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News Breaks
July 21, 2014
07:03 EDTNVS, ANACAnacor, Sandoz enter into agreement for commercialization of Kerydin in the U.S.
Anacor Pharmaceuticals (ANAC) announced that it has entered into an exclusive agreement with Sandoz, a Novartis (NVS) company, pursuant to which Sandoz will distribute and commercialize Anacorís drug KERYDIN topical solution, 5% in the United States. PharmaDerm, the branded dermatology business of Sandoz, will be responsible for the sales and marketing of KERYDIN. On July 8, Anacor announced that the U.S. FDA approved the New Drug Application for KERYDIN, the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States, according to Podiatry Today. The agreement with Sandoz entitles Anacor to upfront payments totaling $40M and an additional milestone payment of $25M expected to be paid in January 2015. Under the agreement, Sandoz and Anacor will share equally, under a long-term profit-sharing arrangement, the gross profits accrued by Sandoz on sales of KERYDIN, except that in 2015 Anacor will start receiving profit-sharing payments after the first $50M of gross profits have been accrued by Sandoz. The long-term profit-sharing arrangement includes cumulative minimum profit-sharing payments to Anacor in 2016 totaling $45M. Anacor will also have the option to repurchase all rights in KERYDIN from Sandoz on the later of three years from launch or December 31, 2017, at a price to be determined pursuant to the agreement. Under the terms of the agreement, Anacor will supply product to Sandoz at cost through Anacorís contract manufacturers, and Sandoz will be responsible for all of its selling, marketing, distribution, general and administrative costs related to the commercialization of KERYDIN. Anacor will hold the NDA and will be responsible for any further development of KERYDIN.
News For ANAC;NVS From The Last 14 Days
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September 1, 2015
16:33 EDTNVSAmgen, Novartis enter agreement for Alzheimer's, migraine research
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August 28, 2015
05:32 EDTNVSNovartis renews pledge with WHO to end leprosy
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August 27, 2015
11:15 EDTANACAnacor management to meet with Jefferies
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August 25, 2015
15:02 EDTNVSMylan says USPTO institutes IPR of two Copaxone patents
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August 24, 2015
13:15 EDTNVSFDA expands use of Novartis' Promacta to include children ages 1 and older
Ligand Pharmaceuticals (LGND) announced that the FDA has approved an expanded use for Promacta, a Novartis (NVS) product, to include children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was acquired by Novartis in March from GlaxoSmithKline (GSK). Promacta was discovered as a result of research collaboration between GSK and Ligand Pharmaceuticals and was developed by GSK. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 years of age and older and in 2008 for use in adult patients with the same condition. The label expansion of Promacta was based on data from two double-blind, placebo-controlled trials, including the largest Phase 3 clinical trial in this patient population. Treatment with Promacta significantly increased and sustained platelet counts among pediatric patients with chronic ITP with an insufficient response to prior chronic ITP therapies, and some patients taking concomitant ITP medications were able to reduce or discontinue their use of these medications, primarily corticosteroids. Promacta should be used only in those whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
12:11 EDTNVSNovartis announces FDA approves expanded use for Promacta
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August 21, 2015
08:10 EDTANACAnacor: Coalition seeks to invalidate patents for Kerydin
In a regulatory filing, Anacor said that on August 20, a hedge fund -- acting with affiliated parties and proceeding under the name of the Coalition for Affordable Drugs X LLC -- filed petitions with the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office seeking to institute inter partes review proceedings to invalidate Anacor Pharmaceuticals, Inc.'s Orange Book-listed U.S. Patents Nos. 7,582,621 and 7,767,657 covering KERYDIN topical solution, 5%.If one or more of CFAD's IPR petitions are accepted by the PTAB, the Company will have three months to file its preliminary responses. Upon receipt of the Company's preliminary responses, the PTAB will have another three months in which to institute or deny the IPR proceedings. If the IPR proceedings are instituted by the PTAB, CFAD will have an opportunity to challenge the validity of some or all of the claims in the Kerydin Orange Book Patents before the PTAB. The Company is currently reviewing CFAD's IPR petitions and intends to vigorously oppose the institution of the IPR proceedings and, if the IPR proceedings are instituted, to vigorously defend the Kerydin Orange Book Patents.
05:25 EDTNVSNovartis acquires all remaining rights to Ofatumumab from GSK
Novartis (NVS) announced that it has entered into an agreement to acquire all remaining rights to Ofatumumab from GlaxoSmithKline (GSK). Ofatumumab, a fully human monoclonal antibody which targets CD20, is being developed for relapsing remitting multiple sclerosis, or RRMS, and other autoimmune indications. Novartis previously acquired the rights to Ofatumumab for oncology indications and it is marketed under the brand name Arzerra. Novartis will be responsible for the worldwide development, regulatory and commercialization activities for Ofatumumab. Under the terms of the agreement, Novartis will make an initial upfront payment of $300M to GSK for the acquisition of the compound and a further payment of $200M payable following the start of a phase III study in MS by Novartis. Upon completion of pre-determined milestones, contingent payments of up to $534M may be made. Novartis will also pay royalties of up to 12% to GSK on any future net sales of Ofatumumab in autoimmune conditions.
August 20, 2015
05:29 EDTNVSNovartis Odomzo gains EU approval for laBCC
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August 18, 2015
09:19 EDTNVSPiper Jaffray biopharma analyst holds an analyst/industry conference call
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