Week 45: FDA announces new animal health funding plan, pathways to addiction uncovered

Posted on November 19, 2018 in Uncategorized

A new pathway to help understand alcohol addiction uncovered

Researchers may have found a pathway in the brain between alcohol and a protein responsible for encoding memories. This pathway is said to be impacted by alcohol, altering the ability to encode memories as either aversive or rewarding and incite cravings. This new data may be helpful in treating those with addictions and alcohol dependency, even those who have sought treatment and are facing relapse.

The researchers out of Brown University, led by Karla Kaun, studied the brains of fruit flies and how they encode memories via molecular pathways that are comparable to humans. They wanted to study how drugs of abuse can interfere with the creation of memories, making them rewarding in nature despite their neurotoxic effects. Data present from the study, covered in Biotechniques, indicates that there is a link between the Dopamine-2-receptor protein and the categorizing of memories in  relation to alcohol consumption, along with a relation between the amount of alcohol consumed in a certain window of time and the brain’s ability to normalize that pathway after consumption.

This may give insight to the study of other commonly abused drugs, such as opiates, and being able to treat addiction.

Are opioid overdose reversal drugs stable past their expiration date?

A new study,  covered by Pharm Tech, suggests that they are. This study looked into intranasal and injectable naloxone (Narcan and Evzio, respectively) to see whether they were deemed effective when administered after their printed expiration date. The current range of efficacy is between 18 months and two years after manufacturing. Spurred by real-life scenarios in hospitals, the naloxone products in question were kept at room temperature and were anywhere between six to 19 months past their expiration.

The next phase of this study will be to look at the efficacy of products five years past their expiration, evaluating microbiological stability amongst others.

This study was presented on November 6th at the 2018 American Association of Pharmaceutical Scientists PharmSci 360 Annual Meeting held in Washington, D.C. and contributes to the conversation of the opioid crisis currently happening in the US.

Concerns continue to rise over drug resistant infections

Drug resistance “superbugs” are increasing in frequency, cited Reuters. It is said that resistant infections caused by these pathogens are responsible for killing around 33,000 people per year in Europe, with concerns over this reaching more than that of the flu, HIV, and tuberculosis combined.

The European Center for Disease Control (ECDC) is worried about an increase in cases that are resistant to the most powerful class of antibiotics available now called carbapenems. This class of antibiotics are used as a last resort when treating those with infections resistant to regular treatments. When this option is no longer available, treatment can become incredibly difficult or even impossible, with it being stated that the evolution of these superbugs to resist multiple antibiotics are the biggest threat facing medicine. The ECDC published a study looking at 5 types of infections caused by superbugs resistant to antibiotics and noted that 75% of cases contracted were associated with hospital stays or healthcare clinics, commonly referred to as healthcare-associated infections. Coordination to help combat these cases should be a global effort due to the specific cases that happen in each country, eluded the study.

Humira biosimilars have officially entered the EU market, and everybody is talking about it

One report from states that up to an 80% discount in Nordic countries have been documented, but those sales only account for 4 to 5% of total biosimilars sales and are a unique case due to their competitive nature. With the US FDA approving Sandoz’s biosimilar Hyrimoz, a version of AbbVie’s Humira (adalimumab), it is expected to hit the market end of September 2023.

As stated by BioPharma Reporter, Hyrimoz is “approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis in patients four years of age and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.”

The Novartis subsidiary hasn’t released a list price yet but is optimistic that it can deliver savings to patients by the billions come 2023, when the licensing agreement they reached with AbbVie comes into effect. Three other biosimilars are slated to be released in 2023, with Amgen’s version hitting the market January 31st, Samsung Bioepis on June 30th, and Mylan’s on July 31st. AbbVie will have five more years of sales reaching well into the billions until then.

However, AbbVie’s exclusivity in the European market ended in last month. This saw three biosimilars enter the market and increase competition, one of them being Hyrimoz.

