Novartis
Interferon beta-1b - Extavia; 2-166-Interferon beta1 (human fibroblast reduced), 17-L-serine-; interferon betaser, recombinant; NVF233
Status - marketed in U.S. and Europe
Organizations involved:
Novartis AG – World mark.; Parent
Bayer Schering Pharma AG – Manuf.; R&D; Tech.
Boehringer Ingelheim Pharma KG – Manuf.
Biogen Idec – Patent dispute
Cross ref.: See the entry for Betaseron/Betaferon from Bayer Schering for further information. Extavia is Betaseron/Betaferon relabeled by Bayer Schering for marketing by Novartis.
Nomenclature: Extavia [TR]; Extavia (Interferon beta-1b) Kit [FDA]; Interferon beta-1b [FDA USAN INN BAN]; 2-166-Interferon beta1 (human fibroblast reduced), 17-L-serine- [CAS; beta is Greek letter]; 145155-23-3 [CAS RN]; 96778-78-8 [CAS RN]; Human Recombinant Betaser17 Interferon [SY]; Interferon beta1, 17-L-serine-, (2S-(2R*,5R*))- [SY]; interferon betaser [SY]; NVF233 [SY Novartis]
Companies.: See the Betaseron/Betaferon entry. Novartis gained rights to its own branded version of Betaseron (Betaferon in Europe) through agreements with Bayer-Schering related to the Novartis' acquisition of Chiron. Presumably, the interferon beta-1b for Extavia marketed in Europe is manufactured, like Betaferon, by Boehringer Ingelheim. Bayer produces Extavia for Novartis and gets a “double- digit” percentage royalty from Novartis.
FDA class: Biologic BLA
Status: On May 26, 2008, EMEA, European Union (EU), granted approval to Extavia for the treatment of early and relapsing forms of multiple sclerosis (MS). On Jan 22, 2009, Novartis formally launched Extavia in Europe.
Indications: [Full text of the "Indications and USAGE" section of the product labeling/insert];
EXTAVIA (Interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.
Tech. transfer: See the Betaseron entry.
In June 2010, Biogen Idec filed patent infringement suits against Bayer Schering and other interferon beta manfacturers alleging violation of U.S. patent 7,588,755 claiming certain interferon beta gene sequences. Biogen Idec had
been negotiating an 8 1/2% patent license with Bayer, but Bayer
eventually refused to take a license at any price and proceeded to file a declaratory judgment action on
May 27, 2010 in the U.S. District Court in New Jersey. Biogen Idec responded with a patent infringement suit
in the same court the following day. As of late 2012, nothing significant has been reported from this, suggesting the case was dropped, failed, or was settled out of court.
Market: Extavia marked Novartis' first entry into the MS treatment field. Extavia allows Novartis to establish itself in the multiple sclerosis community before introducing its FTY720 MS therapeutic. Betaseron has been the standard-of-care for multiple sclerosis in the U.S. for over 16 years.
In the U.S., along with their prescription for Extavia, patients are given access to a Novartis support program including a nurse helpline, one-on-one injection training and reimbursement support services. Extavia patients also have an autoinjector available to them from Novartis.
In Aug. 2010, BioTrends (Decision Resources, Inc.) reported, "While most neurologists see Extavia as a “me-too” drug that was not needed on the market, the small amount of reported current use is mostly driven by managed care requirements or out-of-pocket cost concerns. Promotional activity, although a factor that does appear to influence uptake of Extavia, is significantly lower than that associated with other disease-modifying agents. And while neurologists report a high level of interest in Novartis’ pending multiple sclerosis (MS) therapy, Gilenia (fingolimod, FTY-720), a fair number of neurologists viewing Extavia as a “me too” agent report frustration with Novartis for bringing Extavia to market."
Companies involvement:
Full monograph
212.5 Interferon betaser, rDNA/
Nomenclature:
Extavia [TR]
Extavia (Interferon beta-1b) Kit [FDA]
Interferon beta-1b [FDA USAN INN BAN]
2-166-Interferon beta1 (human fibroblast reduced), 17-L-serine- [CAS; beta is Greek letter]
145155-23-3 [CAS RN]
96778-78-8 [CAS RN]
Human Recombinant Betaser17 Interferon [SY]
Interferon beta1, 17-L-serine-, (2S-(2R*,5R*))- [SY]
interferon betaser [SY]
NVF233 [SY Novartis]
FDA Class: Biologic BLA
Year of approval (FDA) = 2008
Date of 1st FDA approval = 20080815
(in format YYYYMMDD)
Biosimilars/biobetters-related U.S. Patents: | expired; 4,588,585 had been extended to 2007
Note, this product is an an authorized (bio)generic verion of (identical to) Betaseron |
U.S. Patent Expiration Year: | 2011 |
U.S. Biosimilars Data Exclusivity Expiration: | 2020 |
U.S. Biosimilars Orphan Exclusivity Expiration: | 2013 |
U.S. Biosimilars Launchability Year: | 2020 |
U.S. Biobetters Launchability Year: | 2007 |
Biosimilars/biobetters-related EU Patents: | expired (2007 aribtrarily used); Note, this product is an an authorized (bio)generic verion of (identical to) Betaseron |
EU Patent Expiration Year: | 2007 |
EU Biosimilars Data Exclusivity Expiration: | 2018 |
EU Biosimilars Orphan Exclusivity Expiration: | 2018 |
EU Biosimilars Launchability Year: | 2018 |
EU Biobetters Launchability Year: | 2007 |
Index Terms:
biopharmaceutical products
exempt from CBER lot release requirements
human materials used<!-- humansource -->
Interferon, Human Fibroblast (Gb-23-902-531), Second International Standard
recombinant DNA
Escherichia coli (E. coli)
acetic acid
Albumin (Human)
butanol, 2-
butanol, 2-methyl-2-
dextrose
dithiothreitol (DTT)
ethylenediaminetetraacetic acid (EDTA)
iodosobenzoic acid
mannitol
octanol
Sephacryl
Sephadex
sodium chloride
sodium dodecyl sulfate (SDS)
sodium hydroxide
sodium pyrophosphate
sucrose
EU200 Currently Approved in EU
UM001 Marketed Product in US
US200 Currently Approved in US
EM001 Marketed Product in EU
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