Gísli Herjólfsson, CEO and co-founder of Controlant, Ásthildur Otharsdóttir, Chairman of the Board of Controlant, and Guðmundur Árnason, CFO. Icelandic pharmaceutical supply chain company Controlant announced today that it had secured $40 million in new financing advised by Apax Credit, the credit-investing arm of Apax Partners LLP (“Apax”). The company has…
Icelandic pharmaceutical supply chain company Controlant announced today that it had secured $40 million in new financing advised by Apax Credit, the credit-investing arm of Apax Partners LLP (“Apax”).
The company has in recent years become a global leader in the digital transformation of pharma supply chains. Controlant’s goal is to deliver zero-waste supply chains through digitalization, automation, and transformation of the pharma supply chain.
CEO Gísli Herjólfsson said in a press release that the financing by Apax Partners, would help the company expand globally and capitalize on strong tailwinds in the supply chain technology sector.
“As pharma companies continue to innovate at pace and introduce breakthrough medicines and vaccines, it is incredibly important that modern supply chains match this pace and serve as enablers in ensuring medicines reach patients safely, and sustainably. That is our vision, and we are working tirelessly to create the next generation of zero-waste supply chains for our pharma customers”, said Herjolfsson.
Controlant has seen rapid growth in recent years, in part spurred by its role in the distribution of COVID-19 vaccines.
The company’s revenue doubled in 2022, rising from $68 million in 2021 to $133 million.
Press release from Alvotech REYKJAVIK, Iceland, Sept. 05, 2023 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO, the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that Faysal Kalmoua has been appointed Alvotech’s Chief Operating Officer and Hafrun Fridriksdottir is stepping down following resubmission of the…
Press release from Alvotech
REYKJAVIK, Iceland, Sept. 05, 2023 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO, the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that Faysal Kalmoua has been appointed Alvotech’s Chief Operating Officer and Hafrun Fridriksdottir is stepping down following resubmission of the Biologics License Application (BLA) for AVT02, Alvotech’s proposed high-concentration interchangeable biosimilar to Humira® (adalimumab).
Faysal has served as Head of Portfolio and Project Management since earlier this year and as a member of Alvotech’s Board of Directors since 2020. Previously, he held various senior management positions at Alvogen and Synthon. He has a master’s degree in Chemistry from Radboud University Nijmegen and an executive MBA from Insead.
“It is a great pleasure to welcome Faysal to the role of Chief Operating Officer, as he knows our operations and portfolio intimately,” said Robert Wessman, Chairman and CEO of Alvotech. “We were extremely grateful last year when Hafrún agreed to lend her extensive pharma industry experience to the Alvotech team, and her passion for operational excellence and quality will continue to be an inspiration for the entire team.”
“I am thrilled to take part in Alvotech’s remarkable journey,” said Faysal Kalmoua. “I look forward to continue working with the exceptionally talented and dedicated team assembled and contributing to the Company’s further development into a global leader in the biosimilars industry.”
About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial operating performance of Alvotech and may include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory submissions, review and interactions, including the resubmission of a BLA for AVT02 and a potential reinspection of Alvotech’s manufacturing facility, the satisfactory responses to the FDA’s inspection findings and resolution of other deficiencies conveyed following the inspection of Alvotech’s manufacturing site, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, including for AVT04, and market launches, the estimated size of the total addressable market of Alvotech’s pipeline products, the availability of financing options, including the size, timeline, securities, terms and conditions of, and use of proceeds from, a potential financing. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expect,” “intend,” “will,” “estimate,” “anticipate,” “believe,” “predict,” “potential,” “aim” or “continue,” or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the outcome of any legal proceedings that may be instituted against Alvotech or others following the business combination between Alvotech Holdings S.A., Oaktree Acquisition Corp. II and Alvotech; (2) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (3) the ability to maintain stock exchange listing standards; (4) changes in applicable laws or regulations; (5) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (6) Alvotech’s estimates of expenses and profitability; (7) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (8) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (9) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (10) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (11) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (12) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (13) Alvotech’s ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (14) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements; (15) Alvotech’s ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (16) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (17) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (18) the potential impact of the ongoing COVID-19 pandemic on the FDA’s review timelines, including its ability to complete timely inspection of manufacturing sites; (19) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, war in Ukraine and global geopolitical tension, and the ongoing and evolving COVID-19 pandemic on the Company’s business, financial position, strategy and anticipated milestones; and (20) other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication.
CONTACTS
Alvotech Investor Relations
Benedikt Stefansson
[email protected]
Originally published on 5 September.
Press release from Alvotech Product revenue for the first six months of 2023 increased to $22.7 million, compared to $3.9 million for the same period in 2022 Investors, including Teva Pharmaceuticals, subscribed to Alvotech’s subordinated convertible bonds for an aggregate amount of $140 million in July 2023 Expanded its existing commercialization partnerships with Teva Pharmaceuticals…
REYKJAVIK, Iceland, Aug. 30, 2023 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported unaudited financial results for the first six months of 2023 and provided a summary of recent corporate highlights.
“We continue to make significant investments in our manufacturing and quality processes and receiving US approval for AVT02, our interchangeable biosimilar candidate to high-concentration Humira®, remains of highest priority,” said Robert Wessman, Chairman and CEO of Alvotech. “Meanwhile, we are expanding our global commercialization partnerships, based on extensive due diligence, which we believe demonstrates our partners’ trust in Alvotech and the strength of our platform approach to biosimilars development and manufacture. We are pleased with the recently concluded financing round which we believe also showed the capital markets’ confidence in our progress.”
