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Ipsen to Host an Investor Day to Highlight Its Innovative R&D Pipeline and Provide Financial Outlook for 2022

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  • 5 new chemical entities advancing in pipeline
  • 9 significant regulatory submissions planned from 2019 to 2022
  • 2022 financial outlook of Group Net Sales around €3.2 billion1
    and
    Core Operating margin greater than 32.0% of net sales

PARIS–(BUSINESS WIRE)–Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven
biopharmaceutical group, today will host an Investor Day in Paris to
present a comprehensive corporate update, with a focus on its advancing
R&D pipeline.

David Meek, Chief Executive Officer of Ipsen stated: “The
business momentum of Ipsen is strong, delivering industry-leading
top-line growth and investing to build an innovative and sustainable
pipeline. The execution of our R&D strategy over the last two years
through accelerating key internal programs and externally sourcing
innovation has significantly strengthened the focus and value of our
pipeline
.

Ipsen currently has five new chemical entities in clinical
development, nine significant regulatory submissions planned from 2019
to 2022 and several mid-to-late-stage program readouts in the coming
months. We remain committed to executing on our top-line, bottom-line
and pipeline growth strategy to create and deliver long-term value to
patients and shareholders.

In Rare Diseases, palovarotene is a late-stage and largely
de-risked drug candidate for the treatment of rare and extremely
disabling bone disorders with no current treatment options. Palovarotene
has Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric
Disease designations and is supported by robust clinical data. The
company expects to submit an NDA to the FDA in the second half of 2019
for the first indication of fibrodysplasia ossificans progressiva (FOP).

In Neuroscience, Ipsen is pursuing two new therapeutic
indications to maximize the potential of Dysport®. The
Company is also leveraging its research and development expertise
building upon its neurotoxin franchise to advance its proprietary
next-generation neurotoxin program with a fast-acting neurotoxin to
enter Phase 2 clinical development in the second half of 2019 and a
long-acting neurotoxin in preclinical development.

In Oncology, there are numerous ongoing mid-to-late-stage
programs to broaden the scope of Cabometyx® (cabozantinib)
and Onivyde® (irinotecan liposomal). The Phase 3 CheckMate
9ER trial in combination with nivolumab has the potential to strengthen
Cabometyx®’s presence in the first-line renal cell cancer
market, with top-line results expected in the first half of 2020. In
addition, the Phase 3 trial in combination with atezolizumab for
first-line hepatocellular carcinoma has the potential to expand the use
of Cabometyx® earlier in the treatment paradigm and to serve
as the registrational trial to enter China.

Regarding Onivyde®, the interim analysis of the Phase 2
combination trial for the treatment of first-line metastatic pancreatic
cancer indicates encouraging results on the disease control rate and has
been accepted as an oral presentation by the ESMO World Congress on
Gastrointestinal Cancer in July 2019. There is also an ongoing Phase 2
trial for second-line small cell lung cancer with top-line results
expected in the second half of 2019.

In earlier-stage Oncology development, Ipsen is advancing its innovative
Systemic Radiation Therapy program with satoreotide (IPN 1070 and IPN
1072) which is expected to move into a Phase 2/3 trial in neuroendocrine
tumors by the first quarter of 2020 and IPN 1087 which is currently in
Phase 1 development for pancreatic cancer. Both are platform
technologies with the possibility to expand to additional solid tumors
and to provide precision targeted treatment to patients.

_______________
1 Assuming current level of exchange
rates

Ipsen will also execute on its external innovation and business
development model in its key therapeutic areas, building on its strong
balance sheet and cash flow generation to acquire assets and invest in
R&D pipeline for long term shareholders’ value.

Along with an R&D pipeline update, Ipsen will also provide updates on
its corporate strategy, commercial highlights of its key Specialty Care
products, and new objectives on its capital allocation strategy and
mid-term financial outlook.

