June 27, 2008

As a company focused on the in vitro fertilisation (IVF) market, Pantec Biosolutions has two significant characteristics that set it aside from its competition. Firstly, the firm is based in Liechtenstein, a tiny principality in Central Europe measuring no more than 24km long. Not the expected headquarters of a medical device manufacturer, but nevertheless, a cluster area for high-end microelectronics and optics companies, as well as a pathway to the major medtech markets in Germany, France and the rest of Europe. Secondly, and more importantly, Pantec believes that its lead product, the PLEASE (painless laser epidermal system) drug delivery platform, is unique in the way that it administers therapy and will allow the company to become a prominent player in the lucrative IVF market.

Pantec is aiming to replace injection-based drug delivery with its painless and cordless needle-free system, which is designed to administer large molecular weight drugs such as proteins, peptides, antibodies or vaccines to a patient. The hand-held system consists of the laser, a disposable tip for creating pores in the patient’s skin and a patch which contains the appropriate drug.

Future success hinges on the results of the preclinical testing of the PLEASE platform, and securing a stronghold in the IVF market.

The disposable tip, which is connected to the laser, is gently pressed onto the patient’s skin and, at the push of a button, begins to create pores. This process can take one to five seconds depending on the size of the drug molecules being applied. After poration is complete, the treated area is covered with the drug patch system, which diffuses the appropriate drug through the dermis where it can be absorbed by the blood system.

Pantec CEO Christof Boehler told Clinica that the company’s future success hinges on the results of the preclinical testing of the PLEASE platform, and securing a stronghold in the IVF market, which he views as a low-risk opportunity. “IVF is definitely our core market,” he said. Pantec values the IVF hormone market at approximately €1.5-2bn ($2.3-3.1bn) globally, and sees lucrative opportunities in each of the world’s leading geographic markets. In Europe, the average cost of an IVF treatment is €5,000 plus an additional €1,000-2,000 in hormone costs. Pantec’s system of renting the PLEASE technology for a low but as yet-undetermined fee (perhaps €5 per day or even lower) compares favourably.

Sparse Competition

Mr Boehler said that he was not aware of any other company that is currently developing laser-based drug delivery technology, but highlighted two competitors that were attempting to replace needle-based treatments with slightly different transdermal delivery platforms. According to Mr Boehler, a firm in Israel is developing high-voltage radiofrequency microporation technology with subsequent drug patch delivery, while an Atlanta, Georgia-based company is designing a method by which micropores are generated by fuses burning down into the skin, again using patches for subsequent drug delivery. Mr Boehler pointed out that Pantec’s technology was painless, minimally-invasive and caused no harm to the patient’s skin.

When Pantec’s technology is approved, the company’s business strategy is to commercialise a patient solution consisting of the PLEASE device alongside drug patches, which will then be distributed by big pharma, specialty pharma or biotech companies.

The CEO said that he expected the PLEASE device to be CE-marked and achieve FDA 510(k) clearance by late 2008 or early 2009. He added that although Pantec was “100% focused on the IVF market”, there was scope for the company to expand into the diabetes, pain, immunology and vaccines fields due to the technology’s ability to deliver a range of large molecular weight drugs directly into the epidermis.

joseph.harvey@informa.com