-=Adamis Pharma (ADMP) : Fast-Track Application for Covid Drug

 

10:54 AM ET 1/10/22 | Dow Jones

Adamis Pharmaceuticals Corp. shares rose more than 30% on Monday after the biopharmaceutical company said it had filed for U.S. Food and Drug Administration fast-track designation for Tempol for the treatment and prevention of Covid-19.

The San Diego company, which is currently conducting a Phase 2/3 study of Tempol in adults with confirmed Covid-19 infection, said the drug has been shown to have antiviral, anti-inflammatory and antioxidant activity.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Adamis said that while the FDA has recently approved oral antiviral Covid-19 drugs, including pills from Pfizer Inc. and the team of Merck & Co. and Ridgeback Biotherapeutics, the company believes Tempol would qualify for the designation because of its unique mechanism of action and safety profile.

-=Adamis Pharma (ADMP) : opioid overdose treatment gets FDA approval

 

Adamis Pharma announces that the U.S. Food and Drug Administration has approved Adamis' ZIMHI 5 mg/0.5 mL product

ZIMHI is a high-dose naloxone injection product FDA-approved for use in the treatment of opioid overdose.

-=Adamis Pharma (ADMP) submits a Covid drug to FDA

• Adamis is requesting the FDA's permission for investigational use of its Covid treatment drug Tempol. 

Tempol has demonstrated both potent anti-inflammatory, anticoagulant, and antioxidant activity. Both inflammatory cytokines and reactive oxygen species (ROS) from cells of the immune system called macrophages and neutrophils damage the lung in Acute Respiratory Distress Syndrome (ARDS). In animal models, Tempol has been shown to decrease proinflammatory cytokines (cytokine storm), and through its potent antioxidant activity has been shown to decrease the harmful effects of ROS. In addition, Tempol has been shown to decrease platelet aggregation, a problem observed in many COVID-19 patients. Numerous published articles describing animal models of ARDS show Tempol to cause a decrease in lung inflammation and preserve lung pathology associated with acute and chronic lung injury. To this end, Tempol has been shown to decrease the genes (HIF-la and HIF-2a) associated with hypoxia. Hypoxia is a key indicator often associated with severe disease and a poor outcome. Controlling hypoxia and the cytokine storm can be considered essential to the successful treatment of COVID-19.

Dr. Dennis J. Carlo, President and CEO of Adamis commented: “With over 23 million COVID-19 infections in the US and over 394,000 deaths in the US (according to the CDC), additional treatments are urgently warranted. We believe that Tempol could play a pivotal role not only in the treatment of COVID-19, but actually in preventing hospitalization. With new mutations occurring in the virus, it is apparent there is an ongoing need for new therapies. 

====Adamis Pharmaceuticals (ADMP) may benefit from rival Mylan's (MYL) pricing fiasco of EpiPens

Adamis Pharmaceuticals (ADMP) could benefit from rival Mylan's (MYL) high price of EpiPens as its own product is reportedly close to approval. Adamis has an epinephrine pre-filled syringe that may be better than the EpiPen, even apart from the price controversy.
Price target: $10