Founded in 1995, Paratek Pharmaceuticals
What Is Omadacycline
Omadacycline is the lead candidate at Paratek being developed as a broad-spectrum antibiotic with IV and oral formulations. The treatment is an antibiotic in a new class of compounds known as aminomethylcyclines. These aminomethylcyclines are related to the tetracycline class.
Tetracyclines were first launched in the 1950s with tolerability and efficacy data that led to extensive use for the treatment of various infections. Unforutnately, as time passes, infections are becoming increasingly resistant to antibiotic, making tetracyclines far less effective. As a result, today’s tetracycline based medications are only used for a few types of infections.
Paratek designed Omadacycline to overcome the challenges faced by antibiotics revolving around tetracyclines. By designing a molecule that substitutes specific positions on the tetracycline chemical structure, Paratek believes that it has overcome tetracycline resistance mechanisms.
The Omadacycline NDA Was Granted Priority Reivew
Omadacycline has caught the attention of the United States Food and Drug Administration (FDA) after positive clinical data (which we will discuss shortly). In fact, after submitting its New Drug Application (NDA) to the FDA, the application was accepted and the regulatory agency granted priority review. Priority review is only granted when the drug being reviewed has the potential to have a tremendous impact on the a disease or diseases.
Considering the declining efficacy of antibiotics, it makes sense that the FDA would grant a priority review here. After all, more and more patients are having to go to the doctor for multiple lines of therapy due to the shrinking efficacy we’re seeing. Therefore, if Omadacycline is capable of overcoming antibiotic resistance, it is a much needed option for patients and physicians alike. Nonetheless, due to the priority review, the PDUFA date is just around the corner on October 4, 2018.
FDA Advisory Committee Meeting Takes Place As We Speak
Later today, we’re going to receive more information on what’s happening with Omadacycline. On June 20th, 2018, Paratek Pharmaceuticals announced that the UFDA had informed the company that the meeting of the Antimicrobial Drugs Advisory Committee of the FDA would take place on the 8th of August.
This meeting is incredibly important and has the ability to act as a catalyst, either positive or negative, for Paratek. The FDA has various advisory committees surrounding various disciplines of medication. These advisory committees comb through the data provided through the New Drug Application, providing their opinion with regard to whether or not a drug should be approved. These advisory committees are built up of leading experts in the disciplines upon which the committees are focused.
Therefore, avisory committee votes hold incredible weight on the FDA’s decision to approve or reject a treatment. In fact, historically, when the advisory committee votes to approve a treatment, that treatment has a strong chance of achieving FDA approval. Adversely, when an advisory committee votes to reject a treatment, the same, strong chance that the FDA’s decision will lead in the direction of the advisory committee’s vote exists.
The Coming Catalyst Represents An Opportunity In The Making
Since July 25, 2018, Paratek Pharmaceuticals has been seeing declines in the market. In that short period of time, the stock has given up more than 9%. It’s arguable that these declines are actually an opportunity in the making. The data surrounding the treatment showed very strong efficacy and good safety and tolerability metrics, suggesting that the advisory committee meeting will be a positive one.So, mark your calendars as August 8th could prove to be a very exciting day.