Drug delivery is important not only for ensuring bioavailability for therapeutic benefit but also for product differentiation and market success. DCAT Value Chain Insights highlights technology advances in drug delivery for injectable and solid-dosage drugs and other products from recent start-ups, partnering deals, and mergers and acquisitions.

Mergers and acquisitions

Vectura Group. The Vectura Group, a Chippenham, UK-based provider of inhaled drug-delivery services, became an acquisition target of two companies in 2021: the private-equity firm, The Carlyle Group, and Philip Morris International (PMI), a cigarette and tobacco manufacturing company. Last month (July 2021), PMI reached an agreement with the board of Vectura Group on the terms of an all-cash, recommended offer to acquire Vectura for an enterprise value of £852 million ($1.2 billion). The agreement followed an earlier offer for Vectura in May (May 2021) from Murano Bidco Limited, indirectly controlled by funds managed by The Carlyle Group. Both companies were asked to submit their final offers for Vectura this week (August 10, 2021) setting up a possible bidding war for the company. 

For PMI, the acquisition is part of the company’s “Beyond Nicotine” strategy, announced in February (February 2021), which set a goal to generate more than 50% of total net revenues (at least $1 billion) from smoke-free products by 2025. The proposed acquisition of Vectura seeks to leverage PMI’s expertise in inhalation and aerosolization into adjacent areas, including respiratory drug delivery and selfcare wellness.

Pharmathen. Last month (July 2021), Partners Group, a private markets firm, agreed to acquire Pharmathen, a CDMO of drug-delivery technologies for complex generics, from the investment firm, BC Partners, which valued Pharmathen at an enterprise value of approximately EUR 1.6 billion ($1.88 billion). Pharmathen specializes in sustained-release drug delivery for long-acting injectables, slow-releasing oral medicines, and ophthalmics.

Partnering

Nanoform. Nanoform, a Helsinki-headquartered company providing nanoparticle formulation and technology services, made several important deals thus far in 2021. The company applies its nanoparticle technology to both small and large molecules with a focus on resolving issues in drug solubility and bioavailability.

Earlier this month (August 2021), Nanoform and Boehringer Ingelheim (BI) executed a master services agreement to initiate projects in preclinical/early development for solving the challenge of poor bioavailability and solubility in new drug candidates. The companies will apply Nanoform’s proprietary Controlled Expansion of Supercritical Solutions (CESS) technology, which enables small-molecule active pharmaceutical ingredient (API) nanoparticles directly from solution.

In May (May 2021), the company formed a collaboration with Celanese, a chemical and excipient producer, to combine its nanoparticle technology with Celanese’s ethylene-vinyl acetate copolymer delivery technology for drug-eluting implants. The aim of the collaboration is develop drug-delivery devices that support increased drug load with enhanced sustained-release properties.

In the emerging field of three-dimensional printing (3DP) for pharmaceuticals, in April (April 2021), Nanoform and Aprecia, a Blue Ash, Ohio-based pharmaceutical company applying 3DP, formed a collaboration to explore the potential of nanoparticle-enabled 3DP dosage forms. Aprecia was the first company to gain approval for a drug made by 3DP by the US Food and Drug Administration (FDA): Spritam (levetiracetam), an oral drug for treating seizures caused by epilepsy. The drug was approved by the FDA in 2015 and was made using Aprecia’s proprietary ZipDose fast-melt technology platform, which uses 3DP-D to produce a porous formulation that rapidly disintegrates with a sip of liquid. While 3DP had been used previously to manufacture medical devices, the approval marked the first time a drug product manufactured using 3DP technology was approved by the FDA.

i2O Therapeutics. Earlier this year (March 2021), i2O Therapeutics, a Boston-based company with a platform for oral delivery of traditionally injectable biological drugs by using ionic liquid technology, formed a research collaboration with Sanofi to investigate the oral delivery of Sanofi’s Nanobody-based medicines, which are currently administered through intravenous or subcutaneous injections. Nanobodies are proprietary therapeutic proteins based on camelid-derived immunoglobulin single variable domains. Sanofi gained its position in Nanobodies through its $4.8-billion acquisition of Ablynx, a Ghent, Belgium-based bio/pharmaceutical company in 2018. Sanofi and i2O Therapeutics will explore a new oral route of administering Nanobodies. i2O Therapeutics announced seed funding in April 2020, which was led by Sanofi Ventures, the corporate venture capital arm of Sanofi, and the JDRF T1D Fund, a venture capital and philanthropy fund focused on Type I diabetes. The company also announced a strategic investment from Colorcon Ventures, the corporate venture capital fund of Colorcon, an excipient manufacturer, in December 2020.

BioMed X. Earlier this year (January 2021), BioMed X, a German research institute, formed a research project with Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to discover novel transport mechanisms in the human intestinal tract that could be utilized for oral delivery of diverse therapeutic modalities, including biologics. Earlier this month (August 2021), the companies formed a research project team, Translocation of Complex Macromolecules Across the Intestinal Epithelial Barrier, to discover novel transport mechanisms in the human intestinal tract that could be used for oral delivery of various macromolar therapeutic modalities

Symvivo. Symvivo, a clinical-stage biotechnology company advancing a proprietary gene-delivery platform, formed a research collaboration with Merck & Co. earlier this year (2021) to provide Merck with an option to take an exclusive license to Symvivo’s bacTRL platform technology for use in advancing delivery of oral vaccines.

Start-ups

InnarisBio. Last month (July 2021), atai Life Sciences, a Berlin, Germany-based clinical-stage bio/pharmaceutical company focused on mental health disorders, and UniQuest, a technology-transfer company commercializing the research of the University of Queensland in Australia, launched InnarisBio, a new company developing sol-gel intranasal drug-delivery technology for therapeutics for mental health disorders to address the problem of overcoming the blood–brain barrier in drug delivery. The sol-gel technology is designed to deliver pharmaceutical compounds as a liquid at room temperature that becomes a gel at body temperature via direct nose-to-brain delivery. In June (June 2021), atai launched an initial public offering of itself with the aim of raising $225 million.

New strategy/management

Reform Biologics. ReForm Biologics is a Woburn, Massachusetts-based bio/pharmaceutical company founded in 2014 to advance a technology platform to enable the subcutaneous dosing of biologics for injectable drugs by identifying and designing excipients that improve viscosity and stability in drug formulations for its internal pipeline and for partnering with other companies. Last month (July 2021), the company named Jim Sherblom, founder of the Massachusetts Biotechnology Council and former Senior Vice President and Chief Financial Officer of Genzyme Corporation, as Executive Chairman. He had earlier joined ReForm as Chairman to lead the company’s strategy to develop a bio-innovative medicine pipeline to convert hospital-based intravenous dosing to subcutaneous injections on an outpatient basis. The company’s technical position is to manage therapeutic viscosity to reduce injection volumes and fluid injection force, thereby enhancing given therapeutics, including those for pediatric applications.