Recent Highlights
In May 2023, Alvotech and Advanz Pharma, expanded their partnership adding five biosimilar candidates which Advanz Pharma has agreed to commercialize in Europe. The agreement includes supply and commercialization of AVT05 (golimumab) and AVT16 (vedolizumab), candidate biosimilars to Simponi® and Entyvio®, respectively, and also includes three additional early-stage, undisclosed biosimilar candidates. Under the terms of the agreement, Advanz Pharma made upfront payments to Alvotech in the aggregate amount of $61 million and agreed to make additional payments for an aggregate amount of up to $287.5 million upon the achievement of certain development and commercial milestones. In conjunction with the corresponding termination of commercialization agreements for three of the biosimilar candidates previously licensed to STADA Arzneimittel (“STADA”), Alvotech repaid in early July $18.9 million to STADA.
In June 2023, Alvotech and Teva Pharmaceuticals Inc. (“Teva”), announced that the partners reached a settlement and license agreement with Johnson & Johnson concerning AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab). The settlement grants a license entry date for AVT04 in the US no later than February 21, 2025.
In June 2023, Alvotech received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for the Company’s second Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira® (adalimumab), which contained data to support approval as a biosimilar and additional information supporting a potential interchangeability designation. The CRL noted that certain deficiencies conveyed following the FDA’s recent reinspection of the Company’s Reykjavik facility must be satisfactorily resolved before the application may be approved.
In July 2023, Alvotech and Teva reached an agreement to expand their existing strategic partnership agreement, pertaining to exclusive commercialization rights in the US by Teva for two new biosimilar candidates developed by Alvotech, as well as line extensions of two current biosimilar candidates. The agreement includes milestone payments to Alvotech, the majority paid following product approvals and upon achieving significant sales milestones, as well as a share of profits from the commercialization of the biosimilars.
In July 2023, Alvotech announced the completion of a convertible private bond placement, in an overseas directed offering directed solely into Iceland to professional clients or eligible counterparties, for a total value of $100 million. Previously, Teva had also agreed to acquire convertible bonds from Alvotech for an additional $40 million, in a separate transaction.
Financial Results for First Six Months of 2023
Cash Position and Sources of Liquidity: As of June 30, 2023, the Company had cash and cash equivalents of $60.5 million, excluding $25.2 million of restricted cash. In addition, the Company had borrowings of $808.6 million, including $22.5 million of current portion of borrowings. Proceeds from the convertible bond placement, as mentioned above, were received subsequent to June 30, 2023.
Product Revenue: Product revenue was $22.7 million for the six months ended June 30, 2023, compared to $3.9 million for the same six months of 2022. Revenue for the six months ended June 30, 2023 consisted of product revenue from sales of AVT02 in select European countries and Canada.
License and Other Revenue: License and other revenue decreased by $38.6 million, which is primarily attributable to the recognition of $34.7 million research and development milestone during the same period in the prior year, due to the completion of the AVT04 main clinical program. The remainder of the decrease is principally due to the net impact of the licensing arrangements changed during the period.
Cost of product revenue: Cost of product revenue was $67.9 million for the six months ended June 30, 2023, as a result of the successful launch of AVT02 in select European countries and Canada.
Research and Development (R&D) Expenses: R&D expenses were $99.6 million for the six months ended June 30, 2023, compared to $86.9 million for the same six months of 2022. The increase was primarily driven by a one-time charge of $18.5 million relating to the termination of the co-development agreement with Biosana for AVT23, and a $24.6 million increase in direct program expenses mainly from three biosimilar candidates, AVT03, AVT05 and AVT06, that entered clinical development in 2022. These increases were partially offset by a decrease of $32.3 million primarily related to programs that have completed clinical phase, and non-recurrence of pre-commercial manufacturing activities.
General and Administrative (G&A) Expenses: G&A expenses were $41.9 million for the six months ended June 30, 2023, compared to $139.1 million for the same six months of 2022. The decrease in G&A expenses was primarily attributable to a $83.4 million non-cash share listing expense, a $21.0 million of transaction costs recognized as a result of the Business Combination, and a $10.6 million of non-recurring IP-related legal expenses incurred during the six months ended June 30, 2022. This decrease was partially offset by a $7.7 million net increase in other general administrative expenses due to incremental costs from operating as a public company. Lastly, the Company recognized $7.5 million of G&A expenses for share-based payments, resulting from the granting of Restricted Share Units (RSUs) during the six months ended June 30, 2023.
Loss for the Period: Loss for the period was $86.9 million, or ($0.39) per share on a basic and diluted basis, for the six months ended June 30, 2023, as compared to a loss of $184.5 million, or ($1.02) per share on a basic and diluted basis, for the same six months of 2022.
Business Update Conference Call
Alvotech will conduct a business update conference call and live webcast on Thursday, August 31 at 8:00 am ET (12:00 noon GMT).
A live webcast of the call will be available on Alvotech’s website in the Investors Section of the Company’s website (https://investors.alvotech.com) under “News and Events – Events and Presentations”, where you will also be able to find a replay of the webcast, following the call for 90 days.
About AVT02 (adalimumab)
AVT02 is a monoclonal antibody and that has been approved as a biosimilar to Humira® (adalimumab) in several countries globally, including the 27 member states of the European Union, Norway, Lichtenstein, Iceland, the UK, Switzerland, Canada, Australia, Egypt and Saudi Arabia. It is currently marketed in multiple European countries and in Canada. Dossiers are also under review in multiple countries globally.
