Pipeline

Ensifentrine (RPL554) is an investigational, first-in-class, dual inhibitor of the enzymes phosphodiesterase 3 and 4 ("PDE3" and "PDE4") that combines bronchodilator and anti-inflammatory activities in one compound. In Phase 2 clinical studies in COPD, Ensifentrine has shown significant and clinically meaningful improvements in lung function, symptoms and quality of life as a monotherapy or added onto a maintenance bronchodilator. In the Phase 3 ENHANCE-2 clinical trial, Ensifentrine showed significant and clinically meaningful improvements in lung function measures and reduced the rate of COPD exacerbations. Ensifentrine has been well tolerated in clinical trials involving more than 2,200 subjects to date.

AeroFact™ is a nasally inhaled surfactant based on a combination of the long-established bovine lung surfactant Alveofact^® (Lyomark Pharma GmbH, Germany) with a precise and highly efficient nasal delivery system featuring Aerogen's next generation "PDAP™" delivery technology and a touch-screen controller interface. Aerosol delivery of pulmonary surfactant to preterm infants through the nose to the lung is extremely demanding, due to both the technically challenging physical properties of the drug and the difficulties inherent in treatment of such small patients, but is achieved by PDAP, a technical breakthrough based on patented enhancements to the Aerogen group's market-leading aerosol generator technology (www.aerogen.com). AeroFact is anticipated to reduce the need for sedation, invasive intubation and mechanical ventilation, all features of current surfactant treatment methods associated with adverse side effects and the potential to exacerbate chronic lung disease in preterm infants.

Bavarian Nordic's vaccine candidate, MVA-BN RSV, is being developed for the prevention of respiratory syncytial virus (RSV) in older adults. The vaccine incorporates five distinct RSV antigens to stimulate a broad immune response against both RSV subtypes (A and B), thus mimicking the immune response observed following a natural response to an RSV infection. The vaccine candidate is based on Bavarian Nordic's proven MVA-BN platform technology, which is employed in several approved vaccines.

In 2021, Bavarian Nordic reported results from a clinical Phase 2 double-blinded, placebo-controlled human challenge trial (n=61), which enrolled healthy adult volunteers, who were randomized to receive either a single vaccination of MVA-BN RSV or placebo. Volunteers were challenged intranasally with an RSV type A strain 28 days after vaccination. The study demonstrated a significant reduction in viral load in vaccinated subjects (n=30) versus placebo (n=31), thus meeting the primary endpoint. In the vaccinated subjects, clinical symptoms typically associated with RSV infections were significantly reduced. Further, the vaccine demonstrated an efficacy of up to 79% in preventing symptomatic RSV infections[1].

Bavarian Nordic has also previously reported strong results from a Phase 2 trial of MVA-BN RSV in 421 older adults, demonstrating that the vaccine was well-tolerated and induced both broad and durable antibody and T-cell responses against RSV, as well as mucosal immune responses that may be important for protection against RSV. The trial included a revaccination of subjects after one year, following which the immune responses were rapidly and significantly increased, notably in subjects with the weakest immunity prior to the booster vaccination*. 

MVA-BN RSV has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for active immunization for prevention of lower respiratory tract disease caused by RSV in adults aged 60 years or older. It has also been granted access by European Medicines Agency (EMA) to its priority medicines (PRIME) scheme for MVA-BN® RSV in active immunization for the prevention of lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus (RSV) in adults ≥60 years of age.

* Jordan E. et al. 2010. J. Infect, Dis. 28:223(6). 1062-1072

Bentrio™ Allergy Blocker is a drug-free nasal spray for personal protection against airborne allergens. Upon application into the nose, Bentrio formsa protective gel layer on the nasal mucosa. This thin fi lm is designed to prevent the contact of allergens with cells; in addition, the compositionserves to bind such particles and help with their discharge. Together, this is designed to reduce the risk of upper respiratory tract viral infectionsand promote alleviation of allergic symptoms.

Ketorolac (NTM-001) is a novel, alcohol-free formulation of ketorolac in a convenient, ready-to-use, pre-mixed bag for continuous 24 hours IV infusion, for the treatment of moderately severe acute pain requiring analgesia at the opioid level, usually in a postoperative setting with the potential benefit of consistent pain relief without the risks associated with opioids, or the disadvantages of bolus short-acting analgesics.

• Treatment of unstable angina

• Long-term treatment of vasospastic angina, acute myocardial infarction, acute left ventricular failure

• 10ml: 10mg isosorbide dinitrate
  

Treatment of acute angina pectoris, prophylaxis of acute angina pectoris, acute myocardial infarction, acute left ventricular failure

• 16g: 0.471g isosorbide dinitrate

• 1.25mg isosorbide dinitrate / spray

• Long-term treatment of coronary artery disease (CAD)

• Long-term treatment and prevention of angina pectoris (including postmyocardial infarction)

• Long-term treatment of chronic congestive heart failure in combination with cardiac glycosides
  

• 50mg

• 10 capsules / 20 capsules / 30 capsules
  

Treatment of Iron Deficiency Anemia

• 10 capsules / 30 capsules

• Each capsule contains 0.15 grams of elemental iron