Stockholm, December 21st , 2017 – Peptonic Medical AB (publ) (’Peptonic’ or ’Company’) today announced that it has entered a tech transfer agreement with Orion Corporation, headquartered in Espoo, Finland. Under the agreement, the two companies will exchange information and collaborate to prepare for the commercial manufacture of VagiVital™ – a product that Peptonic plans to launch in 2018. In addition to the tech transfer agreement, the companies have signed a terms sheet for a final agreement regarding the commercial manufacture of VagiVital™.
– We are very pleased to have partnered with a world class player like Orion for the manufacture of VagiVital™, says Johan Inborr, CEO of Peptonic. The Orion collaboration gives to VagiVital™ the quality label that it deserves and to Peptonic the possibility for the development of additional products.
The first part of the process of obtaining the CE mark for VagiVital™, i.e. the implementation of a Quality Management System (QMS) according to ISO 13485 in Peptonic, has now been completed. The second and final part i.e. the development and approval of a so called Technical File, is well underway and is progressing according to plan. This means that the CE mark for VagiVital™ is expected during Q1 2108. Once the CE mark has been obtained, marketing and sales of VagiVital™ can commence in the EU.
For more information, please contact;
Johan Inborr, CEO
Mobile: +46 708 853 893
E-mail: [email protected]
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 21st December 2017.
Orion is a globally operating Finnish pharmaceutical company – a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. The company is continuously developing new drugs and treatment methods. The core therapy areas of Orion's pharmaceutical R&D are central nervous system (CNS) disorders, oncology and respiratory for which Orion developes inhaled Easyhaler® pulmonary drugs. Orion's net sales in 2016 amounted to EUR 1,074 million and the company had about 3,500 employees. Orion's A and B shares are listed on Nasdaq Helsinki. Founded in 1917, Orion celebrates its centennial anniversary in 2017.
For more information: www.orion.fi/en
About Peptonic Medical
PEPTONIC Medical is an innovative Swedish development company. Our vision is to offer safe and effective treatments for women suffering from vaginal atrophy during menopause and after.
VagiVital™ is a trademark of PEPTONIC Medical. The product is hormone free and is being commercialised for the non-prescription use for the treatment of vaginal atrophy.
The pipeline of PEPTONIC Medical also includes Vagitocin®, which is an oxytocin-based vaginal gel for the treatment of VA. This product candidate is in clinical development phase 2. The development of Vagitocin® is on hold pending additional data on i.a. the mechanism of action.
In July 2014, PEPTONIC Medical was listed on the AktieTorget stock exchange ( www.aktietorget.se , ticker: PMED) in Stockholm.
For more information: www.peptonicmedical.com
About VagiVital ™
VagiVital™ is a hormone free self-care product for the treatment of vaginal atrophy and vaginal dryness. The product has been tested in randomised clinical studies (vaginal atrophy) with very positive results both for objective (vaginal pH and proportion of superficial cells in the vaginal mucosa) and subjective (most bothersome symptoms, such as vaginal dryness, vaginal irritation/itching, dyspareunia and dysuria) parameters. The magnitude of symptom relief is on par with that demonstrated with e.g. estrogen based products on the market today. It was very well tolerated and caused no serious adverse effects.
PEPTONIC Medical plans to launch VagiVital™ as a non-prescription self-care product in 2018.
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