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Stanley Hirsch, often referred to as Mr. Massive Value, has been a disaster for his part time Chairman of the Board involvement in the other company. Just imagine what he could have accomplished if he'd been working full time. Whilst (one of his patented words) he may not be actively involved in the running of Foamix, his association with the company, in whatever role and capacity it might be, should not make one feel warm and fuzzy.
Anyone that is a shareholder of Foamix should be sufficiently concerned that this fraud artist is still associated with their company. It brings into question why the CEO and the rest of the BOD have not taken appropriate action, and why they would want their own names sullied by being so closely linked to this undesirable situation.
We should contact this lawyer to see if he has any association with Richard Rubin. Maybe good old Richard is his uncle or father.
https://ih.advfn.com/stock-market/NASDAQ/foamix-pharmaceuticals-FOMX/stock-news/81129055/shareholder-alert-weisslaw-llp-investigates-foami
interesting tweet out there. A guy selling his research report.
Dr Timos Papagatsias
@_timos_
·
1h
Shingles Treatments Market Business Strategy 2019 by Companies Astellas Pharma, Foamix, Novartis
To my knowledge Foamix hasn't mentioned Shingles. No hit on their web site.
link to tweet. Twitter changed the way we can copy tweets. Made it harder
https://publish.twitter.com/?query=https%3A%2F%2Ftwitter.com%2F_timos_%2Fstatus%2F1196791769767088129&widget=Tweet
I was prescribed a cream when I had Shingles. Don't know who made it.
It would be hard to do a study, it clears up in a couple of weeks.
But it did hurt.
Wonder how many stop looses the MM's are taking out along the way? Looks like maybe some at 3.25 at the open!
Foamix Announces Enrollment Completion of Phase 2 Acne Clinical Trial for FCD105 Minocycline 3% and Adapalene 0.3% Combination Foam
http://www.foamix.com/news-releases/news-release-details/foamix-announces-enrollment-completion-phase-2-acne-clinical
Great Read on FOMX: https://rezamusic.yolasite.com/fomx.php
Foamix Announces Enrollment Completion of Phase 2 Acne Clinical Trial for FCD105 Minocycline 3% and Adapalene 0.3% Combination Foam
REHOVOT, Israel and BRIDGEWATER, N.J., Nov. 18, 2019 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (FOMX) (Foamix or the Company), a specialty pharmaceutical company, today announced the completion of Phase 2 clinical trial enrollment of FCD105 for the treatment of moderate-to-severe acne vulgaris. The trial will evaluate the efficacy and safety of the investigational topical combination foam, which comprises minocycline 3% and adapalene 0.3%.
“We are truly grateful to participants, caregivers and clinical centers for their commitment and diligence in enrolling this trial so rapidly. We look forward to completing the remainder of this study and we now expect to report topline data in the second quarter of next year (Q2 2020)," said David Domzalski, Chief Executive Officer of Foamix. “This announcement follows a series of important milestones for Foamix this year and, if approved, FCD105 would be our first follow-on product intended for the treatment of acne, behind the recently approved AMZEEQ.”
Study Design
The Phase 2 clinical trial planned to enroll approximately 400 patients, aged 12 years and older, with moderate-to-severe acne vulgaris. This prospective, randomized, double-blind, vehicle-controlled trial is being conducted at multiple sites throughout the United States. Patients are randomized to one of four treatment arms: FCD105 foam, 0.3% adapalene foam, 3% minocycline foam or vehicle foam and will self-apply their assigned treatment once daily for 12 weeks. The study design follows current regulatory standards in evaluating the safety and efficacy of combination products of this type.
The primary endpoints are: (1) the proportion of patients achieving treatment success at Week 12 based on an Investigator’s Global Assessment (success is defined as a score of “clear” or “minimal” and at least a two-category improvement from baseline), (2) the mean change from baseline in inflammatory lesion counts in each treatment group at Week 12, and (3) the mean change from baseline in non-inflammatory lesion counts in each treatment group at Week 12. Safety evaluations include reported adverse events, skin tolerability assessments, physical examinations and vital signs.
About FCD105
FCD105 is Foamix’s proprietary 3% minocycline, 0.3% adapalene combination foam formulation intended for the treatment of moderate-to-severe acne vulgaris. FCD105 combines the bacteriostatic and anti-inflammatory properties of minocycline with the third-generation retinoid, adapalene, which acts in regulating the differentiation of follicular epithelial cells. Oral minocycline and topical adapalene products are approved for use in the treatment of acne vulgaris in the United States, with the latter available in combination and as monotherapy. Pending a successful development program, the FCD105 NDA is intended to be filed under a 505(b)(2) regulatory pathway.
About Acne Vulgaris
Acne is a chronic, inflammatory skin condition that affects the skin’s oil glands and hair follicles. It is characterized by both inflammatory lesions (papules and pustules) and non-inflammatory lesions (open and closed comedones) affecting primarily the face and other areas of the body. Acne affects approximately 40 to 50 million people in the U.S. alone, of whom approximately 10 million have moderate-to-severe disease that significantly impacts self-esteem and quality of life. For most people, acne diminishes over time and tends to disappear or decrease, by age 25. However, some individuals, particularly women, can experience acne much later in life.
About Foamix Pharmaceuticals
Foamix is a specialty pharmaceutical company working to solve some of today’s most difficult therapeutic challenges in dermatology and beyond.
With expertise in topical medicine innovation as a springboard, the Company is working to develop and commercialize solutions that were long thought impossible, including the world’s first topical minocycline, AMZEEQ. Its proprietary Molecule Stabilizing Technology (MST™) is utilized in the Company’s dermatology products and in other products currently in development: FMX103 for the potential treatment of moderate to severe papulopustular rosacea and FCD105 for the potential treatment of moderate to severe acne. Foamix is a different type of specialty pharmaceutical company by design, driven to see the solutions, overcome barriers in all aspects of business, and reimagine what’s possible for conditions with high unmet needs. Foamix uses its website as a channel to distribute information about Foamix and its product candidates from time to time.
Filing of Certain Prospectuses and Communications in Connection With Business Combination Transactions (425)
Filed by Foamix Pharmaceuticals Ltd.
Pursuant to Rule 425 under the Securities Act of 1933
and deemed filed pursuant to Rule 14a-12
under the Exchange Act of 1934
Subject Company: Foamix Pharmaceuticals Ltd.
Commission File No.: 001-36621
November 14, 2019
Dear Foamix Employees:
As you know, earlier this week, on November 11, 2019, Menlo Therapeutics Inc. (“Menlo”) and Foamix Pharmaceuticals Ltd. (“Foamix”) entered into a merger agreement pursuant to which Foamix will become a wholly-owned subsidiary of Menlo. While Menlo is the legal acquirer in the transaction, Foamix shareholders will receive shares in Menlo such that Foamix shareholders will own at least 59% of the combined company following the closing of the merger.
This note is intended to summarize the treatment of your Foamix equity awards that will be converted into equity awards of Menlo if and when the merger is closed. Please note that the following is only a general summary and that the terms of the merger agreement, together with your equity award agreement and the applicable equity plan under which your award was granted, will govern in the event of any conflict between this communication and those documents.
Stock Options. As of the closing of the merger, each outstanding Foamix stock option, whether or not vested, will be assumed by Menlo and converted (in a manner intended to preserve the “spread” value of the Foamix stock options at the time of the conversion) into a stock option to purchase Menlo common stock (“Menlo Options”). More specifically, if you hold Foamix stock options at the closing of the merger, you will receive Menlo Options that will convert into a number of shares of Menlo common stock (rounded down to the nearest whole number of shares) equal to the product obtained by multiplying: (1) the number of Foamix shares subject to stock options that you have immediately prior to the closing of the merger by (2) the Exchange Ratio (0.5924, which is subject to adjustment, as described below).
Each Menlo Option will have a per share exercise price equal to the quotient obtained by dividing: (1) the per share exercise price of the Foamix stock option by (2) the Exchange Ratio (with any fractional cents rounded up to the next higher number of whole cents). The Menlo Options will be subject to the same terms and conditions as applied to your applicable Foamix stock options as of immediately prior to the closing of the merger, including terms related to tax, vesting schedule, expiration and treatment on termination of employment.