About AVT03 (denosumab)
AVT03 is a human monoclonal antibody and a biosimilar candidate to Prolia® and Xgeva® (denosumab). Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, preventing the RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction [1]. AVT03 is an investigational product and has not received regulatory approval in any country. Biosimiliarity has not been established by regulatory authorities and is not claimed.
About AVT04 (ustekinumab)
AVT04 is a monoclonal antibody and a biosimilar candidate to Stelara® (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses [2]. AVT04 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
About AVT05 (golimumab)
AVT05 is a biosimilar candidate for Simponi® and Simponi Aria® (golimumab). Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha. Elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis [3]. AVT05 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
About AVT06 (aflibercept)
AVT06 is a recombinant fusion protein and a biosimilar candidate to Eylea® (aflibercept), which binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [4]. AVT06 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
About AVT16 (vedolizumab)
AVT16 is a biosimilar candidate for Entyvio® (vedolizumab). Vedolizumab is an integrin receptor antagonist and is used for the treatment of moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease [5]. AVT16 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
[1] https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Prolia/prolia_pi.pdf
[2] https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf
[3] https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SIMPONI-pi.pdf
[4] https://www.regeneron.com/downloads/eylea_fpi.pdf
[5] https://content.takeda.com/?contenttype=PI&product=ENTY&language=ENG&country=USA&documentnumber=1
Use of trademarks
Humira is a registered trademark of AbbVie Inc., Prolia and Xgeva are registered trademarks of Amgen Inc. Stelara, Simponi and Simponi Aria are registered trademarks of Johnson & Johnson Inc. Elyea is a registered trademark of Regeneron Pharmaceuticals Inc. Entyvio is a trademark of Millenium Pharmaceuticals Inc.
About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline contains eight biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial operating performance of Alvotech and may include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory submissions, review and interactions, including the resubmission of a BLA for AVT02 and a potential reinspection of Alvotech’s manufacturing facility, the satisfactory responses to the FDA’s inspection findings and resolution of other deficiencies conveyed following the inspection of Alvotech’s manufacturing site, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, including for AVT04, and market launches, the estimated size of the total addressable market of Alvotech’s pipeline products, the availability of financing options, including the size, timeline, securities, terms and conditions of, and use of proceeds from, a potential financing. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential”, “aim” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the outcome of any legal proceedings that may be instituted against Alvotech or others following the business combination between Alvotech Holdings S.A., Oaktree Acquisition Corp. II and Alvotech; (2) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (3) the ability to maintain stock exchange listing standards; (4) changes in applicable laws or regulations; (5) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (6) Alvotech’s estimates of expenses and profitability; (7) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (8) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (9) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (10) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (11) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (12) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (13) Alvotech’s ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (14) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements; (15) Alvotech’s ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (16) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (17) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (18) the potential impact of the ongoing COVID-19 pandemic on the FDA’s review timelines, including its ability to complete timely inspection of manufacturing sites; (19) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, war in Ukraine and global geopolitical tension, and the ongoing and evolving COVID-19 pandemic on the Company’s business, financial position, strategy and anticipated milestones; and (20) other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication.
CONTACTS
Alvotech Investor Relations and Global Communication
Benedikt Stefansson
[email protected]
Unaudited Condensed Consolidated Interim Statements of Profit or Loss and Other Comprehensive Income or Loss
| Six months ended 30 June 2023 |
Six months ended 30 June 2022 |
||
| USD in thousands, except for per share amounts | |||
| Product revenue | 22 715 | 3 932 | |
| License and other revenue | (2 460) | 36 186 | |
| Other income | 45 | 142 | |
| Cost of product revenue | (67 909) | (17 813) | |
| Research and development expenses | (99 582) | (86 884) | |
| General and administrative expenses | (41 910) | (139 147) | |
| Operating loss | (189 101) | (203 584) | |
| Share of net loss of joint venture | (2 706) | (1 266) | |
| Finance income | 122 480 | 50 968 | |
| Finance costs | (64 300) | (52 406) | |
| Exchange rate difference | (3 081) | 4 744 | |
| Non-operating profit | 52 393 | 2 040 | |
| Loss before taxes | (136 708) | (201 544) | |
| Income tax benefit | 49 854 | 17 073 | |
| Loss for the period | (86 854) | (184 471) | |
| Other comprehensive loss | |||
| Item that will be reclassified to profit or loss in subsequent periods: | |||
