Cardiol, BioNTech, Novartis - Inventory at three high-flyers

Cardiol Therapeutics - LANCER study gets patient growth

Cardiol Therapeutics is a life sciences company focused on researching and developing anti-inflammatory therapies to treat cardiovascular disease. Before pharmaceutical drugs receive regulatory approval and thus find their way into the market, various clinical studies are required to accurately research and document the mode of action of the therapeutics. Another milestone has now been reached for Cardiol Therapeutics in Phase II/III of its future cannabidiol-based product. Cannabidiol, also known as CBD, is an active ingredient from the female hemp plant discovered in 1940. The US FDA and regulatory authorities in Brazil and Mexico are now giving Cardiol the green light to enroll patients vaccinated against COVID as participants in the large-scale LANCER study.

The LANCER trial is designed to evaluate the efficacy and safety of CardiolRx™ as cardiopulmonary protective therapy to reduce mortality and major cardiovascular events in patients hospitalized with COVID-19 who have a history, or risk factors, for cardiovascular disease. In plain English, this also means that myocarditis patients can be treated with it.

By enrolling the vaccinated patient cohort, the Company expects to recruit more than 50% of patients by the end of the first half of 2022. Total patient enrollment is expected to be completed in the second half of 2022. That is excellent news for investors as the pace for completion of the study is increased.

"Given the compelling evidence for the anti-inflammatory protective properties of cannabidiol, we believe CardiolRx™ has the potential to reduce a number of cardiopulmonary complications associated with COVID-19 infection. Interest in the LANCER trial remains strong, and Cardiol continues to activate new clinical research sites to accelerate patient enrollment," said Andrew Hamer, MD, Chief Medical Officer of Cardiol Therapeutics. "The repeated waves of COVID-19 outbreaks combined with inconsistent vaccine and booster vaccination underscore the need for therapeutics for high-risk patient populations, particularly those with significant cardiovascular risk factors. Despite the challenges posed by ongoing changes to the standard of care, we are confident that the recently approved protocol changes will help achieve our goals for LANCER patient enrollment."

With or without vaccination against COVID-19, the risk and likelihood of developing myocarditis has increased significantly since the emergence of the Coronavirus. Therefore, the research conducted by Cardiol Therapeutics with a naturally occurring active ingredient is all the more valuable.

BioNTech - Production plant in Rwanda

A global pandemic requires global action to mitigate the situation. So BioNTech announces it will also produce the vaccine in Rwanda, Africa, over the next 24 months. "Local vaccine production in Rwanda and Africa is a success. It requires strong and sustainable partnerships between all stakeholders, including collaboration between academia and the pharmaceutical industry," said Minister of Health Dr. Daniel Ngamije during a health event at Gikondo University in the city of Kigali.

From an investor perspective, things are happening at this Company. The European Medicines Agency (EMA) announced this week that BioNTech/Pfizer is now officially approved for children 12 years and older. In use as 'Comirnaty,' the vaccine is already approved in the EU as a two-dose first-line treatment in adolescents and adults and children five years and older. A booster dose colloquially referred to as a booster is currently permitted from the age of 18.

The EMA's recommendation is based on data from a study in Israel on a booster dose of the vaccine in adolescents aged 16 and older. As yet, this recommendation is not a free pass to vaccinate children in the EU. In order to offer boosters in this age group, other factors must be considered - for example, the risk of side effects such as contracting myocarditis. With a population of more than 13 million, Rwanda currently has 129,516 Corona-infected people and 1,457 deaths, with a vaccination rate of 56%.

Svenja Schulze, Germany's Minister for Economic Cooperation and Development, described BioNTech's planned investment in Rwanda as a step toward achieving vaccine equity. "COVID-19 was a wake-up call that the world is not okay until Africa is okay. We can only overcome complex challenges like this pandemic with the help of global solidarity, innovation and collaboration among partners," she said, adding, "Equal access to vaccines is the way out of this pandemic." Schulze is a strong advocate for investments like those made by BioNTech. She said that vaccine donations and financial support for Africa are not a sustainable way to combat the pandemic. A dedicated vaccine production plant, on the other hand, is.

Novartis - Production site in Ireland changes ownership

Swiss big pharma player Novartis is parting ways with one of its manufacturing sites in Ireland. The Company announced Tuesday that it has agreed to sell the Ringaskiddy plant to British contract manufacturer Sterling Pharma Solutions. The plant produces ingredients for a range of oncology, respiratory, cardiovascular, dermatology, central nervous system and transplantation drugs. The Company is silent about the total amount of the transfer.

The quarterly figures from Q4 are a different story. Net sales in Q4 were USD 13.2 billion (+4%, +6% cc), benefiting from volume growth of 11%, including 1% due to the reclassification of contract manufacturing from other revenues to sales. CEO Vas Narasimhan commented, "Novartis finished with mid-single-digit sales growth, margin expansion and strong free cash flow. Our market-specific growth drivers continue to perform well across all geographies, reinforcing our confidence in our medium- and long-term growth prospects. Our capital allocation priorities remain balanced as we continue to invest in innovation while initiating a return of capital to our shareholders."

A heart failure therapeutic saw the strongest growth at a whopping 34%. In sales terms, that is USD 949 million. Heart failure occurs when the heart muscle can no longer pump enough oxygenated blood around the body. That leads to symptoms such as shortness of breath and swollen legs. On the psychological level, patients, most of whom are elderly, find it difficult to accept living with the symptom of heart failure because they often associate it with failure and weakness.

The second product from Novartis is a treatment for psoriasis, which generated 13% sales growth. Primarily through sales in Europe, China and the US. Interestingly, this is a drug that is injected into patients. Again, it can only be assumed that the suffering of an eczema-like skin condition must be many times greater than a weekly injection to relieve symptoms.

A look at the Company's PhaseIV clinical trials reveals a focused strategy for treating rare diseases and proven blockbusters. These include a compound to alleviate sickle cell anemia and compounds to treat asthma, multiple sclerosis, and heart failure.

The development of pharmaceutical drugs from the molecule to the prescription as an active ingredient by the physician is subject to strict regulations. In clinical trials, the mode of action and course of treatments are carefully tested on various patient cohorts before a product is approved for sale. The Coronavirus is giving the issue of cardiovascular disease new impetus. Cases of heart muscle inflammation such as myocarditis are becoming more frequent. With the product from Cardiol Therapeutics, a drug with a natural medicinal active ingredient is paving its way into the mass market. It is guaranteed to be an exciting investment for long-term investors. The pipeline at BioNTech and Novartis is also well filled to help people worldwide. Be it through new jobs like in Rwanda or through blockbusters against asthma, psoriasis and heart failure.