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Moberg Pharma and Cadila Pharmaceuticals enters agreement for late-stage development and commercialization of BUPI

STOCKHOLM, March 22, 2015. Moberg Pharma AB (OMX: MOB) today announced that Moberg Pharma and Cadila Pharmaceuticals Limited – one of the largest healthcare manufacturing groups in India – entered a Development and License Agreement for BUPI – a novel lozenge formulation of bupivacaine for pain management in oral mucositis patients.

Under the Development and License Agreement, Cadila Pharmaceuticals will conduct a phase III program 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 program 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.

About Oral Mucositis and BUPI
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 U.S., 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 anesthetic with a well-established long acting effect, currently available on the market for other indications as an injectable.

About this information
Moberg Pharma discloses this information pursuant to the Swedish Securities Markets Act and/or the Financial Instruments Trading Act. The information was submitted for publication at 8.30 am (CET) on March 22, 2016.

For additional information, please contact:
Peter Wolpert, CEO, Phone: +46 (0)70 - 735 71 35, E-mail: peter.wolpert@mobergpharma.se
Anna Ljung, CFO, Phone: +46 (0)70 – 766 60 30, Email: anna.ljung@mobergpharma.se
Dr. Manjul Joshipura, Vice President, Medical Services: +91 – 2718 – 225001-15 (Ext. 857), Email: manjul.joshipura@cadilapharma.co.in


About Moberg Pharma, www.mobergpharma.com
Moberg Pharma AB (publ) is a rapidly growing Swedish pharmaceutical company with OTC sales operations in the U.S. and a distributor network in more than 40 countries. The company’s portfolio includes the OTC brands Kerasal®, Kerasal Nail®, Balmex®, Domeboro®. Kerasal Nail®(Emtrix®or 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. The company is growing organically as well as through acquisitions. Internal development programs focuses on innovative drug delivery of proven compounds and include two clinical stage assets, MOB-015 (onychomycosis) and BUPI (pain management in oral mucositis). Moberg Pharma has offices in Stockholm and New Jersey and the company’s shares are listed on the Small Cap list of the NASDAQ OMX Nordic Exchange Stockholm (OMX: MOB).

About Cadila Pharmaceuticals Ltd, www.cadilapharma.com
Cadila Pharmaceuticals Limited is one of the largest privately held pharmaceutical companies in India, headquartered at Ahmedabad, in the state of Gujarat, India. Over the last six decades, it has been developing and manufacturing pharmaceutical products and selling and distributing these in over 100 countries around the world. An integrated healthcare solutions provider with pharmaceutical product basket, it caters to over 45 therapeutic areas that include cardiovascular, gastrointestinal, analgesics, haematinics, anti-infectives and antibiotics, respiratory agents, anti-diabetics and immunologicals. It employs more than seven thousand employees including over two hundred people outside India in 49 countries of Africa, CIS, Japan and USA. Cadila Pharmaceuticals was the first Indian company to get IND approvals by USFDA for clinical trials to be conducted in India. Subsequently, the company has filed 5 INDs with USFDA.