12/10/2021, 09:25 Driving Menarini's Future With Decisive Steps :: Scrip

It is two years since Barker Ergun took over as CEO of Menarini, joining from Merck KGaA's healthcare unit.
Her appointment caught the eye not only because she became one of the few women to head up a global top
30 pharmaceutical company, but also that family-owned Menarini, seen in some circles as somewhat
conservative, had appointed a CEO from outside.
In an interview with Scrip, Barker Ergun dismissed the claim that the family firm founded in 1886 by
Archimede Menarini and headquartered in Florence, was parochial and inward-looking, saying that "this is a
company with a huge entrepreneurial mindset that has made acquisitions in Spain, Germany, Eastern
Europe, Turkey, Asia-Pacific and US coupled with an unsurpassed partnering track record. We are evolving
the culture further today helped by the tremendous changes the pandemic triggered and to make the
company a truly global one, combining its commercial excellence with an innovation power we are creating."
The list of Menarini's co-marketing partners includes most of the top 20 pharma companies where the
company is well known for its portfolio in cardiology with Daiichi Sankyo Co., Ltd.’s anticoagulant Lixiana
(edoxaban) and blood pressure tablet Benicar (olmesartan), as well as Gilead Sciences, Inc.’s Ranexa
(ranolazine).

However, Barker Ergun stressed that "even though we are number six globally in cardiology area,
cardiovascular is not an area for research for us and commercial partnerships will continue to be the model
where we are also very open to new modalities." The same goes for respiratory disease, where Menarini has
long-standing relationships with the major players e.g. it co-markets GlaxoSmithKline plc's Ellipta portfolio of
medicines for chronic obstructive pulmonary disease such as Trelegy (fluticasone
furoate/umeclidinium/vilanterol) and Anoro (umeclidinium/vilanterol) as well as the UK drug giant's Nucala
(mepolizumab) for severe asthma in selected markets.

Focus On Big Three Disease Areas

“The world’s leading cause of death today is still cardiovascular disease followed by cancer and respiratory
diseases. Our strategy going forward is to add oncology as the third key focus area as we concentrate on this
trio of still unresolved diseases to broaden and increase our impact,“ she noted.
In fact, the company did not have to wait too long to make its first key step to enter oncology. Nine months
after the new CEO joined, Menarini acquired Stemline Therapeutics, Inc., a deal that was valued at up to
$677m, giving it access to the blood cancer drug Elzonris (tagraxofusp) which was already marketed in the
US. Barker Ergun said: "We started our talks with Stemline's leadership during J.P. Morgan in January 2020
and completed the deal during the first lockdown in June, which hit Italy particularly hard. The whole
transaction was virtual and we could not even visit the company HQ in New York City, another profound
example of how much COVID-19 forced everyone to change practice with a new normal that we all had to
adapt to".
Menarini had to fend off competition to buy
Stemline which gave the firm an approved product,
as Elzonris got the green light in the US for blastic Menarini Seals Stemline Merger
plasmacytoid dendritic cell neoplasm (BPDCN) in By Kevin Grogan
December 2018, a rare disease of the bone marrow 11 Jun 2020
and blood that can affect multiple organs and
develop into leukemia.  Barker Ergun said that with The purchase gives the Italian firm ownership of the
the deal, "we went straight into commercial blood cancer therapy Elzonris which is already
oncology and entered into the US pharma space approved in the US and attracted the attention of
where we were previously only present with our another potential acquirer before Menarini clinched
diagnostics division. This was a key strategic move the deal to buy Stemline. 
for us."
Read the full article here
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12/10/2021, 09:25 Driving Menarini's Future With Decisive Steps :: Scrip

The first treatment to get the green light for

BPDCN, Elzonris is still the only approved therapy for BPDCN. It is a targeted therapy directed to the
interleukin-3 receptor-α (CD123) present on a wide range of malignancies. The CEO told Scrip that while
BPDCN is a rare disease and a relatively small market, Elzonris "has the potential to be a pipeline in a
product.  We are looking at a number of hematologic diseases where CD123 is expressed, such as chronic
myelomonocytic leukemia, myelofibrosis and acute myeloid leukemia. We are particularly encouraged by the
early results we are seeing for AML, which will be shared in upcoming congresses."
The path towards approval in Europe for Elzonris has been less smooth. It finally got the thumbs-up in
January 2021, following an arduous two-year journey through the EU regulatory process that included an
initial rejection and a subsequent re-examination by the European Medicines Agency. Barker Ergun noted
that Elzonris has just been launched in Germany with other EU countries to follow soon. (Also see "Elzonris: A
Case Study In Divergent Regulatory Decisions" - Pink Sheet, 16 Jun, 2021.)

