High-Quality Glaxo Could Still Have Something Left
Stephen Simpson, CFA • 10 Comments
Stephen Simpson, CFA • 10 Comments
Dec. 18, 2015, 4:37 AM
- GlaxoSmithKline (NYSE:GSK) has agreed to pay Bristol-Myers Squibb (NYSE:BMY) up to $1.5B to acquire the U.S. company's pipeline of HIV drugs.
- The deal will boost ViiV Healthcare, Glaxo's HIV unit in which Pfizer (NYSE:PFE) and Shionogi (OTCPK:SGIOY) are junior partners, with the hope of returning to earnings growth in 2016.
- Revenue from the HIV business increased 65% in Q3, offsetting falling sales elsewhere in the company's large pharmaceuticals unit.
- Update: Glaxo's purchase includes both late stage and preclinical/discovery stage assets. The late stage asset purchase consists of an upfront payment of $317M, milestones up to $518M and tiered royalties on net sales. The preclinical/discovery asset purchase consists of an upfront payment of $33M, milestones up to $587M and tiered royalties on net sales.
- The two independent transactions should be completed in H1 2016.
- GSK will host a conference call this morning at 9:00 am ET to discuss the deal.
Dec. 16, 2015, 11:10 AM
- In a regulatory filing, GlaxoSmithKline (GSK +0.8%) reports that it has received positive top-line results from its Phase 3 program (three trials) assessing sirukumab, a monoclonal antibody that binds to interleukin 6 (IL-6), for the treatment of moderate-to-severe rheumatoid arthritis (RA). The company is developing the product candidate in collaboration with Janssen Biologics (JNJ +0.2%) in a partnership that began in December 2011.
- Long-term safety and efficacy data are being collected in ongoing extensions of the late-stage trials (SIRROUND-D, -H and -T). No unexpected safety issues have been observed to date.
- The company plans to present full results from the three studies at future scientific conferences and submit them for publication. It also intends to file marketing applications for RA in 2016.
- Sirukumab is one of Glaxo and Johnson & Johnson's potential blockbusters that they are counting on to drive future growth.
Dec. 15, 2015, 7:29 AM
- Thinly traded nano cap Neothetics (NASDAQ:NEOT) craters 75% premarket on light volume in response to its announcement that two Phase 3 clinical trials, AbCONTOUR1 and AbCONTOUR2, assessing lead product candidate LIPO-202 for reduction of central abdominal bulging due to subcutaneous fat (potbelly) failed to achieve their primary or secondary efficacy endpoints.
- CEO George Mahaffey says, "We are disappointed by these unequivocally negative results. We expected LIPO-202 to demonstrate better efficacy based on the results we saw in the Phase 2b RESET trial. We continue to analyze the data from [the two Phase 3s] to fully understand the trial results and to evaluate our future plans."
- LIPO-202 is an injectable formulation of salmeterol xinafoate, a well-known long-acting beta2-adrenergic receptor agonist used in several commercially available inhaled drugs, including GlaxoSmithKline's (NYSE:GSK) SEREVENT DISKUS. Earlier studies suggested that salmeterol xinafoate activates beta2-adrenergic receptors in fat cells, triggering the metabolism of triglycerides and shrinking them via a process called lipolysis.
Dec. 14, 2015, 4:52 PM
- Amgen (NASDAQ:AMGN) reacquires the rights to Prolia (denosumab), XGEVA (denosumab) and Vectibix (panitumumab) in 48 countries in Asia, South America, Europe, and other regions from GlaxoSmithKline (NYSE:GSK). The deal includes the new territories of Brazil, China, Colombia, Hong Kong, Israel, Singapore, South Korea, Taiwan and Thailand.
- GSK has owned the rights to Prolia and XGEVA since 2009 and Vectibix since 2010 under a license from Amgen. Total sales of the three in 2014 were $111M.
- Under the terms of the new agreement, Amgen will pay GSK undisclosed milestone payments upon signing and on the successful transition of the products back to Amgen. The majority of markets should transition back to Amgen within 12 months. The transaction is expected to be accretive to non-GAAP earnings in 2017.
Dec. 10, 2015, 2:59 AM
- New Ebola cases have surfaced in Liberia, the worst hit of all Ebola-affected nations, suggesting that the fight against the disease could take months, or even years, to fully eliminate.
- Recent scientific studies and case reports indicate the Ebola virus can persist in survivors' bodily fluids months longer than previously thought.
- Liberia has already been declared Ebola-free (42 days pass without a new episode of hemorrhagic fever) twice this year, only to see new cases appear.