2022 Financial outlook

Ipsen provides its 2022 financial outlook to reflect the strong momentum
of its Specialty Care business and the impact from the acquisition of
Clementia closed in April 2019:

  • Group Net Sales around €3.2 billion2
  • Core Operating margin greater than 32.0% of net sales

This outlook includes only the existing commercial portfolio of products
under current approved indications and assumes the approval and launch
of palovarotene in FOP indications3 only. It assumes the
earliest possible entry of somatostatin analog (SSA) generics based on
market intelligence. It does not include the potential short-term, low
single-digit Core Operating margin dilution of business development
transactions to further accelerate building an innovative and
sustainable pipeline.

Webcast and Conference call

Ipsen will host an audio and video webcast and conference call of the
Investor Day on Tuesday 14 May 2019 at 1:00 p.m. (CEST, BST+1) available
at www.ipsen.com.
Participants should dial in to the call approximately 5 to 10 minutes
prior to its start. No reservation is required to participate in the
conference call.

Standard International: +44 (0) 2071-928-000
France and continental
Europe: + 33 (0) 1 76 70 07 94
UK: 08-445-718-892
U.S.:
1-6315-107-495

Conference ID: 8463129

A recording will be available for 7 days on Ipsen’s website.

About Ipsen

Ipsen is a global specialty-driven biopharmaceutical group focused on
innovation and Specialty Care. The group develops and commercializes
innovative medicines in three key therapeutic areas – Oncology,
Neuroscience and Rare Diseases. Its commitment to Oncology is
exemplified through its growing portfolio of key therapies for prostate
cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic
cancer. Ipsen also has a well-established Consumer Healthcare business.
With total sales over €2.2 billion in 2018, Ipsen sells more than 20
drugs in over 115 countries, with a direct commercial presence in more
than 30 countries. Ipsen’s R&D is focused on its innovative and
differentiated technological platforms located in the heart of the
leading biotechnological and life sciences hubs (Paris-Saclay, France;
Oxford, UK; Cambridge, US). The Group has about 5,700 employees
worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United
States through a Sponsored Level I American Depositary Receipt program
(ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com.

_______________
2 Assuming current level of exchange
rates
3 Including both flare-up and chronic indications
for FOP

Forward Looking Statement

The forward-looking statements, objectives and targets contained herein
are based on the Group’s management strategy, current views and
assumptions. Such statements involve known and unknown risks and
uncertainties that may cause actual results, performance or events to
differ materially from those anticipated herein. All of the above risks
could affect the Group’s future ability to achieve its financial
targets, which were set assuming reasonable macroeconomic conditions
based on the information available today. Use of the words “believes”,
“anticipates” and “expects” and similar expressions are intended to
identify forward-looking statements, including the Group’s expectations
regarding future events, including regulatory filings and
determinations. Moreover, the targets described in this document were
prepared without taking into account external growth assumptions and
potential future acquisitions, which may alter these parameters. These
objectives are based on data and assumptions regarded as reasonable by
the Group. These targets depend on conditions or facts likely to happen
in the future, and not exclusively on historical data. Actual results
may depart significantly from these targets given the occurrence of
certain risks and uncertainties, notably the fact that a promising
product in early development phase or clinical trial may end up never
being launched on the market or reaching its commercial targets, notably
for regulatory or competition reasons. The Group must face or might face
competition from generic products that might translate into a loss of
market share. Furthermore, the Research and Development process involves
several stages each of which involves the substantial risk that the
Group may fail to achieve its objectives and be forced to abandon its
efforts with regards to a product in which it has invested significant
sums. Therefore, the Group cannot be certain that favorable results
obtained during pre-clinical trials will be confirmed subsequently
during clinical trials, or that the results of clinical trials will be
sufficient to demonstrate the safe and effective nature of the product
concerned. There can be no guarantees a product will receive the
necessary regulatory approvals or that the product will prove to be
commercially successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements. Other risks and
uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation; global
trends toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent in new
product development, including obtaining regulatory approval; the
Group’s ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of
international economies and sovereign risk; dependence on the
effectiveness of the Group’s patents and other protections for
innovative products; and the exposure to litigation, including patent
litigation, and/or regulatory actions. The Group also depends on third
parties to develop and market some of its products which could
potentially generate substantial royalties; these partners could behave
in such ways which could cause damage to the Group’s activities and
financial results. The Group cannot be certain that its partners will
fulfil their obligations. It might be unable to obtain any benefit from
those agreements. A default by any of the Group’s partners could
generate lower revenues than expected. Such situations could have a
negative impact on the Group’s business, financial position or
performance. The Group expressly disclaims any obligation or undertaking
to update or revise any forward-looking statements, targets or estimates
contained in this press release to reflect any change in events,
conditions, assumptions or circumstances on which any such statements
are based, unless so required by applicable law. The Group’s business is
subject to the risk factors outlined in its registration documents filed
with the French Autorité des Marchés Financiers. The risks and
uncertainties set out are not exhaustive and the reader is advised to
refer to the Group’s 2018 Registration Document available on its website
(www.ipsen.com).

