HORSHOLM, Denmark, Aug. 21, 2003 (PRIMEZONE) -- Summary: The Pharmexa (Other:PMXAY) Group had turnover of kDKK 8,138 in the first 6 months of 2003 and realised a net loss of kDKK 69,337. Research and development costs totalled kDKK 68,098. The half-year result was in line with expectations and Pharmexa maintains its financial forecast for the full year.Status on Pharmexa's activities
Continued important progress in the project portfolio Pharmexa has initiated a clinical phase I trial with HER-2 AutoVac (TM) Protein in breast cancer patients in the US, at two leading cancer centres in Cleveland and Pittsburgh, and the first 7 out of 10 patients are currently undergoing treatment. Pharmexa will now have the opportunity to observe whether the desired immune response can be generated in patients against the cancer protein HER-2.
The company's collaboration with H. Lundbeck regarding a new ground-breaking drug against Alzheimer's disease entered into preclinical development in the first half-year of 2003, with a view to select one AutoVac (TM) Alzheimer's molecule and two back-up molecules within the next 12 months for the up-coming clinical trials.
Cost reductions completed
The first half-year was also marked by the refocusing and cost reduction process Pharmexa initiated in the beginning of the year. These changes have now been implemented so that the company operates at a significantly reduced cost level.
High productivity maintained
In the first half-year of 2003 Pharmexa maintained its high productivity and a number of important results were achieved. As previously mentioned, the company started a clinical trial in the United States with the HER-2 AutoVac (TM) Protein breast cancer programme. In addition, approval was obtained to initiate a phase II trial in Great Britain and Denmark with the HER-2 AutoVac (TM) DNA programme. However, this trial has been postponed for priority reasons. The collaboration with H. Lundbeck regarding a new ground-breaking drug against Alzheimer's disease continued to develop satisfactory and additional good results were obtained in the TNF-alpha programme against rheumatoid arthritis.
Hence, Pharmexa has reduced the number of research and development projects but has maintained maximal momentum and focus on prioritised projects.
The table below shows Pharmexa's pipeline. This well-diversified portfolio is comprised of project with significant commercial potential. The company's product candidates target breast cancer, rheumatoid arthritis, osteoporosis and Alzheimer's disease. Furthermore, Pharmexa's license partner Schering-Plough is likewise working on a high potential product in the veterinary field.
Target Indication Rights Status
In-house R&D programmes
HER-2 DNA Breast cancer Pharmexa Phase II
HER-2 Protein Breast cancer Pharmexa1 Phase I
TNF-alpha Rheumatoid Pharmexa Pre-clinical
arthritis development
RANKL Bone disorder Pharmexa Research
Partnered research
programmes
Undisclosed Alzheimer's H. Lundbeck Pre-clinical
disease development
Undisclosed Animal Health Schering-Plough Research
1) GlaxoSmithKline has an option on this project should Pharmexa
decide to out-license after phase I.
Important milestones ahead
Pharmexa's focus has shifted from research to development. One of the most important tasks in Pharmexa in the coming years will be to examine the safety and efficacy of the AutoVac (TM) Protein technology in humans.
With the exception of the HER-2 AutoVac (TM) DNA project, all other projects in the pipeline, i.e. HER-2 Protein, TNF-alpha, RANKL and AutoVac (TM) Alzheimer's, are AutoVac (TM) Protein projects where the goal is to get the patient itself to generate antibodies against disease associated proteins in the body. Several successful drugs on the market today have validated this concept, i.e. in breast cancer and rheumatoid arthritis where artificial antibodies are injected into the patients with good effect.
In the beginning of 2004 Pharmexa will be able to observe whether patients in the ongoing US phase I trial generate antibodies against the cancer protein HER-2. Generating antibodies in patients is, together with a new out-licensing agreement, Pharmexa's primary objective in the short term.
If the phase I trial in the US shows the desired results it will significantly increase the chances of a therapeutic effect. The phase II trial, which is planned to be initiated during 2004 will be designed to show with statistical certainty such therapeutic effect in patients.
That point in time when statistical evidence of a drug's effect is obtained is called "proof of concept" in patients and is an important milestone in all drug development.
Obtaining "proof of concept" in patients with the first AutoVac (TM) Protein product is the most important goal for Pharmexa in the medium term.
It is Pharmexa's expectation that obtaining "proof of concept" in patients in the HER-2 AutoVac (TM) Protein project may have a significant effect on the value of the entire Pharmexa project portfolio and significantly increase the company's commercial and strategic options.
Already last year Pharmexa announced promising results with the AutoVac (TM) DNA technology in breast cancer, another variant of the company's technology. Pharmexa showed that the AutoVac (TM) DNA technology was safe and able to induce a killer-cell based immune response in breast cancer patients. However, the HER-2 AutoVac (TM) DNA phase II trial was postponed for priority reasons. Pharmexa believes there may be an advantage in out-licensing this project in combination with the HER-2 AutoVac (TM) Protein programme, which is expected to enter phase II clinical trials next year. The two HER-2 AutoVac (TM) projects may therefore be combined in a future development process.
Pharmexa's financial situation
By the end of the first half-year of 2003 Pharmexa had cash and cash equivalents, and marketable securities of approximately DKK 100 million. Following the refocusing and cost reductions implemented in the first half-year of 2003 and taking into consideration expected revenue under existing collaborations, the company expects to be able to finance its activities until the end of the second quarter of 2004. New outlicensing agreements may extend this period.
Outlook for 2003
Pharmexa's financial forecast for the full year is unchanged in accordance with the company's stock exchange announcement no. 15 dated May 26, 2003.
For 2003, Pharmexa expects decreasing research and development costs relative to 2002. In aggregate, Pharmexa's research and development costs will be approximately DKK 114 million.
Pharmexa's administrative expenses will likewise decrease compared to 2002. Net revenues are expected to increase compared with 2002.
Against this background, Pharmexa expects a loss before net financials of approximately DKK 80 million in 2003. However, this result depends on the success of the company's ongoing out-licensing activities and financial position.Additional information:
Soren Mouritsen, chief executive officer, telephone +45 4516 2525 Jakob Schmidt, chief financial officer, telephone +45 4516 2525
Certain parts of the release contain forward-looking information with respect to the plans, projections and future performance of the company, each of which involves significant uncertainties. The company's actual results may differ materially from the information set forth in these statements.
Please click on the link provided to view the entire press release with financials: http://reports.huginonline.com/914704/122042.pdf