On January 23, 2023 Sandoz, the global leader in off-patent (generic and biosimilar) medicines, reported that it has signed an agreement to acquire worldwide product rights for leading systemic antifungal agent Mycamine (micafungin sodium, Funguard in Japan) from Astellas (Press release, Sandoz, JAN 24, 2023, View Source,%C2%AE%20in%20Japan)%20from%20Astellas [SID1234626466]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Closing is anticipated in the course of H1, 2023, subject to standard conditions and regulatory approvals.

Astellas reported Mycamine sales of JPY 18.9 billion (USD 135 million) for the year ending March 31, 2022. The announcement comes after Sandoz successfully completed the acquisition of GSK’s global cephalosporins portfolio in October 2021.

Sandoz CEO Richard Saynor said: "Acquiring this leading and respected global brand will significantly reinforce the Sandoz global hospital offering, as well as complement our existing global leadership position in generic antibiotics."

He added: "This will also be an important addition to our growing portfolio of anti-infective therapies aimed at combatting the spread of antimicrobial resistance, by providing the right drug to the right patient at the right time."

Sandoz Anti-Infectives global medical lead Nicholas Adomakoh said: "Modern medicine is increasingly characterized by the need for complex interventions involving highly vulnerable patients. This welcome and timely portfolio addition will allow us to respond even better to the needs of patients and clinicians across the healthcare continuum."

Mycamine is a leading global echinocandin, one of three major classes of antifungal agents, with a global patient base of well over two million. It is a therapy of choice in hospitals and intensive care units worldwide, a proven prophylactic in hematology and oncology patients, and widely used in organ transplants.

Mycamine is indicated for treatment of invasive candidiasis and espophageal candidiasis, which are currently both on the rise with a higher occurrence of associated hospital outbreaks, as well as prevention of candida and aspergillus infections in patients undergoing hematopoietic stem cell transplantation.

On January 23, 2023 Clinigen Limited (‘Clinigen’) (‘the Company’), the global pharmaceutical services company, reported the company has entered into an agreement to divest Proleukin (interleukin-2 (aldesleukin)), to Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) (‘Iovance’), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor infiltrating lymphocyte (TIL) and peripheral-blood lymphocyte (PBL)) (Press release, Clinigen Group, JAN 23, 2023, View Source [SID1234635196]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Terms of the agreement include an upfront payment of £166.7 million, a £41.7 million milestone payment upon first approval of lifileucel in advanced melanoma, and double-digit Proleukin global sales royalties from Iovance to Clinigen. The transaction is expected to close in the first quarter of 2023, subject to required regulatory approvals and clearances and other customary closing conditions.

The divestment of Proleukin is an important step in Clinigen’s previously stated strategy of increasing its focus on those areas of the pharmaceutical services market where it has a growing and sustainable competitive advantage. Clinigen provides a strong and highly differentiated offering in pharmaceutical services where the platform provides market-leading access solutions from the clinical phase through to the commercial stage of the drug product life cycle.

David Bryant, Interim Chief Executive Officer of Clinigen, said: "Today’s announcement is a significant milestone for Clinigen as it continues its evolution as a business focused on critical high-value pharmaceutical services. The divestment helps accelerate that services focus, while returning value to the business and allowing Clinigen to benefit from potential future economic value in Proleukin.

"We have had a long-standing partnership with Iovance and believe they are the right partner to take Proleukin forward and ensure continued availability of this important medicine to patients and healthcare professionals."

Greenhill & Co is serving as financial advisor and White & Case LLP as legal advisor to Clinigen.

On January 23, 2023 Viewpoint Molecular Targeting, Inc., a precision oncology company developing alpha-particle therapies and complementary diagnostic imaging agents, reported the first dosing of two neuroendocrine tumor patients with therapeutic intent. VMT-α-NET, which is being developed for the treatment and diagnosis of somatostatin receptor subtype 2 (SSTR2) expressing neuroendocrine tumors, was administered to the patients in early December (Press release, Viewpoint Molecular Targeting, JAN 23, 2023, View Source [SID1234628253]). The dosed patients were diagnosed with confirmed-advanced somatostatin expressing neuroendocrine tumors (NETs).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The administration of VMT-α-NET was under the supervision of the patients’ doctor, Dr. Ishida Sen MBBS, Director and Head of Nuclear Medicine at Fortis Hospital, New Delhi, in partnership with BJ Madan, a diagnostic & therapeutic radiopharmaceutical company in New Delhi. No acute adverse reactions were observed in the first 10 days post administration and patients remain stable and in good condition.

"Preclinical and clinical data associated with this new radiopharmaceutical demonstrates significant potential to help our NET patients," noted Dr. Sen. "We are pleased that the patients are doing well, and we have appreciated the professionalism and scientific strength of the Viewpoint team."

