High-Quality Glaxo Could Still Have Something Left
Stephen Simpson, CFA • 10 Comments
Stephen Simpson, CFA • 10 Comments
Fri, Apr. 1, 1:06 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of GlaxoSmithKline's (GSK -0.9%) Strimvelis (GSK2696273) for the treatment of patients with ADA-SCID (severe combined immunodeficiency due to adenosine deaminase deficiency) for whom no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available. ADA-SCID is a rare disorder caused by the lack of an enzyme called adenosine deaminase which leads to a compromised immune system.
- Stremvelis is a stem cell gene therapy created from the patient's own cells. It was originally developed in Italy and advanced by GSK under a 2010 collaboration agreement.
- A final decision from the European Commission usually takes about 60 days.
- Now read GlaxoSmithKline: A Positive Outlook For 2016
Fri, Apr. 1, 10:00 AM
- Array BioPharma (ARRY -3.7%) slumps on increased volume in response to its announcement that it has terminated its Phase 3 study, MILO, assessing binimetinib in low-grade ovarian cancer due to lack of efficacy. Detailed results will be shared with the scientific community at a later date.
- Binimetinib inhibits a protein kinase enzyme called MEK, which plays a key role in a certain cellular signaling pathway that is over-activated in certain cancers, especially those that express the mutations BRAF, KRAS and NRAS. It is being investigated in BRAF-positive (COLUMBUS study) and NRAS-positive (NEMO study) melanoma.
- Array licensed binimetinib to Novartis (NVS -2.3%) in 2010 but reacquired the rights after Novartis acquired GlaxoSmithKline's (GSK -1.7%) oncology business in early 2015.
- Now read Earnings Peek: Array BioPharma Has A Lot Going On And A Lot of Money
Thu, Mar. 31, 7:12 AM
- Gilead Sciences (NASDAQ:GILD) submits a New Drug Application (NDA) to the Japanese Pharmaceutical and Medical Devices Agency (PMDA) seeking clearance of tenofovir alafenamide (TAF) for the treatment of hepatitis B virus (HBV) infection.
- TAF has similar efficacy as Viread (tenofovir disoproxil fumarate, TDF) at one-tenth the dose while being less stressful on bones and kidneys. Viread is marketed in Japan for the treatment of HBV by GlaxoSmithKline (NYSE:GSK) under the brand name Tenozet.
- More than 1M Japanese are chronically infected with HBV.
Tue, Mar. 29, 7:24 AM
- The Japanese Ministry of Health, Labor and Welfare approves GlaxoSmithKline's (NYSE:GSK) Nucala (mepolizumab) for the treatment of bronchial asthma in patients at least 12 years old with refractory asthma whose symptoms are inadequately controlled with standard treatment.
- Nucala, a monoclonal antibody that binds to interleukin-5 (IL-5), was cleared in the U.S. in November 2015. IL-5 plays a key role in regulating the function of eosinophils, white blood cells that increase in number in asthma. It is administered as a 100 mg fixed-dose subcutaneous injection every four weeks.
Thu, Mar. 17, 4:30 AM
- GlaxoSmithKline (NYSE:GSK) CEO Andrew Witty plans to step down in 2017 after almost a decade at the helm that brought both transformation and discontent.
- He has faced criticism for Glaxo's lagging share performance, sluggish U.S. sales, and a bribery scandal in China that led to a $489M fine.
- However, Witty also oversaw the biggest reorganization since the merger that created Glaxo 15 years ago. Last year, he swapped the company's cancer drugs division for Novartis' vaccines business and cash. The companies also formed a joint venture to sell consumer health products.
Mon, Mar. 14, 9:54 AM
- In a regulatory filing, Theravance Biopharma (TBPH +1.2%) reports that it inked a Share Purchase Agreement with Glaxo Group Limited (GSK -0.1%) for the sale of 1,301,015 unregistered ordinary shares at $17.70 (~$23M). Closing date is March 17.
- Glaxo owned a ~22% stake in Theravance at the end of 2015.
Tue, Mar. 8, 9:13 AM
- Sydney, Australia-based Benitec (NASDAQ:BNTC) announces that its DNA-directed RNA interference (ddRNAi) candidate, BB-HB-331, showed robust and durable hepatitis B virus (HBV) suppression in vivo following a single administration.
- The HBV suppression activity of BB-HB-331 was assessed in the Phoenix mouse model in which murine liver cells were replaced by human hepatocytes which made them susceptible to HBV infection. Once infected, the mice received a single systemic injection of BB-HB-331. Serum antigen levels, HBV viral proteins and extracellular HBV DNA were measured once per week for the duration of the eight-week study.
- Results showed a 1.83 log knockdown of serum HBV DNA, equivalent to a 98.5% reduction of circulating HBV. In addition, intracellular HBV DNA was reduced 94.9% while HBV surface antigen (HBsAg) and e antigen (HBeAg) were reduced by 97.6% and 92.6%, respectively. The results validated the previously reported in vitro findings.
