Teva’s Patent Infringement Surprises Judge

Back in 2017, there were various claims that Teva had violated its patents by inducing doctors to prescribe a generic of Teva similar to a Coreg of GlaxoSmithKline’s and was hit by a $235 million fine for the infringement of the patent. The fine was overruled by a U.S. District Judge Leonard P. Stark. 

Background of GSK’s Coreg: 

The GSK’s Coreg was approved in 1995. It is used for the treatment of high blood pressure and heart failure or after a heart attack. It works by blocking a few natural processes and eventually reducing the blood pressure to avoid strokes and heart attacks.

The drug was marketed in the U.S.for heart failure, and thus, Teva’s generic was not approved due to patent protection. 

In 2011, the U.S. Food and Drug Administration (FDA) indicated Teva to work on its label but after revision, it still included the use for heart failure which the GSK had a patent for, thus in 2017, GSK sued Teva for infringement of the labels, the verdict of which was in favor of Teva back in 2018 and the suit was closed. 

Case Revival: 

Recently, GSK urged the U.S. courts to look into the verdict against Teva again and Teva to pay GSK more than $235 million for the infringement of the patent. 

There was an argument in the federal courts to revive the case, and the jury was confused about how the verdict had been given in favor of Teva back in 2017. One of the judges from the panel was recorded saying that she couldn’t find a stronger case of induced infringement of the drug’s patent, as all the three indications were cited in the generic label and even after the re-write of the label, it infringed the GSK’s patent. 

Recent updates: 

The three-judge panel asked harsh questions regarding the suit, and it left Teva in shock that the lawsuit they had gotten rid of back in 2017 is back again. The jury questioned the intention of Teva by asking if they had issued those press releases as goodwill or to let the doctor’s know that they can prescribe this drug. The lawyer stated that Teva never had the intention to issue the same releases as Coreg’s, but just wanted to inform the physicians that a generic was about to hit the market. Another Teva spokesperson refused to comment on the case. 

The case is still ongoing, but one thing is for sure, Teva has faced many similar lawsuits in recent years of which the GSK lawsuit is just one. The company is slowly declining, with an increase in debt. Moody, a debt-rating agency rated its outlook from ‘stable’ to ‘low,’ and the amount the company has to pay for settlements could affect its ability to pay back $2 billion of debt. With all these troubles, the investors must be looking for a door to escape.

Abbvie’s New Blockbuster Drug For Rheumatoid Arthritis

AbbVie has recently made headlines owing to various different ventures that it has been making in the pharmaceutical community. Whether it is introducing new drugs or antibiotics to the medical industry, or investing in collaborations with other pharmaceutical companies, AbbVie has definitely established itself as a pioneer in several medical fields. In recent news, AbbVie has received official approval by the FDA for their brand new drug, Rinvoq. This drug mainly aims to treat adults with early/late onset, moderate to severe forms of Rheumatoid Arthritis (RA). The exact details and recommended dosage etc. can be found in the sections below. 

What is Rinvoq? 

For starters, Rinvoq is a drug designed to combat Rheumatoid Arthritis. It has been optimized for patients who have experienced or reported inadequate responses from other drugs such as Methotrexate based ones. This includes the pool of patients who are intolerant to the aforementioned drugs, and so Rinvoq has appeared on the scene. Distribution of Rinvoq is expected to start in August this year to pharmaceutical companies all over the United States. 

Rinvoq has been in the works for quite a while. It is part of the FDA’s SELECT program campaign that has recently undergone three different phases of approval for the treatment of RA. Clinical trials have been held by housing over forty thousand under analysis on a nationwide scale. These trials and studies have taken into account patient histories with particular attention to Methotrexate based drugs to the treatment of RA specifically. 

Image via AbbVie

How does it work? 

While Rinvoq is a relatively new venture as compared to its predecessor Humira, AbbVie hopes that it will leave a mark as well. Now, patients who have undergone trials with Rinvoq have been reported to be in clinical remission ever since the start of treatment. Although some of these patients were thought to be under the placebo effect, most did accurately report having achieved remission around the twelve-week mark. This clinical remission supposedly lasts till the twenty-four or twenty-six-week mark. Some side effects of Rinvoq, however, may be a source of alarm because they entail a wide range of lung tract infections that may even prove fatal in the long run. 

