AHF backs FTC challenge to big pharma junk patents
May-June . 2024 | The HEALTH
Foreign News
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IN A May 3 update , Fierce Pharma Asia reported that Japan ’ s Ono Pharmaceutical will buy kinase inhibitor expert Deciphera for US $ 2.4 billion . Novartis invested further in radiopharmaceuticals with two deals . WuXi Biologics has withdrawn from the 2024 BIO International Convention as the US grows hostile against certain Chinese biotech companies . 1 . Japan ’ s Ono pays US $ 2.4b for Qinlock maker Deciphera as biotech readies another approval run Ono Pharmaceutical , which sells the PD-1 inhibitor Opdivo in Japan , is buying Deciphera Pharmaceuticals for US $ 2.4 billion . Besides the FDA-approved gastrointestinal stromal tumour drug Qinlock , Deciphera has a kinase inhibitor discovery platform . Ono also expects the acquisition to accelerate its business development in the US and Europe , CEO Gyo Sagara said . 2 . Novartis pays PeptiDream US $ 180m as radiopharma big bang continues Novartis made two radiopharmaceutical deals this week . It penned a US $ 180 million peptide-drug conjugate deal with Japan ’ s PeptiDream . The deal includes up to US $ 2.71 billion in potential
Corporate moves by big pharma
milestones . PeptiDream will develop macrocyclic peptides against targets selected by Novartis for conjugation with radionuclides . In the second deal , Novartis agreed to acquire Mariana Oncology for US $ 1 billion upfront . 3 . WuXi Biologics withdraws from 2024 BIO convention amid worsening geopolitical tensions WuXi Biologics has pulled out of the 2024 BIO International Convention . Both WuXi Bio and WuXi AppTec will be absent from the biotech event of the year , despite consistently having a presence there in the past few years . Their absence comes amid a US biosecurity crackdown targeting certain Chinese drug manufacturers and service providers . 4 . Takeda ditches industry trade
group BIO following exits by WuXi
AppTec , Pfizer and UCB Meanwhile , Takeda has left the Biotechnology Innovation Organisation ( BIO ). “ We believe it will allow us to further refine the focus of our resources and continue to play an active role in advancing innovation and advocating for policies that put patients first while improving the global healthcare ecosystem ,” a Takeda spokesperson said in a statement . 5 . AstraZeneca , Daiichi tout Enhertu trial win in earlier , broader HER2- low breast cancer AstraZeneca and Daiichi Sankyo said their Enhertu had beat chemotherapy on progression-free survival in HRpositive , HER2-low metastatic breast cancer patients who had tried at least one prior line of endocrine therapy . The readout came from the phase 3 DESTINY- Breast06 trial , which could move the antibody-drug conjugate one line earlier to HER2-ultralow cancer . 6 . Astellas hitches a ride in Poseida ’ s convertible for US $ 50m cell therapy collaboration Astellas ’ Xyphos Biosciences has signed on two solid tumour cell therapy candidates from Poseida Therapeutics for US $ 50 million upfront and US $ 550 million in milestones . The two will combine Poseida ’ s allogeneic CAR-T platform with Xyphos ’ ACCEL platform , which uses a convertible CAR construct with a tumour-associated antigen-specific antibody-like molecule .
AstraZeneca withdraws Covid-19 vaccine globally
ASTRAZENECA , the Anglo-Swedish pharmaceutical giant , has initiated a global withdrawal of its Covid-19 vaccine , Vaxzevria . It cites various reasons , including a surplus of alternative vaccines and concerns over rare side effects .
The move came after the company v oluntarily withdrew its European Union marketing authorisation effective May 7 , as reported by The Telegraph . The decision , made on March 5 and enacted in May , signifies a strategic shift for AstraZeneca amidst evolving circumstances surrounding Covid-19 vaccination efforts .
The company highlighted a decline in demand for Vaxzevria , attributing it to the availability of updated vaccines targeting new virus variants . This surplus of alternatives rendered the manufacturing and supply of Vaxzevria unnecessary .
Acknowledging the broader context , Astra- Zeneca emphasised its role in combating the pandemic , stating that over 6.5 million lives were estimated to have been saved in the first year of vaccine use alone , with more than three billion doses supplied globally .
