P.D.: Grifols compro el 35% del capital de Aradigm el pasado 28 Agosto 2013 mediante la suscripción de 25,7 millones de dólares (19,8 millones de euros) en una ampliación de capital cuyo importe total asciende a 40,7 millones de dólares (31,3 millones de euros), sin prima de emisión.
Grifols cuenta con dos miembros en el consejo de administración de Aradigm.
Esta adquisición se enmarca dentro de un acuerdo estratégico global, ya que Grifols suscribió un contrato de licencia exclusiva de ámbito mundial con Aradigm Corporation para el desarrollo y comercialización del fármaco Pulmaquin.
La firma será la responsable de los gastos de desarrollo y clínicos para las indicaciones de bronquiectasia hasta un máximo de 65 millones, mientras que Aradigm tendrá derecho a recibir de Grifols hasta 25 millones de dólares de forma escalonada, ligados al cumplimiento de determinados hitos en el desarrollo del producto.
Grifols será el responsable de las actividades comerciales y satisfará a Aradigm un 'royalty' teniendo en cuenta las ventas mundiales.
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HAYWARD, Calif., Apr 30, 2014 (BUSINESS WIRE) -- Aradigm Corporation (“Aradigm” or the “Company”) today announced the dosing of the first patient in the ORBIT-3 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) Phase III pivotal clinical trial of Aradigm’s proprietary formulation of inhaled ciprofloxacin (Pulmaquin®) for the treatment of non-cystic fibrosis bronchiectasis (non-CF BE).
The first patient was dosed by respiratory physician Dr. Douglas Fiedler at Nebraska Pulmonary Specialties, LLC. “I am very pleased to participate in this study to investigate the potential benefits of a new medication for my patients with a chronic debilitating respiratory disease for which we do not have any good evidenced-based treatments yet,” said Dr. Fiedler.
“With our Phase III trials under way now, it is gratifying that many clinicians around the world will be joining our effort to find a treatment for an unmet medical need in patients with the severe condition of non-cystic fibrosis bronchiectasis,” said Juergen Froehlich, MD, Chief Medical Officer of Aradigm.
The Phase III clinical program for Pulmaquin in BE consists of two worldwide, double-blind, placebo-controlled pivotal trials (ORBIT-3 and ORBIT-4) that are identical in design except for a pharmacokinetics sub-study to be conducted in one of the trials. Each trial will enroll approximately 255 patients into a 48 week double blind period consisting of 6 cycles of 28 days on treatment with Pulmaquin or placebo plus 28 days off treatment, followed by a 28 day open label extension in which all participants will receive Pulmaquin (total treatment duration approximately one year). The superiority of Pulmaquin vs. placebo during the double blind period will be evaluated in terms of the time to first pulmonary exacerbation (primary endpoint), while key secondary endpoints include the reduction in the number of pulmonary exacerbations and improvements in the quality of life measures. Lung function will be monitored as a safety indicator.
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