larger doses than consisting of topics drugs since the drug has a harder time to hit the site of infection.
Minocycline is widely prescribed like an oral generic and branded deaden with narcotics. Solodyn had $378 million in sales in year ending January 2015 in the same manner with a branded time release minocycline custom medicine used to treat moderate to caustic acne vulgaris for ages 12 years and older. It has numerous side effects (link) and drug interactions otherwise than that it works. In 2009, the FDA added verbal minocycline to its Adverse Event Reporting System, a roll of medications under investigation by the FDA, appropriate to its severe side effects.
Foam has spotless advantages over oral drugs and also has advantages over creams, lotions and other probable drugs. The foam product leaves ~t one residue, holds it shape until applied, swift and easy to apply (no immoderate rubbing), absorbs quickly, used only formerly per day at night, is a extremely low dose (when compared to parole) and has no systemic drug-of the same nature side effects. Most importantly, FMX101 completed Phase II trials, and at the time that compared with the trials of the current contest (oral and topical drugs), it shows upper healing qualities, again with no systematic drug-related side effects.
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Just look at the strong Phase II twelve week study results of FMX101 compared in opposition to Solodyn, Epiduo and Aczone clinical trials. Note that these are the pair oral and topical bestselling treatments since acne. Sales of Solodyn, Epiduo and Aczone exceeded $1.1 billion during the year ending January 2015. What did change the direction of out to be a surprise to direction was the trial showed foam minocycline had a wide impact on reducing non-inflammatory lesions overmuch. Note from the diagram above that parole minocycline has no effect on non-tending to inflammation lesions. That in itself is a big selling point to prescribing physicians. Additionally, a questionnaire was given to the burden participants and the FOMX 20-F states the results:
“Additionally, in questionnaires filled confused upon completion of the trial, 86% of the patients receiving the 4% dosage rated the physic as “very-highly” or “highly” sufficient compared to drugs they had formerly used, 98% of all patients were commonly satisfied with the ease of use of the foam and 92% of altogether patients indicated they preferred the froth-based treatment over alternative topical products they had used in the after .”
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These are quotes from the 20-F filing:
“Our clinically and statistically significative Phase II clinical trial results show that our high dose minocycline spume, FMX101, provides a faster, more sufficient treatment than the reported results on the side of oral minocycline, the current standard of care in quest of moderate-to-severe acne, and does in this way with fewer side effects. Based put ~ these results, we believe that FMX101 has the possible to become the new standard of care during the moderate-to-severe acne place of traffic. We are currently investing the full age of our efforts and resources to enter upon two independent Phase III clinical trials in the United States ~ the sake of FMX101 during the third quarter of 2015.”
“We believe that FMX101, granting that approved, will capture a significant interest of the acne treatment market, and may level expand the overall acne market through attracting new patients who avoid current manipulation options due to their limited effectiveness and potentially grave systemic side effects.”
Solodyn was approved in May 2006 in quest of acne treatments. It is an verbal extended release drug which offers a unbroken but very low dose of the antibiotic minocycline. Its patents emit from the lungs in 2018. Solodyn sales were $378 million for the year ending January 2015. To impose the sales potential of FMX101 in prospective, a questionnaire was given to the physicians in reference to choosing between oral and topical minocycline, 77% would prefer topical minocycline over oral minocycline.
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Oracea, another oral medication originally approved in May 2006 to manage rosacea, which is another inflammatory pelt condition, is also being used adhering acne. It features an ultra-moderate dose of the antibiotic doxycycline in a tale configuration. Oracea has plenty of sect effects which can be read up~ the body the FDA website.
Looking at the acne probable treatment options available, it becomes superficial that minocycline is difficult to stabilize in a probable form. None of the top five acne not demonstrative brands contain minocycline. The CEO Dov Tamarkin not long ago stated he believes FOMX is the without more company to create a stable minocycline in a limited foam formulation.
Hovione also currently manufactures and supplies Foamix with pharmaceutical grade minocycline despite use in FMX101 and other products. In 2014, Hovione submitted ~y IND for Phase I and II clinical trials of a strange topical product containing minocycline for the method of treating of inflammatory skin disease, including acne and rosacea. The of the present day product is said to be a minocycline not demonstrative gel suspension. While it may be transformed out to be a competing proceeds I believe that the FOMX formulation demise have better attributes than the topical gel.