The Exchange Ratio is subject to adjustment if the results of Menlo’s two Phase III PN trials are adverse. If the results of Menlo’s two Phase III PN trials are known prior to the closing of the merger, then the Exchange Ratio will be adjusted as follows: (1) if goals are achieved in both Phase III PN trials before May 31, 2020, then no adjustment will be made to the Exchange Ratio; (2) if goals are achieved in only one Phase III PN trial by May 31, 2020, the Exchange Ratio will be adjusted to 1.2739; and (3) if goals are not achieved in either of the Phase III PN trials, the Exchange Ratio will be adjusted to 1.8006. If the closing of the merger occurs after May 31, 2020, and the results of the two Phase III PN trials have not yet been delivered in accordance with the merger agreement, then the Exchange Ratio will be adjusted to 1.8006.
For example, if you hold a total of 100 outstanding Foamix stock options with a $3 per share exercise price as of immediately prior to the closing of the merger and the goals are achieved for both of the Phase III PN trials, your Foamix stock options will be converted into a total of 59 Menlo Options with a $5.07 per share exercise price at the closing of the merger.
If the goals are not achieved for either of the Phase III PN trials, your Foamix stock options will be converted into a total of 180 Menlo Options with a $1.67 per share exercise price at the closing of the merger.
If, however, the results of Menlo’s two Phase III PN trials are not known prior to the closing of the merger and the closing is occurring prior to May 31, 2020, then the holders of shares of Foamix common stock will receive contingent stock rights (“CSRs”) convertible into shares of Menlo common stock based on the results of Menlo’s two Phase III PN trials. If any CSR is converted into shares of Menlo common stock after the closing of the merger, then the board of directors of Menlo will adjust the number of shares and exercise price of your stock option in accordance with the terms of the applicable equity plan. The CSR adjustment mechanic is complicated, and additional details regarding the mechanics of this adjustment will be communicated if an adjustment is necessary when the results of the Phase III PN trials are known.
RSUs. Similarly, as of the closing of the merger, each outstanding Foamix restricted stock unit (“RSU”), whether or not vested, will be assumed by Menlo and converted (in a manner intended to preserve the value of the Foamix RSU at the time of the conversion) into an RSU of Menlo (a “Menlo RSU”) that settles into a number of shares of Menlo common stock (rounded down to the nearest whole number of shares) equal to the product obtained by multiplying: (1) the number of Foamix shares subject to Foamix RSUs that you have immediately prior to the closing of the merger by (2) the Exchange Ratio. The Exchange Ratio may be adjusted as described above if the results of Menlo’s two Phase III PN trials are known prior to the closing of the merger or if the closing of the merger occurs after May 31, 2020, and the results of the two Phase III PN trials have not yet been delivered in accordance with the merger agreement. If, however, the results of Menlo’s two Phase III PN trials are not known prior to the closing of the merger and the closing is occurring prior to May 31, 2020, then the holders of shares of Foamix common stock will receive CSRs. If any CSR is converted into shares of Menlo common stock after the closing of the merger, then you will receive additional restricted stock units so that the total number of restricted stock units is equal to what you would have received had such results been known prior to the closing of the merger.
Your Menlo RSUs will be subject to the same terms and conditions as applied to your applicable Foamix RSUs as of immediately prior to the closing of the merger, including terms related to tax, vesting, and treatment on termination of employment.
ESPP. The closing of the merger is estimated to occur in late Q1/early Q2 of 2020. At that time, we expect to be in the middle of an offering period under our Foamix ESPP. At the closing of the merger, the outstanding offering period will be shortened and terminated shortly prior to the closing date (the “designated date”). Foamix will make any pro-rata adjustments that may be necessary to reflect the shortened offering period, and will cause each outstanding purchase right under the Foamix ESPP to be exercised as of the designated date. At the closing of the merger, you will own outright shares of Foamix common stock purchased under the Foamix ESPP for that offering period, and each such share of Foamix common stock will then be converted into shares of Menlo common stock using the Exchange Ratio as described above. At the closing of the merger, Menlo will assume the Foamix ESPP and thereafter Menlo will be permitted to grant purchase rights under the assumed ESPP in accordance with applicable law.
2
If you have any questions, please contact me at 908.458.9213.
Sincerely,
Mutya Harsch
General Counsel
3
FOMX accumulation going straight up, great sign for what's to come.....
These people run Foamix and they have worked at top posts at ALL the biggest Pharmas in the world, they all have impeccable backgrounds.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151813572
I feel for you but, when Hirsch came in to be Chairman of the board he didn't then nor now "run the company" nor does he here he is a director.
I feel bad for you, but when he was brought in it was an OTC penny stock that was literally a penny. If you through 80K at a stock that was a penny .01 and never saw an opportunity to bail, then you must have sat on your hands and if you bought in above a penny because it was a seed stock pumped by traders, I feel for you but you should have known better. It was a literal penny (under actually it was .003) before it shot to $3.50 for a day an hour or so or whatever it was, then went back to a penny.
To blame a board member is ridiculous, it was a weed stock which got pumped they all did, Corona got suckered for BILLIONS. All weed stocks/companies were BS the only ones to make money in weed is the govt of the states that made it legal and tat is why they made it legal so "they" could get more money and get paid.
Your anger should be at yourself in 5 years that was a literal penny stock except for a week/month and that is a board members fault?
Sorry but your anger should be placed at yourself.
You should have bailed on a pump then played the bottom till you made your $$ back, sitting in it as not the right move as it was never going back to dollars or even a dollar. You can always work yourself out of a stock they all disappoint at some point, from the blue chips down, its how you play that bottom it is at, that decides your fate in the end.
Sitting and holding isn't the way, adding at the very bottom and flipping that bottom in your case 40 times in 2 years would have been better than just sitting.
Peace out.
I sold all my shares at $3.50 , not gonna ride this one down into the black hole. Hirsch is involved with this. His leadership in his other part time company,which was also a medical weed type deal (supposedly making a long awaited cream for skin disorders) went from 3.23 in March of 2017 , down to $.0071. Now that company is talking a700:1 REVERSE SPLIT. Effectively erasing all small investors from their shares and money.
Don’t ride this down like I did with that stock!!! I watched $80,000 go down to $760.00 before I would believe it was over.
I will keep watching this one, maybe I’ll buy it back but , only if I get this at a steal. They have thrown in more speculative chance BACK in this one, and I cannot trust Hirsch.
Good luck!!
TKO
The first question was important
page 6,7 and 8
https://seekingalpha.com/article/4305713-foamix-pharmaceuticals-ltd-fomx-ceo-dave-domzalski-q3-2019-earnings-and-merger-announcement?page=6
Question-and-Answer Session
Operator
Thank you. [Operator Instructions] Our first question is from Louise Chen with Cantor Fitzgerald. Please proceed.
Louise Chen
Hi. Congratulations on the deal. And thanks for taking my questions here. So, I had a few. First question, I had is, can you talk about the build-up of your joint commercial infrastructure? How many sales reps there will be? The marketing cost, the ad campaigns?
And then, the second question I had was, on Amzeeq, your expectations for uptake, reimbursement, patient co-pay assistance, anything along those lines? And then, last question I had here was on the CPUO study, the Phase II data that's coming up.
Since that, has been based on our diligence a very large indication potentially and maybe even larger than PN. Just curious if that turns out to be positive, if there's any renegotiation of the deal terms or what's in the agreement for that? Thank you.
Dave Domzalski
Great, thanks Louise. So, let's talk about the commercial build-out. I could turn it over to Matt Wiley our Chief Commercial Officer, so Matt?
Matt Wiley
So, yeah, thanks Dave. And thanks, Louise. So we have better than 90% of our sales infrastructure now in place. We expect, the balance of that to be ready prior to launch. That team has kicked off its home study and training beginning last week. And we'll be training through the balance of this year.
As Dave said in the prepared remarks, we are going to have our launch meeting, in early January. And then sales team will be out promoting Amzeeq. Regarding the question about market access and co-pay, so, we haven't guided on uptake for Amzeeq.
Our market access team was active, at the AMCP meeting a couple of weeks ago, and engaging with payers. We expect our compendia load, later this month, which will also disclose our final pricing, from a wholesale acquisition cost perspective.
And then, that typically starts the clock, for how payers then, put products in the queue for review. But we do have ongoing meetings and negotiations, with plans today.
