September MAA filing for Rhucin in EU planned, and approval would make it third time lucky.

Pharming reduced its convertible debt to €35.8 million ($49.7 million) on signing agreements with a number of bondholders to convert €9 million ($12.5 million) worth of bonds into 8 million shares. The company separately raised €0.7 million ($1 million) in cash by issuing another 1 million ordinary shares under its standby equity distribution agreement (SEDA) with Yorkville Advisers (YA) Global Masters. Pharming now has 109.5 million outstanding ordinary shares.

The SEDA with YA Global, signed in April 2009, means Pharming can ask YA Global to purchase up to €20 million ($27.8 million) in shares over the course of the 36-month arrangement. The latest share acquisition by YA Global takes its total investment to €1.2 million ($1.7 million).

Pharming confirms it remains on track to file a new MAA for its hereditary angioedema drug, Rhucin®, in September 2009. Based on recent feedback from the FDA, Pharming is also preparing its BLA for Rhucin and says that it will request a pre-BLA meeting in the second half of 2009.

In December 2007 and again in March 2008 the EMEA’s Committee for Medicinal Products for Human Use recommended against approving the Rhucin. The last negative vote was based on insufficient evidence of clinical benefits of Rhucin® in repeated use and particularly the potential for undesirable immune responses following repeated administration. 

Pharming had €16.0 million ($22.2 million) in cash including marketable securities at March 31, 2009, compared with €23.5 million ($32.6 million) at the end of 2008 and €65.3 million ($90.6 million) at the end of 2007. Net loss in the first quarter of 2009 was €6.2 million ($8.6 million) compared with €2.9 million ($4 million) in the first quarter of last year.

Related News from Pharming

Aslan Group Pays $25M for Rights to Pharming’s Lactoferrin (Nov. 18, 2008)
Pharming Acquires Licenses to Fibrinogen Patents from GTC Biotherapeutics for $500,000 (June 25, 2008)
Pharming Sites Obtain GMP Status for Production of Drug against Hereditary Angioedema (July 13, 2007)

Previous articleLonza to Manufacture Elusys’ Antianthrax mAb
Next articleSpectrum Garners $9.5M in New Financing Round