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Janssen reports positive clinical trial data for its Xarelto to treat PAD effects

Johnson & Johnson’s (NYSE:JNJ) Janssen Pharmaceutical Companies recently announced analysis data on the benefits of Xarelto.

The Phase 3 Voyager PAD clinical trial evaluated the Xarelto (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in reducing severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization (LER).

Data from two analyses reinforced the benefit of Xarelto by demonstrating positive effects delivered by the vascular dose in PAD patients with and without chronic kidney disease (CKD) and in PAD patients with and without a history of statin therapy. Xarelto significantly reduced hospitalizations due to thrombotic events in patients who underwent LER compared to patients who took aspirin alone, Janssen said in a news release.

Voyager PAD, a study of 6,564 patients across 542 sites in 34 countries, randomized patients at a 1:1 ratio for receiving the Xarelt…

Janssen looks to win new indication in Europe for Imbruvica for untreated mantle cell lymphoma

Johnson & Johnson‘s Janssen unit (NYSE:JNJ) has filed a submission of a Type II variation application to the European Medicines Agency (EMA) for the potential approval of Imbruvica (ibrutinib) with bendamustine and rituximab (BR) to treat adults with previously untreated mantle cell lymphoma (MCL).

The indication would cover patients who are not suitable for autologous stem cell transplantation (ASCT).

Bendamustine is a chemotherapy drug while and rituximab is a monoclonal antibody that slows or stops cancer growth.

JNJ shares ticked up 0.38% to $169.36 today.

Ibrutinib was jointly developed by J&J’s Janssen Biotech unit and Pharmacyclics LLC, an AbbVie company.

Image courtesy of Janssen

In the U.S, the drug first won approval for mantle cell lymphoma in 2013. The drug has won a series of new indications since then.

A daily Bruton’s tyrosine kinase…

Janssen’s pathway strategy for immune-mediated inflammatory disease shows promise in gastroenterology

Tens of millions of Americans have immune-mediated inflammatory diseases (IMIDs), including conditions as diverse as rheumatoid arthritis, psoriasis, multiple sclerosis and inflammatory bowel disease.

Because such diseases have an inflammatory component, a single biologic could treat multiple IMIDs. “We are committed to investigating inflammatory pathways to develop therapies that can potentially address the immense unmet need for patients living with immune-mediated diseases,” said Dr. Jan Wehkamp, Janssen’s vice president, gastroenterology disease area leader.

And thus, a drug like Janssen’s Tremfya (guselkumab), which is now indicated to treat moderate-to-severe plaque psoriasis and psoriatic arthritis in adults, could find use in gastroenterological conditions such as Crohn’s disease (CD) or ulcerative colitis (UC).

Tremfya selectively blocks the p19 subunit of interleukin (IL)-23.

Johnson & Johnson inks agreement to have its COVID-19 vaccine manufactured in Africa

Johnson & Johnson (NYSE:JNJ) announced today that it completed an agreement for the manufacturing of its COVID-19 vaccine in Africa.

The landmark agreement, made between Johnson & Johnson’s Janssen Pharmaceuticals and South Africa-based Aspen SA Operations, allows for the first COVID-19 vaccine to be manufactured and made available by an African company for people living in Africa, with aims of increasing COVID-19 vaccination rates across the continent.

Get the full story at our sister site, Pharmaceutical Processing World.

Johnson & Johnson inks agreement to have its COVID-19 vaccine manufactured in Africa

Johnson & Johnson (NYSE:JNJ) announced today that it completed an agreement for the manufacturing of its COVID-19 vaccine in Africa.

The landmark agreement, made between Johnson & Johnson’s Janssen Pharmaceuticals and South Africa-based Aspen SA Operations, allows for the first COVID-19 vaccine to be manufactured and made available by an African company for people living in Africa, with aims of increasing COVID-19 vaccination rates across the continent.

According to a news release, only about 12% of people in Africa are fully vaccinated, which falls well short of the World Health Organization’s target of 70% population coverage for all countries. Johnson & Johnson has shipped more than 200 million vaccine doses to Africa through a combination of advance purchase agreements with the African Vaccine Acquisition Trust, South Africa and Gavi, the Vaccine Alliance, on behalf of the COVAX Facility, along with government donations.

The c…

Johnson & Johnson pauses COVID-19 vaccine production in Dutch plant

The plant will resume production of its COVID-19 vaccine in a matter of months, the paper reported. The company is also working to enlist other facilities to help produce the vaccine, but they are either currently not operational or haven’t received regulatory approval.

While the J&J vaccine has failed to find widespread use in wealthy countries, it remains popular in portions of the developing world, including much of Africa. The vaccine has less-demanding storage requirements than the first generation of mRNA vaccines and offers robust protection against a range of variants when administered as a two-dose series.

Get the full story from our sister site, Pharmaceutical Processing World.

Johnson & Johnson pauses COVID-19 vaccine production in Dutch plant

Johnson & Johnson (NYSE:JNJ) has decided to temporarily suspend production of its COVID-19 vaccine in Leiden in the Netherlands to prioritize production of an investigational respiratory syncytial virus (RSV) vaccine, according to The New York Times.

