Teva Pharmaceutical Industries Ltd. (“Teva”) and Shanghai Fosun Pharmaceutical (Group) Co. (“Fosun Pharma”) recently announced a partnership to accelerate the development of Teva’s TEV-56278, a novel fusion protein that uses Teva’s ATTENUKINE™ technology to target cytokine activity to tumor cells while reducing toxic side effects. The new drug is intended…
Inventions made in a particular country are generally first-filed in that country before entering the United States via a direct Paris Convention filing or, more commonly, a PCT national stage entry. Convenience, national pride, and foreign filing license laws encourage such home country first-filings. It is well known that the…
In the last few weeks, the PTAB has granted institution of eight IPRs filed by Merck on Johns Hopkins patents directed to methods of treatment using pembrolizumab. The eight patents are generally directed to methods for treating cancer in a patient having a tumor that exhibits a high microsatellite instability…
In a decision that issued last week, a Patent Trial and Appeal Board (“PTAB”) panel instituted inter partes review (“IPR”) of a petition filed by Merck Sharp & Dohme LLC (“Merck”) for a patent owned by The Johns Hopkins University (“Johns Hopkins”), U.S. Patent No. 11,591,393 (the ’393 patent). The…
On September 20, Merck announced that the U.S. Food and Drug Administration (FDA) granted priority review status to Merck’s supplemental Biologics License Application (sBLA) seeking approval for its anti-PD-1 therapy KEYTRUDA (pembrolizumab) in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy, as a treatment for newly…
This week Formycon AG (“Formycon”) announced details of its previously undisclosed pipeline project for FYB206, Formycon’s biosimilar of KEYTRUDA (pembrolizumab). KEYTRUDA is approved for the treatment of advanced melanoma, lung and other types of carcinoma. According to the press release, Formycon fully owns the development and commercialization rights for FYB206,…
Last week, PlantForm Corporation, PlantPraxis Biotecnologia and Bio-Manguinhos/Fiocruz announced that they are entering into a research and development agreement to develop pembrolizumab, a biosimilar of Keytruda®, for the Brazilian Market. According to the announcement, Bio-Manguinhos is a Brazilian government institution responsible for technology development and production of vaccines, reagents and…
On Sept. 1, 2020, NeuClone Pharmaceuticals announced that they are developing biosimilar candidates referencing OPDIVO and KEYTRUDA. According to NeuClone, the two biosimilar candidates “are in the advanced states of pre-clinical development.” This brings the number of NeuClone’s biosimilar pipeline to 8 announced products with another 12 in development that…
At yesterday’s European Society for Medical Oncology (ESMO) meeting, Merck Sharp & Dohme Corp. announced positive data from two studies regarding its Keytruda ® (pembrolizumab) biologic. According to Merck’s press release, Keytruda performed better than the standard of care chemotherapy as a first line therapy for patients with metastatic non-small…
Merck Sharp & Dohme Corp. has challenged Genentech’s U.S. Patent No. 7,923,221 (Cabilly III) with a complaint for declaratory judgment in the Central District of California. The patent relates to methods to produce antibody products. Merck received FDA approval to market Keytruda® (pembrolizumab) for treating certain melanomas and lung cancers, and…