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Moderna sues Pfizer-BioNTech over mRNA technology; three Biocon units hit by FDA’s Form 483s
In pharma news this week, Moderna has filed two lawsuits – one in the US and another in Germany – against rival coronavirus vaccine makers Pfizer and BioNTech alleging that the partners copied its patented messenger RNA technology to create their own Covid-19 shot.
Novartis has decided to spin off its generics unit Sandoz to sharpen its focus on patented prescription medicines. The Swiss pharma expects the spin off to be completed by the second half of 2023.
In regulatory news, the US Food and Drug Administration (FDA) has issued Form 483s with 11 observations each to two Biocon Biologics facilities in Bengaluru, India. Another Biocon plant in Johor, Malaysia, has also received a Form 483 with six observations. The agency has also handed a Form 483 to a facility owned by Aurobindo Pharma’s US-based subsidiary.
In approvals, Sanofi’s rare disease drug Xenpozyme (olipudase alfa) has bagged FDA approval to treat adult and pediatric patients with non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) – a rare, progressive and potentially life-threatening genetic disease. The European Commission has granted conditional marketing authorization to Johnson & Johnson’s Tecvayli as a monotherapy to treat adult patients with relapsed and refractory multiple myeloma (RRMM). The EC has also granted authorization to BioMarin’s one-time gene therapy — Roctavian — to treat adults with severe hemophilia A who need regular treatments to prevent bleeding episodes. Meanwhile, Sanofi’s hemophilia A drug has bagged FDA’s priority review status.
AstraZeneca has bagged several drug approvals in Japan. Its diabetes med Farxiga has shown significant reduction in the risk of hospitalization and death in people with all types of heart failure. And Delaware-based biotech Incyte’s cancer drug Pemazyre has received an add-on approval to treat a group of very rare and aggressive blood cancers known as myeloid/lymphoid neoplasms (MLNs).
Pfizer has said its experimental respiratory syncytial virus (RSV) vaccine, RSVpreF, has achieved a vaccine efficacy of 66.7 percent against RSV-associated lower respiratory tract illness. And buyout talks between Merck and Seagen have hit a roadblock with the two companies failing to agree on a price.
Moderna sues Pfizer-BioNTech over mRNA tech infringement
Moderna has filed two lawsuits – one in the US and another in Germany – against rival coronavirus vaccine makers Pfizer and BioNTech alleging that the partners copied its patented messenger RNA technology to create their Covid-19 shot.
According to Moderna, the duo copied two key elements of its patent-protected technologies. The first alleged infringement is of the mRNA structure that Moderna has claimed its scientists started working on in 2010 and were the first to demonstrate in human trials in 2015. In their Covid-19 vaccine, Pfizer-BioNTech made the same chemical modification to the mRNA to help it evade the immune system, Moderna has alleged.
The second is related to the coding of a spike protein that Moderna claims to have developed while manufacturing a shot for the coronavirus that causes Middle East Respiratory Syndrome (MERS).
Pfizer said it was “surprised” by Moderna’s lawsuit and will “vigorously defend” itself against the allegations. BioNTech said its “work is original,” and it will vigorously defend against all allegations of patent infringement.
Meanwhile, the FDA has amended the emergency use authorizations (EUAs) of Moderna and Pfizer-BioNTech’s Covid-19 vaccines to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months after primary or booster vaccination. The bivalent vaccines contain two mRNA components of SARS-CoV-2 virus, the original strain and the other one for the Omicron variant.
Novartis to spin off its generics business Sandoz next year
Novartis has decided to spin off its generics unit — Sandoz — into a publicly traded, standalone business to sharpen its focus on patented prescription medicines. Novartis expects the spin off to be completed by the second half of 2023. Once separated, Sandoz will become Europe’s largest generics company, Novartis has said. The strategic review of Sandoz had been initiated in October.
Meanwhile, the drugmaker plans to shut down its Sandoz oral solid dosage plant in Wilson, North Carolina, by the end of 2023. The plant makes tablets and capsules for Canada and the US. The 246 employees working at the plant have been informed about the closure. Novartis is also closing additional office space in Durham, North Carolina.
