Overcoming Obstacles in Drug Development

Eran Gabbai and Ayelet Dilion Mashiah of Do-Coop Technologies describe a new technology that is turning the tide in the pharmaceutical industry.

“R&D is in trouble because of shrinking pipelines. To fund new research you need sustained revenue from previous durgs”
-Ayelet Dilion Mashiah

What challenges face the pharma industry?

Ayelet Dilion Mashiah. R&D is in trouble because of shrinking pipelines. To fund new research, you need sustained revenue from previous drugs. But the number of new drugs is dropping, because of R&D obstacles that kill a drug before the clinical trials. It's a vicious cycle spiraling into a crisis.

Which obstacles are fatal for a new drug?

Eran Gabbai. The worst are poor efficacy and toxicity. Many new compounds are hydrophobic, only solubilized with an aggressive solvent. After pre-clinical success, the high toxicity of the solvent requires a different vehicle for the clinical phase. That change can undermine earlier data and cause unpredictable results.

If you overcome those, you hit a third obstacle – the behavior of intracellular water, which is different from bulk or lab water. Those differences are generally misunderstood, and in vivo efficacy in humans can be affected as a result.

These obstacles are so prevalent that around 75 percent of drug discoveries are shelved as impractical. Some 60 percent of these failures are from solubility issues alone.

ADM. Pharma companies are losing $80 billion a year, just from solubility setbacks.

EG. The beauty of Neowater is that it overcomes all these obstacles. Neowater shifts the physical and chemical properties of bulk or lab water. Its proprietary structure is nontoxic, inert, and remarkably stable. So Neowater can be the vehicle for both in vitro and in vivo testing.

Best of all, Neowater resembles intracellular water in handling both hydrophobic and hydrophilic compounds. Its compatibility with the natural biological environment also reduces the need for co-solvents or surfactants used in drug formulation, reducing toxicity levels while enhancing compound efficacy.

How would you categorize Do-Coop's business value for the pharma industry?

ADM. Neowater works unlike any other drug delivery system. But because Neowater is generic, it provides the optimal vehicle for many compounds with only minimal customization. Companies can register new IP with existing API (active pharmaceutical ingredients), based on an extended therapeutic window.

Additionally, Neowater was submitted to the FDA for compound integration without needing a separate toxicity control. Companies using Neowater-based compounds will see faster, more cost-effective progression.

EG. With a single delivery vehicle, efficient use of R&D capital rises, as do the discoveries that can become viable. Neowater also provides better hydration and bioavailability in formulations, greater control in sustained-release formulas, and long-term stability in stored products.

What successes has Do-Coop had so far?

ADM. We partnered with Champions Biotechnology, who are developing oncology drugs. They were hunting everywhere for a solubilizer for SG410, their benzoylphenylurea (BPU) sulfur analog. It was a 'brick' compound with no therapeutic window at all.

Using Neowater, Do-Coop enabled a liquid formulation that can be taken for in vivo studies, with at least the same activity as with DMSO. Champions will have early Biomerk Tumorgraft results for Neowater-based SG410 by late 2009.

As an example of using existing API, we connected a third party with a reformulated cyclosporine (based on Neowater) as an immuno-suppressive agent for eye treatment. As you know, Allergan owns the IP for cyclosporine eye drops. But because Neowater extends its therapeutic window with a formulation that doesn't intrude upon Allergan's IP, new IP could be created.

Incidently, the cyclosporine was originally an in-house POC. We are not a drug producer. We license Neowater technology, merging Neowater IP with our customers' IP. Our business model is receipt of royalties and milestone payments only. The pharma companies reap the other rewards.

EG. In the end, our society benefits from medical advances that can be brought to market for lower cost, in less time and with fewer glitches along the way. So we all win with Neowater.

Eran Gabbai is the inventor of Neowater and the entrepreneur who founded Do-Coop Technologies Ltd, of which he is President and CEO.

Ayelet Dilion-Mashiah is the VP of Business Development and CFO of Do-Coop Technologies Ltd.