Abbott and Fournier agree to pay $22.5 million for blocking generic fenofibrate

Makers of the popular cholesterol-lowering drug TriCor have agreed to pay $22.5 million to resolve allegations that they illegally kept generic versions off the market. As a result of these practices, consumers and state governments paid higher prices for the cholesterol drug.

Under the agreement, Abbott and Fournier will pay $22.5 million to the states. North Carolina's share of nearly $800,000 will go to the state's Medicaid program, a joint federal-state program that provides health insurance for the poor. TriCor is a brand-name prescription drug that uses the active ingredient fenofibrate to regulate trigyliceride and cholesterol levels.

Cooper and the other attorneys general allege that since 1998, Abbott and Fournier have successfully monopolized sales of fenofibrate drugs by blocking generics from the market. The companies crafted elaborate schemes like filing multiple patents with the Federal Drug Administration and then filing patent infringement lawsuits to delay generic versions of TriCor. The attorneys general also contend that Abbott and Fournier thwarted competition by making various clinically insignificant changes to the dosage and form of TriCor and manipulating the drug codes used to create generic substitutions. Under the settlement, Abbot and Fournier have agreed not to delete the drug codes for the latest version of TriCor in the event a generic manufacturer seeks FDA approval of a generic version of the drug.

USPTO has launched Interactive Patent Pendency Model (PPM)

The USPTO on December 19 announced the launch of an interactive patent pendency model (PPM) that enables users to see how overall application pendency is affected by the number of examiner hires per year; the amount of overtime worked, and patent filing levels. In one example, the model shows that an additional 1,000 examiners hired in the period during 2010-2012 could reduce the backlog from 719,000 to just over 470,000 by the end of 2012. Alternatively, if no new examiners were hired and no overtime was allowed, the current backlog could increase to 1,651,000, and the first action pendency would increase from 25 months to 67 months. The PPM was established to further the USPTO's efforts to increase transparency and to reduce patent pendency. The PPM webpage can be found in the Patent statistics area of the USPTO Web site.

Arbitration result between Asahi Kasei and CoTherix, Inc. of the US

A final ruling has been issued in arbitration proceedings between Asahi Kasei Pharma and CoTherix regarding a license agreement for CoTherix to develop fasudil, a rho-kinase inhibitor discovered and owned by Asahi Kasei Pharma. In June 2006 the two parties concluded a license agreement whereby Asahi Kasei Pharma granted CoTherix rights for the development and commercialization of fasudil. In January 2007 CoTherix discontinued the development of fasudil, and in October 2007 Asahi Kasei Pharma initiated arbitration proceedings with the International Chamber of Commerce in California seeking compensation for breach of the terms of the license agreement. In its final ruling, the arbitration panel has ordered CoTherix to pay Asahi Kasei Pharma approximately US$91 million. Asahi Kasei Pharma is now examining the details of this ruling and the effect the ruling will have on its financial results. The financial effect of the ruling will be disclosed upon final confirmation.

Amgen and Roche end EPO patent infringement dispute

Roche has admitted the infringement and validity of Amgen's EPO Patents. Court has entered Permanent Injunction and Roche would launch its pegylated-erythropoietin (peg-EPO) product in the US market in mid-2014. The final judgement and injunction was entered by US District Court in Boston against Roche prohibiting Roche from infringing Amgen's patents on recombinant erythropoietin (EPO), thus bringing the five-year patent infringement dispute to an end. Roche conceded with the decision that the five Amgen EPO patents involved in the lawsuit are valid, enforceable and infringed by Roche's pegylated-erythropoietin (peg-EPO) product MIRCERA. The settlement terms do not include any financial payments between the parties.

NicOx submits naproxcinod MAA to the EMEA

NicOx S.A. has submitted a Marketing Authorization Application (MAA) for naproxcinod to the European Medicines Agency (EMEA) through the centralized procedure, seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis (OA). This follows the submission of a NDA to the USFDA in September that has recently been accepted for filing. Naproxcinod is NicOx's lead investigational compound and the first in a new class of anti-inflammatory agents known as CINODs (Cyclooxygenase-Inhibiting Nitric Oxide Donators). The MAA file is supported by data from a large program of 34 clinical trials that involved more than 4,000 subjects treated with naproxcinod.

NicOx's lead investigational compound is naproxcinod, an NCE and a first-in-class CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory drug candidate for the relief of the signs and symptoms of osteoarthritis. NicOx submitted a NDA for naproxcinod to the USFDA in September 2009 and a MAA to the EMEA in December 2009, following the successful completion of three pivotal phase 3 studies. The NDA for naproxcinod was accepted for filing by the FDA in November 2009 and the FDA has set a target date of July 24 2010, for the completion of its review. The FDA and the EMEA will evaluate the data submitted. NicOx does not wish to make any claims in regard to naproxcinod’s safety or efficacy prior to its potential approvals.

