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NewAmsterdam Pharma acquires Obicetrapib from Amgen

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• AMG 899 or Obicetrapib to be developed by Netherlands-based company to be headed up by Dr. Michael Davidson and Dr. John Kastelein

• Obicetrapib, a potent ApoB and LDL-c lowering small molecule drug, will be tested in patients not well controlled on statins and statin-intolerant patients

• Pivotal Phase III studies in dyslipidemia planned to start in 2021

Naarden, the Netherlands, August 25, 2020: NewAmsterdam Pharma B.V. (“NAP”) has acquired the rights to Obicetrapib (AMG 899) from Amgen.

The new Company, spearheaded by Michael Davidson, MD (CEO) and John Kastelein, MD, PhD, FESC (CSO), is currently working with the U.S. Food and Drug Administration (FDA) on a comprehensive phase 3 clinical development program, including a cardiovascular outcome trial (CVOT) for obicetrapib. NAP is targeting for these trials to begin in 2021. To this end, the Company has received seed funding of approximately EUR 20M from Dutch investment firm Forbion as well as its Founders and will be raising a substantial financing round before year-end.

Obicetrapib is a cholesteryl ester transfer protein (CETP) inhibitor which targets Apolipoprotein B (ApoB) and low-density lipoprotein cholesterol (LDL-c) in the body. Obicetrapib is being developed for patients who are not well controlled on statins and patients who are statin-intolerant. Approximately 32 million people globally have statin-associated side effects or as a result of side effects, have discontinued their statin therapy.1

A Phase 2b study called TULIP, published in The Lancet showed that obicetrapib significantly reduced the number of ApoB-containing particles that constitute LDL-c and was well-tolerated in patients with mild dyslipidaemia. 2 The randomized, double-blind, placebo-controlled study tested the drug in 364 patients, to assess the safety, tolerability, and efficacy of the potential therapy.

In 2017, Amgen decided to discontinue the internal development of obicetrapib for strategic reasons and pursue out-licensing opportunities. Forbion believes that this drug could address very substantial unmet medical needs and therefore initiated conversations with Amgen to continue developing the asset. For this purpose, it has established NewAmsterdam Pharma B.V.

Financial terms of the acquisition of Obicetrapib by NAP from Amgen were not disclosed.

Sander Slootweg, Managing Partner at Forbion commented:
“NewAmsterdam Pharma constitutes a very attractive investment opportunity, as obicetrapib has the potential to address the huge and poorly served patient segment of patients at risk of cardiovascular disease, currently not well controlled on statins or those even completely statin-intolerant. With over 30 million patients meeting these criteria, we believe that obicetrapib has mega-blockbuster sales potential. For this reason, we were able to attract a top founder team with Michael Davidson MD as CEO, who recently sold his previous company Corvidia Therapeutics, Inc. to Novo Nordisk and John Kastelein as CSO, after selling his previous company Staten Biotech to the same Novo Nordisk, in an option structure.

1 Zhang, Ann Intern Med 2014
2 Hovingh GK, Kastelein JP, van Deventer SJH, Round P, Ford, J, Saleheen D, et. al. Cholesterol ester transfer protein inhibition by TA-8995 in patients with mild dyslipidaemia (TULIP): a randomised, double-blind, placebo-controlled phase 2 trial. The Lancet 2015.386(9992): 452-460. DOI: https://doi.org/10.1016/S0140-6736(15)60158-1

Michael Davidson, CEO of NewAmsterdam Pharma added:
“As we know today, the real culprit of heart disease is ApoB particle numbers. Obicetrapib being a highly potent small molecule, it holds great potential as a powerful tool to lower ApoB in patients, who otherwise cannot tolerate statin therapy. Phase 2 testing of obicetrapib has shown us very promising results with regard to patient tolerance, which we look forward to further examine in this next phase of research.”

John Kastelein, CSO of NewAmsterdam Pharma concluded:
“In my opinion, obicetrapib is a best-in-class CETP inhibitor. From the phase IIB trial in nearly 400 patients, we observed an average LDL-C lowering of 45% at a 5 mg daily dose, with a clean safety profile and excellent tolerability. A key lesson from previous phase III studies with other CETPi molecules is not to combine CETPi with high-dose statins, because of an observed interaction. This makes obicetrapib an ideal drug for statin-intolerant patients and those not well controlled on maximally tolerated dose of statins. We have devised a comprehensive clinical development plan, including a CVOT, to show all favorable attributes of obicetrapib.”
-Ends-

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