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News Breaks
April 28, 2014
07:27 EDTNVS, LLY, GSK, SNY, PFEDrug companies targeting myostatin, WSJ reports
Drug companies, including Novartis (NVS), Eli Lilly (LLY), Sanofi (SNY), Pfizer (PFE) and Glaxosmithkline (GSK), are looking make a drug that targets myostatin, a naturally occurring protein that curbs muscle growth, the Wall Street Journal reports. All the companies' drugs are in clinical or earlier-stage testing, and the first drug could be approved in 2016. Reference Link
News For NVS;LLY;GSK;SNY;PFE From The Last 14 Days
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July 22, 2014
16:18 EDTPFEPuma Biotech now responsible for R&D expenses associated with legacy trials
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09:55 EDTGSKLupin, private equity funds weigh bids for GSK's older drugs, Reuters reports
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July 21, 2014
07:38 EDTNVSNovartis management to meet with JPMorgan
Meetings to be held in Los Angeles/Pasadena on July 24 and in San Francisco on July 25 hosted by JPMorgan.
07:11 EDTGSK, SNY, NVSInternational Society of DNA Vaccines to hold a conference
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07:03 EDTNVSAnacor, 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.
July 17, 2014
08:34 EDTNVSVanda requests award of $539M in proceedings with Novartis
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08:08 EDTPFEBristol-Myers, Pfizer announce enrollment in Phase IV EMANATE trial for Eliquis
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07:18 EDTGSKMylan wins motion to enjoin GlaxoSmithKline from production of generic product
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06:23 EDTGSKGlaxoSmithKline admits to bribing Chinese officials in 2001, FT reports
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05:32 EDTNVSNovartis reconfirms FY14 revenue guidance up at low to mid single digit rate
The company stated, "We are reconfirming our outlook for FY14. Group net sales in 2014 are expected to grow at a low to mid-single digit rate. Group core operating income is expected to grow ahead of sales in 2014, and now refined to mid to high-single digit. This outlook recognizes the entry of generic competition for Diovan monotherapy in the U.S. on July 7, including an authorized generic from Sandoz on the same date. If June average exchange rates prevail for the remainder of the year, the currency impact for the year would be -1% on sales and -3% to -4% on core operating income."
05:29 EDTNVSNovartis reports Q2 Core EPS $1.34, consensus $1.42
Reports Q2 revenue $14.6B, consensus $14.81B. Reports continued pipeline progress with positive regulatory decisions and significant clinical trial data released in Q2.
July 16, 2014
10:36 EDTPFETreasury calls on Congress to halt inversion deals
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09:27 EDTPFEPfizer to acquire InnoPharma for upfront cash payment of $225M
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09:03 EDTSNYSanofi held talks on mature drugs with Abbott, Mylan, PE firms, Reuters says
Sanofi (SNY) has shopped an $8.5B portfolio of mature drugs to Abbott (ABT), Mylan (MYL) and private equity firms, according to Reuters, citing an internal company document circulated by the CGT union. Sanofi is considering whether to sell, carve out or create a joint venture for the portfolio of about 200 drugs, but a Sanofi spokesman said no decision has yet been made, the report noted. Reference Link
08:21 EDTLLYEli Lilly reports beta-amyloid imaging results in Alzheimer's Disease
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07:59 EDTPFETreasury Secretary urges Congress to take action on tax inversions
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07:14 EDTGSKIsis Pharmaceuticals earns $1M milestone payment from GlaxoSmithKline
Isis Pharmaceuticals (ISIS) has earned a $1M milestone payment from GlaxoSmithKline (GSK) related to the advancement of the Phase 2/3 study of ISIS-TTRRx in patients with familial amyloid polyneuropathy. ISIS-TTRRx is an antisense drug in development with GSK for the treatment of transthyretin amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerve and/or heart tissues. Including this milestone payment, Isis has generated $27M in upfront and milestone payments for advancing ISIS-TTRRx. If GSK elects to exercise its option to exclusively license the ISIS-TTRRx program, Isis is eligible to receive a license fee, regulatory and sales milestone payments and double-digit royalties on sales of ISIS-TTRRx.
07:05 EDTLLYEli Lilly and Immunocore partner to develop cancel therapies
Eli Lilly and Immunocore today announced they have entered into a co-discovery and co-development collaboration to research and potentially develop novel T cell-based cancer therapies. Immunocore will receive an upfront fee of $15M per program for the discovery of novel ImmTACs against jointly-selected cancer targets in order to generate preclinical candidate packages. If Lilly accepts a preclinical candidate package to develop and potentially commercialize, Immunocore will receive an opt-in fee of $10M and will have an option to continue co-development with Lilly on a cost-sharing and profit-sharing basis. If Immunocore does not exercise its option, it will be entitled to potential future significant milestone and royalty payments.
07:04 EDTPFEPfizer says primary endpoint met in Phase 3 study of BeneFIX
Pfizer announced the positive results of a Phase 3 study comparing a prophylaxis regimen of BeneFIX Coagulation Factor IX 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B. The top-line results of the study showed that the primary study endpoint was met and hemophilia B patients taking once-weekly BeneFIX showed a statistically significant reduction in the annualized bleeding rate relative to on-demand treatment with BeneFIX. In the study, the median ABR value, a commonly used measure of efficacy for prophylaxis regimens in hemophilia, was 2.0 for the prophylaxis regimen, compared to 33.6 for the on-demand regimen, representing a 94% decrease in bleeding rates. The mean ABR value was 3.6 for the prophylaxis period, compared to 32.9 for the on-demand treatment, which represents a reduction of 89%. Study results also showed that prophylaxis treatment significantly reduced both spontaneous and traumatic ABR compared to on-demand treatment with BeneFIX. In addition to meeting the primary endpoint, the secondary study endpoints showed that none of the 1,254 prophylaxis infusions administered during the study were associated with a less than expected therapeutic effect occurrence, which was defined as a spontaneous bleed occurring within 48 hours of a prophylaxis infusion. These results are preliminary, top-line data and are subject to additional analyses. Complete results from this study will be submitted for presentation at upcoming medical congresses and submitted for publication in a peer-reviewed journal.
05:38 EDTGSKGSK, Theravance initiate Phase III IMPACT study
GlaxoSmithKline (GSK) and Theravance (THRX) announced the start of a global phase III study, known as IMPACT, to evaluate the efficacy and safety of the 'closed' triple combination of FF/UMEC/VI in patients with chronic obstructive pulmonary disease, or COPD. IMPACT is the first pivotal phase III study in a programme to evaluate a once-daily closed triple combination treatment of an inhaled corticosteroid, or ICS; a long-acting muscarinic antagonist, or LAMA; and a long-acting beta2-adrenergic agonist, or LABA, in patients with COPD. The IMPACT study will enrol approximately 10,000 patients and assess whether the combination of FF, or fluticasone furoate, an ICS, UMEC, or umeclidinium, a LAMA, and VI, or vilanterol, a LABA, all delivered in GSK's Ellipta inhaler, can reduce the annual rate of moderate and severe exacerbations compared with two approved once daily COPD treatments, Relvar/Breo Ellipta, FF/VI, which is an ICS/LABA combination, and Anoro Ellipta, UMEC/VI, which is a LAMA/LABA combination.
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