Seed Innov Regulatory News (SEED)

09 May 2023 

SEED Innovations Limited

("SEED" or the "Company")

Investee Company Update: Little Green Pharma Ltd

SEED Innovations Ltd, the AIM-quoted company investing in fast-growing and industry-leading businesses with a focus on the medical cannabis, health, and wellness space, is pleased to note an announcement released on the ASX by its portfolio company, Little Green Pharma Ltd ('LGP')

The Company owns 7,324,796 ordinary shares in LGP representing 2.45% of LGP's issued share capital. 

The following extract from the announcement is set out without material changes or adjustments and the announcement in full can be accessed from the following link: https://investor.littlegreenpharma.com/site/content/

LGP wins extended French government tender

Highlights:

· LGP appointed a primary CBD oil manufacturer for third year of extended national French medicinal cannabis Trial

· Reaffirms LGP's commitment to one of the largest EU markets critical to LGP's EU strategy, which portfolio includes Germany, the UK, Denmark, Poland, and Italy

· Provides Company with significant first mover advantage in future French market and cements LGP's reputation as a key and reliable medicinal cannabisproduct supplier across France

· Company to obtain unique insight and influence over development of future medicinal cannabis statutory framework in France including reimbursement status

· Continued Trial participation consistent with Company's long-term growth strategy and prior Trial investment as well as supplying much needed medication to patients 

· Trial has reported consistently positive clinical results to date, with continuing success anticipated to catalyse legalisation of a French medicinal cannabis Total Addressable Market of up to €5.6 billion

· Gives LGP a rare first mover opportunity to capitalise on one of the largest potential medicinal cannabis markets in Europe

Little Green Pharma Ltd (ASX: LGP, "LGP" or the "Company") is pleased to announce its re-appointment as a primary supplier of its 1:20 THC:CBD medicinal cannabis oil to the extended French national medicinal cannabis trial ("Trial") in partnership with leading French pharmaceutical distributor IntselChimosand its manufacturing partner, Centre Lab ("Partnership").

The Trial has already shown consistently beneficial clinical outcomes over its first two years, with 91% of the current 1,453 patients reporting positive results and various expert reports on the Trial interim results all providing positive feedback[1].To date, the Company has supplied its 1:20 THC:CBD and CBD50 oils to patients in the Trial, and as the majority supplier of the Trial during this period the Company has become a well-recognised supplier in the French market and has a strong relationship with French pharmaceutical regulators.

Following the Trial's initial success, in September 2022 the French government announced it proposed to extend the Trial for a third year, until March 2024[2]. The terms of the extended Trial tender are substantially similar to the original Trial terms[3] save that the suppliers will now also be compensated with €14 per unit during the extended period. The Company also tendered and has also been awarded on the basis that its total supply obligation is capped at ~11,000 units.

The Trial is conducted across France and LGP is the only supplier to have provided both ratios of CBD dominant products, with 85% of the 3,000 Trial patients having started their Trial with an LGP product, and with participating prescribers trained specifically in prescribing LGP products.

As the majority supplier to the Trial to date, LGP's continued participation allows the Company to capitalise on its historic investment while cementing its reputation among French regulators, prescribers and patients as a longstanding and trusted supplier of medicinal cannabis products, as well as providing access to the supply and dispensing pathways in France.

LGP's role as an ongoing supplier to the Trial will also consolidate the Company's significant first mover advantage in a future French medicinal cannabis market, as well as giving the Company unique insight and influence over the development of a future medicinal cannabis statutory and economic framework in France, including its reimbursement status.

The resulting Trial study will comprise one of the largest European data collections on cannabis, with the success of the Trial already generating calls by patient associations for the legalisation of medicinal cannabis as soon as possible.

LGP's partners in the Trial comprise Intsel Chimos, a French pharmaceutical company and recognised hospital distributor with a track record of more than 50 years in the space and specialising in the importation and distribution of medicines (including narcotics) to French hospitals and dispensaries;and Centre Lab, a pharmaceutical manufacturer who works closely with IntselChimosin France. Under the Partnership, LGP will manufacture and supply its medicines into France while IntselChimosand Centre Lab will undertake batch-release, distribution, medical information, and pharmacovigilance obligations to the Trial. LGP believes working with a longstanding local French distributor provides the Partnership with unique insights into the French pharmaceutical market. The Partnership will also share the costs of manufacturing the extended Trial product equally between them.

The Company has also separately submitted a bid to supply its CBD 50 oil product for the extended Trial period, which tender has now closed and is being assessed for award. Under these tender terms, bidders are permitted to bid commercial prices up to a cap of up to €1 million for the equivalent of 22,500 bottles of LGP's CBD 50 (50ml) medicinal cannabis oil.

LGP believes its success in the Trial continues to confirm the advantages of developing a robust, export-led sales strategy as well as its status as a significant global exporter of medicinal cannabis. With a potential Total Addressable Market of $5.6 billion[4], if legalised in France LGP believes the limited number of Trial suppliers will give LGP a rare first mover opportunity to capitalise on one of the largest potential medicinal cannabis markets in Europe.

End of Little Green Pharma Ltd announcement: 

- Ends -

For further information on the Company please visit: www.seedinnovations.co or contact: 

Notes 

Seed Innovations Ltd 

SEED Innovations is an AIM quoted investment company focused primarily on disruptive high growth life sciences and technology businesses particularly within the medical cannabis arena. The Company's strategy is to identify early-stage opportunities that have an upcoming investment catalyst and grow its portfolio in terms of value whilst limiting the number of investee companies to a level where relevant time can be devoted to each. 

About Little Green Pharma 

Little Green Pharma is a global, vertically integrated and geographically diverse medicinal cannabis business with operations from cultivation and production through to manufacturing and distribution. 

The Company has two global production sites for the manufacture of its own-branded and white-label ranges of GMP-grade medicinal cannabis products, being a 21,500m2 cultivation and 4,000m2 GMP manufacturing facility capable of producing over 30 tonnes of medicinal cannabis biomass per annum located in Denmark (EU) and an indoor cultivation and manufacturing facility located in Western Australia capable of producing ~3 tonnes of medicinal cannabis biomass per annum. 

Little Green Pharma products comply with all required Danish Medicines Agency and Therapeutic Goods Administration regulations and testing requirements. With a growing range of products containing differing ratios of active ingredients, Little Green Pharma supplies medical-grade cannabis products to Australian, European and overseas markets. 

The Company has a strong focus on patient access in the emerging global medicinal cannabis market and is actively engaged in promoting education and outreach programs, as well as participating in clinical investigations and research projects to develop innovative new delivery systems.