Contacts

Media
Christian Marcoux
Senior Vice President,
Global Communications
+33 (0)1 58 33 67 94
[email protected]

Fanny Allaire
Director, Ipsen France Hub,
Global Communications
+33 (0) 1 58 33 58 96
[email protected]

Financial
Community

Eugenia Litz
Vice President, Investor
Relations
+44 (0) 1753 627721
[email protected]

Myriam Koutchinsky
Investor Relations Manager
+33 (0)1
58 33 51 04
[email protected]


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Cannabis

Cannabis Capsule Global Analysis Report 2024: Market to Reach $79.2 Billion in 2028 – Forecast to 2033 Featuring GW Pharmaceuticals, Trulieve Cannabis, Green Thumb Industries, Tilray, Columbia Care

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Innocan

Innocan Pharma Initiates FDA Approval Process for Liposome Injection Therapy for Chronic Pain

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innocan-pharma-initiates-fda-approval-process-for-liposome-injection-therapy-for-chronic-pain

With its submission of a Pre-IND Meeting Request Letter, Innocan initiates the regulatory process with the U.S. Food and Drug Administration (FDA) for the approval of its prolonged CBD release technology for human use

HERZLIYA, Israel and CALGARY, AB, April 22, 2024 /PRNewswire/ — Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTCQB: INNPF) (“Innocan” or the “Company”), is pleased to announce that is has reached a key milestone: the Company submitted its letter of application for a Pre-IND meeting, the first phase in the FDA approval process in the United States for Innocan’s Liposome-Cannabidiol (LPT-CBD) injectable treatment of chronic pain.

With the global market for pain therapeutics widely expected to exceed US$100 billion by 2032[1], LPT therapy which requires only one single monthly subcutaneous injection, is positioned as a highly attractive alternative to opioid-based approaches. Opioids have and continue to take a significant human toll in recent years, with more than three-quarters of drug overdose deaths in the United States involving opioids, according to the United States Center for Disease Control and Prevention[2].

Innocan’s therapy has shown consistent efficacy in multiple pre-clinical trials in recent years of it’s LPT-CBD injectable treatment through prolonged and controlled release of CBD in animals with chronic pain conditions. Innocan’s Pre-IND Meeting Request Letter to the FDA is a key milestone and important first step in seeking approval of its LPT-CBD therapy for use in humans. At the Pre-IND meeting, the objective will be to obtain guidance from the FDA on the preclinical and clinical development plan, enabling the initiation of an Investigational New Drug (IND) program in the United States.

Iris Bincovich, CEO of Innocan, commented: “We are extremely excited to embark on this next stage in the development of LPT-CBD injectables, this is a major Milestone for Innocan Pharma. We have invested significant effort and many thousands of person-hours in its research and development, accumulating a wealth of preclinical data that will serve as the foundation for our participation in the FDA process. This is a key milestone for Innocan and marks our first step towards the FDA’s recognition of our technology. We see significant potential for our therapy, with an addressable market for pain management therapeutics expected to exceed US $100 billion by 2032, and we look forward to tapping that.

Dr. Joseph Pergolizzi, Innocan’s FDA Advisory Board Member, added:

“We have worked hard to catalogue the data collected as part of our animal LPT therapy testing program and prepare it for the FDA. We look forward to working under FDA guidance, with the goal of completing the review process as quickly and efficiently as possible. We believe that Innocan’s unique treatment method, if and when it should become FDA-approved has the potential of being a highly valuable non-opioid addition in the medical arsenal of the management of chronic pain.”