Dave Domzalski
Thanks. Yeah, I'll offer a few comments on the upcoming CPUO study. And I'll turn it over to Steve. So obviously we look forward to the results at the turn of the year. We're obviously bullish on the prospects of that being a successful study outcome.
I'll reiterate, near-term focus will be on PN, as it is really the most advanced product. What we'll be focusing on is, keeping R&D spend locked in on the PN indication. And quite frankly, most of that spend is winding down.
So, we couple that with our R&D spend, that's basically complete for 103, FMX103. So we're going to focus as we move forward, on preparing commercially for Amzeeq as Matt pointed $3 the dominant work for PN.
I think this goes to the core tenet of the deal, which is leveraging our existing infrastructure for Amzeeq, for three potential launches over the course of the next 24 months. Clearly, we believe there is a lot of inherent strategic value for other indications for serlopitant.
And we will obviously be thoughtful about timing and spend in the near-term, in light of the significant revenue opportunities that we view for Amzeeq, one or three in a PN indication.
I think to answer your question is, there ability to change the structure of the deal? The short answer to that is no. It's that the deal has been well thought out to provide meaningful upside potential to Menlo's shareholders assuming a positive Phase 3 readout in PN. But additionally there's protection for Foamix shareholders on the downside in the case that there happens to be mixed results or negative results.
But certainly how we view it collectively as a management team is that we're certainly planning for success. We feel quite good about the probability of success for obviously the PN indication and CPUO indication. So, I'll turn it over to Steve for any additional thoughts or color.
Steve Basta
Yes. Louise. Well, thank you, David. And Louise one of the things that you've correctly observed the CPOU market opportunity I think is a really significant market opportunity. We also think the PN market opportunity is a really significant market opportunity. PN is a nearer-term commercialization event. And so clearly as the commercial team at Foamix in sort of thinking about the indication launches, thinking about acne, thinking about rosacea, thinking about PN as near-term launches that's sort of the core commercial focus on how we get to profitability.
CPUO provides one of the longer-term growth opportunities and. I think creates really a significant upside. How we thought about it from a Menlo perspective in terms of the value creation that the CPUO Phase 2 data bring is really embedded in the premium that already exists in the transaction.
So, we are; A, getting a premium to the current market cap relative ratios and that's sort of the embedded value of the program including the upside potential for the multiple additional indications and we're going to own 41% of the company going forward.
So, if there is value to be created from the multiple additional indications, the Menlo shareholders participate in a really meaningful way in the context of the upside from those programs, while being in a structure that because of the leverage of having multiple products, can achieve profitability both sooner and to a greater degree than the companies could separately. And therefore there's future opportunity to pursue the upside opportunities from future products and future indications without having to experience the dilution that it would take for us to finance all of those individually as separate companies.
So, there's already an embedded premium that captures the value of the program and there is significant upside to be shared by the Menlo shareholders because we're going to own a significant stake of the combined company.
Louise Chen
Okay, great. Thank you and congrats again.
And those shareholders are the ones I care about.
Not the weak, the traders, the flippers or the shorts.
Thanks for your adds here explaining the merger etc to everyone, much appreciated.
Peace out.
Certain significant shareholders of Foamix and Menlo, together with the CEOs of both companies, have entered into agreements, whereby they have agreed to vote the shares they hold at the time of the shareholder meeting in favor of the merger
Thank you for the simplified explanation. That helped me a lot. Looks like mane investors do not see this merger as a positive and are selling.
From the 425 filing
At the effective time of the Merger (the “Effective Time”), each ordinary share, par value NIS 0.16 per share, of Foamix (“Foamix Shares”) issued and outstanding immediately prior to the Effective Time will be deemed transferred under Israeli law to Menlo in exchange for the right to receive (i) 0.5924 shares (the “Exchange Ratio”) of common stock of Menlo (“Menlo Common Stock”) and (ii) one contingent stock right (a “CSR”; and collectively, the “CSRs”) which will be subject to the terms and conditions of a contingent stock rights agreement (the “CSR Agreement”), as further described below (collectively, the “Merger Consideration”).
The Merger Consideration will be subject to adjustment prior to the Effective Time as described in paragraphs (A), (B) and (C) immediately below, in the event (i) on or prior to May 31, 2020, Foamix and Menlo have received in the form set forth in Exhibit 2.4(g)(ii) to the Merger Agreement the top-line primary endpoint results of one or both of the Phase III double-blinded, placebo-controlled trials for the treatment of pruritus associated with prurigo nodularis, referenced by Protocol Numbers MTI-105 (United States) and MTI-106 (Europe) (each, a “Phase III PN Trial”) (the “Efficacy Determination”) or (ii) if the Efficacy Determination is not delivered to Foamix and Menlo on or prior to May 31, 2020.
(A)
If the Efficacy Determination reports that Serlopitant Significance (as defined in the Merger Agreement) was achieved in both Phase III PN Trials on or before May 31, 2020, then there will be no adjustment to the Exchange Ratio;
(B)
If the Efficacy Determination reports that (1) Serlopitant Significance was achieved in only one Phase III PN Trial on or before May 31, 2020 and (2) Serlopitant Significance was not achieved or has not been determined in each case on or before May 31, 2020 in the other Phase III PN Trial, then the Exchange Ratio will instead be 1.2739 shares of Menlo Common Stock; and
(C)
If the Efficacy Determination reports that Serlopitant Significance was not achieved in both Phase III PN Trials or the Efficacy Determination has not been delivered on or before May 31, 2020, then in each case the Exchange Ratio will instead be 1.8006 shares of Menlo Common Stock.
No fractional shares of Menlo Common Stock will be issued in the Merger, and Foamix shareholders will receive cash in lieu of fractional shares, as specified in the Merger Agreement.
Also, at the Effective Time, each Foamix option and Foamix restricted stock unit award that is outstanding immediately prior to the Effective time will be assumed by Menlo. Each Foamix restricted stock unit award will be converted into a restricted stock unit award relating to Menlo Common Stock (an “Adjusted RSU Award”) and will have the same terms and conditions as applied to the Foamix restricted stock unit award immediately prior to the Effective Time. The Adjusted RSU Award will settle in the number of shares of Menlo Common Stock equal to the product obtained by multiplying (i) the number of Foamix Shares subject to the Foamix restricted stock unit award immediately prior to the Effective Time by (ii) the Exchange Ratio. Additionally, at the Effective Time, each Foamix option will be converted into an option to purchase Menlo Common Stock (an “Adjusted Option”) with the same terms and conditions as applied to the Foamix Option; however, the Adjusted Option will cover a number of shares of Menlo Common Stock equal to the product of (i) the number of Foamix Shares subject to the Foamix option immediately prior to the Effective Time and (ii) the Exchange Ratio, and will have an exercise price per share equal to the quotient of (i) the exercise price per Foamix Share subject to such Foamix option immediately prior to the Effective Time divided by (ii) the Exchange Ratio. All Foamix warrants outstanding immediately prior to the Effective Time will be converted into warrants to purchase shares of Menlo Common Stock.
If the CSR converts into shares of Menlo Common Stock in accordance with the terms of the CSR Agreement described below, (i) holders of Adjusted RSU Awards will receive a number of additional restricted stock units based on the additional shares of Menlo Common Stock that each ordinary share receives upon conversion of a CSR and (ii) the Menlo Board shall make equitable adjustments to the exercise price per share and the number of shares of Menlo Common Stock subject to the Adjusted Option to reflect the value of the ordinary shares distributable in respect of the CSR.
The way I think it will play out. Your broker will turn in your FOMX shares and you will receive new MNLO shares. The number of shares you receive will depend on (1) the price of MNLO (2) the results of their CSR's.
It gets complicated with the dates and votes. Lets say Q2 2020 will be very exciting. If the products fail to get approved. You get more shares of MNLO. If both fail MNLO will tank, but the company will be merged and FOMX 2 products will lead the way out of the disaster. The value of the stock will be very diluted, but it won't be zero.
If both MNLO phase 3 trials are successful and get FDA approval. You will be very happy.
Unfortunately it's not risk free. MNLO has had rejections before.
I listened to the replay, Q&A, to hear the analysts. They all seemed to be pleased.
