Recent experience includes:
Pharmaceutical and medical devices supplier
Advising a pharmaceutical and medical devices supplier on exemptions to US sanctions for sale and supply of medical products.
Atalanta Therapeutics
Atalanta was formed to develop drugs to treat neurodegenerative diseases (such as Alzheimer's and Huntingdon's disease) through siRNA, small interfering RNA which can be use to silence gene expression and stop the progression of disease. We have advised Atalanta, a Boston-based company, in relation to the manufacturing agreement for the first of its products to enter clinical trials. The manufacturer was also US-based – the firm was instructed because of our knowledge of the market for manufacture of specialist drug products.
A viral vector contract development and manufacturing company
Our life sciences team has specialist experience in relation to the manufacture of biologics, with their increased batch sizes and value, longer production processes and the commercial issues around procuring manufacturing slots associated with the production of large molecule products. We advised on development and manufacturing supply agreements for viral vectors to deliver market-leading cell and gene therapy products as well as commercial supply arrangements for manufacturing suites. Many of these agreements are not governed by English law – we are instructed for our market knowledge.
Incyte
We advised Incyte in relation to the network of manufacturing agreements for tafasitamab, a product which it co-commercialises with MorphoSys. Drug substance is made by a number of manufacturers and then transformed into drug product. Each of the collaboration partners is responsible for separate elements of the supply-chain, which has resulted in a complex arrangements.
We have previously advised Incyte in relation to a selection of commercial and competition issues, including the procurement of equipment for the fit-out of their biologics manufacturing facility.
Celltrion
Celltrion is a manufacturer of biosimilars (generic biologics products), based in South Korea. They are also a client of our Seoul office. We have advised Celltrion in relation to various issues relating to their distribution arrangements with Pfizer for infiliximab, marketed originally under the Remicade brand and now off-patent.
Oxford Biomedica
Advised this FTSE250 gene and cell therapy company on a number of transactions including:
- §on the new three year Master Services & Development Agreement with AstraZeneca UK Ltd, which would facilitate potential future manufacturing opportunities for the AstraZeneca COVID-19 vaccine.
- a licence and supply agreement with Arcellx, Inc. for LentiVector® Platform for CAR-T Therapeutics.
- the manufacture of AZD1222, the adenoviral COVID-19 vaccine candidate developed by Oxford University and commercialised by AstraZeneca.
- a licence and clinical supply agreement with Juno Therapeutics, a Bristol-Myers Squibb company. The agreement granted Juno Therapeutics a non-exclusive licence to Oxford Biomedica’s LentiVector® platform for its application in CAR-T and TCR-T programmes in oncology and other indications, and additionally put in place a five year Clinical Supply Agreement, which may be extended further. Oxford Biomedica received an upfront payment of $10 million in cash and the agreement provides for the potential of up to an additional $86 million to be payable to Oxford Biomedica upon achievement of certain development and regulatory milestones related to multiple products and indications; up to $131 million in sales-based milestone payments and an undisclosed royalty on the net sales of products sold by Juno Therapeutics utilising the LentiVector® platform.
Sana Biotechnology
We have acted for Sana in relation to agreements for the manufacture of clinical product for their early stage portfolio, as well as in relation to the procurement of materials for manufacture.
Recipharm
Recipharm is a manufacturer of mRNA, microbiome and viral vector based products for a range of diseases. We have acted for a number of the group companies within the Recipharm group, notably Arranta Bio in relation to the creation of their template documents and the negotiation of a number of customer agreements.
