Orphan drug status for P113D

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Orphan drug designation granted for P113D

   Demegen, Inc., (DBOT) announced that orphan drug status was

granted for the

 company's patented P113D peptide for the treatment of cystic fibrosis

(CF)

 infections by the U.S. Food and Drug Administration.

   Orphan drug designation is granted when a disease occurs in

less than 200,000

 patients in the United States. Benefits from orphan drug status can

include a

 period of marketing exclusivity, tax credits for clinical research

expenses, and

 clinical development assistance.

   Cystic fibrosis is a genetic disease, which affects

approximately 30,000

 children and young adults in the United States and another 40,000

worldwide. The

 gene defect causes thickened mucous in the lungs that creates an

ideal

 environment for bacterial infections, particularly Pseudomonas

aeruginosa. These

 lung infections can lead to mortality in CF patients.

   P113D is derived from histatins, which are compounds found

naturally in human

 saliva. P113D has demonstrated activity against CF patient clinical

isolates of

 bacteria that are resistant to traditional antibiotics. The compound

is stable

 and maintains activity in sputum of CF patients. A number of

preclinical

 toxicology evaluations need to be completed before human trials can

be

 authorized.

   Ekstrom, president of Demegen said: " There is a very real need

for new

 treatment options for CF patients with chronic infections. Demegen is

actively

 seeking to solidify partnerships with parties that have expressed

interest in

 developing P113D. The orphan drug designation should help that

effort. The

 company also appreciates the funding support it has received from the

Cystic

 Fibrosis Foundation. "

Becki

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