realfast95
5年前
Clinical Focus | January 2020
An Update on the Use of Minocycline for the Treatment of Acne
Advances in formulation technology have led to the development of a stable topical minocycline that recently received FDA approval. Here’s what you should know.
Joshua Zeichner, MD
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Antibiotics are a mainstay of treatment for acne vulgaris for their direct anti-inflammatory effects and indirect anti-inflammatory effects by lowering C. acnes levels in the skin. Oral tetracyclines, such as minocycline and doxycycline, are considered first line for moderate to severe acne. Best practice is to limit the duration of use of antibiotics and combine with benzoyl peroxide-containing agents to minimize the risk of bacterial resistance.1 Topical antibiotics, like clindamycin and erythromycin, are an attractive option because of limited systemic exposure. They are commonly used in regimens along with other actives or as part of fixed-dose combination drugs. With the emergence of bacterial resistance, the utility of these topical antibiotics has decreased.2 For this reason, effective topical antibiotic options to treat acne remain an unmet need.
Up to Date: An Overview of Tetracyclines for Acne
Tetracycline antibiotics exert a variety of anti-inflammatory effects in the skin, which is why they are beneficial in treating acne. They downregulate production of proinflammatory cytokines (eg. TNF-a, IL-1?) and C. acnes lipase enzymes.3 Tetracyclines suppress neutrophil chemotaxis and subsequent production of reactive oxygen species.3 Finally, they decease matrix metalloproteinase and nitric oxide activity4 and reduce arachidonic acid metabolites by inhibition of phospholipase A2.3,5
The structure of minocycline offers specific advantages over other tetracyclines. It is highly lipophilic, enhancing high penetration into sebum and resulting in high follicular concentrations. Systemic absorption is virtually unaffected by stomach contents, including dairy. Of the tetracyclines, minocycline has been shown to have the lowest level of C. acnes resistance based on mean inhibitory concentrations (MICs).6 It has also been shown to have the largest log reductions in C. acnes counts, as compared to doxycycline, tetracycline, trimethoprim-sulfamethoxazole, and erythromycin.7
Minocycline has been available in the United States since 1971. Minocycline, particularly in immediate-release systemic formulas, has been associated with several potential adverse events.
Extended-release formulations were subsequently brought to the market in an attempt to limit potential adverse events. The extended-release formula allows for maintained efficacy despite lower doses. Lower maximum plasma concentration resulted in reductions in acute vestibular side effects. In 2006, extended-release minocycline became the first minocycline formula that was FDA approved for the treatment of inflammatory and non-nodular moderate to severe acne.8
Vestibular side effects, such as dizziness, may occur with immediate-release systemic formulas, but are less likely with longer-acting formulations. Idiosyncratic hypersensitivity reactions, DRESS syndrome, pneumonitis, and minocycline-induced lupus-like reactions are rare.9 Finally, minocycline-related hyperpigmenation may occur. This is most common with long-term exposure. All of the reported cases of pigmentation occurred after a minimum treatment of eight months and a cumulative dose of at least 70g of the drug.10
Topical application of minocycline has the advantage of limiting both systemic exposure and potential serious adverse events. Despite its introduction to the market more than 40 years ago, the structure of minocycline made it difficult to stabilize in a topical preparation. However, advances in formulation technology have led to the development of a stable topical minocycline that recently received FDA approval. Amzeeq (FMX-101), a novel lipohilic topical minocycline 4% foam from Foamix, is now approved for the treatment inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients down to the age of 9.11
In Phase 2 and 3 clinical trials, the drug was found to be safe and effective. A pharmacokinetic study evaluating once-daily topical application of Amzeeq foam 4% for up to 21 days did not demonstrate any significant systemic exposure.12 In its Phase 3 clinical trials, the drug met both of its co-primary endpoints, with statistically significant reductions in inflammatory lesion counts at week 12 compared to baseline, as well as week 12 treatment success, defined as clear or almost-clear with a 2-point reduction in global assessment score.13
