Thu, Jun. 23, 6:07 PM
- Janssen (NYSE:JNJ) says Health Canada has approved SIMPONI (golimumab) for the treatment of adults with severe active non-radiographic axial spondyloarthritis (nr-AxSpA) with objective signs of inflammation as indicated by elevated C-reactive protein ("CRP") and/or magnetic resonance imaging ("MRI") evidence who have had an inadequate response to or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
- This is the fifth indication for SIMPONI in Canada, which was approved originally by Health Canada in 2009 for adults living with moderately to severely active rheumatoid arthritis ("RA").
Thu, Jun. 23, 8:19 AM
- As expected, the European Commission approves Gilead Sciences' (NASDAQ:GILD) Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 in patients at least 12 years old who weigh at least 35 kg without known mutations associated with resistance to the non-nuclease reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine and who have a viral load less than 100K HIV-1 RNA copies/mL.
- Odefsey combines Gilead's Descovy (emtricitabine/tenofovir alafenamide) with Janssen Sciences Ireland UC's (NYSE:JNJ) rilpivirine (Edurant). It is the second single table regimen approved in Europe based on Descovy (Genvoya was the first).
- The European Medicines Agency's Advisory Committee adopted a positive opinion recommending approval in April.
- Recent SA articles: Pro & Con
Tue, Jun. 21, 7:54 AM
- Impax Laboratories (NASDAQ:IPXL) acquires a group of 15 generic drugs from Teva Pharmaceutical Industries (NYSE:TEVA) and affiliates of Allergan (NYSE:AGN) for total consideration of $586M. The transaction also includes the return of the rights to the pending abbreviated New Drug Application (ANDA) for a generic version of Johnson & Johnson's (NYSE:JNJ) Concerta (methylphenidate hydrochloride) to Impax.
- The deal will be immediately accretive to Impax's earnings. The group generated ~$150M in sales and ~$100M in gross profit in 2015. Per IMS, the U.S. market for the portfolio is ~$3.1B.
- Impax will finance the acquisition with cash on hand and $400M in term loans.
- Teva divested the products to satisfy U.S. Federal Trade Commission conditions for its planned acquisition of Allergan's generics business.
Mon, Jun. 20, 10:06 AM
- Enanta Pharmaceuticals (ENTA +2.5%) commences the proof-of-concept portion of its ongoing Phase 1 study evaluating EDP-494, a pan-genotypic cyclophilin inhibitor, in patients with hepatitis C virus (HCV) genotypes 1 or 3 infection. The double-blind, randomized phase will assess the safety, pharmacokinetics and anti-viral activity of two different oral doses of EDP-494 in treatment-naive HCV patients, administered once daily for 14 days.
- According to the company, there is increasing resistance to currently available direct-acting HCV antivirals (DAAs). EDP-494 avoids this problem via its unique mechanism of action, inhibiting a protein called cyclophilin which plays an essential role in HCV replication. EDP-494 is called a host-targeting antiviral which means that it targets the host proteins that are involved in the viral life cycle. Other HCV therapies are categorized as virus-targeting antivirals since they act directly on viral proteins. It says cyclophilin inhibitors may have the highest barrier to resistance of any class of HCV treatments.
- After the Phase 1 is completed, Enanta intends to develop EDP-494, in combination with one or more DAAs, for treatment-resistant HCV infection.
- HCV-related tickers: (GILD +1.6%)(JNJ +1.1%)(BMY +1%)(MRK +1%)(GSK +3.4%)(RGLS +0.7%)(ABBV +1.7%)
Sat, Jun. 11, 8:58 AM
- A Phase 3 clinical trial, EPOANE 3021, evaluating Janssen's (NYSE:JNJ) EPREX (epoetin alfa) for the treatment of anemia in adult patients with low or intermediate-1 risk myelodysplastic syndromes (MDS) met its primary endpoint. The results were presented at the 21st Annual Congress of the European Hematology Association in Copenhagen.
- EPOANE 3021 randomized 130 subjects to receive either epoetin alfa or placebo over 24 weeks. Patients receiving epoetin alfa experienced a statistically significantly higher erythroid response rate (31.8%) compared to placebo (4.4%) (p<0.001). Also, significantly less patients in the treatment group required a transfusion (24.7% versus 54.1%). Time to first transfusion favored epoetin alfa as well.
