Melanie Sena is community editor of Pharmaceutical Technology.

Melanie Sena

 (GSK) reported that a US federal appeals court has ruled against Pronova Biopharma Norge AS in its patent litigation regarding Lovaza (omega-3-acid ethyl esters). The Lovaza patents are owned by Pronova and licensed to GSK. The patents relate to compositions and methods of using omega-3 fatty acids. GSK has marketing rights for Lovaza in the US and Puerto Rico. Reversing a lower court ruling, the appellate court found the asserted claims of Pronova’s patent (US Patent 5,656,667) invalid and remanded the case to the district court with orders to enter judgment in favor of the appellant Abbreviated new drug application filers. 

The Lovaza patents are owned by Pronova and licensed to GSK. The patents relate to compositions and methods of using omega-3 fatty acids. GSK has marketing rights for Lovaza in the US and Puerto Rico.

Lovaza remains available, and GSK is not aware that FDA has approved any generic versions to date.

Articles

GSK reported that the Court of Appeals has ruled against Pronova Biopharma Norge AS in its patent litigation regarding Lovaza.

GSK Responds to Patent Ruling Reversal on Lovaza

 and Merck & Co. have formed a licensing agreement for Merck’s oral, small-molecule inhibitor of WEE1 kinase (MK-1775). MK-1775 is currently being evaluated in Phase IIA clinical studies in combination with standard of care therapies for the treatment of patients with certain types of ovarian cancer.

WEE1 helps to regulate the cell-division cycle. The WEE1 inhibitor MK-1775 is designed to cause certain tumor cells to divide without undergoing the normal DNA repair processes, ultimately leading to cell death. Preclinical evidence suggests that the combination of MK-1775 and DNA damage-inducing chemotherapy agents can enhance antitumor properties in comparison to chemotherapy alone.

Under the agreement, AstraZeneca will pay Merck a $50-million upfront fee. In addition, Merck will be eligible to receive future payments tied to development and regulatory milestones plus sales-related payments and tiered royalties. AstraZeneca will be responsible for all future clinical development, manufacturing, and marketing. The agreement is subject to approval of customary antitrust provisions. 

AstraZeneca and Merck & Co. form a licensing agreement for Merck?s oral small-molecule drug for ovarian cancer.

AstraZeneca and Merck Enter License Agreement for Ovarian Cancer Therapy

Recognized for establishing quality standards for medicines, food ingredients, and dietary supplements, the 

 (USP) announced the selection of its 2013-2014 USP Global Fellows. The Global Fellowship program has awarded $150,000 in research grants to support the work of early-career scientists with the goal of advancing research priorities in small moleculedrugs, biologics, excipients, dietary supplements, and food ingredients that address specific USP scientific or research needs.

Each year, USP conducts a competitive process for selecting fellows who are engaged in full-time study in a PhD or Pharm. D. program, medical school, or dental school, and whose works are directly relevant to USP’s priorities.

For the 2013-2014 academic year, three $50,000 USP Global Fellowship awards have been presented to the following students:

•        Adam L. Kaylor, PhD candidate, Georgia Institute of Technology, School of Chemistry and Biochemistry

Area of Research—Development of a new pulsed plasma ion source for counterfeit drug analyses by portable ion-mobility spectrometry and rapid liquid chromatography-mass spectrometry (LC-MS).

•        Haichen Nie, M.S., Purdue University, College of Pharmacy, Department of Industrial and Physical Pharmacy

Area of Research—Sustainable medicines for Africa—Development of monographs and associated knowledge to increase access to HIV/AIDS medicines for resistant infections (Darunavir-Ritonavir).

•        Sharla M. Peters, Postdoctoral candidate, Howard University, College of Medicine, Department of Biochemistry and Molecular Biology

Area of Research—Development of a multiplex real-time polymerase chain reaction assay for the detection of ruminant material in adulterated products.

Each of the Global Fellows will communicate regularly with a scientific liaison from USP headquarters in Rockville, Maryland, providing updates on his or her work and the relevance of its progress to USP’s priorities. In addition, each fellow will be invited to give a poster presentation at an USP-sponsored meeting or event during the course of the academic year.

Source:  

For the 2013-2014 academic year, three $50,000 USP Global Fellowship awards have been presented.

US Pharmacopeia Announces 2013-2014 Global Fellowships

 announced that FDA has granted Priority Review status for the Biologics License Application (BLA) for its investigational drug vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis (UC). A BLA was submitted in June 2013 seeking approval for vedolizumab for the treatment of adults with moderately to severely active Crohn's disease (CD) or UC.

CD and UC are the two most common types of inflammatory bowel disease. While CD and UC treatment options are available, many patients may not achieve or maintain remission of their disease.

The BLA filings were supported by the GEMINI Studies, a four-study clinical program investigating vedolizumab in 2700 patients in nearly 40 countries, making it the largest Phase III clinical trial program conducted to date simultaneously evaluating both CD and UC. Enrolled patients had failed at least one conventional therapy, including glucocorticoids, immunomodulators, and/or a tumor necrosis factor-alpha (TNF-alpha) antagonists. TNF-alpha antagonist and conventional therapy failure patients included those with inadequate response, loss of response, or those who were intolerant.

Phase III study results for vedolizumab were published recently in the New England Journal of Medicine.

Source: 

Takeda's drug vedolizumab is granted priority review status for the treatment of adults with moderately to severely active ulcerative colitis.

Takeda's Drug Vedolizumab is Granted Priority Review Status by FDA

, in partnership with INVICRO and 3D Imaging, held the groundbreaking for its new Imaging Center, which is set to open in Spring 2014 at the MPI Research corporate headquarters in Mattawan, Michigan. Pharmaceutical researchers will have access to a cyclotron facility directly connected to vivarium, permitting drug radiolabeling and in-depth studies across a variety of animal models.

The 10,000 ft

, two-story imaging center is the latest joint effort between MPI, INVICRO, and 3D Imaging, which have collaborated on more than 100 imaging projects to date. The multimillion-dollar project will include INVICRO’s molecular imaging informatics team and 3D Imaging’s radiopharmaceutical group.

Many of the expanded imaging solutions, including nonhuman primate PET and CT imaging capabilities, became available in July 2013.

Source: 

MPI's new Imaging Center is set to open in Spring 2014 at the company's headquarters in Michigan.

MPI Research Breaks Ground on New Imaging Center

, a subsidiary of BD, reports that FDA has approved a third drug to be offered in the BD Simplist line of prefilled generic injectables. The third BD Simplist product to launch is ondansetron injection, 

 (USP) 4 mg/2 mL (2mg/mL), an injectable antiemetic. 

Ondansetron injection, which is used to prevent postoperative nausea and vomiting, is currently on the FDA drug shortage list due to recent demand increases and supply issues faced by other manufacturers. The product can be used with initial and repeat courses of emetogenic cancer chemotherapy. 

In March, BD announced that it would be manufacturing generic pharmaceutical products for the first time through it subsidiary BD Rx. BD Rx also manufactures metoclopramide injection, and diphenhydramine hydrochloride Injection, USP within the BD Simplist prefilled injectables line of products. BD Simplist prefilled injectables are designed to decrease the number of steps in the traditional vial and syringe injection sequence, thereby reducing the potential risk of medication error. 

BD Rx plans to launch 20 to 30 drugs in its BD Simplist line of products during the next few years and is targeting generic injectables in doses most commonly relied on by clinicians in both the hospital and surgical center settings.

FDA approves BD Simplist product ondansetron injection, an injectable antiemetic.