- Previously: Sierra Leone declared free of Ebola (Nov. 08 2015)
- Ebola-related stocks: JNJ, GSK, HEB, BCRX, NLNK, NNVC, INO, OTCQB:GOVX, SRPT, CMRX, PLX, NSPH, LAKE, APT, VSR, SMED
Nov. 27, 2015, 10:43 AM
- The FDA's Psychopharmacologic Drugs Advisory Committee will meet on Tuesday, December 1, to review privately held Fabre-Kramer Pharmaceuticals' New Drug Application (NDA) for gepirone hydrochloride extended-release tablets for the treatment of major depressive disorder (MDD).
- FDA briefing doc
- Company briefing doc
- Draft questions
- MDD-related tickers: (OTCQB:VSTA)(OTCPK:OTSKY)(OTCPK:TKPYY)(NYSE:PFE)(NASDAQ:ALKS)(NASDAQ:AVNR)(NYSE:TEVA)(NASDAQ:SHPG)(NYSE:LLY)(NYSE:GSK)
Nov. 12, 2015, 11:59 AM
- A study by not-for-profit ethics and governance watchdog Bioethics International (BI) of all clinical trials submitted to the FDA for drugs approved in 2012 showed a wide range of disclosure of results with almost all falling far short of full transparency. The lack of sharing of all trial data has been one contributor to the erosion of public trust in drug companies. According to BI President Jennifer Miller, Ph.D., only 12% of Americans believe that pharmaceutical firms are honest and ethical.
- Companies were ranked by both legal requirements to disclose data per the 2007 U.S. Food and Drug Administration Amendments Act (FDAAA) and the ethical standard that all human-based research should be publicly available in order to contribute to generalized knowledge.
- The cross-sectional analysis of the 2012 data showed that 39 new medicines and 48 new drug entities were cleared by the FDA, 15 by 10 large firms. Researchers identified 318 relevant clinical studies (out of a total of 342) involving 99,599 participants. A median of 57% of the trials were registered, 20% reported results in clinicaltrials.gov, 56% were published and 65% were either published or reported results. Almost half of all reviewed drugs had at least one undisclosed Phase 2 or 3 study.
- Gilead Sciences (GILD -1.1%) didn't fare too well, providing only 21% of the data on its HIV combo med Stribild. Sanofi (SNY -3%) was also cited for its lack of reported data on MS drug Aubagio. Firms scoring well included GlaxoSmithKline (GSK -1.2%), Johnson & Johnson (JNJ -0.9%) and Pfizer (PFE -0.4%). All disclosed 100% of their trial data for at least one drug.
- BI is in the process of expanding its rankings to include other years.
- On a positive note, the major players have indicated a keen interest in doing a better job sharing trial data, motivated, no doubt, by the work of interested observers such as BI.
- ETFs: BIB, BIS GRX, IRY, IXJ, BME
Nov. 11, 2015, 7:23 AM
- Results from a Phase 3 clinical trial, BLISS-SC, showed that patients with active autoantibody-positive systemic lupus erythematosus (SLE) treated with GlaxoSmithKline's (NYSE:GSK) Benlysta (belimumab) plus standard-of-care (SoC) treatment showed greater reductions in disease activity compared to placebo plus SoC. The data were presented at the American College of Rheumatology/Association for Rheumatology Health Professionals Annual Meeting in San Francisco.
- The primary endpoint of the study was the difference in disease activity as measured by the Systemic Lupus Erythematosus Responder Index at week 52. Significantly more patients treated with weekly subcutaneous injections of 200 mg Benlysta plus SoC (60.8%) showed reduced disease activity compared to placebo plus SoC (48.8%; p=0.0011).
- Patients in the Benlysta cohort also experienced a greater delay in time to severe flare versus placebo (both with SoC treatment) (170.0 days vs. 116.5 days; p=0.0003). In patients receiving more than 7.5 mg/day of prednisone (n=503), 18.2% of those receiving Benlysta plus SoC were able to reduce their steroid use by at least 25% during weeks 40 - 52 compared to 11.9% for placebo plus SoC, but the results fell short of statistical significance.
- The overall safety profile was consistent with earlier BLISS studies. The incidence of treatment-related adverse events was 31.3% vs. 26.1% for placebo. The most common were infections/infestations (18.7% vs. 18.9%).
- SVP Paul-Peter Tak says, "Despite use of current [SoC], about 60% of lupus patients continue to experience persistent symptoms and sever disease flares. This is GSK's third successful Phase 3 study of belimumab in patients with lupus, the results of which reinforce our belief in the BLyS pathway as a means of reducing underlying disease activity. On the basis of these data, we expect to progress towards global regulatory filings for a belimumab subcutaneous formulation which, if approved, will provide appropriate patients with a new approach to treatment administration."