Europe approves chronic myeloid leukemia med: The European Commission has approved Novartis’ Scemblix (asciminib) for the treatment of adult patients with chronic myeloid leukemia (CML), previously treated with two or more tyrosine kinase inhibitors (TKIs).
FDA issues Form 483s to three Biocon Biologics facilities in India, Malaysia
The FDA has issued Form 483s with 11 observations each to two Biocon Biologics facilities in Bengaluru, India. Another Biocon Biologics plant in Johor, Malaysia, has also received a Form 483 with six observations.
The agency conducted three on-site inspections of Biocon Biologics’ seven manufacturing facilities across two sites in Bengaluru and one at Johor between August 11 and 30.
Biocon said the inspections pertained to biosimilar bevacizumab, rh-insulin and insulin aspart and a capacity expansion inspection for biosimilar trastuzumab. The inspections also included multiple drug substance and drug product facilities and other support infrastructure at these sites.
The agency’s observations suggest the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications and computerized tools to aid risk assessment and investigations and other procedural and facility upgrades, Biocon said. The drugmaker plans to submit its corrective and preventive action to the FDA within the stipulated time frame.
Form 483 to Aurobindo’s US subsidiary: The FDA has also issued a Form 483 with one observation to a facility owned by Aurobindo Pharma’s US-based subsidiary, Aurolife Pharma. The observation is procedural in nature and there are no data integrity issues, the drugmaker said. The facility manufactures metered dose inhalers and derma products.
J&J’s Tecvayli bags first authorization in Europe for multiple myeloma
The European Commission has granted conditional marketing authorization to Johnson & Johnson’s Tecvayli (teclistamab) as a monotherapy to treat adult patients with relapsed and refractory multiple myeloma (RRMM). Patients who have received at least three prior therapies and have witnessed disease progression on the last therapy can receive the treatment. This is the first approval for the bispecific antibody. Tecvayli is now up against J&J and Legend’s Carvykti and Bristol Myers Squibb’s Abecma.
AbbVie, J&J’s Imbruvica wins first pediatric nod: The FDA has approved the expanded use of J&J and AbbVie’s Imbruvica as a treatment for chronic graft versus host disease (cGVHD) in children one year and above. The nod is for a second line use. GVHD is a life-threatening complication that occurs when the donor’s white blood cells attack the recipient’s cells after blood or bone marrow stem cell transplants.
Merck’s bid to buy Seagen stalls: Last month, we had carried news about Merck being in talks to buy Seagen for an estimated US$ 40 billion. According to news reports, the talks between Merck and Seagen seem to have hit a roadblock with the two companies failing to agree on a price. The potential deal still remains on the table and can happen soon, a Bloomberg report said.
Pfizer posts positive phase 3 trial results for RSV vaccine, closes in on GSK
Pfizer is closing in on GSK in the respiratory syncytial virus (RSV) vaccine race. In a placebo-controlled trial with about 37,000 participants, Pfizer’s experimental drug candidate, RSVpreF, has achieved a vaccine efficacy of 66.7 percent against RSV-associated lower respiratory tract illness, defined by two or more symptoms. In a more severe version of the disease, defined by the presence of three or more symptoms, the vaccine’s efficacy jumped to 85.7 percent. The data monitoring committee indicated that the therapy was well-tolerated with no safety concerns. Rivals GSK, Moderna and Johnson & Johnson are also in the race to finish their RSV vaccine trials.
BioMarin’s Roctavian bags EU nod, becomes first gene therapy for hemophilia A
The European Commission has granted conditional marketing authorization to BioMarin’s one-time gene therapy Roctavian (valoctocogene roxaparvovec) to treat adults with severe hemophilia A who need regular treatments to prevent bleeding episodes. With this authorization, Roctavian has become the first hemophilia A gene therapy to be approved anywhere in the world.
People who have hemophilia A lack the factor VIII protein that aids in the clotting of blood. Roctavian delivers a functional gene into the patient, which is designed to enable the body to produce factor VIII on its own. The FDA had handed a CRL to the therapy in August 2020, requesting more follow-up data. BioMarin now plans to resubmit its application to the agency by the end of September.
