Announcements for newly approved specialty drugs often state that the product will be available through specialty pharmacy in limited distribution. However, the early press releases rarely specify the specialty pharmacy(ies) selected as the designated partner(s).
Here are ten LD deals that have been publicly confirmed subsequent to their approvals.
Onco360 to Distribute Vyloy
Onco360 has been selected as a national pharmacy partner by Astellas for Vyloy (zolbetuximab-clzb), approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) positive, as determined by an FDA-approved test.
Onco360 to Distribute Gomekli
Onco360 has been selected as a national pharmacy partner by SpringWorks Therapeutics, Inc. for Gomekli (mirdametinib) for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.1
Orsini to Distribute Attruby
Orsini has been selected by BridgeBio to distribute Attruby (acoramidis), an orally administered treatment for cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM). ATTRUBY is a near-complete (≥90%) stabilizer of transthyretin for the treatment of adults with ATTR-CM, to reduce cardiovascular death and cardiovascular-related hospitalization.
Orsini to Distribute Kebilidi
Orsini announced that it has been chosen by PTC Therapeutics as the exclusive specialty pharmacy provider for the adeno-associated virus vector-based gene therapy Kebilidi (eladocagene exuparvovec-tneq). Kebilidi is approved for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency.
Orsini to Distribute Yorvipath
Orsini is partnering with Ascendis Pharma for the distribution of Yorvipath, a FDA approved parathyroid hormone analog (PTH1-34) indicated for the treatment of hypoparathyroidism in adults
PantherRx Rare to Distribute Attruby
PantherRx Rare has been selected by BridgeBio to distribute Attruby (acoramidis), an orally administered treatment for cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM). ATTRUBY is a near-complete (≥90%) stabilizer of transthyretin for the treatment of adults with ATTR-CM, to reduce cardiovascular death and cardiovascular-related hospitalization.
Panther Rx Rare to Distribute Yorvipath
PantherRx Rare is partnering with Ascendis Pharma for the distribution of Yorvipath, a FDA approved parathyroid hormone analog (PTH1-34) indicated for the treatment of hypoparathyroidism in adults
Panther Rx Rare to Distribute Tryngolza
PantherRx Rare was selected by Ionis Pharmaceuticals, Inc. for the distribution of Tryngolza (olezarsen), the first and only treatment approved by the FDA as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
Panther Rx Rare to Distribute Crenessity
PantherRx Rare was selected by Neurocrine Biosciences, Inc. for the distribution of Crenessity (crinecerfont), an oral selective corticotropin-releasing factor type 1 (CRF1) receptor antagonist indicated to improve androgen control and enable a reduced glucocorticoid dose in patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).
AnovoRx Specialty Pharmacy to Distribute Increlex
AnovoRx has been named the exclusive distributor of Increlex (mecasermin injection) from Eton Pharmaceuticals (following the acquisition of Increlex from Ipsen S.A. Increlex is a biologic product used to treat pediatric patients 2 years of age and older who suffer from the severe primary insulin-like growth factor 1 deficiency (SPIGFD) a rare condition.
