This week, a U.S. district court dismissed thousands of lawsuits involving the heartburn drug Zantac, pushing up stocks of
GSK
GSK
,
Sanofi
SNY
and
Pfizer
PFE
. Pfizer/BioNTech received FDA’s emergency approval for Omicron BA.4/BA.5-adapted COVID vaccine for kinds under five years of age. Pfizer and
AbbVie
ABBV
announced research collaborations with private biotechs.
N
o
vartis
’
NVS
pipeline candidate, iptacopan provided clinically meaningful increases in hemoglobin levels in complement-inhibitor-naïve patients with paroxysmal nocturnal hemoglobinuria (PNH).
Recap of the Week’s Most Important Stories
U.S. Court Dismisses Zantac Lawsuit, Relief to GSK, SNY, PFE:
A Multi-District Litigation (MDL) court of Southern Florida
dismissed all lawsuits alleging that heartburn drug Zantac
(ranitidine) causes cancer.
In the MDL, plaintiffs identified five different types of cancers (liver, bladder, pancreatic, esophageal, and stomach). There were around 50,000 claims in the MDL. The court has dismissed all MDL cases alleging the five cancers.
The U.S. district court verdict brought relief to companies like GSK, Sanofi and Pfizer, which marketed prescription or over-the-counter (OTC) Zantac (ranitidine) medicines. If the claims in the MDL had been proved, the liabilities of these drugmakers could have been in billions. Several personal injury cases were filed in federal and state courts, alleging that Zantac (ranitidine) medicines cause cancer. However, GSK, Pfizer, Sanofi, all denied that Zantac causes cancer, citing scientific consensus. Though several thousands of cases remain pending in various U.S. state courts and the MDL ruling can still be appealed, it meaningfully reduces the companies’ liabilities and removes a major overhang.
Novartis’ PNH Candidate Meets Goal in Phase III Study:
Novartis’ phase III study (APPOINT-PNH) evaluating investigational oral monotherapy iptacopan in complement-inhibitor-naïve patients with PNH
met the primary endpoint
. Top-line data from the study showed that a significantly greater proportion of patients who were given iptacopan (200 mg twice daily) experienced clinically meaningful increases of 2 g/dL or more in hemoglobin-level from baseline without the need for blood transfusions. APPOINT-PNH is the second study on iptacopan in PNH. The first pivotal study, APPLY-PNH, also met its two primary endpoints. Top-line results for the pivotal APPLY-PNH were announced in October. In the study, iptacopan demonstrated clinically meaningful superiority over anti-C5 treatments. Novartis will include APPOINT-PNH data in the regulatory filings
of iptacopan in 2023.
Novartis’ pivotal phase III PSMAfore study evaluating Pluvicto for treating patients with PSMA–positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen-receptor pathway inhibitor therapy
met its primary endpoint
. In the study, Pluvicto demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival. This is the second phase III study on Pluvicto that has met the primary endpoint. Earlier, the phase III VISION study showed that patients with PSMA–positive mCRPC who received Pluvicto plus standard of care after being treated with other anticancer treatments like ARPI and taxane-based chemotherapy experienced statistically significant reduction in risk of death. Novartis will discuss PSMAfore phase III data with the FDA next year to seek label expansion approval. Pluvicto was approved to treat PSMA–positive mCRPC who have been treated with ARPI and taxane-based chemotherapy in the United States in March based on data from the VISION study.
Pfizer Gets FDA Nod for Omicron Jab in Kids Under 5:
The FDA granted emergency approval to Pfizer/BioNTech’s Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third dose (3-µg) in its three-dose primary series for
children under five years of age
. The approval for the Omicron BA.4/BA.5 jab in this age group is not as a booster but as part of the primary series. Children in this age group get three doses as their primary series. With the emergency approval of the Omicron BA.4/BA.5-adapted vaccine, kids in the six months through four years age group would get two 3-µg doses of the original Pfizer-BioNTech COVID-19 vaccine followed by a third 3-µg dose of the Omicron BA.4/BA.5-adapted bivalent vaccine as part of their three-dose primary series Pfizer is ready to ship the doses immediately once the U.S. Centers for Disease Control and Prevention (“CDC”) recommends their use.
Pfizer/BioNTech’s Omicron BA.4/BA.5-adapted bivalent vaccine is authorized as a booster shot for people five years and above in the United States and European Union (EU).
The
FDA accepted and granted priority review
to Pfizer’s biologics license application (BLA) seeking approval for its bivalent respiratory syncytial virus (RSV) vaccine candidate, RSVpreF for the prevention of lower respiratory tract disease caused by RSV in older adults (aged 60 and above). The FDA’s decision is expected in May 2023.
Pfizer formed a research collaboration with Clear Creek Bio to develop a papain-like protease (PLpro) inhibitor, a new class of oral antivirals for treating COVID-19. Once the companies identify a PLpro candidate, Pfizer will take care of further development and commercialization activities.
AbbVie’s New Collaboration and Option Deal:
AbbVie announced a strategic worldwide collaboration and option to license deal with HotSpot Therapeutics for its discovery-stage, small molecule IRF5 inhibitor for the treatment of autoimmune diseases. For the deal, AbbVie will pay HotSpot an upfront cash payment of $40 million, with the latter also being entitled to up to $295 million in option fees and research and development milestones and potential commercial milestone payments.
The NYSE ARCA Pharmaceutical Index rose 0.56% 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, AbbVie rose the most (2.7%), while Roche declined the most (1.6%).
In the past six months, all the stocks were in the green, with Merck gaining the most (27.2%).
(See the last pharma stock roundup here:
PFE & AZN Ink New M&A Deals, LLY Meets Alzheimer’s Study Goal
)
What’s Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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