Antisoma`s Lead Product, Pemtumomab (Formerly Known as Theragyn) Granted European Orphan Drug Status
(PR Newswire)Antisoma plc, the UK-based biopharmaceutical company developing novel therapies for cancers, announces that it has today been notified by the European Commission that its lead product pemtumomab has been designated as an ~~~orphan~~~ medicine.- Jun 01 7:01 AM ET
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Posted on: 06/01/2001
"Yahoo - Antisoma's Lead Product, Pemtumomab (Formerly Known as Theragyn) Granted European Orphan Drug Status"
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Friday June 1, 7:01 am Eastern Time
Antisoma's Lead Product, Pemtumomab (Formerly Known as Theragyn) Granted European Orphan Drug Status
LONDON, June 1 /PRNewswire/ -- Antisoma plc, the UK-based
biopharmaceutical company developing novel therapies for cancers, announces
that it has today been notified by the European Commission ("EC") that its
lead product pemtumomab (formerly known as Theragyn) has been designated as an
This provides 10 years' market exclusivity once any
marketing authorisation application ("MAA") is approved.
European Orphan Drug legislation became law in April 2000 and 26 products
have since been designated as having Orphan Drug status.
was adopted in the US over 18 years ago to encourage the development of
medicinal products for the treatment of rare or life-threatening diseases that
might otherwise be commercially unviable.
The legislation has been highly
effective with over 150 Orphan products granted marketing authorisation.
Pemtumomab was granted US Orphan Drug status in April 1999.
Glyn Edwards, Chief Executive Officer of Antisoma, said: "This is another
important step in the development of Antisoma's product pemtumomab for the
treatment of ovarian cancer.
We now have Orphan Drug Status in the world's
two major pharmaceutical markets, the US and the EU.
The market protection
afforded by the Orphan Drug legislation provides significant encouragement to
develop potentially more effective therapies, such as pemtumomab, for the
treatment of ovarian cancer and other life-threatening diseases."
Visit http://www.antisoma.com for further information about Antisoma.
- Orphan medicinal products
- To receive Orphan Drug status in the EU, the Company needed to establish
that the condition for which Orphan Drug status was sought was life
threatening and affected not more than five in every 10,000 people in the EC
(around 175,000 people in total). In the US, the equivalent legislation
requires a prevalence of less than 200,000 individuals.
Market exclusivity in the EU
The cornerstone of the EU regulations is market exclusivity granted to the
Exclusivity means that the Member States and the EC will
not, for a period of 10 years, issue subsequent marketing authorisation or
extend any existing marketing authorisation for the same therapeutic
indication in respect of a similar medicinal product.
This is intended to
allow a sufficient return to justify investment in the development of orphan
Exclusivity rights arise when an orphan medicine is approved under the
centralised procedure and protects against approval of a similar medicinal
product for the same therapeutic indication.
"Similar" is defined in terms
that distinguish chemical, biological or radiopharmaceuticals and require an
identical pharmacological and toxicological profile.
The ten-year period is subject to a reduction to six years if the criteria
for orphan drug status are no longer met or when the product is marketed at a
price that allows for an "unreasonable profit."
Exclusivity does not prevent approval of a similar product when a second
applicant can establish that their product is safer, more effective or
otherwise clinically superior.
Antisoma is a biopharmaceutical company developing novel products for the
treatment of cancer.
Using its drug development experience, the Company aims
to produce safer and more effective tumour targeting therapies for
commercialisation by pharmaceutical partners.
Antisoma acquires the rights to
promising new product candidates through partnerships with internationally
recognised academic or cancer research institutions.
These include the lead
product candidate, pemtumomab, which was licensed from the Imperial Cancer
Research Fund and is currently in a Phase III study as adjuvant treatment for
ovarian cancer, with designated Orphan Drug status in the US and EU.
Laboratories has a worldwide exclusive licence to develop, market and sell the
Antisoma's therapeutic product candidates are:
Product candidate Indication(s) Current stage of development
pemtumomab Ovarian cancer Phase III
Gastric cancer Phase II
Therex Breast cancer Phase I
TheraFab Lung cancer Phase I
AngioMab Brain cancer Pre-clinical
Thioplatin Cancer Pre-clinical
Targeted apoptosis Cancer Pre-clinical
hu BC-1 Other solid tumours Pre-clinical
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