So I'm still not sure what's happening here. When this merger happens, will I have the same amount of shares I had before in FOMX or is this going to change?
Ambulance chasers just put out PRs to hope they can get something. Perceptive is an insider (holds 18% of the stock) in the end I think it is good for FOMX, not so much the other way around.
Peace out.
To clarify what I said earlier about being a reverse merger.
This deal appeared another board today, and they called it a reverse merger, I challenged, and they explained.
These are the message links
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=152208625
https://investorshub.advfn.com/boards/replies.aspx?msg=152210990
lawyers have started to arrive
7:09 pm ET
FOAMIX ALERT: Bragar Eagel & Squire, P.C. Investigates Proposed Sale of FOMX and Encourages Investors to Contact the Firm
PR Newswire
3:16 pm ET
Shareholder Investigation Alert: Halper Sadeh LLP Investigates Whether the Sale of These Companies is Fair to Shareholders - FOMX, CISN, PEGI, AXE
* * $FOMX Video Chart 11-11-19 * *
Link to Video - click here to watch the technical chart video
This is a strange transaction. A reverse merger where we get MNLO shares in exchange for FOMX.
The way I see it, the worse case is that Foamix is worth 82% for this exchange if both products of MNLO fail to get approved.
3.55 using Friday's close.
Summary article on the deal out of Israel
https://en.globes.co.il/en/article-foamix-mergng-with-us-co-menlo-1001306783#utm_source=RSS
Foamix Pharmaceuticals (FOMX) PT Lowered to $15 at Cowen, Positive on Deal
November 11, 2019 11:24 AM EST Send to a Friend
Cowen analyst Ken Cacciatore lowered the price target on Foamix Pharmaceuticals (NASDAQ: FOMX) to $15.00 (from $30.00) while maintaining ...
https://www.streetinsider.com/Analyst+Comments/Foamix+Pharmaceuticals+%28FOMX%29+PT+Lowered+to+%2415+at+Cowen%2C+Positive+on+Deal/16116426.html
watch list - revised
slight delay
Last 3.14 Last
3.09 Price Crosses 9 Day Moving Average Stalls
3.00 3-10-16 Day MACD Moving Average Stalls
3.00 14-3 Day Raw Stochastic at 20%
Low 2.98 Low
2.97 Price Crosses 18 Day Moving Average Stalls
2.93 38.2% Retracement From 52 Week Low
1-Month Low 2.66
The most recent analyst action on $MNLO was this
10/18/2019 HC Wainwright Initiated Coverage Buy $11.00
Crap hold on while I remove foot from mouth. WTF?
Well, pre-market is saying a complete fiasco
And they had already better had large shareholder buy-in because it violates terms of the loan.
Pretty nice events. Might see 7-10 bucks sooner than I thought
Strong combined balance sheet with cash through H1 2021
Foamix shareholders expected to own approximately 59% and Menlo shareholders approximately 41% of the combined company, subject to adjustment
Foamix Pharmaceuticals EPS beats by $0.05
https://seekingalpha.com/news/3517435-foamix-pharmaceuticals-eps-beats-0_05
Conference call and webcast scheduled by Foamix for November 11, 2019, at 8:30 a.m. Eastern Time
FOMX had a river of catalyst the next 7 months, now with MNLO's pipeline the river got wider and runs deeper
They are at/near PDUFA stage I think on a couple
Now we can see why the Biotech whisperer Joeseph Edleman more than doubled his position in August, these boys at FOMX know what they are doing IMHO.
$FOMX Foamix Reports Third Quarter 2019 Financial Results and Provides Corporate Update
on November 10, 2019 News and Tags: FOMX with 0 comments
REHOVOT, Israel, and BRIDGEWATER, N.J., Nov. 11, 2019 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) (“Foamix” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced financial results for the three and nine months ended September 30, 2019 and provided a corporate update.
“The recent FDA approval of AMZEEQ™ for moderate-to-severe acne was a major milestone for Foamix as we transition to becoming a commercial stage organization. AMZEEQ is the first FDA approved topical form of minocycline and its approval represents a significant step in our goal of enhancing the standard of care for acne sufferers in the U.S.,” said David Domzalski, Chief Executive Officer of Foamix. “Our commercial team is now in the final stages of preparing for the U.S. launch of AMZEEQ, which is on track to occur in January 2020. We were very pleased also, by the FDA acceptance of our NDA for FMX103, minocycline topical foam for moderate-to-severe papulopustular rosacea, which puts us in sight of potential approval for this product in 2020. Our pipeline continues to advance and we recently initiated a Phase II clinical trial to evaluate the safety and efficacy of our combination foam FCD105 for acne.”
“We are excited to announce today that we have entered into a definitive merger agreement with Menlo Therapeutics,” added Mr. Domzalski. “The combination of the two companies accelerates our progression to becoming a leading dermatology-focused company with several late-stage assets that can leverage the commercialization infrastructure we are building. Menlo’s lead product candidate, serlopitant for pruritus associated with prurigo nodularis, represents a breakthrough therapy for a dermatologic condition with no currently approved treatment options. Its addition means we have the potential for three commercial launches in a two year timeframe. The combination also strengthens our balance sheet. Upon closing we expect to have sufficient cash to fund operations through the first half of 2021.”
Third Quarter and Recent Corporate and Regulatory Update:
Today, announced the signing of a definitive merger agreement with Menlo Therapeutics (“Menlo”) to create a combined specialty pharmaceutical company focused on the dermatology space.
Menlo’s lead product candidate, serlopitant, for pruritis associated with prurigo nodularis (PN), complements Foamix’s existing portfolio and addresses a significant unmet medical need for a serious disease state.
Two Phase III clinical trials of serlopitant in PN are fully enrolled, with results expected in March or April 2020.
Foamix’s sales and marketing infrastructure will provide significant leverage for a potential launch of serlopitant.
The pro-forma cash position of the combined companies was $169.0 million as of September 30, 2019.
Received FDA Approval for AMZEEQ™, the first FDA approved topical form of minocycline. AMZEEQ topical foam, 4% (formerly known as FMX101) indicated for the treatment of inflammatory lesions of nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older.
Long term open label safety portions of studies FX2014-04 and FX2014-05, investigating AMZEEQ in moderate to severe acne, were published in the Journal of Clinical and Aesthetic Dermatology (JCAD).
Entered into a long-term contract manufacturing & supply agreement for AMZEEQ and product candidate FMX103 with ASM Aerosol Service.
The Company’s New Drug Application (“NDA”) for FMX103 minocycline topical foam (1.5%) for the treatment of moderate-to-severe papulopustular rosacea was accepted by the FDA, which has set a targeted PDUFA action date of June 2, 2020.
Enrolled the first patient in the Phase II clinical trial to evaluate the safety and efficacy of FCD105, a combination topical foam comprising minocycline and adapalene for the treatment of moderate-to-severe acne vulgaris.
Presented data on topical product candidates for acne and rosacea at 39th Annual Fall Clinical Dermatology Conference, in Las Vegas.
Intellectual property
The US Patent and Trademark Office (U.S. P.T.O.) issued U.S. Patent No. 10,398,641 relating to method of use of certain minocycline formulations, which expires September 2037 and provides additional coverage for AMZEEQ.
U.S. P.TO. issued U.S. Patent No. 10,463,742, which provides additional coverage for FCD105 and which expires in 2030.
Entered into a settlement and license agreement with an affiliate of Teva Pharmaceuticals to resolve pending patent litigation involving Finacea foam.
Secured up to $64 million in financing from Perceptive Advisors and OrbiMed.
Financial Results for the Third Quarter Ended September 30, 2019
Revenues
The Company reported no revenues for the quarter ended September 30, 2019, compared to $0.9 million in the quarter ended September 30, 2018. The decrease was a result of the continued suspension of the manufacturing of Finacea by our partner LEO Pharma A/S (“LEO”) due to a failure on the part of LEO’s active pharmaceutical ingredient (“API”) manufacturer to meet the required specifications in the finished product. LEO has informed us that they are working diligently to address the issue in order to be able to produce sufficient supply of the finished product to meet the demand for Finacea in the market. This supply chain issue for Finacea is not related to the manufacturing, production or supply of AMZEEQ, FMX103, or any of the Company’s other product candidates.