About Innocan

Innocan is a pharmaceutical tech company that operates under two main segments: Pharmaceuticals and Consumer Wellness. In the Pharmaceuticals segment, Innocan focuses on developing innovative drug delivery platform technologies based on advanced cannabinoids science, to treat various conditions to improve patients’ quality of life. This segment involves two drug delivery technologies: (i) LPT CBD- loaded liposome platform facilitating exact dosing and the prolonged and controlled release of CBD into the blood stream. The LPT delivery platform research is in the preclinical trial phase for: Pain Management. In the Consumer Wellness segment, Innocan develops and markets a wide portfolio of innovative and high-performance self-care products to promote a healthier lifestyle. Under this segment, Innocan has established a joint venture by the name of BI Sky Global Ltd. that focuses on advanced targeted online sales. https://innocanpharma.com/

For further information, please contact:

For Innocan Pharma Corporation:
Iris Bincovich, CEO

+1-516-210-4025

+972-54-3012842

+442037699377
[email protected]

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

Cautionary note regarding forward-looking information

Certain information set forth in this news release, including, without limitation, information regarding research and development, collaborations, the filing of potential applications with the FDA and other regulatory authorities, the potential achievement of future regulatory milestones, the potential for treatment of conditions and other therapeutic effects resulting from research activities and/or the Company’s products, requisite regulatory approvals and the timing for market entry, is forward-looking information within the meaning of applicable securities laws. By its nature, forward-looking information is subject to numerous risks and uncertainties, some of which are beyond Innocan’s control. The forward-looking information contained in this news release is based on certain key expectations and assumptions made by Innocan, including expectations and assumptions concerning the anticipated benefits of the products, satisfaction of regulatory requirements in various jurisdictions and satisfactory completion of requisite production and distribution arrangements.

Forward-looking information is subject to various risks and uncertainties which could cause actual results and experience to differ materially from the anticipated results or expectations expressed in this news release. The key risks and uncertainties include but are not limited to: general global and local (national) economic, market and business conditions; governmental and regulatory requirements and actions by governmental authorities; and relationships with suppliers, manufacturers, customers, business partners and competitors. There are also risks that are inherent in the nature of product distribution, including import / export matters and the failure to obtain any required regulatory and other approvals (or to do so in a timely manner) and availability in each market of product inputs and finished products. The anticipated timeline for entry to markets may change for a number of reasons, including the inability to secure necessary regulatory requirements, or the need for additional time to conclude and/or satisfy the manufacturing and distribution arrangements. As a result of the foregoing, readers should not place undue reliance on the forward-looking information contained in this news release concerning the timing of launch of product distribution. A comprehensive discussion of other risks that impact Innocan can also be found in Innocan’s public reports and filings which are available under Innocan’s profile at www.sedar.com.

Readers are cautioned that undue reliance should not be placed on forward-looking information as actual results may vary materially from the forward-looking information. Innocan does not undertake to update, correct or revise any forward looking information as a result of any new information, future events or otherwise, except as may be required by applicable law.

[1] https://www.gminsights.com/industry-analysis/pain-management-drugs-market

[2] https://www.cdc.gov/opioids/data/index.html

Logo – https://mma.prnewswire.com/media/2046271/3968398/Innocan_Pharma_Corporation_Logo.jpg

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Curaleaf

Curaleaf Completes Acquisition of Northern Green Canada

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Bolsters Company’s Advantage in Several Key Emerging Markets, including Australia, New Zealand, Germany, Poland and the United Kingdom

NEW YORK, April 22, 2024 /PRNewswire/ — Curaleaf Holdings, Inc. (TSX: CURA) (OTCQX: CURLF) (“Curaleaf” or the “Company”), a leading international provider of consumer cannabis products, announced today the closing of its acquisition of Northern Green Canada (“NGC”), a vertically integrated Canadian licensed cannabis producer focused primarily on expanding in the international market through its EU-GMP certification. The accretive acquisition amplifies the Company’s strategic advantage in established European markets including Germany, Poland and the United Kingdom and provides a foothold in the emerging markets of Australia and New Zealand.

