The Board of Directors of Peptonic Medical AB (publ) (Peptonic or Company) today announced the decision to commence the process of obtaining CE-marking for the vaginal gel that was used as a placebo in a recently completed 2b study conducted by the Company. Once the CE-mark has been obtained, the Company intends to launch the product as a non-prescription option for relief of the symptoms of vaginal atrophy (e.g. dryness, irritation and itching).
The decision to CE mark the product is based both on the results of the clinical study, in which the gel demonstrated a marked and statistically significant symptom alleviating effect, and on the outcome of an initial evaluation of the possibility to obtain a CE mark for the gel. The Board believes the prospects for a successful launch are good as there is high demand for efficacious, well-documented, estrogen-free products for vaginal atrophy.
The clinical phase 2b study concluded that the vaginal gel demonstrated very high efficacy in the relief of symptoms in women who suffer from vaginal atrophy. This has been confirmed by the principal investigators who monitored the trials.
“The gel demonstrated surprising efficacy in terms of symptom relief for the patients. The most bothersome symptoms (MBS) were dryness, itching/irritation and pain during sexual intercourse,” said Aino Fianu Jonasson, Associate professor in urogynecology at the department of obstetrics and gynecology at Karolinska University Hospital Huddinge and principal investigator of the study. “I see the gel as an alternative to prescription products for women who suffer from vaginal dryness, and who do not want to, or cannot, use estrogen.”
“This is a fantastic opportunity for Peptonic Medical. By launching a non-prescription product we will be able to reach the entire vaginal atrophy market – and moreover reach it much faster than through a drug registration process,” said Johan Inborr, CEO of Peptonic Medical. “Furthermore, our product has unique clinical documentation in terms of treatment efficacy, which will give us a clear competitive advantage in marketing.”
The Board estimates that CE marking for the gel can be obtained within a year and expects the product to be launched in the Nordic region in 2018. The company is planning to manage marketing and distribution of the product in the Nordic region in-house, while collaborating with partners of these activities in other countries. The Nordic market for topical vaginal atrophy products, most of which are estrogen-based, is estimated at SEK 700 million.
In parallel with the application for CE marking, the requirements for obtaining the equivalent certification in the USA are being evaluated.
The Board of Peptonic Medical has also decided to continue an investigation of the unexpected results of the phase 2b clinical study. These efforts aim to find an explanation for the lack of effect of the oxytocin, and also to evaluate different options for developing an oxytocin-based product going forward.
As previously announced, an information meeting for the shareholders was held April 11, at which, the CEO, Johan Inborr, announced that the Board intends to submit a proposal for a rights issue, subject to the shareholders’ approval at the Annual General Meeting (AGM) b on May 18, 2017. The proceeds of the rights issue will be used to finance the development and market launch of the vaginal gel as a non-prescription, CE-marked product.
The Board will present a detailed proposal well in advance of the AGM. Johan Inborr’s presentation from the information meeting is available on the Company’s website:
www.peptonicmedical.se/presentation-fran-informationsmote-den-114/
For more information, please contact;
Johan Inborr, CEO
Mobile: +46 708 853 893
E-mail: johan.inborr@peptonicmedical.se
This information is information that Peptonic Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 19th April 2017.
About PEPTONIC medical AB
Peptonic Medical AB (publ) is an innovative Swedish biopharma company developing products within the field of women’s health. The Company was founded in 2009 and its first candidate drug product is Vagitocin® – an estrogen-free product for the treatment of vaginal atrophy.
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