FDA tentatively approves Perrigo psoriasis treatment
Sales of the ethical version of the treatment, Olux, totaled $78 million in the twelve months ending July.
Eitan Tapiro 3 Sep 06 10:53
Perrigo Co. (Agis Industries) (Nasdaq:PRGO; TASE:PRGO) announced on Friday that it had been granted tentative approval from the US Food and Drug Administration (FDA) on its abbreviated new drug application (ANDA) for Clobetasol Propionate Topical Foam, 0.05%., for the treatment of scalp dermatoses. The ethical version of the drug, Olux is marketed by Connectics Corporation (Nasdaq: CNCT) and had sales totaling $78 million in the twelve months ending July.
If successful in the legal action, and upon final approval, Perrigo expects to be granted 180 days of generic marketing exclusivity. On October 19, 2005, Connetics filed suit in the US District Court of New Jersey to prevent Perrigo from proceeding with the commercialization of its product. Litigation is currently ongoing.
Published by Globes [online], Israel business news - www.globes.co.il - on September 3, 2006
Sunday, September 03, 2006
Sunday, August 20, 2006
Foamix lice treatment demonstrates 96% efficacy in Phase II/III study
Foamix lice treatment demonstrates 96% efficacy in Phase II/III study
The medical start-up anticipates launching PerFoam on the Israeli market in 2006
by Globes correspondent 19/07/2005
Medical start-up Foamix Ltd. has announced the results of its Phase II/III study of one of its lead products, PerFoam, for the treatment of lice. Trial data shows evidence of safety and a 96% efficacy rate. Foamix anticipates launching PerFoam in the Israeli market in 2006, and in the global market in 2006/7. PerFoam, comprised of 1% permethrin and two proprietary enhancers, is an alcohol-free, non-irritating, drip-free foam for the treatment of head lice. Permethrin is the recommended active ingredient for the treatment of lice by the American Academy of Pediatrics. However, data show that lice have developed resistance to permethrin in shampoo, lotion and cream rinse formulations. There is also evidence of scalp and eye irritation resulting from the application of the currently available products.
The study, titled, "An open study to assess the efficacy, safety and usability of a 1% Permethrin Foam, in the treatment of head lice (pediculosis capitis) in pediatric patients," was conducted at the Laniado Medical Center, Netanya. Dr. Avner Shemer, senior dermatologist was the principal investigator of the study. Fifty-six children, ages 3-16, infested with head lice, were treated with PerFoam. PerFoam was applied to the hair for 10 minutes and then washed. Treatment was repeated 10 days later. According to the study, "PerFoam proved effective in killing the lice on the first application in 54 of the 56 children (96.4%). Furthermore, in 60% of the children, lice eggs were completely eradicated after the first application. The product was easily applied and caused no discomfort to the treated children. There was no evidence of eye or skin irritation.”
“The efficacy of PerFoam is remarkably high, despite the commonly known resistance of lice to current treatments in this region,” said Professor Arie Hadani, the entomologist of the study.
Lice are parasitic insects generally found on human heads. Preschool and elementary-age children, 3-10 years of age, and their families are infested most often from this easily spread condition. Hundreds of millions of cases of louse infestation are reported annually worldwide, with a clear increase over the past few decades.
The local market in Israel for anti-lice treatment products value is NIS 10 million a year. The over-the-counter (OTC) anti-lice products generates approximately NIS 7 million out of the total market. It has been estimated that 10-12 million Americans are infested yearly with lice. Elementary school-age children account for a quarter of this number. The current US market for head-lice treatment products is estimated at $120 million.
Foamix is a pre-IPO, privately held company, currently engaged in a $5 million financing round. Headquartered in Ness Ziona, the company develops alcohol-free, non-inflammable, stable foam products for prescription, OTC and cosmetic uses. Applications include dermatology, gynecology, cosmetics, cosmeceuticals, wound healing and burn care. The company was founded in January 2003 by CEO Dr. Dov Tamarkin, COO Meir Eini and chief technology officer Dr. Doron Friedman. The Company employs 22 people and has 22 patents pending. Foamix recently received three US patent approvals for its OilGel topical delivery platform. Foamix will be exhibiting at booth 1713 at the American Academy of Dermatology meeting in Chicago from July 20 - 24th at the Hyatt Regency in Chicago.
*the author of this blog is invested in Foamix :-)
The medical start-up anticipates launching PerFoam on the Israeli market in 2006
by Globes correspondent 19/07/2005
Medical start-up Foamix Ltd. has announced the results of its Phase II/III study of one of its lead products, PerFoam, for the treatment of lice. Trial data shows evidence of safety and a 96% efficacy rate. Foamix anticipates launching PerFoam in the Israeli market in 2006, and in the global market in 2006/7. PerFoam, comprised of 1% permethrin and two proprietary enhancers, is an alcohol-free, non-irritating, drip-free foam for the treatment of head lice. Permethrin is the recommended active ingredient for the treatment of lice by the American Academy of Pediatrics. However, data show that lice have developed resistance to permethrin in shampoo, lotion and cream rinse formulations. There is also evidence of scalp and eye irritation resulting from the application of the currently available products.
