Fri, Jun. 26, 11:57 AM
- Bedford, MA-based ConforMIS (Pending:CFMS) is set for its IPO of 9M shares of common stock at $14 - 16.
- The commercial stage medical technology firm develops joint replacement implants that are individually sized and shaped (customized) to fit each patient's unique anatomy. Off-the-shelf implants rarely fit perfectly, some have overhang (implant is too large and protrudes over the bone) while others have underhang (the implant is too small and part of the bone is exposed).
- The company uses its iFit Image-to-Implant software to convert a CT scan to a 3D model which is then used to design the implant. Disposable plastic instruments, called iJigs, are constructed with an in-house 3D printer that enable a more accurate, reproducible and simplified surgical procedure. Most of the metal components are made by third party suppliers who deliver them on a "just-in-time" basis.
- 2014 Financials ($M): Revenues: 48.2 (+39.2%); Gross Profit: 17.5 (+140.0%); Operating Expenses: 63.0 (+15.3%); Net Loss: (45.7) (+4.5%); CF Ops: (43.5) (+7.0%).
- Related tickers: (NYSE:JNJ) (NYSE:ZMH) (NASDAQ:WMGI)
Thu, Jun. 25, 12:08 PM
- Johnson & Johnson (JNJ +0.4%) announces the availability of Invega Trinza (three-month paliperidone palmitate) in the U.S., its schizophrenia treatment that requires dosing only four times a year. The FDA cleared it in May.
- The company's Invega franchise generated over $2.3B in sales the past four quarters.
- Previously: FDA clears Janssen's long-acting anti-psychotic drug (May 19)
Wed, Jun. 10, 9:30 AM
- Biogen (NASDAQ:BIIB) and Samsung Bioepis announce results from separate Phase 3 trials comparing their biosimilar candidates to their respective reference products. The data were presented at the European League Against Rheumatism Annual Congress in Rome, Italy.
- 24-week data from one Phase 3 study comparing SB4 to the etanercept reference product Enbrel (NASDAQ:AMGN) in patients with moderate-to-severe rheumatoid arthritis (RA) showed equivalent efficacy. 596 patients were randomized to receive either SB4 (n=299) or Enbrel (n=297). The ACR20 (American College of Rheumatology: 20% improvement in RA symptoms) response rate at week 24 in the full analysis set was 73.8% in the SB4 arm versus 71.7% in the Enbrel arm. Full 52-week data will be available at a later date.
- 30-week data from a second Phase 3 comparing SB2 to the infliximab reference product, Remicade (NYSE:JNJ), in patients with moderate-to-severe RA also showed equivalent efficacy. 584 patients were randomized to receive either SB2 (n=291) or Remicade (n=293). The ACR20 response rate at Week 30 in the full analysis set for the SB2 arm was 55.5% compared to 59.0% in the Remicade arm.
- Data from a Phase 1 study assessing the pharmacokinetic equivalency of another biosimilar candidate, SB5, to its reference product, adalimumab [AbbVie's (NYSE:ABBV) Humira], will be presented as well.
- Samsung Bioepis is a joint venture between Biogen and Samsung Biologics.
Thu, May 28, 12:42 PM
- Boston Scientific (BSX +1.8%) loses another product liability lawsuit related to its transvaginal mesh. A Delaware court has ordered the company to pay plaintiff Deborah Barba $25M in compensatory damages plus $75M in punitive damages, according to the law firm that represented Ms. Barba.
- Last month, the company announced that it reached agreements to settle 2,970 mesh-related suits for $119M. In November, it lost a suit brought by four women who claimed they were injured from the use of the product. The award was $26.7M.
- Lawyers are having a field day suing mesh manufacturers. Boston Scientific, Johnson & Johnson (JNJ -0.3%) and C.R. Bard (BCR -0.5%) still face close to 70K product liability lawsuits alleging poor design. The mesh, implanted in women for the treatment of incontinence and/or to support internal organs, had a tendency to erode over time causing organ damage and pain.
- Previously: Boston Sci loses first federal case over vaginal mesh product (Nov. 14, 2014)
Thu, May 28, 10:22 AM
- As expected, the European Commission approves privately-held Boehringer Ingelheim's single-pill Synjardy (empagliflozin/metformin hydrochloride) for glycemic control in adult type 2 diabetics. The product was developed under its alliance with Eli Lilly (LLY +0.3%).
