Santaris Pharma's HIF-1 alpha antagonist begins second phase 1 study against solid tumours and lymphoma

The Company’s collaboration partner Enzon Pharmaceuticals, Inc. has initiated a second clinical study of EZN-2968 to evaluate additional dosing schedule

Copenhagen, Denmark – 2nd November 2007 – Santaris Pharma A/S today announced the initiation of an open-label, non-randomized Phase 1 study with its HIF-1 alpha antagonist (EZN-2968) licensed outside Europe in 2006 to Enzon Pharmaceuticals, Inc. USA. The study is designed to evaluate the safety, tolerability, and pharmacokinetics of the HIF-1 alpha anta­gonist in a daily for 5 days schedule in approximately 30 patients with advanced solid tumors or lymphoma.

“We are very encouraged that Enzon Pharmaceuticals has initiated the second phase 1 study with EZN-2968, a novel RNA-targeted drug based on Santaris Pharmas Locked Nucleic Acid (LNA) technology,” said Keith McCullagh, CEO of Santaris Pharma A/S. “The early safety data on the ongoing cancer trial are encouraging and Enzon is now evaluating alternative dose schedules in this second human study in patients with advanced cancer.”

The investigational drug blocks the production of Hypoxia-inducible factor-1 alpha (HIF-1 alpha), a key regulator of a large number of genes important in cancer biology, including many involved in angio­genesis, cell proliferation, apoptosis and cell invasion. HIF-1 alpha is low in normal cells, but ele­vated in a variety of cancers. High expression of HIF-1 alpha is strongly correlated with poor prognosis and re­sis­tance to the­rapy. Therefore, drugs that inhibit HIF-1 alpha are expected to block multiple mechanisms that control cancer progression.

Enzon Pharmaceuticals took over the development EZN-2968 from Santaris Pharma in July 2006 along with a Survivin RNA antagonist but is developing both drugs for the commercial benefit of both companies. If successful, Enzon will market the drugs outside Europe and Santaris Pharma will commercialize them within Europe. The companies are also collaborating in drug discovery to create up to six additional pro­prietary product candidates from Santaris Pharma’s LNA technology platform. The novel RNA antagonists are all directed against novel cancer targets selected by Enzon.

ENDS

For further information, please contact:

Randi Krogsgaard,

Director of Communications, Santaris Pharma

Tel +45 45179879 (direct) +45 4517 9820 (Company)

Mobile/Cell +45 20488384 E-mail: rmk@santaris.com

For UK media relations, contact:

Adam Michael, a.michael@northbankcommunications.com ,
Direct line: +44 (0)20 7268 3233 Mobile: +44 (0)7775 881813
Main tel: +44 (0)20 7268 3002 Fax: +44 (0)20 7268 3102

Forward Looking Statements
This written announcement contains forward-looking statements, identified by the use of forward-looking words such as "believes," "expects," "may," "will," "should", "potential," "anticipates," "plans" or "intends" and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from the future results, events or developments indicated in such forward-looking statements. Such factors include, but are not limited to the timing, success and cost of clinical studies; the ability to obtain regulatory approval of products, market acceptance of and future demand for Santaris products and the impact of competitive products and pricing. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. No assurance can be given that the future results covered by the forward-looking statements will be achieved. All information in this press release is as of the date of this press release and Santaris does not intend to update this information.

NOTES FOR EDITORS

About Santaris Pharma

Santaris Pharma is a clinical-stage biopharmaceutical company focused on developing a new class of drugs intended to switch off the expression of harmful genes. Called RNA Antagonists, these new drugs are being developed by Santaris and its corporate partners for the treatment of cancer and metabolic disorders. Created in May 2003 and backed by a broad group of leading international life science venture capital investors, Santaris Pharma completed a Euro 40m second round of equity financing in May 2006. In July 2006, the Company entered into a global partnership with Enzon Pharmaceuticals of New Jersey to co-develop and commercialise a series of Santaris RNA Antagonists for improving the treatment of cancer.

Santaris Pharma’s RNA Antagonist drug pipeline is based on its unique LNA technology. LNA drugs, with their high potency and biostability, have the potential to transform the field of RNAi medicines, making specific and effective gene silencing a reality in human medicine. If this potential is realised, even in part, it may be possible to design new drugs to treat the underlying genetic causes of disease rather than just the physical symptoms. Santaris Pharma holds the world wide patent rights to the exploitation of LNA in pharmaceuticals and presently has three drugs in preclinical or clinical development. The lead drug candidate, SPC2996, is currently undergoing international, multicenter, phase I/II clinical studies in Chronic Lymphocytic Leukemia (CLL).

For further company information see www.santaris.com