Daria G. Husni

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On Aug 25, 2023, Sirio Europe (SIRIO) announced that it will launch two new pharma-targeted softgels at CPHI Barcelona 2023. The new formulations were created to adhere to the rising demand for products with more natural actives for both menopause and improved eye health. They are part of the company’s strategy to create new nutraceutical combinations in Europe alongside premium over-the-counter (OTC) brands and large pharmacy chains. Sirio created two ready-to-launch concepts for CPHI Barcelona, in an effort to help its partners innovate and move to market faster.

Sirio’s menopause softgel contains evening primrose oil as an appeal to market demands for plant-based products; the softgel is both vegan and gluten free. Each softgel will contain 500mg of evening primrose oil, as well as 45mg of Gamma Linolenic Acid, which Sirio stated is known to help regulation of immunity, cholesterol, and menstrual cycles.

Sirio’s eye health softgel uses a new special vision care complex, which contains a combination of Lutein, Zeaxanthin, and Astaxanthin. These three ingredients, according to Sirio, help maintain eye heath and improve hand-eye coordination. Sirio suggested that the product could prove successful in the growing prosumer market for gamers. This softgel will be available immediately and come with end-to-end service.

Sara Lesina, Sirio’s general manager Europe, added in a Sirio press release: “There is now a global drive towards exceptional quality and the highest manufacturing standards for nutraceuticals. Our ideal partners are those that share these values and are looking to develop products that have enhanced bioavailability, proven shelf life, and critically for a consumer facing product, far better organoleptic qualities.” Sirio plans to showcase their new softgels (as well as a range of gummies) at CPHI Barcelona 2023 in stand 1A30.

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The new products aim to aid consumers with menopause and eye health-related issues.

Sirio Europe Announces New Softgel Formulations

On Aug 24, 2023, FDA approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri, an injection for adults with relapsing forms of multiple sclerosis (MS). Tyruko is a biosimilar to Tysabri (natalizumab) used in adult patients with moderate to severe active Crohn’s disease (CD) with inflammation symptoms who are unable to receive normal CD therapies. Tyruko was approved to treat three types of MS: clinically isolated syndrome (a singular, initial emergence of MS symptoms), relapsing-remitting disease (episodes of new neurological symptoms and then periods of stability), and active secondary progressive disease (it occurs after a relapsing-remitting course, where patients’ disability gradually worsens with additional relapses).

The approval of Tyruko supports FDA’s mission to cultivate competition in the biological marketplace, giving more patients access to safe and high-quality medications at a more affordable price point. FDA’s approval is based on evidence that there is no meaningful difference between Tyruko and Tysabri’s safety, purity, and potency.

MS is a chronic inflammatory autoimmune disease of the central nervous system that interferes with signals between the brain and the rest of the body. It is more common in women than men and is one of the most common neurological disabilities in young adults. Often relapses, episodes of declining function and new symptoms, are followed by remissions, or recovery periods. As time goes on recovery may falter, which leads to a decline in function and an increase in disability.

Natalizumab products (Tyruko and Tysabri included) have a warning on the increased risk of progressive multifocal leukoencephalopathy, which is a viral infection in the brain that typically leads to severe disability or death. Because of this risk, natalizumab products are only available through a drug distribution program and are only given to patients enrolled in a risk evaluation and mitigation strategy (REMS). Patients must be evaluated by REMS-certified prescribers for three to six months before the first infusion, every six months after, as well as immediately and six months after stopping the treatment. Additional information and warnings pertaining to natalizumab products can be found on the 

FDA’s approval of Tyruko was granted to Sandoz.

This is the first biosimilar to Tysabri, an injection for adults with multiple sclerosis. 

FDA Approves Biosimilar to Treat Multiple Sclerosis

On Aug. 23, 2023, Alterity Therapeutics, a biologics company focusing on developing treatments for neurodegenerative diseases, announced that the European Patent Office granted the company a new composition of matter patent. The patent safeguards a new class of iron chaperone drug candidates that treat major neurodegenerative diseases. According to the company, excess iron in the brain is well documented to be implicated in the pathology of critical neurodegenerative diseases, such as Alzheimer’s and Parkinson’s diseases.

The patent, “Compounds for Methods of Treating Diseases,” Patent No. 3938364, is effective Aug. 23, 2023, when it is published in the European Patent Bulletin. It covers more than 150 novel pharmaceutical compositions created to redistribute excess iron implicated in neurodegenerative diseases. The patent grants Alterity 20 years of exclusivity over the compounds claimed in the patent, allowing the company further development and commercialization opportunities.

Alzheimer’s disease, a progressive neurologic disorder that causes the brain to atrophy, is the most common cause of dementia, affecting between 60% and 70% of the 50 million dementia patients worldwide. While there are medications to slow the disease, there is currently no cure. Parkinson’s disease, a neurodegenerative disorder that causes uncontrollable body movement and neuropsychiatric symptoms, is the second most common neurodegenerative disorder in the world, affecting more than 10 million people worldwide.

“The granting of this patent is an important component of our strategy to become a leader in the development of drugs that target critical neurodegenerative diseases,” said David Stamler, M.D., chief executive officer of Alterity, in an Alterity press release. “Through restoration of normal iron balance in the brain, we have the potential to slow disease progression of diseases including Parkinson’s and Alzheimer’s. This patent helps protect our approach and expands our portfolio as we look to develop novel disease modifying treatments for these debilitating conditions.”

