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Pfizer/Valneva Lyme Disease Vaccine Candidate Enters Phase II
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Pfizer (PFE - Free Report) and its partner Valneva, a France-based private specialty vaccines company, announced the initiation of a phase II study for their jointly developed vaccine candidate, for Lyme disease, an infectious disease caused by the Borrelia bacterium, which is spread by ticks.
The phase II study (VLA15-221) on the multivalent protein subunit vaccine, VLA15, will include 600 healthy participants, both adult and pediatric subjects (5-17 year). This is the first study on a Lyme disease vaccine candidate to include a pediatric patient population and is also the only candidate in clinical development at present. No human Lyme disease vaccine is currently available.
The aim of the study is to see if VLA15 can be used in populations that are at risk of contracting Lyme disease, potentially including children aged five years and older. The study will evaluate VLA15 at two different schedules (Month 0-2-6 or Month 0-6) receiving the selected dose of 180µg
Pfizer announced the collaboration with Valneva to co-develop and commercialize VLA15 in April last year. For the deal, Pfizer made an upfront payment of $130 million to Valneva. In addition, Valneva will also be entitled to receive $35 million in development milestones and $143 million in early commercialization milestone payments. Per the deal, the first dose in the above phase II study has triggered a milestone payment of $10 million from Pfizer to Valneva.
Pfizer’s stock has declined 5.6% so far this year compared with 1.3% decrease for the industry.
Pfizer boasts a thriving vaccines business, accounting for around 15% of its worldwide sales. Its total vaccine sales were $6.6 billion in 2020, rising 2% year over year, on an operational basis. An important vaccine in its portfolio is 13-valent pneumococcal conjugate vaccine Prevnar 13/Prevenar 13. Importantly, its 20-valent pneumococcal conjugate vaccine candidate, 20vPnC is under priority review with the FDA with a decision expected in June.
Most importantly, Pfizer and partner BioNTech (BNTX - Free Report) have successfully developed a two-shot vaccine, BNT162b2, for COVID-19 in record time, which is now approved for emergency/temporary use in more than 50 countries worldwide. In fact, Pfizer expects approximately $15 billion in sales from BNT162b2 in 2021.
Moderna (MRNA - Free Report) , AstraZeneca (AZN - Free Report) and J&J have also successfully launched their COVID-19 vaccines.
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
Image: Bigstock
Pfizer/Valneva Lyme Disease Vaccine Candidate Enters Phase II
Pfizer (PFE - Free Report) and its partner Valneva, a France-based private specialty vaccines company, announced the initiation of a phase II study for their jointly developed vaccine candidate, for Lyme disease, an infectious disease caused by the Borrelia bacterium, which is spread by ticks.
The phase II study (VLA15-221) on the multivalent protein subunit vaccine, VLA15, will include 600 healthy participants, both adult and pediatric subjects (5-17 year). This is the first study on a Lyme disease vaccine candidate to include a pediatric patient population and is also the only candidate in clinical development at present. No human Lyme disease vaccine is currently available.
The aim of the study is to see if VLA15 can be used in populations that are at risk of contracting Lyme disease, potentially including children aged five years and older. The study will evaluate VLA15 at two different schedules (Month 0-2-6 or Month 0-6) receiving the selected dose of 180µg
Pfizer announced the collaboration with Valneva to co-develop and commercialize VLA15 in April last year. For the deal, Pfizer made an upfront payment of $130 million to Valneva. In addition, Valneva will also be entitled to receive $35 million in development milestones and $143 million in early commercialization milestone payments. Per the deal, the first dose in the above phase II study has triggered a milestone payment of $10 million from Pfizer to Valneva.
Pfizer’s stock has declined 5.6% so far this year compared with 1.3% decrease for the industry.
Pfizer boasts a thriving vaccines business, accounting for around 15% of its worldwide sales. Its total vaccine sales were $6.6 billion in 2020, rising 2% year over year, on an operational basis. An important vaccine in its portfolio is 13-valent pneumococcal conjugate vaccine Prevnar 13/Prevenar 13. Importantly, its 20-valent pneumococcal conjugate vaccine candidate, 20vPnC is under priority review with the FDA with a decision expected in June.
Most importantly, Pfizer and partner BioNTech (BNTX - Free Report) have successfully developed a two-shot vaccine, BNT162b2, for COVID-19 in record time, which is now approved for emergency/temporary use in more than 50 countries worldwide. In fact, Pfizer expects approximately $15 billion in sales from BNT162b2 in 2021.
Moderna (MRNA - Free Report) , AstraZeneca (AZN - Free Report) and J&J have also successfully launched their COVID-19 vaccines.
Pfizer has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
These Stocks Are Poised to Soar Past the Pandemic
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
See the 5 high-tech stocks now>>