truda (pembrolizumab). Moderna will also utilize the upfront
payment to fund a portion of the build-out of a GMP manufacturing facility in suburban Boston for the purpose of personalized
cancer vaccine manufacturing.
In June 2016 Merck bought the clinical-stage biotech Afferent
Pharmaceuticals in a deal worth up to $1.25 billion. The move
gave Merck access to Afferent’s lead investigational candidate
AF-219 for chronic cough treatment. Merck purchased all outstanding shares of Afferent for an upfront fee of $500 million, and
could pay an extra $750 million linked to certain clinical development and commercial milestones.
AF-219 is a selective, non-narcotic, orally-administered P2X3
antagonist currently being evaluated in a Phase IIb clinical trial for
the treatment of refractory, chronic cough, as well as in a Phase II
clinical trial in idiopathic pulmonary fibrosis (IPF) with cough.
P2X3 receptors are believed to play a key role in the sensitization of certain sensory nerves, which become activated under
pathological conditions mediated by a common cellular signal,
ATP, when it is released in high concentrations due to cellular
distress following injury or infection. Afferent’s compounds are
designed to selectively block ATP activation of P2X3 channels,
potentially reducing a range of sensory signs and symptoms.
Merck also acquired IOmet Pharma, bolstering its preclinical immuno-oncology pipeline. The UK-based drug discovery
company is focused on cancer immunotherapy and cancer metabolism. Merck gained its preclinical pipeline of IDO (indole-
amine-2,3-dioxygenase 1), TDO (tryptophan-2,3-dioxygenase),
and dual-acting IDO/TDO inhibitors. IOmet became a wholly
owned subsidiary of Merck.
Also of note, in March 2016, after 20 years, Merck and Sanofi
Pasteur ended their joint vaccines operations in Europe. After
concluding their joint venture, both companies said the plan was
to integrate their respective European vaccine businesses into
their operations, independently manage their product portfolios
and pursue separate growth strategies in Europe.
The joint venture Sanofi Pasteur MSD, owned on a 50/50 basis, was created in 1994 to develop and commercialize vaccines
from both companies’ pipelines in 19 European countries. Numerous vaccines from Sanofi and MSD’s development pipelines
were launched, addressing key unmet medical needs. While the
joint venture was successful over the past two decades from a
public health and commercial perspective, the companies said
that after considering their individual strategic priorities, alongside the economic and regulatory environments for vaccine operations in the EU, it was best to manage their respective vaccine
product portfolios independently. CP