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Gene therapy company uniQure has entered into a global licensing agreement with Apic Bio for APB-102 to treat patients with amyotrophic lateral sclerosis (ALS) caused by mutations in superoxide dismutase 1 (SOD1). uniQure will also provide tiered royalties ranging from mid-single digits to low double digits on the net sales.
According to the revised deal, Daiichi Sankyo and Kite will transfer the Marketing Authorization for Yescarta to Gilead’s Japan subsidiary, Gilead Sciences K.K., The therapy’s sales and promotion works in Japan following the transfer of marketing authorisation will be carried out by the Kite Cell Therapy Business Unit at Gilead Sciences K.K.
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. This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies.
South Korean biotechnology company Alteogen has signed an exclusive license agreement with Swiss company Sandoz to develop and market biosimilar products that are enabled by the former’s Hybrozyme technology. Additionally, the company will have an option to license Alteogen’s Hybrozyme technology for two more products.
Women’s healthcare company TherapeuticsMD has sign ed agreements for licensing its products to the Mayne Pharma affiliate in the US. Additionally, TherapeuticsMD will grant Mayne the exclusive license to market Annovera in the US. TherapeuticsMD will also get a 20-year royalty stream linked to Mayne’s net product sales.
Stealth BioTherapeutics has made an exclusive licensing agreement with Pharmanovia for the commercialisation of its elamipretide to treat Barth syndrome.
Takeda has signed an exclusive licence agreement with HUTCHMED (China) and its subsidiary HUTCHMED to develop and market the latter’s fruquintinib. The China National Medical Products Administration (NMPA) approved fruquintinib for marketing in September 2018. The submission is planned to be completed in the first half of this year.
Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. Biomm will gain exclusive rights for the distribution and marketing in Brazil of the proposed biosimilar to Janssen’s Stelara.
Antares Pharma's auto-injector technology is of particular interest to Halozyme, which believes that the various markets to which it could be applied represent billions of dollars in potential sales.
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. .
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. On choosing the candidate, the company will oversee the complete development, production and marketing.
The next step will be to start a rolling submission for a Biologics License Application (BLA) for its COVID-19 vaccine with the FDA this month. Moderna has reported the first profitable quarter in the companyâs history: after 10 years of research and several billion dollars of investment in its mRNA platform.
Brii Biosciences (Brii Bio) has exercised an option for the acquisition of exclusive development and marketing rights for Vir Biotechnology’s investigational antibody, VIR-3434, for Hepatitis B in Greater China, under a partnership agreement.
The NDA is supported by the data package licensed to Ocumension by Nicox as well as the Phase III clinical trial in China. Zerviate, 0.24% was compared to emedastine difumarate ophthalmic solution, 0.05%, an antihistamine, which is marketed under undeb Emadine brand name.
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 post Lava fires up a $700m cancer licensing deal with Seagen appeared first on.
On 24 October, American vaccine developer Vaxcyte shared positive topline data from a Phase I/II study of its multivalent conjugate pneumococcal vaccine VAX-24 , bringing the 24-valent pneumococcal jab one step closer to market. VAX-24 has forecasted sales of $21 million in the same year. Competition in an increasingly heated market.
PharmaEssentia may be entitled to receive certain milestone payments along with royalties based on sales of the product. Pint-Pharma will obtain and maintain all marketing authorisations and will commercialise BESREMi in the region. It holds orphan drug designation in the US to treat PV.
Under the terms of the license and commercialisation deal, Dr. Reddy’s will get licence for the development and commercialisation of toripalimab in India, Panama, Peru, Colombia, South Africa, Brazil, Argentina, Chile, Uruguay, and Mexico. Junshi Biosciences may get an aggregate of up to $728.3m
Acute myeloid leukemia (AML) is part of a market of blood malignancies that commercial cell therapies have not managed to penetrate yet. None of these products are in a registrational trial, and as such, GlobalData does not anticipate their entry into the AML market earlier than 2028.