- The FDA cleared IV-administered Benlysta in March 2011.
Nov. 5, 2015, 6:58 AM
- The FDA approves GlaxoSmithKline's (NYSE:GSK) Nucala (mepolizumab) as an add-on maintenance treatment of severe eosinophilic asthma in patients at least 12 years old. It is the first and only biologic cleared by the FDA that targets interleukin-5 (IL-5), which 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. Patients will receive Nucala in addition to their normal medications for severe asthma.
- The commercial launch will commence as soon as possible. The FDA clearance is the first regulatory approval anywhere in the world. The inclusion of patients as young as 12 years old is a surprise since the FDA's advisory committee voted 10-4 against the use of Nucala in adolescents. It voted 14-0 in favor of approval in adults.
- Nucala is not approved for the treatment of other eosinophilic conditions or for the relief of acute bronchospasm or status asthmaticus.
- Clearance in Europe should happen this month. In late September, the EMA's CHMP adopted a positive opinion recommending approval.
- Over 240M people worldwide live with asthma. About 5% (12M) fail to achieve symptom control with existing medicines.
- Previously: Ad Comm green lights Glaxo's mepolizumab for eosinophilic asthma, but only for adults (June 11)
- Previously: Europe's CHMP give thumbs up to Glaxo's Nucala for severe asthma (Sept. 24)
Nov. 4, 2015, 12:48 PM
- Johnson & Johnson (JNJ) acquires privately held Novira Therapeutics, a clinical stage biopharmaceutical firm developing therapies to cure chronic hepatitis B infection within one year of treatment, for an undisclosed sum. The transaction should close this quarter.
- Novira's lead product candidate is NVR 3-778, a orally available, small molecule, direct-acting antiviral that inhibits the HBV core or capsid protein. HBV core is an attractive drug target since it is plays a key role in viral replication and survival. NVR 3-778 disrupts the HBV life cycle by inducing the assembly of defective capsids. According to the company, its inhibitors, when used in combination with current standard-of-care drugs (nucleosides and interferon), should deliver greater and faster suppression of viral DNA and new virus production.
- Selected HBV-related tickers: (ARWR +2.1%)(GILD -1%)(CTRV -3.2%)(ABUS +2.6%)(DVAX -1.8%)(MRK +0.7%)(SNY -0.8%)(GSK +0.1%)(ISIS +2.1%)(ALNY +3.1%)(BMY -0.6%)
Nov. 3, 2015, 11:38 AM
- In a presentation to investors today in New York, GlaxoSmithKline (GSK -1.7%) discussed its long-term pipeline of ~40 potential new medicines across six core areas of its business: HIV & Infectious Diseases, Oncology, Immuno-Inflammation, Vaccines, Respiratory and Rare Diseases.
- The company believes that 80% of product candidates presented have the potential to be "first-in-class" with novel mechanisms of action. Late-stage candidates profiled included Nucala (mepolizumab) for eosinophilic asthma, Shingrix (zoster) a vaccine for the prevention of shingles, sirukumab for rheumatoid arthritis, daprodustat for anemia, cabotegravir for HIV, a combination vaccine for the prevention of bacterial meningitis and a new inhaled therapy for COPD.
- Management says it can potentially file for up to 20 new drugs by 2020 (seven are already in late-stage development). In the 2016/17 time frame, it can potentially start Phase 2 development for ~30 new molecular entities and product line extensions and Phase 3 development for ~20 NMEs and PLEs.
- During the period 2021/25, it has the potential to file marketing applications for up to 20 additional assets.
- 2016-2020 Outlook: New Pharmaceutical and Vaccine products, launched in the past three years, together with current pipeline candidates, should generate at least ₤6B in sales per year by 2020. Core EPS should grow at a CAGR of mid-to-high single digits on a constant currency basis.
Nov. 3, 2015, 9:32 AM
- A Phase 2b clinical trial, LATTE 2, assessing long-acting injectable formulations of Viiv Healthcare's (NYSE:GSK) (NYSE:PFE) (OTC:SGIOF) (OTCPK:SGIOY) cabotegravir and Janssen's (NYSE:JNJ) EDURANT (rilpivirine) for the maintenance treatment of HIV-1 infection met its primary endpoint at 32 weeks. The results showed the two-injectable-drug regimen was comparable in maintaining viral suppression rates to a three-drug oral regimen of cabotegravir and two nucleoside transcriptase inhibitors.