Future Prospects for Rinvoq

Aside from the work that needs to be done to improve upon potential side effects and setbacks from the Rinvoq treatment, AbbVie is also looking forward to releasing another brand new drug into the market not too far into this year. With approvals for such drugs by the FDA, the pharmaceutical industry can definitely hope for more improvements and new treatments in order to help more patients that are ailing with disorders much like RA itself. 

Conclusion

With cases of Rheumatoid Arthritis riddling a large chunk of the adult population in the United States, a drug such as Rinvoq has been long overdue, and AbbVie has indeed taken the time to perfect it and present it to the public such that they reap the benefits in the long term.

Will AbbVie will win the market share for Rheumatoid Arthritis? Comment your thoughts!

Genentech Signs Billion Dollar Deal with Sosei Heptares and Skyhawk

Genentech Inks Deal With Skyhawk And Sosei

Introduction

Genentech and Convelo Therapeutics collaborated to accelerate their discovery of the drugs to deal with different targets, such as the patients who are suffering from neurological disorders like multiple sclerosis (MS). The two companies decided to work together to discover the therapies for MS as well as other myelin disorders. According to the deal, Convelo will receive an undisclosed upfront payment and also some support during the search from Genentech. 

Since the financial terms of Convelo were not disclosed, Genentech decided to enter into another deal whose worth is $1 billion today. The deal was between Genentech and Japan-based Sosei group. They joined hands in the discovery of novel medicines that would modulate G Protein-Coupled Receptor GPCR targets.

Genentech inks discovery deals with Skyhawk, Convelo

Genentech made a deal of $100 million ($1 billion) biobucks with G Protein-Coupled Receptor (GPCR) specialist Sosei Heptares and under this deal; both the companies will work on new meds that modulate GPCR targets. According to Nature, it is believed that between one third and one-half of all marketed drugs act by binding to GPCRs. If this is true, then it completely explains why Genentech was interested in this target.

They decided to focus on two things; one focused on cancer and neurodegenerative diseases, and the other focused on neurological disorders.

For this purpose, Sosei Heptares will combine its GPCR focused structure bases drug design with Genentech’s experiment and Skyhawk will use its Sky STAR technology to find out about small molecules that can modulate RNA splicing and treat numerous oncology and neurological disorders. 

Moreover, the good news is that Genentech is now going to discover both oncology and neurodegeneration and promises to develop market drugs for multiple diseases. In exchange, it only demands the promise of future payments and royalties. 

This agreement proves to be very helpful and exclusive for Genentech all over the world, as it gets the license to develop potential therapeutics that is directed to multiple targets. On the other hand, Skyhawk receives an upfront payment and gets the eligibility to receive all the future payments and royalties. This agreement also says that, if anything happens to clinical development or commercialization, Genentech would be held responsible for that. 

The Genentech collaboration comes to two months after Skyhawk teamed up with Takeda Pharmaceutical and after a year, it penned $60 million with Celgene, and now they could license up to five new drug candidates from the deal. 

As for the deal with Convelo, both Genentech and Convelo will work on new therapies for a better treatment that might revive fatty substances which not only protects but also gives a covering on nerve fibers that appears just like some coating. 

According to James Sabry,

“We believe that GPCRs are that class which plays a great role to cure many diseases. Thanks to Sosei Heptares, because of him, there are more and more drugs being discovered every year, his outstanding capabilities accelerated the discovery of drugs.”

Mallinckrodt and Silence Therapeutics Partner up for RNAi

At first, you need to have a little introduction to these two companies. They both are pharmaceuticals. They provide medicines and research related to medicine. What are they and what do they do? Here’s the introduction.

Mallinckrodt

An Irish–tax registered manufacturer, known as Mallinckrodt Pharmaceuticals of specialty pharmaceuticals, generic drugs, and imaging agent in 2017 generated 90% of sales from the U.S. healthcare system. With such a large network, it is one of the finest and leading pharmaceuticals.

Silence Therapeutics

A biotechnology company that develops therapeutic gene technology based on RNA interference. They are responsible and have major involvement in developmental research of targeted RNAi therapeutics for the treatment of serious diseases.

What is RNAi?

RNAi or RNA Interference is a biological process in our internal body. RNA interferes with RNA to cut it down from double-stranded RNA to single and then to further more pieces. This process inhibits gene expression or translation by targeting RNA and neutralizing it. 

