November 17th, 2022 | 13:48 CET
BioNxt Solutions, Pfizer, Bayer - Biotech and pharma stocks in focus
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"[...] As a company dedicated to developing treatments for rare heart diseases, we see this as an opportune moment to contribute to the fight against heart disease and make meaningful strides in improving heart health worldwide. [...]" David Elsley, CEO, Cardiol Therapeutics Inc.
Born in Bielefeld, she studied German, English and psychology. The emergence of the Internet in the early '90s led her from university to training in graphic design and marketing communications. After years of agency work in corporate branding, she switched to publishing and learned her editorial craft at Hubert Burda Media.
BioNxt Solutions - Mental health through the power of nature
Wars and other life-threatening events lead to traumatic experiences for soldiers and civilians worldwide. Experiences so horrific and unspeakable that they are literally burned into the brain and cannot be put into words. When traumatized, victims simultaneously experience powerlessness, fear and loss of control. The situation is perceived as life-threatening, whether through mental or physical violence. Traumatic events have such a strong effect on the autonomic nervous system that it undergoes lasting changes. Traumas anchor themselves deeply in the subconscious. What is hidden serves as protection against overwhelming feelings and disturbing images. But the root cause seeks its way in symptoms such as addictions or depression.
To bring these repressed images back into consciousness and thus enable goal-directed therapy, scientists use controlled psychoactive substances such as psilocybin to help patients access their repressed memories. In contrast to hypnosis, traumatic experiences can be brought to consciousness under medical supervision with hallucinogenic substances. Because one thing is now well known: Those who report terrible things in a trance and remember nothing afterwards are not one step ahead.
The Canadian company BioNxt Solutions (ISIN CA0909741062) has dedicated itself to the further research and commercialization of psychedelics. The growing body of evidence and ongoing studies indicates that psilocybin is a potential therapeutic for depression, anxiety, PTSD, and other psychiatric disorders.
A large-scale study illustrates that the psychedelic compound, found in so-called "magic mushrooms," can alleviate severe depression when combined with psychotherapy. This offers hope for people for whom existing antidepressants are failing. In the body, psilocybin breaks down into a substance called psilocin, which releases waves of neurotransmitters in the brain. MRI scans show that brain activity becomes more active under psilocin, and different brain regions communicate with each other more than usual.
BioNxt Solutions works closely with pharmaceutical industry leaders to accelerate research and technology development and commercialize products with an entrepreneurial approach and a commitment to efficiency, effectiveness and accessibility. The global mental health market size was USD 381.98 billion in 2020 and is estimated to reach USD 527.44 billion by 2030, growing at a CAGR of 3.40%. From its inception, the Company has relied on an aggregating data platform to build its competitive advantage.
David Nutt, professor of neuropsychopharmacology at Imperial College London explained that psilocybin's rapid action suggests that it interrupts negative cycles of rumination in patients, acting like a "reset" on the brain. Patients thus experience a fresh start and are a big step further in their healing process by reliving, becoming aware of and resolving their traumas. In addition to products for mental health, BioNxt Solutions also develops and researches solutions for treating Parkinson's disease and multiple sclerosis.
Pfizer - Speeding ahead without long-term data
Bringing a vaccine to market usually takes several years. The process from development to commercialization is subject to strict regulations. Initially, research focuses on finding a new pathogen. Scientists study it to identify antigens from which a vaccine can be derived. Prior to clinical trials, vaccine candidates are tested on bacteria, cells and tissue. That is followed by animal testing. The clinical phase is the final stage before a manufacturer can seek approval for its product. This process consists of sequential steps, which can take as long as 15 years from virus analysis to actual approval.
The traditional model of recruiting patients for clinical trials has been in place for decades and is often criticized for everything from a general lack of access to representative populations to specific inequities in trial design related to age, gender, race and ethnicity.
