Alimta Case Returned to Court of Appeal for New Ruling
PRNewswire/ — The German Federal Supreme Court has granted the appeal by Eli Lilly and Company (NYSE: LLY) in the case of Eli Lilly and Company v. Actavis, vacating the prior decision denying infringement. The German Supreme Court returned the case to the Court of Appeal (Dusseldorf) for further proceedings. The case concerns whether Lilly’s vitamin regimen patent for Alimta® (pemetrexed disodium) would be infringed by a generic competitor that had stated an intention to market a dipotassium salt form of pemetrexed in Germany.
“We are pleased with the ruling by the German Federal Supreme Court granting our appeal regarding infringement of Alimta’s vitamin regimen patent in Germany,” said Michael J. Harrington, senior vice president and general counsel for Lilly. “This ruling supports our continuing belief that Alimta’s vitamin regimen patent would be infringed by the entry of generic pemetrexed products, including alternative salt forms, in Europe prior to June 2021.”
Harrington also stated, “We continue to emphasize that protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve. Intellectual property rights provide assurances of market exclusivity that help support the development of the next generation of innovative medicines to treat unmet medical needs.”
The separate infringement proceeding and validity challenge with Hexal AG will continue unaffected by this ruling. The preliminary injunction against Hexal was confirmed by the German Court in late May 2016 and will stay in force pending any further appeal by Hexal and the outcome of the cases on the merits. The separate infringement proceedings with ratiopharm GmbH should continue, taking this ruling into account.
In major European countries, the compound protection for Alimta expired in December 2015. The patent protection for the Alimta vitamin regimen will expire in June 2021.
AUDIENCE: Endocrinology, Internal Medicine, Nephrology, Pharmacy
ISSUE: FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk. read more
AMA Confronts the Rise of Nootropics
CHICAGO – Responding to the safety concerns generated by a growing personal use of nootropics, physicians at the Annual Meeting of the American Medical Association (AMA) today adopted new policy discouraging the nonmedical use of prescription drugs for cognitive enhancement in healthy individuals.
Nootropics – the so-called smart drugs – include a variety of prescription drugs, supplements, or other substances that claim to improve cognitive functions of healthy individuals, particularly executive function, memory, learning or intelligence.
Prescription drugs that are FDA-approved to treat attention-deficit hyperactivity disorder or narcolepsy are commonly associated with the off-label use by students and others seeking to boost memory, learning or other aspects of cognition. Such use is associated with a variety of adverse mental health conditions and patterns of substance misuse. read more
Orfadin® 20 mg capsule approved in the US
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that the Food and Drug Administration (FDA) has approved a higher strength 20 mg capsule of Orfadin® (nitisinone) for the treatment of Hereditary Tyrosinaemia type-1 (HT-1). HT-1 is a rare genetic disease that affects infants and children. It is progressive and may result in liver and kidney complications and can be fatal if untreated. read more
Hansa Medical AB (publ) today announced that additional data from the ongoing US Phase II study with IdeS in kidney transplantation was presented at the 2016 American Transplant Congress (ATC) in Boston on June 14 at 6:00 pm (EDT).
The ongoing Phase II study at Cedars Sinai Medical Center is an investigator-initiated study that is looking at the effects of IdeS in enabling kidney transplantation in highly sensitized kidney transplant patients. Recruitment for the study will be up to 20 patients. read more
Medivir investigates possible corporate split and separate listing of commercial operations
Medivir AB (Nasdaq Stockholm: MVIR ) today announces that the Board of Directors has tasked the company management with reviewing the possibility of dividing the company’s operations into two independent companies and achieving a separate listing for the commercial pharmaceutical portfolio. read more
FDA approves stomach-draining obesity treatment
The AspireAssist system consists of a thin tube implanted in the stomach, connecting to an outside port on the skin of the belly. About 20 minutes after finishing a meal, users connect the port to an external device, which drains some of the recently-consumed food into the toilet.
The manufacturer — Aspire Bariatrics based in King of Prussia, Pennsylvania — says its system removes about 30 percent of food stored in the stomach before it begins causing weight gain.
TOKYO–(BUSINESS WIRE)–PeptiDream Inc., a public Tokyo-based biopharmaceutical company (“PeptiDream”) (TOKYO:4587) announced today that it has earned a milestone for the dosing of a first patient in a clinical trial by its alliance partner, Bristol-Myers Squibb Company (BMS). This is the first program to enter clinical testing out of the discovery collaboration between the two companies. The molecule being advanced in clinical testing was discovered by Bristol-Myers Squibb starting from an active lead macrocyclic compound identified by Peptidream using its PDPS technology and provided to BMS for further optimization.