- Diabetes-related tickers: (SNY -0.5%)(JNJ +0.1%)(OTCQB:ISLT)(OTCQB:BTHE)(VTAE -2.4%)(MRK +0.4%)(NVO -1.5%)(ABT +0.2%)(VKTX +1.4%)(HPTX)(OTCPK:TKPYY +0.3%)(ALR -0.4%)(MNKD -0.8%)(TNDM -1.6%)
- Previously: European Ad Comm recommends approval of combo pill for type 2 diabetes (March 30)
Thu, May 28, 9:20 AM
- The FBI is investigating what Johnson & Johnson (NYSE:JNJ) knew about the hazards of its laparoscopic power morcellator before it pulled it off the market in July of last year. The FDA warned the medical community last November that the device, which was used to cut up uterine fibroids for removal through tiny incisions in the abdomen, could increase a woman's risk of cancer. According to the agency, women undergoing fibroid surgery have a one in 350 chance of harboring uterine sarcoma. The cutting action of the morcellator blades could contribute to the spread of the cancer cells to other parts of the body.
- The FBI has interviewed a retired pathologist who alerted the company in a letter about the potential risk in 2006 and a California woman who has collected ~400 names of patients and families who may have been harmed by the device.
- Company spokesman Matthew Johnson confirmed the pathologist's 2006 letter and added that the firm revised its operating instructions as a result, adding to language already present which cautioned about the potential spread of suspected malignant tissue.
- The FBI also interviewed a Pennsylvania anesthesiologist who underwent the procedure in 2013 at a Boston hospital. The hospital acknowledged that it worsened her cancer in addition to another patient the year before.
- Previously: Johnson & Johnson withdraws fibroid treatment device from market (July 30, 2014)
- Previously: J&J halts the sale of Ethicon device (April 30, 2014)
Tue, May 26, 7:40 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for Janssen's (NYSE:JNJ) Simponi (golimumab) for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis (nr-axial SpA) who have had an inadequate response to or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
- Nr-axial SpA is a painful and potentially progressive condition that principally affects the spine and pelvic joints. It is characterized by chronic lower back pain and stiffness.
- Simponi, currently cleared for the treatment of moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis and moderate-to-severe ulcerative colitis, is a human monoclonal antibody that binds to tumor necrosis factor (TNF)-alpha, a protein that is overproduced in chronic inflammatory diseases. Merck (NYSE:MRK) has the marketing rights in the EU.
Thu, May 21, 9:30 AM
- Alongside Goldman's list of 50 stocks appearing most as top holdings at hedge funds is its list of the 50 top shorts.
- New additions this quarter: Baxter Intl (NYSE:BAX), UPS, Marriott (NASDAQ:MAR), NextEra (NYSE:NEE), Ford (NYSE:F), National Oilwell Varco (NYSE:NOV), McDonald's (NYSE:MCD), M&T Bank (NYSE:MTB), CenturyLink (NYSE:CTL), Amgen (NASDAQ:AMGN), Pioneer Natural (NYSE:PXD), Duke Energy (NYSE:DUK), Seagate (NASDAQ:STX), AbbVie (NYSE:ABBV), Cisco (NASDAQ:CSCO).
- The full list (in order of $ value of short interest): AT&T (NYSE:T), Disney (NYSE:DIS), IBM, Verizon (NYSE:VZ), Intel (NASDAQ:INTC), Kinder Morgan (NYSE:KMI), Exxon (NYSE:XOM), Pfizer (NYSE:PFE), J&J (NYSE:JNJ), Deere (NYSE:DE), Caterpillar (NYSE:CAT), Exelon (NYSE:EXC), GE, Boeing (NYSE:BA), Halliburton (NYSE:HAL), Fox (NASDAQ:FOXA), Comcast (NASDAQ:CMCSA), UTX, Regeneron (NASDAQ:REGN), Merck (NYSE:MRK), salesforce.com (NYSE:CRM), AbbVie (ABBV), Conoco (NYSE:COP), Wal-Mart (NYSE:WMT), Eli Lilly (NYSE:LLY), Celgene (NASDAQ:CELG), Schlumberger (NYSE:SLB), AutoZone (NYSE:AZO), Wells Fargo (NYSE:WFC), Emerson (NYSE:EMR), McDonald's (MCD), Reynolds (NYSE:RAI), Target (NYSE:TGT), Accenture (NYSE:ACN), Coca-Cola (NYSE:KO).
