PR96762

MIAMI and FLORENCE, Italy and NAARDEN, Netherlands June 28, 2022 /PRNewswire=KYODO JBN/

- 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

disease.

"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."

Advisors

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

events.

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:

www.newamsterdampharma.com.

https://www.newamsterdampharma.com/] ;

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 www.menarini.com.

[https://www.menarini.com/en-us/]

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.

https://doi.org/10.1016/s0140-6736(15)60158-1

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SOURCE: Menarini Industrie Farmaceutiche Riunite