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Merck has reported an increase in group net sales by 12.9% The growth in sales was driven by all regions and business sectors, particularly Life Science. in group sales in fiscal 2022. Additionally, due to the acquisition of Exelead, a biopharmaceutical contract development and manufacturing company, sales increased by 0.4%.
Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.
Shionogi will waive royalty payments on product sales in all countries under this deal as long as Covid-19 is listed by the World Health Organization as a Public Health Emergency of International Concern. In the Phase III portion of a Phase II/III clinical trial in Asia, ensitrelvir met the primary endpoint.
Biogen has exercised an option to license Denali Therapeutics ’ (Denali) programme to develop immunotherapies for the treatment of Alzheimer’s disease. Denali is also expected to receive potential development and commercial milestone payments upon achieving certain milestones, along with royalties based on the future net sales of the drug.
With the chemists and druggists across the country opposing the sale of drugs through online, the Central government is taking a stand that the sale of medicines should be strictly under the provisions of the existing regulations and the State Licensing Authorities (SLAs) are legally empowered to act against violation of the legal provisions.
Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. The therapy, which completed a Phase I trial, is now being assessed in an international Phase III clinical trial that includes participants from China and Eastern European countries.
Eli Lilly shared new Phase II trial data showing that its experimental siRNA therapy, lepodisiran, leads to reductions in levels of lipoprotein(a) (Lp(a)) a genetically inherited risk factor for heart disease in adults with elevated levels of the marker. The 400 mg dose was the highest lepodisiran dose in the trial.
German biotechnology firm 3B Pharmaceuticals (3BP) has entered into a licensing agreement with Novartis Innovative Therapies for its fibroblast activation protein (FAP)-targeting peptide technology. Tiered royalties on net sales are also included in the deal. FAP-2286 is being investigated as a peptide-targeted radionuclide therapy.
The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June. […]
At least seven more pharma companies and a federation of pharma manufacturers have approached the Delhi High Court against the Central Government’s order in the beginning of June prohibiting manufacturing, distribution and sale of 14 fixed dose combinations (FDCs) licensed prior to the year 1988.
While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The biotech said earlier it planned to seek FDA approval to start clinical trials towards the end of 2022.
On concluding this trial, Roche will gain the right to develop and market the licenced products across various indications, contingent on approval. Roche also holds an option for licensing second arenaviral cancer immunotherapy. According to the agreement, Roche will make $25m in upfront payment to Hookipa. .
Sanofi announced data from a real-world clinical trial that demonstrated its RSV antibody nirsevimab delivered an 83% reduction in hospitalisations in infants with respiratory syncytial virus (RSV)-related lower respiratory tract disease (LRTD). Nirsevimab is being jointly developed between Sanofi and AstraZeneca.
Related: Arrowhead Pharmas New Rare Disease Campaign for FCS Highlights Importance of Lowering Triglycerides The FDAs approval of Crenessity was based on two randomized, double-blind, placebo-controlled trials in 182 adults and 103 children with classic CAH. Crenessity marks the third approved drug for Neurocrine. billion in revenue by 2024.
Innate is also eligible to receive a total of up to $1.43bn (€1.35bn) in preclinical, clinical, regulatory and commercial milestone payments and royalty payments on net sales in the future. Initially, the companies signed a research collaboration and licensing agreement in 2016 to develop and assess up to two bispecific NK cell engagers.
On 8 May 2023, China-based Bliss Biopharmaceutical (BlissBio) announced a clinical trial collaboration with Eisai to develop BB-1701, an antibody-drug conjugate (ADC) for multiple cancer types. The drug became a blockbuster last year, with sales reaching $1.9bn, up from $599m in 2021. targeting ADC.
The NDA is supported by the data package licensed to Ocumension by Nicox as well as the Phase III clinical trial in China. Nicox granted exclusive license to Ocumension to develop and commercialise Zerviate in China and most of the Southeast Asian markets.
Several oncology products now have “blockbuster” status where sales exceed $1 billion annually. This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. Keytruda (Pembrolizumab) and Opdivo (Nivolumab).
It’s a key moment for the two companies, as expansion into HER2-low breast cancer has been held up as a key requirement for Enhertu (trastuzumab deruxtecan) if it is to achieve its multibillion-dollar sales expectations. billion upfront to license rights to Enhertu in a deal that could be worth up to $6.9 AZ paid a hefty $1.4
GlaxoSmithKline’s pitch to shareholders kicked off this afternoon with an optimistic view of its late-stage pipeline – including some big sales predictions for products like its respiratory syncytial virus (RSV) vaccine and new blood cancer drug Blenrep. billion takeover of Tesaro in 2019. £1 mRNA ambitions.
AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.
Roche, a global leader in biotechnology and diagnostics, has entered into an exclusive collaboration and licensing agreement with Zealand Pharma, a specialist in innovative therapeutics, to co-develop and co-commercialize petrelintide as a potential foundational therapy for people with overweight and obesity. billion $1.4 billion $1.4
This followed positive results from CSL’s Phase III HOPE-B trial (NCT03569891). Already a big player in haemophilia treatments, CSL licensed exclusive global rights to Hemgenix from gene therapy developers uniQure back in 2021. In the study, Hemgenix reduced or eliminated the need for prophylactic treatment in 94% of patients.
The drug is currently licensed in combination with chemotherapy for patients with classical Hodgkin lymphoma, both as frontline therapy and for those at risk of progressing or having progressed following stem cell transplantation. Tivdak, a tissue-factor targeting ADC that was developed in collaboration with Genmab, was approved in 2021.