Wed, May 20, 8:13 AM
- At a meeting today with analysts, Johnson & Johnson's (NYSE:JNJ) Janssen Pharmaceuticals announced plans for regulatory approval of more than 10 new drugs between 2015 and 2019, each with the potential to generate at least $1B in sales, in addition to over 40 line extensions of existing and new medicines. It projects top-line growth above the industry average through 2019.
- Janssen's product portfolio is focused on five core therapeutic areas: Immunology, Infectious Diseases & Vaccines, Neuroscience, Cardiovascular & Metabolism and Oncology. It has launched 14 new products since 2009, seven of which will achieve blockbuster status (sales of $1B+) this year.
- Late stage products include daratumumab for multiple myeloma; sirukumab for rheumatoid arthritis; guselkumab for psoriasis; JNJ-927 (ARN0509) for pre-metastatic prostate cancer; imetelstat for myelofibrosis; JNJ-493 for urothelial cancer; esketamine for treatment-resistant depression and AL-8176 for hepatitis C.
- In February of this year, Janssen announced the launch of three new research platforms focused on disease prevention, disease intervention and the microbiome, with the intent to potentially change the way diseases are managed.
- According the IMS Health, the global pharmaceutical market reached $1T last year with 40% of the growth coming from specialty drugs. It is expected to grow ~3% per annum through 2019.
Tue, May 19, 5:02 PM
- Achillion Pharmaceuticals (NASDAQ:ACHN) enters into an exclusive global license and collaboration agreement with Janssen Pharmaceuticals (NYSE:JNJ) to develop and commercialize one or more of Achillion's hepatitis C candidates, including ACH-3102, ACH-3422 and sovaprevir.
- Under the terms of the agreement, Achillion will be eligible to receive various development-, regulatory- and sales-based milestones valued as much as $1.1B and tiered royalties between mid-teens and low-twenties on worldwide commercial sales. Janssen will be responsible for all development costs within the partnership as well as all the costs associated with commercialization of the HCV assets. In addition, Johnson & Johnson Innovation JJDC, J&J's venture capital subsidiary, will invest $225M in Achillion via the purchase of ~18.4M shares of common stock at $12.25 per share.
- One key objective of the collaboration is the development of a short-duration pan-genotypic oral regimen for the treatment of HCV infection.
- Achillion is hosting a conference right now to discuss the deal.
- ACHN is down 2% after hours on robust volume.
Tue, May 19, 8:36 AM
- Under its Priority Review scheme, the FDA approves Janssen Pharmaceuticals' (NYSE:JNJ) Invega Trinza (three-month paliperidone palmitate) for the treatment of schizophrenia. Administered only four times per year, it is the longest dosing interval now available. The commercial launch will commence in ~three weeks.
- Before starting Invega Trinza, patients must be adequately treated with Invega Sustenna (one-month paliperidone palmitate) for at least four months.
- Schizophrenia affects ~2.4M Americans. The Invega franchise generated over $2.3B for J&J over the past four quarters.
Mon, May 18, 8:47 AM
- At the American Psychiatric Association meeting in Toronto, Intra-Cellular Therapies (NASDAQ:ITCI) presented additional data from a 335-subject Phase 2 clinical trial evaluating its lead product candidate, ITI-007, in patients with schizophrenia.
- The study met its primary efficacy endpoint of a statistically significant improvement in psychosis as measured by the change from baseline at day 28 in PANSS total score versus placebo.
- Patients in the intent-to-treat population who received once-daily 60 mg ITI-007 showed improved negative symptoms as did a subgroup of those with prominent negative symptoms. The effects were not observed in patients treated with risperidone (branded version: Janssen Pharmaceuticals' (NYSE:JNJ) Risperdol). Also, a subgroup of schizophrenia patients who had co-morbid depression that were treated with ITI-007 showed a statistically significant anti-psychotic effect not observed in the risperidone cohort.
- Treatment with ITI-007 demonstrated a favorable tolerability profile with little or no weight gain, favorable effect on metabolic measures and a reduced risk of akathisia (feeling of restlessness) and hyperprolactinemia (elevated prolactin in the blood which may cause breast enlargement in men).
- ITI-007 is currently in Phase 3 development.
- ITCI is up 5% premarket on light volume.
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%)
Johnson & Johnson is a holding company, which is engaged in the research and development, manufacture and sale of products in the health care field within its Consumer, Pharmaceutical and Medical Devices, and Diagnostics business segments.
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