On January 12, 2021 Sanofi reported EUROAPI as the name for the future leading European company dedicated to the development, production and marketing of active pharmaceutical ingredients (API) (Press release, Sanofi, JAN 12, 2021, View Source [SID1234574487]).

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EUROAPI will represent the "made in Europe" API state-of-the-art industrial capabilities and technologies, with approximately €1 billion in expected sales by 2022. It will rank number 1 in small molecules API, and number 2 on the global API market2. Addressing recent increasing medicine shortages that critically impact patient care, EUROAPI will ensure additional API supply capacities for Europe and beyond, and help balancing the industry’s heavy reliance on API sourced from other regions.

Sanofi also announces the appointment of Karl Rotthier as the EUROAPI future Chief Executive Officer, effective January 18th. Karl Rotthier, 53 years old, is a seasoned leader with a strong API business experience. He was most recently the Chief Executive Officer of Centrient Pharmaceuticals, and had the opportunity throughout his 29-years international career in the Netherands, Germany, Austria, Belgium and Singapore, to also drive operational carve-outs and spin-offs.

Karl will lead the creation of EUROAPI together with the new company Management Team towards its growth ambitions. EUROAPI will employ 3,200 skilled employees and be headquartered in France. A planned IPO on Euronext Paris would be evaluated with a decision expected by 2022, subject to market conditions.

Philippe Luscan, Executive Vice President, Global Industrial Affairs at Sanofi, said: "We are very pleased today to unveil EUROAPI and welcome Karl to lead this future industry champion, as it gives further substance to our ambitious project. Sanofi is fully committed to the new company’s success, including by establishing a long-term customer relationship with EUROAPI and holding a minority stake of approximately 30% in it. To provide the optimal conditions for success, Sanofi intends the new company to be debt free in order to maximize its future investment capacities."

Karl Rotthier, future CEO of EUROAPI emphasizes: "I am particularly delighted to join EUROAPI and look forward to working with my colleagues in creating an agile, stand-alone company, able to unlock its growth potential in a market sustainably growing at a pace of 6% per year3. Building on a strong industrial legacy built over decades and broad expertise and experience, EUROAPI would help secure a greater stability in supplying quality drugs to millions of patients worldwide."

The project announced by Sanofi in February 2020, consists of creating a standalone company which will combine Sanofi’s API commercial and development activities with six of its European production sites: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). EUROAPI will have significant competitive strengths, including a broad portfolio of 200 APIs with both volume and niche products, high standards of quality and industrial means, competitive pricing and technologies across Europe, and will leverage an extensive commercial network covering more than 80 countries.

*About Active Pharmaceutical Ingredients (API)

Active pharmaceutical ingredients or APIs are the chemicals or biologicals which have a beneficial therapeutic effect in a medicine. These are the essential molecules used in the composition and the production of any drug.

On January 12, 2021 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported that a member of the senior management team is presenting at the following virtual conferences (Press release, BerGenBio, JAN 12, 2021, View Source [SID1234574333]):

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Solebury Trout Management Access Event. 6-15 January 2021

H.C. Wainwright Bioconnect 2021, 11-14 January 2021

SEB Virtual Nordic Healthcare Conference, 18-19 January 2021

Live presentation at 9.40am CET on 18 January

The presentations will be made available at www.bergenbio.com after the events.

On Jan 12, 2021 PharmaDrug Inc., a specialty pharmaceutical company focused on the development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs, is pleased to announce that it has entered into a binding letter of intent (the "LOI"), dated January 11, 2021, to acquire Sairiyo Therapeutics Inc. ("Sairiyo") (the "Acquisition"). (Press release, Pharmadrug, JAN 12, 2021, View Source [SID1234574069]).

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Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration ("FDA") approval.

Sairiyo is advancing the clinical development of its lead drug candidate, Cepharanthine, a repurposed and reformulated naturally-derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases. Cepharanthine is a natural product and an approved drug used for more than 70 years in Japan to treat a variety of acute and chronic diseases. In clinical research, Cepharanthine exhibits multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic properties.1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials. Sairiyo has applied for FDA orphan drug designation of Cepharanthine in certain cancer indications and is also leveraging its expertise in drug discovery by evaluating novel uses of psychedelic and cannabinoid compounds for unmet medical needs.

