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pSivida (PSDV) Has Its Own Brexit, Consolidates U.K. Operations to Massachusetts HQ

7/26/2016 6:45:33 AM

pSivida Has Its Own Brexit, Consolidates U.K. Operations to Massachusetts HQ July 26, 2016
By Mark Terry, Breaking News Staff

pSivida Corp. (PSDV), headquartered in Watertown, Massachusetts, is performing its own “Brexit,” and closing its U.K. facilities and consolidating all research and development to Watertown.

pSivida focuses on miniaturized, sustained-release drug delivery systems. Its Durasert technology is a very small device that can have already approved drugs inserted, which are then injected into the body. Instead of a patient receiving regular injections from their physician, a single injection of a microinsert acts as a very long-acting time-release capsule that could last for months or even years.

So far it’s been approved for eye-related diseases. It licensed Durasert to Pfizer (PFE) for the development stage of latanoprost, and to Alimera Sciences (ALIM) for Iluvien. Iluvien has been approved by the U.S. Food and Drug Administration (FDA) to treat Diabetic Macular Edema in patients that have already had corticosteroids and didn’t have a significant increase in intraocular pressure. Global sales were reported as slightly over $22 million in 2015, with growth expected.

The other marketed product is Retisert for posterior uveitis, which it markets with Bausch & Lomb. But the company has hopes of launching its first wholly-owned product, Medidur, for posterior uveitis, in the next couple years. The company hopes to apply for approval in Europe later this year and in 2017 in the U.S.
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But the company has another product in its pipeline, which if it were to get approval, would push pSivida into a much broader and more lucrative market. It is what Paul Ashton, the company’s chief executive officer, calls a “biocompatible silica-based matrix,” which is dubbed Tethadur. It’s similar to Durasert, but instead of being filled with regular drugs, would be loaded with biologics. Instead of manipulation of chemicals, biologics are large, complex molecules or mixtures of molecules that are made using recombinant DNA technology. They are typically manufactured in a living system like a microorganism, plant or animal cells.

If approved, the company’s Tethadur would allow it to work in the biosimilars market, which is just taking off, but could possibly go as high as $80 billion, although most current estimates are lower.

Just last week, pSivida announced that data from preclinical studies of Tethadur loaded with monoclonal antibody Avastin, an oncology drug manufactured by Roche (RHO), was positive. Generic versions of Avastin are expected to launch in the U.S. in 2019 and in Europe in 2022, and there are already more than a dozen biosimilars being developed for the drug.

“We are pleased with these Tethadur study results, which demonstrated a number of important points necessary for the sustained biologic drug delivery we are seeking to provide,” Ashton said in a statement. “Avastin was loaded into Tethadur at a high level required for sustained delivery; Tethadur successfully delivered the Avastin on a level, controlled basis over an extended period; the potency of Avastin remained at high levels on release from Tethadur, which is key to providing a sustained therapeutic effect; and Tethadur itself dissolved into silicic acid on a controlled basis.”

As part of its consolidation plan, pSivida indicates the shuttering of its UK operations will save about $900,000 annually. As of August 2015, the company employed 26 people between its two locations. The company indicates it plans to hire more people in the near future, but does not plan to expand its current Watertown facilities.

“We look forward to the seamless consolidation of the Durasert and Tethadur research and development work being done in our U.K. and our U.S. facilities in a single location,” said Ashton in a statement. “We believe this restructuring will focus our research-and-development efforts and facilitate product development while reducing operating expenses.”

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