Cephalon license exercise

RNS Number : 6468M

Immupharma PLC

02 February 2009

 



For Immediate Release                                                                                   02 February 2009

Cephalon exercises right to license Lupuzor™.  

ImmuPharma to receive an additional $30m..

ImmuPharma PLC ('ImmuPharma') (LSE:IMM), the specialist drug discovery and development company, is pleased to announce that Cephalon, Inc (NASDAQ: CEPH) will exercise its option to license the worldwide rights to Lupuzor™, following the recent positive interim results of ImmuPharma's Phase IIb study. Cephalon will pay ImmuPharma $30 million for licensing the worldwide rights of LupuzorTM. The various future cash milestone payments upon the achievement of certain regulatory and sales milestones  (including the option and license fees) may total up to approximately $500 million. In addition to the cash milestone payments, ImmuPharma will receive royalties on commercial sales of LupuzorTM.

Cephalon will be responsible for all activities and expenses for Phase III studies, regulatory filings and subsequent commercialization of the product worldwide.  It is expected that Cephalon will initiate plans to implement pivotal Phase III clinical trials this year.

ImmuPharma received a $15 million upfront fee at the initiation of the deal in November 2008 whereby it granted Cephalon the option for the exclusive license to LupuzorTM.  Following receipt of this additional license fee of $30 million, ImmuPharma will have approximately $ 50 million of cash on its balance sheet.

Dimitri Dimitriou, Chief Executive Officer said: 'We are delighted to have Cephalon as our partner. We have chosen Cephalon for a number of reasons and the chemistry between our teams has been exceptional. Cephalon has strong commercialisation expertise and are familiar with success in specialist areas. Their profile is a very good fit with LupuzorTM. The deal puts ImmuPharma in a privileged position and enables the progression and commercialisation around the world of our most advanced asset. '

Frank Baldino, Jr., Ph.D., chairman and CEO of Cephalon said: 'These study results are encouraging and bring us one step closer to providing the first specific medication for the treatment of lupus to patients living with this chronic, potentially life-threatening disease.'

For further information please contact: 

ImmuPharma PLC: 

Dimitri Dimitriou, Chief Executive Officer                            [phone]

Richard Warr, Chairman                                                     [phone]

Dr Robert Zimmer, President & Chief Scientific Officer     [phone]

Buchanan Communications:

Lisa Baderoon                                                                     [phone] 

Rebecca Skye Dietrich                                                       [phone]

Panmure Gordon & Co                                                    [phone]

Andrew Burnett

Rakesh Sharma

More information on the company can be found at www.immupharma.com

Notes to Editors:

About Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development, and commercialization of many unique products in three core therapeutic areas: central nervous system, pain, and oncology. A member of the Fortune 1000 and the S&P 500 Index, Cephalon currently employs approximately 3,000 people in the United States and Europe.  U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. The company's European headquarters are located in Maisons-Alfort, France. 

About ImmuPharma

ImmuPharma PLC is a drug discovery and development company headquartered in London, UK and quoted on AIM of the London Stock Exchange (LSE:IMM). It has research operations in France (ImmuPharma (France) SA) and Switzerland (ImmuPharma AG). ImmuPharma is dedicated to the development of novel drugs, largely based on peptide therapeutics, to treat serious medical conditions such as autoimmune diseases characterised by:

• blockbuster potential in niche markets

• low promotional costs in few specialised physicians and centres and

• lower risk of drug development and lower development costs

ImmuPharma is a currently developing drug candidates for five different medical conditions, each of which would represent a significant breakthrough in its field. The furthest advanced drug candidate targets Lupus, a disease for which there is currently no cure or specific treatment. The other four address 1) cancer, 2) moderate to severe pain (such as that experienced by cancer sufferers and post-operative patients), 3) MRSA and similar severe hospital-acquired resistant infections and 4) inflammation. 

All five have significant sales potential as well as low marketing costs and a relatively low risk of development failure. One or more have the potential to be fast-tracked by the US Food and Drug Administration according to 'Guidance for Industry: Fast Track Drug Development Programs - Designation, Development and Application Review' issued July 2004 and could therefore obtain their market authorization by 2010. 

Key to the potential success of ImmuPharma is its unique collaborative agreement with Centre National de la Recherche Scientifique, France's scientific research institution. This agreement grants ImmuPharma worldwide exclusive rights to exploit certain key discoveries.

In addition to its five leading drug candidates, ImmuPharma has a drug development pipeline using its rights to a virtual chemical library of hundreds of thousands of molecules as well as an innovative technology for converting peptides to drug candidates. 

ImmuPharma has the option to commercialise its assets itself or to license them to other pharmaceutical companies at an earlier stage. 

The products

Treatment of Lupus (IPP-201101)

This is a long-term treatment for Lupus, a chronic, life-threatening autoimmune disease where the immune system attacks healthy cells. There is currently no cure and existing medications only treat the symptoms whereas ImmuPharma's drug candidate has the potential to produce remission of the disease in a substantial proportion of patients.

Based on independent forecasts, the value of ImmuPharma's Lupus drug is estimated to be 'substantial' with peak annual sales forecast to generate in excess of $4 billion.

Cancer (IPP-204106)

IPP-204106 has a dual mechanism of action, acting both in preventing angiogenesis as well as proliferation. IPP-204106 is a nucleolin antagonist, the lead molecule in a family of pseudopeptides designed to block the activity of a protein called nucleolin. Located essentially in the nucleus of normal cells where it is protected, nucleolin is much more abundant at the surface of the cells which are proliferating as well as the surface of active endothelial cells where it can be a target for antagonist peptides.

Cell surface expressed nucleolin is involved in the proliferation processes as well as in cell transformation. It is also a receptor for many growth factors and plays a key role in angiogenesis. Nucleolin antagonists have therefore both anti-angiogenic and anti-proliferative properties.

Preclinical data have shown that nucleolin antagonists inhibit the growth of tumours and metastasis in many cancer types. They prevent the implantation of tumours and block angiogenesis. They also inhibit the proliferation of certain types of leukaemia cells. Based on the mechanism of action nucleolin antagonists are active as long as surface nucleolin is present, irrespective of the type of cancer. Preliminary data have also shown the absence of toxicity.

Severe pain relief (IPP-102199)

ImmuPharma is developing a non-addictive compound for relieving moderate to severe pain, such as experienced by cancer sufferers and post-surgical patients. Most existing treatments are opioid-based (explain) and tend to have serious side effects. ImmuPharma's new treatment is based on met-enkephalin, the body's internal analgesic. IPP-102199 is being developed to have major advantages over morphine such as longer pain relief duration and reduced side effects. The market for chronic opioids in the US currently exceeds $3.5 billion and is growing by more than 10 to 20 per cent a year.

Antibiotic for MRSA and similar highly resistant infections (IPP-203101)

This is a novel antibiotic to counter the effects of MRSA and other severe hospital-acquired, resistant infections which affect some two million people in the US, according to the US Centers for Disease Control and Prevention. ImmuPharma's drug candidate uniquely uses an electrical charge rather than biochemical methods against MRSA and other bacterial strains. It is hoped this novel approach will reduce their potential to become resistant. 

 

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