Dec. 3, 2014, 6:33 PM
- Array BioPharma (NASDAQ:ARRY) +24% AH says it reached a deal with Novartis (NYSE:NVS) to regain global rights to its binimetinib cancer treatment as well as an upfront payment of $85M.
- The agreement is subject to NVS and GlaxoSmithKline (NYSE:GSK) completing a series of transactions which were unveiled in April and remain subject to regulatory approval.
- ARRY says binimetinib is advancing in three phase 3 clinical trials and that it plans to file for its first regulatory approval in H1 2016.
Dec. 3, 2014, 3:36 PM
- Actelion Ltd (OTCPK:ALIOF) (OTC:ALIOY) submits a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Uptravi (selexipag) for the treatment of patients with pulmonary arterial hypertension (PAH).
- Selexipag is selective IP prostacyclin receptor agonist. Prostacyclin activates the IP receptor inducing vasodilation and inhibiting proliferation of vascular smooth muscle cells. If approved, it will be the first such drug cleared for use in PAH.
- In April 2008, the company signed a license agreement with Nippon Shinyaku under which Actelion has global development and commercialization rights to selexipag outside of Japan. The firms will be partners in Japan.
- Actelion plans to submit an NDA to the FDA shortly.
- PAH-related tickers: (GSK -0.8%)(GILD -1.9%)(MSTX -1.5%)(ARNA +1.7%)(OTCPK:BAYRY -1.8%)(UTHR -1.2%)
Dec. 1, 2014, 9:05 AM
- The Australian Pharmaceutical Benefits Scheme (PBS) approves the reimbursement of GlaxoSmithKline (NYSE:GSK) and Theravance's (NASDAQ:THRX) Anoro Ellipta (umeclidinium/vilantrol) for the maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Reimbursement will begin December 1, 2014.
- COPD afflicts ~530K Australians.
- Previously: Anoro Ellipta cleared in Australia
Nov. 30, 2014, 5:24 AM
- GlaxoSmithKline (NYSE:GSK) is poised to announce a workforce restructuring as soon as this week that will include hundreds of job cuts in the U.S., Bloomberg reports.
- U.S. sales are flagging due to increased respiratory drug competition, including the company’s best-selling Advair asthma medication.
- Glaxo pledged in October to cut costs by £1B ($1.56B) over three years, with half the savings coming in 2016.
Nov. 28, 2014, 9:49 AM
- Lyon, France-based Flamel Technologies (FLML +0.6%) sells its Pessac, France-located manufacturing and development facility to Swedish CDMO (contract development and manufacturing organization) Recipharm for €10.6M as part of a five-year service agreement. Flamel retains access to the capabilities of Pessac as well as other Recipharm facilities for its production and development activities. The sale includes the royalty contract for Coreg CR with GlaxoSmithKline (GSK +0.3%).
- Flamel and Recipharm agree to negotiate an agreement with the objective of incorporating the former's drug delivery technology into the latter's contract development business.
- In a separate transaction, Recipharm will make a €10.5M investment in Flamel's common stock.
Nov. 28, 2014, 9:23 AM
- The European Commission approves Boehringer Ingelheim's Vargatef (nintedanib), in combination with docetaxel, for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology, after first-line chemotherapy. Adenocarcinoma is the most common form of lung cancer.
- Nintedanib is an oral angiokinase inhibitor which simultaneously inhibits endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR) signalling pathways. It is currently being investigated in various other cancers.
- Earlier this month, Europe's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion supporting approval of nintedanib, branded as Ofev, for the treatment of ideopathic pulmonary fibrosis (IPF). The FDA approved it for IPF in October.
- Previously: Europe Ad Comm supports approval for BI pulmonary fibrosis drug
- Previously: BI begins enrollment in Phase 3 CRC trial
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Lung cancer-related tickers: (NYSE:BMY) (NYSE:MRK) (NASDAQ:CLVS) (NASDAQ:FPRX) (NASDAQ:BIND) (NYSE:GSK) (NASDAQ:ARIA) (NASDAQ:ECYT) (NYSE:AZN) (OTC:MKGAF) (OTCPK:MKGAY) (NASDAQ:ONTY) (NYSE:PFE) (NASDAQ:HTBX) (OTCQX:RHHBY) (NASDAQ:INCY)
Nov. 28, 2014, 7:41 AM
- GlaxoSmithKline (NYSE:GSK) declines to exercise its option to license Dynavax's (NASDAQ:DVAX) DV1179, an investigational bifunctional inhibitor of toll-like receptors (TLR) 7 and 9, after it failed to meet its pharmacodynamic endpoints related to the reduction in interferon alpha-regulated genes in a Phase 1b/2a study in patients with active systemic lupus erythematosus.
- Dynavax will now have full global rights to develop DV1179 and other TLR 7/9 inhibitors for all indications.
Nov. 27, 2014, 2:38 AM
- An experimental Ebola vaccine from GlaxoSmithKline (NYSE:GSK) produced an immune response in all 20 healthy volunteers who received it, and did not cause any serious side effects, Reuters reports quoting the New England Journal of Medicine.
- The early-stage clinical trial, which began on Sept. 2, is primarily aimed at assessing how safe the vaccine is and will monitor the volunteers for 48 weeks.
Nov. 26, 2014, 3:48 PM
- The Federal Trade Commission approves GlaxoSmithKline's (GSK +0.4%) proposed acquisition of Novartis' (NVS +0.6%) vaccines business and the proposed creation of a consumer healthcare joint venture between the two firms.
