Pfizer said it will acquire privately held, specialty pharmaceutical company NextWave Pharmaceuticals for $255 million, with NextWave shareholders eligible to receive additional payments of up to $425 million based on certain sales milestones. NextWave, focused on products for treating ADHD and related CNS disorders, markets Quillivant XR (methylphenidate hydrochloride), a once-daily liquid ADHD medication approved in September. Pfizer entered into an option and merger agreement with NextWave during second-quarter 2012 and made an option payment of $20 million. Pfizer is now exercising its option to acquire the company. Deal terms call for Pfizer to pay $255 million to NextWave shareholders at the close of the transaction, expected during the fourth quarter subject to regulatory approval. Shareholders are eligible to receive additional payments of up to $425 million based on certain sales milestones.
NovoNordisk's ultra long-acting insulins Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) won positive recommendations from the European Medicines Agency (EMA). Once-daily Tresiba has a duration of action beyond 42 hours, the company said. Ryzodeg can be administered once- or twice-daily. Financial analyst Soren Lontoft, of Sydbank, was quoted by Reuters as estimating peak annual sales of Tresiba at around 22 billion Danish crowns ($3.9 billion) worldwide and around 6 billion in Europe. An approval would challenge Sanofi's 10-year dominance in the long-acting insulin market, Lontoft, said, as quoted by Reuters. Both basal insulin products are headed for a review by US regulators on Nov. 8.
The EMA also rejected a treatment for Alzheimer's disease from Lundbeck called Acrescent, as studies presented did not present a clear benefit. The treatment combines two substances, memantine hydrochloride and donepezil hydrochloride, which already have approval in the EU as separate treatments, the EMA said.