| READ! Nabriva has granted one of Roivant's subsidiary an exclusive license to develop and commercialize lefamulin in the greater China region, specifically the People's Republic of China, Hong Kong, Macau, and Taiwan.|
The Roivant's affiliate will be solely responsible for all clinical development and regulatory filings necessary to secure approval in the covered territories.
Both companies will establish a joint development committee to review and oversee all development and commercialization plans.
Roivant will make an upfront payment of approximately $5 million to Nabriva along with approximately $90 million in additional payments tied to the successful completion of certain regulatory and commercial milestones related to lefamulin for community-acquired bacterial pneumonia (CABP).
Additionally, Nabriva will be eligible to receive low double-digit royalties on sales upon approval in the covered territories.
Roivant has a Broad Therapeutic Portfolio and Deep Development and Commercialization Expertise
Dr. Colin Broom, Chief Executive Officer of Nabriva, stated that Roivant has a broad therapeutic portfolio and deep development and commercialization expertise, making the company an excellent partner as Nabriva pursue bringing an important and much-needed new treatment option for CABP and potentially other serious bacterial infections to China and surrounding territories. Dr. Colin added that the funding from this agreement will also contribute to the Company's efforts to prepare for a successful launch should lefamulin be approved in the United States.
Lefamulin Successful in Late-Stage CABP Study
In September 2017, Lefamulin completed LEAP 1 study, a pivotal, international Phase-3 clinical trial. The study evaluated the efficacy and safety of intravenous (IV) to oral lefamulin in adult patients with moderate to severe CABP compared to moxifloxacin with or without adjunctive linezolid. In LEAP 1, lefamulin met both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) primary endpoints of non-inferiority compared to moxifloxacin with or without adjunctive linezolid.
Nabriva Anticipates Filing NDA in the Second Half of 2018
In the US, Nabriva anticipates filing a New Drug Application (NDA) in the second half of 2018 contingent on positive results from its second, pivotal Phase-3 clinical trial of lefamulin for CAPB, which is referred to as LEAP 2. Top-line data from LEAP 2 is expected in the spring of 2018. LEAP 2 is designed to assess the efficacy and safety of oral lefamulin compared to oral moxifloxacin in adult patients with moderate CABP.
About Community-Acquired Bacterial Pneumonia
CABP refers to pneumonia contracted by a person with little contact with the healthcare system. CABP is a leading cause of illness and death worldwide. Its causes include bacteria, viruses, fungi, and parasites. Symptoms and signs are fever, cough, sputum production, pleuritic chest pain, dyspnea, tachypnea, and tachycardia. Diagnosis is based on clinical presentation and chest x-ray.
Lefamulin is a semi-synthetic derivative of pleuromutilin that inhibits a key process for bacterial growth. In pre-clinical studies, lefamulin has demonstrated a targeted spectrum of activity against pathogens that most commonly cause CABP, including multi-drug resistant strains. Due to its novel mechanism of action, low incidence of cross-resistance between other antibacterial agents commonly used to treat CABP, and low propensity for bacterial resistance to develop, lefamulin has the potential to be used as a first-line empiric monotherapy for the treatment of CABP.Re: Analyst AVG PT $17.63 link..Re: Spiked over $14 last data...last $4.73..Re: T...
| Reply to burp - Msg #2728968 - 04/11/2018 10:45|