1. Novartis secures supply for Zolgensma
In May of this year, Novartis received a landmark approval for its spinal muscular atrophy gene therapy treatment and followed up the news with a landmark price, at $2.1m (€1.89m) per patient. Since the announcement, Novartis has revealed numerous partnership projects aimed at securing the supply of the product to patients, even down to the manner in which the product will move through the supply chain.
In July, the company, through its subsidiary AveXis, found a partner, in Catalent, for the long-term manufacture of Zolgensma (onasemnogene abeparvovec-xioi). The product will be produced by Paragon at its manufacturing center in Baltimore, US.
Looking to the future of AveXis’ pipeline, Novartis also announced a strategic partnership with BIA Separations, to work on the purification process for Zolgensma and for the rest of its investigational gene therapy pipeline.
2. Paragon has a busy month
Paragon, recently acquired by Catalent, added a further deal beyond its link-up with AveXis, through a collaboration agreement with Passage Bio. The latter is a genetic medicines company, which is aiming to progress its pipeline of gene therapies into clinic.
With this in mind, Passage entered the partnership to help build out its manufacturing capability and decided upon Paragon. Paragon will develop a manufacturing suite for clinical and commercial supply of Passage’s investigational therapies, which is expected to be operational by 2020.
3. Servier partners to advance Bio-S project
Pall Biotech will utilize its end-to-end solutions for the development and manufacture of Servier’s monoclonal antibodies (mAbs) and recombinant proteins. The solutions will be implemented at Servier’s Gidy, France facility, and will support the development of the company’s oncology drug production pipeline.
The project will work to develop therapeutic candidates from early-stage R&D to the clinic, with 2,000L bioreactor capacity added.
4. Amicus settles on a manufacturing partner
Amicus Therapeutics, a biotech working on rare metabolic diseases, will have its gene therapy programs manufactured by Brammer Bio, which was recently acquired by Thermo Fisher Scientific. The partnership will see Brammer be responsible for the clinical and commercial manufacture of Amicus’ intrathecal adeno-associated virus Batten disease gene therapy programs. Amicus has two lead programs for the disease, CLN6 and CLN3.
5. Mundipharma signs licensing deal with Singaporean biosimilar developer
Mundipharma continues the expansion of its biosimilar portfolio by agreeing with Prestige Biopharma to market Tuznue (trastuzumab) in selected European countries. Mundipharma gains the license to market the biosimilar of Roche’s Herceptin in France, Spain, Norway, Sweden, Denmark, Finland, Portugal, Switzerland and Austria. On concluding the deal, Mundipharma now distributes four biosimilars across Europe – two biosimilars to Herceptin, as well as biosimilars to Remicade (infliximab) and Mabthera (rituxumiab).