She added that with the Stemline buy, "we also acquired a promising pipeline beyond Elzonris," which
includes SL-701, an immunotherapeutic for glioblastoma multiforme. "We have interesting Phase II results
and we are looking to see the best development path forward in this area of huge unmet need," Barker Ergun
stated. “Overall, we are very pleased with the acquisition placing us in the right innovation ecosystem in the
east coast of the US, allowing us to unlock and accelerate more innovation in the coming years.

Shortly after signing off the Stemline deal, Menarini continued to increase its footsteps in oncology by
licensing Radius Health, Inc.'s late-stage breast cancer treatment elacestrant.

In July last year, Menarini paid the US firm $30m

upfront (and up to $320m in additional milestones
along with royalties) to get global rights to Menarini Expands In Cancer With Radius Drug
elacestrant, an oral selective estrogen receptor Deal
degrader (SERD) in development for estrogen By Kevin Grogan
receptor-positive (ER+)/human epidermal growth 27 Jul 2020
factor receptor 2-negative (HER2-) breast cancer.
The drug is currently being evaluated in the Although Elonzris, the therapy at the heart of its
EMERALD Phase III study for patients who have recent acquisition of Stemline has just been rejected in
received prior treatment with one or two lines of Europe, Italy's Menarini is pushing on with its
endocrine therapy, including a cyclin-dependent expansion in oncology and is paying $30m upfront to
kinase (CDK) 4/6 inhibitor. get the rights to Radius Health's Phase III hope
The late-stage oral SERDs space is becoming a busy elacestrant.
one with offerings from Sanofi (amcenestrant), Read the full article here
❯
AstraZeneca PLC (camizestrant) and Roche Holding
AG (giredestrant) also being developed to improve
upon the older SERD fulvestrant (AstraZeneca’s Faslodex and generics), which is administered as two
intramuscular injections a month.
Barker Ergun said: "Oral SERDS have the potential to become the next backbone therapy for ER+/HER2-, the
biggest segment in metastatic breast cancer. We are aware that this is a crowded field but elacestrant
differentiates with its mechanism of action in that it also possesses selective estrogen receptor modulator
(SERM) characteristics which may allow us to differentiate in some sub-segments. In addition, it is the only
SERD that can cross the blood-brain-barrier and target breast cancer metastases in the brain, an important
unmet need where we have already started development efforts."
The results from EMERALD evaluating elacestrant as a monotherapy are expected before the end of the year
and will guide Menarini's future plans in expanding the current development program in combinations.

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12/10/2021, 09:25 Driving Menarini's Future With Decisive Steps :: Scrip

Elsewhere, in the diagnostics division, the company is focusing to accelerate the development of its multiple
myeloma offering based on circulating tumor cells (CTC) technology, in a market that is totally dependent on
invasive bone marrow-based procedures. “As one of the very few companies in the sector to have both
pharma and diagnostics arms with a unique capability with CTCs, we believe we are well positioned to make
a broader impact in oncology in the coming years, capitalizing on our diagnostics and pharma capabilities
where our goal is to be recognized as an important player in oncology in targeted therapies," Barker Ergun
said.
The company is aligning its culture in a world where "everything is mega fast and the possibilities in
unlocking breakthrough innovation with technology have become more achievable than ever." Barker Ergun
concluded. “We are aware this will take a while and there will be bumps in our innovation journey. Yet we are
excited as a board to make this evolution happen, so Italy’s leading pharma company can make its mark in
bringing innovative treatments and diagnostics solutions globally to cancer patients."

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