| Exchange rate differences on translation of foreign operations | (1 523) | (4 243) | |
| Total comprehensive loss | (88 377) | (188 714) | |
| Loss per share | |||
| Basic and diluted loss for the period per share | (0,39) | (1,02) |
Unaudited Condensed Consolidated Interim Statements of Financial Position
| USD in thousands | 30 June 2023 |
31 December 2022 |
|||||
| Non-current assets | |||||||
| Property, plant and equipment | 231,989 | 220,594 | |||||
| Right-of-use assets | 101,402 | 47,501 | |||||
| Goodwill | 11,886 | 11,643 | |||||
| Other intangible assets | 14,007 | 25,652 | |||||
| Contract assets | 8,312 | 3,286 | |||||
| Investment in joint venture | 43,613 | 48,568 | |||||
| Other long-term assets | 2,053 | 5,780 | |||||
| Restricted cash | 25,187 | 25,187 | |||||
| Deferred tax assets | 260,301 | 209,496 | |||||
| Total non-current assets | 698,750 | 597,707 | |||||
| Current assets | |||||||
| Inventories | 79,366 | 71,470 | |||||
| Trade receivables | 16,307 | 32,972 | |||||
| Contract assets | 19,129 | 25,370 | |||||
| Other current assets | 34,988 | 32,949 | |||||
| Receivables from related parties | 1,656 | 1,548 | |||||
| Cash and cash equivalents | 60,466 | 66,427 | |||||
| Total current assets | 211,912 | 230,736 | |||||
| Total assets | 910,662 | 828,443 | |||||
Unaudited Condensed Consolidated Interim Statements of Financial Position
| USD in thousands | 30 June 2023 |
31 December 2022 |
|||||
| Equity | |||||||
| Share capital | 2,271 | 2,126 | |||||
| Share premium | 1,224,814 | 1,058,432 | |||||
| Other reserves | 38,308 | 30,582 | |||||
| Translation reserve | (2,965) | (1,442) | |||||
| Accumulated deficit | (1,740,968) | (1,654,114) | |||||
| Total equity | (478,540) | (564,416) | |||||
| Non-current liabilities | |||||||
| Borrowings | 786,175 | 744,654 | |||||
| Derivative financial liabilities | 229,046 | 380,232 | |||||
| Other long-term liability to related party | 7,440 | 7,440 | |||||
| Lease liabilities | 87,416 | 35,369 | |||||
| Long-term incentive plan | – | 544 | |||||
| Contract liabilities | 57,387 | 57,017 | |||||
| Deferred tax liability | 45 | 309 | |||||
| Total non-current liabilities | 1,167,509 | 1,225,565 | |||||
| Current liabilities | |||||||
| Trade and other payables | 43,931 | 49,188 | |||||
| Lease liabilities | 7,983 | 5,163 | |||||
| Current maturities of borrowings | 22,463 | 19,916 | |||||
| Liabilities to related parties | 1,137 | 1,131 | |||||
| Contract liabilities | 58,978 | 36,915 | |||||
| Taxes payable | 1,520 | 934 | |||||
| Other current liabilities | 85,681 | 54,047 | |||||
| Total current liabilities | 221,693 | 167,294 | |||||
| Total liabilities | 1,389,202 | 1,392,859 | |||||
| Total equity and liabilities | 910,662 | 828,443 | |||||
Unaudited Condensed Consolidated Interim Statements of Cash Flows
| Six months ended 30 June 2023 |
Six months ended 30 June 2022 |
||
| USD in thousands | |||
| Cash flows from operating activities | |||
| Loss for the period | (86 854) | (184 471) | |
| Adjustments for non-cash items: | |||
| Gain on extinguishment of SARs liability | – | (4 803) | |
| Share listing expense | – | 83 411 | |
| Share-based payment expense | 11 911 | 5 555 | |
| Depreciation and amortization | 10 934 | 9 977 | |
| Loss on disposal of property, plant and equipment | 323 | – | |
| Change in allowance for receivables | 18 500 | – | |
| Share of net loss of joint venture | 2 706 | 1 266 | |
| Finance income | (122 480) | (50 968) | |
| Finance costs | 64 300 | 52 406 | |
| Exchange rate difference | 3 081 | (4 744) | |
| Income tax benefit | (49 854) | (17 073) | |
| Operating cash flow before movement in working capital | (147 433) | (109 444) | |
| (Increase) in inventories | (7 896) | (15 606) | |
| Decrease in trade receivables | 16 665 | 24 092 | |
| Increase / (decrease) in liabilities with related parties | (102) | 2 825 | |
| (Increase) / decrease in contract assets | 1 215 | (20 398) | |
| (Increase) / decrease in other assets | 3 711 | (11 384) | |
| Increase / (decrease) in trade and other payables | (6 182) | 17 408 | |
| Increase / (decrease) in contract liabilities | 37 679 | (12 226) | |
| Increase / (decrease) in other liabilities | 4 395 | (6 963) | |
| Cash used in operations | (97 948) | (131 696) | |
| Interest received | 25 | 8 | |
| Interest paid | (29 427) | (9 220) | |
| Income tax paid | (652) | (248) | |
| Net cash used in operating activities | (128 002) | (141 156) | |
| Cash flows from investing activities | |||
| Acquisition of property, plant and equipment | (22 594) | (17 660) | |
| Disposal of property, plant and equipment | 133 | 379 | |
| Acquisition of intangible assets | (2 764) | (9 309) | |
| Restricted cash in connection with the amended bond agreement | – | (14 914) | |
| Net cash used in investing activities | (25 225) | (41 504) | |
| Cash flows from financing activities | |||
| Repayments of borrowings | (84 507) | (1 414) | |
| Repayments of principal portion of lease liabilities | (3 700) | (5 033) | |
| Proceeds from new borrowings | 93 561 | 10 786 | |
| Gross proceeds from the private placement equity offering fee | 136 877 | – | |
| Gross private placement equity offering fee paid | (4 141) | – | |
| Proceeds from warrants | 6 365 | – | |
| Gross proceeds from the PIPE Financing | – | 174 930 | |
| Gross PIPE Financing fees paid | – | (5 561) | |
| Proceeds from the Capital Reorganization | – | 9 827 | |
| Proceeds from loans from related parties | – | 110 000 | |
| Net cash generated from financing activities | 144 455 | 293 535 | |
| (Decrease) increase in cash and cash equivalents | (8 772) | 110 875 | |
| Cash and cash equivalents at the beginning of the period | 66 427 | 17 556 | |
| Effect of movements in exchange rates on cash held | 2 811 | 7 | |
| Cash and cash equivalents at the end of the period | 60 466 | 128 438 |
Originally published on 30 August.