The patent grants Alterity 20 years of exclusivity over a new class of iron chaperone drug candidates. 

Alterity Therapeutics Given European Composition of Matter Patent for Neurodegenerative Diseases

On Aug. 22, 2023, Revive Therapeutics, a specialty life sciences company focused on creating treatment for medical needs and rare disorders, announced it has initiated the development of a new formulation of Bucillamine. This formulation will be used to mitigate public health emergencies, including pandemic influenza, emerging infectious diseases, and medical emergencies such as incidents and attacks. The company also plans to experiment with the new formulation as an antioxidant and anti-inflammatory treatment for orphan indications in rare inflammatory diseases.

Revive began a sponsored research agreement with the University of Waterloo, which will be conducted at the Wettig Research Group and led by Dr. Shawn Wettig, PhD. Dr. Wettig is Principle Investigator, Professor, and Assistant Vice President for Graduate Studies at the University of Waterloo. His research includes physical chemistry, biochemistry, solution thermodynamics, and cell biology applied to self-assembling systems. The sponsored research will focus on developing a “novel lyophilized Bucillamine injectable formulation for public health medical emergencies and rare inflammatory disorders.”

Once the formulation development is finished, Revive plans to continue research on Bucillamine through several initiatives: developing as an injectable to treat rare disorders, working with pharmaceutical partners on regulatory approvals and new studies, and pursuing possible government funding and evaluation opportunities in the United States and Canada. The current formulation has a projected completion date of end-2023.

The formulation will be used to mitigate emerging infectious diseases and public health emergencies.

Revive Therapeutics Announces Initiation of New Bucillamine Formulation Development

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On Aug. 21, 2023, Pfizer announced that FDA granted Breakthrough Therapy Designation for ABRYSVO, an immunization given to pregnant individuals at a gestation period of 32 to 36 weeks to prevent Respiratory Syncytial Virus (RSV) in infants. According to Pfizer, this is the first US approval of a maternal vaccine to protect infants from birth to six months from lower respiratory tract disease (LRTD) due to RSV. RSV affects around 500,000 to 600,000 infants each year, and nearly all children experience an RSV infection by the time they are two years old. This vaccine aims to protect infants ages six months or lower, who are most venerable to serious consequences from RSV.

The approval decision is based on data from the Phase III clinical trial, a randomized, double-blinded, placebo-controlled study which included over 7000 pregnant individuals. The results were published in 

 in April 2023. ABRYSVO is a bivalent RSV prefusion F vaccine; it is unadjuvanted and made of two preF proteins meant to enhance protection against RSV A and B strains. According to Pfizer, it is the only company with an RSV vaccine to protect older adults, as well as infants through maternal immunization.

There will be two additional clinical trials evaluating ABRYSCO. One will be in children ages 2–<18 with higher risk for RSV, while the other will evaluate immunocompromised adults ages 18 and older at high risk for RSV. Safety information for ABRYSCO can be found on Pfizer’s 

“Newborns and young infants—whose immune systems are still developing and are not yet strong enough to defend against infections—may now be protected from RSV from the moment of birth through maternal immunization,” said Eric A.F. Simões, M.D., Clinical Professor, Pediatrics-Infectious Diseases, University of Colorado School of Medicine and Children’s Hospital Colorado, Aurora, in a Pfizer press release. “The approval of Pfizer’s ABRYSVO is a major triumph as it helps ensure no delay in potential RSV protection during an infant’s most vulnerable first six months of life and offers healthcare providers a new opportunity to help prevent severe RSV.”

The immunization, meant to protect infants aged six months or lower, is given to pregnant individuals at a gestation period of 32 to 36 weeks.

Vaccine for Respiratory Syncytial Virus in Infants Granted Breakthrough Therapy Designation

On Aug. 16, 2023, the European Medicines Agency (EMA) released a press statement to announce that their Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing data on the possible risk of neurodevelopmental disorders (NDDs) developing in children because of paternal use of valproate medicines. The data being assessed is from a retrospective observational study conducted by companies as an obligation after a previous review of valproate use during pregnancy. The study compared the development of NDDs (including autism spectrum disorder) in children from men taking valproate with the development in children from men taking lamotrigine or levetiracetam (other epilepsy treatments). It was conducted in multiple registry databases in Denmark, Sweden, and Norway.

The results may indicate an increased rate of NDD development in children born to men taking valproate three months from conception, but PRAC found several important limitations with the data from the study. It had questions about the definition of NDDs used in the study, and the specific type of epilepsy the fathers had, as higher dosages of valproate can be prescribed more frequently for certain types of epilepsy associated with NDDs. Additionally, after the results were submitted, the companies also informed PRAC on errors in the Norwegian database.

Because of these limitations, PRAC requested the companies to submit analyses of corrected data as well as more information as soon as possible. PRAC will review the new data when it is available before it makes an EU-wide recommendation. In the meantime, some Member States are using interim national recommendations. EMA reminded male patients taking valproate to not stop taking their medicine without consulting their doctor, as symptoms from their epilepsy or bipolar disorder could worsen, and sudden discontinuation could trigger seizures. Previous recommendations of women during pregnancy to avoid exposure to valproate remain in place.

The assessment aims to determine whether valproate use in men could lead to neurodevelopmental disorders in their children.  