The study, titled, "An open study to assess the efficacy, safety and usability of a 1% Permethrin Foam, in the treatment of head lice (pediculosis capitis) in pediatric patients," was conducted at the Laniado Medical Center, Netanya. Dr. Avner Shemer, senior dermatologist was the principal investigator of the study. Fifty-six children, ages 3-16, infested with head lice, were treated with PerFoam. PerFoam was applied to the hair for 10 minutes and then washed. Treatment was repeated 10 days later. According to the study, "PerFoam proved effective in killing the lice on the first application in 54 of the 56 children (96.4%). Furthermore, in 60% of the children, lice eggs were completely eradicated after the first application. The product was easily applied and caused no discomfort to the treated children. There was no evidence of eye or skin irritation.”
“The efficacy of PerFoam is remarkably high, despite the commonly known resistance of lice to current treatments in this region,” said Professor Arie Hadani, the entomologist of the study.
Lice are parasitic insects generally found on human heads. Preschool and elementary-age children, 3-10 years of age, and their families are infested most often from this easily spread condition. Hundreds of millions of cases of louse infestation are reported annually worldwide, with a clear increase over the past few decades.
The local market in Israel for anti-lice treatment products value is NIS 10 million a year. The over-the-counter (OTC) anti-lice products generates approximately NIS 7 million out of the total market. It has been estimated that 10-12 million Americans are infested yearly with lice. Elementary school-age children account for a quarter of this number. The current US market for head-lice treatment products is estimated at $120 million.
Foamix is a pre-IPO, privately held company, currently engaged in a $5 million financing round. Headquartered in Ness Ziona, the company develops alcohol-free, non-inflammable, stable foam products for prescription, OTC and cosmetic uses. Applications include dermatology, gynecology, cosmetics, cosmeceuticals, wound healing and burn care. The company was founded in January 2003 by CEO Dr. Dov Tamarkin, COO Meir Eini and chief technology officer Dr. Doron Friedman. The Company employs 22 people and has 22 patents pending. Foamix recently received three US patent approvals for its OilGel topical delivery platform. Foamix will be exhibiting at booth 1713 at the American Academy of Dermatology meeting in Chicago from July 20 - 24th at the Hyatt Regency in Chicago.
*the author of this blog is invested in Foamix :-)
Sunday, August 13, 2006
Infinity Venture Capital Leads US $4.5 Million Round in AppliSonix
TEL AVIV, Israel--(BUSINESS WIRE)--Aug. 1, 2006--Infinity Venture Capital announced today it is leading a US $4.5 million investment round in Applisonix, a medical aesthetics device company focused on developing and marketing a breakthrough hair removal solution utilizing ultrasound (HIFU) technology. Other investors include Infinity's technology incubator Maayan Ventures, Magari Limited, Cyventure Capital and Athena Cyprus, which is part of the Cyprus Funds and Kanit Group. Applisonix had a valuation of slightly more than US $6.5 million before this investment.
The financing announced today is earmarked to support the continuation of product development and the commencement of clinical trials. The hair removal market is estimated at $10 billion and continues to grow.
Applisonix's technology is likely to positively impact the lives of millions of men and women worldwide. Applisonix's technology offers an easy and painless means to get rid of unwanted hair for a long period. It doesn't burn the skin and works with all hair and skin pigment types. Alternatives such as shaving, waxing, chemical melting, plucking, electrolysis, lasers and intense pulse light treatments are soon likely to be bad dreams of the past," said Amir Gal-Or, Managing Partner, Infinity Venture Capital and Co founder of Partners500.
The financing announced today is earmarked to support the continuation of product development and the commencement of clinical trials. The hair removal market is estimated at $10 billion and continues to grow.
Applisonix's technology is likely to positively impact the lives of millions of men and women worldwide. Applisonix's technology offers an easy and painless means to get rid of unwanted hair for a long period. It doesn't burn the skin and works with all hair and skin pigment types. Alternatives such as shaving, waxing, chemical melting, plucking, electrolysis, lasers and intense pulse light treatments are soon likely to be bad dreams of the past," said Amir Gal-Or, Managing Partner, Infinity Venture Capital and Co founder of Partners500.
Painless hair removal - that will be the day
Do you believe that one day we will have real Painless Permanent hair removal applications that will not expose our body to painful treatments or hazardous exposure to radiation? well that will be the day, and that day is not far away.
One of the companies that i am working with is called AppliSonix. They are developing an affordable next-generation personal devices that utilize an innovative ultrasonic technology to remove hair surfaces with a long lasting and painless effect. So yes that will be the day :-)
The following web posting was translated for your amusement
Q: "Hi .. I wanted to inquire on how men can remove hair from their back in the comfort of their home (ALONE)!!! and what Wax brand do you recommend or any other application.
A: "1. worm up the Wax brand of choice ... 2. spread a generous layer of wax on the wall at the relevant height ... 3. Stand with your back facing the wall and lean back .. 4. wait three minutes . 5 and run (ouch@#$$#) ... after a few sessions one can peal the carpet off the wall. "
One of the companies that i am working with is called AppliSonix. They are developing an affordable next-generation personal devices that utilize an innovative ultrasonic technology to remove hair surfaces with a long lasting and painless effect. So yes that will be the day :-)
The following web posting was translated for your amusement
Q: "Hi .. I wanted to inquire on how men can remove hair from their back in the comfort of their home (ALONE)!!! and what Wax brand do you recommend or any other application.
A: "1. worm up the Wax brand of choice ... 2. spread a generous layer of wax on the wall at the relevant height ... 3. Stand with your back facing the wall and lean back .. 4. wait three minutes . 5 and run (ouch@#$$#) ... after a few sessions one can peal the carpet off the wall. "
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