TABLE 2 An at-a-glance review of phosphate binders (16,17) Formulations Common adverse Medication available effects Notes Calcium Capsule, Hypercalcemia 25% elemental acetate tablet, oral calcium (PhosLo, solution Eliphos, Phoslyra
, Calphron) Calcium Chewable or Hypercalcemia 40% elemental carbonate non-chewable calcium (Turns, tablets others) Ferric Tablet Diarrhea, nausea, Increases serum citrate constipation, iron (Auryxia) dark-colored stool Lanthanum Chewable Nausea, vomiting, Less than .
The study was designed as a randomized, controlled, 3-arm open-label, cross-over Phase I study to demonstrate the bioequivalence of Phoslyra to PhosLo Gelcaps in healthy subjects.
The treatment sequences were ABC, BCA, and CAB, where A was Phoslyra, B was PhosLo Gelcaps, and C was calcium citrate (Figure 1).
Study medication dosages with each meal were 30 mL Phoslyra (667 mg calcium acetate per 5 mL), six PhosLo Gelcaps (667 mg calcium acetate/Gelcap), and five-5 calcium citrate caplets (950 mg calcium citrate/caplet), resulting in a daily dose of 90 mL Phoslyra and 18 PhosLo Gelcaps.
Insulin levels were measured to detect any potential effects of Phoslyra on serum insulin.
Nabi will acquire all of the shares in BTA for new shares in the name of Biota Pharmaceuticals and BTA will be de-listed from the ASX; Nabi's assets at merger will include USD54m in cash, a right to receive royalties from PhosLyra
and an interest in NicVAX.
The new Biota Pharmaceuticals will have royalty generating products Relenza, Inavir and potentially PhosLyra
, programmes for respiratory syncytial virus (RSV) and hepatitis C (HCV-NN), a broad spectrum antibiotic targeting gyrase (GYR), a USD231m (EUR175m) worth contract with Barda to develop laninamivir, as well as a USD100m cash interest in the nicotine conjugate vaccine NicVAX.
Under the agreement with Fresenius, Nabi can collect Phoslyra royalties until ten years after the closing date or 14 November 2016.
5m milestone payment tied to approval of a new indication for PhosLo along as well as approximately USD65m in potential royalty payments based on annual sales of Phoslyra over a base amount.
5m) payment from Fresenius USA Manufacturing Inc that was triggered by the first commercial sale of Phoslyra.
These assets included the rights to a new liquid formulation of PhosLo that Fresenius has commercialised as Phoslyra.