- The data have been submitted to the regulatory agency in France, the reference health authority, seeking an expanded label for EPREX in the EU to include this new use. A decision should be made in the next few months.
- EPREX is currently approved for the treatment of anemia in patients with renal insufficiency/failure, those with non-myeloid malignancies receiving chemo, adults with mild-to-moderate anemia who scheduled for elective surgery and to augment autologous blood collection in anemic adults who are scheduled for major elective surgery.
- Anemia affects the vast majority of MDS sufferers but there are no erythropoiesis stimulating agents approved for this patient population.
Fri, Jun. 10, 9:25 AM
- Janssen Research & Development, LLC (NYSE:JNJ) announces results from from a Phase 3 clinical trial, MMY3003 (POLLUX), assessing DARZALEX (daratumumab), in combination with standard-of-care lenalidomide and dexamethasone (L+D), in patients with multiple myeloma (MM) who have received at least one prior line of therapy. The results were presented at the 21st Annual Congress of the European Hematology Association in Copenhagen.
- Patients receiving daratumumab and L+D experienced a 63% reduction in the risk of disease progression or death compared to patients receiving L+D alone (hazard ratio = 0.37). Median progression-free survival (PFS) has not been reached in the daratumumab cohort but it has (18.4 months) for those treated with L+D alone.
- The proportion of complete responders also favored daratumumab/L+D (43%) versus L+D (19%) (p<0.0001) as did very good partial responders (76% vs. 44%; p<0.0001).
- Daratumumab is a human IgG1k monoclonal antibody that binds to CD38, a protein expressed on the surface of many immune cells. Once bound, it induces rapid tumor cell death through multiple mechanisms.
- In May, the European Commission approved DARZALEX for the treatment of adult patients with relapsed/refractory MM who have been previously treated with an immunomodulatory agent (e.g., lenalidomide) and a proteasome inhibitor [e.g., Takeda's Velcade (bortezomib)].
Thu, Jun. 9, 8:31 AM
- FibroGen (NASDAQ:FGEN) announces that collaboration partner Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY) has initiated a Phase 3 clinical trial in Japan evaluating roxadustat for the treatment of anemia in patients with chronic kidney disease (CKD) on hemodialysis. The action triggers a $10M milestone payment to FibroGen.
- Under FibroGen's 2004 license agreement with Yamanouchi (predecessor to Astellas), Astellas is responsible for the development costs of roxadustat in Japan and makes payments to FibroGen based on the achievement of certain milestones.
- Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein transcription factor that "turns on" the production of red blood cells (erythropoiesis). Its value proposition is the ability to maintain hemoglobin levels in CKD patients without affecting inflammation and potentially avoiding the need for ongoing intravenous iron repletion therapy as needed with epoetin alfa [Janssen's (NYSE:JNJ) Procrit]
Wed, Jun. 8, 8:23 AM
- A 1,670-subject Phase 3 clinical trial, SIRROUND-D, evaluating sirukumab in adult patients with moderately to severely active rheumatoid arthritis (RA) met both co-primary endpoints. The data will be presented at the Annual European Congress of Rheumatology on June 11 in London.
- Results showed patients treated with sirukumab experienced significantly less joint destruction than placebo (p<0.001) from baseline to week 52 as measured by a method called Sharp van der Heijde Score which is used to measure joint damage observed in X-ray images. The sirukumab group was also superior to placebo in the proportion of patients achieving ACR20 (20% improvement in RA symptoms) at week 16 (p<0.001).
- All major secondary endpoints were also met. Regulatory applications are on tap for Q3.
- Sirukumab is being co-developed by GlaxoSmithKline (NYSE:GSK) and Janssen Biologics (NYSE:JNJ) in a partnership that began in late 2011. It is a human monoclonal IgG kappa antibody that binds to interleukin-6 (IL-6), a cytokine that plays a key role in autoimmune conditions. The companies expect it to be a blockbuster generating peak sales of $1B+.
Tue, Jun. 7, 10:43 AM
- Micro cap Regulus Therapeutics (RGLS -4.9%) slumps on average volume after its announcement of Phase 2 data on lead product candidate RG-101 for the treatment of hepatitis C virus (HCV) infection failed to excite investors.