In summary, FMX101 reduces both inflammatory and non-inflammatory lesions further effectively than most top brands, is made from minocycline which is already a top selling parole acne drug, has no systemic remedy-related side effects, is easy to apply, leaves no residue and works in a more excellent way than currently marketed treatments. Management has analyzed the prescriber base and believes 50 to 75 sales violate could adequately target the 4,538 dermatologists who scratch 80% of all script volume. Now put some great marketing skills with a pamphlet presenting impressive trial result of FMX101 and you regard an incredible opportunity to penetrate the acne mart.
FMX103 for Rosacea
FMX103 is a minocycline froth meant for the treatment of rosacea. Rosacea is a of long duration skin disorder that is characterized by facial redness and inflammatory lesions. An estimated 16 the multitude people in the U.S. alone endure from rosacea. Rosacea and acne lesions are dermatologically homogeneous in many ways.
The most commonly used probable drugs are Finacea (azelaic acid), Metrogel (metronidazole). Oral antibiotics such as oracea (doxycycline) and solodyn (minocycline) are moreover often prescribed. Based on clinical data of FMX101 for moderate-to-hard acne, FOMX intends to conduct incipient clinical trials in the belief that FMX103 faculty of volition be a safe and effective manipulation for rosacea. Foamix plans to set on foot a Phase II clinical trial by FMX103 for rosacea in 2015. At the end of 2014, the total market despite rosacea was $1.2 billion.
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FMX102 for Impetigo
FMX102 is actuality developed for the treatment of impetigo, including cases of impetigo caused ~ means of MRSA. FMX102 is a lower drench of 1% minocycline formulation. In a clinical unhappiness, it achieved a success rate of 81.3% in sole three days of treatment and 100% in 14 days through twice-daily applications. All MRSA-infected patients were prodigal of the bacteria after seven days of handling. While no head-to-head trials require been conducted this contrasts with a clinical potency rate of between 71% and 96% subsequent to eight to 12 days of three general condition of affairs daily applications achieved by Bactroban, one of the topical drugs comprising the current colors of care, as reported in its outcome label.
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They conducted a seven-day randomized, double-blind Phase II clinical proof of 32 pediatric patients ages couple to fifteen with at least brace impetigo lesions. Eleven patients had confirmed MRSA taint. Patients receiving FMX102 twice daily practised an 81.3% success rate in barely three days and a 100% fortunate hit rate in 14 days. Moreover, FMX102 was well tolerated, with none of the trial participants experiencing at all drug-related side effects. Additionally, ~ the agency of treating the infection in as tiny as three days, FMX102 may effectively bourn the transfer of infection from person child to the other. The circle plans to initiate Phase III clinical trials with FMX102 in the second half of 2015.
FMX104 notwithstanding EGFRI-induced rash
Cancer patients agitation Epidermal Growth Factor Receptor Inhibitors (EGFRI) drugs, similar as Erbitux and Vectibix, are vain by severe acne-like rashes attached the face and upper trunk. These rashes be able to be associated with pain, itching, and infections. These symptoms be able to create compliance issues, and lead to patients modifying their dosages of EGFRI drugs or discontinuing method of treating completely.
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There are nay approved treatments for EGFRI-induced incautious; oral doxycycline and minocycline are popularly used ‘off-label’ to treat patients. Though verbal antibiotics are often considered the model of care, they have systemic margin effects and potential drug-drug interaction by EGFRI products.
FOMX has developed a steady topical formulation of doxycycline (FDX104). They give faith to since doxycycline and minocycline have pharmacologic correspondence that FDX104 will be an cogent treatment for EGFRI-induced rash. That is based put ~ Phase II trial results of FMX101 (minocycline spume. spray) against acne. FOMX is currently conducting a Phase I/II clinical distress for FDX104 in cancer patients who are treated through Erbitux or Vectibix. FDX104 may be eligible for orphan drug designation. In the U.S., a sponsor that develops an orphan drug has marketing exclusivity toward seven years post-approval by the FDA. There is no doxycycline topical drug currently available.
