Cadila Pharmaceuticals Ltd and Moberg Pharma AB have entered a development and license agreement for BUPI – a novel lozenge formulation of bupivacaine for pain management in oral mucositis patients.
Under the agreement, Cadila Pharmaceuticals will conduct a phase III programme in India and is granted an exclusive license to commercialize BUPI in India and Africa, with the exception of South Africa. Moberg will receive the rights to use all data generated from the development programme outside India and Africa and a royalty on sales in India and Africa. The parties may also agree on a supply agreement for a subsequent commercial phase. Financial terms were not disclosed.
In June 2015, Moberg Pharma received a Eurostars grant which provides co-financing of one phase III study for BUPI in Europe. A phase II study was recently completed with positive results which supported the efficacy and safety of BUPI. This agreement with Cadila in combination with the Eurostars grant means that Moberg’s investment for phase III trials is substantially reduced.
“We are excited to enter this collaboration with Cadila Pharmaceuticals and to leverage our combined innovation capabilities as well as Cadila’s clinical, manufacturing and commercialization capabilities in India. Establishing innovative partnership models supports Moberg’s commitment to bringing novel treatments to patients in underserved niches,” said Peter Wolpert, CEO of Moberg Pharma AB.
“In line with our philosophy to bring innovative solutions to unmet medical needs, we are delighted to partner with Moberg Pharma on BUPI to bring more efficacious pain management to patients with oral mucositis, a condition with high prevalence in India”, said Dr Rajiv I Modi, chairman and managing director, Cadila Pharmaceuticals Ltd., India.
Oral mucositis (OM) is a painful inflammation and ulceration of the mucous membranes lining the mouth. OM is a common and often debilitating complication of cancer treatment which affects 80% of patients with head and neck cancer receiving radiotherapy, almost all patients undergoing bone marrow transplantation, and a wide range of patients receiving chemotherapy. OM makes the patient less likely to comply with their cancer treatment, increases mortality and morbidity and contributes to rising health care costs. In the US, every year approximately 400 000 patients suffer from OM during cancer therapy. The patent pending BUPI technology encompasses novel lozenge formulations of bupivacaine, a local anaesthetic with a well-established long acting effect, currently available on the market for other indications as an injectable.
Moberg Pharma AB is a rapidly growing Swedish pharmaceutical company with OTC sales operations in the US and a distributor network in more than 40 countries. The company’s portfolio includes the OTC brands Kerasal, Kerasal Nail, Balmex, Domeboro. Kerasal Nail(Emtrixor Nalox in certain markets) is a leading OTC treatment of nail disorders in the U.S., Canada and several EU markets and is currently being launched in Southeast Asia.