Press release from Herantis Pharma Plc Herantis Pharma Plc, Company Release, August 24, 2023, at 08:00 EEST “During 1H 2023, the Phase 1a clinical study with subcutaneous dosing of HER-096 has progressed according to plan. We are very pleased that we now have moved into part 2 of the study with dosing of elderly healthy…
Press release from Herantis Pharma Plc
Herantis Pharma Plc, Company Release, August 24, 2023, at 08:00 EEST
“During 1H 2023, the Phase 1a clinical study with subcutaneous dosing of HER-096 has progressed according to plan. We are very pleased that we now have moved into part 2 of the study with dosing of elderly healthy volunteers to assess the blood-brain barrier penetration of HER-096, safety and tolerability. Topline data of the clinical study is expected in Q4 2023, which is an important milestone on our way towards developing a disease-modifying therapy for slowing or stopping the progression of Parkinson’s disease. In addition, we have been able to welcome European Innovation Council (EIC) Fund as a new investor in potential future capital raises.” said Antti Vuolanto, CEO of Herantis.
Herantis Pharma Plc (“Herantis”), a clinical-stage biotechnology company developing disease modifying therapies for Parkinson’s disease, released today the company’s 1H 2023 report. The full report is attached to this release and is also available at the company’s website: www.herantis.com.
A webinar (in English) will be held today at 10:00 EEST / 9:00 CEST.
Registration details: Herantis’ 1H 2023 Report Webinar
Please join the webinar a few minutes in advance. You need a Zoom account to register for this event.
Business highlights January – June 2023:
• Herantis announced approval of Clinical Trial Application (CTA) for a Phase 1a study for HER-096 in February.
• In April, Herantis signed the European Innovation Council (EIC) Accelerator grant agreement. Herantis will receive €2.5 million grant funding from EIC Accelerator program and is eligible for up to €15 million in direct equity investments from the EIC Fund, the investment arm of the EIC, subject to certain customary term conditions.
• First healthy volunteer was dosed in the Phase 1a clinical study for the Parkinson’s disease drug candidate, HER-096, on April 19. The Phase 1a clinical study will assess safety, tolerability, and blood-brain barrier penetration of subcutaneously administered HER-096.
Events after the reporting period:
• July 4, 2023, Herantis announced the start of recruitment of healthy volunteers for part 2 of the ongoing Phase 1a clinical study of HER-096.
• August 22, 2023, Herantis announced that dosing of the healthy volunteers in part 2 of the HER-096 Phase 1a clinical study has been started.
Key figures:
| EUR thousands | January – June | Full Year | ||
| 2023 | 2022 | 2022 | ||
| Other operating income | 280 | 0 | 135 | |
| Payroll and related expenses | 852 | 1 563 | 2 649 | |
| Depreciation and amortization | 0 | 80 | 160 | |
| Other operating expenses | 1 836 | 2 726 | 5 319 | |
| Profit for the period | – 1 795 | – 5 665 | – 9 324 | |
| Cash flow from operating activities | – 1 717 | – 5 517 | – 8 944 | |
| January – June | Full Year | |||
| 2023 | 2022 | 2022 | ||
| Equity ratio % | – 36.1 | 36.4 | – 0.9 | |
| Basic and diluted loss per share EUR | – 0.11 | – 0.47 | – 0.64 | |
| Number of shares at end of period | 16 912 394 | 16 909 994 | 16 912 394 | |
| Average number of shares | 16 912 394 | 12 078 568 | 14 654 149 | |
| EUR thousands | 30-Jun-23 | 30-Jun-22 | 31-Dec-22 | |
| Cash and securities1) | 4 909 | 9 586 | 5 991 | |
| Equity | – 1 855 | 3 599 | – 60 | |
| Balance sheet total | 5 141 | 9 894 | 6 232 | |
| 1) June 2023: Cash = 3 926′ and Securities = 983′ June 2022: Cash = 8 641′ and Securities = 945′ Dec 2022: Cash = 5 036′ and Securities = 955′ | ||||
Summary and outlook for 2023
The first healthy volunteer in Herantis’ Phase 1a clinical study for HER-096 was dosed in April 2023. The Phase 1a study, which includes assessment of safety, tolerability, and blood-brain barrier penetration in healthy volunteers, is carried out in Finland. Topline data is expected in Q4 2023. Successful completion of the study would represent a significant milestone for Herantis.
2023 milestones for HER-096 are:
• Phase 1a clinical trial application (CTA) regulatory approval (targeted 1H/2023)
– achieved February 20, 2023
• First HER-096 human dose in Phase 1a study (targeted 1H/2023)
– achieved April 19, 2023
• Phase 1a read-out: Evidence of HER-096 safety and blood-brain barrier penetration in humans (targeted in Q4/2023)
For more information, please contact:
Julie Silber/Gabriela Urquilla
Tel: +46 (0)7 93 486 277/+46 (0)72-396 72 19
Email: [email protected]
Certified Advisor: UB Securities Ltd, Finland: +358 9 25 380 225
Company website: www.herantis.com
About Herantis Pharma Plc
Herantis Pharma Plc is a clinical-stage biotechnology company developing disease modifying therapies for Parkinson’s disease. Herantis’ lead product HER-096, is an advanced small synthetic chemical peptidomimetic molecule developed based on the active site of the parent CDNF protein. It combines the compelling mechanism of action of the CDNF protein with the convenience of subcutaneous administration. The ongoing Phase 1a clinical study will assess safety, tolerability, and blood-brain barrier penetration of subcutaneously administered HER-096. Top-line data is expected by Q4-2023.
