Tuesday 5 May 2020
Here is our summary of the day's hottest RNS alerts from across London's Alternative Investments Market (AIM).
Optibiotix Health Plc (OPTI.L)
Distribution of products in China and Hong Kong
OptiBiotix Health plc, a life sciences business developing compounds to tackle obesity, cardiovascular disease and diabetes, announced it has entered into a three-year distribution agreement with Pierce Group Asia subsidiary, Pierce ESIM Pte Limited.
Founded in 2002 and headquartered in Singapore, Pierce specialises in cross border corporate development and investments with a focus on high growth partnerships. Pierce is an Asian focused B2B product developer and distributor with an experienced leadership team and extensive corporate network.
The agreement grants Pierce exclusive rights to import and commercialise OptiBiotix's SlimBiome® and LPLDL® to manufacture, develop, and sell a wide range of finished products to China and Hong Kong, with the aim of maximising the financial return for both parties. Under the agreement, Pierce will also conduct business development activities in other Asia-Pacific geographies to advance OptiBiotix's commercial interests. Market exclusivity is linked to minimum yearly order quantities.
This agreement is an important step in meeting the growing need for weight management and cardiovascular products in the large consumer markets of China and the Asia Pacific.
China has the largest number of overweight or obese people worldwide with about 46% of adults and 15% of children being obese or overweight (Wang, Y. Lancet 2019)
Non-communicable diseases account for 87% of total adult deaths in China of which cardiovascular diseases ("CVD") account for almost half (45%)
China has one of the highest CVD death rates in the world with one in five adults in China estimated to have cardiovascular disease
The Chinese Vitamins, Minerals & Supplements industry increased 9.2% between 2017 and 2018 to reach a total market size of US$21 billion.
This agreement represents another strategic step to take OptiBiotix's SlimBiome® and LPLDL® to international markets and follows on from the announcement of over 60 commercial agreements in the last three years. These include deals for Gulf Cooperation Countries (RNS: 17 March 2020); Australasia (RNS: 31 March 2020); Europe including Italy (RNS 21 June 2018) , Germany (RNS 15 March 2019), Russia (RNS: 9 January 2019); India (RNS: 16 May 2018 and 7 January 2019); South America (RNS: 12 February 2020) and the USA (RNS: 22 May 2018 and 31 January 2020).
Faron Pharmaceuticals (FARN.L)
Clevegen manufacturing agreement
Faron Pharmaceuticals Oy, the clinical stage biopharmaceutical company, announced today that global contract development and manufacturing organisation AGC Biologics has been selected to be the commercial scale manufacturer of Clevegen, Faron's wholly-owned novel precision cancer immunotherapy targeting Clever-1 positive tumour associated macrophages (TAMs) in selected metastatic or inoperable solid tumours.
The recent clinical progress with Clevegen and recommendations from the data monitoring committee of the ongoing phase I/II MATINS study to expand Clevegen's development across nine different cancer types indicate a requirement for increased Clevegen drug substance. The commercial scale manufacturing process established by AGC Biologics will also provide a dossier to support future regulatory filings in Europe and the US. Faron believes that AGC Biologics, with its regulatory knowledge on commercial scale production, global state-of-the art facilities spanning three continents and multiple cGMP (current good manufacturing practices) manufacturing lines at a variety of scales for mammalian cell culture allows for capacity and technological flexibility to meet the Company's needs. AGC Biologics has decades of experience in manufacturing of biotechnological products, including commercial market supplies of FDA, PDMA and EMA approved products.
For full RNS details, see: https://www.investegate.co.uk/faron-pharma--oy/rns/clevegen-manufacturing-agreement/202005050700068814L/
Sensyne Health Plc (SENS.L)
Sensyne Health launches BPm-Health product
Sensyne Health plc, the UK Clinical AI technology company, today announces it has launched BPm-Health to help pregnant women monitor blood pressure remotely in response to the UK government guidelines for all pregnant women to follow stringent social distancing and minimise face-to-face contact.
BPm-Health will be offered free to the NHS for one year to support hospital maternity services during the coronavirus pandemic. The formal launch of the product comes after the successful completion of recruitment of a 3000 participant multicentre trial (BuMP) involving 15 NHS Trusts, led by the Nuffield Department of Primary Care Health Sciences, University of Oxford. The BuMP app was transferred to Sensyne Health earlier this year and re-engineered under the company's Quality Management System.
BPm-Health is one of three apps listed by the Royal College of Obstetricians and Gynecologists (RCOG) in its recent guidance 'Self-monitoring of blood pressure in pregnancy'  .
The announcement follows the high interest and uptake by the NHS of Sensyne Health's offer, announced on 27 March 2020, to provide GDm-Health, a remote monitoring system for the management of diabetes in pregnancy, free to the NHS for one year.
There has been an increasing recognition of the acceptability and benefits of self-monitoring of blood pressure during pregnancy (see references below). The COVID-19 pandemic is now increasing the need for healthcare professionals to advocate blood pressure self-monitoring in order to reduce face-to-face consultations for pregnant whilst maintaining care for the woman and her baby.
BPm-Health aims to help expectant mothers to self-monitor their blood pressure, communicating results to their healthcare team remotely rather than at face-to-face clinic appointments. Women are sent alerts when it is time to take a reading, and can then record data on the patient app. The app displays RCOG advice on what women should do dependent on the results submitted.