us fda orphan drug status
PAII's investment in Pharmaxis receives US FDA Orphan Drug status Friday February 25, 8:00 am ET
CALGARY, Feb. 25 /PRNewswire-FirstCall/ - Patch International Inc. (PAII: OTCBB), is pleased to report that Pharmaxis (PXS: Australian Stock Exchange) announced today that the United States Food and Drug Administration (FDA) has granted an Orphan Drug status for the company's product Bronchitol(TM), for the treatment of bronchiectasis. Patch holds 11.2 million shares in Pharmaxis with a non-discounted value of approximately $10.5 million USD, and is the company's second largest shareholder behind the Rothschild Group. Shares of Pharmaxis have increased over 20% on larger than normal volume this week. Consequently the value of PAII's investment has increased by the same percent.
David Stadnyk, President of PAII stated, "We are extremely pleased to find out that our investment in Pharmaxis has received Orphan Drug status from the FDA this quickly. This landmark for our investment is a great bonus for PAII shareholders. As this investment increases, our underlying asset value also increases. We are looking forward to using the proceeds from this investment and deploy this substantial cash into oil and gas assets. PAII's shares are trading at less than half of the current asset value. We have just started to undertake a substantial marketing campaign over the next few months to build shareholder awareness and value. Our goal is to become a mid-range oil and gas company and this investment will greatly accelerate this goal."
Orphan Drug status has been granted to Pharmaxis on the basis of Bronchitol's ability to aid the treatment of bronchiectasis, an incurable, degenerative and chronic inflammatory condition of the lungs affecting over half a million people worldwide.
Orphan Drug status is granted by the US FDA to those products intended for the diagnosis, prevention, and treatment of rare diseases, or conditions where no current therapy exists or would be improved. Orphan Drug status entitles Pharmaxis to a range of incentives including a seven-year period of market exclusivity and study design assistance that will substantially contribute to rapid approval.
For more information about Pharmaxis, go to www.pharmaxis.com.au.
PAII is a junior oil and gas producer that currently earns oil revenue from 19 wells. PAII has property in Canada, the US and has made significant progress on oil and gas opportunities in Algeria, Libya, and Tunisia. PAII has a significant investment in a pharmaceutical company that is currently worth over $10.5 million USD to PAII. We plan to use the proceeds from this investment to build our oil and gas assets.
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