Takeda Gets GI Candidate – And Possibly Company – In Altos Deal
This article was originally published in PharmAsia News
Executive Summary
In the latest in a string of deals, Takeda's agreement to acquire global rights to Altos's gastroparesis candidate - and possibly the company itself - gives the Japanese giant another asset in its core gastrointestinal area.
Takeda Pharmaceutical Co. Ltd. has entered into a final agreement with Altos Therapeutics to develop and commercialize globally the small US firm's gastroparesis candidate ATC-1906, along with an exclusive option for the outright acquisition of privately held Altos.
ATC-1906 is Altos's only R&D asset and is now moving into early clinical development for gastroparesis symptoms. The acquisition option became active on the date of the agreement in return for an undisclosed upfront payment by Takeda, and will run until an undisclosed "period of time" following the completion of Phase I studies with the molecule.
Exercise of the option would trigger a further payment to Altos, which would also be eligible to receive additional funds related to a Takeda-led clinical development program, plus key commercial milestones. Neither side is disclosing further details of the financial terms.
Gastroparesis is a chronic disorder of gastrointestinal motility caused by delayed gastric emptying, and sufferers feel full quickly after eating and commonly have abdominal discomfort, nausea, vomiting. The condition may be linked to diabetes - which can damage the stomach nerves - but is also idiopathic (unknown) in origin.
The Altos drug, an oral dopamine D2/3 receptor antagonist, addresses the nausea and vomiting associated with gastroparesis, which is caused by the activation of dopamine receptors. "We believe that this agreement will expedite the development of this important medicine," Altos president and CEO Dr. Roger Whiting said in a statement.
Current symptomatic treatments include domperidone or metoclopramide to cause stomach contractions, erythromycin, and standard anti-emetics to control nausea and vomiting. However, the first two drugs can be associated with side-effects, and Takeda says ATC-1906 may have an improved safety profile.
Strategic Rationale
Along with oncology and CNS, the gastrointestinal area is one of Takeda's strategic areas of therapeutic focus under its current mid-term turnaround plan to recover from several large patent expiries over the past few years (Also see "Takeda Turnaround In Full Flow As New Products Deliver" - Scrip, 12 May, 2016.).
Besides its older, now genericized proton pump inhibitors, the company's big new commercial hope in the field is Entyvio (vedolizumab), a biologic for ulcerative colitis and Crohn's disease, which Takeda says is on track to achieve blockbuster status within a few years.
An oral RORyt inverse agonist is also in Phase I for Crohn's, but otherwise the disclosed early clinical GI pipeline is bare.
Los Altos, California-based Altos has been using a "semi-virtual" business model tapping into external advisors and service providers that its co-founders adopted successfully in their previous venture.
Whiting and Altos executive chairman Dr. Roberto Rosenkranz sold their previous acute pain-focused company, Roxro Pharma Inc., to Daiichi Sankyo Co. Ltd.'s US subsidiary Luitpold Pharmaceuticals Inc. in late 2010, after it had successfully obtained US FDA approval of Sprix (ketorolac tromethamine) nasal spray.
Limited Competition
More broadly, there appear to be relatively few drugs for gastroparesis in clinical development. Among the most advanced candidates, Evoke Pharma Inc.'s intranasal 5-HT3/dopamine D2 antagonist and 5-HT4 agonist metoclopramide (EVK-001; partnered with Mallinckrodt AG) is in Phase III for diabetic gastroparesis, and Rhythm Pharmaceuticals Inc.'s ghrelin-targeting injected peptide relamorelin (partnered with Ipsen) is in Phase IIb for the same indication, according to Informa's Biomedtracker
.
GlaxoSmithKline PLC's oral motilin receptor agonist camicinal is also in Phase II for diabetic and other gastroparesis, as is Theravance Biopharma Inc.'s velusetrag, an oral small molecule 5-HT4 agonist (partnered with Alfa Wassermann SPA).
In 2011, the Japanese venture RaQualia Pharma Inc. licensed its 5-HT4 partial agonist RQ-10 to South Korea's CJ CheilJedang Corp. for development for gastroparesis in selected Asian markets.