WATERTOWN, Mass. & NEW YORK, Aug 16, 2011 (BUSINESS WIRE) -- Drug delivery company pSivida Corp. /quotes/zigman/111048/quotes/nls/psdv PSDV +1.88% (asx:PVA) today announced it has entered into an evaluation agreement with Hospital for Special Surgery (HSS), a world leader in orthopedics, rheumatology and rehabilitation, to investigate pSivida's drug delivery technologies in orthopedics.
This agreement follows pSivida's announcement in June that it has renegotiated its collaboration agreement with Pfizer to focus solely on developing a bioerodible sustained release implant for glaucoma and ocular hypertension. (This program is already in clinical trials).
"We believe this orthopedic evaluation agreement is important for pSivida as our drug delivery technology, originally developed for ophthalmology, is being investigated in broader areas of medicine," said Dr Paul Ashton, President and CEO of pSivida. "We are excited to be working with Hospital for Special Surgery because of their long history of innovation and research in orthopaedic surgery."
(RTTNews) - pSivida Corp. (PSDV: News ) is a drug delivery company primarily focused on ophthalmology. The company's most advanced product candidate Iluvien for the treatment of diabetic macular edema, which was rejected by the FDA last year, faces the regulatory agency for a second time in November.
Founded in Australia and incorporated in the U.S. in June 2008, pSivida is listed on the Nasdaq, Australian and Frankfurt exchanges. The company has two products approved by the FDA - Retisert for the treatment of uveitis, an inflammatory eye disease, and Vitrasert for the treatment of AIDS-related cytomegalovirus retinitis. Both these products are being sold by Bausch & Lomb Inc., a leading ophthalmic goods firm.
The fate of pSivida's most advanced investigational drug Iluvien for the proposed treatment of diabetic macular edema will be decided by federal regulators in November. Diabetic macular edema, or DME, is a common diabetes complication, which causes retinal blood vessels in a diabetic's eyes to deteriorate and leak.
Iluvien, an injectable, non-erodable, intravitreal implant, was licensed by pSivida to Alimera Sciences Inc. (ALIM: News ) in exchange for a $15 million licensing payment. This is the drug candidate's second go-around with the FDA.
Last June, Alimera submitted a New Drug Application for Iluvien to the FDA seeking approval for diabetic macular edema, and in the following month that year, submitted a Marketing Authorization Application in certain European Union countries. The NDA for Iluvien was based on 24-month data from two pivotal phase three clinical trials - collectively dubbed as the FAME Study. The trials demonstrated that significant percentage of patients treated with Iluvien showed improvement in best corrected visual acuity of 15 or more letters at 2 years compared to those receiving placebo.
Iluvien did not, however, pass muster and the FDA, citing a couple of issues, sent the application back to the company in December of 2010. In its Complete Response Letter, the FDA asked for analyses of safety and efficacy data through month 36 of the FAME Study and additional information regarding controls and specifications concerning the manufacturing, packaging and sterilization of Iluvien.
Addressing the concerns outlined in the Complete Response Letter, pSivida's licensee partner Alimera resubmitted the New Drug Application for Iluvien on May 12, 2011. Being a Class 2 resubmission, the FDA is expected to decide on the Iluvien NDA by November 12, 2011
There is currently no FDA approved drug therapy for treating DME (Diabetic Macular Edema) and the only FDA approved method for treating DME involves laser photocoagulation therapy, which can leave irreversible blind spots. It is estimated that in the U.S., about 75,000 new cases of diabetic macular edema develop each year. According to experts, DME represents a vast market potential in excess of $1 billion.
The FDA-approved wet AMD treatment Lucentis developed by Roche Group's Genentech is also being investigated as a potential treatment of DME in the U.S. Earlier this year, Lucentis was approved for treatment of visual impairment due to DME in Europe.
If Iluvien is approved, pSivida will be entitled to a $25.0 million milestone payment from Alimera and 20% of profits from the sales of the drug by Alimera.
In addition to diabetic macular edema, Iluvien is also being evaluated as a potential treatment for wet and dry age-related macular degeneration as well as Retinal Vein Occlusion. Alimera is conducting phase II clinical trials with Iluvien for the three potential indications.
pSivida's other products in clinical development include, BrachySil for the treatment of solid tumors and Durasert/latanoprost program for glaucoma.
BrachySil, which uses BioSilicon technology, is a medical device containing beta-emitting phosphorous 32-P that is administered under a local anesthetic via direct, intraturmoral injection using a fine gauge needle with ultrasound or CT guidance. BioSilicon technology was discovered and developed by QinetiQ, one of the largest research agencies in Europe.
pSivida also has a collaborative research and license agreement with Pfizer Inc. (PFE) for the Durasert/latanoprost program. The original agreement between the two companies was inked in April 2007 and was amended in June of this year. Under the restated agreement, pSivida is eligible to receive up to $168.8 million plus royalties. Pfizer is the largest shareholder in pSivida holding 9% of the outstanding shares.
A quick look at pSivida's balance sheet...
Barring fiscal year 2010, the company has incurred operating losses each year since inception and, at March 31, 2011, had a total accumulated deficit of $226.8 million. The company has cash of $23.1 million, which includes net proceeds of $10.1 million in a registered direct offering completed earlier this year, and no long term debt.
The company is scheduled to report its fourth quarter and full year results on September 19. As the company awaits a regulatory decision, it remains to be seen if the second time will prove a charm for the diabetic macular edema drug.
PVA Price at posting:
$4.00 Sentiment: Buy Disclosure: Held