Under compassionate use circumstances, VMT-α-NET may be made available to qualified doctors in some countries. In this circumstance, Viewpoint supplied drug precursors and isotopes for the local production of its proprietary radiotherapeutic, VMT-α-NET.

"We are highly committed to the rapid development of alpha-particle radionuclide therapy for cancer," said Viewpoint CEO Thijs Spoor. "We are pleased to support Dr Sen’s team in making this product available for her patients."

The progress of these patients will be followed by Dr. Sen and her team over the coming months. The safety and effectiveness of the treatments will be evaluated by Dr. Sen’s team with laboratory testing, observation of NET-associated symptoms, and repeat medical imaging.

In the U.S., VMT-α-NET will imminently enter a Phase 1 imaging and therapy study, to be conducted at various hospitals and clinics. VMT-α-NET, is categorized as an investigational new drug by the U.S. Food and Drug Association and the administration of VMT-α-NET for compassionate use is completely independent from and not within the scope of the Company’s Phase 1 trial.

On January 23, 2023 Swiss Rockets, a Basel-based incubator and accelerator of start-up companies in oncology and infectiology, reported that it acquired all assets and intellectual property of Piqur and transferred them to Torqur (Press release, Torqur, JAN 23, 2023, View Source [SID1234627671]). Torqur is a platform for the discovery and efficient development of innovative anti-cancer therapies targeting the metabolic PI3K/mTOR intracellular signalling pathway.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Piqur Therapeutics AG, a biotech spin-off company of the University of Basel, was co-founded by Dr. Vladimir Cmiljanovic in 2011 to develop bimiralisib, a potent and balanced pan-PI3K/mTOR inhibitor, discovered by Vladimir and his sister Dr. Natasa Cmiljanovic during their Ph.D. studies at the University of Basel. Since 2018 Vladimir and Natasa have been working together to further develop bimiralisib and a pipeline of next-generation PI3K/mTOR inhibitors under Swiss Rockets’ expertise.

The PI3K/mTOR intracellular signalling pathway is often abnormally activated and has a significant role in cancer formation. The lead candidate bimiralisib is a balanced pan-PI3K/mTOR inhibitor formulated for oral and topical administration. Promising early clinical activity has been demonstrated in multiple phase 1/2 studies allowing further development towards proof-of-concept studies in various oncology and dermatology indications.

Over 10 years, Piqur received funding of CHF 100+ million. Dr. Vladimir Cmiljanovic explains: "With these assets in our hands, we founded Torqur, which is now in possession of a drug candidate in clinical phase II for different solid tumours with potential to be further developed for various additional indications such as lymphomas, skin cancers and brain tumours." Torqur also has a pipeline of additional molecules which have already entered initial stages of development and is strengthening its pipeline by investing in the development of next-generation PI3K/mTOR inhibitors to form a robust portfolio of therapeutic areas in oncology and beyond.

Torqur is committed to providing next-generation potent PI3K/mTOR inhibitors for targeted cancer therapies to support patients’ quality of life and extended survival. With the company’s know-how, extensive drug development experience, and a broad network of internationally recognized experts and partners, Torqur believes it can deliver the best treatment and most promising outcomes to patients.

On January 23, 2023 NovAccess Global Inc., a Colorado corporation ("NovAccess" or the "company"), reported previously entered into three securities purchase agreements dated August 20, 2021, February 15, 2022, and May 5, 2022 (collectively, the "Agreements"), with AJB Capital Investments, LLC ("AJB") (Filing, 8-K, NovAccess Global, JAN 23, 2023, View Source [SID1234626477]). Pursuant to the Agreements, NovAccess issued promissory notes to AJB representing loans provided by AJB to the company totaling $1.75 million. Also pursuant to the Agreements, NovAccess paid AJB commitment fees totaling 1,575,000 unregistered shares of the company’s common stock (the "commitment fee shares"). If AJB is unable to sell the commitment fee shares for amounts specified in the Agreements, then AJB may require NovAccess to issue additional shares or pay cash in the amount of the shortfall (the "make-whole rights"). However, AJB may only exercise its make-whole rights within time frames following the loan dates specified in the Agreements (the August 20, 2021 and February 15, 2022 make-whole rights each have a term of 18 months and the May 5, 2022 make-whole rights have a term of 36 months). The August 20, 2021 make-whole rights expire on February 20 of this year. To avoid forcing AJB to sell the commitment fee shares in order to take advantage of its make-whole rights, on January 20, 2023 NovAccess entered into a letter agreement with AJB extending the exercise period for the make whole-rights to 72 months. As amended by the letter agreement, the make-whole rights now expire on August 20, 2027, February 15, 2028, and May 5, 2028. The letter agreement makes additional less material revisions to AJB’s make-whole rights and harmonizes the make-whole rights among the Agreements.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The letter agreement with AJB is filed as an exhibit to this Current Report on Form 8-K. The description above is qualified in its entirety by reference to the full text of the agreement.