Global bio-nanotech company pSivida Limited (NASDAQ:PSDV, ASX:PSD, Xetra:PSI) today announced that on 30 December 2005 it completed the acquisition of Control Delivery Systems, Inc. ("CDS") a private US drug delivery company located in the Boston, Massachusetts area. CDS has been renamed pSivida Inc.
This acquisition is an integral part of pSivida's on-going US growth strategy. CDS' portfolio of products and product candidates includes two approved and marketed products, one Phase III product and other early-stage product candidates. This combination will bring additional development and regulatory expertise to pSivida's management team and provide pSivida with an operating base in the Boston biotech hub, enhancing its overall visibility as well as access to the US scientific and investment communities. Australian publication Bioshares recently announced pSivida's acquisition of CDS as the 'biotech M&A deal of the year', citing pSivida's increased presence in the US, current revenue stream and synergies for combining the two companies' technologies and expertise.
The acquisition follows the overwhelming approval by pSivida shareholders at the AGM held in November, with 99.9% of proxies in favor. pSivida is now one of the world's first bio-nanotech companies with product and licensing revenues and has operations in the US, UK, Singapore and Australia. pSivida shares are traded on the NASDAQ, Frankfurt and Australian exchanges.
The acquisition has been funded through the issue of 16 million pSivida American Depositary Shares ("ADSs") to CDS stockholders, representing 41.5% ownership of the combined company. CDS shareholders will be subject to lock-up periods ranging from 6 to 9 months, while pSivida Executive Directors have agreed to a voluntary 6 month lock-up period.
pSivida now owns the only two FDA approved sustained release drug delivery systems for the back of the eye, being Vitrasert and Retisert. pSivida also now owns another sustained release drug delivery system in phase III trials, Medidur, at a time when the ophthalmology market is growing strongly, particularly in developing drugs for age related macular degeneration and diabetic retinopathy.
Retisert, marketed by global US ophthalmology company Bausch & Lomb, is a treatment for chronic, non-infectious uveitis affecting the posterior segment of the eye, a debilitating eye disease that is the third largest cause of blindness in the US, affecting 175,000 people. Retisert was approved in October 2005 for full US CMS (Medicare) coverage at a rate of US$19,345, which is 106% of the wholesale price of the device of US$18,250.
"Bausch & Lomb in its last quarterly commentary said that the sales outlook for Retisert is bright," said Mr Gavin Rezos, MD and CEO of pSivida Limited. In addition to uveitis, Bausch & Lomb has the right to use Retisert as a delivery system for compounds to treat other eye diseases.
Former CEO of CDS, Dr Paul Ashton has accepted the position of Executive Director of Strategy of pSivida Limited and will be based at pSivida Inc. headquarters near Boston.
Combined company's marketed products and lead product candidates:
Marketed Retisert for An intravitreal drug implant marketed by
uveitis Bausch & Lomb, approved by the FDA for
the treatment of chronic non-infectious
uveitis affecting the posterior segment
of the eye, a sight threatening
inflammatory disease that is the third
largest cause of blindness in the US.
Two long-term, multi-center clinical
trials of Retisert for DME are also
ongoing.
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Marketed Vitrasert for An intravitreal drug implant marketed by
CMV Retinitis Bausch & Lomb, approved by the FDA for
the treatment of AIDS-related
Cytomegalovirus (CMV) Retinitis, a
blinding condition in immune compromised
patients.
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Phase III Medidur for An injectable, non-erodible intravitreal
Diabetic Macular device for DME, designed to be
Edima (DME) administered in an office procedure.
DME is a major cause of vision loss in
working age patients.
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Phase IIb BrachySil A non-degradable, radioactive 32-
for non-operable phosphorus form of BioSilicon for
liver cancer the treatment of non-operable liver
cancer tumours.
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Phase IIa BrachySil A non-degradable, radioactive 32-
(1st half for non-operable phosphorus form of BioSilicon for
2006) pancreatic cancer the treatment of non-operable pancreatic
cancer tumours.
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Pre- BioSilicon A new and unique material produced from
clinical platform elemental silicon for use in controlled-
technology release drug delivery and other
applications across the healthcare
sector.
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Vitrasert and Retisert are trademarks of Bausch & Lomb incorporated