However , concerns over rare side effects , notably thrombosis with thrombocytopenia syndrome ( TTS ), prompted regulatory scrutiny and public apprehension .
The vaccine withdrawal extends beyond the EU , with other countries also discontinuing its use .
Australia , for instance , ceased administering the vaccine in March 2023 , following a phasedout approach initiated in June 2021 due to the proliferation of newer vaccine options . Known initially as Covishield , the AstraZeneca vaccine was rebranded as Vaxzevria in 2021 .
It was authorised for individuals aged 18 and older , administered in two doses typically spaced three months apart . Despite its overall safety and efficacy , the vaccine carried a rare but serious risk of TTS , affecting approximately two to three individuals per 100,000 vaccinated .
Novartis acquires Mariana Oncology
NOVARTIS has announced its acquisition of Mariana Oncology , a preclinical-stage biotech firm headquartered in Watertown , Massachusetts , USA .
Specialising in pioneering radioligand therapies ( RLTs ) for cancers with high unmet needs , Mariana Oncology ’ s addition enhances Novartis ’ RLT portfolio , research capabilities , and clinical supply infrastructure , aligning with Novartis ’ strategic focus on oncology and RLT innovation .
The acquisition includes Mariana Oncology ’ s diverse RLT programmes , from lead optimisation to early development across solid tumour indications like breast , prostate , and lung cancer . Notably , it encompasses the development of candidate MC-339 , an actinium-based RLT targeted at small-cell lung cancer .
Novartis Biomedical Research President Fiona Marshall expressed enthusiasm about the acquisition . “ The acquisition of Mariana Oncology reflects our commitment to radioligand therapy as one of our company ’ s key technology platforms
AIDS Healthcare Foundation ( AHF ) has expressed its support for the US Federal Trade Commission ( FTC ) as it moves to challenge major pharmaceutical companies , including GSK , for their use of what are termed “ junk patents ”.
These patents are being utilised anticompetitively to prevent generic competition and keep drug prices artificially high .
According to AHF President Michael Weinstein , big pharma ’ s practice of filing multiple derivative patents on existing drugs is not a form of innovation but rather
and strengthens our leadership in this field .
“ We are excited to work with the Mariana team to bring forward next-generation RLTs for patients living with cancer and shape the future of RLT as a pillar for oncology treatment .”
Radioligand therapies , also known as radiopharmaceuticals , combine a tumour-targeting molecule with a therapeutic radioisotope to precisely deliver radiation to tumours while minimising damage to surrounding tissues .
Through the acquisition , Novartis aims to expand the application of RLTs to various cancer types , leveraging Mariana Oncology ’ s expertise and capabilities .
Novartis Oncology for Biomedical Research Global Head Shiva Malek emphasised the company ’ s dedication to advancing RLT research . “ As pioneers in radioligand therapies , we are dedicated to building on our scientific leadership and expanding the breadth of these potentially transformative treatments to a broader range of cancer types .”
Novartis ’ current RLT portfolio includes two approved therapies for metastatic castration-resistant prostate cancer and certain types of gastroenteropancreatic neuroendocrine tumours .
With ongoing clinical studies and assets targeting prostate cancer and exploring novel isotopes and disease areas , Novartis aims to continue innovating in the RLT space .
The acquisition agreement involves an upfront payment of US $ 1 billion to Mariana Oncology , with an additional US $ 750 million contingent upon meeting specified milestones .
AHF backs FTC challenge to big pharma junk patents
a display of greed . “ They pull every trick in the book to extend lucrative monopolies on a wide range of treatments for HIV , diabetes , asthma , weight loss , and more , and the public is left paying the bill .”
GSK has notably prevented several middle-income countries , including Colombia and Trinidad and Tobago , from accessing generic
versions of the HIV drug dolutegravir by leveraging their patent monopoly . This forces these countries to purchase the GSK-branded version at significantly higher prices .
AHF has collaborated with civil society partners to address these issues . In a significant development for HIV treatment access , Colombia has recently issued a compulsory licence for dolutegravir . This will enable it to treat a larger number of individuals with generic versions of the drug at a fraction of the cost of the branded regimen .