- The ongoing mid-stage study is assessing a four-week once-daily treatment regimen of RG-101, in combination with Gilead Sciences' (GILD +0.5%) Harvoni (ledipasvir/sofosbuvir) or Janssen's (JNJ +0.1%) Olysio (simeprevir) or Bristol-Myers Squibb's (BMY +0.4%) Daklinza (daclatasvir) in 79 treatment-naive patients with HCV genotypes 1 and 4 infection.
- Cure rates, defined as sustained virologic response 12 weeks following the end of treatment (SVR12), were 100% for the combination with Harvoni, 96.3% for the combination with Olysio and 91.7% for the combination with Daklinza.
- 24 weeks after the end of therapy, however, the cure rates dropped to 80.0% and 88.9%, respectively, for Olysio and Daklinza but remained at 100% for Harvoni, clouding the picture for RG-101's efficacy.
- RG-101 is a microRNA therapeutic, specifically a GalNAc-conjugated anti-microRNA targeting microRNA-122. MicroRNAs are small bits of RNA, typically 20 - 25 nucleotides long, that do not encode proteins but regulate gene expression. Researchers believe as many as two-thirds of human genes are regulated by microRNAs.
Fri, Jun. 3, 7:37 AM
- Bayer (OTCPK:BAYRY) and Espoo, Finland-based Orion expand their 2014 agreement to jointly develop BAY-1841788 (ODM-201) in prostate cancer, currently in Phase 3 development (ARAMIS study) for the treatment of high-risk non-metastatic castration-resistant prostate cancer.
- The new indication will be for the treatment of newly diagnosed metastatic hormone-sensitive prostate cancer, in combination with docetaxel, in men who are starting first-line hormone therapy.
- A Phase 3 study, called ARASENS, will begin enrolling patients in late Q4. The double-blind, placebo-controlled trial will randomize ~1,300 subjects 1:1 to receive either BAY-1841788 (ODM-201) or placebo in combination with an androgen deprivation therapy of the investigator's choice started no more than 12 weeks before randomization. The primary endpoint is overall survival.
- BAY-1841788 is an oral androgen receptor antagonist.
- Prostate cancer-related tickers: (NASDAQ:MDVN)(OTCPK:ALPMY)(NYSE:VRX)(NASDAQ:TTHI)(NASDAQ:EDAP)(NASDAQ:TKAI)(NYSE:JNJ)(NASDAQ:TSRO)(NYSE:AZN)(NASDAQ:EGRX)(NASDAQ:OGXI)
Thu, Jun. 2, 7:01 AM
- Johnson & Johnson (NYSE:JNJ) inks an agreement to acquire privately held Vogue International, a developer of salon-influenced and nature-inspired hair care and personal products, for ~$3.3B in cash.
- Vogue's products are sold in the U.S. and 38 other countries.
- The transaction should close in Q3. It is not expected to impact J&J's 2016 sales or earnings guidance announced on April 19.
Tue, May 31, 7:33 AM
- The European Commission approves the use of IMBRUVICA (ibrutinib) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL), adding to the original approval in October 2014 for adults with CLL who have received at least one prior therapy or first line in the presence of a 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy or patients with relapsed/refractory mantle cell lymphoma.
- IMBRUVICA, a Bruton's tyrosine kinase (BTK) inhibitor, is being co-developed by Janssen's Cilag GmbH International (NYSE:JNJ) and AbbVie's (NYSE:ABBV) Pharmacyclics LLC.
- The FDA approved IMBRUVICA for treatment-naive CLL patients in March.
Fri, May 27, 4:56 PM
- Globus Medical (NYSE:GMED) initiated with Equal Weight Rating and $26 (8% upside) price target by Barclays.
- TG Therapeutics (NASDAQ:TGTX) initiated with Buy rating $18 (133% upside) price target by SunTrust Robinson Humphrey.
- Karyopharm Therapeutics (NASDAQ:KPTI) initiated with Outperform rating and $13 (35% upside) price target by Raymond James.
- SAGE Therapeutics (NASDAQ:SAGE) initiated with Sell rating and $18 (43% downside risk) price target by Chardan Capital.
