Only two months after the Federal Trade Commission (FTC) said it was eyeing a crackdown on “improper” patents listed at the FDA, the agency has filed a challenge against more than 100 patents in the agency’s Orange Book. The patents cover drugs marketed by the likes of AbbVie, AstraZeneca, Boehringer Ingelheim, GSK and Teva, among other companies, the FTC said in a Tuesday release. In all, the commission has sent letters to 10 companies notifying them of the patent disputes. The FTC argues “improper” listings in the FDA’s Orange Book—the registry of patents on approved medicines—can throw up hurdles to competition in the drug industry. Specifically, improper patents can trigger regulatory delays for would-be generics challengers and throw up legal hurdles for generics players, the commission says. Some of the medicines targeted in this crackdown include AbbVie’s Restasis and Viatris’ EpiPen autoinjectors. As the antitrust agency points out, FDA regulations ...
By Tyler Patchen While Moderna’s total revenue for the third quarter beat Wall Street expectations, the vaccine maker on Thursday posted a loss as demand for its COVID-19 shots declined. Moderna announced that overall sales for the third quarter were $1.8 billion, down from $3.4 billion in the same period of 2022. Net product sales for Moderna were also down 44% from last year due to a “lower sales volume” but partially offset by a higher average selling price the company unveiled. In the third quarter, Moderna said it saw charges of $1.3 billion for “inventory writedowns,” which were related to “excess and obsolete COVID-19 products.” Investors were not pleased as Moderna’s stock price fell over 15% pre-market on Thursday. “Through this quarter, we demonstrated our ability to increase share in the U.S. market, and we now expect this year’s vaccination rate to be similar to last fall,” Moderna CEO ...
As COVID revenues dwindle for pandemic stalwart Pfizer, the company is turning attention to its respiratory syncytial virus (RSV) vaccine launch and a potential entry into the hot obesity market. With only five months of sales under its belt, Pfizer’s RSV vaccine Abrysvo is “doing better than we thought,” Chief Commercial Officer Angela Hwang said on the company’s third-quarter earnings call, touting “very fast uptake” for the new shot. After a pair of approvals in late May and August, Abrysvo pulled in revenues of $375 million during the third quarter, Pfizer said Tuesday. Earlier this year, the shot won FDA nods to immunize older adults and then as a maternal vaccination to protect infants. In both settings, the Pfizer offering is facing off against Big Pharma competition. In the adult RSV vaccine marketplace, Pfizer is challenging GSK and its immunization Arexvy. GSK is set to report its third-quarter results Wednesday. ...
The Danish artificial intelligence (AI) biotech Evaxion has announced plans to develop an mRNA vaccine against gonorrhea in partnership with Afrigen Biologics. Gonorrhea antigens identified through Evaxion’s EDEN platform have shown strong protective effects in preclinical trials, as per the company. The partnership will investigate the function of these antigens when presented in the mRNA form. After the validation phase, the partners will discuss an agreement for clinical development and commercialisation, with the opportunity to involve additional collaborators. Cape Town, South Africa-based Afrigen Biologics is set up as a specialised centre to support mRNA vaccine development and technology transfer, will take charge of developing the mRNA vaccine in low and middle-income countries and African territories. Gonorrhea is a sexually transmitted infection, caused by the bacteria Neisseria gonorrhoeae. It heightens the vulnerability to HIV, a prevalent health concern in many low and middle-income countries (LMICs). Birgitte Rønø, Evaxion’s Chief Scientific Officer ...
It’s a boom time in the cell and gene therapy market, with manufacturers making moves to secure a larger piece of the pie. Wednesday, two CDMOs revealed acquisitions that will bolster their production capabilities and increase their global presence. Korean manufacturer SK pharmteco has taken a controlling stake in the Philadelphia-based Center for Breakthrough Medicines (CBM) for an undisclosed sum. Meanwhile, England’s Oxford Biomedica said it is in talks with Institut Mérieux to buy out its subsidiary, ABL Europe, for 15 million euros ($16 million). SK’s move comes after it invested $350 million in CBM in January of last year. As part of the agreement, SK had an option to increase its stake, which it exercised, becoming its largest stockholder. CBM was established in 2019 at a former GSK site. The prior funding allowed CBM to begin building end-to-end manufacturing capabilities. SK boasted that the site will be the world’s ...
Biopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. Analysts anticipate that the trend will continue in 2023 and into 2024 as companies attempt to beef up their portfolios.During second quarter earnings calls, many heavy-hitters—including Johnson & Johnson, Bristol Myers Squibb and Merck—expressed urgency in their quest for deals. With so many buyers in competition, sellers are finding offers that are more attractive. For example, Merck’s $10.8 billion proposal to acquire Prometheus in April came at a 75% premium. In July, Biogen’s $7.3 billion deal for Reata represented a 59% markup. “There’s been such a consistent pick up in momentum in anything above a billion [dollars],” Cody Powers, an M&A expert with ZS Principal, said in an interview. “I think we’re back on the gravy train of where we were a couple of years ago in terms of premiums.” In 2019, the industry ...
Pfizer’s respiratory syncytial virus (RSV) vaccine has been approved by the European Commission (EC) to protect both infants and older adults against RSV-caused lower respiratory tract disease (LRTD). The EC’s decision allows Abrysvo to be given as a single dose to adults aged 60 years and older, and those who are 24 to 36 weeks into their pregnancy to protect their babies from birth until they are six months old. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can cause severe illness in young infants and older adults. In the EU, about 245,000 yearly hospital admissions have been associated with RSV in children aged under five years, while the virus is estimated to cause more than 270,000 hospitalisations in older adults each year. The EC’s decision, which follows a recent recommendation from the European Medicines ...
As GSK’s ViiV Healthcare looks to widen the reach of its HIV franchise, Médecins Sans Frontières (MSF) has been working to secure access to the company’s long-acting HIV prevention drug, Apretude, for more than a year. Now, the organization is airing grievances about the negotiation process with an open letter to ViiV’s executive team. MSF is calling on the company to take out what it says are problematic new amendments to the proposed purchase agreement. Since last June, MSF has been stuck in contract negotiations with ViiV for Apretude, according the letter from Sidney Wong, executive co-director of MSF’s access campaign, and Philip Aruna, team leader for MSF’s southern Africa region. The sides almost reached a deal in December, but ViiV subsequently changed the terms because of supply limitations, Wong and Aruna wrote. Thanks to last-minute edits that deviate from standard MSF purchase agreements, the new contract more closely resembles ...
Following FDA approvals for fellow PAPR inhibitors made by AstraZeneca/Merck and Pfizer, Johnson & Johnson has got its own combo approval in prostate cancer. The tablet treatment, known commercially as Akeega, combines J&J’s androgen-directed Zytiga (abiraterone acetate) and the PARP inhibitor niraparib, which is sold by GSK as Zejula in other indications. The FDA has signed off on its use along with the corticosteroid prednisone, but only in a subset of mCRPC patients—those with BRCA mutations. Akeega will compete with AstraZeneca and Merck’s Lynparza as well as Pfizer’s Talzenna in the indication. Eleven weeks ago, the FDA gave Lynparza the same narrow label for those with the BRCA-positive tumors. Talzenna’s approval covers a broader population, including other mutations in the homologous recombination deficiency family. Under a 2016 deal with Zejula’s developer Tesaro, J&J carved out rights to the drug in prostate cancer. GSK then bought out Tesaro in 2019. The ...
CS Pharmaceuticals (CSP) has acquired AxeroVision for an undisclosed fee, in a move that will involve a dry eye disease (DED) candidate being transferred over to the UK-based ocular therapeutics company. CSP, which is headquartered in London but develops and commercialises treatments for eye diseases in China, will continue developing AXR-270, a selective glucocorticoid receptor agonist. The drug has been in a phase of developmental dormancy. In August 2021, AxeroVision released positive Phase II results for the candidate in 129 patients with DED with meibomian gland dysfunction (MGD). In a statement announcing the 2021 results, AxeroVision – which spun out from GSK in 2016 – said it was planning to enrol around 800 patients in a Phase III trial comparing the eye cream with a vehicle, and a new drug application/marketed authorisation application filing expected in 2024. However, the company did not issue any further updates on the drug since ...
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