Research and Development Expenses
Research and development expenses for the quarter ended September 30, 2019 were $12.5 million, representing a decrease of $0.6 million, or 4.6%, compared to $13.1 million for the quarter ended September 30, 2018. The decrease in research and development expenses resulted primarily from a decrease of $5.0 million in clinical trial expenses due to the completion of AMZEEQ and FMX103 clinical trials, offset by an increase of $2.6 million in payment related to the submission of our NDA for FMX103, an increase of $0.8 million in payroll and payroll-related expenses due to an increase in headcount and salaries and $0.7 million increase in consulting expenses.
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the quarter ended September 30, 2019 were $10.7 million, an increase of $7.4 million, or 224%, compared to $3.3 million for the quarter ended September 30, 2018. The increase in selling, general and administrative expenses resulted primarily from an increase of $6.4 million in advisors and consulting expenses in connection with the pre-commercialization activities and an increase of $0.8 million in payroll and payroll-related expenses due to an increase in headcount.
Net Loss
Our net loss for the three months ended September 30, 2019 was $23.2 million, as compared to $15.5 million for the three months ended September 30, 2018, representing an increase of $7.7 million, or 49.6%. The increase was primarily due to an increase in expenses for pre-commercialization activities.
Cash & Cash Equivalents
At September 30, 2019, Foamix had cash and cash equivalents of $75.7 million, compared to cash and cash equivalents of $99.4 million at December 31, 2018.
Financial Results for the Nine Months Ended September 30, 2019
Revenues
Total revenues decreased by $2.4 million, or 89%, to $0.3 million for the nine months ended September 30, 2019, compared to $2.7 million for the nine months ended September 30, 2018. The decrease for the nine months ended September 30, 2019 is due to the ongoing failure of LEO’s contract manufacturer to produce the API for Finacea in compliance with the required specifications and quality. LEO has informed us that they are working diligently to address the issue in order to be able to produce supply of the finished product. This supply chain issue for Finacea is not related to the manufacturing, production or supply of any of our other products or product candidates, including AMZEEQ and FMX103.
Research and Development Expenses
Research and development expenses for the nine months ended September 30, 2019 were $35.9 million, representing a decrease of $16.9 million, or 32%, compared to $52.8 million for the nine months ended September 30, 2018.
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the nine months ended September 30, 2019 were $22.9 million, representing an increase of $12.9 million, or 129%, compared to $10.0 million for the nine months ended September 30, 2018.
Net Loss
Net loss for the nine months ended September 30, 2019 was $57.4 million, compared to $60.1 million for the nine months ended September 30, 2018, representing a decrease of $2.7 million, or 5%. The decrease was primarily due to the decrease in research and development costs related to clinical trials of AMZEEQ and FMX103.
Foamix and Menlo Therapeutics to Merge, Creating a Combined Company Focused on the Development and Commercialization of Therapeutics for Dermatologic Indications
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November 11, 2019 06:00 ET | Source: Menlo Therapeutics Inc.
Combination establishes a dermatology-focused company with a broad portfolio of an approved product and late-stage dermatology assets
Menlo’s serlopitant for pruritus associated with prurigo nodularis (“PN”) complements Foamix’s existing portfolio and addresses a significant unmet medical need for a serious disease state
Foamix’s sales and marketing infrastructure will provide meaningful leverage to potential launches for product candidates FMX103 for rosacea and Menlo’s serlopitant for pruritus associated with prurigo nodularis
Strong pipeline with several meaningful near-term catalysts
Strong combined balance sheet with cash through H1 2021
Foamix shareholders expected to own approximately 59% and Menlo shareholders approximately 41% of the combined company, subject to adjustment
Conference call and webcast scheduled by Foamix for November 11, 2019, at 8:30 a.m. Eastern Time
REHOVOT, Israel, BRIDGEWATER, N.J. and REDWOOD CITY, Calif., Nov. 11, 2019 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX ) (“Foamix”) and Menlo Therapeutics Inc. (Nasdaq: MNLO) (“Menlo”) today announced that they have signed a definitive merger agreement to create a combined biopharmaceutical company focused on the commercialization and development of therapeutics to serve patients in the dermatology space. The Boards of Directors of both Foamix and Menlo have unanimously approved the transaction.
The combined company will have a diversified portfolio including an approved product and three late-stage product candidates focused on dermatologic indications.
Foamix recently received FDA approval for AMZEEQ™ (minocycline) topical foam, 4%, for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in adults and pediatric patients 9 years of age and older. AMZEEQ™ is the first topical formulation of minocycline. Foamix is finalizing the implementation of the commercial infrastructure in preparation for a U.S. commercial launch anticipated in January 2020.
Foamix recently submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for FMX103 (minocycline) topical foam, for the treatment of moderate-to-severe papulopustular rosacea. The FDA set a Prescription Drug User Fee Act action date of June 2nd, 2020. If approved, FMX103 would be the first minocycline product available for rosacea patients. Foamix is also conducting a Phase II trial for FCD105, a topical combination foam of minocycline and adapalene, currently being evaluated for the treatment of moderate-to-severe acne vulgaris.
Menlo’s lead late stage product candidate, serlopitant, is being developed as a novel treatment for pruritus (itch). Two Phase III clinical trials of serlopitant for the treatment of pruritus associated with prurigo nodularis (“PN”) are fully enrolled, with results expected in March or April 2020. Serlopitant has received Breakthrough Therapy Designation by the FDA for the treatment of pruritus associated with PN and has the potential to be the first approved therapy for this indication. Serlopitant is also being evaluated for chronic pruritus of unknown origin (“CPUO”), currently in Phase II clinical trials, and for pruritus associated with psoriasis, which had positive Phase II data.
The combined company has a compelling product portfolio and late-stage pipeline. There are multiple near-term milestones:
Commercial launch of AMZEEQ™ anticipated in January 2020
Phase II clinical trial results for serlopitant for the treatment of CPUO in January or February 2020
Phase III clinical trial results in the U.S. and Europe for serlopitant for the treatment of pruritus in PN in March or April 2020
FMX103 PDUFA action date of June 2, 2020
Phase II clinical trial results for FCD105 for treatment of moderate to severe acne with top-line data expected in mid-2020
NDA submission, assuming Phase III success for serlopitant for the treatment of pruritus in PN, in H2 2020
Rationale for the Transaction
The rationale for this transaction is to create value for the combined shareholders of Foamix and Menlo that can be more advantageous together than separately through several synergies:
Commercial leverage: Foamix’s dermatology sales and marketing organization can more effectively launch Menlo’s near-term potential breakthrough product for pruritus associated with PN
Cost savings: by utilizing Foamix’s commercial organization and G&A infrastructure, the companies could save approximately $50 million per year versus the stand-alone estimated duplicate organization costs in future years
Reduced financing need: the combined cash from the companies provides runway through H1 2021
Creates a leading dermatology company with multiple products
Transaction Details
The transaction is structured as a stock-for-stock exchange, enabling the Foamix and Menlo shareholders to share in the upside advantages of combining the companies. Recognizing the near term data coming from Menlo’s Phase III trials in PN, the transaction accounts for the data outcomes by providing a premium to Menlo in the event that both trials are successful, while creating a mechanism to provide more shares to Foamix shareholders to provide downside adjustment if one or both PN trials do not hit their primary endpoint.
Under the terms of the merger agreement, each share of Foamix stock will be exchanged for 0.5924 of a share of Menlo common stock and a contingent stock right (“CSR”). The exchange ratio (prior to any adjustment through the CSR) implies a 18% premium to Menlo shareholders based upon the 10-day average volume weighted trading price for each company. Foamix shareholders will own approximately 59% of the combined company and Menlo shareholders will own approximately 41% on a pro forma, fully diluted basis, giving effect to all dilutive stock options at the time of announcement, units and warrants but without taking into account any adjustment to the exchange ratio or through the CSR. The exchange ratio or CSR may result in the delivery of additional shares of Menlo common stock to Foamix shareholders dependent upon the Phase III trial results for serlopitant for the treatment of pruritus in PN. There are certain adjustments to the ownership levels for each company’s shareholders as follows that result from an adjustment to the exchange ratio under the Merger Agreement prior to closing or post-closing through the issuance of CSRs to Foamix shareholders:
If one of the Phase III PN trials fails to meet its primary endpoint at or before May 31, 2020, Foamix shareholders will receive an additional 0.6815 of a share of Menlo common stock for each Foamix share, increasing pro forma ownership of the combined company by Foamix shareholders to 76%
If both Phase III PN trials fail to meet their primary endpoints at or before May 31, 2020, Foamix shareholders will receive 1.2082 additional Menlo shares for each Foamix share, increasing pro forma ownership of the combined company by Foamix shareholders to 82%
If both the Phase III PN trials are successful with results announced by May 31, 2020, then no additional Menlo shares will be issued to Foamix shareholders and pro forma ownership by Foamix shareholders will remain 59%
In the event that the results of the Phase III PN trials are received prior to closing (or if the results of neither trial has been announced by May 31, 2020 and the closing occurs thereafter), then the exchange ratio will be amended based on the clinical trial results and no CSRs will be issued.
