Mon, Aug. 3, 6:55 AM
- AstraZeneca (NYSE:AZN) and Isis Pharmaceuticals (NASDAQ:ISIS) build upon their existing partnership by establishing a strategic collaboration to discover and develop antisense therapies for cardiovascular, metabolic and renal diseases. Under the terms of the agreement, ISIS will receive an upfront fee of $65M, development and regulatory milestones and tiered double-digit royalties on net commercial sales.
- Antisense drugs are short, chemically modified, single-stranded nucleic acids that target RNA. They are designed to inhibit the production of disease-causing proteins.
Thu, Jul. 30, 9:00 AM
- AstraZeneca (NYSE:AZN) Q2 results ($M): Total Revenues: 6,307 (-6.7%); Product Sales: 5,836 (-9.6%); U.S.: 2,356 (-3.4%); Europe: 1,261 (-23.1%); Established ROW: 785 (-14.3%); Japan: 522 (-9.8%); China: 583 (+11.3%); Emerging Markets: 1,434 (-1.8%).
- Sales by segment: Cardiovascular & Metabolic: 2,452 (-4.4%); Oncology: 707 (-6.7%); Respiratory, Inflammation & Autoimmunity: 1,225 (+1.1%); Infection, Neuroscience & GI: 1,452 (-24.3%).
- Key Product Sales: Crestor: 1,310 (-9.7%); Symbicort: 842 (-9.3%); Nexium: 647 (-33.4%); Onglyza: 208 (-12.6%).
- Net Income: 696 (-9.1%); EPS: 0.55 (-10.0%); CF Ops: 1,080 (-48.1%).
- Shares are up 2% premarket on modest volume.
Thu, Jul. 30, 8:33 AM
Thu, Jul. 30, 7:57 AM
- Roche (OTCQX:RHHBY) submits its Premarket Approval (PMA) application to the FDA seeking clearance for its cobas EGFR Mutation v2, a companion diagnostic test for AstraZeneca's (NYSE:AZN) Orphan Drug-, Fast Track- and Breakthrough Therapy-tagged AZD9291.
- Patients with non-small cell lung cancer (NSCLC) who have adenocarcinoma with tumor containing an EGFR (epidermal growth factor receptor) sensitizing mutation respond initially to current EGFR TKI therapies. About 67% relapse and develop drug resistance due to, in large part, the acquisition of a mutation called T790M. Patients with this mutation will most likely benefit from treatment with AZD9291.
- Roche's second generation test is built upon its current FDA-cleared assay for EGFR mutations. It is designed to identify a broad spectrum of EGFR mutations in patients with NSCLC, including T790M.
Wed, Jul. 29, 5:30 PM
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Tue, Jul. 28, 12:57 PM
- Privately-held Boehringer Ingelheim (BI) enters into an exclusive license and collaboration agreement with Seoul, Korea-based Hanmi Pharmaceutical to develop and commercialize HM61713, a third generation epidermal growth factor receptor (EGFR)-targeted therapy for the treatment of EGFR mutation-positive lung cancer.
- Under the terms of the agreement, Hanmi will receive an upfront payment of $50M, milestones up to $680M and tiered double-digit royalties on net sales. BI will have exclusive global commercialization rights to HM61713 except South Korea, China and Hong Kong.
- HM61713 is an orally active, irreversible EGFR mutation-selective tyrosine kinase inhibitor (TKI). It is currently in Phase 2 development for the treatment of patients with non-small cell lung cancer with T790M mutations who have developed resistance to other EGFR-targeting agents. A Phase 3 study will commence next year.
- EGFR-related tickers: (AZN +0.3%)(OTCQX:RHHBY +1.3%)(OTCPK:ALPMY) (OTCPK:ALPMF) (BMY +0.1%)(LLY +1.4%)(GSK -0.1%)(AMGN +4.3%)
Tue, Jul. 28, 10:08 AM
- The European Medicines Agency validates Teva Pharmaceutical Industries' (TEVA -1.6%) Marketing Authorization Application (MAA) for reslizumab for the treatment of inadequately controlled asthma in adult patients with elevated blood eosinophils despite an inhaled corticosteroid-based regimen. A final decision by the European Commission is anticipated in H2 2016.