- BB-HB-331 combines the gene silencing of RNA interference with the therapeutic potential of gene therapy. It is comprised of an AAV8 capsid (protein shell of a virus) and recombinant DNA engineered to express three short hairpin RNAs that target and inhibit viral RNA expressed from three regions across multiple HBV genotypes. The company plans to advance BB-HB-331 to clinical development.
- Previously: Benitec Biopharma's ddRNAi therapeutic candidate shows potent anti-HBV antigen activity in preclinical testing; shares up 14% (Dec. 7, 2015)
- HBV-related tickers: (NASDAQ:GILD)(OTCQB:COCP)(NYSE:GSK)(NASDAQ:IONS)(NASDAQ:DVAX)(NYSE:JNJ)(NASDAQ:ARWR)(NYSE:MRK)(NASDAQ:CTRV)(NASDAQ:ABUS)(NYSE:SNY)(NASDAQ:ALNY)(NYSE:BMY)
- Update: Shares up 26% in early trading.
Mon, Feb. 29, 3:06 AM
- GlaxoSmithKline's (NYSE:GSK) chairman is starting the process of seeking a new chief executive to succeed Andrew Witty, although a handover at the top of Britain's largest drugmaker is not expected before 2017.
- According to people familiar with the matter, Chairman Philip Hampton has held a number of meetings with shareholders during which he has made clear that succession planning will be a priority for the board over the next couple of years.
Fri, Feb. 26, 1:53 PM
- GlaxoSmithKline (GSK -0.9%) initiated with Hold rating and 1400p price target (-0.7% downside risk) by Cantor Fitzgerald.
- Shire plc (SHPG -0.6%) initiated with Buy rating by Cantor Fitzgerald.
- Insulet (PODD +8.7%) initiated with Sell rating and $15 (53% downside risk) price target by Empire Asset Management.
- MacroGenics (MGNX +2.2%) initiated with Equal Weight rating and $20 (29% upside) price target by Morgan Stanley.
- Biogen (BIIB +0.8%) initiated with Buy rating and $345 (30% upside) price target by Citigroup.
- Boston Scientific (BSX -0.3%) initiated with Buy rating and $21 (22% upside) price target by SunTrust Robinson Humphrey.
- Other initiations by Citigroup: Amgen (AMGN +1.1%) Neutral rating and $165 (11% upside) price target; Celgene (CELG +1.4%) Buy rating and $130 (25% upside) price target; Regeneron Pharmaceuticals (REGN) Buy rating and $480 (22% upside) price target; Alexion Pharmaceuticals (ALXN +0.1%) Neutral rating and $165 (18% upside) price target.
- IMS Health Holdings (IMS +0.2%) initiated with Outperform rating and $31 (19% upside) price target by Leerink Swann.
- Ocera Therapeutics (OCRX +5.7%) initiated with Buy rating and $10 (229% upside) price target by Brean Capital.
- Repligen (RGEN +3.8%) initiated with Buy rating and $36 (35% upside) price target by Craig-Hallum.
- Mesoblast (MESO -2.2%) initiated with Neutral rating and $5.50 (12% downside risk) price target by Chardan Capital.
- Ultragenyx Pharmaceutical (RARE +1.2%) initiated with Buy rating and $80 (29% upside) price target by Leerink Swann.
- Teva Pharmaceutical Industries (TEVA -0.2%) initiated with Outperform rating with $68-71 (21% upside from midpoint) price target by Wells Fargo.
- Medivation (MDVN +9.8%) initiated with Buy rating and $46 (28% upside) price target by Bank of America.
- Collegium Pharmaceutical (COLL -0.1%) initiated with Outperform rating and $35 (83% upside) price target by William Blair.
Wed, Feb. 24, 1:40 PM
- ViiV Healthcare, the HIV-focused joint venture between GlaxoSmithKline (GSK -1.1%), Pfizer (PFE -0.5%) and Shionogi Limited (OTC:SGIOF)(OTCPK:SGIOY), announces the results from a 41-week Phase 2a study, ECLAIR, assessing the safety, tolerability, dosing and satisfaction with long-acting, injectable cabotegravir as monotherapy for the prevention of HIV infection in adult males not at high risk of acquiring HIV. The data were presented at the Conference on Retroviruses and Opportunistic Infections in Boston.
- ECLAIR randomized 127 HIV-negative subjects 5:1 to cabotegravir or placebo beginning with a safety assessment on oral cabotegravir 30 mg or placebo tablet for four weeks followed by an intramuscular injection of 800 mg cabotegravir or placebo (sterile saline) every 12 weeks for three cycles.
