Regarding pSivida’s dependence upon Iluvien’s success...
Bridge, thanks for the update concerning Iluvien which I consider to address the same economic market as SRDX’s I-vation TA.
Based on the tone of its 2/11/2009 10-Q, pSivida seems to be depending upon an unrealistically quick FDA approval of Iluvien to remain viable after Jan 2010. The Phase III trial is fully recruited with the last patient scheduled to have the two-year follow-up visit in October 2009. Filing for FDA approval is planned for early calendar 2010 (per the 2/12/2009 8-K and the PR you posted).
I am surprised that pSivida is still in financial straights. As Dew had posted a year ago, #msg-18468280, pSivida had signed what appeared to me to be a lucrative collaborative research agreement with Pfizer. Under the terms of the agreement pSivida had the potential to receive up to $155M in development and sales related milestones. It seems that the Pfizer agreement is currently generating the minimum payment of $2M/yr.
The relevant statement in the 10-Q is found on page 8; i.e.
Liquidity
Cash and cash equivalents totaled approximately $9.8 million at December 31, 2008 compared to $15.6 million at June 30, 2008. The Company believes that it can fund its operations as currently conducted through at least December 31, 2010. This expectation is based on the assumptions that the Company continues to receive the Pfizer quarterly $500,000 research and development funding, Alimera continues to fund the development of Iluvien, the Company resumes receiving Retisert royalties from Bausch & Lomb during the fiscal year ending June 30, 2010 and the Company receives the scheduled conditional note payments from Alimera. However, whether and when the Company will require or desire to raise additional capital will depend upon many other factors, including, but not limited to:
• the continuation of the Company’s collaborations with Pfizer and Alimera on their existing terms, including their continued funding of the Company’s programs and the receipt of applicable milestone, royalty, note and other payments, and their ability to finance such funding and payments;
• the development, regulatory approval and commercialization of Iluvien, which is the Company’s primary product candidate currently in development;
• the amount and timing of sales of Retisert, which affect the timing of the resumption of Retisert royalty payments and the amount of such royalty payments;
• the scope and extent of the Company’s internally funded operations, including its programs for BrachySil (including any Phase III clinical trials for BrachySil for pancreatic cancer), any new product candidates, or any new business opportunities;
• the Company’s ability to establish and maintain strategic arrangements for Brachysil or any other product candidates for research, development, clinical testing, manufacturing and marketing;
• the success of the Company’s products and product candidates, including the timing and costs of regulatory approvals and the commercial success of approved products;
• the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims; and
• changes in the Company’s operating plan, including the pursuit of new business opportunities, which may affect its need for capital
In addition, the Company’s future cash position beyond December 31, 2010 also depends significantly on the regulatory approval and marketing of Iluvien. Alimera has agreed to pay the Company $25.0 million upon FDA approval of Iluvien and a 20% share in the future profits of Iluvien.There is no assurance that the FDA will approve Iluvien or that Iluivien will achieve market acceptance even if it is approved by the FDA.
AI