- Reslizumab is an investigational humanized monoclonal antibody that binds to interleukin-5 (IL-5), a cytokine that plays a key role in the activation and growth of eosinophils, a type of white blood cell that is elevated in the lungs and blood of many asthmatics. High levels of eosinophils correlate with disease severity so binding to IL-5 inhibits its ability to stoke eosinophil levels.
- Teva's Biologics License Application (BLA) is currently under review by the FDA. A decision is expected in March 2016.
- Asthma-related tickers: (SNY -0.1%)(GSK -0.4%)(AZN -0.7%)(OTCQX:RHHBY)(AMGN +2.2%)(MRK -1.1%)(NVS +0.7%)(THRX +1.5%)
Mon, Jul. 27, 4:04 AM
- Boosting its rare disease medicine offerings, Sanofi (NYSE:SNY) has agreed to buy cancer drug Caprelsa from AstraZeneca (NYSE:AZN) for as much as $300M, including an upfront payment of $165M and sales milestone payments of up to $135M.
- Caprelsa is currently sold in 28 countries for treating medullary thyroid carcinoma and had sales last year of $48M.
Wed, Jul. 22, 8:16 AM
- A Phase 3 clinical trial (SUMIT) assessing AstraZeneca's (NYSE:AZN) Orphan Drug-tagged selumetinib in combination with dacarbazine for the treatment of uveal melanoma failed to achieve its primary endpoint of progression-free survival (PFS). The full analysis of the data is ongoing.
- Selumetinib, licensed from Array BioPharma (NASDAQ:ARRY) in 2003, is under development for the second-line treatment, in combination with docetaxel, of KRAS-positive advanced non-small cell lung cancer, differentiated thyroid cancer and neurofibromatosis Type 1. It inhibits the MEK enzyme in the RAS/RAF/MEK/ERK pathway in cancer cells to prevent the tumor from growing.
- Uveal melanoma (UM), comprising 5% of all melanoma cases, occurs when cancer cells grow in the tissues of the eye. No effective treatments for advanced UM exist.
- AZN shares are off a fraction premarket on light volume. ARRY is off 15% premarket on higher-than-normal volume.
Tue, Jul. 14, 6:51 AM
- The FDA approves AstraZeneca's (NYSE:AZN) Orphan Drug-tagged IRESSA (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
- IRESSA is an oral EGFR tyrosine kinase inhibitor which works by blocking the activity of the EGFR tyrosine kinase enzyme that plays a key role in the growth and survival of cancer cells.
- The Orphan Drug label provides IRESSA a seven-year period of market exclusivity for EGFR-mutation-positive NSCLC. It is approved in 91 countries for the indication. The companion diagnostic test used to determine mutation status was developed by Qiagen (NASDAQ:QGEN).
Thu, Jul. 9, 7:14 AM
- AstraZeneca (NYSE:AZN) sells its ex-U.S. rights to Entocort (budesonide) to Zeria Group's Tilliotts Pharma AG for $215M. The transaction, expected to close in H2, does not involve the transfer of any AZN employees or facilities. The product, approved in over 40 countries, generated $53M in sales outside of the U.S. in 2014. A regulatory submission in Japan is expected in the next few months. The divestiture will not impact AZN's 2015 financial guidance.
- Entocort is indicated for the first-line treatment of mild-to-moderate Crohn's disease in the ileum and/or ascending colon. As an enema, its is indicated to the induction and maintenance of clinical remission of distal ulcerative colitis in the rectum, sigmoid colon and descending colon.
- AstraZeneca and Par Pharmaceutical are commercialization partners in the U.S.
Wed, Jul. 8, 8:56 AM
- Ironwood Pharmaceuticals (NASDAQ:IRWD) reports that commercialization partner AstraZeneca (NYSE:AZN) is set to file a marketing application in early 2016 with the Chinese Food and Drug Administration (CFDA) seeking approval for linaclotide for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C). If cleared, it will be the first prescription drug available in China for both male and female patients with IBS-C.
