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INNOVATIVE DRUGS

  • PROJECT # 140611

The Company has a new technology company focusing on radioimmunotherapy with novel targeted antibodies for hematology and solid tumors.

The Company has a patented platform technology for the development of bispecific
monoclonal antibodies combined with radioisotopes to address unmet medical needs in hematology and oncology.

The Company has secured the worldwide rights of their products in all radiopharmaceutical indications and the preclinical dossier is completed.

The market potential is in excess of $100 million in US alone in this indication based on an estimated cost per patient of $30,000. The Orphan Drug Status for thir drug, already obtained in both Europe and the US for the Hodgkin lymphoma indication, offers a fast track regulatory pathway for approval and provides market exclusivity for 10 and 7 years in Europe and in the US, respectively, from the approval date.

The company develops a drug for pancreatic cancer which has a broad and well-protected patent estate. This drug can also be developed in hepatic cancer and neuroblastoma.

Keywords: Hodgkin lymphoma, pancreatic cancer, hepatic cancer, neuroblastoma, orphan drug, radioimmunotherapy.

  • PROJECT # 140612

TNF-inhibitors like Remicade and Humira ($9.4 Billion in FY2013 sales) fail in up to 40% of patients with inflammatory bowel diseases (IBDs) such as ulcerative colitis (UC) and Crohn’s disease (CD). The company is developing a novel antibody that targets the innate immune response to treat inflammation. Currently undergoing a global Phase II study in patients with UC, the drug has the potential to displace existing therapies while offering a superior safety profile in a segment predicted to grow to $15 Billion by 2019.
Patients with moderate to severe UC, CD and asthma have high eotaxin-1 levels. The drug binds to eotaxin-1, which is considered to be the underlying cause of inflammation. This unique pathway allows the Company to treat IBD before symptoms are evident; while conventional therapies are only administered after symptoms are observed, limiting their efficacy. This suggests that this drug could replace the standard of care (i.e. TNF-inhibitors) in a segment worth $15 Billion.
Bullous pemphigoid (BP), a chronic inflammatory skin disease, which affects 30,000 people worldwide, creates a unique opportunity for the Company to position its drug as an orphan drug, where patients have no treatment options available and mortality is high (40% 1st-year mortality). The Company will initiate a Phase II study with top-line results expected 2H of 2014. With a rapid and clear path to market, BP represents an additional $600-$900 Million business opportunity for the Company.

Keywords: Inflammatory bowel diseases, Crohn’s disease, ulcerative colitis, severe asthma, TNF-factors, TNF-inhibitors, bullous pemphigoid, phase II study.

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