The adjustments to ownership levels were designed with the intent of providing protection to Foamix shareholders in the event that either of these important serlopitant clinical trials were not successful. To the extent the CSRs are issued, they will not be registered or separately tradeable, and there will be restrictions on their transfer.
The combined company will be led by David Domzalski, CEO of Foamix and headquartered in New Jersey. The board of the combined company will consist of five members designated by Foamix (including Mr. Domzalski) and two members designated by Menlo (including Steve Basta, its CEO).
The transaction is subject to approval of the merger by Foamix shareholders, approval of the share issuance to Foamix shareholders by Menlo stockholders, as well as regulatory approvals and satisfaction of other customary closing conditions. Certain significant shareholders of Foamix and Menlo, together with the CEOs of both companies, have entered into agreements, whereby they have agreed to vote the shares they hold at the time of the shareholder meeting in favor of the merger and/or share issuance (subject to limited exceptions). The transaction is expected to be completed in late Q1/early Q2 of 2020.
Combination Creates a Differentiated Dermatology-Focused Company
The combination of the two companies is expected to capitalize on the collective skills sets, internal expertise and combined assets to create a comprehensive and more scaled biopharmaceutical company focused on dermatology. Foamix’s mission is to improve the lives of patients by developing and commercializing proprietary, innovative and differentiated drugs in dermatology, and plans to leverage its infrastructure to efficiently commercialize a portfolio of products while continuing to develop new therapies.
Foamix is currently developing the commercial infrastructure to support the upcoming U.S. commercial launch of AMZEEQ™ anticipated in January 2020. The initial launch intends to focus on 6,000 high-prescribing dermatologists. The commercialization plans for FMX103 and serlopitant for pruritus associated with PN, if approved, will utilize the established sales force and commercial infrastructure for AMZEEQ™ requiring minimal additional investment.
David Domzalski, Foamix Chief Executive Officer, said: “The combination of Menlo with Foamix accelerates our progression in becoming a leading dermatology-focused company with several late-stage assets that can leverage the commercialization infrastructure we are building to support the launch of AMZEEQ™. Serlopitant for pruritus associated with PN represents a breakthrough therapy for a dermatologic condition with no currently approved treatment options. Further, Foamix’s drug development platform will continue to bring novel dermatology product candidates into the clinic, including FCD105, which recently began enrollment in its Phase II trial. The combined company will look to continue developing products that will leverage the existing infrastructure. We are excited about the momentum our company has now, and want to thank our employees and partners for their hard work and deep commitment as we enter this next phase.”
Steve Basta, Menlo Chief Executive Officer, said: “Our goal with this merger is to maximize value by developing and commercializing our assets in the context of a broader dermatology franchise. A combination with Foamix will help de-risk and accelerate serlopitant’s commercial launch, assuming approval. The Foamix management team also brings extensive R&D and commercial expertise, having developed two novel topical therapies for acne and rosacea at Foamix, and also in leading the successful commercial launches of several dermatology products prior to Foamix. We are excited about what these two companies can accomplish together.”
The combined company is expected to have sufficient cash to support its operational plans through the first half of 2021.
Barclays acted as exclusive financial advisor to Foamix. Skadden, Arps, Slate, Meagher & Flom, LLP and Meitar, Liquornik, Geva, Leeshem and Tal acted as Foamix’s legal counsel in connection with the transaction. Guggenheim Securities, LLC acted as exclusive financial advisor to Menlo. Latham & Watkins LLP and Herzog, Fox & Neeman acted as Menlo’s legal counsel in connection with the transaction.
There will be a conference call and webcast with slides, at 8:30 a.m. Eastern Time today Monday, November 11th, with Foamix and Menlo to discuss the merger and respond to questions.
Investors Dial:
Int’l Investors Dial:
Investors in Israel Dial:
Conference ID:
Webcast:
877-407-0784
201-689-8560
1 809 406 247
13696725
http://public.viavid.com/index.php?id=137044
The webcast and slides will also be archived for a period of 90 days on the Investor Relations web pages of Foamix (http://www.foamix.com/investors/events-and-presentations/events) and Menlo (http://ir.menlotherapeutics.com/).
About Acne
Acne is a chronic, inflammatory skin condition that affects the skin’s oil glands and hair follicles. It is characterized by both inflammatory lesions (papules and pustules) and non-inflammatory lesions (open and closed comedones) affecting primarily the face and truncal areas of the body. Acne affects approximately 40 to 50 million people in the U.S. alone, of whom approximately 10 million have moderate to severe disease that may impact self-esteem and quality of life. For most people, acne diminishes over time and tends to disappear or decrease, by age 25. However, some individuals, particularly women, can experience acne much later in life.
About Foamix Pharmaceuticals
Foamix is a specialty pharmaceutical company working to solve some of today’s most difficult therapeutic challenges in dermatology and beyond.
With expertise in topical medicine innovation as a springboard, the Company is working to develop and commercialize solutions that were long thought impossible, including the world’s first topical minocycline, AMZEEQ™. Its proprietary Molecule Stabilizing Technology (MST™) is utilized in the Company’s dermatology products and in other products currently in development: FMX103 for the potential treatment of moderate to severe papulopustular rosacea and FCD105 for the potential treatment of moderate to severe acne.
Foamix is a different type of specialty pharmaceutical company by design, driven to see the solutions, overcome barriers in all aspects of business, and reimagine what’s possible for conditions with high unmet needs.
Foamix uses its website as a channel to distribute information about Foamix and its product candidates from time to time. Foamix may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Foamix’s website in addition to following its press releases, filings with the Securities and Exchange Commission, public conference calls, and webcasts. For more information, visit www.foamix.com.
About Serlopitant
Serlopitant is a small molecule, highly selective NK1 receptor antagonist. Two critical mediators of the urge to scratch are Substance P, or SP, and its receptor, the neurokinin-1 receptor, or NK1 receptor. SP is a naturally occurring peptide in the tachykinin neuropeptide family. Tachykinins have a broad range of functions in the nervous and immune systems. SP binding of NK1 receptor has been shown to be a key mediator of sensory nerve signaling, including the itch-scratch reflex and the vomiting reflex.
About Menlo Therapeutics
Menlo Therapeutics Inc. is a late-stage biopharmaceutical company focused on the development of serlopitant, a once-daily oral NK1 receptor antagonist, for the treatment of pruritus. The company’s clinical development program for serlopitant covers three indications and includes two ongoing Phase 3 clinical trials for the treatment of pruritus associated with prurigo nodularis, a Phase 3-ready clinical program for the treatment of pruritus associated with psoriasis, and a Phase 2 clinical trial for the treatment of chronic pruritus of unknown origin.
closed at 4.34 and high of the day 4.35
isn't that a good sign for swing traders going into next week?
up 9% on no news
Minocycline Foam Safe, Effective for Acne, According to Long-Term Trial Data
November 8, 2019
https://www.dermatologyadvisor.com/home/news/minocycline-foam-safe-effective-for-acne-according-to-long-term-trial-data/
Minocycline foam 4% (Amzeeq; Foamix) appears to be safe and effective for moderate to severe acne, according to findings from a long-term, open-label safety study.
The 52-week study included patients from 2 double-blind studies (FX2014-04 and FX2014-05) who completed 12 weeks of treatment with minocycline foam 4% (n=657). These patients continued treatment with the topical therapy for an additional 9 months.
