Limited Distribution Deals Announced

Announcements for newly approved specialty drugs often state that the product will be available through specialty pharmacy in limited distribution. However, the press releases rarely specify the specialty pharmacy(ies) selected as the designated partner(s).

Here are several LD deals that have been recently publicly confirmed subsequent to the approvals.

Amber Specialty Pharmacy Added to Pfizer’s Limited Distribution Network for Oncology Portfolio

August 03, 2022  — OMAHA, Neb.–(BUSINESS WIRE)–Amber Specialty Pharmacy announced that they will begin dispensing 13 Pfizer oncology products. The pharmacy’s comprehensive service model will support patients, caregivers, and oncology specialists throughout the country. 

The Pfizer portfolio of oncology products now supported by Amber Specialty Pharmacy includes:

  • Besponsa® (inotuzumab ozogamicin)
  • Bosulif® (bosutinib)
  • Braftovi® (encorafenib)
  • Daurismo® (glasdegib)
  • Ibrance® (palbociclib)
  • Inlyta® (axitinib)
  • Lorbrena® (lorlatinib)
  • Mektovi® (binimetinib)
  • Mylotarg® (gemtuzumab ozogamicin)
  • Sutent® (sunitinib malate)
  • Talzenna® (talazoparib)
  • Vizimpro® (dacomitinib)
  • Xalkori® (crizotinib)

Biologics by McKesson is now the Exclusive Specialty Pharmacy Provider of XERMELO

CARY, N.C., July 25, 2022 -Biologics by McKesson has been selected by TerSera Therapeutics LLC, as the exclusive specialty pharmacy provider for XERMELO (telotristat ethyl), effective Sept. 1, 2022. XERMELO is used for the treatment of Carcinoid Syndrome Diarrhea in adults who are not adequately controlled by somatostatin analog (SSA) therapy. XERMELO was approved by the FDA in 2017, as an orally administered, tryptophan hydroxylase inhibitor indicated for use in combination with SSA therapy for the treatment of Carcinoid Syndrome Diarrhea in patients with metastatic neuroendocrine tumors. 

ORSINI SPECIALTY PHARMACY SELECTED AS LIMITED DISTRIBUTION PARTNER FOR AMVUTTRA

ELK GROVE VILLAGE, Ill., July 20, 2022 /PRNewswire/ — Orsini Specialty Pharmacy was chosen by Alnylam Pharmaceuticals as a specialty pharmacy partner for AMVUTTRATM (vutrisiran). AMVUTTRA is indicated to treat the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.  A rare, rapidly progressive, and often fatal disease, hATTR amyloidosis affects approximately 50,000 patients worldwide. 

ORSINI SPECIALTY PHARMACY SELECTED AS THE EXCLUSIVE SPECIALTY PARTNER FOR ZTALMY

ELK GROVE VILLAGE, Ill., July 28, 2022 /PRNewswire/ — Orsini Specialty Pharmacy announced that Marinus Pharmaceuticals, Inc. has selected it as the exclusive specialty pharmacy for ZTALMY(ganaxolone). ZTALMY is the first and only treatment approved specifically for seizures associated with CDKL5 deficiency disorder (CDD) in patients two years of age and older.  CDKL5 deficiency disorder (CDD) is a serious and rare genetic disorder caused by a cyclin-dependent kinase-like 5 (CDKL5) gene mutation. 

PANTHERx Rare Announces Partnership with Biocodex for the Distribution of DIACOMIT (stiripentol)

PITTSBURGH, June 27, 2022 /PRNewswire/ — PANTHERx Rare announces that it has been selected by Biocodex as their new exclusive U.S. pharmacy distribution partner for DIACOMIT® (stiripentol). DIACOMIT is a new molecular entity approved by the FDA in 2018 for the adjunctive treatment of seizures associated with Dravet syndrome in those 2 years of age and older taking clobazam. An orally administered antiseizure, DIACOMIT is given as either a capsule or powder for suspension. Dravet syndrome, also known as Severe Myoclonic Epilepsy Infancy (SMEI), is a rare epileptic disorder typically diagnosed in infancy occurring in 1 in 15,700 individuals in the United States.

Soleo Health Named as Limited Drug Distribution Partner for Administration of LEQVIO

July 26, 2022  — FRISCO, Texas–(BUSINESS WIRE)–Soleo Health announced that it has been selected as a limited distribution partner for cardiovascular drug LEQVIO, manufactured by Novartis. LEQVIO subcutaneous injection is indicated as an adjunct to diet and statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-C).  Soleo Health will administer to patients in their homes or at one of the Company’s Ambulatory Infusion Centers (AICs) nationwide.

Soleo Health Selected As a Specialty Pharmacyto provide Cuvitru

Administered subcutaneously, Cuvitru is manufactured by Takeda Pharmaceutical Company Ltd. Cuvitru replaces antibodies not working correctly or are missing from one’s body to help protect it against infection. CUVITRU is for treating primary immunodeficiency (PI) in adults and children two years of age and older.

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