Azur Pharma Ltd. Enters Into Definitive Agreement With BioSante Pharma…
Scientists at the Buck Institute for Age Research have identified for the first time biomarkers of aging which are highly predictive of both chronological and physiological age. Biomarkers are biochemical features that can be used to measure the progress of disease or the effects of treatment. The research involves nematode worms, microarrays which measure changes
Full Post: Scientists identify biomarkers for chronological and physiological age prediction
Azur Pharma Limited has announced that it has entered into a definitive agreement with BioSante Pharmaceuticals, Inc to acquire U.S. rights to Elestrin.
Elestrin is a fast drying gel formulation of estradiol which is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause. Elestrin was approved by the U.S. Food and Drug Administration (”FDA”) in December 2006 and is patented through June 2022. Under the terms of the agreement, Azur paid BioSante US$3.3 million comprised of a product licensing fee and payment for the transfer of the trademark and inventories, amongst other items. In addition, Azur Pharma will pay BioSante royalties and contingent milestones based on future net sales of Elestrin.
Azur will market Elestrin to estrogen prescribing physicians in the U.S., comprised mostly of gynecologists, through its women’s health and urology sales force. Mr. Seamus Mulligan, Chairman and CEO of Azur, commented, “We are impressed with the potential for Elestrin in the United States given its approved ultra-low dose regimen. The product is an important addition to our women’s health product portfolio and we look forward to launching our Elestrin efforts in early 2009.” “We are excited to sign this agreement with Azur,” said Mr. Stephen M. Simes, President and CEO of BioSante. “We believe Azur has excellent, established relationships with the leading U.S. gynecological practitioners who write the majority of estrogen prescriptions. Azur is in an excellent position to capture an important share of the U.S. estrogen therapy market, which is currently estimated at approximately US$1.4 billion in annual sales, of which the transdermal segment, mostly patches, is about US$260 million. We look forward to working with Azur on the successful marketing of Elestrin.”
Wyeth Pharmaceuticals, a division of Wyeth, and Santaris Pharma have announced that the companies have entered into a worldwide strategic alliance to discover, develop and commercialize new medicines based on Santaris Pharma’s proprietary Locked Nucleic Acid (LNA) drug platform, which allows specific targeting and regulation of microRNAs (miRNAs) and messenger RNAs (mRNAs) as a means to
Full Post: Wyeth and Santaris Pharma to collaborate on RNA-based medicines
Watson Pharmaceuticals, Inc. has received approval from the United States Food and Drug Administration to market its over-the-counter Nicotine Polacrilex Gum USP, coated mint flavor, in the 2 mg and 4 mg strengths. Nicotine Polacrilex Gum, coated mint flavor, is the generic equivalent of GlaxoSmithKline Consumer Healthcare’s Nicorette (R) fresh mint gum, which is used
Full Post: Watson Pharmaceuticals receives FDA approval for mint coated nicotine gum
Mylan Inc. has announced that it and its subsidiary, Mylan Pharmaceuticals Inc., have entered into a settlement agreement with Novartis Pharmaceuticals Corp., Novartis Corp. and Novartis International AG related to Letrozole Tablets, the generic version of Novartis’ Femara. Mylan’s Vice Chairman and CEO Robert J. Coury commented: “We are very pleased to have reached this
Full Post: Mylan settles with Novartis on Femara
Sun Pharmaceutical Industries Ltd. announced that together with its subsidiaries, it has received final approval from U.S. FDA for several Abbreviated New Drug Applications (ANDA). Approval was received for generic hydocodone bitartate with acetaminophen (APAP) tablets. Approval was also received for generic Aredia(R), pamidronate disodium for injection USP, generic Lopid (R), gemfibrozil tablets, USP, and
Full Post: Sun Pharmaceutical receives FDA approvals for 4 generics
Synerx Pharma, LLC has announced the submission to the FDA of Isosulfan Blue Injection (generic equivalent to Lymphazurin, Covidien (formerly US Surgical)). This ANDA submission is the culmination of a four year joint effort by Synerx Pharma, LLC and its exclusive raw material supplier Apicore, LLC. According to Synerx Pharma and Apicore, the active ingredient
Full Post: Synerx Pharma announces FDA submission of Isosulfan Blue injection ANDA