The drug was safe and well tolerated, with no serious treatment-related adverse events. The most common treatment emergent adverse events (occurring in at least one percent of patients) were upper respiratory tract infections, worsening acne, headache, elevated CK, and influenza. The majority of these events were mild to moderate in severity. Notably, hyperpigmentation was only observed in one patient out of 1,488 and deemed to be post-inflammatory. The drug was found to be non-irritating and not associated with photosensitivity.13,14
Despite high levels of bacterial resistance to both topical and systemic antibiotics, in vitro data evaluating Amzeeq shows that it maintains its potency with a low rate of promoting bacterial resistance. In vitro studies comparing the Amzeeq formulation to several other antibiotics showed that Amzeeq had the lowest mean inhibitory concentration against C. acnes. Amzeeq was found to be four times more potent than tetracycline, eight times more potent than clindamycin, and more than 32 times more potent than erythromycin against C. acnes. Moreover, after 15 repeated exposures, Amzeeq maintained its antibacterial activity against C. acnes, while high levels of resistance developed with exposure to clindamycin.15
Minimizing Resistance
While effective in treating acne, the major concern with use of antibiotics is the development of resistant organisms. Topical application is beneficial in that it limits systemic exposure and disruption of the gut microbiome. However, the potential for local resistance of both C. acnes and commensal organisms may occur. One strategy to minimize the development of bacterial resistance is to deliver high enough drug concentrations to kill all susceptible organisms and prevent growth of mutants.
The term “mutant selection window” refers to the concentration of antibiotics that kills bacteria, but may still allow for growth of mutant organisms and can thus result in bacterial resistance. Antibiotic doses high above the mean inhibitory concentration may be needed to keep drug levels outside this window and prevent bacterial resistance. However, it may be impractical or impossible to dose many systemic antibiotics this way because of potential side effects. Notably, as these adverse events do not exist with the use of topical antibiotics, it is possible to deliver concentrations of topical antibiotics outside of the mutant selection window.16,17 This alone may prevent the development of bacterial resistance and circumvent the need for concurrent use of benzoyl peroxide alongside the topical antibiotic.
More data are needed to fully evaluate this concept with respect to this novel topical formulation of minocycline.
https://practicaldermatology.com/articles/2020-jan/an-update-on-the-use-of-minocycline-for-the-treatment-of-acne?c4src=topic:acne:feed
realfast95
5年前
Foamix Announces AMZEEQ™ (minocycline) Achievement of Preferred Status on Express Scripts National Preferred Formulary, One of the Largest Commercial Formularies in the U.S.
January 14, 2020 at 8:00 AM EST
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Preferred Coverage Effective Immediately on Express Scripts National Preferred, Flex, and Basic Formularies
AMZEEQ is the First FDA Approved Topical Form of Minocycline for the Treatment of Moderate to Severe Acne
REHOVOT, Israel and BRIDGEWATER, N.J., Jan. 14, 2020 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) (“Foamix” or the “Company”), a specialty pharmaceutical company, today announced a coverage update for its novel AMZEEQTM (minocycline) topical foam, 4%. AMZEEQ is indicated 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 minocycline to be approved by the U.S. Food and Drug Administration (FDA) for any condition.
The Company announced that AMZEEQ has achieved preferred coverage effective immediately on the Express Scripts National Preferred, Flex, and Basic commercial formularies. As a preferred medication, AMZEEQ will be available at a lower out-of-pocket cost to the represented Express Scripts plan members compared to acne medications which are non-preferred or excluded.
The Company recently announced that the annual list price of AMZEEQ is $485 per 30-gram canister, a lower per unit cost than that of current brand leaders within the acne prescription market.
“As one of the largest pharmacy benefit managers in the U.S., Express Scripts’ decision to include AMZEEQ as a preferred agent on its national formularies is a significant step toward ensuring access to AMZEEQ for millions of moderate to severe acne patients,” said David Domzalski, Chief Executive Officer of Foamix. “We believe our pricing and overall access strategy prioritizes patients and their healthcare providers by providing a novel, first-of-its-kind acne treatment at pricing designed to help reduce barriers to treatment with AMZEEQ.”
