Project status

At present, we have obtained the permission (No.843 dated December 7, 2016) of regulatory authorities of the Russian Federation and have started clinical trials (CT) on healthy volunteers. Until December 2017, it is planned to complete the 1st phase of CT, prepare a protocol for the 2nd phase of CT, and submit a prepared dossier for permission to conduct the 2nd phase of CT according to therapy indications within 30 days after knee or hip replacement surgery. Until May 2018, it is planned to obtain permission to conduct the 2nd phase of CT. From June 2018 - start of the 2nd phase of CT, which, as now follows from the preliminary program for the 2nd phase of CT, can last 12-15 months.

Since the current project participants do not have their own resources for the 3rd phase of CT, there are various options for further promotion of the project. For example, as one of options - it is supposed that the project will be divided according to the territorial character of patents and licenses will be sold to those interested in development of the project in certain countries, and received funds will provide participation in further international studies, registration of the drug in the case of successful completion of 3rd phase of CT and entry of the drug into the market of the Russian Federation. In this case, it should be expected that the conduct of the 3rd phase according to therapy indications within 30 days after knee or hip replacement surgery, as well as the procedure for drug registration in the Russian Federation, will take from 18 to 24 months and end in the first half of 2021.

Later, at the post-registration stage, it is planned to expand indications of the drug for prevention and prophylaxis of deep vein thromboembolism, stroke and embolism in patients with nonvalvular atrial fibrillation.

 Description of existing patents and applications

  • Patent or patent application for the invention “Urethanes, ureas, amides and related Xa factor inhibitors”

Patent No. 2011221601.  Rights were transferred to PharmaDiall LLC

Australia

Patent BR 11 2012 021884-0 A2. In the course of transfer of rights to PharmaDiall LLC

Brazil

Patent No. 2,791,875 issued on June 2, 2015. Rights were transferred to PharmaDiall LLC

Canada

Patent No. CN102971294B issued on March 25, 2015. Rights were transferred to PharmaDiall LLC

China

Patent No. NK1182700 dated November 20, 2015. Rights were transferred to PharmaDiall LLC

Hong Kong

Application No. 221727 The decision on patent issuance was published on November 30, 2016. Rights were transferred to PharmaDiall LLC

Israel

Application No.2317/MUMNP/2012, in the course of examination

India

Application No. 2012-556036, decision on patent issuance was received on August 30, 2016. Rights were transferred to PharmaDiall LLC

Japan

Application No.10-2012-7025881, in the course of examination

South Korea

Patent No. MX/a/2012/009976 dated October 5, 2015. In the course of transfer of rights to PharmaDiall LLC

Mexico

Patent No. 602769 issued on May 5, 2015. Rights were transferred to PharmaDiall LLC

New Zealand

Patent No.1070106 issued on November 25, 2014. Rights were transferred to PharmaDiall LLC

Ukraine

Application No.13/599,038. The decision on patent issuance was received on March 11, 2016. In the course of transfer of rights to PharmaDiall LLC

USA

Patent No. 2012/07345 issued on September 25, 2013. Rights were transferred to PharmaDiall LLC

South Africa

Application No.11 750 982.8-1462, in the course of examination Rights were transferred to PharmaDiall LLC

EPO

Patent No. 015918 issued on December 30, 2011. Valid in: Russia, Belarus, Kazakhstan, Azerbaijan, Armenia, Moldova, Turkmenistan, Tajikistan, Kyrgyzstan. Rights were transferred to PharmaDiall LLC

EAPO

  • Patent Application EAPO 201600486 dated June 15, 2016 “Pharmaceutical compositions comprising the N-(5-chloropyridin-2-yl)-2-({4-[ethanoydoyl(methyl)amino]benzoyl}amino)-5-methylbenzamide anticoagulant".
  • Patents and patent applications: in 16 countries on the basis of PCT/ RU2011 / 000129 dated March 2, 2011. The intellectual property protection strategy was copied from Xarelto (Bayer)