Osteoarthritis Stem Cell Therapy Could Be On Sale In India By 2020

A novel Indian stem cell injection treatment intended to slow down joint damage caused by osteoarthritis and potentially avert replacement surgery will undergo domestic Phase III trials this year and could be on sale in the country by 2020 under a licensing deal between Alkem Laboratories and biotech firm Stempeutics.

 Alkem Laboratories Ltd., a major drug maker headquartered in Mumbai, has struck a licensing deal with the Indian clinical stage biotech firm Stempeutics Research Pvt Ltd for a stem cell therapy, Stempeucel, to which Alkem gains sole marketing rights. Stempeutics will manufacture and supply the product, which may become the first of its type in its intended use in India.

The therapy is aimed at helping patients with osteoarthritis by curbing inflammation, reducing pain and possibly regenerating cartilage. Stempeutics says Stempeucel is not intended to serve as a "cure" for arthritis but aims rather to delay the damaging progression of the disease to the point when patients require joint replacement surgery. It offers a novel treatment approach to osteoarthritis and "will substantially improve the quality of life" of patients, said Alkem’s managing director Sandeep Singh.

The companies didn’t disclose financial details of their agreement but Alkem said it will make upfront as well as royalty and various regulatory and sales-based milestone payments to Bangalore-based Stempeutics, which specializes in developing stem cell therapies.

Stem cell treatment is a rapidly emerging area of biomedical research in India, where Alkem said the potential for such therapies is around $540m and is expected to grow rapidly.  Helped by the new deal, "We are progressing well towards our goal of bringing the first stem cell based product for osteoarthritis treatment in India in the near future,"  said Stempeutics’ business development director Dr. Raviraja Seetharam.

The launch of Stempeucel in partnership with Stempeutics would also mark Alkem’s first foray "into this futuristic [stem cell] segment, further strengthening our pain management franchise," Alkem said.

Set For Phase III Trials

But before any launch can take place, Stempeutics - which is 49% owned by Indian generics giant Cipla Ltd. - still has to carry out Phase III clinical trials in India.

Stempeucel comprises bone marrow stem cells from multiple donors that are processed using Stempeutics’ proprietary technology. The company says this method is a more effective and inexpensive way to produce stem cells than using stem cells from one donor, allowing the manufacture of more than a million clinical doses from a single set of master cell banks.

"In the Phase III trials, we’re going to administer Stempeucel using ultrasound guidance,” said Stempeutics' chief executive officer B.N. Manohar. The company in the trials is going as well to "use new MRI techniques called T2 mapping to assess the quality of articular cartilage and also to assess the quantitative analyses of articular cartilage," he added.

Stempeutics said it had already completed successful Phase II clinical trials of Stempeucel in India for the treatment of osteoarthritis. Those trials showed that a single intra-articular 25 million-cell injection dose of Stempeucel was well tolerated and had positive effects on long-term pain reduction and resulted in improvement in patients’ stiffness and physical function, it said.

"Current osteoarthritis treatments are more symptomatic in nature whereas Stempeucel has a potential to address the root cause of the disease," Manohar added. Stempeucel, Stempeutics’ lead product, offers a novel treatment approach to osteoarthritis and "will substantially improve the quality of life" of patients, predicted Alke’s managing director Sandeep Singh.

A number of researchers globally are investigating how to treat arthritis in the knee and other joints without using surgery, and the idea of a "miracle jab" injection that could eliminate the disease has become a focus area. However, the search for an effective stem cell approach is complicated by the fact arthritis involves over 100 varieties of joint inflammation. While many doctors already use various forms of stem cell therapy to treat arthritis, it is still considered a promising but unproven therapy and is not standard practice. The World Health Organization estimates that 10-15% of all adults over 60 have some degree of osteoarthritis.

"Cell therapy and tissue engineering-based approaches are being used to address the issue of repair of damaged articular cartilage. Allogeneic MSCs [mesenchymal stem cells]are rapidly emerging as an investigational product for cartilage repair. The anti-inflammatory and immunomodulatory properties of MSCs suggest these cells can reduce inflammation and (result in) pain reduction in the knee,” the companies said in a statement.

Stempeucel At Advanced Stage For Buerger’s

Stempeutics, founded in 2006 and part of India’s Manipal Education and Medical Group, says Stempeucel is already in an "advanced stage" of clinical trials for treating critical limb ischemia, a disorder caused by Buerger’s Disease. The ailment, common among smokers, involves progressive inflammation and clotting of arteries and veins in the feet, leading to severe pain and ulcers and the condition may finally require limb amputation.

The company has already notched up a string of achievements with Stempeucel in relation to Buerger’s including a Japanese process patent and an orphan drug designation in the European Union, as well as a US process patent and a Chinese patent.

In May 2016, India’s Drug Controller General gave limited approval for the manufacturing and marketing of Stempeucel for the treatment of Buerger’s. With that approval, the product became the fifth off-the-shelf stem cell product to be approved by a regulatory body anywhere in the world, Stempeutics said.

Stempeutics says its goal is to be able to market Stempeucel globally for Buerger’s Disease, for which the market is estimated at $1.5bn worldwide. It’s now scouting for a licensing partner for the drug in this setting.

Stempeutics did not disclose possible pricing in osteoarthritis but said the company was keen to "develop innovative production techniques for making the product affordable for the common man."