There are few things that make Prof. Daphna Heffetz, CEO of pharmaceutical start-up TransPharma, happier than being in the lab, but a multimillion-dollar payment might be one of them.

Recently, TransPharma announced a $35 million licensing and development agreement with Eli Lilly for its ViaDerm-hPTH (1-34) product for the treatment of osteoporosis. It’s another step in fulfilling Heffetz’s dream to helm an Israeli company creating practical applications for biotech research and development.

TransPharma’s ViaDerm drug delivery system comprises a handheld electronic control unit that uses radiofrequency to create microscopic microchannels in the outer layer of the skin, allowing for transdermal delivery of a wide variety of drugs from a patch.

ViaDerm-hPTH (1-34), administered transdermally using TransPharma’s proprietary technology, is currently in Phase II clinical testing. TransPharma and Lilly will both fund and participate in phase II clinical development activities.

If successful, Lilly will be responsible for further development activities and the potential commercialization of any transdermal PTH products. However, a $35 million upfront payment is a pretty good indication of Lilly’s faith in the product.

“We know the technology works,” Heffetz tells ISRAEL21c. “The oral drugs on the market, including Lilly’s Evista, prevent bone loss but don’t build up bone. Human parathyroid hormone 1-34 is a hormone that exists in the body; this molecule is a known anabolic therapy that builds bone. Lilly’s Forteo (teriparatide) has the same active ingredient but must be injected. The ViaDerm system enables it to be administered easily at home.

“There are other patches on the market today, but they are placed on intact skin,” she continues. “The drug diffuses from the patch through an almost impermeable outer layer of skin. So, only small molecules can pass through the patches: hormone replacements, testosterone, and some pain management therapies.”

Other patches contain skin-irritating enhancers. “We don’t use enhancers,” she says.

She believes ViaDerm’s RF-Microchannel pretreatment solves the pore penetration problem. “The microchannels bypass the outer, non-viable layer of skin. When the patch containing the drug is placed on the area, it diffuses through the inner layer of the skin and from there to the systemic circulation. Our aim is to use the advantage of drug delivery through the skin and enlarge our portfolio of drugs to include high weight molecules – biotechnology proteins such as PTH,” she says.

Under the current agreement, in addition to the upfront payment from Lilly, TransPharma may also receive development and sales milestones, as well as royalties on sales if a transdermal PTH product is successfully commercialized.

The agreement provides Lilly with exclusive worldwide rights to ViaDerm-hPTH (1-34) for osteoporosis only. Lilly will have non-exclusive access to the ViaDerm delivery system for other drugs, leaving the field clear for agreements with other companies – all in line with Heffetz’s plans for TransPharma.

“Our business model is to develop drug products,” she tells ISRAEL21c. “We initiate development of drug products and license them through co-development, and, in the future, we intend to get nearer the specialty pharmaceuticals market by ourselves.”

At this stage, TransPharma is focusing on the ViaDerm delivery platform, “and we have other drugs in the pipeline that look very promising.”

The TransPharma pipeline, she says, is unique in that it is multidisciplinary. “We’re developing combination products which are the future generation [for medication]. At our headquarters, we have two R&D departments, one for device development, one for drug development; a mechanical workshop and preclinical laboratory.”

A graduate of the Weizmann Institute, Heffetz still spends time in the lab. This too, is in line with her plans. “I did my masters, doctorate and post doc studies at Weizmann in biochemistry and molecular biology. But I always I wanted to be in industry,” she says. “I wanted to integrate something active with science, and I loved the lectures we got from people from all over the world who came from industry.”

Israel’s biotechnology arena was sorely underdeveloped in the early ’90s, but Heffetz found a position at Savyon Diagnostics where, over seven years, she rose through the ranks to spend her last two years there as CEO. “Although it was a small company, it was mature in that it had development, manufacturing and sales in Japan, Europe and the US, and I learned a lot about the chain of operations,” she says.

Heffetz took those skills with her when she founded TransPharma in 2000.

“I wanted to be in a startup because the CEO continues to be involved with R&D and I’m still very tied to it. I jump for joy every time an experiment succeeds. That makes me most happy.”

Did Heffetz or Dr. Gwen Krivi, VP of Lilly Research Labs, have a personal concern for osteoporosis as a disease afflicting women primarily? “I haven’t yet met Dr. Krivi, but for me, I have to say ‘no’. We’re just always on the lookout for drugs that exist on the market which we can reformulate to our system,” she says.

Nonetheless, she notes, there are a good number of women involved at TransPharma. “Most of the management is women. Ruth Alon of Pitango Venture Capital is the chairman of the board and Ronit Bendori represents Evergreen Venture Partners. I didn’t intend for it to happen. You just interview people and take the most qualified people with whom you have the best chemistry. It just worked out that way.”