Sanofi’s hemophilia A drug gets FDA’s priority review status: Two months after being granted a breakthrough therapy designation, Sanofi and its partner Sobi’s investigational hemophilia A drug — efanesoctocog alfa — has received a priority review from the FDA. The agency is slated to review the drug by February 28, 2023.
Astra says Farxiga cuts death risk for all forms of heart failure
An analysis of a late-stage trial of AstraZeneca’s blockbuster diabetes drug Farxiga (dapagliflozin) has shown that the drug significantly reduces the risk of hospitalization and death in people with all types of heart failure. According to the pharma giant, Farxiga is the first heart failure drug to show mortality benefit across all forms of heart failure.
The oral drug also reduced the risk of hospitalization due to heart failure by 29 percent irrespective of patients’ left ventricle ejection fraction (LVEF) range. Ejection fraction measures the heart's ability to pump oxygen-rich blood into the body.
AstraZeneca is planning to submit its application with the FDA for the expanded use of the drug. Farxiga is already approved in type 2 diabetes, chronic kidney disease and certain heart failure patients. If approved, it will compete against rival SGLT2 inhibitors – Novartis’ Entresto and Eli Lilly and Boehringer Ingelheim’s Jardiance.
Temporarily stops former exec from joining GSK: Hours before its outgoing executive Chris Sheldon was to take up a position at GSK, AstraZeneca has blocked the move in a court in London. The court granted Astra an injunction in the legal battle. Astra had first sued Sheldon in July, alleging that his joining GSK before February 2023 would result in a breach of a noncompete agreement that’s valid for six months.
Bags drug approvals in Japan: AstraZeneca’s long-acting antibody combination Evusheld (tixagevimab and cilgavimab) has been approved in Japan for both prevention (pre-exposure prophylaxis) and treatment of symptomatic disease caused by SARS-CoV-2 infection. The Japanese regulatory agency has granted back-to-back approvals to three rare disease treatments from Astra. This includes Astra and Merck’s Lynparza (olaparib) for the adjuvant treatment of patients with BRCA-mutated, HER2-negative early breast cancer, who are at high risk of recurrence; Tagrisso (osimertinib) for the adjuvant treatment of patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after surgery; and Ultomiris (ravulizumab) to treat adult patients with generalized myasthenia gravis (gMG).
After approvals in Japan, Europe, Sanofi’s rare disease drug gets FDA’s thumbs up
Months after Japan and Europe granted marketing authorization to Sanofi’s Xenpozyme (olipudase alfa) to treat a rare genetic disease known as Niemann-Pick, the drug has scored an approval in the US. The FDA has approved the intravenously infused treatment for non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) – a rare, progressive and potentially life-threatening genetic disease. This is the first drug to be approved for the disease in the US.
Amgen’s Lumakras beats chemo in late-stage NSCLC study: Amgen’s cancer drug Lumakras has outperformed chemotherapy in a late-stage clinical trial. The drug beat chemotherapy to meet its primary goal of extended progression-free survival, a measure of how long patients can go without their cancer growing, in patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) who had previously received other drugs. Amgen said Lumakras showed significant survival benefit compared to intravenous docetaxel chemotherapy, the standard of care, in a phase 3 study. Lumakras is the first and only targeted drug approved by the FDA to treat KRAS G12C-mutated NSCLC.
Incyte’s cancer drug bags add-on approval to treat aggressive blood cancers
Delaware-based biotech Incyte’s cancer drug Pemazyre has received an add-on approval to treat a group of very rare and aggressive blood cancers known as myeloid/lymphoid neoplasms (MLNs). The drug can now be used to treat adults who have MLNs which didn’t respond to a previous therapy or progressed even after it, and who have fibroblast growth factor receptor 1 (FGFR1) rearrangement. The drug was originally approved in 2020 as a treatment for bile duct cancer.
Bayer’s Kerendia trial: Bayer has said its drug Kerendia has been successful at reducing the risk of sudden cardiac death across a range of patients with early- to late-stage chronic kidney disease (CKD) and diabetes. Kerendia reduced the risk of sudden cardiac death by 25 percent versus placebo. It also cut the risk of death from a cardiovascular event by 18 percent. These results came from two late-stage trials that enrolled 13,000 patients.
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