YM Biosciences
 | This article relies largely or entirely on a single source. (January 2017) |
| Industry | Pharmaceutics Biotechnology |
|---|---|
| Founded | 1992 |
| Founders | David Allan (CEO) Tarrnie Williams (Director) |
| Defunct | 2013 |
| Fate | Merged into Gilead Sciences |
| Successor | Gilead Sciences |
| Headquarters | , |
| Products | CYT-387 |
| Revenue | $21 million In 2012 |
| Website | www.ymbiosciences.com |
"YM BioSciences Inc." is a Canadian drug development company primarily focused on advancing CYT-387, an orally administered inhibitor of both the JAK1 and JAK2 kinases, which have been implicated in a number of hematological and immune cell disorders including myeloproliferative neoplasms and inflammatory diseases as well as certain cancers. Positive interim results have been reported from a Phase 1/2 trial of CYT-387 in 166 patients with myelofibrosis. In addition, YM has several preclinical programs underway with candidates from its library of novel compounds identified through internal research conducted at YM BioSciences Australia.
It is also the first company from any major-market country to enter into a relationship with the Cuban Government for the development of a number of that country's biopharmaceuticals with first licenses concluding in 1995. In 2013 Gilead Sciences completed the acquisition of YM Biosciences for US $510 million.
Research
The principal medicine of interest was a monoclonal antibody – Nimotuzumab – targeting the epidermal growth factor receptor. YM received Orphan Drug Designation from the FDA for Nimotuzumab in 2004; received a number of single-patient IND clearances starting in 2005 (with the first patient treated at Doernbecher Children’s Hospital of Oregon Health and Science University for inoperable, recurrent, diffuse intrinsic pontine glioma) subsequent to approval from the Office of Foreign Asset Control in March 2006; that approval was subsequently extended to unlimited clinical use so that, in August 2007 YM received clearance from the FDA to conduct a Phase II trial in the same indication. That trial was conducted at seven leading cancer institutes across United States including: Memorial Sloan-Kettering, M.D. Anderson, John's Hopkins, University of Florida, Vanderbilt Children's Hospital, Children's Hospital/University of Colorado and NYU Medical Center.
This was the first IND in history ever cleared by the United States FDA for clinical trials with Cuban-origin biopharmaceuticals and certainly the first Orphan Drug designation. The public press release describing this is on YM's public chronology of activities in the United States.
In 2010, after investing many many years of lobbying the State Department, and, specifically, as a consequence of the assistance from Senators John Kerry, Christopher Dodd and Richard Lugar, respectively, the then Chairman and ranking members of the Senate Foreign Relations Committee as named in YM's then press release (http://www.prnewswire.com/news-releases/ym-biosciences-usa-receives-clearance-from-us-treasury-department-to-extend-clinical-program-for-nimotuzumab-62188902.html) YM was cleared by the Office of Foreign Assets Control to import Nimotuzumab for unlimited clinical development and were cleared by the FDA for Phase II trials in both Non-Small Cell Lung cancer and Brain Metastases from NSCLC.