Integrating NGC’s international operation will equip Curaleaf with a secure and consistent high quality, non-irradiated, indoor EU-GMP flower supply, essential to maintaining its leading positions in Germany, the United Kingdom and Poland.

“We are thrilled to welcome NGC formally to the Curaleaf family of global brands,” said Boris Jordan, Founder and Executive Chairman of Curaleaf. “This is an incredibly important deal for our international expansion strategy, as we’ll be able to bolster our supply of high quality EU-GMP certified flower immediately to key European markets as well as enter the fast-growing markets of Australia and New Zealand.”

The global cannabis market is projected to generate $55 billion in sales by 2027. Emerging markets beyond the United States and Canada, including Germany, Australia and New Zealand are expected to contribute $6.3 billion of the $55 billion projection.

Terms of the acquisition of NGC include an initial payment at closing of the Company’s Subordinate Voting Shares valued at approximately US $16 million, subject to a typical post-closing adjustment. An earnout may also be paid in 2025 based upon 2024 performance of NGC’s operations, up to 50% of which will be cash and the rest paid in additional Subordinate Voting Shares. The issuance of Subordinate Voting Shares in connection with the acquisition of NGC has been conditionally approved by the Toronto Stock Exchange, subject to fulfilling customary listing conditions.

About Curaleaf Holdings
Curaleaf Holdings, Inc. (TSX: CURA) (OTCQX: CURLF) (“Curaleaf”) is a leading international provider of consumer products in cannabis with a mission to enhance lives by cultivating, sharing and celebrating the power of the plant. As a high-growth cannabis company known for quality, expertise and reliability, the Company and its brands, including Curaleaf, Select, Grassroots, JAMS, Find and Zero Proof provide industry-leading service, product selection and accessibility across the medical and adult use markets. Curaleaf International is the largest vertically integrated cannabis company in Europe with a unique supply and distribution network throughout the European market, bringing together pioneering science and research with cutting-edge cultivation, extraction and production. Curaleaf is listed on the Toronto Stock Exchange under the symbol CURA and trades on the OTCQX market under the symbol CURLF. For more information, please visit https://ir.curaleaf.com.

Forward Looking Statements
This media advisory contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward–looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans”, “expects” or, “proposed”, “is expected”, “intends”, “anticipates”, or “believes”, or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. More particularly and without limitation, this news release contains forward-looking statements and information concerning the expected benefits of the acquisition of NGC, and the Company’s planned expansion on internal markets, the Company’s anticipated strategic advantages in European markets and emerging markets, the integration of NGC’s internal operations, the anticipated global cannabis market, and the listing of shares issuable in connection with the acquisition on the Toronto Stock Exchange. Such forward-looking statements and information reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company with respect to the matters described in this new release, including the Company’s ability to successfully realize the expected benefits of the acquisition, and the Company’s ability to fulfil the listing conditions imposed by the Toronto Stock Exchange. Forward-looking statements involve risks and uncertainties, which are based on current expectations as of the date of this release and subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements, including the failure to realize the expected benefits of the acquisition, or the Company’s failure to fulfil the listing conditions imposed by the Toronto Stock Exchange. Additional information about these assumptions and risks and uncertainties is contained under “Risk Factors and Uncertainties” in the Company’s latest annual information form filed on March 6, 2024, which is available under the Company’s SEDAR profile at http://www.sedar.com, and in other filings that the Company has made and may make with applicable securities authorities in the future. Forward-looking statements contained herein are made only as to the date of this press release and we undertake no obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. The Toronto Stock Exchange has not reviewed, approved or disapproved the content of this news release.

INVESTOR CONTACT
Curaleaf Holdings, Inc.
Camilo Lyon, Chief Investment Officer
[email protected]

MEDIA CONTACT
Curaleaf Holdings, Inc.
Tracy Brady, SVP Corporate Communications
[email protected]

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