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Date: 2007-11-29

Type of information: Granting of a patent

Product name: Traumakine® - FP-1201

Compound: human recombinant interferon-beta 1a

Therapeutic area: Lung diseases - Respiratory diseases - Rare diseases

Action mechanism:

protein. FP-1201/Traumakine® is a human recombinant interferon-beta 1a. In acute lung injury (ALI) and acute respiratory distress syndrome (ARDS), the predominant patho-physiological result is increased vascular leakage, which has been shown to be due to the lack of adenosine, an end product of AMP degradation by 5’-nucleotidase (CD73). Adenosine acts to enhance endothelial barrier function via adenosine receptor activation. Therefore, any biological substance, which acts to increase adenosine level, will reduce vascular leakage and be of benefit in ALI/ARDS patients. Such substances are type I interferons, and especially the interferon-beta (IFN-beta). IFN-beta has been shown to up-regulate 5’-nucleotidase (also known as a CD73 molecule and expressed abundantly by normal endothelial cells) and prevent ALI in animal models (Kiss et al. (2007) Eur. J. Immunol. 37:3334). Traumakine® has been granted Orphan Drug Designation in Europe which allows a period of 10 years of market exclusivity following marketing approval by the EMA.

Company: Faron Pharmaceuticals (Finland)

Disease:

acute lung injury (ALI) acute respiratory distress syndrome (ARDS)

Latest news:

* On December 29, 2015, Faron Pharmaceuticals said that the company has applied for the orphan status in the U.S.

* On 29 November 2007, the European Comission has granted orphan designation to Faron Pharmaceuticals  for the treatment of acute lung injury.

Patents:

* On March 1, 2016, Faron Pharmaceuticals announced that it has filed a national application for a new formulation patent in Finland with filings to be expanded over the next 2 years to almost all countries worldwide under the Patent Co-operation Treaty (PCT). The patent further protects Faron’s final FP-1201-lyo (lyophilised interferon-beta or Traumakine®) formulation for the intravenous treatment of acute respiratory distress syndrome (“ARDS”) and other vascular diseases. The new formulation, which has not previously been made public, is already in use in Faron’s pivotal, pan-European INTEREST trial, the recruitment of which the Company expects to be completed in 10-16 months from now. Besides several granted patents and pending filings, Faron has also sought exclusivity for Traumakine® through orphan drug designations (ODD) and has been successful in Europe regarding ARDS. The Company has also sought ODD in the USA where the application is ongoing. Faron’s Japanese licensing partner Maruishi Pharmaceutical Co., Ltd. is also planning to file an orphan application in Japan.

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE: 2007-11-29

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes