This month in business
Remember Allergan’s eyeing-up of Salix?
Back when Allergan was trying to avoid takeover by Valeant, they looked at buying the specialist pharmaceutical company, Salix, for US$11 billion. Why? Doing so would wipe out their particularly attractive net cash proportion. It appears that Salix was suffering from inventory issues – wholesalers had amassed too much stock of their biggest-selling products, Uceris, Apriso and Xifaxan. Salix’s Q4 2014 and Q1 2015 sales will therefore have suffered. After their deal with Allergan fell through, Salix was then briefly courted by Actavis – who went on to buy Allergan instead.
EMA’s CHMP recommend Chiesi’s Holoclar for limbal stem cell deficiency
Chiesi Farmaceutici S.p.A.’s Holoclar – an ex vivo autologous corneal epithelial cell preparation (that includes stem cells) has been recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for approval in the EU. The recommended indication is for the treatment of adult patients with moderate to severe limbal stem cell deficiency, and Holoclar is the first advanced therapy medicinal product containing stem cells receive this recommendation.
Alcon’s Travatan label is expanded
Travatan (travoprost 40 μg/mL eyedrops) has a new indication in the EU: the “decrease of elevated intraocular pressure in pediatric patients aged 2 months to <18 years with ocular hypertension or pediatric glaucoma.” The European Medicines Agency gave approval based principally on the results of a multicenter, double-blind Phase III clinical trial (NCT01652664), which showed that travoprost therapy was associated with a reduced IOP by the second week of treatment, which was maintained throughout the 12 weeks of the study.
FDA gives the thumbs-up to RESCAN 700, ranibizumab in diabetic retinopathy, and MANF for RP.
The FDA has given marketing approval for Zeiss’ intraoperative OCT, RESCAN 700, as well as granting breakthrough therapy designation for ranibizumab for the treatment of diabetic retinopathy. Amarantus BioScience’s mesencephalic astrocyte-derived neurotrophic factor (MANF) – an apoptosis inhibitor/ growth factor – has also received orphan drug designation for retinitis pigmentosa. Preclinical studies have shown protective effects in the retina, and toxicology studies have demonstrated MANF to be well-tolerated after a single intravitreal administration of a therapeutically relevant dose.