Business Development

Developing Core Assets

Monetizing Other Assets
 
Partnerships and Out-licensing

Business Development

Current Alliances.Currently none of the company's technologies or products is encumbered in commercial alliances. We have developed strategic alliances with academic and Government institutions to develop our programs in collaboration with scientists of world-renown.

Partnering Outlook.Since none of our programs are encumbered at this stage, we are keeping options open to expanding our competency horizon to include later stage drug development and commercialization. However, it is highly likely that the initial product candidates will be partnered with pharmaceutical and biotechnology companies. We will endeavor to retain a participating role in further development as we build in-house expertise for advanced development and commercialization of future products. Earlier stage alliances will likely involve technologies such as immunoconjugates enabling technology, non-oncology therapeutic areas and ex-US development of oncology products.

With multiple programs in our pipeline, it is essential that we prioritize and focus our efforts. Thus, our business model is designed to provide near-term revenues that will help finance additional in-house development programs in time. These alliances will generate licensing fees and milestone payments and then provide royalty income to Onconova (see section on Business Development).

Developing Core Assets

ON 01910.Na. This is our lead program. Onconova intends to take this product into advanced clinical trials (to proof of principle in man) in the USA. Overseas development may be carried out by geographic partnering with regional companies. Licensing would preferably occur after Phase II results are in hand, to enhance product value.

Ex-RAD™. This program is expected to be funded by grant support, primarily from the US Department of Defense. Eventual product sales for the radioprotectant are expected to be to World governments, requiring minimal marketing resources. Ex-RAD™ will be marketed by Onconova world-wide.

Monetizing Other Assets

Immunoconjugates. Our medicinal chemistry program has been highly productive and yielded compounds of very high potency that are suitable for use with monoclonal antibodies.  We are offering this “immunoconjugates” program to several biopharmaceutical companies.  The partner company will be responsible for developing monoclonal antibodies conjugates containing our drug for various therapeutic applications.  These transactions will bring a revenue stream to Onconova and provide independent commercial validation of our compounds.

Bcr-Abl Inhibitor. One of the major discoveries made by Onconova scientists in 2003 was a novel small molecule NCE targeting the Bcr-Abl tyrosine kinase.  This enzyme has been successfully targeted by Novartis leading to the approval of Gleevec® in 2001.  This product will approach the $2.0 billion mark in sales in 2005, and is expected to grow in double digits for several years, and several opportunities exist for a competing or complementary product.  First, patients are developing resistance to Gleevec at approximately 15% per annum.  Secondly, the high cost of this therapy may impede further sales growth of the product.  Our product candidate Bcr-863 has exhibited several points of distinction:

      • Activity in Gleevec® resistant cells
      • New enzyme inhibition spectrum, including targeting of EGFR
      • Synergistic activity with Gleevec®

While several new compounds addressing Gleevec® resistance have entered development recently, we believe that our program provides several unique features, including the ability to target all of the mutations found in patients.  This discovery may represent a significant advance in the field, providing a unique opportunity for a substantial early stage (pre-clinical) licensing transaction with a major pharmaceutical company.

JAK2 Inhibitor.  Recently, many hematological diseases have been shown to have a molecular defect in a tyrosine kinase involved in signal transduction. This enzyme is believed to be an excellent target for intervention with drugs in diseases such as polycythemia vera and several other chronic diseases. We are developing potent ihibitors of this enzyme with the following profile:

      • Non-ATP competitive compuonds
      • New enzyme inhibition spectrum,
      • Potential for oral and inhectible formulations

We expect to advance one or more compounds in this class to advanced development in the second half of 2007.



Copyright 2006 • Onconova Therapeutics, Inc