Monday, January 25, 2016

First Patient Enrolled in Clinical Trial to Test Novel Gene Therapy for Hemophilia A

 

In this Issue

•  IVIG/Albumin Supply Index
•  Open Market Pricing
•  New Products from FFF
•  Current Medicare
IVIG / SCIG Rates
•  Resources
•  Subscribe to IG Living and BioSupply Trends Quarterly

BioMarin announced that it has initiated a Phase I/II clinical study to evaluate the safety and efficacy of its investigational adeno-associated virus (AAV)-factor VIII vector, which is designed to partly restore plasma factor VIII concentrations to levels needed for blood clotting in severe hemophilia A. [ read more ]

IVIG Treatment Effective for SLE Patients with Concomitant Infection

In a recent study, intravenous immune globulin (IVIG) effectively treated patients with active systemic lupus erythematosus (SLE) and concomitant infection, as well as hematological and cardiac involvement. [ read more ]

A New Approach to Predict Evolution of Influenza Viruses Can Enhance Vaccine Efficacy

New study results suggest that genomic information from circulating influenza viruses can help in producing more efficient seasonal flu vaccines. The researchers were able to develop a simple approach for reliable real-time tracking and prediction of viral evolution based on whole-genome sequences of influenza viruses.
[ read more ]

Industry News

 
 

From Kedrion Biopharma

Kedrion Biopharma has gained exclusive
rights to market Biotest Pharmaceuticals' Bivigam
(immune globulin intravenous [human] 10% liquid)
for the treatment of primary immunodeficiency
in the U.S. [ read more ]

From Baxalta

Dublin-based Shire has agreed to acquire Baxalta for a total consideration of approximately $32 billion. The combination of the two companies will create the world’s leading supplier of therapeutics for rare diseases, both in revenue and depth of development-stage product pipeline.
[ read more ]

From Arsia Therapeutics

The Cambridge, Massachusetts-based biopharmaceutical start-up Arsia Therapeutics announced a new collaboration with Biogen to investigate formulations of intravenously infused hemophilia treatments that could be administered at home through subcutaneous injections. [ read more ]

From Baxalta

In December, the U.S. Food and Drug Administration (FDA) approved Vonvendi, von Willebrand factor (recombinant), for use in adults 18 years of age and older who have von Willebrand disease (VWD). It is the first FDA-approved recombinant von Willebrand factor, and is approved for the on-demand (as needed) treatment and control of bleeding episodes in adults diagnosed with VWD. [ read more ]

IVIG & Albumin Supply Index

 
 

Featured Product Of The Month

Bivigam (BioTest)

BIVIGAM (immune globulin intravenous (human) 10% liquid) is indicated for the treatment of primary humoral immunodeficiency, including but not limited to the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies. The product has a median half-life of 30 days, contains no sucrose/glucose/maltose, is stabilized with glycine, has trace amounts of IgA, contains a latex-free stopper, features tamper-evident seals and can be stored for up to 24 months (until expiration date on vial packaging) at 2 degrees to 8 degrees Centigrade.

For more information about Bivigam, go to biosupply.fffenterprises.com

Nuwiq (Octapharma)

NUWIQ is a recombinant antihemophilic coagulation Factor VIII indicated in adults and children with Hemophilia A for: 1) on-demand treatment and control of bleeding episodes; 2) perioperative management of bleeding; and 3) routine prophylaxis to reduce the frequency of bleeding episodes. Nuwiq is not indicated for the treatment of von Willebrand Disease. It is available in four vial sizes: 250 IU, 500 IU, 1000 IU and 2000 IU. Store at 2 – 8°C (35 – 46°F) for up to 24 months. Do not freeze.

Miacalcin (Mylan Institutional)

MIACALCIN (calcitonin-salmon) synthetic injection is for subcutaneous or intramuscular use and is indicated for the following conditions: 1) hypercalcemia; 2) Paget’s disease of bone; and 3) postmenopausal osteoporosis. It is available as a sterile solution in individual 2 mL multi-dose vials containing 200 IU per mL, and should be refrigerated between 2 degrees to 8 degrees Centigrade.

Zarxio (Sandoz Inc.)

ZARXIO (filgrastim-sndz) injection is for subcutaneous or intravenous use. It is a leukocyte growth factor indicated to: 1) patients with cancer receiving myelosuppressive chemotherapy; 2) patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; 3) patients with cancer undergoing bone marrow transplantation; 4) patients undergoing autologous peripheral blood progenitor cell collection and therapy; and 5) patients with severe chronic neutropenia. This product must be stored in a refrigerator at 2 degrees to 8 degrees in the original pack to protect from light. Do not shake, do not freeze. Prior to injection, the product may be allowed to reach room temperature for a maximum of 24 hours.

Imovax Rabies (Sanofi Pasteur)

IMOVAX Rabies is a vaccine indicated for pre-exposure and post-exposure prophylaxis against rabies and is approved for use in all age groups. The freeze-dried vaccine is stable if stored in the refrigerator between 2 degrees to 8 degrees Centigrade. Do not freeze. The product is a sterile, stable, freeze-dried suspension of rabies virus prepared from strain PM-1503-3M obtained from the Wistar Institute, Philadelphia, PA.

These products can be ordered from FFF Enterprise's BioSupply Online Ordering System or by calling Wow! Customer Care at (800) 843-7477.

Current Medicare IVIG / SCIG Rates

Rates per gram are effective January 1, 2016, through March 31, 2016.

Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
IVIG
Bivigam J1556 $77.72 $76.47
Carimune NF J1566 $69.79 $68.67
Flebogamma J1572 $78.72 $77.46
Gammagard S/D J1566 $69.79 $68.67
Gammaplex J1557 $74.62 $73.43
Octagam J1568 $84.88 $83.52
Privigen J1459 $76.51 $75.28
SCIG
Hizentra J1559 $84.69 $83.33
HyQvia J1575 $108.30 $106.56
IVIG / SCIG
Gammagard Liquid J1569 $76.23 $75.01
Gammaked J1561 $83.53 $82.19
Gamunex-C J1561 $83.53 $82.19

*Reflects 2% sequestration reduction applied to 80% Medicare payment portion as required under Budget Control Act of 2011.

Resources

FFF customers may order the following complementary resources to help you with your practice:

•  IG Immune Globulin (Human)
•  Hyperimmune Globulins
•  Anti-Inhibitor, Factor VIIa & IX
•  Factor VIII & von Willebrand Factor
•  Seasonal Influenza Vaccine

Subscribe to IG Living

IG Living is the only magazine for the immune globulin (IG) community for patients who suffer from chronic illness and their caregivers.

Subscribe to BioSupply
Trends Quarterly

BioSupply Trends Quarterly magazine is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace.

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