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Double Bond Pharmaceutical strengthens the team

Double Bond Pharmaceutical has employed Alisha Gupta, MSc in Biomedicine, to strengthen the team for clinical development of their products. Alisha has recently completed her studies and has already been intensively engaged in entrepreneurship and research and has done an internship in Boston to deepen her knowledge in biomedicine. "We are looking forward to an intensified work load in our clinical development next year, and are very pleased to expand the team with even more creativity, knowledge, innovation and new energy." - commented Igor Lokot, CEO of Double Bond Pharmaceutical.

DBP's first purchase order from Closter Pharma

As previously announced, Double Bond Pharmaceutical and CLOSTER PHARMA SAS (Colombia) signed a distribution agreement for Temodex in Mexico, Brazil, Colombia, Peru, Ecuador and Costa Rica in September 2018. At the beginning of November, Double Bond Pharmaceutical and Closter Pharma organized an exchange of experience where eight doctors from leading hospitals in Colombia were able to meet and exchange experience with developers, manufacturers and users of Temodex in Minsk, Belarus. For three days, they had the opportunity to be with their Belarussian colleagues and see with their own eyes

DBP launches a new website

Double Bond Pharmaceutical has now launched a new, more modern website where staff members themselves appear in front of the camera. "We are a modern and innovative company that invites everyone to follow us in our daily lives and thought that the website should reflect this. - Igor Lokot, CEO of Double Bond Pharmaceutical comments, "Communication with the outside world is important to us, and the website is the first source of information for many new partners, customers and investors. We are proud to be consequent and show who we are."

Iulia Karlsson appointed new CEO of FarmPharma

An extraordinary board meeting of DBP's subsidiary FarmPharma AB, which took place yesterday at 14:00 CET at the company's office in Uppsala, elected Dr Iulia Karlsson to be the new CEO of the company. Igor Lokot, former CEO of FarmPharma, became chairman of the board and the number of board members increased to four. "Fast and efficient development of FarmPharma requires a lot of commitment and energy, as well as creative innovation, I am therefore very pleased that Dr Iulia Karlsson is the new CEO of the company", - commented Igor Lokot, CEO of Double Bond Pharmaceutical and Chairman

Clinical trial of Inofer: half of the patients already recruited

The tenth patient of twenty has now been recruited for the clinical study of the iron tablets Inofer, which Drugsson AB (subsidiary of Double Bond Pharmaceutical) has the rights to in Sweden, Norway, Denmark and Finland. This means that the study is proceeding according to plan. The clinical trial of Inofer was approved as previously reported, by the Swedish Medical Products Agency and the Ethical vetting board on 20 June, commencing on October 4 when the first patient received treatment with Inofer tablets. The study is conducted at Skellefteå Hospital and is led by chief physician Kurt

DBP gets free Protocol Assistance from EMA for SI-053

Double Bond Pharmaceutical has submitted an application to EMA for scientific advice, known as Protocol Assistance, for SI-053. The assistance will be given during a pre-submission meeting, where DBP is able to get advice on issues and plans that exist for SI-053 before the more formal procedure starts. The assistance is free of charge since the product has orphan drug status, and is expected to be completed in March 2019. Double Bond Pharmaceuticals goal is to then start the clinical trial with SI-053 as soon as possible. “The possibility to consult the agency to discuss the development

Patent protecting Temodex and SI053 covering the Eurasian market has been granted

The institution of Physical and Chemical Problems´ (Minsk) patent application, which protects Temodex and SI053 has been granted by the Eurasian Patent Organization (EAPO). The patent approval provides protection for the products on the Eurasia market at least through 2036. The Eurasian patent is a part of a patent family filed in collaboration with Double Bond Pharmaceutical. The international patent application protecting SI053 received a positive Written Opinion during the international phase, and has just entered the national phase in US, EP, Asia, and other countries of interest. "I

Double Bond Pharmaceutical and Closter Pharma perform experience exchange

In week 44, i.e during 29/10 – 2/11, eight doctors from leading hospitals in Colombia will meet and exchange experiences with developers, manufacturers and users of Temodex in Belarus. During three days, they have the opportunity to be with their Belarussian colleagues and see with their own eyes how Temodex is manufactured and used on site. "It is gratifying to meet the enthusiasm of our colleagues from Colombia and see their zeal to learn more about Temodex" -commented Igor Lokot, CEO of Double Bond Pharmaceutical. "I am proud to be part of introducing our innovative product in Latin

