Global Briefs: Biogen, Merck & Co., CureVac & More
A roundup of news from Biogen, Merck & Co., CureVac and Natco Pharma. Highlights below.
* Biogen Gets Favorable Ruling over Generics of MS Drug
* Merck & Co. Receives CRL from FDA for Chronic Cough Drug Candidate
* CureVac Loses Patent Ruling to BioNTech over COVID-19 Vaccine
* Natco Pharma Completes Transition of Dash Pharma to Natco USA
Biogen Gets Favorable Ruling over Generics of MS Drug
Biogen has announced that the European Commission has revoked the centralized marketing authorizations for generic versions of Biogen’s multiple sclerosis drug, Tecfidera (dimethyl fumarate) held by Accord, Mylan, Neuraxpharm, Polpharma and Teva. Tecfidera had 2022 sales of $1.4 billion.
In reaching this decision, Biogen says the European Commission affirmed that Biogen is entitled to full data protection and marketing protection for Tecfidera.
Tecfidera is entitled to marketing protection until February 3, 2025, and is the only dimethyl fumarate treatment for multiple sclerosis that may be lawfully placed on the market for sale in the EU until that date, according to information from Biogen.
Merck & Co. Receives CRL from FDA for Chronic Cough Drug Candidate
The US Food and Drug Administration has issued Merck & Co. a Complete Response Letter (CRL) regarding Merck’s new drug application (NDA) for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.
In the CRL, the FDA concluded that Merck’s application did not meet substantial evidence of effectiveness for treating RCC and UCC. The CRL was not related to the safety of gefapixant. Merck is reviewing the FDA’s feedback to determine next steps (as reported on December 20, 2023).
Source: Merck & Co.
CureVac Loses Patent Ruling to BioNTech over COVID-19 Vaccine
CureVac, a Tübingen, Germany-based bio/pharmaceutical company, has announced that the nullity action filed by BioNTech, a Mainz, Germany-based bio/pharmaceutical company, against the German part of CureVac’s COVID-19 patent was granted by the German Federal Patent Court. CureVac says it will appeal before the German Federal Court of Justice.
The ruling represents a first decision on validity in ongoing patent litigation between CureVac and BioNTech in Germany, which involves a total of eight CureVac intellectual property rights. Proceedings continue regarding the seven remaining rights, for which validity, infringement and potential damages will be decided individually, according to CureVac.
Natco Pharma Completes Transition of Dash Pharma to Natco USA
Natco Pharma, a Hyberadad, India-based bio/pharmaceutical company, has announced that Dash Pharmaceuticals, a company that markets, sells, and distributes generic pharmaceutical products, has officially transitioned to Natco Pharma USA, the US subsidiary of Natco Pharma. As of January 2, 2024, all products marketed by the company will transition to the Natco Pharma USA label, with no changes to the current National Drug Code (NDC) numbers.
Source: Natco Pharma