Innovus Pharma Provides Regulatory and Commercial
Post# of 94265
Posted On: 01/10/2014 7:59:37 AM
Innovus Pharma Provides Regulatory and Commercial Update on the Label Indication for Zestra(R) for Female Sexual Desire Disor...
Innovus Pharmaceuticals, Inc., ("Innovus Pharma" or the "Company") www.innovuspharma.com (OTCBB:INNV) today announced that its newly acquired wholly-owned subsidiary, Semprae Laboratories, Inc. ("Semprae") is working with Health Canada to finalize the packaging for the indication for its topical over the counter ("OTC") Natural Health Product, Zestra®, for the temporary improved sexual desire in women suffering from female sexual desire disorder" ("FSDD"). The first Canadian Product License approval for this indication was obtained by Semprae in July 2012, but never applied to the Zestra® label. The Company is expected to finalize the new packaging for this product with Health Canada with the approved FSDD indication within 90 days. In addition, the Company is filing to expand the indication to women with Female Sexual Arousal Disorder (FSAD) due to statistically significant improvement in arousal and Female Sexual Function Index (FSFI) scores observed in its large clinical trial in women with FSAD.
As support for its Canadian Product License approval for Zestra®, Semprae included clinical data from a sixteen-week randomized, placebo controlled double-blind, parallel design trial in over 256 women (including women with FSAD) in the U.S. published in the Journal of Sex & Marital Therapy, 36:1, 66-86, which demonstrated statistically significant efficacy in FSFI score including desire, arousal and treatment satisfaction for the product as compared to placebo.
The addition of the NHP Product License for Zestra® for FSDD, adds a second product to the Company's portfolio of OTC products that have been approved in Canada. Innovus Pharma previously announced that it received approval of its Product License for Eject Delay™, its Benzocaine-based topical treatment for premature ejaculation.
"To our knowledge, Zestra™ is the only OTC NHP product to receive an approval for the FSDD indication from Health Canada," said Dr. Bassam Damaj, President and Chief Executive Officer of Innovus Pharma. "The product is currently on the Canadian market in retail chains and pharmacies and its sales in 2013 in Canada accounted for approximately 10% of the total worldwide revenues for this product without any marketing or detailing to physicians. With the addition of the approved indication labeling for Zestra® for FSDD, the Company intends to promote the product to gynecologists and sex therapists either directly or through potential partners to expand its market share and potentially grow its sales," continued Dr. Damaj.
About Zestra® and FSDD
Zestra® is a patented blend of natural oils clinically-proven in double-blind placebo-controlled clinical trials in over 256 women to increase in a statistical significant manner the arousal, desire and satisfaction in women. The product has been on the U.S. and Canadian markets for approximately five years through major retailers such as Walmart, Target and K-Mart and drug wholesalers such as McKesson, Cardinal Health and HD Smith and through online sales. Zestra® Glide™ is an accompanying water based lubricant developed and sold by Semprae Labs, a wholly-owned subsidiary of Innovus Pharma. For more information visit www.zestra.com
Zestra® is the first NHP product to receive approval for the indication of FSDD in Canada. FSDD is a subset of Female Sexual Disorder ("FSD"), which also includes Female Sexual Arousal Disorder ("FSAD"). To date, no product has been approved in the U.S. and Canada to treat FSAD or FSDD, a persistent or recurring inability to attain or maintain adequate sexual excitement until the completion of a sexual activity. The diagnosis can also refer to an inadequate lubrication-swelling response normally present during arousal and sexual activity causing personal distress. Published papers on the FSD market size estimate it to be equal or larger than the market for erectile disorder in males, and possibly larger.
About EjectDelay™ and Premature Ejaculation
EjectDelay™ is an over-the-counter ("OTC") U.S. Food and Drug Administration and Health Canada compliant proprietary topical treatment containing the drug benzocaine and indicated for delay of premature ejaculation. The drug typically works within minutes of application to the glans of the penis. In clinical trials, the application of benzocaine has been shown to delay premature ejaculation by several minutes. For more information visit www.ejectdelay.com.
Premature ejaculation ("PE") is the most common sexual disorder reported by men but is still under-diagnosed and under-treated. PE can happen at any age and its prevalence is consistent across all ages. In an article in The Journal of Sexual Medicine in 2007 Sex Med 2007, D.L. Patrick, D. Rowland and M. Rothman state, "Global studies consistently report that 20-30% of men experience PE worldwide. This means that PE is experienced at similar rates across the globe."
About Innovus Pharmaceuticals, Inc.
Innovus Pharma, headquartered in La Jolla, California, is an emerging leader in the over the counter sexual disorder medicines and consumer health products. Our product pipeline consists of EjectDelay™ for premature ejaculation, CIRCUMSerum™ to alleviate reduced penile sensitivity, Zestra® for enhancement of sexual desire and FSAD and Zestra® Glide as an accompanying water based lubricant.
For more information, go to www.innovuspharma.com.
