API is focused on the marketplace for biopharmaceutical products for treating cancer. According to the American Cancer Society, half of all men and one third of all women will develop at least one form of cancer during their lifetime.  There are more than 1.5 million new cancer cases per year in the U.S.  and nearly 12.7 million worldwide, excluding non- melanoma skin cancers.  Worldwide sales of biopharmaceutical products for treating cancer are approximately $50 billion per year with U.S.  sales being approximately half of that.  Biopharmaceutical cancer treatments include a variety of drugs, but two categories predominate: cytotoxic chemotherapy and targeted therapies.  Other approaches (e.g. hormonal therapy, phototherapy, cryotherapy etc.) are used less frequently.

Cytotoxic chemotherapy remains a mainstay of cancer treatment, however, its use is limited by its substantial killing of normal cells in addition to cancerous ones.  That gave rise over the last 15 years to targeted therapies, of which the biggest segment is represented by monoclonal antibodies (mAbs), large proteins that can very selectively bind to cancer cells and attack them while largely sparing surrounding normal tissue.  Monoclonal antibodies for cancer indications represent approximately 30% of all cancer drug sales, or about $15 billion per year.  A total of 11 mAbs for treating cancer have been approved to date.  Many approved mAbs are commercially very successful.  Herceptin, a breast cancer mAb, had $5.1 billion sales in 2010 and Avastin, approved in 2004 and indicated in a number of cancers, reached $6.0 billion in sales in 2010.

However, despite their commercial success, monoclonal antibodies have limited potency, as evidenced by the fact that out of hundreds of antibodies under development only 11 have been approved for sale in the U.S.  to date.  Even though they are excellent at targeting cancer cells, mAbs often lack sufficient killing power to eradicate these cells completely.  A relatively new approach to treating cancer is to combine the precision of targeting molecules with the proven killing power of radiation or cytotoxic chemotherapy by attaching powerful killing agents referred to as payload to precise molecular carriers, mostly monoclonal antibodies.  Three key categories of payloads are alpha emitting radioisotopes, beta emitting radioisotopes and cytotoxic chemotherapeutics.  API’s technology is based on using alpha emitting radioisotopes as a payload attached to monoclonal antibodies.  This technology allows for use of alpha emitters in a wide variety of cancer indications where there are appropriate monoclonal antibodies available.  API is primarily focused on blood borne cancers and metastases of solid cancers.  

Table below summarizes annual incidences, target patient populations and potential market sizes in key territories (U.S., Europe and Japan) for the initial target indications in which API’s platform technology showed significant promise.  Market analysis for antiangiogenesis is not shown as it could be applicable to all solid cancers.  Calculation of market sizes is based on assumed pricing of $50,000 per patient comparable to the two approved radioimmunotherapy drugs and is at the low end of recently approved antibody based treatments in oncology.

Market opportunities for the key API products

* Incidence in key markets only.  Key markets include US, Europe and Japan.
** Market potential calculated based on the assumption that API products will be priced at $50,000 in line with other radioimmunotherapy drugs already on the market and at the low end of recently approved antibody products.

However, the biggest market potential for API lies in the fact Company’s platform technology is potentially applicable to a wide variety of cancers.  Clinical work with API’s platform has already been performed in unrelated physician sponsored trials for Non-Hodgkin Lymphoma (NHL), malignant melanoma and brain cancer.  Preclinical work by institutions and companies other than API has focused on bladder cancer, ovarian cancer, breast cancer, prostate cancer, antiangiogenesis and a number of other cancer related indications.  Should any of these clinical and preclinical attempts result in advancement on the path to regulatory approval, API intends to leverage its IP position in the area to seek business relationships with other parties owning complementary IP.  Many of the markets which could arise from earlier stage based on API’s technology platform work present large opportunities.  Potentially, almost any cancer that can be targeted by mAbs could be treated with API’s platform technology.