A Medical Device Daily

Global bio-nanotech company pSivida (Boston/Perth, Australia) said it has signed a non-binding memorandum of understanding (MOU) with Nordic Biotech Advisors. The MOU provides for Nordic Biotech II K/S or affiliates and co-investors to make an A$5.2 million (US$4 million) corporate investment in pSivida and an A$28.5 million (US$22 million) investment over time in a Special Purpose Vehicle (SPV) to fund the expected amount of pSivida’s portion of costs to develop its lead ophthalmic product, Medidur, for the treatment of the chronic eye disease diabetic macular edema (DME).

At closing, the company will receive a total of A$6.5 million (US$5 million), consisting of the A$5.2 million equity investment and a payment by the SPV to pSivida of A$1.3 million (US$1 million). The transaction is subject to completion of due diligence and final documentation.

Upon closing, Nordic will invest A$5.2 million (US$4 million) in pSivida by purchasing newly issued shares of preferred stock. The preferred stock will be convertible into American Depository Shares (ADSs) at a conversion price of US$2 per share and will contain anti-dilution protection.

pSivida will issue warrants to Nordic with a face amount equal to $A2.6 million (US$2 million), an exercise price of $US2 per ADS and anti-dilution protection. An additional A$4.5 million (US$3.5 million) will be invested in the SPV at closing, of which A$1.3 million (US$1 million) will be paid to pSivida by the SPV.

The remaining A$24 million (US$18.5 million) of SPV investment by Nordic will be made in regular installments to fund the expected amount of pSivida’s share of development costs.

pSivida and Alimera Sciences are currently co-funding the development and will co-share in the profits of Medidur for DME, which is in Phase III multi-national clinical trials.

After this transaction closes, the SPV will receive pSivida’s profit share payments under the Alimera co-development agreement and will distribute the payments to Nordic and pSivida. Revenues distributed by the SPV would initially be paid 75% to Nordic and 25% to pSivida, subject to certain adjustments.

After cumulative revenues paid to Nordic equal four times its investment in the SPV, the split of revenues will become 50% to both Nordic and pSivida. After cumulative revenues paid to Nordic equal eight times its investment in the SPV, 80% of the SPV revenues will be paid to pSivida and 20% to Nordic.

After closing, at an extraordinary general meeting at a date yet to be set, pSivida will seek shareholder approval to give Nordic a full exchange right on the A$28.5 million (US$22 million) SPV interest into pSivida ADSs at US$2 per share. If approved, Nordic will have the option to either share SPV revenues or convert all or part of its SPV investment into ADSs, in which case forfeiting that portion of its share of the SPV revenues.

If shareholders do not approve the full exchange right, Nordic may elect to stop funding, in which case Nordic’s interest in the SPV revenues will be reduced.

pSivida’s lead FDA-approved ophthalmic product is Retisert for the treatment of uveitis, a leading cause of blindness in the U.S. Medidur essentially differs from Retisert in that it is injected behind the eye in a simple office procedure, whereas Retisert is surgically inserted in a hospital procedure. Medidur and Retisert can deliver the same steroid (fluocinolone acetonide or FA), at a similar rate to the back of the eye.

Sustained delivery of FA to the back of the eye has previously been shown to reduce edema in patients with DME, reduce the progression of their diabetic retinopathy and most importantly, at three years provides a clinically significant increase in many patients vision. These results were generated in a 198-patient clinical trial conducted in the U.S. by Bausch & Lomb (Rochester, New York), licensee of Retisert.

Medidur is being evaluated by several companies, including global pharmas and smaller biotech companies, for the delivery of their proprietary compounds to treat other eye diseases. pSivida said it expects that one of these evaluations will lead to a license for pSivida’s drug delivery products.

Separately, pSivida reported that it has entered into a collaboration with a global electronics and technology company to evaluate its nano-structured silicon BioSilicon technology for the development of transdermal drug-delivery systems. The collaboration combines the expertise of the undisclosed company in the development and production of microelectromechanical systems with pSivida’s core competency in drug delivery.

During the 12-month program, the parties will jointly develop and evaluate a range of biodegradable porous silicon structures, including microneedles, for the controlled release of drugs via the transdermal route.

There is significant interest in transdermal delivery systems for the delivery of a range of therapeutic entities, from conventional small drug molecules to larger peptides, proteins and vaccines. pSivida said Frost & Sullivan has estimated the U.S. transdermal drug delivery market as reaching $4.5 billion by 2012.

Candela lasers okayed in Canada

Candela (Wayland, Massachusetts) said that Health Canada cleared for distribution three new models of the company’s flagship Vbeam Pulsed Dye Laser — the Aesthetica, Platinum and Perfecta — in Canada.

Vbeam, which Candela said is recognized as the gold standard laser for vascular treatment, now features a pigmented lesion handpiece that allows effective treatment for total rejuvenation by treating reds and browns. Also new is the Vbeam unique micro-pulse technology that provides consistent, gentle heating, allowing for highly effective purpura-free treatments, it said.

Dennis Herman, senior vice president, North American sales, marketing and service for Candela, said, “The expansion of Perfecta into Canada means that practitioners will have more choices and greater flexibility to meet their individual practice needs. The versatility of Perfecta’s purpura-free treatment allows practitioners to expand their cosmetic offerings while still treating the medical patient.”

The technology behind the new Vbeam family allows practitioners to treat stubborn skin conditions more aggressively than before, but without the undesired side effects of laser bruising, or purpura. Laser treatment of pigmented lesions is expected to increase 19% in 2007, making it one of the primary indications for which patients seek laser treatment. Candela said the pigmented lesion handpiece adds versatility to pulsed dye technology and allows practitioners to diversify treatment capabilities with a single device.

“The Vbeam Perfecta is a great option for patients who want fast results and better looking skin without the side effect of bruising or downtime that sometimes occurs with other pulsed dye treatments or peels,” said Dr. Gerald Boey, director of the Arbutus Laser Center (Vancouver, British Columbia). “I’m looking forward to offering my patients more cosmetic rejuvenation treatments including treating sun and age spots, spider veins, red noses and rosacea, and still treat medical indications such as hemangiomas, venous lakes and even warts.”

Cleveland Clinic at pan-American conference

Three Cleveland Clinic physicians held a symposium on prevention, diagnostic and surgical treatment of colorectal cancer at the XXX Panamerican Congress of Gastroenterology, organized by the Mexican Association of Gastroenterology, in Cancun, Mexico, earlier this month.

The symposium involved Carol Burke, MD; Feza Remzi, MD; and Aaron Brzezinski, MD.

The Cleveland Clinic also had an informational booth at the conference. The clinic’s Global Patient Services is a department dedicated to meeting the needs of international patients who receive their care at the Cleveland Clinic.

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