Company presentation - Mondobiotech

IP protection & orphan market exclusivity
Intellectual Property protection and market exclusivity are essential for succeeding in developing new therapeutic
options in rare diseases. Our products platforms are protected in a dual way, through Orphan Drug Status
Designations and a novel patent concept on products and/or indications.
Orphan Drug Regulations
in Europe and USA
• In USA rare diseases are regulated by the Jan. 4th,
1983 Orphan Drug Act (ODA).
• In Europe rare diseases are regulated by the year
2000 EU Regulation 141/2000.
• Major advantages of the Orphan Drug Regulations are:
• Grants for research.
• Free protocol advice assistance.
• Free or consistent costs reductions
for new applications, marketing
authorizations and post-authorization
activities.
• Fast-track procedures and approvals.
• Seven years (USA) and ten years
(EU) market exclusivity after market authorization.
Mondobiotech
Orphan Drug Status Designations (ODS)
2003 EMEA:
ODS for Aviptadil in PAH and CTEPH received 23/12/2003
(EU/3/03/173).
2005 FDA:
ODS for Aviptadil in PAH received 22/02/2005.
2005 EMEA:
ODS for Interferon gamma in IPF received 30/05/2005
(EU/3/05/281).
2005 FDA:
ODS for Aviptadil in ARDS received 01/06/2005.
2006 EMEA:
ODS for Aviptadil in Acute Lung Injury (ALI)
received 28/08/2006 (EU/3/06/395).
Mondobiotech Patents
2005: Interferon gamma patent (EP 0 795 332 B1) for: “Medical use of Gamma Interferon in Interstitial Lung Diseases” received 01/06/2005.
2007: Started the patent application program to cover more than 300 product platforms for rare diseases.
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