Patients suffering from Ankylosing Spondylitis (AS) may have a new potential treatment option

Coming out of Oregon Health and Science University in Portland, Oregon are results from a new Phase III clinical trial for a biologic drug called ixekizumab. Previously, patients with AS were treated with a tumor necrosis factor (TNF) to control symptoms caused by a chronic inflammation, affecting the back and causing sacroiliac joint damage. Around 30 to 40% of patients being treated with TNF either didn’t achieve symptom relief or control of the disease, with many others not being able to receive TNF due to health contraindications. Read the results of the study reported to European Pharmaceutical Review.

Universal flu vaccines for humans… using llamas?

In the wake of the suspected ‘antigenic drift’ that occurred last year and the impact it had on coverage from current flu vaccines, there was a call to create a more universal form of coverage. The current state of flu vaccines does not allow for coverage of mutated influenza strains or protect against pandemic strains such as H1N1, or swine flu. It has also been reported that the population that is most vulnerable, such as the elderly, are still left without adequate coverage. There are some vaccines out there that have the potential to cover against some mutated strains, but do not allow for cross-strain coverage and must be dose regularly throughout the season.

One possible solution that has arisen from a Series A fundraised project is preparing for Phase I clinical trials; a piece on states that the universal flu vaccine can cover many strains of the flu and protect a larger population. The company, InvVax, has developed a potential solution which has demonstrated preclinical success after building in a mechanism to the vaccine that can help prevent immune evasion and overcome any potential mutations while keeping the vaccine stable within the immune system. The mechanisms being targeted within this new vaccine are referred to as ‘invariant regions.’  There are currently other solutions in the process.

But wait, what about the llamas?

A team of scientists from Scripps Research Institute is leading a study posted in Fierce Biotech to develop a universal flu vaccine. By isolating and broadly neutralizing single-domain antibodies (sdAbs), the team holds out hope that a vaccine covering “almost all” influenza viruses can be developed and last for an entire flu season. The team first immunized a group of llamas against the flu, the isolated four sdAbs and linked them together in a ‘multidomain antibody dubbed MD3606.’

Llamas are a member of the camelid family; a group of animals including alpacas and camels characterized by their long, slender neck and limbs with two distinct toes rather than hooves, as well as sharing a similar but different digestive system to that of ruminants. The reason why camelids were specifically used is due to their ability to produce sdAbs in heavy chains, not light chain, making this unusual for antibody development. This idea to use sdAbs is not unique to this group, with multiple other sdAbs-derived treatments being in the works through Sanofi, one being used to treat against certain rare blood disorders. Another group of researchers out of University of California Riverside are using this class of animals to develop cancer-fighting antibodies.

The first group of mice treated with the newly developed flu vaccine were said to be covered against almost all influenza A and B viruses and said to be more powerful than current existing treatments.

A follow up from last week..

Genentech files cites ‘brazen’ theft of trade secrets in suit against former employees accused of trading secrets to Taiwanese biotech company, JHL. The Roche company wishes to ban any biosimilars that resulted from the theft of these trade secrets. The lawsuit states that the information shared helped create the business trajectory that JHL was on. See what else FiercePharma has reported on this topic.

FDA has announced new plan to advance innovation in animal and plant biotechnology

It is no secret that WMC is a huge fan of the animal health industry (if this is news to you, surprise!). That is why we are excited to share this story that FDA Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram announced a new action plan covered in Pharmaceutical Technology to clarify current approaches to product development and provide support to innovation in the animal and plant health industry, while advancing missions of public health and safety.

The announcement said it would “address common questions from biotech developers and public health interest groups. Priority areas identified by the plan are applying modern, efficient and risk-based regulatory pathways; strengthening public outreach and communication; and increasing engagement with domestic and international partners.”

Focus will be put on developing framework and regulatory oversight on the intentional genetic modification of plants and animals, and any animal biotechnology products (food or drug) that derives from it, with the intention to drive innovation while maintaining safety. The goal is work both domestically and globally in this space.