Minocycline, a broad-spectrum antibiotic known for its efficacy in treating moderate to severe acne, has not previously been available as a topical treatment due to its instability in traditional topical formulations. In AMZEEQ, Foamix has leveraged its proprietary Molecule Stabilizing Technology (MST™) platform to deliver minocycline in a foam-based vehicle that maintains the stability of the active ingredient while delivering it directly on the skin.
AMZEEQ was approved by the U.S. Food and Drug Administration in October 2019. The Company has previously announced that the product is available in pharmacies nationwide as of January 13th.
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 adults and pediatric 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 sebaceous 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. Its proprietary Molecule Stabilizing Technology (MST™) is utilized in Amzeeq, the world's first topical minocycline, and in the Company's 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 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 and the commercialization plans of AMZEEQ, including the pricing, availability and healthcare and patient adoption of AMZEEQ to treat moderate to severe acne vulgaris in adults and pediatric patients. 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.
Corporate Contact:
Ilan Hadar, CFO
Foamix Pharmaceuticals Ltd.
+972-8-9316233
ilan.hadar@foamixpharma.com
Media Relations:
Rebecca Schechner
Zeno Group
312-586-3429, x5632
rebecca.schechner@zenogroup.com
U.S. Investor Relations:
Joyce Allaire
LifeSci Advisors, LLC
646-889-1200
jallaire@lifesciadvisors.com
realfast95
5年前
In compliance with the Companies Law, 5759-1999 of the State of Israel and the regulations promulgated thereunder (the “Companies Law”), Foamix Pharmaceuticals Ltd. (“Foamix” or the “Company”) hereby notifies its shareholders that it will hold an extraordinary general meeting of shareholders (the “Meeting”) on Thursday, February 6, 2020 at 11:00 a.m. Eastern Standard Time (“EST”) at the Company’s U.S. offices, located at 520 U.S. Highway 22, Suite 204, Bridgewater, New Jersey 08807. The record date for the determination of the holders of Foamix ordinary shares, par value New Israeli Shekels 0.16 per share (“Foamix ordinary shares”), entitled to vote at the Meeting is Monday, January 6, 2020.
At the Meeting, Foamix shareholders will be asked to vote on the following two proposals:
· Approval and adoption of (i) the Agreement and Plan of Merger dated November 10, 2019 (as amended by Amendment No. 1 to the Agreement and Plan of Merger, dated as of December 4, 2019, and as may be further amended from time to time, the “Merger Agreement”), by and among Menlo Therapeutics Inc., a Delaware corporation (“Menlo”), Giants Merger Subsidiary Ltd., a company organized under the laws of the State of Israel and a wholly-owned subsidiary of Menlo (“Merger Sub”), and Foamix, a copy of which was attached as Exhibit 2.1 to Foamix’s Current Report on Form 8-K, filed with the U.S. Securities and Exchange Commission (the “SEC”) on November 12, 2019; (ii) the merger of Merger Sub with and into Foamix (the “Merger”) on the terms and subject to the conditions set forth in the Merger Agreement and in accordance with the provisions of Sections 314-327 of the Companies Law, following which Merger Sub will cease to exist, and Foamix will become a wholly-owned subsidiary of Menlo; (iii) (a) the Merger consideration for Foamix’s shareholders, consisting of 0.5924 of a share of Menlo common stock (subject to upwards adjustment to 1.2739 or 1.8006 shares of Menlo common stock if one or both of Menlo’s Phase III PN Trials (as defined in the Merger Agreement), respectively, fail to demonstrate Serlopitant Significance (as defined in the Merger Agreement)) for each Foamix share that is issued and outstanding (other than any dormant share under the Companies Law and any Foamix share that, immediately prior to the Effective Time (as defined in the Merger Agreement), is owned by Foamix, Menlo or Merger Sub, or by any direct or indirect wholly-owned subsidiary of Foamix, Menlo or Merger Sub) and that will be deemed transferred to Menlo upon the Merger and (b) if the closing of the Merger occurs on or before May 31, 2020 and the Efficacy Determination (as defined in the Merger Agreement) has not yet been received, one contingent stock right, subject to the terms and conditions of the contingent stock rights agreement, the form of which was attached as Exhibit 10.3 to Foamix’s Current Report on Form 8-K, filed with the SEC on November 12, 2019; and (iv) all other transactions contemplated by the Merger Agreement, all upon the terms and subject to the conditions set forth in the Merger Agreement (the “Merger Proposal”).