Mylan sued for its generic version of Vytorin by Schering and MSP Singapore

Mylan has been sued by Schering and MSP Singapore Company in the US District Court for the District of New Jersey alleging patent infringement for filing an ANDA with the USFDA for Ezetimibe and Simvastatin tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg. This product is the generic version of Vytorin tablets. Mylan says that it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for the product and expects to qualify for 180 days of sole marketing exclusivity once final US FDA approval is obtained. Vytorin Tablets had approximately US$ 1.6 billion in sales for the same strengths for the 12 months ending September 30, according to IMS Health.

Mylan receives tentative approval for Efavirenz tablets

Mylan has received tentative approval from the USFDA for its NDA for Efavirenz Tablets, 50 mg, 100 mg and 200 mg. The approval was secured by the company's subsidiary Matrix Laboratories Limited under the President's Emergency Plan for AIDS Relief (PEPFAR). These innovative paediatric dosages in tablet form were developed by Matrix for use in treating paediatric HIV/AIDS, the company said. Efavirenz is a non-nucleoside reverse transcriptase inhibitor (nNRTI) that has been found to be effective in many combination regimens for the treatment of HIV infection, both in treatment-naive and in treatment-experienced individuals.

Lupin settles Alzheimer drug litigation with Forest Laboratories

Pharma major, Lupin announced today that it has settled all ongoing Hatch Waxman litigation relating to memantine tablets, Lupin's generic version of Forest Laboratories, Alzheimer disease treatment "Namenda" tablets. As per the terms of the settlement, Lupin will be licensed under the relevant patents and would be free to commercially launch its generic product in Jan 2015 or earlier in certain circumstances. Lupin had earlier filed a Paragraph IV certification to US Patent No 5,061,703, contesting that the patent was invalid or had not been infringed, resulting in the subsequent litigation with Forest.

AstraZeneca Loses Appeal against Dr. Reddy's for generic Prilosec

The U.S. Court of Appeals for the Federal Circuit has rejected AstraZeneca AB’s appeal of a lower court decision that Dr. Reddy's Laboratories Ltd.’s generic version of popular over-the-counter antacid Prilosec did not infringe (omeprazole delayed-release) capsules OTC did not infringe two US patents, Nos 5,900,424 and 5,690,960. Judge Colleen McMahon of the U.S. District Court for the Southern District of New York dismissed the suit in March, finding thatDr. Reddy’s drug used a different form of omeprazole magnesium (with less than 1 percent crystallinity), the primary ingredient in Prilosec, than that covered in the AstraZeneca patents.

Astra argued that Dr. Reddy’s had infringed its patents based on the doctrine of equivalents, but Judge McMahon deflated that line of reasoning, as well. “Because AstraZeneca argued to the USPTO that its patented product could be distinguished from other products because it was more than 70 percent crystalline, it cannot now argue that a product less than 70 percent crystalline infringes under the doctrine of equivalents,” she said.

IPblogger to provide time to time update on new molecules

IPblogger shall timely provide information on new molecules with updates. Its a small initiative and IPblogger shall need your support in this small effort.

This month, the information is regarding Nalfurafine hydrochloride. Pruritus is a common symptom seen in up to 90% of uremic patients, especially those with chronic renal failure requiring hemodialysis. The cause and mechanism of induction of pruritus are not known. Research and studies have revealed that an imbalance in the endogenous opioid system may be responsible for pruritus, with particular involvement of the kappa opioid system. The existing kappa opioid receptor agonists lack morphine-like adverse effects and are associated with dysphoria and psychotomimetic alterations. Thus, research efforts continue to focus on new kappa opioid agonists with novel structures to circumvent unwanted adverse effects.

Nalfurafine hydrochloride is a novel kappa opioid receptor agonist that is highly selective for the kappa opioid receptor in vitro and displays potent antipruritic activity in vivo. A single dose of an oral formulation was shown to alleviate itch in hemodialysis patients suffering from severe pruritus. The kappa-opioid agonist nalfurafine hydrochloride (Remitch^®) was approved and launched for the first time in spring 2009 in Japan, where it is indicated for the improvement of pruritus in hemodialysis patients who have not responded to conventional treatment. Nalfurafine was codeveloped by Toray, Japan Tobacco and Torii Pharmaceuticals; it is manufactured and marketed by Toray. It has orphan drug status in Japan for the approved indication.