Sanofi, Astra’s RSV med bags nod in Europe, UK; GSK’s blood cancer drug flunks late-stage trial

By PharmaCompass

2022-11-10

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Sanofi and AstraZeneca’s Beyfortus has been authorized in both Europe and the UK as the first preventive treatment for respiratory syncytial virus (RSV) disease in newborns and infants. RSV is a common and highly contagious viral disease that infects children below two years.

The US Food and Drug Administration (FDA) has approved Regeneron’s Libtayo in combination with platinum-based chemotherapy as a first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations. And England’s NICE has recommended Merck’s blockbuster drug Keytruda in combination with chemotherapy in adults with early-stage triple-negative breast cancer who are at high risk of recurrence or locally advanced breast cancer.

Two years after receiving an accelerated approval, GSK’s Blenrep has flunked a phase 3 trial for relapsed or refractory multiple myeloma, putting at risk the drug’s continued approval in the US.

Ipsen’s pancreatic cancer treatment — Onivyde in combination with 5 fluorouracil/leucovorin and oxaliplatin (Nalirifox regimen) — has hit the mark in a phase 3 pancreatic cancer trial. Despite Ionis Pharmaceuticals posting positive mid-stage results for its thrombosis prevention candidate, fesomersen, partner Bayer has decided to return the rights of the drug back to the biotech.

In deals, Australian vaccine maker CSL Seqirus has inked a potential US$ 4.5 billion licensing deal with Arcturus Therapeutics to gain access to the US drug developer’s messenger RNA vaccine technology. Viatris will acquire two eye disease drug developers — Oyster Point Pharma and Famy Life Sciences — for around US$ 700 million. And Sanofi has entered into a potential US$ 1.2 billion partnership with artificial intelligence-based drug development firm Insilico Medicine to develop drugs for up to six new targets.

In court cases, the US Supreme Court has declined to hear a bid by Bristol Myers Squibb’s Juno Therapeutics to reinstate a US$ 1.2 billion award in its patent fight with Gilead Sciences’ subsidiary Kite Pharma over lymphoma drug Yescarta. A federal court in Boston has ordered Eli Lilly to pay Teva Pharmaceuticals US$ 176.5 million post a trial to determine whether its migraine drug Emgality infringed three Teva patents. Meanwhile, the US Supreme Court has agreed to hear Amgen’s bid to revive two patents of its cholesterol medication Repatha that were previously invalidated by a lower court following a legal challenge by Regeneron and Sanofi.

Sanofi, Astra’s drug bags EU, UK nod as first preventive RSV treatment in infants

A week after Pfizer said its respiratory syncytial virus (RSV) vaccine is highly effective at protecting newborns when the shot is administered to mothers late in their pregnancy, Sanofi and AstraZeneca made history in Europe by bagging authorization for their own RSV med.

The duo’s drug — Beyfortus (nirsevimab) — has been authorized in Europe as the first preventive treatment for RSV lower respiratory tract disease in a broad population of newborns and infants. And four days after bagging the European Commission’s approval, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) also approved nirsevimab. RSV is a common and highly contagious seasonal viral disease that infects children below two years.

The long-acting single-dose intramuscular injection has been authorized for broad use in infants, including those born healthy, preterm children and children with certain medical conditions.

The nod for the monoclonal antibody is based on data from multiple clinical programs. Data from a phase 3 trial showed that Beyfortus provided a 74.5 percent reduction in lower respiratory tract infections caused by RSV requiring medical care in healthy infants. In the US, nirsevimab is still under regulatory review as a potential breakthrough therapy.

Meanwhile, data shared by Pfizer last week pointed out that its RSV vaccine is 81 percent effective at preventing severe lower respiratory tract illnesses in infants in the first three months. And in the infant’s first six months, the vaccine was about 70 percent effective at preventing severe illness requiring hospitalization or assisted breathing. Pfizer said it will apply to the FDA for the approval of the vaccine by the end of this year.

FDA panel votes in favor of Astra’s new asthma drug: The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted overwhelmingly (16 to 1) in favor of AstraZeneca and Avillion’s PT027 (albuterol/budesonide) for the treatment of asthma in people aged 18 years and older. The panel said the benefits of the drug outweigh the risks. However, the panel delivered a split decision on adolescent use and voted against its approval in children.

GSK’s blood cancer drug flunks late-stage confirmatory trial

Two years after receiving an accelerated approval, GSK’s Blenrep (belantamab mafodotin) has flunked a phase 3 trial for relapsed or refractory multiple myeloma, putting at risk the drug’s continued approval in the US.

