This week, the FDA granted emergency authorization to booster shots of
Pfizer
PFE
/BioNTech’s COVID-19 vaccine for use in children 5 to 11 years of age and also approved
Lilly
’s
LLY
novel diabetes treatment, Mounjaro (tirzepatide) injection.
AbbVie
ABBV
and
AstraZeneca
AZN
announced new licensing deals with small private biotechs.
Recap of the Week’s Most Important Stories
FDA Approves Lilly’s Novel Diabetes Treatment
: The FDA approved Lilly’s
dual GIP and GLP-1 receptor agonist
, Mounjaro (tirzepatide) injection for treating type II diabetes. Mounjaro is a novel diabetes treatment, which has shown impressive blood sugar reductions and weight loss in a broad range of type II diabetes patients in the SURPASS studies. Mounjaro will be available in six doses as an auto-injector pen. It is expected to be launched in the United States in the next few weeks.
FDA Gives Emergency Nod to Pfizer’s COVID Jab for Kids 5-11:
The FDA granted emergency use authorization (EUA) to a booster/third dose of Pfizer/BioNTech’s mRNA-based COVID-19 vaccine, Comirnaty
for children aged between 5 years and 11 years
. The expanded EUA to include a booster dose for children was based on data from a phase II/III study, which showed a 36-fold increase in neutralizing antibodies against the Omicron variant in children who were given the booster dose. A booster dose of Comirnaty is already authorized for all adults and adolescents aged 12 years to 15 years while a second booster dose or “fourth” dose is authorized for older adults and some immunocompromised individuals. Comirnaty is the only COVID-19 vaccine with a EUA for use in children as primary series as well as for a third dose.
AbbVie Buys Option Rights to Novel Inflammation Candidate:
AbbVie received an
option to license worldwide rights
for certain IL-2 muteins, including the next-generation inflammatory candidate, CUG252 from precision medicines biotech, Cugene. CUG252 is being evaluated in a phase I study in healthy volunteers while Cugene plans to conduct a phase Ib study in patients with autoimmune/inflammatory disease during the option period. For the deal, AbbVie will make an upfront payment of $48.5 million to Cugene while also being entitled to make future development and regulatory milestone payments. If AbbVie chooses to exercise the option, it will have to make an option exercise payment and will then take care of all future clinical development and commercialization activities related to CUG252.
AstraZeneca Buys Rights to COVID Antibody:
AstraZeneca
acquired an exclusive worldwide licence
from London-based private biotech, RQ Biotechnology Ltd to develop and market monoclonal antibodies (mAbs) against the COVID-19 virus, SARS-CoV-2. For the rights, RQ Bio will receive upfront and milestone payments of up to $157 million while also being eligible for single-digit royalties on future sales of mAbs.
AstraZeneca’s cocktail mAb, Evusheld, a combination of two long-acting antibodies, tixagevimab and cilgavimab, is already authorized for pre-exposure prophylaxis (prevention) of COVID-19.
The NYSE ARCA Pharmaceutical Index rose 0.7% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
In the last five trading sessions, AstraZeneca rose the most (5%) while J&J declined the most (2.2%).
In the past six months, AbbVie rose the most (31.2%) while Roche declined the most (16.7%).
(See the last pharma stock roundup here:
PFE’s Biohaven Buyout Offer, BAYRY’s Q1 Earnings Update
)
What’s Next in the Pharma World?
Watch for regular pipeline and regulatory updates next week.
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