At Week 52, study findings showed that treatment with minocycline foam continued to reduce inflammatory lesions and was associated with Investigator’s Global Assessment treatment success. Moreover, patient satisfaction remained high with minocycline foam which was consistent with scores obtained at Week 12.
Application site reactions occurred in <2% of patients during the open-label study. Additionally, the assessment of facial dermal tolerability at Week 52 showed >95% of patients had “none” or “mild” signs and symptoms; no severe local tolerability scores were recorded. The most common treatment-emergent non-dermal adverse event was nasopharyngitis.
Related Articles
Aklief Cream Approved for Acne Vulgaris
Aczone Gel 7.5% Approved to Treat Acne in Younger Patients
NDA Submitted for First-in-Class Acne Cream
The Food and Drug Administration (FDA) recently approved Amzeeq as the first topical minocycline treatment for inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged ≥9 years. Amzeeq uses Foamix’s proprietary Molecule Stabilizing Technology (MST) platform to deliver minocycline, a tetracycline-class drug, in a foam formulation
The Company expects Amzeeq to be available in January 2020. The product will be supplied in a 30-gram aerosol container.
For more information visit foamix.com.
This article originally appeared on MPR
https://www.empr.com/home/news/minocycline-foam-safe-effective-for-acne-according-to-long-term-trial-data/
Looks like the beginning of a BIG breakout to me.
Just food for thought
Breakout trade
CONFIRMED breakout above 3.97
Target: 4.49, 12.8% Stop: 3.84 Loss: 3.5%
P/L ratio: 3.7 : 1 - Excellent
Rosacea Treatment Market 2019-2026: Foamix Pharmaceuticals Ltd., ALLERGAN, Bausch Health, Sol-Gel Technologies Ltd., Bayer AG, Nestlé, PRUGEN
https://www.openpr.com/news/1863691/rosacea-treatment-market-2019-2026-foamix-pharmaceuticals
(I didn't get the document, just putting out the information)
11-08-2019 08:15 AM CET | Health & Medicine
Press release from: Data Bridge Market Research
Rosacea Treatment Market 2019, A recent report published by Data Bridge Market Research provides a unique guidance in thoughtful details regarding the development factors, used a top-down and bottom-up approach to keep it error-free and accurate. The researchers have used primary and secondary methodologies to collect data and its analysis.
The ROSACEA TREATMENT MARKET data covered in the report will give the reader a comprehensive understanding of the market as well as the major players in terms of production and the regions with high demand and supply.
This market is rising gradually with a steady CAGR of 3.8% in the forecast period of 2019-2026 Few of the leading organizations’ names are listed here- Foamix Pharmaceuticals Ltd., ALLERGAN, Bausch Health, Sol-Gel Technologies Ltd., Bayer AG, Nestlé, PRUGEN, Merck & Co., Inc., AbbVie Inc., Unilever, Croda International Plc, Colorescience, Inc., Perrigo Company plc, Aclaris Therapeutics, Inc., Lupin Pharmaceuticals, Inc., Supernus Pharmaceuticals, Inc, Dr. Reddy’s Laboratories Ltd., Mylan N.V. among others.
Request for sample copy or PDF with (Market Segments, Forecast, Key player's and TOC) @ https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-rosacea-treatment-market
Let’s know why the report is worth considering-
Rosacea is a chronic, inflammatory skin condition that is characterized by redness on skin. The symptoms are most common at cheeks, nose and forehead. The blush of redness can also spreads to other parts such as ears, chest and back. It could be triggered due to heat, caffeine or stress.
Rosacea is often underdiagnosed or misdiagnosed as acne, making it hard to find out the exact prevalence rate of the disease. This disease is more prevalent in fair skin people. An estimated of 14 million people in the America suffers from rosacea.
Performs Competitive Analysis: The Rosacea Treatment report incorporates the detailed analysis of the leading organizations and their thought process and what are the methodologies they are adopting to maintain their brand image in this market. The report aides the new bees to understand the level of competition that they need to fight for to strengthen their roots in this competitive market.
Highlights following MARKET DRIVERS AND RESTRAINT:
Increasing government initiatives and investments in the treatment market will contribute in the market growth
Increasing research and development of advanced formulations for treatment of different types of rosacea and acne are expected to drive the market growth
Multiple patent expiries brings a significant number of generic products that hampers the growth of market
Off-label usage of medicines for rosacea can also restrict the market growth
Rosacea is often underdiagnosed or misdiagnosed as acne hampers the market growth
Purchase this Report with 30% Discount at -https://databridgemarketresearch.com/request-a-discount/global-rosacea-treatment-market
Conducts Overall ROSACEA TREATMENT Market Segmentation: This knowledgeable market research report offers lucrative opportunities by breaking down complex market data into segments on the basis of –
By Type (Erythematotelangiectatic Rosacea, Papulopustular Rosacea, Ocular Rosacea, Phymatous Rosacea),
Drugs Class (Antibiotics, Immunosuppressants, Corticosteroids, Others), Drugs (Rhofade, Mirvaso, Oracea, Others),
Route of Administration (Oral, Topical, Others),
End Users (Hospitals, Homecare, Specialty Clinics, Others),
Distribution Channel (Hospital Pharmacy, Online Pharmacy, Retail Pharmacy, Others)
The ROSACEA TREATMENT report covers market shares for global, Europe, North America, Asia Pacific and South America. The analysis of this report has been used to examine various segments that are relied upon to witness the quickest development based on the estimated forecast frame.
Key Developments in the Market:
In August 2019, Foamix Pharmaceuticals Ltd. submitted a New Drug Application (NDA) to the U. S. FDA for FMX103 (minocycline) for the treatment of moderate-to-severe papulopustular rosacea. This application is based on the positive topline results of phase III clinical trials of FMX103. This drug candidate will be an efficacious treatment with a well-tolerated profile and will be present in a convenient topical foam formulation
Primary Respondents
Demand Side: Doctors, Surgeons, Medical Consultants, Nurses, Hospital Buyers, Group Purchasing Organizations, Associations, Insurers, Medical Payers, Healthcare Authorities, Universities, Technological Writers, Scientists, Promoters, and Investors among others.
Supply Side: Product Managers, Marketing Managers, C-Level Executives, Distributors, Market Intelligence, and Regulatory Affairs Managers among others.
Strategic Points Covered in TOC:
Chapter 1: Introduction, market driving force product scope, market risk, market overview, and market opportunities of the global Hair Tie market
Chapter 2: Evaluating the leading manufacturers of the Rosacea Treatment market which consists of its revenue, sales, and price of the products
Chapter 3: Displaying the competitive nature among key manufacturers, with market share, revenue, and sales
Chapter 4: Presenting Rosacea Treatment market by regions, market share and with revenue and sales for the projected period
Chapter 5, 6, 7, 8 and 9: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions
Read Complete Details with TOC @ https://www.databridgemarketresearch.com/toc/?dbmr=global-rosacea-treatment-market
Contact:
Data Bridge Market Research
US: +1 888 387 2818
UK: +44 208 089 1725
Hong Kong: +852 8192 7475
Email: Corporatesales@databridgemarketresearch.com
About Us:
Data Bridge set forth itself as an unconventional and neoteric Market research and consulting firm with unparalleled level of resilience and integrated approaches. We are determined to unearth the best market opportunities and foster efficient information for your business to thrive in the market. Data Bridge endeavors to provide appropriate solutions to the complex business challenges and initiates an effortless decision-making process.
This release was published on openPR.
Nice, have to admit they keep all the bases covered with protecting their goods etc.
Its good to have something to protect and sue people for and win, shows its a decent money maker.
Peace out.
REHOVOT, Israel and BRIDGEWATER, N.J., Nov. 07, 2019 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (FOMX) (“Foamix” or the “Company”), a specialty pharmaceutical company, announced today that the U.S. Patent and Trademark Office has issued U.S. Patent No. 10,463,742, reciting waterless compositions comprising a retinoid and a tetracycline antibiotic, as well as methods of using those compositions in treating dermatological disorders. This newly issued patent, which expires in 2030, is the latest U.S. patent to be issued to Foamix in connection with Foamix’s drug development programs for treating acne vulgaris.
“We are delighted with the addition of this new patent, which provides additional coverage for our combination product candidate, FCD105, a topical foam for moderate-to-severe acne with a retinoid and minocycline,” said David Domzalski, Chief Executive Officer of Foamix. “The patent demonstrates our continued development of our patent portfolio and our commitment to innovation in dermatology.”
