Amneal Pharmaceuticals Inc., of Bridgewater, N.J., said it entered a settlement agreement with Actavis Laboratories FL Inc., of Ft. Lauderdale, Fla., and Actavis Pharma Inc., of Parsippany, N.J., resolving patent litigation related to the Parkinson's disease drug Rytary (carbidopa-levodopa). The litigation has been pending in the U.S. District Court for the District of New Jersey and resulted from Actavis' submission of an abbreviated NDA to the FDA seeking approval to market a generic version of Rytary. Under the terms, Amneal will grant Actavis a license to begin selling a generic version of Rytary on July 31, 2025, or earlier under certain circumstances. Additional details regarding the settlement were not disclosed. The launch of Actavis' generic product is contingent upon Actavis receiving final approval from the FDA.
Aquinnah Pharmaceuticals Inc., of Cambridge, Mass., was awarded $3.4 million from the National Institute of Neurological Disorders and Stroke (NINDS) in a competing grant to advance novel therapeutic drug candidates toward the clinic for treating patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. Aquinnah is developing drugs designed to slow or potentially reverse the progression of ALS. This is the firm's second NINDS grant awarded to support its approach, which targets the prevention of pathological TDP-43 stress granule protein complexes found in the brains of most ALS patients.
Contravir Pharmaceuticals Inc., of Edison, N.J., said it regained compliance with Nasdaq listing requirements, specifically the minimum bid price rule.
Cormedix Inc., of Berkeley Heights, N.J., last Thursday received a notice from the NYSE American market that, based on its form 10-Q for the quarter ended March 31, filed on May 15, the company does not meet a continued listing standard. Specifically, it is not in compliance with the rule that requires stockholders' equity of $2 million or more if it has reported losses from continuing operations and/or net losses in two of its three most recent fiscal years, and other rules. Cormedix must submit to the NYSE American, no later than July 16, a plan to address how it intends to regain compliance.
Merck KGaA, of Darmstadt, Germany, signed a strategic collaboration agreement with Chinese internet health care company Alibaba Health Information Technology Ltd., of Hong Kong, to provide Chinese patients and their families with improved access to patient-centric health care services. The companies said the collaboration will focus on the areas of drug tracking and tracing and internet health services, and will jointly explore areas such as pharmaceutical e-commerce and artificial intelligence. The pact will start with Alibaba's drug tracking platform, combining Merck's expertise in diabetes, thyroid disorders and cardiovascular diseases with Alibaba's strengths in online health care to help ensure safety and security of drug use, while generating consistent value for patients through a series of add-on services, the companies said.
Protagonist Therapeutics Inc., of Newark, N.J., reported preclinical data at the European Hematology Association meeting in Stockholm showing that PTG-300, its injectable hepcidin mimetic, demonstrated proof-of-mechanism activity in a mouse model of beta-thalassemia.
Samumed LLC, of San Diego, presented preclinical data at the European League Against Rheumatism 2018 Annual European Congress of Rheumatology in Amsterdam on its Wnt inhibitors SM-04690 and SM-04755. In a rat model of knee osteoarthritis, SM-04690 reduced inflammation, improved pain and protected cartilage compared with vehicle. In a mouse model of psoriasis, SM-04755 decreased skin and ear thicknesses and improved skin appearance and mouse weight compared with untreated mice. In two rat models of tendinopathy, SM-04755 accelerated improvement of microscopic tendon appearance compared with untreated mice.
Zosano Pharma Corp., of Fremont, Calif., disclosed the publication regarding Adhesive Dermally-Applied Microarray (ADAM) technology for the delivery of the migraine drug zolmitriptan in the Journal of Pharmaceutics. The test evaluated how different in vitro skin models influenced the absorption of zolmitriptan with ADAM. This standardized method of testing produced a model for evaluating the efficiency of intracutaneous delivery of zolmitriptan. The model will be helpful as Zosano continues to assess the efficiency of small molecules delivered with ADAM, the company said. M-207 is company's ADAM formulation of zolmitriptan, and it consists of titanium microprojections coated with drug. The drug-coated microneedles break through the stratum corneum and penetrate into the epidermis and dermis, where the dry drug coating is dissolved by the surrounding skin interstitial fluid. In February 2017, the company made public statistically significant results from the Zotrip pivotal study, which demonstrated that the 3.8-mg dose of M-207 met both co-primary endpoints. (See BioWorld Today, Feb. 14, 2017.)