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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

Press Release

SOURCE: Antisoma plc

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 "orphan" medicine. 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. Similar legislation 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.

  • NOTES:
  • 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 orphan medicine. 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 medicines.

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

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. Abbott Laboratories has a worldwide exclusive licence to develop, market and sell the product.

    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

SOURCE: Antisoma plc

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