Japanese pharmaceutical company, Takeda, has entered into collaboration with Bionumerik Pharmaceuticals, with the intention of marketing Bionumerik's Tavocept (dimensa), a chemoprotective drug that relieves the neurotherapy commonly associated with chemotherapy.
News of this agreement and the companies' intentions underlie the growing need for an effective treatment option to better manage the side effects that result from many chemotherapeutic products. There is currently no FDA-approved treatment to prevent or reduce neuropathy caused by chemotherapy drugs.
Under the terms of the deal Takeda has agreed an upfront payment of $52 million (€42m) in the form of an equity investment to BioNumerik in addition to development milestone payments. The two companies have also agreed to share overall profits from the US and Canadian sale of Tavocept.
The FDA recently granted 'fast track' development designation for Tavocept, which is currently undergoing Phase III trials. Under the terms of the alliance agreement, Takeda Pharmaceuticals North America will market Tavocept following its approval in the US and Canada.
On a strategic level, Takeda's agreement to enter such an arrangement is evidence of its commitment to building a US presence and building the company name of Takeda Pharmaceuticals North America. It already has a significant US presence with TAP Pharmaceutical Products, a joint venture between Takeda and Abbott Laboratories.
Yasuchika Hasegawa, Takeda's president said: "We hope that Tavocept will enable us to offer new options to combat the neuropathy associated with anti-cancer agents in the US and Canada."
The collaboration represents uncharted territory for the two companies but success with Tavocept could represent a virtual monopoly of the chemoprotective drug market. However, the problem of developing such a drug is exacerbated by fact that chemotherapy side effects, their severity and the frequency of episodes differs from person to person.
Most chemotherapy drugs cause side effects, including neuropathy, nausea, and reductions in the numbers of white and red blood cells produced by the bone marrow. These symptoms may not dissipate even after anticancer drug treatments are concluded, and can harm the patient's quality of life (QoL) over the long term.
Tavocept is intended to prevent or mitigate the numbness, pain and loss of feeling in the hands and feet that can be caused by chemotherapeutic drugs. Its mechanism of action protect cells against the damage or impairment to the functions of the intra-cellular protein, tubulin, associated with the nausea caused by the taxane and platinum classes of antitumour drugs, both of which are commonly used in cancer therapy.