Innovus Pharma Files Its Product License Application for Commercialization of CIRCUMserum(TM) as a Natural Health Product for...
Innovus Pharmaceuticals, Inc., ("Innovus Pharma" or the "Company") www.innovuspharma.com (OTCBB:INNV) today announced that the Company filed its Product License Application with Health Canada as a Natural Health Product (NPN) to market its reduced penile sensitivity topical treatment CIRCUMserumTM with the indication to alleviate reduced penile sensitivity. CIRCUMserumTM has the active medicinal ingredient cinnamon oil (cinnamaldehyde) 0.75% and works by activating the transient receptor potential channel A1 (TRPA1) channels leading to exciting the nociceptive responsive nerve endings to increase penile sensitivity without affecting the thickness of the skin. If accepted by Health Canada, CIRCUMserumTM will be available over-the-counter as a 0.75% strength in 10mL metered dose dispenser and will not require a prescription. The product is not reimbursed by the Canadian government, therefore, the Company will be able to set the retail price through its potential commercial partners.
The approval process takes up to six months in Canada for this type of product, assuming no additional information is requested by Health Canada.
The Company, along with its US partner Centric Research Institute, has gathered extensive human, non-human primate and rodent efficacy data to support the mechanism of action of the product, its efficacy and safety.
"If approved by Health Canada for commercialization in Canada, to our knowledge, CIRCUMserumTM will be the first to market, and the only product approved, to alleviate reduced penile sensitivity in that country," said Dr. Bassam Damaj, President and Chief Executive Officer of Innovus Pharma. "Having CIRCUMserumTM be a NPN in Canada, bearing the indication of alleviating reduced penile sensitivity, would be a great value added to the product and a great accomplishment for the Company," continued Dr. Damaj.
In addition, the Company is in the process of obtaining guidance from the relevant health authorities in Europe and the Middle East in order to file market authorizations for the product in these territories.
About CIRCUMserumTM and Reduced Penile Sensitivity
Innovus Pharma acquired ex-US rights to CIRCUMserumTM from CRI in early 2013.
Reduced Penile Sensitivity (RPS) refers to the condition of decreased sensation in the penis during sexual activity. Subjects with RPS report difficulty in stimulating the penis, maintaining erection, and/or achieving orgasm. The duration of intercourse is typically prolonged due to delayed orgasm.
Normal ejaculation is quantified and diagnosed by the time it takes a man to ejaculation from penetrating the vagina. Normal men will ejaculation between 4-8 minutes following penetration of the vagina. Loss of sensation in the penis will cause men to ejaculate after longer than 15 minutes and may take up to 30 minutes, with some never being able to ejaculate.
CIRCUMserumTM is an all-natural cream with the active medicinal excipient cinnamon oil (cinnamaldehyde) at 0.75%. CIRCUMserumTM activates the TRPA1 channels, leading to exciting the nociceptive responsive nerve endings to increase penile sensitivity without affecting the thickness of the skin. For more information visit www.circumserum.com.
About Innovus Pharmaceuticals, Inc.
Innovus Pharma, headquartered in La Jolla, California, is an emerging pharmaceuticals company that delivers innovative and uniquely presented and packaged health solutions through its over-the-counter medicines and consumer and health products.
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 CIRCUMserumTM and to achieve its other development, commercialization and financial objectives. Even if this product is successfully approved by Health Canada, there is no guarantee that the Company will be able to make money on sales. 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 the Company filed its Product License Application with Health Canada as a Natural Health Product (NPN) to market its reduced penile sensitivity topical treatment CIRCUMserumTM with the indication to alleviate reduced penile sensitivity. CIRCUMserumTM has the active medicinal ingredient cinnamon oil (cinnamaldehyde) 0.75% and works by activating the transient receptor potential channel A1 (TRPA1) channels leading to exciting the nociceptive responsive nerve endings to increase penile sensitivity without affecting the thickness of the skin. If accepted by Health Canada, CIRCUMserumTM will be available over-the-counter as a 0.75% strength in 10mL metered dose dispenser and will not require a prescription. The product is not reimbursed by the Canadian government, therefore, the Company will be able to set the retail price through its potential commercial partners.
The approval process takes up to six months in Canada for this type of product, assuming no additional information is requested by Health Canada.
The Company, along with its US partner Centric Research Institute, has gathered extensive human, non-human primate and rodent efficacy data to support the mechanism of action of the product, its efficacy and safety.
"If approved by Health Canada for commercialization in Canada, to our knowledge, CIRCUMserumTM will be the first to market, and the only product approved, to alleviate reduced penile sensitivity in that country," said Dr. Bassam Damaj, President and Chief Executive Officer of Innovus Pharma. "Having CIRCUMserumTM be a NPN in Canada, bearing the indication of alleviating reduced penile sensitivity, would be a great value added to the product and a great accomplishment for the Company," continued Dr. Damaj.
In addition, the Company is in the process of obtaining guidance from the relevant health authorities in Europe and the Middle East in order to file market authorizations for the product in these territories.
About CIRCUMserumTM and Reduced Penile Sensitivity
Innovus Pharma acquired ex-US rights to CIRCUMserumTM from CRI in early 2013.
Reduced Penile Sensitivity (RPS) refers to the condition of decreased sensation in the penis during sexual activity. Subjects with RPS report difficulty in stimulating the penis, maintaining erection, and/or achieving orgasm. The duration of intercourse is typically prolonged due to delayed orgasm.
Normal ejaculation is quantified and diagnosed by the time it takes a man to ejaculation from penetrating the vagina. Normal men will ejaculation between 4-8 minutes following penetration of the vagina. Loss of sensation in the penis will cause men to ejaculate after longer than 15 minutes and may take up to 30 minutes, with some never being able to ejaculate.
CIRCUMserumTM is an all-natural cream with the active medicinal excipient cinnamon oil (cinnamaldehyde) at 0.75%. CIRCUMserumTM activates the TRPA1 channels, leading to exciting the nociceptive responsive nerve endings to increase penile sensitivity without affecting the thickness of the skin. For more information visit www.circumserum.com.
About Innovus Pharmaceuticals, Inc.
Innovus Pharma, headquartered in La Jolla, California, is an emerging pharmaceuticals company that delivers innovative and uniquely presented and packaged health solutions through its over-the-counter medicines and consumer and health products.
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 CIRCUMserumTM and to achieve its other development, commercialization and financial objectives. Even if this product is successfully approved by Health Canada, there is no guarantee that the Company will be able to make money on sales. 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