- Viking Therapeutics (NASDAQ:VKTX) initiated with Buy rating with a $5 (285% upside) price target by Maxim Group.
- Fibrocell Science (NASDAQ:FCSC) resumed with Buy rating and $7 (229% upside) price target by Roth Capital Partners.
- Asterias Biotherapeutics (NYSEMKT:AST) initiated with Buy rating and $5.50 (61% upside) price target by Chardan Capital.
- Quorum Health (NYSE:QHC) initiated with Market Perform rating and $14 (6% upside) price target by Avondale Partners.
- Radius Health (NASDAQ:RDUS) initiated with Buy rating and $55 (57% upside) price target by H.C. Wainwright.
- Johnson & Johnson (NYSE:JNJ) initiated with Sell rating and $94 (17% downside risk) price target by Standpoint Research.
- NuVasive (NASDAQ:NUVA) upgraded to Overweight from Equal Weight by Barclays. Price target raised to $63 (15% upside) from $58.
- Zimmer Biomet Holdings (NYSE:ZBH) upgraded to Buy from Hold with a $125 (2% upside) price target by Argus Research.
- Relypsa (NASDAQ:RLYP) upgraded to Equal Weight from Underweight with a $9 (50% downside risk) price target by Morgan Stanley. To be adjusted after ZS-9 rejection.
- Ionis Pharmaceuticals (NASDAQ:IONS) downgraded to Market Perform from Outperform by BMO Capital Markets. Price target lowered to $26 (18% upside) from $55.
- Patterson Companies (NASDAQ:PDCO) downgraded to Hold from Buy by Evercore ISI. Price target lowered to $48.50 (0% upside) from $49.50.
- United Therapeutics (NASDAQ:UTHR) downgraded to Sell from Hold with a $114 (3% downside risk) price target by Argus Research.
- Boston Scientific (NYSE:BSX) downgraded to Neutral from Buy with a $24.20 (7% upside) price target by BTIG Research.
- Neovasc (NASDAQ:NVCN) downgraded to Neutral from Buy by Ladenburg Thalmann. Price target removed.
Fri, May 27, 9:46 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of AstraZeneca's (AZN -0.7%) fixed-dose combination of saxagliptin and dapagliflozin for the treatment of adults with type 2 diabetes (T2D).
- Clinical data supporting the application showed the saxa/dapa combo with metformin statistically significantly reduced HbA1c levels compared to patients treated with placebo that required additional control to existing saxagliptin and metformin or dapagliflozin and metformin therapy. Another study showed the saxa/dapa combo added to metformin produced superior reductions in HbA1c compared to dapagliflozin or saxagliptin alone added to metformin.
- A final decision from the European Commission usually takes ~60 days.
- In October 2015, the FDA rejected the company's NDA citing the need for more clinical data.
- Related tickers: (NYSE:NVO)(NYSE:JNJ)(NYSE:SNY)
Tue, May 24, 8:39 AM
- The FDA approves the use of Janssen Pharmaceuticals' (NYSE:JNJ) INVOKAMET, a fixed-dose combination of INVOKANA (canagliflozin) and metformin hydrochloride, for first-line treatment of adults with type 2 diabetes (T2D).
- INVOKAMET was first approved in the U.S. in August 2014 as an adjunct to diet and exercise to improve blood glucose control in adults with T2D not adequately controlled by either canagliflozin or metformin or who are already being treated with both medications separately.
Mon, May 23, 4:52 PM
- The FDA accepts for review the Biologics License Application (BLA) from Samsung Bioepis for SB2, its biosimilar to Janssen's (NYSE:JNJ) Remicade (infliximab). SB2 is the company's first biosimilar to be submitted for review in the U.S.
- If approved, Merck (NYSE:MRK) will be responsible for marketing and distribution.
- Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen (NASDAQ:BIIB). It has 13 biosimilar candidates in its pipeline, including six in its first wave.
Johnson & Johnson operates as an investment holding company with interests in health care products. It engages in research and development, manufacture and sale of personal care hygienic products, pharmaceuticals and surgical equipment. The company, through its subsidiaries operates in three... More
Industry: Drug Manufacturers - Major
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