J&J launches innovative study for expanded use of Invokana
Johnson & Johnson (JNJ) unit Janssen Pharmaceutical Companies, together with PRA Health Sciences (PRAH), initiates a first-of-its-kind clinical trial evaluating Invokana (canagliflozin) in adults with heart failure, with preserved or reduced ejection fraction, with or without type 2 diabetes (T2D).
The 1,900-subject study, called CHIEF-HF, will generate patient-reported outcomes via app-based questionnaires and physical activity data via a smartphone app and wearable activity device (daily step count and stairs climbed).
All contact with participants will be done virtually with no in-person clinical visits required. The company says the patient-centric perspective is not typically captured in a registration trial.
The FDA first approved the SGLT2 inhibitor in May 2013 for T2D, followed by a CV benefit claim in October 2018 and to reduce the risk of hospitalization in patients with T2D and diabetic kidney disease in September 2019.
Novartis to cut 150 jobs at Shanghai site in shift to commercial development
Novartis (NYSE:NVS) will cease early-stage research at its Shanghai campus in order to focus on commercial development.
The company will axe ~150 jobs as a result, ~12% of the 1,300 workers employed there, but will add 340 positions over the next four years.
Research operations at its Swiss headquarters and in Massachusetts and California will continue.
Vertex teams up with Molecular Templates in HSCT conditioning regimens
Vertex Pharmaceuticals (NASDAQ:VRTX) will collaborate with Molecular Templates (NASDAQ:MTEM) to discover and develop novel targeted conditioning regimens aimed at enhancing the process of hematopoietic stem cell transplantation (HSCT), including transplants conducted as part of treatment with gene therapy candidate CTX001, in Phase 1/2 development with CRISPR Therapeutics (NASDAQ:CRSP) for transfusion-dependent beta thalassemia and sickle cell disease.
The parties will focus their efforts on discovering a new conditioning regimen leveraging MTEM’s engineered toxin body platform, designed to boost the successful engraftment of new cells by selectively targeting and removing specific cells that can interfere with the process.
Under the terms of the agreement, VRTX will pay MTEM $38M upfront, including an equity investment, up to $522M in milestones and tiered royalties on net sales on up to two targets. VRTX will have the option to exclusively license the molecules against the designated targets for any indication.
MTEM is up 13% premarket on light volume.
Alkermes acquires Rodin Therapeutics for up to $950M
Alkermes plc (NASDAQ:ALKS) has agreed to acquire privately held Rodin Therapeutics, a developer of small molecule therapies to treat synaptopathies, expanding its development activities in neurodegenerative disorders.
Under the terms of the agreement, ALKS will pay $100M in upfront cash and up to $850M in milestones.
The transaction should close by month-end.
Aerie Pharma to acquire Avizorex Pharma
Aerie Pharmaceuticals (NASDAQ:AERI) has signed an agreement for the acquisition of Avizorex Pharma, S.L. (AVX Pharma), a Spanish ophthalmic pharmaceutical company developing therapeutics for the treatment of dry eye disease, in an all-cash transaction.
Aerie will make an upfront payment of $10M and AVX Pharma shareholders will be eligible to receive additional payments subject to achievement of certain milestones, plus royalties on net sales of approved products from AVX Pharma’s development pipeline.
In addition to AVX-012, Aerie will also be acquiring rights to other compounds targeting TRPM8. The transaction is expected to close before year end.