Ferndale Laboratories, Inc. and Foamix Enter Development of an Innovative Foam for the Treatment of Atopic Dermatitis

FERNDALE, Michigan and NESS ZIONA, Israel, November 5 /PRNewswire/ -- Ferndale Laboratories Inc. and Foamix Ltd. announced today that the two companies have agreed to jointly develop non-steroidal foam for the treatment of atopic dermatitis.

According to this agreement, Foamix will be responsible for developing the foam formulations and Ferndale will have an option to continue definitive development and worldwide commercialization of the product. Additional terms were not disclosed.

Atopic dermatitis is very common in all parts of the world. It affects about 10% of infants and 3% of the total population in the United States. It can occur at any age but is most common in infants to young adults. The skin rash is very itchy and can be widespread, or limited to a few areas.

The development of the foam product will be directed to fortify the skin barrier by delivering a very high concentration of barrier-enhancing oils in an easy-to-apply formulation. Non-steroidal therapy is important for safe, long-term management of atopic dermatitis and the associated symptoms. Poor adherence to maintenance treatment for atopic dermatitis and parental anxiety about using topical steroids are common features seen among children with atopic dermatitis, and therefore, foams, which do not need extensive rubbing for spreading and absorption, offer an improved treatment modality for this disease.

"We believe that the Foamix foam offers an effective and convenient way to deliver treatment to patients with atopic dermatitis. These are often very young children who would benefit from the ease and comfort of use, combined with the efficacy of treatment," said James T. McMillan II, Chief Executive Officer of Ferndale.

"We are very proud to partner with an industry leader such as Ferndale," said Foamix CEO Dr. Dov Tamarkin. "Foam offers properties that increase usability, encourage compliance and boost user satisfaction. Foamix foams are alcohol-free and they can be designed to provide skin barrier properties, which are crucial for effective atopic dermatitis treatment, while using delicate, FDA approved ingredients, to ensure the safety of the patients," he noted.

About Ferndale

Ferndale is a specialty pharmaceutical company focused on developing, manufacturing, marketing and selling branded prescription pharmaceutical products in the under-served medical specialties of dermatology, colon/rectal surgery and OB-Gyn.

Read more on http://www.ferndalelabs.com.

About Foamix:

Headquartered in Ness Ziona, Israel, Foamix Ltd. is a specialty pharmaceutical company focused on the development of topical foam products for prescription, OTC and cosmetic applications. Foamix's state-of-the-art foams provide controlled delivery of a variety of active ingredients. Foamix is a privately held company, whose business model is based on partnering with leading pharma companies to develop products utilizing its proprietary foam technologies. We currently collaborate with 8 pharmaceutical companies on 10 projects in the development of proprietary dermatological and gynecologic foam drugs; and we have our own in-house pipeline of dermatological and gynecological drugs in foam presentation.

The company's development capabilities range from initial development of foam formulations to scale-up, GMP manufacturing, preclinical and clinical studies. Foamix holds 3 US patents and has 48 US patents pending, with corresponding national applications worldwide.

For additional information please visit http://www.foamix.co.il/

The blog owner is invested in Foamix and is not verey objective :-)

Foamix Acquires Rights to Dual Chamber Aerosol Foam Technology

Monday October 29, 8:52 am ET

NESS ZIONA, Israel, October 29 /PRNewswire/ -- Foamix Ltd. (http://www.foamix.co.il), a specialty pharmaceutical company focused on the development of topical foam products, announced today that it has licensed the exclusive worldwide rights for a dual chamber aerosol device from Wella AG. With its brands in Hair Care and Cosmetics, Wella is part of The Procter and Gamble Group since 2003.

"Combination pharmaceutical products are becoming a prominent component of topical therapy, as demonstrated by acne medications combining benzoyl peroxide with antibiotics and retinoids, psoriasis drugs combining Vitamin D analogs and steroids and anti-pigmentation drugs that combine steroids, hydroquinone and retinoids; however, due to compatibility constraints, creating a stable combination product with reasonable shelf life is a challenge. This license will enable us to incorporate two or more active agents in the same pharmaceutical product, with no stability concerns," said Foamix CEO Dr. Dov Tamarkin. "We are committed to continuing progress at the forefront of topical therapy, and our ability to develop stable, safe and effective combination drugs will provide added value for Foamix and for our industry partners," he added.

According to the license agreement, Foamix has the exclusive rights to use the dual-chamber device for all topical and intra-vaginal drug products requiring prescription. The financial terms of the agreement were not disclosed.

The device is protected by US Patent No. 6,305,578, EP 1075325 and JP 2000-600768; and Foamix has its own patent applications, covering a broad spectrum of foam vehicles and drugs that can be incorporated in this device.

