Country for PR: United Kingdom
Contributor: PR Newswire Europe
Wednesday, June 29 2022 - 01:50
NewAmsterdam Pharma and the Menarini Group Sign Licensing Deal to Commercialize Obicetrapib in Europe
MIAMI and FLORENCE, Italy and NAARDEN, Netherlands June 28, 2022 /PRNewswire-AsiaNet/

- Combines NewAmsterdam's lead clinical program obicetrapib with Menarini's 
deep cardiovascular disease and regional expertise 
- Total deal value of over 1 billion euros; including 142.5 million euros 
upfront payment and committed R&D funding plus potential milestones and 
double-digit royalties on net product sales in Europe 
- Obicetrapib is a next-generation oral, low-dose and once-daily CETP inhibitor 
for which promising safety and strong LDL-lowering efficacy has been observed 
in patients with dyslipidemia through Phase 2b

NewAmsterdam Pharma (NewAmsterdam), a clinical-stage company focused on the 
research and development of transformative oral therapies for major metabolic 
diseases, and the Menarini Group (Menarini), an Italy-based, privately held, 
international pharmaceutical company, today announced an exclusive license 
agreement for the commercialization of obicetrapib, if approved, in Europe, 
either as a monotherapy or as part of a fixed dose combination with ezetimibe, 
for cardiovascular diseases. Obicetrapib is NewAmsterdam's next-generation 
oral, low-dose and once-daily cholesteryl ester transfer protein (CETP) 
inhibitor therapeutic candidate, for which a promising safety and efficacy 
profile as an LDL-lowering adjunct to maximally tolerated statin therapy in 
patients with dyslipidemia has been observed through Phase 2b trials. Under the 
collaboration agreement, NewAmsterdam will retain all rights to commercialize 
obicetrapib, if approved, in the rest of the world, as well as rights to 
develop certain forms of obicetrapib for other diseases such as Alzheimer's 
"We are delighted to enter into this agreement with Menarini," said Michael 
Davidson, M.D., chief executive officer of NewAmsterdam Pharma. "As we advance 
obicetrapib through late-stage clinical development, we believe now is the 
right time to begin laying the groundwork for our global product launch. 
Menarini is a leading pharmaceutical company with substantial cardiovascular 
expertise and the greatest share of voice among cardiologists, internists and 
general practitioners across major European markets, as well as strong 
relationships with key opinion leaders.  We believe they are the right partner 
to accelerate efforts to maximize the delivery of obicetrapib, upon approval, 
to the millions of hyperlipidemia patients in Europe who are underserved by 
existing options."  

The collaboration expands Menarini's existing cardiology portfolio of 18 
products, which address the most widespread cardiometabolic diseases and aim to 
prevent and reduce risk factors associated with chronic conditions, with the 
goal of helping patients restore their quality of life.

 "Obicetrapib, if approved, could radically alter the treatment landscape in 
cardiovascular disease by providing an effective and oral option for 
hyperlipidemia patients in Europe" said Elcin Barker Ergun, Chief Executive 
Officer of the Menarini Group. "As a leading company in cardiovascular 
treatments area, we find it an excellent fit to our portfolio and look forward 
to collaborating with NewAmsterdam Pharma to advance its development."

Subject to the terms of the agreement, NewAmsterdam will receive an upfront 
payment of 115 million euros, as well as 27.5 million euros in committed R&D 
funding, for a total of 142.5 million in committed consideration.  NewAmsterdam 
will be eligible to receive up to 863 million euros in potential clinical, 
regulatory and commercial milestones, bringing the total potential deal value 
to 1,005.5 euros million. In addition, Menarini will pay NewAmsterdam tiered 
double-digit percentage royalties from the teens to mid-twenties on net sales 
of obicetrapib in Europe.

Pursuant to the terms of the agreement, NewAmsterdam will be responsible for 
further clinical development of obicetrapib and the parties will cooperate in 
regulatory activities to secure approval for the product.  Menarini will be 
responsible for all commercialization activities in the licensed territory.
"This alliance exemplifies NewAmsterdam's strategy of engaging with the right 
partner at the right time with the right deal," said Lina Gugucheva, chief 
business officer of NewAmsterdam Pharma.  "In addition to Menarini's strong 
commercial credentials in the cardiovascular field in Europe, this agreement 
also brings in proceeds that we expect will substantially fund obicetrapib's 
development through planned Phase 3 data readouts, while allowing NewAmsterdam 
to retain substantial participation in the potential commercial opportunity in 
an important major market."


Moelis & Company LLC is acting as financial advisor and Covington & Burling LLP 
is acting as legal advisor to NewAmsterdam Pharma. Goldman Sachs is acting as 
financial advisor to Menarini.

