allergan plc (AGN) Key Developments
Allergan plc and Humana Inc. Announces Research Partnership to Improve Health Outcomes
Oct 2 15
Allergan plc announced a multi-year research collaboration with Humana Inc. to explore new ideas and ways to improve the health and well-being of patients, members and their caregivers. A main objective of the Allergan and Humana collaboration is to study key issues and obtain a more comprehensive understanding of opportunities for improvement in care delivery. Under the terms of the agreement, Allergan and Humana will initially focus on the following initiatives: variety of diseases, patient/caregiver relationship and interventional research. One of the collaboration's first projects focuses on Alzheimer's patients' caregiver burden. Unlike caregiving for many terminal illnesses, caregiving for Alzheimer's disease may persist for much longer given that patients with Alzheimer's disease can live for many years.
Allergan plc Receives Approval from the U.S. Food and Drug Administration to Market JUVEDERM® ULTRA XC
Oct 1 15
Allergan plc announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market JUVEDERM® ULTRA XC for injection into the lips and perioral area for lip augmentation in adults over the age of 21. JUVEDERM® ULTRA XC instantly adds fullness to the lips and is the only dermal filler that has proven results lasting up to one year for lip augmentation. Since JUVEDERM® formulations were first approved in the United States in 2006, physicians and patients have relied on them to correct moderate to severe facial wrinkles and folds, such as the parentheses lines around the nose and mouth. This heritage has continued with introduction of JUVEDERM® VOLUMA XC for age-related mid-face volume loss in 2013, and now, with JUVEDERM® ULTRA XC for lip augmentation. In clinical trials of JUVEDERM® ULTRA XC, the majority of subjects reported improvement in the softness, smoothness and natural look and feel of their lips through one year. In clinical trials, 79% of subjects showed a meaningful improvement in lip fullness three months after treatment. Additionally, more than 78% of subjects reported an improvement in their overall satisfaction with the look and feel of their lips at one year after treatment. JUVEDERM® ULTRA XC is a smooth gel formulation made up of a modified form of hyaluronic acid (HA), a naturally occurring sugar found in the human body. The role of HA in the skin is to deliver nutrients and help the skin retain its natural moisture and softness. The gel formulation also contains a small amount of local anesthetic (lidocaine), which helps to improve the comfort of the injection.
Allergan plc Provides Earnings Guidance for the Second Half Ending December 31, 2015
Sep 28 15
Allergan plc provided earnings guidance for the second half ending December 31, 2015. For the period, the company expects GAAP net loss attributable to ordinary shareholders of $682.0 million to $517.0 million, EBIT of $272.0 million to $72.0 million, adjusted EBIT of $3,800.0 million to $4,000.0 million, diluted loss per share of $1.74 to $1.32. Revenue is expected to be greater than $8 billion. On non-GAAP basis, net income attributable to ordinary shareholders of $2,600.0 million to $2,765.0 million, diluted earnings per share of $6.25 to $6.65.
Allergan Launches Generic Version of INVEGA® (Paliperidone)
Sep 25 15
Allergan plc announced that it has launched a generic version of Janssen's INVEGA® (paliperidone extended-release tablets) in the U.S. Allergan is the first company to receive FDA approval for and launch a generic version of INVEGA®. INVEGA® extended-release tablets are indicated for the treatment of schizophrenia in adults and adolescents (12-17 years of age).
Amgen and Allergan Announce Positive Top-Line Results from Phase 3 Study of Biosimilar Candidate ABP 215
Sep 23 15
Amgen and Allergan plc announced a Phase 3 study of biosimilar candidate ABP 215 met its primary and secondary endpoints. The study evaluated the efficacy and safety of ABP 215 compared with Avastin (bevacizumab) in adult patients with advanced non-squamous non-small cell lung cancer (NSCLC). The primary endpoint, an assessment of objective response rates (ORR), was within the prespecified margin for ABP 215 compared to bevacizumab, showing clinical equivalence. Safety and immunogenicity of ABP 215 were comparable to bevacizumab. Secondary endpoint results were consistent with the primary finding and included risk difference of ORR, duration of response and progression-free survival (PFS). ABP 215 is being developed as a biosimilar to bevacizumab, a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2, thus inhibiting establishment of new blood vessels necessary for the maintenance and growth of solid tumors. Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of nine biosimilars in development. Allergan is also independently developing biosimilars.