About Foamix

Headquartered in Ness Ziona, Israel, Foamix Ltd. is a specialty pharmaceutical company focused on the development of topical foam products for prescription, OTC and cosmetic applications. Foamix's state-of-the-art foams provide controlled delivery of a variety of active ingredients. Foamix is a privately held company, whose business model is based on partnering with leading pharma companies to develop products utilizing its proprietary foam technologies. We currently collaborate with 8 pharmaceutical companies on 10 projects in the development of proprietary dermatological and gynaecologic foam drugs; and we have our own in-house pipeline of dermatological and gynecological drugs in foam presentation.

The company's development capabilities range from initial development of foam formulations to scale-up, GMP manufacturing, preclinical and clinical studies. Foamix holds 3 US patents and has 48 US patents pending, with corresponding national applications.

The blog owner is invested in Foamix and is not verey objective :-)

Best foam forward

By Anna Lewcock http://www.in-pharmatechnologist.com/

16/07/2007 - An Israeli drug delivery firm is developing a new vaginal drug delivery system, making use of bio-adhesive foams to offer a more convenient and effective treatment option for women with gynaecological complaints.

Foamix,, a company specialising in foam formulations for a variety of applications, showed off its latest research into the vaginal foam product at last week's Controlled Release Society meeting in California, profiling its advantages over current products and presenting promising study results.

The foam products are set to challenge the traditional vaginal treatments, currently limited to ointments, pessaries, creams or gel-type formulations, which can be inconvenient and messy for the patient as well as tricky to administer and likely to leak.

The foam products, according to the company, solve all these problems in one go.

"Vaginal delivery is a neglected market," Doron Friedman, Foamix' chief technology officer told in-PharmaTechnologist.com at the CRS meeting.

"Women have a lot of trouble with current vaginal delivery systems - foam is simple."

The vaginal foam the company has developed is composed of US Food and Drug Administration (FDA) approved ingredients, is easy to apply with a simple disposable applicator, and spreads evenly over the vaginal cavity surface.

The foam is also bio-adhesive, of key importance in vaginal preparations as it affects the adhesion of the formulation to the mucosal surface and consequently the presence of the active drug at the target treatment site.

The company presented a poster showing the in vitro and in vivo adhesion profile of its vaginal foam at the annual meeting last week, with results showing that various formulation of the foam exhibit adhesive force in the same range as Dalacin (clindamycin), Pharmacia's antibiotic vaginal cream.

In in vivo studies with female sheep, the company found that the foam expanded effectively to cover the vaginal cavity and cervix area, which remained covered after 15 minutes. There were no signs of overflow, dripping or irritation after administration.

Foamix also studied the foam's lubrication profile, comparing it to the "gold standard" in vaginal lubrication - KY Gel. The company's research found that the foam's viscosity and lubricating properties were indeed comparable to the marketed KY product.

The foam itself can be formulated with a variety of drug compounds, and according to Friedman the company can reformulate almost any type of semi-solid to be compatible with the foam delivery system.

Due to the fact that initial products are also likely to be simple reformulations of existing treatments, the regulatory pathway will be relatively short, allowing for quicker time to market.

Friedman anticipates entering clinical studies with specific drugs next year, having only earlier this year inked a deal with women's healthcare and dermatology specialist Warner Chilcott to collaborate on the development of a therapeutic gynaecologic foam.

Aside from its gynaecological focus, Foamix also works on topical foam products for the delivery of active ingredients in the areas of dermatology, wound care and burn care. The company currently partners with eight pharmaceutical companies on ten products making use of the proprietary foam drug delivery system, as well as developing its own in-house pipeline of foam-based treatments.

The blog owner is invested in Foamix and is not verey objective :-)

Foamix Signs R&D Collaboration and License Agreement with Dr. Reddy’s for the Development and Commercialization of Psoriasis Foam

Ness Ziona, Israel, January 24, 2007 /PRNewswire/
Foamix Ltd., the leader in the development of topical foam delivery systems, announced today that they have executed a worldwide license agreement with Dr. Reddy’s Laboratories (NYSE:RDY), for the development of a novel prescription emollient foam for the treatment of psoriasis.

Under the terms of the agreement, Foamix will receive certain development fees and milestone payments. Upon commercialization of the product, Foamix will receive royalty based on net sales. “Foamix has a proven track record for developing innovative dermatological specialty foam products. We are happy to partner with them in developing a novel topical foam product to address the unmet needs of psoriasis patients," said Jeffrey Wasserstein, Executive Vice President, of Dr. Reddy's.
"We are proud to partner with Dr. Reddy's who is building a specialty pharmaceutical presence in branded dermatology by developing innovative topical products, both internally and through third party in-licensing, that will be detailed directly to dermatologists" said Foamix CEO, Dr. Dov Tamarkin.