The market for a topical doxycycline is totally large. I believe FOMX is solely pursuing EGFRI-induced rash at this time since it may be eligible for orphan mix with ~s designation and because there are nay approved treatments. Once approved and forward the market, it may experience opposite label usage. Oracea had off label sales of $399 a thousand thousand for year ending January 2015 ~ the sake of treatment of Acne. Let’s not overlook that Oracea is an oral fashion of doxycycline.
FOMX shows 9 pre-clinical products for that which is less than development on the company website (conjoin). These candidates are from a vast variety of indications which FOMX owns worldwide rights and what one. are all based on formulations and adaptations of their patented, capricious foam platforms.
FOMX is developing a concatenation of fully configured, stable foam formulations through drugs that are known to effectively discuss common dermatological indications, including atopic dermatitis, psoriasis, genital warts and actinic keratoses, herpes and fungal infections.
One ~ion under development for non-inflammatory acne is based forward a formulation of one of their foam platforms that combines minocycline and a different active pharmaceutical ingredient. I imagine we may have existence receiving more information on the result when it reaches clinical development. Right a little while ago the company is keeping a tight edge on the product.
FOMX began ~ the agency of partnering their foam application technology to pharmaceutical companies that wanted to widen product brand by creating new improved designs of their existing physic. Several agreements have been made and FOMX be disposed receive milestone payments and royalties in successi~ sales when approved. These statements are from the 20-F filing:
“In addition to our product candidates, we be favored with entered into development and license agreements through various pharmaceutical companies such as Bayer, Merz and Actavis, combining our spume technology with a drug selected by the licensee to create new products by improved efficacy and ease-of-practice. Each license agreement entitles us to homage payments, contingent payments and royalties from sales of somewhat new products that are commercialized. Each agreement is exclusive only to the specific drug that is licensed, leaving us the rights to commercialize and open products with other drugs for the sort indications using our proprietary foam technology during the time that also allowing the licensee to put the new products to any indication with its specific drug. The prospective products under these various agreements are popularly in pre-clinical Phase II, Phase III and pre-approval stages. To age, none of these prospective products esteem been effectively commercialized.”
“In addition, we esteem entered into development and license agreements …… that, from our inception in 2003 to December 31, 2014, require generated $18.1 million in revenues.”
Bayer licensed from FOMX a foam vehicle for its compound azelaic sharp which they’re developing for rosacea. Finacea (azelaic pungent) gel is currently marketed by Bayer in opposition to Acne and had $149 million in sales towards year end January 2015. The patents in the place of Finacea gel expire in 2018 and Bayer hopes to succeed it with a better acting foam product with a long patent life. Bayer using FOMX technology filed the NDA in the fourth cut to pieces of last year. A FDA rejoinder is expected before the end of this year. Based ~ward existing sales for Finacea FOMX expects to get approximately $10 million annually in majesty fees.
FMX101 Phase II woe results clearly showed advantages over the pair oral and topical acne treatments, and I calculate upon the product to quickly rise to a rise above others selling treatment for acne if it is FDA approved. With the top 4 brands selling over $350 million each, I anticipate at least $300 very great number of sales within the first divers years of marketing. Considering the FDA admonition on oral minocycline, I presume prescribers decree try the FMX101 product on patients in commutation for solodyn (time release minocycline). If everything goes to the degree that planned, then FMX101 will command a liberal part of the prescription based acne place of traffic.
With the U.S. acne emporium at $3 billion, the rosacea market at $1.2 billion and the Impetigo mart approximately $330 million, FOMX has a very large market opportunity to address.
FOMX has $110 very great number in cash and a capitalization of $360 the multitude, putting the enterprise value at a same discounted $250 million in my persuasion.
FOMX is in the early stages of proper a profitable specialty pharmaceutical company, and I make no doubt of it will have remarkable success similar to a business and as an investing..
Source: Foamix Is Going To Disrupt The $3 Billion Market For Acne, Buy It Now
Disclosure: The author is long FOMX, PFNX, INSY. (More…)The inventor wrote this article themselves, and it expresses their be in possession of opinions. The author is not receiving indemnification for it (other than from Seeking Alpha). The father has no business relationship with any company whose stock is mentioned in this count.
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