"The proposed acquisition of Sairiyo Therapeutics builds on our foundation of developing and commercializing controlled substances and naturally-derived medicines in Europe while expanding our opportunities with an FDA focused strategy and leveraging Sairiyo’s expertise in the discovery and development of novel uses and reformations of naturally-derived compounds for significant clinical unmet needs, thus paving the way for PharmaDrug to become a fully-integrated specialty pharmaceutical company," said Daniel Cohen, Chairman and CEO of PharmaDrug.

Under the terms of the LOI, PharmaDrug proposes to acquire all of the issued and outstanding shares of Sairiyo in consideration for the issuance of an aggregate of 75,000,000 units of PharmaDrug ("Units"). Each Unit will be comprised of one common share of PharmaDrug and one common share purchase warrant (a "Warrant") of PharmaDrug. Each Warrant will entitle the holder thereof to acquire one common share in the capital of PharmaDrug at any time on or before the 18 month anniversary of the issuance of the Warrants at an exercise price of $0.10 per share. Following completion of the transaction Sairiyo will be a wholly-owned subsidiary of the Company.

Completion of the transaction is subject to customary closing conditions, including completion of due diligence, negotiation of definitive agreements and receipt of all necessary approvals. If such conditions are not satisfied it is possible that the proposed transaction will not be completed on the terms set forth herein or at all. The parties anticipate completing the definitive agreements within the next 30 days, and anticipate that the transaction will be completed in the first quarter of 2021.

On January 12, 2021 Eligible PEA PME), a company specializing in decryption of the human genome which performs interpretable genomic analyses for academic and private laboratories, reported its unaudited sales revenue for 2020 (Press release, Integragen, JAN 12, 2021, View Source [SID1234574001]). 2020 revenue amounted to €9.0 million, a 10% increase compared to €8.1 million on a likefor-like basis with 2019 results.

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The company experienced sales growth in almost all of the service lines with strong growth particularly associated to the partnership with the Groupement Coopératif de Santé (GCS) SeqOIA. The services provided by the Evry laboratory also improved despite the context of the COVID-19 health crisis which has added complexities to the services provided on the Evry site. Finally, the microbiology sequencing platform operated for the Institut Pasteur, whose contract was renewed at the start of 2020, also experienced sales growth. Revenue associated with the company’s software tools accelerated during the second half of the year achieving 37% growth compared to the prior year with over 1,600 bioinformatic analyses performed during 2020.

The company’s cash position as of 31 December 2020 was €5.0 million compared to €2.8 million1 at the end of 2019. The company benefited from obtaining a French State Guaranteed Loan (PGE) €1.8 million in May 2020 and has generated positive cash flows for the past 3 semesters.

The friendly takeover bid launched by the Belgian company OncoDNA in September 2020 resulted in the takeover by OncoDNA in November 2020 resulting in a capital of IntegraGen increasing XX.X%. OncoDNA is a Belgian company recognized internationally for precision medicine in oncology. OncoDNA has developed offerings for clinicians that help guide the choice of the treatments for patients with advanced cancers. This merger enables the two companies to become a European leader 1 Before taking debt into account Clinical Genomics Experts 2/2 in the field that operates in more than 100 countries directly or through distributors and employees more than one hundred employees exclusively in the service of genomics and its applications.

OUTLOOK 2021: NEW, DYNAMIC COMMERCIAL OFFERINGS RESULTING FROM THE MERGER WITH OncoDNA Several factors will support the company’s continued commercial momentum during 2021. First, the merger with OncoDNA and associated commercial synergies between the two companies will generate sales in new segments and geographic areas. Additionally, multi-year contracts currently in place will produce increases in order intake for the company’s sequencing services business that will provide additional revenue growth.

Bernard Courtieu, CEO of IntegraGen, commented: "2020 has been an exceptional year for IntegraGen in several ways. Our business activities achieved double-digit growth and the company strengthened its cash position despite the considerable impact of theCOVID-19 health crisis. The successful merger with OncoDNA positions the new group as a European leader in the analysis of the human genome. This is not only beneficial for all stakeholders and partners of the company, but first and foremost patients with cancer who will be offered new solutions resulting from our complete offer which combines both laboratory tests and software tools for oncology."