- Viral suppression rate (plasma HIV-1 RNA <50 c/ml) at week 32 for the two-drug regimen dosed every eight weeks was 95% and 94% for those dosed every four weeks. This compared favorably to 91% for the three-drug regimen.
- Patients on the four-week regimen reported more adverse events (AEs) leading to withdrawal (5%; n=6) than those on the eight-week regiment (2%; n=2) and those on the oral regimen (2%; n=1). The most common AE was injection site pain (93% of injection recipients). Two patients in the eight-week cohort withdrew for injection intolerance. Two patients, one in the eight-week group and one in the oral group, experienced virologic failure.
- Cabotegravir is an investigational integrase strand transfer inhibitor and analogue of ViiV's Tivicay (dolutegravir). It is being evaluated as a once-daily oral tablet and as a long-acting intramuscular injection.
- The results will be presented at an upcoming scientific conference.
Nov. 3, 2015, 8:55 AM
- Regulus Therapeutics (NASDAQ:RGLS) is up 5% premarket on light volume in response to its announcement of a clinical trial collaboration and formulation development agreement with GlaxoSmithKline (NYSE:GSK) related to Regulus' investigational microRNA therapeutic RG-101 and Glaxo's investigational non-nucleoside NS5B polymerase inhibitor, GSK2878175, for the treatment of HCV infection.
- The companies intend to initiate a Phase 2 clinical trial in Q1 (outside of the U.S.) that will assess a single subcutaneous dose of 4 mg/kg of RG-101 in combination with a daily oral dose of 20 mg of GSK2878175 for up to 12 weeks in treatment-naive patients with chronic HCV genotypes 1 and 3 infection.
- Concurrent with the trial, Glaxo will work on a long-acting parenteral for injection (LAP) formulation of GSK2878175 that could be a good administrative fit with RG-101.
- Neither company has further obligations or commitments beyond the Phase 2 study.
Nov. 3, 2015, 7:24 AM
- GlaxoSmithKline (NYSE:GSK) and Merck (NYSE:MRK) announce the initiation of a Phase 1 clinical trial assessing Glaxo's investigational GSK3174998 as monotherapy and in combination with Merck's KEYTRUDA (pembrolizumab) in patients with locally advanced, recurrent or metastatic solid tumors that have progressed after standard treatment. The primary endpoints are adverse events and dose-limiting toxicities. According to clinicaltrials.gov, the estimated study completion date is January 2020.
- GSKJ3174998 is a humanized IgG1 anti-OX40 monoclonal antibody that was discovered via a collaboration with MD Anderson Cancer Center. OX40 is a tumor necrosis factor receptor found on the surface of activated CD4+ and CD8+ T cells. OX40 agonism stimulates the immune system while reducing the immunosuppressive effects of regulatory T cells sometimes found in tumors.
- KEYTRUDA is a humanized monoclonal antibody that increases the ability of the body's immune system to fight tumor cells by blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2.
Oct. 29, 2015, 9:10 AM
- Pfizer (NYSE:PFE) and GlaxoSmithKline (NYSE:GSK) enter into a multi-year collaboration to develop a next-generation design of Pfizer's portable, continuous, miniature and modular (PCMM) prototype for oral solid dose (OSD) pharmaceutical development and manufacturing.
- Pfizer's current PCMM prototype is an autonomous transportable pod that can be shipped from location to location and quickly brought online creating a fully functional GMP-compliant module. Glaxo will leverage its know-how in continuous processing to help create a next-generation design.
- A PCMM facility has as much as a 70% smaller footprint compared to a conventional manufacturing facility while enabling the same equipment to be used for development, clinical trials and commercial manufacturing. It takes about one year to set up versus two - three years for standard processes.
- Financial terms are not disclosed.
Oct. 29, 2015, 6:31 AM
- Allergan (NYSE:AGN) is up 15% premarket on light volume on the news that it is in talks with Pfizer (NYSE:PFE) about a possible merger. If the deal goes through, it would create the world's largest healthcare firm with a market value of $330B, larger than Johnson & Johnson's (NYSE:JNJ) market cap of $278B.
- A lower tax bill is one of the reasons Allergan is an attractive target for Pfizer considering the Botox maker is domiciled in tax-friendly Dublin. The U.S. government clamped down on tax inversion deals last year which scuppered the AbbVie/Shire deal so it is unclear how this might effect Pfizer's ability to change its domicile.
- Potential Pfizer takeover targets GlaxoSmithKline (NYSE:GSK) and Shire (NASDAQ:SHPG) are both down slightly in premarket trading.
- Update: Both Pfizer and Allergan confirm the commencement of "friendly" discussions regarding a potential combination.
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
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