Genmab (GMXAY) announced that worldwide net sales of DARZALEX as reported by Johnson & Johnson (JNJ) were $629M in the first quarter. Net sales were $352M in the U.S. and $277M in the rest of the world. Genmab will receive royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.
Tuesday, April 16, 2019
Recro Pharma extends supply agreement with CDMO division, Teva
Recro Pharma (REPH) announced that its CDMO division, has amended its existing license and supply agreement with Teva (TEVA) to extend the agreement for six years, effective January 1. Under the terms of the amended agreement, Recro Gainesville will continue to supply Teva with Verapamil SR capsules through 2024 and Teva will continue to be Recro Gainesville’s exclusive United States distributor of the product, for which Recro Gainesville is the new drug application holder. The Teva agreement provides to Recro Gainesville the same revenue economics as the original agreement, including both manufacturing and profit sharing components. Prior to this amendment, the license and supply agreement with Teva for Verapamil SR was renewable on a year-to-year basis.
Biofrontera reports secondary endpoint results from Phase 3 PDT study
Biofrontera reported results for the secondary endpoints of its Phase 3 clinical trial evaluating the safety and efficacy of conventional photodynamic therapy, or PDT, with Ameluz in combination with the BF-RhodoLED lamp for the treatment of actinic keratoses, or AK, on the extremities or trunk/neck. Patients were treated with Ameluz on one side of the body and with a placebo gel on the other side. In line with the result for the primary endpoint of the study, which showed a mean lesion clearance rate per patient’s side of 86% for Ameluz compared to 33% for placebo, superiority of Ameluz was demonstrated for all secondary parameters investigated. Even if mild AKs were ignored and only moderate AKs were considered, mean lesion clearance rates per patient’s side were 84% with Ameluz compared to 27% with placebo. In patients treated on the extremities, mean lesion clearance rates per patient’s side were also 84% with Ameluz compared to 27% with placebo. Mean lesion clearance rates in the area trunk/neck were even higher. Furthermore, the comparison parameter “patient complete clearance” also emphasized the superiority of Ameluz: 67% of the patients’ sides were completely cleared 12 weeks after the last PDT compared to 12% of the placebo-treated sides. All of the results were statistically highly significant. Thus, all secondary endpoints also confirm the superiority of Ameluz over the control group. These results support the primary endpoint data for the applications to the European Medicines Agency and FDA, which Biofrontera plans to submit during Q3.
Aquestive Therapeutics: FDA accepts NDA for riluzole oral film
Aquestive Therapeutics announced that the U.S. FDA has accepted the company’s New Drug Application for the investigational product riluzole oral film, which the company intends to market under the brand name Exservan. ROF is a novel formulation of riluzole, which is used as an adjunctive therapy in the treatment of amyotrophic lateral sclerosis. The PDUFA goal date is November 30. The company is exploring commercial opportunities for ROF in the U.S. and abroad.
Sinovac Biotech announces results from Phase III trial of Sabin sIPV
Sinovac Biotech announced that results from the company’s Phase III clinical study of a Sabin strain-based inactivated polio vaccine developed by Sinovac were published in the Journal of Infectious Disease. With Sinovac’s sIPV, efficacy is maintained while common risks associated with legacy vaccines can be mitigated. In comparison to oral polio vaccine, inactivated polio vaccine contains no live virus and thus carries no risk of vaccine-derived poliovirus emergence or vaccine-associated paralytic polio. The study found that the immune responses against the three types of poliovirus in the studied sIPV were not inferior to those achieved with the control IPV and demonstrated a good safety profile. This research implies that the studied sIPV is as effective as IPV in preventing poliovirus infection in infants aged 60-90 days, can be a reliable alternative to conventional IPV and can be a good supplement to OPV in potentially preventing or minimizing VDPV emergence or VAPP. Participants in the sIPV arm of the trial developed neutralizing antibodies against poliovirus types 1, 2, and 3 with seroconversion rates of 98.0% against type 1 poliovirus, 94.8% against type 2, and 98.9% against type 3. Seroconversion rates were higher in the sIPV arm than in the IPV arm against all three types, significantly so against types 1 and 2. Participants in the IPV arm developed neutralizing antibodies against poliovirus types 1, 2, and 3 with seroconversion rates of 94.1% against type 1, 84.0% against type 2, and 97.7% against type 3. This study was a randomized controlled, double-blinded, noninferiority trial investigating the immunogenicity and safety of Sinovac’s sIPV. The study enrolled 1200 healthy infants ages 60-90 days that were randomly assigned at a ratio of 1:1 to receive 3 doses of either sIPV or IPV at days 0, 30, and 60. The safety of the vaccine was assessed for 30 days after each injection. The study was conducted in Pizhou City and Guanyun County in Jiangsu Province, China, from August 2017 to January 2018.
Catalent price target raised to $50 after Paragon deal at Morgan Stanley
Morgan Stanley analyst Ricky Goldwasser said Catalent’s acquisition of Paragon Bioservices solidifies the company’s position in the biologics marketplace and further improves its growth profile. He now model fiscal 2020 revenue of $2.9B and EBITDA of $732M, up from $2.7B and $668M, respectively. Goldwasser raised his price target on Catalent shares to $50 from $46 following the deal announcement and keeps an Overweight rating on the stock.
https://thefly.com/landingPageNews.php?id=2893073
https://thefly.com/landingPageNews.php?id=2893073
Zosano Pharma announces publication of Qtrypta analysis
Zosano Pharma announced the peer-reviewed publication of a review and analysis of recently-completed trials using newly FDA-recommended endpoints in the acute treatment of migraine. The review article was published in Headache. In this analysis, researchers reviewed eight published trials designed in accordance with the Guidance for Industry, that recommended using co-primary endpoints of pain freedom and freedom from most bothersome symptom, or MBS, at 2-hours post-treatment. Using the placebo response rates from these various trials, the authors were able to calculate required sample sizes for future trials and compare these calculations to the sample sizes actually used in completed trials. Included in this analysis was Zosano’s ZOTRIP trial, in which 41.5% of subjects in the Qtrypta 3.8mg arm achieved pain freedom at two hours and 68.3% achieved freedom from their MBS at two hours, as compared to 14.3% and 42.9% respectively in the placebo group. Furthermore, the analysis showed that the average response rates across all active groups of these trials were 30.4% for pain freedom and 46.7% for MBS freedom, compared to 16.8% and 33% respectively for the placebo groups. Using these averages, future trials would need to enroll approximately 180 subjects per arm to demonstrate statistical significance with 80% power. Researchers noted that the majority of the completed trials enrolled far more than this, with subjects per group reaching as high as 751.
https://thefly.com/landingPageNews.php?id=2893085
https://thefly.com/landingPageNews.php?id=2893085
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