- The proportions of participants who completed three injections for cabotegravir and placebo were 93% (n=87/94) and 95% (n=20/21), respectively. The incidences of Grade 2 (moderate) to Grade 4 (life-threatening or disabling) adverse events during the injection phase were 80% (n=75/94) and 48% (n=10/21), respectively. The most common Grade 2-4 AE was injection site pain (59% and 5%, respectively). The incidences of all grades of adverse events during the injection phase were 98% (n=92/94) and 90% (n=19/21), respectively.
- Following repeat injections, 74% (n=67/91) favored long-acting cabotegravir over the oral version.
- ViiV intends to advance cabotegravir to Phase 3 development later this year.
- Related tickers: (NASDAQ:GILD)(NYSE:ABT)(NYSE:BMY)(NYSE:JNJ)(NYSE:MRK)(OTCQX:RHHBY)
Mon, Feb. 22, 12:16 PM
- Bristol-Myers Squibb (BMY -0.4%) completes its previously announced sale of its HIV R&D portfolio to ViiV Healthcare, the joint venture of Pfizer (PFE +1.5%) and GlaxoSmithKline (GSK -1.1%).
- Under the terms of the transaction, BMY received an upfront payment of $350M. It can earn up to $518M in development and regulatory milestones and up to $587M for the discovery and preclinical programs plus tiered royalties on commercial sales. ViiV will also pay sales-based milestones of up to $750M for each of the clinical assets and up to $700M for each of the discovery and preclinical programs.
- The deal does not affect BMY's currently marketed HIV drugs.
- Previously: Glaxo to buy HIV assets from Bristol-Myers Squibb (Dec. 18, 2015)
Mon, Feb. 22, 11:12 AM
Fri, Feb. 19, 12:50 PM
- The FDA accepts for review Mylan's (MYL +2.6%) abbreviated New Drug Application (ANDA) for a generic version of GlaxoSmithKline's (GSK +0.6%) Advair Diskus (fluticasone propionate 100, 250, 500 mcg and salmeterol 50 mcg inhalation powder) for the treatment of asthma and maintenance treatment of chronic obstructive pulmonary disease (COPD). Its action date (GDUFA) is March 28, 2017.
- According to Glaxo's most recent earnings report, Advair (Diskus and HFA) sales in the U.S. last year were ₤1.865B ($2.664B), down 13%.
Fri, Feb. 12, 12:25 PM
- In its first pay-for-delay decision, the U.K.'s Competition and Markets Authority (CMA) dings GlaxoSmithKline (GSK +0.7%) for ₤37.6M ($54.4M) for its activities to delay generic competition to its antidepressant Seroxat (paroxetine) during the period 2001 - 2004.
- According to the Authority, the company paid more than ₤50M to certain firms to delay the launch of their versions, thereby depriving the National Health Service of significantly better pricing. When generics finally hit the market at the end of 2003, prices were 70% below branded Seroxat.
- Despite claims that it did nothing wrong, the company has agreed to the settlement in order to avoid costly litigation.
- The CMA also fined Generics UK (now part of Mylan (MYL -1%)) and its former parent Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) ₤5.8M and Actavis (AGN +0.1%) ₤1.5M as the successor to Alpharma.
Tue, Feb. 9, 12:48 PM
- The FDA designates Adaptimmune Therapeutics' (ADAP -3.6%) NY-ESO-1-T cell therapy a Breakthrough Therapy for the treatment of patients with NY-ESO-1-positive synovial sarcoma, a rare soft tissue cancer that occurs in the joints of the arm, neck or leg.
- The company's therapeutics are based on increased affinity T cell receptors (TCRs) which enable the body's T cells to target cancer proteins inside and outside of cells.
- GlaxoSmithKline (GSK -0.4%) has the exclusive option to develop and commercialize NY-ESO-1 under a 2014 collaboration agreement.
- Breakthrough Therapy status provides for more intensive guidance from the FDA review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
- Previously: Glaxo inks deal on cancer drug development (June 2, 2014)
Tue, Feb. 9, 9:02 AM
- VBI Vaccines (NASDAQ:VBIV) enters into a research collaboration with GlaxoSmithKline (NYSE:GSK) to evaluate VBI's LPV Platform in a defined field.
- The LPV Platform is a proprietary formulation and process that enables vaccines and biologics to maintain their stability, potency and safety. This is an important issue considering most vaccines and biologics are highly sensitive to temperature and physical stress. Most require storage between 4 and 8 degrees Celsius to preserve their integrity. Being able to store these products at room temperature, for example, would be a significant benefit.
- Specific financial terms of the partnership are not disclosed.
- VBIV is up 13% premarket on modest volume.
GlaxoSmithKline Plc operates as a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. It operates in three primary areas of business: Pharmaceuticals, Vaccines and Consumer Healthcare. The Pharmaceuticals business researches,... More
Industry: Drug Manufacturers - Major
Country: United Kingdom
Other News & PR