Yes, it will be difficult for a physician to justify oral minocycline when the topical version Amzeeq is available.
Tweet from a credible resource
dough
@semodough
BAML $FOMX BUY believe non-systemic nature of topical delivery further differentiates safety profile versus systemic adverse events of Solodyn (which occur in rare incidence and are more of a theoretical risk for Solodyn). reiterate our ~$300m peak sales forecast for AMZEEQ
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Foamix Announces Publication of AMZEEQ™ (minocycline) Topical Foam Long Term Safety Data for Treatment Up to 1 Year in Journal of Clinical and Aesthetic Dermatology
News provided by
Foamix Pharmaceuticals Ltd.
Nov 04, 2019, 08:01 ET
REHOVOT, Israel, and BRIDGEWATER, N.J., Nov. 4, 2019 /PRNewswire/ -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) (Foamix or the Company), a specialty pharmaceutical company, announced today the peer review publication of the long term open label safety portions of studies FX2014-04 and FX2014-05 (Studies 04 & 05) in the Journal of Clinical and Aesthetic Dermatology (JCAD). Studies 04 and 05 were conducted by Foamix to support the New Drug Application submission of AMZEEQTM (minocycline) topical foam, which was approved by the U.S. Food and Drug Administration (FDA) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
"Continuing from our earlier publication of Study FX2017-22 in the Journal of the American Academy of Dermatology, we are pleased that the Journal of Clinical and Aesthetic Dermatology has accepted these long-term safety data for publication," said David Domzalski, Chief Executive Officer of Foamix. "I am proud of our entire R&D team for successfully executing on this important clinical program and achieving the approval of AMZEEQ by the FDA. Patients and physicians alike are rightly pushing for innovation in the treatment of acne as there have been very few genuinely novel treatments in recent years. With AMZEEQ, we hope to help address that need."
Highlights from the Long-Term Safety Program:
The open-label safety portions of Studies 04 and 05 enrolled a total of 657 patients, all of whom had completed 12 weeks of AMZEEQ (minocycline) topical foam, 4% or vehicle treatment in the preceding double-blind phases of these studies. Patients continued for up to an additional 40 weeks of open-label treatment with AMZEEQ. Of those enrolled in this safety study, 291 completed a total of 52 weeks of therapy. The key findings from the study are as follows:
Subject satisfaction with AMZEEQ treatment remained high when re-assessed at Week 52 which was consistent with scores obtained at Week 12.
Application site adverse events occurred in less than 2% of patients during the additional 40 weeks of open-label treatment with AMZEEQ. In the assessment of facial dermal tolerability at Week 52, more than 95% of patients had "none" or "mild" signs and symptoms (erythema, dryness, hyperpigmentation, peeling, and itching), and no severe local tolerability scores were recorded.
Non-dermal adverse events were comparable in type and frequency with those reported during the double-blinded portions of each study. The most frequently reported treatment-emergent adverse event was nasopharyngitis (common cold). No serious drug-related adverse events were reported.
"We are extremely encouraged that our comprehensive safety evaluation of AMZEEQ has warranted publication in JCAD. AMZEEQ appears to be well tolerated, with an acceptable safety profile which is an important factor in the treatment of chronic, relapsing dermatological conditions such as acne," said Dr. Iain Stuart, Chief Scientific Officer of Foamix.
About AMZEEQ™
INDICATIONS AND USAGE
AMZEEQ™ (minocycline) topical foam, 4% is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
Limitations of Use: This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated.
IMPORTANT SAFETY INFORMATION
Contraindications: Persons who have shown hypersensitivity to any of the tetracyclines or any other ingredient in AMZEEQ.
Warnings and Precautions:
Flammability: The propellant in AMZEEQ is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.
AMZEEQ is a topical foam. While systemic absorption of AMZEEQ is low, and serious adverse reactions were not seen in clinical studies, the following adverse reactions associated with oral minocycline should be considered:
Teratogenic effects, inhibition of bone growth & permanent tooth discoloration: Use during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth.
Clostridium difficile associated diarrhea (CDAD): If CDAD occurs, discontinue AMZEEQ.
Hepatotoxicity & metabolic effects: If renal impairment exists or if liver injury suspected, discontinue AMZEEQ.
Central nervous system effects: Patients experiencing light-headedness, dizziness or vertigo should be cautioned about driving vehicles or operating heavy machinery.
Intracranial hypertension: Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue AMZEEQ immediately if symptoms occur.
Autoimmune syndromes: Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue AMZEEQ immediately if symptoms occur.
Photosensitivity: Patients should minimize or avoid exposure to natural or artificial sunlight while using AMZEEQ. Advise patients to discontinue treatment with AMZEEQ at the first evidence of sunburn.
Hypersensitivity reactions: Discontinue AMZEEQ immediately if symptoms of anaphylaxis, serious skin reactions, erythema multiforme, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome occur.
Tissue hyperpigmentation: Discoloration of organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves.
Superinfection: Overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue AMZEEQ and institute appropriate therapy.
Adverse Reactions: The most common adverse reaction reported during clinical trials of AMZEEQ was headache.
To report SUSPECTED ADVERSE REACTIONS, contact Foamix Pharmaceuticals Inc. at
1-844-375-3673 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Please see full Prescribing Information.
About Acne
Acne is a chronic, inflammatory skin condition that affects the skin's oil glands and hair follicles. It is characterized by both inflammatory lesions (papules and pustules) and non-inflammatory lesions (open and closed comedones) affecting primarily the face and truncal areas of the body. Acne affects approximately 40 to 50 million people in the U.S. alone, of whom approximately 10 million have moderate to severe disease that may impact self-esteem and quality of life. For most people, acne diminishes over time and tends to disappear or decrease, by age 25. However, some individuals, particularly women, can experience acne much later in life.
About Foamix Pharmaceuticals
Foamix is a specialty pharmaceutical company working to solve some of today's most difficult therapeutic challenges in dermatology and beyond.
With expertise in topical medicine innovation as a springboard, the Company is working to develop and commercialize solutions that were long thought impossible, including the world's first topical minocycline, AMZEEQ. Its proprietary Molecule Stabilizing Technology (MST™) is utilized in the Company's dermatology products and in other products currently in development: FMX103 for the potential treatment of moderate to severe papulopustular rosacea and FCD105 for the potential treatment of moderate to severe acne.
Foamix is a different type of specialty pharmaceutical company by design, driven to see the solutions, overcome barriers in all aspects of business, and reimagine what's possible for conditions with high unmet needs.
Foamix uses its website as a channel to distribute information about Foamix and its product candidates from time to time. Foamix may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Foamix's website in addition to following its press releases, filings with the Securities and Exchange Commission, public conference calls, and webcasts. For more information, visit www.foamix.com.
Forward-Looking Statements
This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release which are not historical facts are forward-looking statements, including, but not limited to, statements regarding the future expectations, plans and prospects for Foamix; anticipated commercialization plans of AMZEEQ including the potential for AMZEEQ to treat moderate to severe acne vulgaris in adults and pediatric patients; and expectations regarding the size of eligible patient population for AMZEEQ and the anticipated patient benefit. Forward-looking statements are based on Foamix's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of various factors including, but not limited to, adverse events associated with AMZEEQ; the outcome of pricing, coverage and reimbursement negotiations with third party payors for AMZEEQ or any other products or product candidates that Foamix may commercialize in the future; whether, and to what extent, third party payors impose additional requirements before approving AMZEEQ prescription reimbursement; the eligible patient base and commercial potential of AMZEEQ or any of Foamix's other product or product candidates; additional competition in the acne and dermatology markets; inability to raise additional capital; Foamix's ability to recruit and retain key employees and its ability to stay in compliance with applicable laws, rules and regulations. Foamix discusses many of these risks in greater detail in its periodic filings with the SEC, including under the heading "Risk Factors" in its most recent annual report and subsequent quarterly reports. Although Foamix believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and Foamix undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.
started trading today on the Berlin exchange
01/11/2019 IL0011334385 Foamix Pharmaceuticals Ltd
n/a Admission mwb fairtrade Wertpapierhandelsbank AG (1172)
Berlin Open Market 04/11/2019
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