At the formulation and packaging end, Hovione Technology added momentum to packaging and delivery innovation by securing global rights to develop and commercialize a new multi-use blister-based dry powder inhaler, Papillon DPI, patented by inventor Dr. Klaus-Dieter Beller. This simple-to-use blister based inhaler promises cost-effectiveness claiming that the cost of goods per dose is competitive to that of a multi-dose inhaler but at a small fraction of the development cost. It also overcomes the risks associated with complex devices: a paradigm shift for pharmaceutical companies developing new inhaled drugs. With substantial corporate investment appetite and innovation momentum, we perceive level of strategic partnerships in inhalation to only expand in the near future.
A similar trend is also observed in the medical devices industry where high product demand is spurring business partnerships and acquisitions among packaging providers. The recent acquisition of Amcor’s three manufacturing facilities by Tekni-Plex for a value of $215 million is a strategic step in this direction to expand their portfolio for medical device manufacturers.
Another large pharma company stepped into the ring this month with Takeda announcing the partnership with Stride Bio Inc. The collaboration and licensing agreement encompasses developing in vivo AAV based therapies for Friedreich’s Ataxia (FA) and two additional undisclosed targets, utilizing novel AAV capsids developed by Stride Bio.
Equally existing are developments that reflect an evolving provider ecosystem for cell therapy companies. As pharma companies’ investment soars, both specialist service providers and bioprocess equipment and consumables companies grapple to meet the evolving demand landscape. While demand is yet to mature, it is critical for these providers to drove adoption early in the manufacturing process development to be able to participated in the future opportunity of scale. Global contract drug manufacturer Catalent announced an all-cash acquisition of Paragon Bioservices that focusses on contract development and manufacturing of gene therapies delivered via adeno-associated virus (AAV) vectors, as well as next-generation vaccines, oncology immunotherapies (oncolytic viruses), and other complex biologics. Pall Corporation also signed an industry participation agreement with New Jersey Innovation Institute (NJII) to support development of its Biopharmaceutical Innovation iLab which will advance the manufacturing of cell and gene therapies. The center will focus on addressing manufacturing process technologies and workforce development challenges faced by the industry. State-of-the-art bioreactors, continuous chromatography units, and an acoustic wave separator have been provided by Pall to NJII as part of the agreement. Pall experts will also be deployed to support the experimental program and provide training on the new equipment. Rapid portfolio shaping, engagement with upstream stakeholders in the innovation continuum and end to end capability will be key for success of bioprocess providers. With 2018 and 2019 turning out to be foundational for adoption of next generation therapies, we expect this partnership landscape to further intensify in the coming moths.
The most encouraging developments this month are on early market creation levers surfacing for the most elusive yet attractive biosimilar market thus far, the United States. Though approvals by the FDA have been forthcoming, the industry still glares at the currently unrealized possibility of an active commercial market. Early encouragement stems from Megellan Rx Management, a pharmacy benefit manager reporting that its biosimilar management program resulted in strong biosimilar uptake. In the case of infliximab biosimilar, the plan was able to achieve a 86% biosimilar use. This switch is reported to have saved health plan members 34% in drug costs for the therapy. While this data from one PBM is a great initial reason to rejoice, it is still not reflective of the broader market scenario. Return realization for several biosimilar developers and continuing corporate investments in the biosimilar segments hinges further intensified market creation efforts. As we look forward, we anticipate two triggers to paly an important catalytic role – a higher level of price driven market creation or FDA blessing through designation of interchangeability.
The foundational research roadmap was published this month in the journal Radiology. It summarizes discussions at a workshop hosted by NIH in Maryland and was co-sponsored by National Institute of Biomedical Imaging and Bioengineering, the Radiological Society of North America, the American College of Radiology, and the Academy for Radiology and Biomedical Imaging Research. In addition to emphasizing a strong collaborative commitment, it includes specific priorities such as validated methods for image de-identification and data sharing to facilitate availability of wider data sets, automated image labeling and annotation methods etc.
The cross-stakeholder engagement comes at an opportune time given the high level of innovation, funding and startup momentum in AI in medical imaging. Strong validation is noted in another funding milestone this month – $27million Series B funding raised by Aidoc, an Israel-based provider of AI solutions for radiologists. This investment will go towards expanding Aidoc’s technology and go-to-market team to support the high market demand for its products. An energetic venture landscape, support of the investor community and the latest development on cross-stakeholder convergence to foster adoption and market creation – we look forward with enthusiasm on potential disruptions at the anvil!
1. Divestiture of rapidly growing secondary pharmaceutical packaging company with strong roster of clients
2. Divestiture of midsize IVD diagnostic company (reagents & POC) in India with robust market footprint and strong product pipeline
- Packaging In Pharma Industry
“Transporting temperature-sensitive pharmaceuticals, biologics and combination products from the point of manufacture to a medical facility—and ultimately the “last mile” to the patient, requires the prevention of temperature excursions throughout the complex supply chain and that’s where packaging plays its part.”
- Pharma Packaging: Global Trends & Local Context – Powering Indian Portfolio Evolution
- Indian Pharma Sector: What Next After Gottlieb?
“Sathguru’s healthcare practice lead Pushpa Vijayaraghavan’s comments in Biospectrum on continued approval momentum and pricing pressure anticipated in regulated market generics and limited impact expected due to resignation of FDA Commissioner Scott Gottileb.”
- Packaging In Pharma Industry