Release issued 9th July 2001

Pharmexa has received approval from the Danish health authorities and ethical committees to initiate phase I/II trials in breast cancer patients with the company's HER-2 DNA AutoVac therapeutic vaccine.

- Pharmexa's therapeutic vaccine constitutes an entirely new treatment paradigm in breast cancer.

- The goal is a new and better treatment for late stage breast cancer patients where it may be possible in the long run to avoid chemotherapy and radiation treatment altogether.

- Three hospitals in Denmark participate, with leading cancer specialists associated with the trial. One additional hospital in London is planned to participate once the trial is approved in the United Kingdom.

How does Pharmexa's product work? Pharmexa's vaccine works by stimulating the patient's own immune response to participate in the treatment of the cancer. This is achieved with Pharmexa's proprietary AutoVac technology. With the AutoVac technology it is possible to point out to the immune system a certain protein known to be important for the growth of the cancer in such a way that this protein is now recognised by the immune system. Subsequently, the immune system attacks the protein with antibodies as well as with so-called killer cells.

The cancer protein targeted by Pharmexa's therapeutic vaccine is a growth factor called HER-2. HER-2 is present in many cancer forms, including breast, ovary, uterus, stomach, bladder, prostate, colon and lung cancers. Pharmexa's HER- 2 DNA AutoVac vaccine induces the immune system to launch killer cells against the cancer and in addition also leads to the creation of antibodies against the HER-2 protein. Pharmexa is also working on another version of the product that works primarily through the creation of antibodies. This product is in pre-clinical development and is expected to enter into clinical trials in patients within 1½ year.

Brief description of breast cancer and existing treatment options Breast cancer is the most common cancer form among women and the most common cause of cancer death among women in Denmark, where approximately 3,500 women are diagnosed with breast cancer every year. The disease is primarily treated with surgery, possibly in combination with chemotherapy and/or radiation treatment. There is an urgent need for better treatment options.

The HER-2 protein is over expressed in up to 30% of breast cancers. HER-2 is a factor in the uncontrolled growth of the cancer cells and is usually associated with a poor prognosis for the patient. A number of treatment options exists against breast cancer, including the monoclonal antibody Herceptin, which works by targeting HER-2. This drug is in the process of achieving status as first line treatment in the United States and has over the course of the last three years achieved annual sales exceeding 275 million dollars.

Pharmexa's product is aimed at the same target as Herceptin, but there are two significant differences: Firstly, Pharmexa's product leads to the formation of killer cells, which selectively attack the cancer cells. In this way Pharmexa hopes in the longer run to be able to avoid chemotherapy and radiation treatment altogether. Herceptin does not lead to the formation of killer cells. Secondly, Pharmexa's product induces the patient's immune system to create its own antibodies. These antibodies are known to be more effective than artificial antibodies, which are administered intravenously at a hospital, as is the case with Herceptin.

Herceptin was recently approved for the treatment of breast cancer in Denmark, but with a price of approximately DKK 100,000 for six months treatment, its use in Denmark has been limited. Common to Herceptin and other monoclonal antibodies are their very high production costs and the large amount of product that needs to be administered. There will therefore also be significant health economic advantages with Pharmexa's technology, because production costs as well as the amount of product that needs to be administered will be much smaller, and hospitalisation during administration is not necessary.

What are the objectives of Pharmexa's phase I/II trial? The primary objective of the trial is to evaluate the safety of Pharmexa's therapeutic vaccine. Other objectives are to observe if HER-2 specific killer cells as well as HER-2 specific antibodies can be induced with the AutoVac concept, and finally to evaluate the efficacy of the treatment in the form of tumour response. The plan is to enrol 27 patients in the trial, which will take place at four hospitals, three in Denmark and one in the United Kingdom. Depending on the speed at which patients are enrolled, Pharmexa expects to announce preliminary data from the trial in the course of 2002.

Pharmexa has established a clinical advisory board with Professor Henning Mouridsen, Rigshospitalet, Copenhagen, Professor Charles Coombes, Hammersmith Hospital in London and Professor Cornelis J. M. Melief, University Hospital Leiden, the Netherlands, as external experts.

What is Pharmexa's strategy in the breast cancer area? Pharmexa has kept all rights in the company's HER-2 AutoVac program. It is Pharmexa's strategy to take the product through the initial clinical phases and past phase II before the program is outlicensed to a third party. Pharmexa has the financial resources to follow this strategy and has in addition over the course of the last year established a development department consisting of some of the most experienced drug developers in Scandinavia. On this background Pharmexa expects to add significant value to its HER-2 AutoVac program in the coming years.

(17th December 2001) Pharmexa in AutoVac cancer license option

(14th December 2001) Pharmexa subsidiary Inoxell announces achievement of first milestone in a collaboration with AstraZeneca

(12th October 2001) AutoVac therapeutic vaccination may be an entirely new way to combat bone destruction