·
Approval, on a non-binding, advisory basis, in accordance with the rules under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), of certain compensation that may be paid or become payable to the named executive officers of Foamix in connection with the Merger and contemplated by the Merger Agreement (the “Executive Compensation Proposal”).
The Executive Compensation Proposal will be presented in accordance with the rules of the Exchange Act, and it is not anticipated that any compensatory payments or benefits will in fact be paid to Foamix’s named executive officers in connection with the Merger.
The Board of Directors of Foamix unanimously recommends that Foamix shareholders vote in favor of each of the above proposals.
As required under the Nasdaq Listing Rules, which supersede Foamix’s articles of association with respect to this issue, the presence, in person or by proxy, at the Meeting of one or more Foamix shareholders who hold, in the aggregate, at least 331/3% of the voting rights in Foamix, is necessary to constitute a quorum at the Meeting. Abstentions and broker non-votes will also be treated as shares present for the purpose of determining the presence of a quorum for the transaction of business at the Meeting.
If within half an hour from the time appointed for the Meeting a quorum is not present, the Meeting will be adjourned for one week, to Thursday, February 13, 2020, at the same time and place. At that adjourned meeting, the same 331/3% quorum requirement will apply.
The vote of all Foamix shareholders is important regardless of whether they attend the Meeting. Accordingly, Foamix asks all shareholders to participate and vote regardless of the number of Foamix ordinary shares they own.
The approval of the Merger Proposal requires the affirmative vote of a majority of the voting rights of Foamix ordinary shares represented, in person or by proxy, and voting thereon at the Meeting, provided that such majority includes at least a majority of the votes cast by Foamix shareholders that are not Menlo, Merger Sub or certain Menlo affiliates, who are present, in person or represented by proxy, and voting (abstentions and broker non-votes are disregarded).
The approval of the Executive Compensation Proposal, which will be presented on a non-binding, advisory basis, requires the affirmative vote of a majority of the voting rights of Foamix ordinary shares represented, in person or by proxy, and voting thereon at the Meeting, pursuant to the rules under the Exchange Act.
The approval of the Merger Proposal, in addition to being required under the Companies Law, is a condition to the completion of the Merger under the terms of the Merger Agreement. Therefore, the Merger cannot be consummated without the approval of the Merger Proposal. None of the steps contemplated in connection with the Merger, including the issuance of Menlo common stock to the Foamix shareholders in exchange for their Foamix ordinary shares, will take place unless the Merger Proposal is approved by Foamix’s shareholders. The Merger and all related steps can, however, be consummated even if the Executive Compensation Proposal is not approved by Foamix’s shareholders at the Meeting.
In addition to the requirement of obtaining Foamix shareholder approval for the Merger Proposal, each of the other closing conditions set forth in the Merger Agreement (including the approval by Menlo’s stockholders of certain of the transactions contemplated under the Merger Agreement) must be satisfied or waived for the Merger to be completed.
Foamix intends, promptly following the record date, to send to its shareholders a proxy statement for the Meeting that also will serve as a prospectus in respect of the shares of Menlo common stock to be issued to Foamix shareholders in the Merger. That proxy statement/prospectus will describe, in detail, the Merger, the Merger Agreement, the proposals to be voted upon at, and additional logistical information related to, the Meeting, the procedure for voting in person or by proxy at the Meeting and various other information related to the Meeting. The Company will also file copies of the proxy statement and a related proxy card with the SEC, which may also be obtained for free from Foamix’s proxy solicitor for the Meeting, Morrow Sodali, LLC, at FOMX@investor.morrowsodali.com. The full text of the proposed resolutions for each proposal, together with the form of proxy for the Meeting, may also be viewed beginning on Monday, January 6, 2020, at the registered office of the Company, 2 Holzman Street (Entrance 2B), Weizmann Science Park, Rehovot, Israel, from Sunday to Thursday, 10:00 a.m. to 5:00 p.m. (Israel time). The telephone number at the Company’s registered office is +972-8-931-6233.
Shareholders of record who are unable to attend the Meeting in person will be requested to complete, date and sign a proxy card and return it promptly in the pre-addressed envelope that will be provided. Shareholders who attend the Meeting in person may revoke their proxies and vote their Foamix ordinary shares at the Meeting. In order to be counted towards the tally of votes at the Meeting, a proxy card must be received at the Company’s Israeli registered office not later than four hours prior to the start of the Meeting (i.e., by 2:00 p.m., Israel time/ 7:00 a.m. Eastern time, on the Meeting date).
If your Foamix ordinary shares are held in “street name” (meaning held through a bank, broker or other nominee), you will be able to direct the record holder of your shares on how to vote your shares by completing and submitting a voting instruction form (including online at www.proxyvote.com). Your voting instructions, if submitted electronically, must be received by 11:59 p.m. EST on Tuesday, February 4, 2020, and if submitted via a physical voting instruction form, must be received by noon, EST, on Wednesday, February 5, 2020, to be counted. If you hold your shares in “street name” and wish to attend the Meeting, you must obtain a legal proxy from the record holder (together with a brokerage or bank statement showing that you owned the shares beneficially as of the record date) to enable you to participate in and to vote your shares at the Meeting (or to appoint a proxy to do so).
In accordance with the requirements of the Companies Law, any shareholder of the Company holding at least 1% of the outstanding voting rights of the Company may submit to the Company a proposed additional agenda item for the Meeting, to our principal executive offices located at 2 Holzman Street, Weizmann Science Park, Rehovot, Israel, Attention: Chief Financial Officer, no later than Monday, December 23, 2019. To the extent that there are any additional agenda items that Foamix’s Board of Directors deems appropriate to add as a result of any such submission, Foamix will publish in a Current Report on Form 8-K an updated notice with respect to the Meeting, which will be available at the SEC’s website, www.sec.gov.
Important Additional Information and Where to Find It
In connection with the proposed strategic combination involving Foamix and Menlo, Foamix and Menlo have been filing relevant materials with the SEC, including a preliminary registration statement on Form S-4 filed by Menlo on December 4, 2019 that includes a joint proxy statement/prospectus to be distributed to Foamix shareholders. Foamix will mail the joint proxy statement/prospectus and a proxy card to each shareholder entitled to vote at the Foamix extraordinary general meeting relating to the proposed merger. INVESTORS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS WHEN IT IS FILED IN FINAL FORM BECAUSE IT WILL CONTAIN IMPORTANT INFORMATION. FOAMIX’S EXISTING PUBLIC FILINGS WITH THE SEC SHOULD ALSO BE READ, INCLUDING THE RISK FACTORS CONTAINED THEREIN.
Investors and security holders may obtain copies of the Form S-4, including the joint proxy statement/prospectus, as well as other filings containing information about Foamix, free of charge, from the SEC’s website (www.sec.gov). Investors and security holders may also obtain Foamix’s SEC filings in connection with the transaction, free of charge, from Foamix’s website (www.Foamix.com) under the link “Investors & Media” and then under the tab “Filings & Financials,” or by directing a request to Foamix, Attention: Ilan Hadar, Chief Financial Officer. Copies of documents filed with the SEC by Menlo will be made available, free of charge, on Menlo’s website (www.Menlotherapeutics.com).
Participants in Solicitation
Foamix, Menlo and their respective directors, executive officers and employees and other persons may be deemed to be participants in the solicitation of proxies from the holders of Foamix ordinary shares in respect of the proposed transaction. Information regarding Foamix’s directors and executive officers is available in its definitive proxy statement for Foamix’s 2019 annual meeting of shareholders filed with the SEC on March 11, 2019, as modified or supplemented by any Form 3 or Form 4 filed with the SEC since the date of such definitive proxy statement. Information about the directors and executive officers of Menlo is set forth in the Form S-4. Other information regarding the interests of the participants in the proxy solicitation will be included in the joint proxy statement/prospectus when it becomes available in final form. These documents can be obtained free of charge from the sources indicated above. This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
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