Altimmune announces ‘positive’ data for NasoVax

Altimmune announces ‘positive’ data from Phase 2a study of NasoVax

Altimmune announces 'positive' data from Phase 2a study of NasoVax. Stockwinners.com
Altimmune announces ‘positive’ data from Phase 2a study of NasoVax

Altimmune (ALT), announced positive data from its Phase 2a study of NasoVAX intranasal influenza vaccine and provided an update on its Phase 1b study of HepTcell targeted immunotherapy in chronic hepatitis B infection.

Results from the Phase 2a study of NasoVAX intranasal flu vaccine in 60 healthy individuals showed 100% seroprotection in the mid- and high-dose groups.

Results from the Phase 1b study of HepTCell in hepatitis B infection showed that HepTcell was well tolerated at all doses tested, while the unblinded T-cell immunogenicity results were inconclusive.

The randomized Phase 2a study compared a monovalent NasoVAX vaccine against an H1 strain of influenza to intranasal placebo in 60 healthy adults across three dose ranges.

In a parallel open label study, a similar population of 20 subjects were given Fluzone, a licensed injectable influenza vaccine. Blood samples from both studies were tested and the lab was blinded to treatment assignment.

Data demonstrated 100% seroprotection for the middle and high dose groups of NasoVAX as compared to 95% seroprotection with Fluzone. Mean antibody titers against influenza, as measured by the hemagglutinin inhibition and microneutralization assays increased up to 4.3-fold, indicating that high levels of immunity were induced in this study population, even with prior immunity to the influenza strain.

The serum antibody responses were also robust and dose dependent. Seroconversion rates and breadth of antibody response were comparable to Fluzone for the highest NasoVAX dose tested. Additionally, compared to Fluzone, the highest dose of NasoVAX induced over nearly 6-fold higher levels of influenza cellular immunity, an important element in defending against influenza disease.

All doses of NasoVAX were well tolerated and there were no cases of fever, serious adverse events or discontinuations. Rates of local and systemic side effects did not increase with dose and were not statistically different than placebo. Subjects will continue to be followed through six months after vaccination to assess durability of antibody response.

The company plans to submit the full data, which will also include mucosal antibody and serum antibody levels at other time points, for presentation at an appropriate scientific conference later this year.

ALT last traded at $1.60.


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GlaxoSmithKline acquires Novartis stake in Consumer Healthcare venture for $13B

GlaxoSmithKline acquires Novartis stake in Consumer Healthcare venture for $13B

GlaxoSmithKline acquires Novartis stake in Consumer Healthcare venture for $13B. Stockwinners.com
GlaxoSmithKline acquires Novartis stake in Consumer Healthcare venture for $13B

GlaxoSmithKline (GSK) announces that it has reached an agreement with Novartis (NVS) for the buyout of Novartis’ 36.5% stake in their Consumer Healthcare joint venture for $13B.

The Consumer Healthcare joint venture was formed as part of the three-part transaction between GSK and Novartis which was approved by shareholders in 2014.

Last year, GSK’s Consumer Healthcare business reported sales of GBP 7.8B.

Under the terms of the original transaction, Novartis has the right, exercisable from March 2, 2018 to March 2, 2035 to require GSK to purchase its stake in the joint venture.

“This put option, in both size and possible timing, creates inherent uncertainty for the Group’s capital planning. The new agreement to buy-out Novartis’ stake removes this uncertainty and improves the Group’s ability to plan allocation of capital to its other priorities,” the company said.

The business expects operating margins to approach “mid-20’s” percentages by 2022 at 2017 CER. The transaction is expected to be accretive to adjusted earnings in 2018 and thereafter, and is expected to “strengthen operational cash flows.”

GSK added, “Together with the Group’s new launch opportunities and expected operational improvements, these financial benefits further support GSK’s increased confidence in its ability to deliver its 2020 outlooks and invest effectively in the Group’s other priorities.”

The transaction is subject to approval by GSK shareholders as Novartis.

NVS closed at $79.68. GSK closed at $37.43.


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