The company’s complete financial results for 2020 will be published on 15 April 2021 prior to the opening of financial markets.

On January 12, 2021 Boehringer Ingelheim and Enara Bio, reported that they have entered into a strategic collaboration and licensing agreement to research and develop novel targeted cancer immunotherapies, leveraging Enara Bio’s Dark Antigen discovery platform (Press release, Boehringer Ingelheim, JAN 12, 2021, View Source [SID1234573995]). This new collaboration combines Boehringer Ingelheim’s approach to tackle cancer through pairing leading science with innovative immune-oncology platforms, such as oncolytic viruses and cancer vaccines, with Enara Bio’s expertise in cancer antigen identification. The aim is to provide potential new therapies for patients with difficult to treat lung and gastrointestinal cancers.

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"We are excited to partner with Enara Bio as part of our mission to bring transformative new treatments to cancer patients," said Jonathon Sedgwick, Ph.D., Senior Vice President and Global Head, Cancer Immunology & Immune Modulation Research, Boehringer Ingelheim. "We are advancing a unique pipeline of cancer cell-directed agents, immuno-oncology therapies and intelligent combination approaches to help combat cancer. Enara Bio’s unique discovery platform offers a novel and highly differentiated approach that will allow us to look beyond the known proteome to identify and characterize Dark Antigens to support the development of T-Cell Receptor (TCR)-directed immunotherapies and therapeutic vaccines. We believe this is a highly innovative and promising approach to the development of the next wave of cancer immunotherapies."

Enara Bio’s proprietary Dark Antigen Platform Technology (EDAPT) will be used to discover and validate novel Dark Antigens in up to three tumor types in the lung and gastrointestinal cancer space. The discovery of shared antigens could lead to the development of vaccines that can be readily utilized to help a broader group of cancer patients.

Dark Antigens represent a new class of cancer-associated antigens that derive from the genomic dark matter, or the portion of the human genome that is normally not expressed as protein. Dark Antigen-encoding sequences are usually silenced in healthy cells but are activated and presented on tumor cells. They are associated with specific cancer types and, importantly, are shared across patients. Since typically not visible to the immune system, they represent a large potential repertoire of novel antigens that can be developed as targets for new immunotherapies.

"We are extremely pleased to enter this strategic licensing agreement, our first major deal leveraging our pioneering Dark Antigen discovery and validation capabilities," said Kevin Pojasek, President and CEO of Enara Bio. "Boehringer Ingelheim is an innovation-led company dedicated to producing breakthrough treatments with a significant focus on cancer. We are excited to build this relationship and are encouraged that Boehringer Ingelheim shares our view of the potential of Dark Antigens to be a source of important and unconventional targets for novel cancer immunotherapies. This agreement provides strong validation for our science and our approach to exploiting the cancer-associated antigenic repertoire derived from genomic dark matter and we look forward to a productive collaboration."

This collaboration with Enara Bio is the latest of several strategic partnerships and acquisitions for Boehringer Ingelheim to build its cancer vaccine platform and provides important validation for Enara Bio’s Dark Antigen platform. The past acquisitions of ViraTherapeutics and AMAL Therapeutics’ vaccine modalities coupled with Enara Bio’s capabilities position Boehringer Ingelheim to develop sophisticated virus and vaccine modalities for its prime/boost vaccine platform.

Under the agreement, Boehringer Ingelheim has the option to license Dark Antigens discovered and validated by Enara Bio. Boehringer Ingelheim will also be responsible for all non-clinical and clinical development, as well as commercialization of associated cancer immunotherapies, including therapeutic vaccines and T-cell redirecting biologics. Enara Bio retains rights to use any discovered antigens for use in cell therapy-based products.

Enara Bio is eligible to receive an upfront payment, together with research/preclinical milestones and licensing fees for each tumor type that is explored. Enara Bio is also eligible to receive more than EUR 876 million in clinical, regulatory and commercial milestones, in addition to royalties on future product sales.