Clinical trial of Inofer has started

Uppsala 2018-10-05The clinical study for the iron tablets Inofer, which Drugsson AB (subsidiary of Double Bond Pharmaceutical) has the rights for in Sweden, Norway, Denmark and Finland has now begun. A clinical trial of Inofer was approved, as previously reported, by the Swedish Medical Products Agency and the Ethical Vetting Board on June 20th and yesterday, 4thof September, the first patient received treatment with Inofer tablets. The study is conducted at Skellefteå lasarett and is headed by chief physician Kurt Boman, senior professor at Umeå University. "We hope the study will

The preclinical development program of SI-053 is complete

The results of the two remaining preclinical studies are now available. The toxicological studies on SI053 and its formulation showed expected results. The study on the excipient was a long-term studyto confirm the safety of the hydrogel in the brain. Neither neurological side effects nor any effects onblood cells were noted. There were no serious adverse events in the GLP-toxicity study of SI-053. The effects noted were dueto the active pharmaceutical ingredient temozolomide, such as an effect on blood cells which wasexpected. Thus, the overall results of the GLP-tox study

Double Bond Pharmaceutical about to sell Temodex in Latin America

Double Bond Pharmaceutical and CLOSTER PHARMA S.A.S (Colombia) have signed a distribution agreement for Temodex in Mexico, Brazil, Colombia, Peru, Ecuador and Costa Rica. The distribution will be carried out by Double Bond Pharmaceuticals wholly owned subsidiary Drugsson AB. Temodex will be registered in respective countries and/or sold by licence. "There is a lot of interest in Temodex in different parts of the world, and we are pleased that we can provide doctors of brain cancer patients with our innovative product," commented Igor Lokot, CEO of Double Bond Pharmaceutical, "Latin

The new issue of shares in FarmPharma via FundedByMe is closed

Today, 26 september the Board of FarmPharma AB, a wholly-owned subsidiary of Double Bond Pharmaceutical, has closed the new issue via FundedByMe. 83 investors participated in the rights issue which brought 770 000 SEK. 77 001 new shares in FarmPharma were issued. Upon registration total number of shares in FarmPharma AB will be 1 077 001 and total share capital will amount to sek 53 850,05. "I am pleased to welcome new shareholders to FarmPharma, but also grateful that our existing DBP shareholders have shown us continued confidence by becoming the main owner of FarmPharma," commented

Article about MGMT study accepted for publication in Neoplasma

A scientific article on Double Bond Pharmaceutical's investigation into how MGMT status affects the effectiveness of treatment with Temodex has been accepted for publication in the journal Neoplasma."The information from the survey provides important understanding into the therapeutic value of Temodex, and we are pleased to publish our findings about Temodex and MGMT in a high-quality scientific journal. Thanks to close cooperation with all involved parties we have been able to accomplish this very quickly. ", - says Igor Lokot, CEO of Double Bond Pharmaceutical. "This survey confirms

Double Bond Pharmaceutical and NIHR signed an agreement for Study Support

Double Bond Pharmaceutical (DBP) and The National Institute for Health Research (NIHR) in the UK have signed an agreement for support with an investigation of rapid study set-up and patient recruitment. The investigation will cover all phases of clinical studies in the UK for DBP project SI053 and include the whole range of services from reviewing protocols, site intelligence and site identification to study set-up and monitoring the performance of the sites. This Study Support Service provided by the National Institute for Health Research is free of charge. “United Kingdom is known for

Double Bond Pharmaceutical pushes start date of Belopenem project forward to October 1st

Double Bond Pharmaceuticals Eurostar project Belopenem will start already October 1, 2018 instead of previously announced November 1, 2018. The project is a collaboration with, amongst others, Karolinska Institutet and SME from France, where Double Bond Pharmaceutical will act as leader as the project's largest participant. "We are eager to develop the BeloGal® platform for new products and are therefore very pleased that we can start work earlier than planned", commented Igor Lokot, CEO of Double Bond Pharmaceutical. More about the Belopenem project: https://mb.cision.com/Main/12720/

In-use stability for SI-053 is ensured

Double Bond Pharmaceutical reports that a European GMP-certified contract manufacturer has examined the highest dose of the SI-053 formulation, the results show that the formulation is stable over time (8 hours). "Formulation stability is quite often a challenge in drug delivery system products and we are happy for this success" - commented Sayeh Erfan, CMC, Operations & Quality Specialist at DBP. "With this study, we have now technically shown a product stability during use in a Phase 1 clinical trial, which is one of the most important milestones in product development" - commented