Aamir Malik, who joined Pfizer as chief business innovation officer in August 2021, is confident and energized following the tremendous success of the Covid vaccine. "At Pfizer, we ask ourselves, what if we partnered with larger cities? What if we leveraged AI and machine learning technologies and applied them to this problem? The pressure is to solve a problem, the pressure is not to do what we did before and work much harder to achieve the same goal in the same way," he adds.
"It was very obvious with the pandemic because it needed to be solved urgently, and we have now applied that concept of speed to everything we do," he told CNBC. "If we can find a way to shorten a drug's development time by three years with a shelf life that is orders of magnitude longer, then we can get a drug to patients three years faster. To make that kind of change takes tremendous ingenuity, but we believe it is possible."
However, the difficulties of shortening times in the context of emergency approvals are only beginning to emerge, so belief in faster study times remains in the distant future. Concerning the Covid-19 vaccine, it is unclear whether long-term health effects in vaccinated individuals are Long Covid or PostVac symptoms. Moderna and Pfizer will now study whether their vaccines cause long-term problems. As part of the new studies, a number of Americans who have experienced rare side effects in the last two years after vaccination will be monitored. Because only the analysis and evaluation of long-term data will show whether a vaccine has any justification or causes such severe damage to health that it puts the actual symptoms of the disease being treated into perspective. In short: it does more harm than good.
In the USA, 613 million doses of the Covid-19 vaccine have been administered to date. According to Bloomberg, more than 12.7 billion vaccine doses have been administered in 184 countries. The latest rate was about 7.07 million doses per day.
Bayer AG - Look into my eyes, little one
Unlike Pfizer, Bayer Group is focusing on expanding patient groups affected by a genetic defect that can lead to blindness. Retinopathy (ROP) is a disease of the retina that, if left untreated, leads to visual deterioration or even loss of vision. If a premature baby is diagnosed with this disease, current treatment methods are poorly adapted to the infant's age. For example, laser treatment of the retina can irrevocably remove too much corneal tissue, resulting in severe myopia in infancy.
Worldwide, approximately 50,000 premature babies are born with this eye condition each year. Doctors speak of a premature birth when a baby is born after the 37th week of pregnancy. Usually, 40 weeks pass. Imagine this: A mother is confronted with the premature birth of her child, which in itself is a strong emotional burden. In addition, she learns that her child may go blind. If there were a glimmer of hope of a palliative medication, what would this mother do?
A study from the medical university of Greifswald now concludes that an eye injection with the active ingredient aflibercept does not show a significant difference compared to laser treatment of the cornea. Literally, the result of the study states, "In infants with ROP, intravitreal aflibercept treatment compared with laser photocoagulation did not meet the criteria for non-inferiority with respect to the primary endpoint, i.e. the proportion of infants achieving treatment success at week 24. More definitive conclusions regarding the comparative effect of intravitreal aflibercept and laser photocoagulation in this population would require additional data.
Here, too, it becomes clear how valuable the time factor and the associated collection and evaluation of collected data is. Hopefully, the study will enable the patent to be extended so that Bayer, together with the US company Regeneron, will continue to have exclusive rights to the active ingredient because further research is needed to demonstrate an effective benefit beyond 24 weeks.
Speed is no advantage, especially in medical research, if long-term effects are ignored. Pfizer, in cooperation with Moderna, is beginning to study the long-term side effects of the Covid-19 vaccine. It may sound tempting to investors if an active ingredient could reach patients three years earlier. The only problem is that the research must be well documented. Bayer is working in its healthcare division to expand its patient group to treat an eye disease and is currently facing a stalemate in the study results. It is not yet clear whether the injection into the eye of premature babies mitigates the increase in visual impairment beyond 24 weeks compared with laser eye treatment. The biotech company BioNxt Solutions has taken a data- and document-supported approach right from the start. Thanks to cloud-based data platform technology, the Company is well-positioned in terms of research and advancing its mental health products and solutions.
Conflict of interest
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