The U.S. Food and Drug Administration (FDA) has approved Paratek Pharmaceuticals’ (PRTK) product Seysara™ (sarecycline) for inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
Paratek has exclusively licensed U.S. development and commercialization rights of Seysara for acne to Allergan PLC, who has assigned such rights to Almirall SA.
Paratek retains development and commercialization rights in the rest of the world.
Seysara (sarecycline) is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties for the potential treatment of moderate to severe acne in the community setting.
Under the terms of the agreement
– Paratek earned a $12 million milestone payment due upon the FDA approval.
– From now on, Paratek is entitled to receive tiered royalties at rates ranging from high single to low double digits on net sales of Seysara.
This this not all the good news for Paratek. The FDA has also granted approval for Paratek’s antibiotic Nuzyra™ (omadacycline).
A Second FDA Approval
In the same day, the U.S. Food and Drug Administration (FDA) has approved Nuzyra™ (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI).
Nuzyra, a modernized tetracycline, is a once-daily intravenous (IV) and oral antibiotic that exhibits activity across a spectrum of bacteria, including, Gram-positive, Gram-negative, atypicals, and drug resistant strains.
According to Paratek, Nuzyra will be available on the market in the first quarter 2019.
To tell us more about the story, Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer of Paratek said, “In the face of ever-increasing antibiotic resistance, the FDA has granted full approval for Nuzyra’s both community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). We are excited to bring to physicians an effective, well-tolerated monotherapy option for the patients. Nuzyra offers clinicians the ability to treat patients with the IV and transition them home to complete treatment with the oral formulation. This potentially helps reduce hospitalizations and the costs associated with hospital stays.”
The approval of Nuzyra is supported by multiple clinical trials within the company’s global development program. Nearly 2,000 adult patients received Nuzyra and it was found to be efficacious, generally safe and well tolerated. As part of the approval, Paratek has agreed to conduct post marketing studies in CABP and pediatrics.
Michael F. Bigham, Chairman and CEO of Paratek said, “”The approval of Nuzyra is a historic milestone for Paratek as it represents 20 years of research and development of this life-saving antibiotic for patients affected by community-acquired infections. There are countless champions of Nuzyra who have been tireless in their efforts to ensure its advancement to commercialization – from patients, clinicians and study investigators to our Paratek team…”
Keith Kaye, M.D., MPH, Director of Clinical Research, Division of Infectious Diseases, University of Michigan said, “Treating pneumonia and skin infections has become increasingly complex as existing antibiotic therapies sometimes have reduced efficacy as resistance continues to grow. This reality makes it increasingly challenging to provide safe and effective treatments to patients. There continues to be a need for novel antibiotics with both IV and oral formulations, such as Nuzyra, to help physicians stay ahead of the evolving resistance landscape.”
The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause 2 million illnesses and approximately 23,000 deaths each year in the United States.The main bacteria causing CABP, Streptococcus pneumoniae, is responsible for 1.2 million infections and 7,000 deaths, whereas ABSSSI is responsible for more than 750,000 hospitalizations. The increase of antibiotic resistance continues to drive the need for new, effective therapies.
Paratek focuses on drugs that target infectious disease and other difficult to treat conditions. What we observed from the firm’s founders’, scientists’ and members of the management’s discussions and tellings, convinced us that the target of the firm’s highly regarded scientists is beating antibiotic resistance and improving the safety of the drugs.
Paratek Pharmaceuticals’ team comprises highly regarded experts in general chemistry and in novel tetracycline chemistry. The company’s product Nuzyra™ (omadacycline) is a new broad-spectrum once-daily intravenous and oral antibiotic being developed for serious community-acquired bacterial infections, including community-acquired bacterial pneumonia, acute bacterial skin and skin structure infections, and urinary tract infections.
The job was well done and the FDA has grated approval for Nuzyra to treat the same infectious diseases Paratek intended to treat. The product will be launched in early 2019.
Antibiotic resistance, if not challenged and defeated would take us back to the time when infection was the #1 killer of babies, children and adults. We enjoy each and every news announcing that scientists in academia or in drug companies have found solutions for one or another of the bacterial resistance to antibiotics. Our excitement doubles when we learn that the FDA has approved two antibiotics that beat resistant infective organisms to antibiotics that used to kill them.
Paratek’s two products have been granted approvals. The acne product when successful also becomes a remedy for those teenagers who suffer tremendously with concerns about themselves because of their acne.
While we love the news from Paratek, we don’t know whether we have to question the reason why investors have sold the stock after hearing the good news, instead of buying into it.
It could be the traders’ rule of thumb, “Sell on Good News”, which should always be considered, or that investors might not have liked the fact that the launch of the wholly-owned product Nuzyra™ (omadacycline) will be early next year instead of now. It could also be that investors believed the royalty decided upon with Almirall might not be fair for Paratek.
Against these possible reasons for investors’ negative reaction, other positive facts include, Paratek’s decision to retain the development and commercialization rights in the rest of the world. Also the fact that marketing the product by the professional market Almirall in the United States should make the potent acne drug a bestseller.
We Loved to hear the news about these two improved antibiotic approvals.
At this moment, the stock is trading at $10.09 UP $0.85
|Stock Trading Price:||$10.99 UP $0.85|
|52-Week Range:||$26.10 – $9|
We believe Paratek has nowhere to go but up.
We will post important news under Today’s Highlights after market hours.