INNOVUS PHARMA'S FORWARD-LOOKING Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, receiving patent protection for any of its products, receiving approval or to be compliant with the requirements of any relevant regulatory authority relating to such products, to successfully commercialize such products as Zestra® and Zestra Glide® and to achieve its other development, commercialization and financial objectives. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Innovus Pharma Contact:
Kevin Holmes
Chesapeake Group
info@chesapeakegp.com
T: 410-825-3930
Innovus Pharmaceuticals, Inc., ("Innovus Pharma" or the "Company") www.innovuspharma.com (OTCBB:INNV) today announced that its newly acquired wholly-owned subsidiary, Semprae Laboratories, Inc. ("Semprae") is working with Health Canada to finalize the packaging for the indication for its topical over the counter ("OTC") Natural Health Product, Zestra®, for the temporary improved sexual desire in women suffering from female sexual desire disorder" ("FSDD"). The first Canadian Product License approval for this indication was obtained by Semprae in July 2012, but never applied to the Zestra® label. The Company is expected to finalize the new packaging for this product with Health Canada with the approved FSDD indication within 90 days. In addition, the Company is filing to expand the indication to women with Female Sexual Arousal Disorder (FSAD) due to statistically significant improvement in arousal and Female Sexual Function Index (FSFI) scores observed in its large clinical trial in women with FSAD.
As support for its Canadian Product License approval for Zestra®, Semprae included clinical data from a sixteen-week randomized, placebo controlled double-blind, parallel design trial in over 256 women (including women with FSAD) in the U.S. published in the Journal of Sex & Marital Therapy, 36:1, 66-86, which demonstrated statistically significant efficacy in FSFI score including desire, arousal and treatment satisfaction for the product as compared to placebo.
The addition of the NHP Product License for Zestra® for FSDD, adds a second product to the Company's portfolio of OTC products that have been approved in Canada. Innovus Pharma previously announced that it received approval of its Product License for Eject Delay™, its Benzocaine-based topical treatment for premature ejaculation.
"To our knowledge, Zestra™ is the only OTC NHP product to receive an approval for the FSDD indication from Health Canada," said Dr. Bassam Damaj, President and Chief Executive Officer of Innovus Pharma. "The product is currently on the Canadian market in retail chains and pharmacies and its sales in 2013 in Canada accounted for approximately 10% of the total worldwide revenues for this product without any marketing or detailing to physicians. With the addition of the approved indication labeling for Zestra® for FSDD, the Company intends to promote the product to gynecologists and sex therapists either directly or through potential partners to expand its market share and potentially grow its sales," continued Dr. Damaj.
About Zestra® and FSDD
Zestra® is a patented blend of natural oils clinically-proven in double-blind placebo-controlled clinical trials in over 256 women to increase in a statistical significant manner the arousal, desire and satisfaction in women. The product has been on the U.S. and Canadian markets for approximately five years through major retailers such as Walmart, Target and K-Mart and drug wholesalers such as McKesson, Cardinal Health and HD Smith and through online sales. Zestra® Glide™ is an accompanying water based lubricant developed and sold by Semprae Labs, a wholly-owned subsidiary of Innovus Pharma. For more information visit www.zestra.com
Zestra® is the first NHP product to receive approval for the indication of FSDD in Canada. FSDD is a subset of Female Sexual Disorder ("FSD"), which also includes Female Sexual Arousal Disorder ("FSAD"). To date, no product has been approved in the U.S. and Canada to treat FSAD or FSDD, a persistent or recurring inability to attain or maintain adequate sexual excitement until the completion of a sexual activity. The diagnosis can also refer to an inadequate lubrication-swelling response normally present during arousal and sexual activity causing personal distress. Published papers on the FSD market size estimate it to be equal or larger than the market for erectile disorder in males, and possibly larger.
About EjectDelay™ and Premature Ejaculation
EjectDelay™ is an over-the-counter ("OTC") U.S. Food and Drug Administration and Health Canada compliant proprietary topical treatment containing the drug benzocaine and indicated for delay of premature ejaculation. The drug typically works within minutes of application to the glans of the penis. In clinical trials, the application of benzocaine has been shown to delay premature ejaculation by several minutes. For more information visit www.ejectdelay.com.
Premature ejaculation ("PE") is the most common sexual disorder reported by men but is still under-diagnosed and under-treated. PE can happen at any age and its prevalence is consistent across all ages. In an article in The Journal of Sexual Medicine in 2007 Sex Med 2007, D.L. Patrick, D. Rowland and M. Rothman state, "Global studies consistently report that 20-30% of men experience PE worldwide. This means that PE is experienced at similar rates across the globe."
About Innovus Pharmaceuticals, Inc.
Innovus Pharma, headquartered in La Jolla, California, is an emerging leader in the over the counter sexual disorder medicines and consumer health products. Our product pipeline consists of EjectDelay™ for premature ejaculation, CIRCUMSerum™ to alleviate reduced penile sensitivity, Zestra® for enhancement of sexual desire and FSAD and Zestra® Glide as an accompanying water based lubricant.
For more information, go to www.innovuspharma.com.
INNOVUS PHARMA'S FORWARD-LOOKING Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, receiving patent protection for any of its products, receiving approval or to be compliant with the requirements of any relevant regulatory authority relating to such products, to successfully commercialize such products as Zestra® and Zestra Glide® and to achieve its other development, commercialization and financial objectives. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Innovus Pharma Contact:
Kevin Holmes
Chesapeake Group
info@chesapeakegp.com
T: 410-825-3930
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