Moberg Pharma acquires global rights to novel topical formulation for treatment of oral pain
ET | Source:Moberg Pharma AB
Moberg Pharma AB (OMX: MOB) announced that the company has entered into a
definitive agreement with Oracain II Aps (Denmark) to acquire all assets and
global rights to a novel and patent pending oral formulation of the proven
substance bupivacaine, for the treatment of pain in the oral cavity. The initial
target indication is pain management for patients suffering from oral mucositis
during cancer therapy.
Oracain has generated promising clinical data supporting safety and efficacy in
several pilot studies – most importantly that the novel lozenge formulation
provides significantly longer and better pain relief than currently available
non-opioid treatment alternatives for patients with oral mucositis. Moberg
Pharma plans to gain additional efficacy data through a phase II study during
this year, to be followed by pivotal studies and registration.
Under the terms of the agreement, Oracain is entitled to an upfront payment of 1
MSEK, additional 5 MSEK after successful phase II data have been generated and a
share of future revenues after such revenues have exceeded Moberg’s accumulated
development costs incurred prior to launch. The acquisition and cost for the
phase II study are financed through available cash resources.
Moberg Pharma plans to pursue several routes to generate near term revenues from
the product, including through licensing marketing rights to partners in select
territories after completion of phase II as well as through sales for
compassionate use for individual patients. Since there is a pressing unmet
medical need for pain relief in oral mucositis, the product can be supplied for
such compassionate use in certain markets prior to regulatory approval. Moberg
Pharma will also examine the possibility for orphan drug status, in the U.S. as
well as in EU.
Furthermore, Moberg Pharma has identified several additional potential
indications for the product beyond oral mucositis, both in the acute and chronic
setting, such as Sjögren’s Syndrome, Burning Mouth Syndrome, endoscopic
procedures, oral intubations and long-term also OTC use. The company estimates
the peak sales potential of the product to 50-100 m$ assuming successful
commercialization in oral mucositis and at least one additional indication.
“We are excited of the opportunity to create a best in class product for a
pressing medical need and to make it available to patients within the next few
years. Oral mucositis is a debilitating side effect of cancer therapy. Oracain’s
clinical data is highly promising and indicates a potential to provide better
and longer pain relief to patients. The acquisition is in line with our strategy
of providing niche products that can create significant value based on proven
molecules with limited development cost, risk and time to market”, said Peter
Wolpert, CEO of Moberg Pharma AB.
“Years of clinical practice in oral mucositis – and frustration of inadequate
treatments for patients suffering of the severe and disabling mouth pain – were
the driving forces behind our innovation. We are excited to partner with Moberg
Pharma who has the capabilities to bring this important medical innovation to
practical use and benefit for patients. The scientific team of Oracain is fully
dedicated to support the continued development”, said Ove Andersen, Chairman of
Oracain and inventor.
About oral mucositis and the acquired technology
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
The 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. The original innovation came
out of work by clinicians at Hvidovre Hospital, Copenhagen, Denmark facilitated
by XOventure GmbH and SEED Capital Denmark.
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 08.30 am (CET) on April 14, 2014.
For further information, please contact:
Peter Wolpert, CEO, Moberg Pharma AB, telephone: +46 707 35 71 35, e-mail:
Peter Östling, IR, Moberg Pharma AB, telephone: +46 76 301 09 78, e-mail:
About Moberg Pharma AB
Moberg Pharma AB (publ) is a rapidly growing Swedish pharmaceutical company with
a direct sales and marketing organization in the US and an extensive distributor
network in more than 40 countries. The company’s OTC portfolio includes the
brands Kerasal®, Jointflex®, Kerasal Nail™, Domeboro®, Vanquish®, Fergon® and
Kaprolac®. Kerasal Nail™ (Nalox™ in certain ex-U.S. markets) is the leading
product for the treatment of nail disorders in the U.S and Nordic market. The
current portfolio will be supplemented by the acquisition and in-licensing of
additional products as well as product development with a focus on innovative
drug delivery of proven compounds. Moberg Pharma has offices in Stockholm and
New Jersey and the company’s shares (OMX: MOB) are listed on the Small Cap list
of the NASDAQ OMX Nordic Exchange Stockholm. For further information, please
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