Successful crowd funding by FarmPharma via FundedByMe

On June 20 this year, FarmPharma AB started a crowd funding campaign to bring together funding for the company's further development. Today, 100% of the minimum target has been achieved and more than 50 investors have chosen to invest their money in FarmPharma's future. The campaign ends at 23:59 on 18/9 2018, or when the maximum funding target is reached. "We are very pleased that FarmPharma has attracted so much interest among investors," commented Igor Lokot, CEO of Double Bond Pharmaceutical and FarmPharma, but it is still about 20 days left of the campaign and now we are working

DBP has signed an agreement of scientific and technical partnership with the Biochemistry cluster of ITMO University

Double Bond Pharmaceutical and the Biochemistry cluster SCAMT of ITMO University (St Petersburg, Russian Federation) have signed an agreement of scientific and technical partnership. “Reverse Innovation is an important part of our business strategy and competitive advantage, - comments Igor Lokot, CEO. – We are happy to broaden our partnership network with another experienced team for the efficient development of both novel and ongoing projects”. More about the Biochemistry cluster SCAMT of ITMO University: https://scamt.ifmo.ru/ This information is information that Double Bond

DBP has signed an agreement with Apotek365 for the sale of Pileseptin and HalsEze

Double Bond Pharmaceuticals subsidiary Drugsson and the online pharmacy Apotek365 has signed an agreement to sell HalsEze and Pileseptin. "Another pharmacy shows interest in the products, and we are happy for the collaboration with Apotek365," commented Igor Lokot, CEO of Double Bond Pharma and Drugsson AB. More about Apotek365: www.apotek365.se More about HalsEze och Pileseptin: www.drugsson.com This information is information that Double Bond Pharmaceutical International AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for

Double Bond Pharmaceutical manufactures first GMP batch of SI053

Double Bond Pharmaceuticals contract manufacturer of SI053 reports that they have successfully manufactured the first GMP batch. The batch is to be used among other things for the stability study for SI053. “There is a lot of work behind this batch and we are very pleased to be able to start the stability study according to plan” says Charlotte Karlsson, Quality Assurance Manager and coordinator of the manufacturing projects. “Getting a material for future clinical trials is an important milestone in the drug development process” commented Igor Lokot, CEO of Double Bond Pharmaceutical.

Double Bond Pharmaceutical receives patent in the United States for the BeloGal® platform

Double Bond Pharmaceuticals patent application for organ-specific administration of hydrophilic cancer drug to the liver which forms the basis for the BeloGal® technology platform has been granted in the United States. Patent approval provides protection for the technology platform BeloGal® and products on the US market at least through 2035. "It is the company's first licensed patent and we are very pleased that it concerns the largest market in the world - the United States. With the patent, we have achieved an important interim goal for the commercialization of our front-line product

The sterilization process for Temozolomide is secured

Double Bond Pharmaceutical reports that technology transfer of the sterilization process for Temozolomide in SI-053 has been conducted with satisfactory results. The process has been carried out by a company specializing in sterilization services located within the EU. The company has previously reported a successful technology transfer of the sterilization process for the SI-053 excipient in a European GMP-certified environment. This means that the sterilization process for SI-053 has been established and the product can now be manufactured for clinical trials. "This is a vital

Double Bond Pharmaceutical has been granted Eurostars funding for development a new product for treatment of pneumonia

A consortium consisted of Double Bond Pharmaceutical together with Karolinska Institute and international partnering SMEs from France has been granted a Eurostars funding. The project has a work name Belopenem and will be focused on developing a novel antibiotic formulation that targets the lung after a simple i.v. injection. The aim of the project is thus to develop a novel and more effective treatment of pneumonia based on Double Bond Pharmaceutical's drug-delivery technology BeloGal®. The project will be conducted for 2 years with the start in November 2018 and result in a fully

Sterilization process for the excipient in SI-053 secured

Double Bond Pharmaceutical reports that transfer of the sterilization process for the excipient in SI-053 has been completed with satisfactory results. The process has been performed by a contract sterilization company in the EU. “This is an important step in the technology transfer process before manufacturing a GMP batch for our upcoming clinical trial” says Igor Lokot, CEO at Double Bond Pharmaceutical. This information is information that Double Bond Pharmaceutical International AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted

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