Takeda has exercised its option to buy PvP Biologics, adding another celiac disease candidate to its clinical pipeline. The Japanese drugmaker pulled the trigger on the deal after getting a look at phase 1 data on the glutenase TAK-062.
PvP entered into an agreement with Takeda early in 2017. The deal gave Takeda the option to buy PvP under predefined terms in return for $35 million. PvP used the cash to take TAK-062, also known as KumaMax and Kuma062, through phase 1 and, in doing so, gather the data Takeda wanted to see before buying the biotech.
Having seen the data, Takeda has exercised its option to buy PvP, paying an undisclosed upfront fee and committing to milestones that could swell the value of the deal to $330 million. Takeda is now gearing up to take TAK-062 deeper into the clinic.
Full details of the phase 1 data that persuaded Takeda to buy PvP are scheduled for publication at an upcoming medical congress. Some details did emerge prior to confirmation of the takeover, though. In November, Takeda revealed clinical data from a three-arm study of 38 subjects that linked TAK-062 to the degradation of 95% of digested gluten.
Manufacturers of dietary supplements already sell glutenases, but Takeda thinks TAK-062 has more catalytic activity than other enzymes designed to break down gluten. According to Takeda, TAK-062 functions optimally at the pH range found in the stomach after a meal and is resistant to common digestive proteases that could otherwise degrade it before it has time to act on gluten.
At Takeda, TAK-062 will slot into a clinical-phase pipeline that already features one celiac disease candidate. Takeda added the other candidate, TAK-101, to its pipeline in October by exercising its option to license the immune-modifying nanoparticle from Cour Pharmaceuticals.
Cour granted Takeda the option to license the asset upon the completion of a phase 2a in 2015 and went on to wrap up the midstage study last year. The 34-subject study hit its primary endpoint, although six participants dropped out due to gluten-related symptoms. Takeda nonetheless saw enough potential in the data to enter into a deal worth up to $420 million in future payments.
Takeda’s willingness to take on two celiac drugs reflects its assessment of the size of the opportunity and differences between the two molecules. While TAK-062 works by enzymatically digesting gluten, TAK-101 is designed to promote immune tolerance. Takeda estimates a subset of 1 million celiac patients have severe symptoms despite being on gluten-free diets, making them highly likely to be interested in taking a therapy.
Other companies have spotted the opportunity. In recent years, GlaxoSmithKline has bought Sitari Pharmaceuticals for its TG2 inhibitor and Provention Bio has licensed a drug from Amgen. However, the field has also faced setbacks, notably when ImmusanT stopped a phase 2 trial after an interim analysis showed its celiac drug was no better than placebo.
Takeda thinks it is better placed than its competitors to seize the celiac opportunity, pointing to its existing gastrointestinal infrastructure that supports revenues of $6 billion to make its case.