US Senate passes bipartisan bill to cut pharma patent abuses; Ipsen inks another ADC deal

By PharmaCompass

2024-07-18

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This week, a bill heralded as “critical” to help “end anti-competitive practices” was passed by the US Senate with unanimous bipartisan support. The bill tackles patent abuses by pharmaceutical companies.

In deals, French drugmaker Ipsen signed its second antibody-drug-conjugate (ADC) deal of the year by securing the rights to an ADC from Foreseen Biotechnology.

Phispers also brings you plenty of news from clinical trials. Pfizer announced “encouraging” data on its once-daily weight-loss pill danuglipron. Roche’s once-daily weight-loss pill CT-996 also posted gains in an early-stage trial. And a study undertaken by the University of Oxford to probe whether Novo Nordisk’s Ozempic (semaglutide) caused neurological problems revealed that the med, in fact, reduced risks of dementia and nicotine use.

In a late-stage trial on prostate cancer patients, Bayer’s Nubeqa (darolutamide) plus androgen deprivation therapy (ADT) significantly slowed metastatic hormone-sensitive prostate cancer (mHSPC) from progressing. Meanwhile, Australian biotech Immutep shared encouraging data from a mid-stage trial of its investigational therapy that treats metastatic head and neck squamous cell carcinoma patients in the front-line setting. The company said it will begin discussions with regulatory agencies to bring the therapy to market.

In news regarding investments, Swiss CDMO CordenPharma said it is investing US$ 981 million to boost its manufacturing capacity in the US and Europe in order to keep pace with the burgeoning demand for glucagon-like peptide 1 (GLP-1) therapies. Sanofi said it is investing an additional US$ 437 million at its facility in Hyderabad (India), and is likely to add another 1,600 jobs.

And in news from the US Food and Drug Administration (FDA), the agency said it is setting up a Rare Disease Innovation Hub to work across rare diseases.

US Senate passes bipartisan bill to reduce ‘patent thickets’ by Big Pharma

The US Senate has unanimously voted to pass a bill to tackle patent abuses by pharmaceutical companies. The bipartisan bill limits the number of patents companies can contend on a drug. The bill seeks to prevent drugmakers from using “patent thickets”, where dozens of patents are deployed to protect a drug from generic competition. The bipartisan bill originally included “product hopping”, where companies switch patients over to a follow-on product whose patent expires later. The bill is said to reduce the federal deficit by US$ 1.8 billion over 10 years.

FDA to set up rare diseases hub: The FDA has announced its plans to establish a Rare Disease Innovation Hub to work across rare diseases. This hub will especially focus on products intended for smaller populations or for diseases where the natural history is variable and not fully understood. The development of therapies for these conditions can be particularly challenging.

Ipsen gains rights to Foreseen’s ADC in potential US$ 1 bn deal

Ipsen has secured the rights to an ADC with first-in-class potential from Foreseen Biotechnology in a deal totaling US$ 1.03 billion in upfront and milestone payments. The candidate has already proven its first-in-class potential in treating multidrug-resistant cancers at the preclinical level. Now, Ipsen will make it phase 1 ready. This is the French drugmaker’s second ADC deal of 2024.

Immutep eyes regulatory path after mid-stage win in head, neck cancer treatment

Immutep shared data from a phase 2b trial of its investigational therapy treating metastatic head and neck squamous cell carcinoma patients in the front-line setting. Eftilagimod alfa, in combination with Merck’s Keytruda, achieved an objective response rate in 11 out of 31 patients (35.5 percent) and a disease control rate of 58.1 percent. The Australian biotech claimed the “results are among the highest recorded for a chemo-free approach in negative PD-L1 patients”.

Pfizer rebounds in obesity, advances once-daily weight-loss pill after setback

Pfizer said it is moving ahead to mid-stage trials with a once-daily version of its GLP-1 drug danuglipron for weight loss. Pfizer trialed various once-daily formulations of the drug and after seeing “encouraging” data picked the candidate with the “most favorable profile”. In December, Pfizer had discontinued a twice-daily version of danuglipron on account of side effects.

Second Roche obesity candidate aces phase 1: Roche revealed that a second drug candidate from its up to US$ 3.1 billion buyout of Carmot Therapeutics has delivered promising results in an early-stage trial. Its once-daily weight-loss pill CT-996 reduced on average 6.1 percent of participants’ starting weight after four weeks. CT-996 works in a similar manner as other blockbuster weight loss drugs, such as Wegovy and Zepbound.

Bayer to expand Nubeqa’s use after late-stage win in prostate cancer trial

Bayer said its drug Nubeqa (darolutamide) plus androgen deprivation therapy (ADT) significantly slowed metastatic hormone-sensitive prostate cancer (mHSPC) from progressing in a late-stage trial. Nubeqa is already approved for adults with mHSPC in combination with the chemotherapy docetaxel. But for those who can’t tolerate chemo, ADT therapy is recommended with hormone therapy. Nubeqa is on track to achieve blockbuster status this year. Bayer targets € 3 billion (US$ 3.28 billion) in peak annual sales for the hormone therapy.

Novo’s Ozempic cuts dementia risk, nicotine use: A study done by the University of Oxford to explore if Novo Nordisk’s Ozempic (semaglutide) may cause neurologic problems found instead that it reduced the risk of dementia and “nicotine misuse”. The findings are the latest in a series of studies that have implied that GLP-1 drugs may have cognitive benefits. The Oxford study puts to bed concerns that semaglutide may increase the risk of suicidal thoughts.

CordenPharma to invest US$ 981 mn in US, Europe to boost GLP-1 capacity

In order to keep pace with the burgeoning demand for GLP-1 therapies, Swiss CDMO CordenPharma said it is investing € 900 million (US$ 981 million) to expand its peptide platform, both at its Colorado site and in Europe. It is the company’s biggest investment and will be used to construct a new facility in Europe for small to large-scale peptide development and manufacturing. The company expects to add about 400 new jobs.

Sanofi invests US$ 437 mn in India: Sanofi is looking to expand its workforce in India with an investment of € 400 million (US$ 437 million). The investment will further expand the French drugmaker’s site in Hyderabad, making it the largest amongst Sanofi’s four global capacity centers. The site presently employs about 1,000 people and its workforce is set to grow to 2,600 over the next couple of years.

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