UK “Innovation Passport” Case Study - Belzutifan 2021

[Ryan]

This was posted by KMall in Y! Board - being that the UK program is in it's infancy, this is 5-Star info notated:

"Ed Koval has been hired to facilitate Partnerships and fully maximize Imetelstats Commercial potential. Period. Once approved in the UK, Imetelstat should find a less resistant path through both FDA and EMA Approvals.

Take a look at Belzutifan.......

Belzutifan Becomes First Medicine Approved Via UK’S New ILAP Pathway
Posted on 3/2/21

Date: March 2, 2021 | Country: UNITED KINGDOM | Region: EU27 + UK, EUROPE | Type: Regulation |

MSD’s belzutifan (formerly MK-6482) has become the first treatment to be awarded an “Innovation Passport” through the Medicines and Healthcare products Regulatory Agency’s (MHRA) new Innovative Licensing and Access Pathway (ILAP)

.....by August 13, 2021, Belzutifan had garnered FDA Approval. 5.5 months later. FACT.

On August 13, 2021, FDA approved belzutifan (brand name Welireg), a hypoxia-inducible factor inhibitor for adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery.

Prior to UK and FDA Approval, Belzutifan was granted Orphan Drug Designation by the EMA......sound familiar ?? :

On 21 August 2020, Orphan Designation EU/3/20/2324 was granted by the European Commission to Merck Sharp & Dohme B.V, Netherlands, for 3-(((1S,2S,3R)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1H-inden-4-yl)oxy)-5-fluorobenzonitrile (also known MK-6482) - Belzutifan, for the treatment of von Hippel-Lindau disease.

With EU Marketing exclusivity for JAKafi, it is still my "conjecture" that Novartis is ONE of multiple potential candidates for Partnership. The fact that Ed Koval has a history with Novartis, can only be a positive:

Ed Koval
Vice President, Business Development & Alliance Management
Novartis

May 2002 - Feb 2010 7 yrs 10 mos

Led all strategic partnering activities for Novartis Pharma's Neuroscience (02-03), Cardiovascular Metabolic (04-07) and Vaccine (07-10) business units. Member of Business Franchise Boards responsible for overall performance of well diversified and profitable multi billion dollar franchises."