The plant will resume production of its COVID-19 vaccine in a matter of months, the paper reported. The company is also working to enlist other facilities to help produce the vaccine, but they are either currently not operational or haven’t received regulatory approval.

While the J&J vaccine has failed to find widespread use in wealthy countries, it remains popular in portions of the developing world, including much of Africa. The vaccine has less-demanding storage requirements than the first generation of mRNA vaccines and offers robust protection against a range of variants when administered as a two-dose series.

Image courtesy of Wikimedia Comm…

Janssen files for European authorization of bispecific antibody teclistama for multiple myeloma

Janssen (NYSE:JNJ) has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for approval of a T-cell redirecting, bispecific antibody to treat relapsed or refractory multiple myeloma (RRMM).

Known as teclistamab (JNJ-64007957), the bispecific antibody targets the B-cell maturation antigen (BCMA) and CD3.1.

In December 2021, Janssen submitted a Biologics License Application (BLA) to the FDA for approval of teclistamab to treat relapsed or refractory (R/R) multiple myeloma.

That same month, EMA granted accelerated assessment for teclistamab.

In the EMA application, Janssen included data from the MajesTEC-1 study testing teclistamab in adults with RRMM.

“We are pleased to announce the submission of teclistamab to the European Medicines Agency. Once again, this shows our commitment to continue to provide innovative, transformative therapies for patients with relapsed or refractory multiple myeloma,” said …

Leyden Labs closes $140M in Series B funding

After announcing a licensing deal for CR9114, a monoclonal antibody for influenza A and B from Janssen (NYSE:JNJ), Leyden Labs has won $140 million in Series B funding.

Amsterdam-based Leyden Labs plans on developing an intranasal spray based on CR9114.

Leading the round were Casdin Capital and GV (formerly Google Ventures).

Leyden plans on using the most recent funding round to advance its pipeline dedicated to targeting a range of respiratory viruses.

In March, Leyden Labs won €40 (approximately $45) million in Series A financing in a round led by GV.

The company notes that its total fundraising is approximately $200 million.

The most recent funding round “underscores our investors’ belief that Leyden Labs’ platform can generate cornerstone products to combat respiratory diseases,” said Koenraad Wiedhaup, a founder and CEO of Leyden Labs, in a press release. “The ongoing COVID-19 pandemic teaches us we need to expand our arsenal of…

Leyden Labs licenses monoclonal antibody for influenza A and B from Janssen

Janssen (NYSE JNJ) and Leyden Labs (Amsterdam) have signed a licensing agreement that gives the latter rights to develop CR9114, an antibody protecting against influenza A and B.

Leyden hopes to commercialize CR9114 as a nasal spray.

Under the terms of the deal, Janssen will get an upfront payment and could receive milestone payments tied to development- and sales-based milestones. Additionally, Janssen stands to receive tiered royalty payments if CR9114 is commercialized.

While COVID-19 continues to dominate the news landscape, influenza continues to kill roughly 20,000 people each year, according to CDC.

Preclinical data shows that CR9114 guards against influenza A and B.

“We believe that mucosal protection and treatment with CR9114 will provide people further control to protect themselves from seasonal flu,” said Koenraad Wiedhaup, CEO of Leyden Labs. “Importantly, CR9114 could also play a key role in preventing future flu pandemics.” Read more

Xarelto wins two additional pediatric indications

Janssen (NYSE:JNJ) has received FDA approval for two new indications for the blockbuster blood thinner Xarelto (rivaroxaban).

The first new indication relates to treating venous thromboembolism (VTE, or blood clots) and reducing the risk of recurrent VTE in pediatric individuals from birth to less than 18 years after at least five days of parenteral anticoagulant treatment.

The second involves using rivaroxaban as a thromboprophylaxis in children at least two years older with congenital heart disease who underwent the Fontan procedure.

Xarelto now has 11 indications in the U.S., more than any other direct oral anticoagulant (DOAC).

Last year, the drug brought in almost $6.5 billion in international revenue.

To win the two new approvals, Janssen submitted data from the EINSTEIN-Jr and UNIVERSE Phase 3 trials.

Pfizer and Bristol Myers Squibb worked with Janssen to develop rivaroxaban.

In related news, a recent study found that o…

Janssen EMEA gets conditional marketing authorisation for Rybrevant in NSCLC patients

Janssen (NYSE:JNJ) has received European authorisation for Rybrevant (amivantamab-vmjw) to treat adults with non-small cell lung cancer (NSCL) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Rybrevant is a fully-human EGFR-MET bispecific antibody.

NSCL is responsible for the majority of lung cancers.

The Conditional Marketing Authorisation (CMA) covers patients who have failed platinum-based chemotherapy.

Amivantamab is the first treatment to win approval in the EU specific to EGFR exon 20 insertion mutations for NSCLC. “Patients with NSCLC harboring EGFR exon 20 insertion mutations represent a specific population who have been underserved by current treatment options that are limited in both number and efficacy,” said Dr. Antonio Passaro, Medical Oncologist at the Division of Thoracic Oncology of the European Institute of Oncology, in a press release.

Clinical trials for amivantamab are underway for sol…