The shares of Herantis are listed on the Nasdaq First North Growth Market Finland.
For more information, please visit https://www.herantis.com
Forward-looking statements
This company release includes forward-looking statements which are not historical facts but statements regarding future expectations instead. These forward-looking statements include without limitation, those regarding Herantis’ future financial position and results of operations, the Company’s strategy, objectives, future developments in the markets in which the Company participates or is seeking to participate or anticipated regulatory changes in the markets in which the Company operates or intends to operate. In some cases, forward-looking statements can be identified by terminology such as “aim,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “guidance,” “intend,” “may,” “plan,” “potential,” “predict,” “projected,” “should” or “will” or the negative of such terms or other comparable terminology.
By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors because they relate to events and depend on circumstances that may or may not occur in the future. Forward-looking statements are not guarantees of future performance and are based on numerous assumptions. The Company’s actual results of operations, including the Company’s financial condition and liquidity and the development of the industry in which the Company operates, may differ materially from (and be more negative than) those made in, or suggested by, the forward-looking statements contained in this company release. Factors, including risks and uncertainties that could cause these differences include, but are not limited to risks associated with implementation of Herantis’ strategy, risks and uncertainties associated with the development and/or approval of Herantis’ drug candidates, ongoing and future clinical trials and expected trial results, the ability to commercialize drug candidates, technology changes and new products in Herantis’ potential market and industry, Herantis’ freedom to operate in respect of the products it develops (which freedom may be limited, e.g., by competitors’ patents), the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions, and legislative, regulatory and political factors.
In addition, even if Herantis’ historical results of operations, including the Company’s financial condition and liquidity and the development of the industry in which the Company operates, are consistent with the forward-looking statements contained in this company release, those results or developments may not be indicative of results or developments in subsequent periods.
Originally published on 24 August.
Article from Controlant The pharmaceutical industry is changing how it approaches automation. While artificial intelligence is the tech buzzword du jour, a focus on intelligent automation has greater, more immediate potential to add value in the supply chain. Defining artificial intelligence vs. intelligent automation Artificial intelligence (AI) is the foundational component of intelligent technology; it…
The pharmaceutical industry is changing how it approaches automation. While artificial intelligence is the tech buzzword du jour, a focus on intelligent automation has greater, more immediate potential to add value in the supply chain.
Artificial intelligence (AI) is the foundational component of intelligent technology; it encompasses many critical capabilities, from automating the supply chain to enabling machine learning and robots to perform tasks. However, everything AI “learns” is from the data sets it is exposed to. AI is widely used in pharma, from predicting behavior to reading sensors faster.
Intelligent automation (IA) can be thought of as a pillar of AI. Organizations like hospital networks or warehouses typically use it sparingly to build work processes or use learning abilities to anticipate customer needs. While IA is programmed with built-in logic, it also learns as it is implemented. The more intelligent automation is used, the better the results. Implementing IA can be transformative for pharma companies in:
Providing real-time visibility across the supply chain
Reducing costs
Increasing efficiency and accuracy
Removing bottlenecks
Improving compliance
Streamlining quality control
Pharma executives are increasingly interested in the potential benefits of IA. PwC found in a recent survey that 79% of pharma executives believe that intelligent automation will significantly impact their industry in the next five years.
A fireside chat at the recent LogiPharma EU 2023 expo between Pfizer’s Head of Temperature Controlled Logistics Projects, Tomas Fant, and Controlant’s CCO, Martin Thaysen, covered a host of topics, including AI vs. IA in pharma.
Intelligent automation is an exciting proposition for pharma supply chain leaders, and Thaysen asked if the industry is on the verge of a massive shift in the way things are done regarding automation.
“We have to walk before we run,” said Fant. “We still have many processes that are just paper processes that have been scanned into a digital form, but they’re not actually full databases that are interconnected or being used in a smart way, and we do see that pharma still has silos with the data and different elements of it.”
Fant added that there has to be a lot of groundwork completed, which will bring a lot of value. “So, not artificial intelligence but, before that, intelligent automation,” he said. “We’re now at the maturity where we can automate so many steps, and we can do that in parallel while keeping an open mind for AI and more advanced technologies.”
Intelligent automation can be a game-changer when it comes to supply chain management. IA solutions can be used to manage the pharma supply chain, from raw materials to finished products. It can also provide new ways to optimize inventory levels, manage suppliers, track and trace products, and streamline transportation management. By using these technologies, manufacturers can improve productivity and efficiency, reduce costs, and improve patient outcomes.
Finding the right platform is critical as pharma companies seek solutions to work toward more automated processes. Intelligent automation will play an important role in streamlining operations.
Find out how Controlant’s Aurora platform can provide real-time visibility and transform your supply chain.
