iCo Therapeutics Executes Bertilimumab License with Immune Pharmaceuticals


Upfront consideration:

  • US $500,000 cash
  • 600,000 IMMUNE shares and 200,000 IMMUNE warrants
  • A 6.14% ownership stake (fully diluted basis) with preferential share features

– US$32 million in milestones plus royalties

– License is for systemic uses, iCo retains exclusive rights to all ocular applications

– IMMUNE expects to initiate new GMP manufacturing with a leading biologics manufacturer and plan for phase II clinical trials in Inflammatory Bowel Disease.

For Immediate Release June 24, 2011

VANCOUVER, Canada – iCo Therapeutics Inc. (TSX-V: ICO) is pleased to announce that Immune Pharmaceuticals (IMMUNE) has licensed Bertilimumab (iCo-008) for systemic uses, pursuant to an option agreement previously announced in December 2010. iCo may receive US $32 million in milestone consideration for the license, plus royalties. iCo retains worldwide exclusive rights to all ocular applications, including a number of sight-threatening diseases.

Upfront consideration includes US $500,000 cash, 600,000 IMMUNE shares and 200,000 IMMUNE warrants. Currently IMMUNE shares are worth US $2 per share.

“We look forward to working with IMMUNE to advance Bertilimumab. IMMUNE has assembled an impressive group of experts and management and we believe the team has the expertise to successfully drive Bertilimumab clinical development,” stated Andrew Rae, iCo’s President and CEO. “We are pleased to have unlocked the value of Bertilimumab in indications outside of our core ocular focus. iCo remains committed to developing Bertilimumab for vernal keratoconjunctivitis and age-related macular degeneration”.

According to Professor Marc Rothenberg, Chief Scientific Officer of IMMUNE and the Director of the Division of Allergy and Immunology and the Center for Eosinophilic Diseases at Cincinnati’s Children’s Hospital, “Bertilimumab has great potential for the treatment of eosinophilic inflammatory bowel diseases (IBD) and eosinophilic gastro-intestinal diseases (EGID). Bertilimumab is the first monoclonal antibody to specifically neutralize human eotaxin-1, a chemokine, associated with inflammatory disease activity in Crohn’s Disease and Ulcerative Colitis”.

Dr. Daniel Teper, CEO of IMMUNE commented: “Bertilimumab is the top priority in IMMUNE’s growing portfolio of Monoclonal Antibodies. We are initiating the manufacturing of a new GMP batch of Bertilimumab with a leading biologics manufacturer and actively preparing for phase II clinical trials”.

About Bertilimumab

Bertilimumab (also known as iCo-008 or CAT-213) is a human immunoglobulin monoclonal antibody targeting eotaxin-1, a member of the chemokine family of proteins that act as messenger molecules between the cells of the immune system. Bertilimumab has been in 126 patients in Phase 1 and 2 studies, has a good safety profile and has shown evidence of efficacy in a severe allergy indication. Bertilimumab may be indicated for inflammatory disorders including Severe Asthma, Inflammatory Bowel Disease (Crohn’s Disease and Ulcerative Colitis).

Marc Rothenberg co-authored a paper, (Takeda et al, Nature 2009. “CCR3 is a Target for Age-related Macular Degeneration Diagnosis and Therapy”), indicating that iCo-008, a ligand for CCR3, may be effective in treating wet age related macular degeneration (wAMD). iCo is currently planning exploratory studies for iCo-008 in wAMD and a Phase 2 study in severe ocular allergies (vernal & atopic keratoconjunctivitis).

iCo licensed the exclusive world-wide rights to Bertilimumab in 2006 from MedImmune Limited (formerly known as Cambridge Antibody Technology Limited), the Global Biologics Unit of AstraZeneca.

About iCo Therapeutics

iCo Therapeutics Inc. is a Vancouver-based reprofiling company focused on redosing or reformulating drugs with clinical history for new or expanded indications. iCo has exclusive worldwide rights to three products: iCo-007, moving into Phase 2 for the treatment of DME, iCo-008 (Bertilimumab); a product with Phase 2 clinical history to be developed for severe ocular allergies and age-related macular degeneration; and iCo-009, an oral formulation of Amphotericin B for sight and life-threatening diseases. Immune Pharmaceuticals licensed systemic rights to iCo-008 in June 2011. iCo-009 also represents a new drug delivery technology with the potential to reprofile other parenteral administered drugs to the oral route of administration. iCo was recently awarded a Gold Leaf Award as the Early Stage Company of the Year from BIOTECanada and is a Canada’s Top 10™ Competition winner. iCo trades on the TSX Venture Exchange under the symbol “ICO”. For more information, visit the Company website at: icotherapeutics.cdmail.biz.

About IMMUNE Pharmaceuticals

IMMUNE Pharmaceuticals is an Israel and U.S. based biopharmaceutical company focused on the development of next generation monoclonal antibodies addressing significant unmet medical needs in the treatment of cancer and inflammatory diseases. IMMUNE Pharmaceuticals has built a robust pipeline of clinical and pre-clinical candidates based on novel targets and novel antibody technologies. For more information, visit the Company website at: www.immunepharmaceuticals.com.

No regulatory authority has approved or disapproved the content of this release. The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.

Forward Looking Statements

Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on iCo Therapeutics’ current beliefs as well as assumptions made by and information currently available to iCo Therapeutics and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by iCo Therapeutics in its public securities filings; actual events may differ materially from current expectations. iCo Therapeutics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.