The International Diabetes Federation estimates that approximately 19 million people in these 7 EU countries are currently living with diabetes, and Alimera estimates that approximately 1 million people living there suffer from DME.
With respect to U.S. regulatory matters, Alimera has reported that it met with the FDA in an effort to gain a better understanding of the regulatory path for ILUVIEN for DME. Alimera further reported that based upon this meeting, it plans to submit a response to the FDA’s second complete response letter to include additional analysis of the benefits and risks of ILUVIEN based upon clinical data available from Alimera’s completed FAME™ Study. Approval in the U.S. would entitle pSivida to a $25 million milestone payment and 20% of net profits, as defined, from U.S. sales of ILUVIEN by Alimera.
“The investigator sponsored Phase I/II dose-escalation study of our bioerodible, injectable latanoprost micro-insert for glaucoma and occular hypertension is ongoing,” continued Dr. Ashton. pSivida granted Pfizer an exclusive option under various circumstances to license the development and commercialization worldwide of this micro-insert for human ophthalmic disease other than uveitis.
“We are encouraged by the progress of our pre-clinical programs. In July 2012, we announced the execution of our first funded technology evaluation agreement for our Tethadur™ protein/antibody delivery technology. The agreement, which is with a leading global biopharmaceutical company, covers the field of ophthalmology. Tethadur is an application of our BioSilicon™ technology platform designed to provide sustained delivery of large biologic molecules, including peptides, proteins and antibodies using an injectable, bioerodible, nanostructured, porous BioSilicon material for drug delivery. A sustained delivery system for these types of molecules which must currently be injected into the eye every one or two months would offer a significant clinical advance in the ophthalmic area."Revenues for the fiscal year ended June 30, 2012 totaled $3.5 million compared to $5.0 million for the prior fiscal year. Revenues in both years included royalty income from sales of Retisert® by Bausch & Lomb and revenue recognition from the June 2011 amendment and restatement of the Pfizer collaboration agreement. In addition, fiscal 2012 reflected revenue recognition from the July 2011 termination of the Intrinsiq license agreement. For the year ended June 30, 2012, pSivida reported a net loss of $24.8 million, or $1.19 per share, compared to a net loss of $8.6 million, or $0.44 per share, for the prior fiscal year. Fiscal year 2012 results included a $14.8 million impairment charge for pSivida’s finite-lived intangible assets arising from the November 2011 complete response letter for ILUVIEN for DME and the resulting significant decrease in pSivida’s share price.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV