Stempeutics ties up with Alkem Labs for phase-III trials for osteoarthritis product

If Bengaluru-based Stempeutics Research is on track with its osteoarthritis product, it could mean delaying, if not entirely avoiding a total knee replacement surgery.

The stemcell-based product Stempeucel is injected into the osteoarthritic patient and it helps reduce the pain and regenerate the eroded cartilage, explains BN Manohar, Stempeutics Chief Executive.

Osteoarthritis (OA) is an alternate indication for which Stempeucel is being clinically tested.

The product is already in an advanced stage of trials for treating Critical Limb Ischemia, a progressive disease that affects blood flow in the lower extremities, feet and toes.

For the new OA indication, Stempeutics has entered into an alliance with Mumbai-based Alkem Laboratories to conduct late stage or phase-III clinical trials this year. It is a regular outlicensing deal, Manohar told BusinessLine , with an upfront payment, milestone payments and royalty on sales, he said without divulging financials.

By 2020, the companies hope to have an off-the-shelf product, ready to roll-out in the market with necessary regulatory approvals.

Current studies indicate that one injection was getting the desired outcome, he said, adding that long term studies would continue to monitor this.

How it will be priced would depend on partner Alkem, he said, adding however, that “it would be lesser than a knee replacement surgery”.

Stempeutics Research is a group company of Manipal Education and Medical Group and drugmaker Cipla has an alliance with it since 2009.

Replacing surgery?

There are at least two lakh people in the country who undergo knee replacement surgery, he said, indicating the potential the product has.

However, he added, it will help those who are not in the X-ray grade 4 category. In this late stage, there is no cartilage to regenerate and a surgery is unavoidable, he explains.

While there are global companies operating in this segment, he said, Stempeutics has a unique technique and its “process is the product and IP (intellectual property)”.

The product is made from stemcells got from healthy volunteers and maintained at their cell bank in Manipal. Three to four donors help generate four to five lakh units of the end product with a long shelf-life, he said.

Stempeutics is now scouting for a similar licensing partner for its CLI product as well, he said, adding that an alliance could be sealed in about two months.