Foamix licenses dermatological product to German co

Potential revenue from the license could total tens of millions of dollar.
Gali Weinreb 14 Jan 07 19:40
Foamix Ltd. has signed a worldwide licensing agreement with dermatology products company Intendis GmbH, a fully owned subsidiary of Bayer Schering Pharma AG, for Foamix’s dermatology foam. The company declined to name the product.
Foamix told “Globes” that the target market was over $1 billion, and potential revenue from the license could total tens of millions of dollars, including the initial payment, payments upon reaching certain milestones, and royalties in the event of success. The product is based on an alcohol-free foam developed by the company.


Foamix was founded with a $5 million investment, and is owned by the company’s entrepreneurs and private investors. The company expects to become profitable this year, and is considering a public offering.

Published by Globes [online], Israel business news - www.globes.co.il - on January 11, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2006

Maayan Ventures medical device co Applisonix set for IPO

The company plans to raise NIS 33-35 million in shares and convertible bonds.
Gali Weinreb 18 Jan 07 13:11
Maayan Ventures Ltd. (TASE:MAYN) medical devices subsidiary Applisonix Ltd. has filed a prospectus to raise NIS 33-35 million in shares and convertible bonds in an IPO on the Tel Aviv Stock Exchange (TASE). Maayan Ventures owns 27.2% of the company.
AppliSonix has already obtained commitments from investment institutions for 80% of the offering. The public tender will be held on January 25. The underwriters are Altshuler Shacham Management Underwriters & Investments Ltd., Excellence Nessuah Underwriting (1993) Ltd., and Leader Underwriters (1993) Ltd.


AppliSonix is developing an ultrasonic depilatory device that delivers ultrasonic waves to the hair root, damaging it ability to function for an extended period. The product will first be developed for use by doctors and cosmeticians, but the company hopes to develop a product for use at home. The company said that its product is more effective and safer than laser or visible wavelength-based depilatory devices, and that it can be used by both blondes and brunettes.

AppliSonix can force the conversion of its convertible bonds if it meets the determining event of a Phase I clinical trial on at least 20 patients by an expert plastic surgeon who testifies that the device is at least as safe and effective as competing devices. This doctor may not have any business or family connection to the company, but he may be paid for the tests and opinion. The company believes that this determining event will be made during the second quarter of 2008.

AppliSonix has already developed a prototype, and it is due to undergo abbreviated US Food and Drug Administration (FDA) marketing approval procedure (510k). If all goes according to plan, the product’s market launch will be in 2009.

AppliSonix has raised $4.5 million to date from Maayan Ventures, Israel Infinity Venture Capital, Athena Cyprus, Cyventure Capital, Magari Ltd. and the Office of the Chief Scientist. The company lost NIS 3.8 million in January-September 2006, mainly because of R&D costs.

Published by Globes [online], Israel business news - www.globes.co.il - on January 18, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2007

I have a personal interests in both Maayan and Applisonix

Foamix collaborates with Warner Chilcott on acne treatment

Foamix collaborates with Warner Chilcott on acne treatment

Foamix will receive an initial payment of several hundred thousand dollars, and subsequent payments based on milestones, and royalties.

Gali Weinreb 8 Jan 07 16:01

Foamix Ltd. and Warner Chilcott Company Inc. (Nasdaq:CRWX) have signed an agreement to jointly develop an antibiotic foam for the treatment of acne. The product will be based on an oral antibiotic treatment for which no company has yet been able to create effectively in an ointment or local form.

Foamix told “Globes” today that it has already developed a preliminary foam version for spreading, and it believes that it will succeed where other companies have failed.

Warner Chilcott will initially pay Foamix several hundred thousand dollars to finance product development. Warner Chilcott will be responsible for obtaining product approval, licensing and marketing. If the product succeeds, the joint development agreement will become a licensing agreement, and Foamix will receive payments on the basis of milestones, as well as royalties. Foamix says its product will come on the market in 2010 or 2011.

The US acne treatment market alone amounts to $1 billion a year.

Foamix CEO Dr. Dov Tamarkin said, “We are very proud to partner with an industry leader such as Warner Chilcott. Foam offers properties that increase usability, encourage compliance and boost user satisfaction. Foamix foams are alcohol-free and able to effectively deliver a broad range of actives.”

Foamix is developing a range of foam-based treatments. The company has joint development agreements with ten dermatology development companies, although none of the agreements is for an acne treatment. The company’s partners include LEO Pharma A/S of Denmark, Stiefel Laboratories Inc. of the US, and Taro Pharmaceutical Industries Ltd. (TAROF.PK) and Trima Israel Pharmaceutical Products Maabarot Ltd.of Israel.

Foamix expects to become profitable soon on the basis of milestone payments from its partners, even though no product is yet on the market. Foamix’s first product, BabyFoamix, due on the market in a few months, will be a foam treatment for diaper rash jointly developed with Trima. Foamix has said that it plans to go public on Nasdaq.

Published by Globes [online], Israel business news - www.globes.co.il - on January 8, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2006