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Orphan designation

On 28 August 2006, orphan designation (EU/3/06/394) was granted by the European Commission to Analytica International GmbH, Germany, for autologous tumor-derived immunoglobulin idiotype coupled to keyhole limpet haemocyanin for the treatment of follicular lymphoma.

The sponsorship was transferred to Analytica International Inc. - Outcomes Research and Pricing, Germany, in May 2011 and subsequently to Biovest Europe Limited, United Kingdom, in September 2011.

What is follicular lymphoma?

Follicular lymphoma is a type of cancer of the lymphatic system. The lymphatic system is part of the body’s immune system and helps fighting infections. It is a complex system made up of organs such as the bone marrow, the thymus (a gland behind the breast bone), the spleen (an organ in the abdomen, near the stomach), and the lymph nodes (or lymph glands, located throughout the body), which are connected by a network of tiny lymphatic vessels. There are two main types of cells, which make up the lymphatic tissue. These cells are called lymphocytes and belong to the group of white blood cells. The two types are called B lymphocytes (B cells) and T lymphocytes (T cells). There are several different types of lymphomas. In follicular lymphoma, the cancer cells are related to the B-lymphocytes. Follicular lymphoma is a life-threatening disease.

What is the estimated number of patients affected by the condition?



What treatments are available?

At the time of submission of the application for orphan drug designation, several medicinal products were authorised in the European Union for use in follicular lymphoma. The choice of treatment depends in particular on the extension of the disease as well as on the responses to therapies previously prescribed.

Autologous tumor-derived immunoglobulin idiotype coupled to keyhole limpet haemocyanin might be of potential significant benefit for the treatment of follicular lymphoma because it may act in a different way from other available medicines and it might improve the long-term outcome of the patients. The assumption will have to be confirmed at the time of marketing authorisation. This will be necessary to maintain the orphan status.

How is this medicine expected to work?

The medicinal product is a vaccine that contains proteins originating from the cancer cells of the patient him/herself and the copper-containing respiratory protein, keyhole limpet haemocyanin, from the gastropod (mollusc) Megathura crenulata. According to the sponsor, a specific protein from the surface of the cancer cells is isolated and manipulated in the laboratory to be further injected back into the patient. It is expected that following the injection of this “patient-specific vaccine”, the body’s defence system (immune system) will recognise this cancer cell protein as a foreign body and will react against it by producing specific antibodies. It is expected that after vaccination, the immune system will not only recognise the vaccine as foreign, but also the cancer cells that carry the same surface protein as that used to prepare the patient-specific vaccine. The patient body’s immune system could then kill these cancer cells.

What is the stage of development of this medicine?

The evaluation of the effects of autologous tumor-derived immunoglobulin idiotype coupled to keyhole limpet haemocyanin in experimental models is ongoing.

At the time of submission of the application for orphan designation, clinical trials in patients with follicular lymphoma were ongoing.

Autologous tumor-derived immunoglobulin idiotype coupled to keyhole limpet haemocyanin was not authorised anywhere worldwide for treatment of follicular lymphoma or designated as orphan medicinal product elsewhere for this condition, at the time of submission.

In accordance with Regulation (EC) No 141/2000 of 16 December 1999, the COMP adopted a positive opinion on 12 July 2006 recommending the granting of this designation.

  • the seriousness of the condition;


Key facts

Product details for <p>Autologous tumor-derived immunoglobulin idiotype coupled to keyhole limpet haemocyanin</p>
Active substanceAutologous tumor-derived immunoglobulin idiotype coupled to keyhole limpet haemocyanin
Medicine NameLympreva
Disease/conditionTreatment of follicular lymphoma
Date of decision28/08/2006
Orphan decision numberEU/3/06/394

Review of designation

Related information

Sponsor’s contact details:

Biovest Europe Limited
Evershed House
70 Great Bridgewater St.
Manchester M1 5ES
United Kingdom
Telephone: +44 845 497 8663
Telefax: +44 845 497 8888

Patients’ associations contact points:

