Fri, May 15, 1:45 PM
- The FDA issues a warning that type 2 diabetic patients taking drugs called sodium-glucose contransporter-2 (SGLT-2) inhibitors to lower their blood sugar may have increased risk of developing ketoacidosis, a serious condition characterized by the buildup of acids, called ketones, in the blood that can be life-threatening if untreated for an extended period. It is caused by an insulin deficiency which forces cells to burn fat for energy instead of glucose which produces ketones.
- The agency is investigating the issue to determine if the safety risk warrants changes to the labeling of currently approved medications. There were 20 reported cases of ketoacidosis in the period from March 2013 to June 6, 2014, all of which required emergency room visits or hospitalization.
- SGLT-2 inhibitors cleared for sale in the U.S. are Johnson & Johnson's (JNJ) Invokana (canagliflozin) and Invokamet (canagliflozin/metformin); AstraZeneca's (AZN -1.4%) Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin/metformin); Eli Lilly (LLY -0.5%) and Boehringer Ingelheim's Jardiance (empagliflozin) and Glyxambi (empagliflozin/linagliptin).
Wed, May 13, 1:00 PM
- Janssen Pharmaceuticals (JNJ +0.1%) receives a Complete Response Letter (CRL) from the FDA regarding its supplemental New Drug Application (sNDA) for its long-acting antipsychotic Invega Sustenna (paliperidone palmitate). It was seeking an expanded label to include data showing treatment with the drug is effective six months longer than other commonly prescribed oral antipsychotics in people with schizophrenia.
- The FDA issues a CRL when it determines that a regulatory application is not approvable in its present form.
- The data supporting the sNDA was based on the PRIDE study which compared Invega Sustenna to other meds within the context of a real world setting. The primary endpoint was time to treatment failure, which was more broadly defined to include psychiatric hospitalization, arrest/incarceration, suicide, treatment supplementation and increased level of psychiatric services, in addition to the typical endpoints of safety, tolerability and lack of efficacy.
- Invega Sustenna was originally cleared by the FDA in July 2009. It generated almost $1.3B in sales over the past four quarters.
- Previously: Janssen seeks expanded label for Invega Sustenna (July 14, 2014)
Tue, May 12, 12:13 PM
- The European Investment Bank loans Copenhagen-based Bavarian Nordic €50M (OTC:BVNKF) (OTCPK:BVNRY) to help it develop its Ebola vaccine and, to a lesser extent, its RSV vaccine candidate and CV-301, a cancer immunotherapy candidate. The funds follow a $100M infusion in January from the Innovative Medicines Initiative (Ebola vaccine), $25M from Johnson & Johnson (JNJ -0.6%) for Ebola and $60M from Bristol-Myers Squibb (BMY -1.4%) for Prostvac.
- The company's pipeline of cancer immunotherapies, infectious diseases vaccines and high value collaborations makes it a prime acquisition target. This one will be gone within a year or two.
Tue, May 12, 10:14 AM
- One consequence of the wind down of the Ebola outbreak in West Africa is that there is little chance that the vaccine trials going on there will show efficacy, according to the World Health Organization. Since the number of cases has dropped substantially, Liberia was declared Ebola-free on Saturday, Guinea reported seven cases last week while Sierra Leone reported only two, there may not be enough data to prove that people are actually protected.
- The FDA's Materials, Vaccines and Related Biological Products Advisory Committee is meeting today to discuss alternative approval paths for Ebola vaccines, considering situations like West Africa. One option for approval is the "animal rule" which grants licensure based on the results from animal studies that show the vaccine is reasonably likely to produce clinical benefit in humans.
- Previously: Ad Comm approaches for alternative development and licensure paths for Ebola vaccine candidates (May 8)
- Related tickers: (MRK -1.2%)(JNJ -0.5%)(GSK -1.2%)(NLNK -22.2%)(EBS -2.8%)
Mon, May 11, 7:03 PM
- Johnson & Johnson's (NYSE:JNJ) Janssen Pharmaceutical Companies expands its policy of enhancing access to its HIV drug darunavir by significantly enlarging the number of low-and middle-income countries to 128 where it agrees not to enforce its patents and controls on the antiretroviral. The expanded geography is twice as large as the original territory announced in its 2012 policy. It applies only to pediatric darunavir products.
- The company's position allows for generic firms to manufacture and distribute their own versions of darunavir with the proviso that the quality is up to standard and the products are sold only in the indicated countries. Manufacturers will be responsible for obtaining permission from other darunavir patent holders and local health authorities.
- The 128 countries are home to 99.8% of children and adolescents living with HIV infection worldwide.
Sun, May 10, 7:06 AM
- The World Health Organization has declared Liberia free of Ebola, marking the end of a national outbreak that infected as many as 400 new victims a week at its peak.
- Liberia has now gone 42 days - twice Ebola's maximum incubation period - since the burial of its last confirmed patient without discovering a new case.
- The disease is still spreading in Sierra Leone and Guinea, though at a slower pace. According to WHO statistics, more than 11,000 people have died from the virus, with about half of them in Liberia.
- Ebola-related stocks: JNJ, GSK, HEB, BCRX, NLNK, NNVC, INO, TKMR, OTCQB:GOVX, SRPT, CMRX, PLX, NSPH, LAKE, APT, VSR, SMED.
Fri, May 8, 1:15 PM
- Mechelen, Belgium-based Galapagos N.V. (OTC:GLPGF) is set for its IPO of 3.776M American Depositary Shares (ADSs) at ~$41 per ADS (based on recent prices and 1.12 euro/dollar exchange rate). The offering also includes 944K ordinary shares that will be sold in Europe and ex-U.S. countries in a private placement. Each ADS represents the right to receive one ordinary share. The closings of the U.S. offering and the ex-U.S. private placement will be conditioned on each other. Some reallocation may occur. Shares will trade under the symbol "GLPG."
- The clinical stage biotech discovers and develops small molecule medicines with novel mechanisms of action that address high unmet medical needs. Its most advanced candidates are in inflammatory-related diseases. These include GLPG0634 (filgotinib) in three Phase 2b trials for rheumatoid arthritis and one Phase 2 for Crohn's disease; GLPG1205 in a Phase 2a trial for ulcerative colitis and GLPG1690 about to enter a Phase 2a study in idiopathic pulmonary fibrosis. Filgotinib is being developed under a collaboration with AbbVie (ABBV +1.1%). Its partnership with J&J's (JNJ +1.9%) Janssen Pharmceutica NV, which began in 2007, to develop 1205 and 1690 ended in March by mutual agreement.
- 2014 Financials (€M): Revenues: 69.4 (-9.4%); Operating Expenses: 36.6 (+116.6%); Net Income: 33.2 (+510.0%); Cash Burn: (75.6) (-999%).
- Previously: Galapagos JAK-1 inhibitor successful in Phase 2 rheumatoid arthritis study (April 14)
- Previously: Galapagos and Janssen part ways in inflammation alliance (March 17)
Fri, May 8, 11:33 AM
- The FDA's Materials, Vaccines and Related Biological Products Advisory Committee meets Tuesday, May 12 to discuss the benefits and risks of various development and approval paths for Ebola vaccines.
- The committee will discuss three: 1) traditional approval based on clinical endpoint efficacy data, 2) accelerated approval and 3) approval under the "animal rule."
- Traditional approval is unlikely to be recommended due to the inability and unethical aspect of comparing the vaccine candidates to placebo and the difficulty of recruiting a sufficient number of subjects due to the significant decline in Ebola infection rates.
- Under accelerated approval, a surrogate endpoint that is reasonably likely to predict clinical benefit (e.g., immune response) may serve as the basis for licensure. In this scenario, post-approval studies would be required to verify and describe the vaccine's clinical benefit.
- The "animal rule" may apply if traditional studies are unfeasible or unethical and accelerated approval cannot be used. In this scenario, approval would based on the results from animal studies that show the vaccine is reasonably likely to produce clinical benefit in humans, provided that safety in humans has been established. Post-approval studies would be required here as well.
- Briefing information
- Related tickers: (MRK +1.5%)(JNJ +1.8%)(GSK +3.2%)(NLNK +3.1%)(EBS -1.6%)
Thu, May 7, 11:13 AM
- Spurred by the progress of a bill moving through Congress that will speed new drugs to market for conditions lacking cures, called The 21st Century Cures Act, the FDA has scheduled a public meeting this summer to address concerns by the drugs industry that regulatory restrictions on what they can say about the off-label use of their products violates their First Amendment right to free speech. Language in the bill is ratcheting up the pressure on the agency to relax its guidelines.
- Drug makers were emboldened on its prospects of changing the rules after an appeals court overturned the conviction of a pharmaceutical sales representative in 2012 who was convicted of promoting off-label uses of the narcolepsy drug Xyrem. The court ruling was based on First Amendment protection for truthful and non-misleading off-label speech.
- The American Medical Association supports the need for physicians to have access to accurate and unbiased information about off-label uses of drugs since it already accounts for as much as 20% of prescribing, with higher levels in oncology and pediatric rare diseases.
- Giving drug firms more leeway in this arena has its detractors, however. Rita Redberg, M.D., Professor of Medicine at the UC-San Francisco says, "At my own medical center we have banned pharmaceutical reps from coming because we don't think they are a good source of information. You don't ask the barber if you need a haircut."
- Pharma companies have a dubious history of breaking the rules governing off-label promotion. Over the past 10 years, 17 firms have paid more than $16B in settlements related to inappropriate off-label selling.
- Further complicating matters is the fact that up to 75% of published pre-clinical trial results cannot be reproduced in later studies.
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (MRK +0.4%)(LLY -0.1%)(PFE +0.3%)(BMY +0.7%)(GSK -4.1%)(OTCQX:RHHBY -1.1%)(SNY -0.6%)(OTCPK:BAYRY -0.5%)(NVS +0.1%)(AZN -0.3%)(JNJ +0.2%)(ABT -0.1%)(ABBV +0.1%)
Tue, May 5, 1:09 PM
- It took a while, but the first major health insurer announces its intention to stop paying for the routine use of the laparoscopic power morcellator. Aetna (AET -2%) says it will cease coverage beginning May 15. Doctors will have to be pre-approved thereafter based on exceptions for pre-menopausal women who want to preserve fertility and have no other treatment options and women for whom other procedures could lead to severe complications or be life-threatening.
- A power morcellator has spinning blades that are used to cut uterine fibroids or the uterus into pieces so they can be removed through small incisions in the abdomen, characteristic of minimally invasive surgery. Cancer cells can hide in fibroid tissue, however, which can be spread by the spinning blades, increasing the women's risk of cancer.
- A year ago, Johnson & Johnson (JNJ -0.9%) stopped selling the product in light the risk. At about the same time, the FDA issued an advisory to clinicians to discourage the use of the device. In July, J&J started withdrawing the product from the market, including the return of already-purchased devices. In November, the FDA formally stated that the devices should not be used on the vast majority of women.
- Other insurers will most certainly follow Aetna's lead.
- Previously: Johnson & Johnson withdraws fibroid treatment device from market (July 30, 2014)
- Previously: J&J halts the sale of Ethicon device (April 30, 2014)
Fri, Apr. 24, 3:52 PM
- Burlington, MA-based CoLucid Pharmaceuticals (Pending:CLCD) is set for its IPO of 5.36M shares of common stock at $13 - 15.
- The clinical stage biopharmaceutical firm is developing a small molecule for the acute treatment of migraine headaches. Lasmiditan, currently in Phase 3 development in an oral tablet form, is a 5-HT1F receptor agonist that blocks the pain transmission without the side effects of the class of migraine therapies called triptans. The 5-HT1F receptor is a serotonin subtype that lacks the vasoconstrictive properties of other serotonin receptors, which can cause adverse cardiac events in patients with cardiovascular or cerebrovascular disease. Top-line data from a Phase 3 study, called SAMURAI, is expected in Q3 2016. A second Phase 3 evaluating an IV formulation of lasmiditan should commence in H1 2016.
- The company licensed lasmiditan from Eli Lilly.
- 2014 financials ($M): Operating expenses: 2.3 (+43.8%); Net Loss: (3.0) (-34.6%); CF Ops: (0.8) (+49.3%).
- Migraine-related tickers: (OFIX +0.4%)(TEVA +1.8%)(AVNR)(RDHL +0.5%)(PTX -3%)(ALDR -0.8%)(ENDP -0.8%)(JNJ +0.6%)(AMGN -0.7%)(DEPO +1.2%)(AGN)
Fri, Apr. 24, 9:05 AM
- At the Liver Meeting in Europe, Merck (NYSE:MRK) presented data from its ongoing C-EDGE pivotal Phase 3 study evaluating its HCV combination of grazoprevir/elbasvir (100mg/50mg) in patients with genotypes 1, 4 or 6.
- Overall, treatment-naive patients treated with the combo for 12 weeks without ribavirin (RBV) showed a cure rate (sustained virologic response 12 weeks after therapy or SVR12) of 95% (n=299/316). Treatment-naive patients co-infected with HIV treated for 12 weeks, without RBV, also showed a cure rate of 95% (n=207/218).
- Treatment-experienced HCV patients treated with the combo, with and without RBV showed cure rates of 94% (n=98/104) and 92% (n=97/105), respectively. Treatment-experienced HCV patients treated for 16 weeks, with and without RBV, showed cure rates of 97% (n=103/106) and 92% (n=07/105), respectively.
- Cure rates in cirrhotic patients ranged from 89 - 100%; non-cirrhotic: 93 - 97%; genotype 1a: 90 - 95%; genotype 1b or other g-1: 96 - 100%; genotype 4: 60 - 100% and genotype 6: 75 - 100%.
- The results were presented at the 50th Annual Congress of the European Association for the Study of the Liver in Vienna, Austria.
- Related tickers: (NASDAQ:GILD) (NYSE:ABBV) (NYSE:JNJ) (NYSE:BMY)
Thu, Apr. 23, 1:34 PM
- Data from two Phase 3 studies evaluating Janssen's (JNJ +0.2%) Olysio (simeprevir) combined with Gilead Sciences' (GILD +1%) Sovaldi (sofosbuvir) for the treatment of chronic HCV-1 infection, with and without cirrhosis, show cure rates as high as 97%.
- In OPTIMIST-1, HCV-1 patients without cirrhosis treated with the combo for 12 weeks showed a cure rate (SVR12) of 97% (n=150/155) while those treated for eight weeks showed 83% (n=128/155).
- In OPTIMIST-2, HCV-1 patients with cirrhosis treated with the combo for 12 weeks showed a cure rate of 84% (n=86/103).
- The results will be presented at this week's 50th Annual Congress of the European Association for the Study of the Liver in Vienna, Austria.
- The FDA cleared the combination therapy for the treatment of HCV-1 infection in November of last year.
- Previously: FDA clears HCV combo (Nov. 6, 2014)
Thu, Apr. 23, 11:02 AM
Tue, Apr. 14, 8:25 AM
- Johnson & Johnson (NYSE:JNJ) Q1 results ($M): Total Revenues: 17,374 (-4.1%); Consumer: 3,390 (-4.7%); Pharmaceutical: 7,726 (+3.0%); Med Devices & Diagnostics: 6,258 (-11.4%).
- Sales growth has decelerated last three quarters in Pharmaceuticals: U.S.: 36.6%, 33.1%, 22.7%, 16.9%; International: 6.8%, 2.8%, -2.7%, -10.7%.
- Sales growth also decelerating in global business: 9.1%, 5.1%, -0.6%, -4.1%.
- Product leaders: Imbruvica: 116 (+999%); Concerta/Methylphenidate: 224 (+49.3%); Xarelto: 441 (+38.2%); Stelara: 549 (+20.4%); Simponi/Simponi Aria: 300 (+15.8%).
- 2015 Guidance: EPS: $6.04 - 6.19 from $6.12 - 6.27
Tue, Apr. 14, 7:47 AM
JNJ vs. ETF Alternatives
Johnson & Johnson is a holding company, which is engaged in the research and development, manufacture and sale ofproducts in the health care field within its Consumer, Pharmaceutical and Medical Devices, and Diagnostics business segments.
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