On December 1, 2020 Ipsen (Euronext: IPN; ADR: IPSEY), a specialty-care focused biopharmaceutical group, reported that it will host a virtual Capital Markets Day to highlight the Group’s new strategic priorities with the aim of driving continued growth and bringing transformative medicines to patients (Press release, Ipsen, DEC 1, 2020, View Source [SID1234572012]).

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David Loew, Chief Executive Officer of Ipsen stated: "Our new Group strategy positions Ipsen for long-term success by focusing together for patients and society. We will reinforce our commitment to Oncology, Rare Disease and Neuroscience by strengthening and accelerating our external innovation efforts and pipeline in clearly-defined segments. Through prioritization and collaboration, we will drive efficiencies to support investment in our pipeline. We are building on a strong foundation of engaged employees, agile development capabilities and global commercial footprint. I am energized to execute on our key strategic priorities to create long-term value for all stakeholders."

Bring the full potential of innovative medicines to patients

Ipsen is focused on maximizing the value of its current Specialty Care product portfolio through commercial excellence and geographic expansion. The Group aims to maximize its core brands Somatuline (lanreotide), Decapeptyl (triptoreline) and Dysport (botulinum toxin type A) and capture the full potential of its innovative oncology products Cabometyx (cabozantinib) and Onivyde (irinotecan liposome injection). If approved, the launch of palovarotene will be a key milestone to bring this medicine to patients with FOP and strengthen Ipsen’s presence in Rare Disease.

A strategic review of the Consumer Healthcare business is proceeding.

Build a high-value sustainable pipeline

Ipsen’s priority is to build a sustainable pipeline to drive long-term growth. Recent initiatives have prioritized the pipeline on the highest potential opportunities and progressed the transformation of the R&D organization. Ipsen is strengthening its external innovation efforts by targeting differentiated medicines in its three core therapeutics areas of Oncology, Rare Disease and Neuroscience, with a broader disease and modality scope than previously defined, and across all stages of clinical development.

Deliver efficiencies to enable targeted investment & growth

Ipsen is committed to generating efficiencies through a focused and agile operating model. Leveraging smart spending, streamlined operations, manufacturing efficiencies and optimizing digitalization, the Group will be able to reinvest in R&D and external innovation to fuel future growth.

Boost culture of collaboration & excellence

Patients and society are at the core of Ipsen’s mission, starting with fully engaged employees and a culture of accountability to perform and compete in the long-term. Ipsen is highly committed to its corporate social responsibility (CSR) initiatives which are centered around employees, community and the environment, as reflected throughout the organization and in the inclusion of responsibility metrics in management compensation.

Mid-term financial outlook and capital allocation strategy

Ipsen provides its financial outlook for the period 2020-20241:

Group Net Sales CAGR2 between +2% and +5%3,assuming potential additional indications
Commitment to invest in R&D supported by SG&A efficiencies
Lower SG&A as a percentage of net sales driven by further focus and optimization
Higher R&D as a percentage of net sales driven by external innovation strategy
External innovation is Ipsen’s number one priority for capital allocation. In support of its external innovation strategy, Ipsen expects to generate by 2024 a cumulative €3bn4 of firepower for pipeline expansion, excluding the sale of any assets.

Webcast

Ipsen will host a video webcast of the Capital Markets Day on Tuesday, 1 December 2020 from 2:00 p.m. to 5:00 p.m. CET (GMT+1) available at www.ipsen.com. Participants should log in to the webcast approximately 5 to 10 minutes prior to its start. No reservation is required to participate in the conference call.

Webcast link: View Source

Please note this event will be streamed live. No dial-in number available.

A recording will be available for 14 days on Ipsen’s website.

1 Ipsen is on track to deliver its previous 2022 financial targets and is committed now to a new 2024 financial outlook

2 Compound Annual Growth Rate

3 At constant exchange rates and scope

4 Based on Net Debt remaining below 2.0x EBITDA

On December 1, 2020 Nordic Nanovector ASA (OSE: NANO) reported that it has completed enrolment into the LYMRIT 37-05 Phase 1 clinical trial of Betalutin (177Lu lilotomab satetraxetan) in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) not eligible for autologous stem cell transplantation (ASCT) (Press release, Nordic Nanovector, DEC 1, 2020, View Source [SID1234571999]).

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Eighteen DLBCL patients were enrolled into the trial at clinical trial sites in the US and Europe and were dosed with three escalating treatment doses of Betalutin (10MBq/kg, 15MBq/kg and 20MBq/kg). A preliminary data readout is expected in H1’2021.

As announced in April 2020, LYMRIT 37-05 will be paused pending analysis of these data, which is expected to inform plans for the further development of Betalutin in R/R DLBCL.

Nordic Nanovector’s primary focus is the timely completion of the pivotal Phase 2b PARADIGME trial of Betalutin in 3rd-line follicular lymphoma (3L FL).

Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector, said: "The completion of recruitment into this dose-finding study in patients with DLBCL is an important milestone. DLBCL remains a significant indication with a large unmet medical need. The data analysis from this trial will form the basis of our considerations for the further development of Betalutin in DLBCL and more broadly across non-Hodgkin’s lymphoma."

The LYMRIT 37-05 study is a Phase 1 open-label, single-arm, dose-escalation study in DLBCL designed to determine the dose to be recommended for further studies in DLBCL and assess the safety, tolerability, pharmacokinetic profile and preliminary anti-tumour activity of a single administration of Betalutin. More information on this study can be found at www.clinicaltrials.gov (NCT02658968).

DLBCL is an aggressive form of non-Hodgkin’s Lymphoma (NHL) that accounts for 30% of all NHL cases1,2. The number of diagnosed incident cases of DLBCL in the seven major markets (US, key five European markets and Japan) was 64,172 in 2018 and is expected to grow to 74,927 in 20283.

Approximately 40% of DLBCL patients relapse after first-line combination treatment with rituximab and chemotherapy. These patients have few therapeutic options, with high-dose chemotherapy and autologous stem cell transplant (ASCT) achieving long-term remissions in only a minority of patients4. Relapsed DLBCL therefore remains a serious unmet medical need.

References

Siegel R, Miller K and Jemal A. Cancer Statistics, 2019. CA Cancer J. Clin. 2019;69(1):7-34
View Source
Non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL), 2020, Decision Resources Group, Clarivate
Liu Y, Barta SK. Diffuse large B-cell lymphoma: 2019 update on diagnosis, risk stratification, and treatment. Am J Hematol. 2019 May;94(5):604-616.