Interferon beta-1a

From Wikipedia, the free encyclopedia


Interferon beta-1a
Systematic (IUPAC) name
Human interferon beta
Identifiers
CAS number	145258-61-3
ATC code	L03AB07
PubChem	?
DrugBank	BTD00093
Chemical data
Formula	C₉₀₈H₁₄₀₈N₂₄₆O₂₅₂S₇
Mol. mass	20027.0 g/mol
Pharmacokinetic data
Bioavailability	?
Metabolism	?
Half life	10 hrs
Excretion	?
Therapeutic considerations
Pregnancy cat.	?
Legal status
Routes	?

Interferon beta-1a is a drug in the interferon family used to treat multiple sclerosis (MS). It is produced by mammalian cells while Interferon beta-1b is produced in modified E. coli. Interferons have been shown to have about a 30–35% reduction in the rate of MS relapses, and to slow the progression of disability in MS patients. None of the products on the market is a cure, but patients today who start early on Interferons may beneficially alter the natural course of the disease.

There are two principal competitors in the market for this drug and one biogeneric / biosimilar one:

Biogen Idec's Avonex®
Serono's Rebif®
CinnaGen's CinnoVex®

1 Overview
2 Avonex
3 Rebif
4 CinnoVex
5 Related drugs
6 See also
7 External links

[edit] Overview

It is believed that Interferon beta based drugs achieve their beneficial effect on MS progression via their anti-inflammatory properties. Studies have also determined that Interferon beta improves the integrity of the blood-brain barrier (BBB), which generally breaks down in MS patients, allowing increasing amounts of undesirable substances to reach the brain. This strengthening of the BBB may be a contributing factor to Interferon-Beta's beneficial effects. These studies were carried out in vitro (outside a living organism; a "petri dish" experiment), so it does not necessarily mean it works the same in people.

Nonetheless, Interferons have side effects. The two main ones are flu-like symptoms, and injection-site reactions. The flu-like symptoms tend to happen immediately after the injection, and last for about half a day. In many patients, these symptoms diminish over time, but some patients continue to experience them over the long term. One can mitigate these symptoms by using a dose that is injected less frequently, and by taking the medication before bedtime. The injection-site reactions can be mitigated by rotating injection sites, or by using one of the medications that requires less frequent injections. Side effects are often onerous enough that many patients ultimately discontinue taking Interferons (or Copaxone®, one of the other disease-modifying therapies requiring daily or weekly injections).

The most commonly reported side effects are injection site disorders, flu-like symptoms, elevation of liver enzymes and blood cell abnormalities. Patients with depression, seizure disorders, or liver problems, should discuss treatment with Rebif with their doctors.

While these drugs improve certain diagnostic test results, many patients report no perceived improvement, along with serious side-effects that substantially reduce quality of life. It is important to recognize that these drugs are intended to treat symptoms and possibly delay disease progression, but do not provide a cure to multiple sclerosis. Furthermore, tolerance develops over time in some patients, due to the development of "neutralizing antibodies," which reduces the effectiveness of these drugs, while side effects may persist even after discontinuation. See patient ratings of Rebif and Avonex, below.

A one month supply of Avonex or Rebif costs $1600 USD.

[edit] Avonex

Avonex is administered once per week intramuscular injection using a 23 gauge 1.25" needle, however a 25 gauge 1" needle has been approved and may be substituted by a physician.[1] It is produced by the Biogen Idec biotechnology company. Originally it was under competition protection in the US under the Orphan Drug Act.

Avonex was approved in the US in 1996, and in Europe in 1997, and is registered in more than 80 countries worldwide. It is the leading MS therapy in the US, with around 40% of the overall market, and in Europe, with around 30% of the overall market.

Biogen Idec markets Avonex in two formulations: the original powder form, which requires the patient to reconstitute it before administration; and a newer pre-reconstituted "liquid Avonex" syringe kit.

[edit] Rebif

Rebif is a subcutaneous injection dosed three times per week. It comes in pre-filled syringes with a 29 gauge needle, thinner than the needle supplied with Avonex. It can be used with the Rebiject II autoinjector.

Rebif is a disease-modifying drug used to treat relapsing forms of multiple sclerosis and is similar to the interferon beta protein produced by the human body. Interferon helps modulate the body’s immune system, fight disease and reduce inflammation. It is co-marketed by Serono and Pfizer in the US under an exception to the Orphan Drug Act.

Rebif was approved in Europe in 1998 and in the US in 2002. It is registered in more than 80 countries worldwide. Rebif is available in a 22 mcg and 44 mcg ready-to-use pre-filled syringe and can be stored at room temperature for up to 30 days if a refrigerator is not available.

[edit] CinnoVex

CinnoVex is the trade name of recombinant Interferon beta 1-a, which is manufacturing as biosimilar/biogeneric in Iran.
CinnoVex is available as powder in 2 ml vials along with injectable distilled water. Each dose contains 30 micrograms of active protein which is equal to 6 million international unit of activity.
An interferon-beta protein developed at the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB, Stuttgart,Germany, in collaboration with CinnaGen company, Tehran, Iran,is now the first therapeutic protein from a Fraunhofer laboratory to be approved as biogeneric / biosimilar medicine.
An interferon-beta-1a, whose biotechnical engineering and production up to the pilot scale was optimized at the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB in collaboration with CinnaGen Company, has now been approved as biogeneric by the Iranian Food and Drug Administration (IFDA).
A more soluble variant of interferon-beta also engineered at the IGB is for example being clinically investigated by the Vakzine Projekt Management (VPM) GmbH in Braunschweig, Germany.

[edit] Related drugs

Closely related is Interferon beta-1b, also indicated for Multiple Sclerosis, and with a very similar drug profile. Interferon beta-1b is marketed only by Berlex in the US as Betaseron and outside the US as Betaferon by Schering AG.