In a study of 325 adults, Blenrep failed to extend progression-free survival when compared to the standard-of-care combo – Bristol Myers Squibb’s Pomalyst and the steroid dexamethasone (PomDex). Patients on GSK’s antibody-drug conjugate lived a median of 11.2 months without their disease worsening or death, compared to a median of seven months for those given PomDex. The difference, however, was not enough to meet the study’s threshold for success. Blenrep also did not do well at shrinking tumors, and had a response rate of 41 percent versus 36 percent for the control group.

Blenrep had won an FDA accelerated approval in 2020 for treating myeloma patients after four prior therapies. Two other studies testing Blenrep in multiple myeloma treatment are ongoing, with results expected in the first half of 2023.

Meanwhile, Pfizer’s investigational cancer drug elranatamab has received a breakthrough therapy designation from the FDA for the treatment of patients with relapsed or refractory multiple myeloma.

CSL Seqirus inks potential US$ 4.5 billion mRNA vaccine deal with Arcturus

Last week, Australian vaccine maker CSL Seqirus inked a licensing deal with Arcturus Therapeutics to gain access to the US drug developer’s messenger RNA vaccine technology. CSL Seqirus will pay the San Diego-based biotech US$ 200 million upfront for an exclusive license to its next generation mRNA technology to develop vaccines for influenza, Covid-19, pandemic preparedness and three other common respiratory infectious diseases. Arcturus will also be eligible for over US$ 4.3 billion in potential milestone payments along with profits and royalties.

Viatris acquires two eye drug developers for around US$ 700 million: Viatris has announced it will acquire two eye disease drug developers — Oyster Point Pharma and Famy Life Sciences — for around US$ 700 million. Under the first deal, Viatris is buying New Jersey-based Oyster Point for around US$ 424 million in cash. The generics drugmaker will pay the biopharma US$ 11 per share along with US$ 2 per share in a contingent value right if certain milestones are met. The deal will give Viatris access to Tyrvaya, a nasal spray treatment for dry eye disease, along with other drug candidates. In the second deal, Viatris is acquiring privately-held Famy for approximately US$ 281 million. Famy will add drug candidates for dry eye, blepharitis and presbyopia to Viatris’ ophthalmology portfolio.

Sanofi inks AI drug discovery pact with Insilico Medicine: Sanofi has entered into a potential US$ 1.2 billion partnership with Insilico Medicine, an artificial intelligence-based drug development firm. The two companies will work together to develop drugs for up to six new targets using Insilico’s AI platform, Pharma.AI. Sanofi will pay Hong Kong-based Insilico US$ 21.5 million to cover upfront and target nomination fees, with further milestone payments stretching to over US$ 1.2 billion along with tiered royalties.

England recommends Merck’s Keytruda for early-stage triple-negative breast cancer

England’s National Institute for Health and Care Excellence (NICE) has recommended Merck’s blockbuster drug Keytruda (pembrolizumab) along with chemotherapy in adults with early-stage triple-negative breast cancer (TNBC) who are at high risk of recurrence or locally advanced breast cancer. The combo treatment can be used before surgery to attempt a reduction in the size of the tumor (neoadjuvant treatment). Keytruda can also be used as a solo treatment after surgery (adjuvant treatment).

The decision marks the first time for patients in England with TNBC who will be able to access immunotherapy at an earlier stage, reducing the risk of their cancer returning and resulting in more positive treatment outcomes. Keytruda’s recommendation is based on data from a phase 3 trial where Keytruda reduced the chance of the disease returning, worsening or death by nearly 40 percent. According to NICE, the recommendation will open Keytruda’s use to around half of the roughly 3,200 people with TNBC in England and Wales.

Regeneron’s Libtayo-chemo combo bags FDA nod for lung cancer: Regeneron Pharmaceuticals has announced that the FDA has approved its PD-1 inhibitor — Libtayo (cemiplimab-rwlc) — in combination with platinum-based chemotherapy as a first-line treatment for adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations. Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemo-radiation. Patients may be treated with this combination irrespective of PD-L1 expression or histology. The only other PD-1 targeting agent approved to treat NSCLC as a monotherapy in the frontline setting is Merck’s Keytruda.