- As a condition of the positive vote, Novartis will divest its private label nicotine replacement therapy transdermal patch, Habitrol, in the U.S. to Dr. Reddy's Laboratories SA (RDY +1.5%).
Nov. 25, 2014, 8:18 AM
- Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
- Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
- Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (NYSE:NVS) (NYSE:AZN) (NASDAQ:AMGN) (NASDAQ:BIIB) (NASDAQ:CELG) (NYSE:LLY) (NYSE:SNY) (NYSE:ABT) (NYSE:ABBV) (NYSE:BMY) (NYSE:MRK) (NYSE:GSK)
Nov. 24, 2014, 9:48 AM
- Merck (MRK -0.7%) enters into an exclusive worldwide license agreement with NewLink Genetics (NLNK +0.5%) to develop and commercialize the latter's investigational rVSV-EBOV (Ebola) vaccine candidate.
- Phase 1 trials are currently underway at Walter Reed Army Institute of Research and the NIAID at the NIH. If successful, the NIH will commence a large, randomized Phase 3 study to evaluate the safety and efficacy of rVSV-EBOV and another investigational Ebola vaccine candidate co-developed by the National Institute of Allergy and Infectious Diseases (NIAID) and GlaxoSmithKline (GSK -0.3%).
- The rVSV-EBOV vaccine was created by scientists at the Public Health Agency of Canada's National Microbiology Laboratory.
Nov. 24, 2014, 8:02 AM
- The European Commission approves AstraZeneca's (NYSE:AZN) Duaklir Genuair (aclidium bromide/formoterol fumarate 340/12 mcg) for the maintenance bronchodilator treatment in adults with chronic obstructive pulmonary disease (COPD).
- The product is a fixed dose combination of two approved long-acting bronchodilators with different mechanisms of action. Aclidium bromide is an anticholinergic or long-acting muscarinic antagonist that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a long-acting beta-agonist that stimulates the B2-receptors in the bronchial smooth muscle resulting in bronchodilation. Both are currently approved as stand-alone therapies for the maintenance treatment of COPD in the U.S. and Europe.
- Genuair is a multi-dose pre-loaded dry powder inhaler that utilizes optical and acoustic signals to inform the patient that the correct dose has been delivered.
- COPD-related tickers: (NYSE:GSK) (NYSE:NVS) (NASDAQ:THRX) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
Nov. 24, 2014, 7:05 AM
- On December 18 GlaxoSmithKline (NYSE:GSK) shareholders will vote on the company's planned acquisition of Novartis' (NYSE:NVS) vaccines business, the latter's acquisition of Glaxo's cancer products and the combination of their consumer healthcare businesses. The total value of the assets involved is ~$20B.
- Previously: Novartis announces billions of dollars in deals with GSK, Eli Lilly
- Previously: Why Glaxo bids adieu to cancer drugs
Nov. 19, 2014, 8:32 AM
- GlaxoSmithKline (NYSE:GSK) has finished recruiting 2,800 people with Chronic Obstructive Pulmonary Disease (COPD) living in Salford, England to participate in a one-year Phase 3 open-label study to explore the effectiveness of Relvar Ellipta (fluticasone furoate "FF"/vilanterol "VI" 100/25 mcg) compared to other COPD treatments when used in a broad group of people living and managing their COPD on a daily basis.
- The Salford Lung Study is the first "real-world" study of its kind in the world for a medicine prior to approval, conducted in one geographic location and run by GSK in collaboration with local healthcare providers.
- Traditionally, drugs are evaluated in carefully-controlled randomized controlled trials on specific patient populations. Frequently, these trials exclude patients with additional conditions, or co-morbidities, that could influence the outcome. There is a need for additional information to complement the results from randomized trials in order to better understand a drug's potential when used in under real world circumstances. The Salford Lung Study is designed to provide this information.
- The primary endpoint of the Salford trial is the mean annual rate of moderate and severe exacerbations. The study should finish in late 2015 with the first results expected in 2016.
- Related ticker: (NASDAQ:THRX)
Nov. 18, 2014, 7:20 AM
- Clovis Oncology (NASDAQ:CLVS) and GlaxoSmithKline (NYSE:GSK) enter into a clinical trial collaboration to evaluate a novel combination therapy targeting mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC). The Phase 1/2 study of Clovis' rociletinib and GSK's trametinib is expected to start in 1H 2015. It will assess the safety and activity of the combination in patients with EGFR mutant NSCLC who were previously treated with an EGFR tyrosine kinase inhibitor.
- Rociletinib is a mutant-selective EGFR inhibitor. Trametinib is an MEK inhibitor.
Nov. 14, 2014, 7:07 AM
- In order to improve its growth prospects, GlaxoSmithKline (NYSE:GSK) plans to sell its portfolio of older prescription medicines sold in North America and western Europe. The group includes Paxil, Imitrex, Zantac and Zofran. The company plans to retain the rights to the drugs in emerging markets where their growth is higher and it intends to retain ownership in its manufacturing facilities.
- Potential buyers, who will have to outsource manufacturing and distribution operations, include Leon Black's Apollo Global Management and KKR.
- The product group's 2014 sales will be ~₤1B ($1.6B) but are declining due to the encroachment of generic competitors. Sources say Glaxo seeks a price of 2x sales or $3.2B.
GSK vs. ETF Alternatives
GlaxoSmithKline PLC incorporated in United Kingdom. The Company creates, discoveres, develops, manufactures and markets pharmaceutical products including vaccines, over-the-counter (OTC) medicines and health-related consumer products.
Other News & PR