BlissBio has the potential to earn up to $2bn in commercial milestone payments, as well as royalties on sales if Eisai exercises its option to license the drug. The drug became a blockbuster last year, with sales reaching $1.9bn, up from $599m in 2021. targeting ADC.
Furthermore, Cerevance will simultaneously out-license a discovery-stage programme to Merck under the partnership. Cerevance will also potentially receive royalty payments on sales of approved products resulting from the partnership. “We
In the past year, Hemgenix has been granted approval by the US Food and Drug Administration (FDA) and has received conditional marketing authorisation from the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This followed positive results from CSL’s Phase III HOPE-B trial (NCT03569891).
The company has just claimed its first approval for the drug in Canada – under the Sohonos brand name – as a treatment for the ultra-rare genetic disorder fibrodysplasia ossificans progressiva (FOP), but was forced to withdraw its marketing application for the drug in the US last summer after a request for more data.
According to the US government, Gilead had repeatedly refused to license patents related to PrEP research undertaken by the Department of Health and Human Services’ (HHS) Centers for Disease Control and Prevention (CDC). Gilead markets both Truvada and its successor Descovy.
The positive results follow approvals in the European Union , UK, and Canada, where nirsevimab is being marketed as Beyfortus, to help treat a disease that led to 3.6 A further potential sum of €440m is dependent on whether regulatory and sales-related milestones are hit. million global hospitalisations in 2019.
The corporation is making as much as $1 million in profits every hour from vaccine sales, according to Oxfam, and its executives boast that revenues will expand exponentially in 2022. ( The Atlantic ).
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.
India’s Dr Reddy’s Laboratories has joined the growing list of pharma companies that are looking to tap into the market for medical cannabis, buying German developer Nimbus Health for an undisclosed sum.
C4 Therapeutics has entered an exclusive licensing agreement with Betta Pharmaceuticals to develop and commercialise CFT8919 across the greater China region. It is expected to accelerate the development of CFT8919 in important international markets.
Bureaucracy, political upheaval, and lack of regulations continue to make Latin America a difficult market for European and North American pharma to enter – and COVID-19 has only worsened these issues. Developing market specialist Dr Zulf Masters OBE takes us through the nuances of being successful in this region.
LegoChem Biosciences and Amgen have signed a multi-target research collaboration and license agreement to develop antibody-drug conjugates (ADC). The company will also be eligible for tiered royalties as a percentage of global commercial sales of the products.
According to the deal, Poseida will offer either exclusive rights or options to Roche for developing and marketing various allogeneic CAR-T programmes in its portfolio targeting hematologic malignancies. Furthermore, Roche will oversee the late-stage clinical development and worldwide marketing of all products under the alliance.
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.
Pfizer recently announced an agreement to acquire Seagen, a biotech company based in the US with four marketed oncology therapeutic agents and a rich pipeline. This figure derives from net product sales in addition to revenues gained from royalties and licensing agreements.
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.
Sosei Heptares , a corporate brand of Sosei Group Corporation, has signed a new drug discovery partnership and option-to-license agreement with AbbVie for discovering, developing and marketing new therapies for neurological ailments. Additionally, AbbVie will make tiered royalty payments based on global product sales to Sosei Heptares.
As a result, multiple vaccines, including Pfizer /BioNTech’s mRNA vaccine, Comirnaty, were licensed for use within a year of development beginning. Many new therapeutics are needed to treat the broad range of bacterial infections, and bringing new antibiotics to market is both difficult and expensive.
The deal encompasses Vivotif and Vaxchora, both marketed vaccines for the prevention of typhoid fever and cholera respectively, and a Phase III vaccine candidate for the prevention of Chikungunya virus, which have now all been transferred to Bavarian Nordic.
Emergence Therapeutics has become the tenth company to license ADC technology from Synaffix. The deal has a total potential value of up to US$360m, plus royalties on commercial sales.
Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.
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.
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).
Additionally, ADC Therapeutics will have an option for licensing chosen antibodies in the future for international development and marketing of antibody-drug conjugates (ADCs). . On net product sales, the company will also receive single-digit royalty payments.
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