Ipsen’s US$ 1 billion drug hits the mark in late-stage pancreatic cancer trial

A regimen involving Ipsen’s pancreatic cancer treatment Onivyde in combination with 5 fluorouracil/leucovorin and oxaliplatin (Nalirifox regimen) has helped newly diagnosed patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) extend their lives in a phase 3 trial. Ipsen had purchased the drug from Merrimack Pharmaceuticals under a potential US$ 1 billion deal in 2017.

The French pharma said the Onivyde combo demonstrated a statistically significant improvement in overall survival compared to a nab-paclitaxel plus gemcitabine regimen. The study also met the secondary endpoint of progression-free survival.

Ipsen now plans to seek FDA approval for the Onivyde combo as a treatment for newly diagnosed mPDAC patients. The drug, in combination with fluorouracil and leucovorin, is approved in the US, Europe and Asia as a treatment for mPDAC after disease progression and following gemcitabine-based therapy.

Lilly, Boehringer touts positive phase 3 results of its diabetes drug: Boehringer Ingelheim and partner Eli Lilly said their diabetes drug Jardiance slowed the progression of chronic kidney disease (CKD) in a late-stage trial. The partners said Jardiance cut the risk of CKD progression and cardiovascular death by 28 percent in the phase 3 trial.

Positive data for Amgen’s obesity drug: An experimental drug from Amgen helped obese people lose up to 15 percent of their body weight in a phase 1 study. In the trial, Amgen tested low and high doses of the drug – AMG 133 – against a placebo in 110 volunteers. After 85 days, patients given three low doses of AMG 133 spaced four weeks apart lost 7 percent of their body weight, while those given three high doses lost 15 percent. The pharma now plans to initiate a phase 2 study early next year.

Bayer returns thrombosis drug to Ionis despite positive phase 2 results

Despite Ionis Pharmaceuticals posting positive mid-stage results for its thrombosis prevention candidate, fesomersen, partner Bayer has decided to return the rights of the drug back to the biotech. The German company has invested over US$ 200 million as part of a 2015 licensing deal with Ionis.

Bayer said it is returning the rights and licenses to Ionis, which will have the full rights to continue the clinical development and future commercialization of fesomersen. Instead, Bayer said it has decided to focus on the development of its own blood thinner drug candidate, asundexian. The drugmaker is planning to initiate phase 3 studies of the drug. Ionis said it is looking for a new partner for fesomersen.

Meanwhile, Ionis announced positive data from a phase 2 study of its experimental drug candidate IONIS-FB-L as a potential treatment for patients with immunoglobulin A nephropathy (IgAN), also known as Berger’s disease. Data showed the drug reduced proteinuria by 44 percent after 29 weeks. Roche is now planning to initiate a late-stage clinical trial of the drug in the first part of 2023.

US apex court rejects BMS’ bid for US$ 1.2 billion award in patent fight with Gilead

The US Supreme Court has declined to hear a bid by Bristol Myers Squibb’s Juno Therapeutics to reinstate a US$ 1.2 billion award in its five-year patent fight with Gilead Sciences’ subsidiary Kite Pharma over lymphoma drug Yescarta.

The SC decision comes a year after a federal appeals court overturned the fine against Gilead’s Kite Pharma for allegedly copying and commercializing a patented CAR-T technology by BMS’ subsidiary Juno Therapeutics. Gilead said the SC decision has “effectively ended” the dispute. Gilead’s Yescarta, along with BMS’ Breyanzi, are approved in the US to treat certain patients with large B-cell lymphoma.

Agrees to hear Amgen’s bid to revive cholesterol drug patents: The US Supreme Court has agreed to hear Amgen’s bid to revive two patents of its cholesterol medication Repatha that were invalidated by a lower court following a legal challenge by Regeneron and Sanofi.

Amgen had first sued Regeneron and Sanofi in 2014 over rival drug Praluent, which functions using a similar mechanism as Repatha. In 2019, a Delaware judge had first sided with Sanofi and Regeneron after a series of wins by Amgen. In 2021, the US Court of Appeals had upheld the lower court’s decision. The two monoclonal antibody drugs had won US approval in 2015.

Lilly to pay US$ 176.5 million to Teva in migraine drug patent case: A federal court in Boston has ordered Eli Lilly to pay Teva Pharmaceuticals US$ 176.5 million post a trial to determine whether its migraine drug Emgality infringed three Teva patents.

The jury agreed with Teva that Lilly’s Emgality violated its rights in the patents, which relate to its own migraine drug Ajovy. Both drugs treat migraines by employing antibodies to inhibit headache-causing peptides.

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