Press release from Novo Nordisk Financial report for the period 1 January 2023 to 30 June 2023, 10 August 2023 Operating profit increased by 30% in Danish kroner and by 32% at constant exchange rates (CER) to DKK 48.9 billion. Sales in North America Operations increased by 45% in Danish kroner (44% at CER). Sales…
Press release from Novo Nordisk
Financial report for the period 1 January 2023 to 30 June 2023, 10 August 2023
| PROFIT AND LOSS | H1 2023 | H1 2022 | Growth as reported |
Growth at CER* |
| DKK million | ||||
| Net sales | 107,667 | 83,296 | 29% | 30% |
| Operating profit | 48,895 | 37,538 | 30% | 32% |
| Net profit | 39,242 | 27,528 | 43% | N/A |
| Diluted earnings per share (in DKK) | 17.41 | 12.08 | 44% | N/A |
| * CER: Constant exchange rates (average 2022). |
Lars Fruergaard Jørgensen, president and CEO: “We are very pleased with the sales growth in the first half of 2023. The growth is driven by increasing demand for our GLP-1-based diabetes and obesity treatments, and we are serving more patients than ever before. The performance in the first six months has enabled us to raise the outlook for the full year. Within R&D, we are very excited about the results from the SELECT trial. Obesity is a serious chronic disease associated with many comorbidities and the results from SELECT demonstrate that comorbidities associated with the condition can be significantly reduced by treating people with semaglutide.
On 10 August 2023 at 13.00 CEST, corresponding to 07.00 am EDT, an earnings call will be held. Investors will be able to listen in via a link on novonordisk.com, which can be found under ‘Investors’.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 59,000 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn and YouTube.
Contacts for further information |
|
| Media: | |
Ambre James-Brown+45 3079 9289 |
Natalia Salomao Abrahao (US)+1 848 304 1027 |
| Investors: | |
Daniel Muusmann Bohsen+45 3075 2175 |
David Heiberg Landsted+45 3077 6915 |
Jacob Martin Wiborg Rode+45 3075 5956 |
Mark Joseph Root (US)+1 848 213 3219 |
Sina Meyer+45 3075 6656 |
Frederik Taylor Pitter+45 3075 8259 |
Company announcement No 52 / 2023
Originally published on 10 August.
Press release from Novo Nordisk Bagsværd, Denmark and Montreal, Canada, 10 August 2023 – Novo Nordisk A/S and Inversago Pharma today announced that Novo Nordisk has agreed to acquire Inversago for up to 1.075 billion US dollars in cash if certain development and commercial milestones are achieved. Inversago Pharma is a private, Montreal-based developer of CB1 receptor-based therapies for…
Press release from Novo Nordisk
Bagsværd, Denmark and Montreal, Canada, 10 August 2023 – Novo Nordisk A/S and Inversago Pharma today announced that Novo Nordisk has agreed to acquire Inversago for up to 1.075 billion US dollars in cash if certain development and commercial milestones are achieved. Inversago Pharma is a private, Montreal-based developer of CB1 receptor-based therapies for the potential treatment of obesity, diabetes and complications associated with metabolic disorders.
The acquisition of Inversago includes the company’s lead development asset INV-202, an oral CB1 inverse agonist. INV-202 is designed to preferentially block the receptor protein CB1 – which plays an important role in metabolism and appetite regulation – in peripheral tissues such as adipose tissues, the gastro-intestinal tract, the kidneys, liver, pancreas, muscles and lungs.
INV-202 demonstrated weight loss potential in a phase 1b trial and is currently in a phase 2 trial for diabetic kidney disease (DKD). Additional pipeline assets are also being developed for metabolic and fibrotic disorders. Novo Nordisk intends to investigate the potential of INV-202 for obesity and obesity-related complications.
“The acquisition of Inversago Pharma will further strengthen our clinical development pipeline in obesity and related disorders,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “This promising class of medicine pioneered by the Inversago team could lead to life-changing new treatment options for those living with a serious chronic disease and, in particular, may offer alternative or complementary solutions for people living with obesity.”
CB1 plays an important role in appetite regulation and other cardiometabolic pathways. The mechanistic and preclinical therapeutic effects of peripheral CB1 receptor blocking are well-studied across a range of cardiometabolic and fibrotic diseases, supporting the potential treatment of many people with current unmet needs.
“We are delighted to join forces with a global leader in the obesity and metabolic disorder space,” said François Ravenelle, chief executive officer of Inversago Pharma. “We believe this combination will help unlock the full medical potential of our CB1 blockers and may one day expand treatment options for people living with metabolic syndrome, obesity and related complications. Novo Nordisk has world-class research facilities, significant global reach and a rich culture of collaboration seeking to bring our therapeutic treatments to market.”
Inversago employs 22 people, who will continue to focus on the successful completion of the ongoing and planned trials, while working closely with Novo Nordisk to drive Inversago’s technology forward in future clinical trials. The closing of the acquisition is subject to receipt of applicable regulatory approvals and other customary conditions and is expected to happen before the end of 2023.
About Inversago Pharma
Based in Montreal Canada, Inversago Pharma, is a privately owned, clinical stage company, and leader in the development of next generation CB1 receptor blocker therapies designed to help patients with complications associated with metabolic and fibrotic diseases. Inversago aims to provide new treatment options that improve the lives of patients affected by a wide range of cardiometabolic disorders. For more information, visit inversago.com.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 59,000 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.
Contacts for further information
| Novo Nordisk Media: | |
Kate Hanna(CA) Ambre Brown Morley |
Natalia Salomao Abrahao (US)+1 848 304 1027 |
| Novo Nordisk investors: | |
Daniel Muusmann Bohsen+45 3075 2175 |
Jacob Martin Wiborg Rode+45 3075 5956 |
David Heiberg Landsted+45 3077 6915 |
Mark Joseph Root (US)+1 848 213 3219 |
Sina Meyer+45 3075 6656 [email protected] |
Frederik Taylor Pitter+45 3075 8259 [email protected] |
| Inversago Media: | |
Philippe Périou |
|
| Inversago Investors: | |
Glenn S. Vraniak1-513-476-2669 |
Originally published on 10 August.
