High dosage NeuroDerm mechanism for Parkinson's disease. .
(photo credit: NEURODERM)
One Israeli company may have a billion-dollar solution to making treatment regimens more convenient and effective for patients with advanced Parkinson’s disease.
Just two weeks ago, the Rehovot-based NeuroDerm announced that it had entered a definitive agreement to be acquired by the Japanese company Mitsubishi Tanabe Pharma for $1.1 billion. While NeuroDerm has a number of technologies in its pipeline, the particular product that attracted the Japanese investment was ND0612 – a liquid medication still under clinical trials that could provide patients with a continuous, less invasive treatment option.
“We have been able to produce a liquid formulation for the first time that can be administered inside the body directly, not through the stomach, but under the skin,” Dr. Sheila Oren, NeuroDerm’s chief medical officer, told The Jerusalem Post on Sunday.
Oren has two decades of international pharmaceuticals experience and has been responsible for the clinical development and marketing of several central nervous system drugs. As chief medical officer at NeuroDerm, she has been overseeing the development of ND0612 and several other medicines that could potentially provide life-changing opportunities to patients.
In patients who suffer from Parkinson’s disease, certain brain cells begin to die and therefore stop producing dopamine, a chemical that is critical to movement, Oren explained. To compensate for that loss of dopamine, replacement therapy through a drug called levodopa, or L-dopa, has thus far been the best treatment option, she said.
Yet as the disease progresses, Oren continued, the neurons disappear completely and the patient becomes entirely dependent on the levels of levodopa in the blood. With no more cells able to manage and store the chemical, the patient is reliant on the medicine, which she said has a very short half-life and therefore requires increasingly frequent dosages.
At this point, the patient often experiences both “off time” periods with decreased motor functions, as well as periods of involuntary movements, known as dyskinesia, due to medicinal overdoses.
According to Oren, the best way to overcome these circumstances is to administer treatment continuously.
Up until now, the only way to dispense continuous levodopa has been through a medicine called Duodopa, a gel that enters the body through a hole in the stomach and is eventually absorbed in the duodenum region of the intestine, Oren said. While this method provides continuous medication, it also comes with potential complications such as tube dislocation or infection of the wound area where the tube is inserted, she explained.
NeuroDerm’s solution aims to improve this mechanism by providing a system through which levodopa can be administered subcutaneously, or under the skin, through a pump similar to those used to provide diabetics with insulin.
“That’s really the invention and why we were able to have that value for a company,” Oren said, referring to the recent acquisition.
In a deal worth $1.1b., Mitsubishi Tanabe Pharma, a publicly traded company on the Tokyo Stock Exchange, agreed to acquire the Israeli firm for $39 per share in cash, according to the companies. The partners anticipate that the transaction will close by the fourth quarter of 2017.
One feature that made a clinical stage company so attractive to Mitsubishi Tanabe was the Israeli firm’s robust patent strategy for this type of liquid formulation, Oren explained. In addition, the technology involves a well-known compound, yet brings a new answer to an existing need, she said.
“It’s easier for us to get over the regulatory hurdles because you don’t have to do everything from the start,” Oren added. “We have the advantage of the new without the disadvantage of the new.”
Although the drug is still only in clinical stages, Oren said that the company plans to submit the necessary commercialization paperwork to the relevant American and European regulatory agencies by the end of 2018. The goal is then to have the product on the market by the end of the following year, she explained.
The subcutaneous liquid formulation for levodopa may be NeuroDerm’s primary product at the moment, but another medicine for cognitive disorders as well as an apomorphine-based drug for Parkinson’s disease are also in the works, Oren said. She expressed her hopes that under Mitsubishi Tanabe, the NeuroDerm team will continue to operate at its current headquarters and provide an R&D platform for the larger company.
In the meantime, she said that NeuroDerm is happy to hear from patients that the levodopa formulation is helping them function more hours of the day.
“They report it as a life-changing situation,” she said.