Mallinckrodt and Silence Therapeutics Partnership

Mallinckrodt is the finest and leading pharmaceutical you can find. With such a vast network, it has the power to change, the power to reach out and help maximum. The one problem they were facing was lack of research and information about RNAi. Silence Therapeutics had all the knowledge of RNAi. With that knowledge, you could even treat deadly cancerous diseases. You may have guessed it until now.

One of the ten principles of microeconomics says Trade can make everyone better off. So, Mallinckrodt holding power to reach out and change and Silence Therapeutics with the information made a deal and became partners.

There were some noticeable points made at the time of their partnership. Some of them are mentioned below.

•    This partnership will allow Silence’s platform in the field of RNAi technology to advance. With more advancement, new ways would come out to solve deadly diseases.

•    The agreement provides Mallinckrodt with an exclusive worldwide license for one preclinical asset that targets a specific protein in the complement pathway, C3 (SLN500), and an option for up to two additional assets with different complement protein targets

•    $20 million upfront payment, long-term development, commercial milestones, and royalties on net sales will be received by Silence.

This collaboration will allow both companies to develop an RNAi drug. This drug would be a group of proteins that are involved in the immune system to fight different diseases. These proteins play an important role in the development of inflammation.

These proteins are also considered to contribute to the pathogenesis of many diseases, including autoimmune diseases. This would change the medical world and show it a better path to find more ways to fight deadly diseases.

Not only will this partnership help in the medical field but would also leave an impact on other companies to indulge themselves in these healthy partnerships to produce the best possible outcome. The business world is a dirty place, and it needs to have examples like these.

Inventor of CRISPR, Feng Chang is Targeting Alzheimer’s

Crispr Pioneer Is Aiming Towards Brain Diseases

In recent news, a CRISPR pioneer, Feng Zhang, from the Broad Institute of MIT and Harvard has started up his own pharma company. Dubbed as Beam Therapeutics, it has made headlines because Zhang has collected up to USD 222 million for research funds and development. Zhang largely focusing on editing gene structure and has recently released a ground breaking invention that is expected to be able to manipulate RNA in genes.

This may equip researchers and scientists to one find cures for different brain diseases, such as the likes of Alzheimer’s. The system developed by Zhang and his co-workers is commonly known as RNA Editing for Specific C to U Exchange, or RESCUE for short. Keep reading to find out everything to know about this new invention and what we can expect.

1.    How does it work?

In their research journal, Zhang and his colleagues explain exactly how this new technology works. To put it simply, the technology works inside the cells of the body and alters the gene responsible for late-onset Alzheimer’s to a non-pathogenic form. Previously, the method used for this purpose caused the DNA to split at certain points, posing the risk of altering the DNA chains permanently.

Zhang’s invention targets RNA instead of DNA by using a muted version of another enzyme. To get into the particular, ‘RESCUE’ targets on the base chains of RNA called Cytosine. Cytosine can then be converted into Uridine, which can help manipulate the process of protein synthesis or similar processes that have to do with the genetic restructuring. 

2.    The science behind the project

Speaking in terms of brain disease, as aforementioned, RESCUE can alter the genetic structure in RNA to alter the variant that poses a risk of Alzheimer’s to a non-pathogenic state. According to Zhang and his team, this removes the risk of late-onset Alzheimer’s altogether. RESCUE and RNA editing can also be used to reverse certain synthesis processes to promote healing of wounds. RESCUE largely works on the principle of altering RNA and activates certain hormones in the body to help further the process.  

3.    Future Projections

Taking inspiration from Zhang’s model, other companies and research groups have also begun work on similar technologies. For the future, researchers are confident that these cures can be extended to help with other diseases as well, including Parkinson’s and Duchenne Muscular Dystrophy. There is still plenty more work that needs to be done on RESCUE itself before it can be used practically. Zhang has said that clinical trials are still a little way down the road. This is because there is a very specific set of technologies needed to develop RESCUE.

Conclusion   

Even though CRISPR technology and RESCUE has some ground to cover before it can be used on people, it is a step in the right direction when it comes to the fight against brain diseases. However, using advanced programming and enhancing the precision of RNA editing, some promising results can be expected shortly.