Additionally, Royalty Pharma is entitled to receive further payments of up to $160m subject to meeting some clinical, regulatory and sales milestones. According to the deal, Royalty Pharma will acquire Arrowhead’s complete royalty interest in olpasiran, which amounts to a royalty of up to the low double digits on global net product sales. .
Merck & Co has signed a licensing deal with the UN-backed Medicines Patent Pool (MPP) that could pave the way for generic companies to manufacture its much-anticipated oral antiviral for COVID-19. ” Under the agreement, MPP will sublicense manufacturing rights to other drugmakers.
Jounce could also receive up to $685 million in future clinical, regulatory and commercial milestone payments, as well as royalties ranging from high single digit to mid-teens based upon worldwide sales, subject to certain adjustments. The post Gilead licenses Jounce immunotherapy for $800m appeared first on.
Ibrexafungerp is currently being evaluated in Phase III clinical trials to treat invasive candidiasis (IC), a life-threatening fungal infection. in sales-related milestone payments, along with tiered royalties on sales across all indications. Additionally, GSK will pay up to $242.5m
Gilead holds an option for licensing MGD024 as a possible therapy to treat specific blood cancers, including myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML). Under the deal, the companies will leverage MacroGenics’ DART platform to develop MGD024 as well as two further bispecific research programmes.
The company will also be entitled to receive up to $40m in additional payments linked to development and sales milestones. The licensing agreement also requires Viatris Japan to pay up to double-digit percentage royalties based on the net sales of the product in Japan.
Akili already has the first and only FDA cleared video game-based digital therapeutic (DTx) for children with attention-deficit hyperactivity disorder (ADHD), but is looking to add to its range via a licensing deal with Australia’s TALi Digital. . TALi is also in line for royalties on sales.
Spanish pharmaceutical firm Ferrer and Swiss biotechnology firm Asceneuron have signed a licensing agreement for the latter’s O-GlcNAcase inhibitor, ASN90, to treat progressive supranuclear palsy (PSP). Additionally, Asceneuron is eligible for tiered double-digit royalties on ASN90’s global net sales.
Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). upfront payment and eligible for royalties on net sales. CSPC Megalith is a subsidiary of CSPC Pharmaceutical Group.
Alimera Sciences has exclusive global rights to Yutiq excluding Southeast Asia, Hong Kong, Macau, China and South Korea, where the therapy was previously licensed to Ocumension Therapeutics. EyePoint Pharmaceuticals will also receive potential royalties on the combined net sales of Iluvien and Yutiq in the US from 2025 to 2028.
LIB Therapeutics has announced that the FDA has accepted its Biologics License Application (BLA) for lerodalcibep, a novel investigational treatment aimed at reducing low-density lipoprotein cholesterol (LDL-C) in a broad patient population. Over 2,400 patients have continued in the 72-week open-label extension trial.
The PhALLCON trial compared Iclusig (ponatinib) to imatinib – sold by Novartis as Glivec/Gleevec, but also available as a generic – on top of a reduced-intensity chemotherapy regimen in 230 patients with this type of leukaemia. The post Takeda’s Iclusig bests imatinib in first-line leukaemia trial appeared first on.
P-BCMA-ALLO1 is currently being analysed in a Phase I clinical trial while an investigational new drug (IND) application for P-CD19CD20-ALLO1 is anticipated next year. The programmes include P-BCMA-ALLO1, an allogeneic CAR-T to treat multiple myeloma and P-CD19CD20-ALLO1, an allogeneic dual CAR-T to treat B-cell malignancies.
According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Under the agreement, Horizon will hold an option for the acquisition of the ADX-914 programme, which is exercisable through a period after concluding the Phase II trials. A fully human anti-IL-7R?
Laboratoires Théa’s sister company, Théa Open Innovation (TOI), has signed a licensing agreement with Galimedix Therapeutics for GAL-101. It is currently ready to enter Phase II/III clinical trials. GAL-101 binds to a specific motif from Aβ that is exposed only in the misfolded Aβ monomer form and can be targeted.
The company is also in line to receive an additional $110m in future milestone payments, depending on the Chikungunya vaccine development and sales performance of the two marketed vaccines. Following the completion of the deal, Bavarian Nordic now boasts the only oral vaccine licensed by the U.S.
Lantheus’ pipeline-building drive in radiopharma has continued with a $260 million upfront deal to license rights to two oncology candidates from POINT Biopharma. billion in milestone payments to POINT if the two radiotherapeutics get FDA approval and meet commercial objectives, plus royalties on net sales.
Daewoong Pharmaceutical has entered an exclusive licensing agreement with CS Pharmaceuticals (CSP) for Bersiporocin, a first-in-class PRS inhibitor, in the Greater China region for Idiopathic Pulmonary Fibrosis (IPF). The Korea Drug Development Fund is supporting the trial by providing funds.
Pfizer has vaulted ahead with its respiratory syncytial virus (RSV) vaccine, closing the gap with GlaxoSmithKline and Johnson & Johnson as the companies strive to bring the first licensed shot to market. At its recent business update, GSK said it was anticipating peak sales of more than $4 billion for its vaccine if approved.
DeepVerge has announced trial data showing its COVID-19 Microtox BT breath test can deliver accurate results in under 60 seconds, with a potential roll-out later this year if further tests support it. It has licensed in a patented breathalyser, the analysts noted. A large clinical trial is ongoing in Dubai.
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