About Obicetrapib

Obicetrapib is a next-generation oral, low-dose and once-daily CETP inhibitor 
in development for lowering low-density lipoprotein cholesterol (LDL-c) and 
preventing major adverse cardiovascular events. More than 100 million people 
globally are not achieving LDL-c goals despite the current available standard 
of care. Obicetrapib was previously tested in ROSE and TULIP[1] randomized 
double-blind, placebo-controlled Phase 2 trials. Results from the ROSE trial, 
presented in November 2021 at the AHA Scientific Sessions, included 
observations that patients on statin therapy who received 5 mg of obicetrapib 
saw an LDL-c reduction of 42%. Patients who were part of the 10 mg cohort were 
observed to experience a 51% reduction versus baseline, while the placebo 
cohort was observed to experience a 7% reduction versus baseline. Both doses 
were observed to be well tolerated, with no serious adverse effects in the two 
cohorts and two serious AEs in the placebo arm. Currently, Obicetrapib is being 
tested in three Phase 3 trials, BROADWAY, BROOKLYN and PREVAIL, and a secondary 
Phase 2 trial, ROSE2. These studies are intended to examine obicetrapib as a 
combination therapy as well as its efficacy in adjunct to diet and a maximally 
tolerated lipid-lowering therapy, and reduction of major adverse cardiovascular 

About NewAmsterdam Pharma

NewAmsterdam Pharma is a private clinical-stage biopharmaceutical company whose 
mission is to improve patient care in populations with metabolic diseases where 
traditional therapies have been unsuccessful or are not tolerated. NewAmsterdam 
is investigating obicetrapib, a next-generation oral, low-dose and once-daily 
CETP inhibitor, as the preferred LDL-c-lowering therapy for high-risk 
cardiovascular disease (CVD) patients. Results from NewAmsterdam's ROSE Phase 
2b trial (presented at AHA Scientific Sessions in 2021) included observations 
that patients receiving obicetrapib 10mg experienced reduced LDL-c by 51% 
versus baseline in patients on statin therapy (vs. a 7% reduction in the 
placebo arm). Based in the Netherlands, NewAmsterdam was founded in 2019 by the 
venture capital firm Forbion and John Kastelein, and closed a $196M (161M 
euros) Series A financing in January 2021 led by Forbion, Morningside Ventures 
and Ascendant BioCapital. For more information, please visit:] ;

About Menarini

The Menarini Group is a leading international pharmaceutical and diagnostics 
company, with a turnover of over $4 billion and over 17,000 employees. Menarini 
is focused on therapeutic areas with high unmet needs with products for 
cardiology, oncology, pneumology, gastroenterology, infectious diseases, 
diabetology, inflammation, and analgesia. With 18 production sites and 9 
Research and Development centers, Menarini's products are available in 140 
countries worldwide. For further information, please visit 

Forward-Looking Statements

Certain statements included in this press release that are not historical facts 
are forward-looking statements. Forward-looking statements generally are 
accompanied by words such as "believe," "may," "will," "estimate," "continue," 
"anticipate," "intend," "expect," "should," "would," "plan," "predict," 
"potential," "seem," "seek," "future," "outlook" and similar expressions that 
predict or indicate future events or trends or that are not statements of 
historical matters. These forward-looking statements include, but are not 
limited to, statements regarding estimates and forecasts of other financial and 
performance metrics and projections of market opportunity; expectations and 
timing related to the success, cost and timing of product development 
activities, including timing of initiation, completion and data readouts for 
clinical trials and the potential approval of NewAmsterdam's therapeutic 
candidate; the size and growth potential of the markets for NewAmsterdam's 
therapeutic candidate; the therapeutic and curative potential of NewAmsterdam's 
therapeutic candidate; and NewAmsterdam's expected cash runway. These 
statements are based on various assumptions, whether or not identified in this 
press release, and on the current expectations of NewAmsterdam's management and 
are not predictions of actual performance. These forward-looking statements are 
provided for illustrative purposes only and are not intended to serve as and 
must not be relied on by anyone as a guarantee, an assurance, a prediction, or 
a definitive statement of fact or probability. Actual events and circumstances 
are difficult or impossible to predict and may differ from assumptions, and 
many are beyond the control of NewAmsterdam. These forward-looking statements 
are subject to a number of risks and uncertainties, including uncertainty 
regarding outcomes of NewAmsterdam's ongoing clinical trials, particularly as 
they relate to regulatory review and potential approval for its therapeutic 
candidate and other business milestones; ability to negotiate definitive 
contractual arrangements with potential customers; the impact of competitive 
therapeutic candidates; ability to obtain a sufficient supply of materials; the 
impact of COVID-19; global economic and political conditions; and the effects 
of competition on NewAmsterdam's business. If any of these risks materialize or 
NewAmsterdam's assumptions prove incorrect, actual results could differ 
materially from the results implied by these forward-looking statements. There 
may be additional risks that NewAmsterdam does not presently know or currently 
believes are immaterial that could also cause actual results to differ from 
those contained in the forward-looking statements. In addition, forward-looking 
statements reflect NewAmsterdam's expectations, plans, or forecasts of future 
events and views as of the date of this press release. NewAmsterdam anticipates 
that subsequent events and developments will cause NewAmsterdam's assessments 
to change. However, while NewAmsterdam may elect to update these 
forward-looking statements at some point in the future, NewAmsterdam 
specifically disclaims any obligation to do so, except as required by law. 
These forward-looking statements should not be relied upon as representing 
NewAmsterdam's assessments as of any date subsequent to the date of this press 
release. Accordingly, undue reliance should not be placed upon the 
forward-looking statements.

[1] Hovingh, G. K., Kastelein, J. J. P., van Deventer, S. J. H., Round, P., 
Ford, J., Saleheen, D., Rader, D. J., Brewer, H. B., & Barter, P. J. (2015). 
Cholesterol ester transfer protein inhibition by TA-8995 in patients with mild 
dyslipidaemia (TULIP): a randomised, double-blind, placebo-controlled phase 2 
trial. In The Lancet (Vol. 386, Issue 9992, pp. 452–460). Elsevier BV.


SOURCE: Menarini Industrie Farmaceutiche Riunite