Press release from Oulu Health PARAS BIOPHARMA (BIOLOGICS CDMO) FINLAND, a leading biopharmaceutical technology development company in the Nordic region, maximises recombinant protein expression in Microbial Systems in its fully-equipped biologics production facility in Finland. The company is pleased to disclose its advancement of up to 12 g or more / L expression of recombinant…
Press release from Oulu Health
PARAS BIOPHARMA (BIOLOGICS CDMO) FINLAND, a leading biopharmaceutical technology development company in the Nordic region, maximises recombinant protein expression in Microbial Systems in its fully-equipped biologics production facility in Finland.
The company is pleased to disclose its advancement of up to 12 g or more / L expression of recombinant protein – fully folded / biologically active in fermentation broth in scale-up studies which can be produced on a commercial scale. This advanced Biomultifold system will be in place and available for future projects to facilitate and bring down costs. Previously, Paras Biopharma achieved 5-8 g / L in expression levels of a specific therapeutic protein.
Advanced Biomultifold Technology will further facilitate higher expression & production levels for Biologics in critical care / rare disease biologics (manufacturing), thus help to bring down the scale-up biologics production costs / unit. The company is pleased to bring these developments in ongoing & upcoming projects on biologics and also to share this knowledge for client biologics CDMO work, as needed.
Full-service expertise for Scale-up Biologics Manufacturing at Paras Biopharma (Biologics CDMO) Finland, using its unique Biomultifold® Technology, can be found at https://www.parasbiopharma.com/technology/biomultifold-technology.php.
About Paras Biopharmaceuticals Finland Oy
Paras Biopharmaceuticals’ major activities are “Biologics CDMO” Services and Biologics & Biosimilar Technology Development & Scale-up, in addition to offering co-development & licensing partnership opportunities of high-value Biologics. Paras Biopharma’s unique technologies (Biomultifold®, Noblecleav® and Cytofold StructQuant®) facilitate achieving high productivity & quality of biologics.
Paras Biopharmaceuticals has established its expertise in critical areas providing biologics CDMO, development of complex proteins from early stage to large scale, and the development of enzymes for medicinal and bioprocess purposes. Paras Biopharmaceuticals has a fully equipped biologics production facility in Finland for the production of recombinant therapeutic products in microbial systems. The state-of-art biologics production plant includes a total floor area of 25,000 ft² and a classified cleanroom of 4,300 ft². Other features include media and buffer preparation, live area (fermentation and harvest & extraction), purification suite (incl. +4°C cold room), final filtration and freeze-drying.
Paras Biopharmaceuticals has a Biologics CDMO Services pipeline https://www.parasbiopharma.com/microbial-biologics-cdmo.php and Biosimilars in Onco-Immunology, Urology, Osteoporosis and Rheumatoid Arthritis.
For more information, please see the company pipeline: http://www.parasbiopharma.com/biosimilars/biosimilars.php
Contact person
Media Relations & Information
Dr. Mark Jackson
Originally published on 31 July.
Press release from Biovan Biovian Oy, a leading contract development and manufacturing organization (CDMO) specializing in biopharmaceuticals, announces a major investment of over €50 million to expand its manufacturing facility in Turku, Finland. The new facility will cover an area of 6,400 sqm (69,000 sqft), and house cutting-edge equipment and advanced technologies to support the…
Press release from Biovan
Biovian Oy, a leading contract development and manufacturing organization (CDMO) specializing in biopharmaceuticals, announces a major investment of over €50 million to expand its manufacturing facility in Turku, Finland.
The new facility will cover an area of 6,400 sqm (69,000 sqft), and house cutting-edge equipment and advanced technologies to support the development, manufacturing, and testing of ATMP (Advanced Therapy Medicinal Products), such as adenoviral and AAV (adeno-associated viral) therapies. It will also feature dedicated Class A to D cleanroom areas for bulk drug substances as well as final drug product manufacture. The expanded facility will adhere to current good manufacturing practices (cGMP) and fulfilling both EU and US GMP requirements ensuring the delivery of safe, reliable, and compliant biopharmaceutical products.
The investment is a strategic move aimed at meeting the growing demand for high-quality biopharmaceutical manufacturing services and further solidifying Biovian’s position as a trusted partner in the biopharmaceutical industry. Together with Biovian’s existing manufacturing facility, the new premises will increase the total area up to 11 500 m2. The additional space complements Biovian’s existing manufacturing facilities in the area and will enable Biovian to undertake larger-scale viral vector as well as microbial protein projects and concurrent manufacturing campaigns by increasing overall production capacity and flexibility.
The expansion project is expected to be completed in December 2024, with the new facility fully operational by 2025. The investment is expected to create 100 job opportunities in the region, adding to Biovian’s already approximately 200 strong team.
Mr. Antti Nieminen, CEO of Biovian, expressed his enthusiasm about the new manufacturing facility: “The new manufacturing facility will not only strengthen Biovian’s position as a key player in the CDMO sector, but also contribute to the growth of the biopharmaceutical industry in Finland and most of all provide vital therapies to patients suffering from today’s untreatable diseases. Biovian aims to facilitate swift drug development and delivery, reducing time-to-market for its customers, all while creating an enjoyable experience. The new manufacturing facility will increase viral vector capacity, but it will also increase our capacity and flexibility in microbial protein. When the new site is up and running, our existing capacity will be transformed to new microbial protein suites. Thus, both microbial and viral vector customers will benefit from this expansion.”
Originally published on 26 July.