- A Phase 3 study conducted mainly in China met all of its primary and secondary endpoints. 60% of linaclotide-treated patients were Abdominal Pain/Discomfort Responders compared to 48.8% for placebo (p=0.001) while 31.7% of the linaclotide group were IBS Degree of Relief Responders versus 15.4% for placebo (p<0.0001). Full results from the trial will be presented at a future medical meeting.
- Ironwood and AstraZeneca are jointly responsible for the development and commercialization of linaclotide in China. AstraZeneca has the bulk of the responsibility for local operations. Per their collaboration, AstraZeneca paid Ironwood an upfront fee of $25M. P&L will be shared on a 55/45 basis (favoring AstraZeneca) that will adjust to 50/50 after a certain milestone is achieved. Ironwood is also eligible for additional commercial milestones of $125M.
- Linaclotide is marketed in the U.S. as Linzess by Actavis and Ironwood and in Europe as Constella by Almirall.
Tue, Jul. 7, 10:50 AM
- Edwards Lifesciences (EW -0.8%) upgraded to Overweight from Equal Weight with a $168 (17% upside) price target (up from $135) by Morgan Stanley.
- HealthSouth (HLS -0.7%) upgraded to Market Outperform from Market Perform with a price target of $54 (15% upside) by JMP Securities.
- AstraZeneca (AZN -0.6%) upgraded to Buy from Hold with an $81 (25% upside) price target by Berenberg.
- Humana downgraded to Hold from Buy by Argus Research.
- Intuitive Surgical (ISRG -1.1%) downgraded to Underweight from Equal Weight by Morgan Stanley. Price target lowered to $500 (6% upside) from $560.
- Aegerion Pharmaceuticals (AEGR -0.5%) downgraded to Sell from Neutral by Guggenheim Securities.
- Centene (CNC -3.3%) downgraded to Equal Weight from Overweight by Barclays. Price target lowered to $81 (20% upside) from $88.
- Raptor Pharmaceutical (RPTP -1.8%) downgraded to Underperform from Perform with an $8 (40% downside risk) price target by Oppenheimer.
- Aetna (AET -3.5%) downgraded to Market Perform from Outperform by FBR Capital Markets. Price target lowered to $120 (6% upside) from $130.
- Baxter International (BAX -2.3%) downgraded to Neutral from Buy by Bank of America. Price target lowered to $40 (8% upside) from $78.
Tue, Jul. 7, 8:45 AM
- The U.S. Department of Justice reports that AstraZeneca (NYSE:AZN) has agreed to pay $46.5M to the U.S. and certain states to resolve allegations that it underpaid rebates owed under the Medicaid Drug Rebate Program.
- Under a separate settlement in the same case, Cephalon (NYSE:TEVA) agrees to pay $7.5M to resolve the same allegations.
- Drug makers are required to pay quarterly rebates to state Medicaid programs in exchange for Medicaid's coverage of their drugs. The rebates are based, in part, on the Average Manufacturer Prices (AMPs) that the companies report to the government for each of their covered medicines. The higher the reported AMP, the higher the rebate. The allegations in this case were that the two firms underreported AMPs by improperly reducing the reported AMPs for service fees they paid to wholesalers which resulted in the government being overcharged for the products.
- The settlements partially resolve a whistleblower suit brought by pharmacist Ronald Streck.
Wed, Jul. 1, 11:30 AM
- Galectin Therapeutics (GALT -0.7%) announces the screening of the first five patients in its Phase 2 study, called NASH-CX, evaluating GR-MD-02 in patients with nonalcoholic steatohepatitis (NASH). The randomized, placebo-controlled study will enroll 156 patients who will receive either one of two doses of GR-MD-02 (2 mg/kg or 8 mg/kg) or placebo. Final data collection is expected in October 2017. The study completion date is February 2018.
- The primary endpoint is the reduction in hepatic portal vein pressure versus placebo as measured by the hepatic venous pressure gradient (HVPG).
- GR-MD-02, the company's lead product candidate in its fibrosis program, is a complex carbohydrate drug that targets galectin-3, a protein that plays a key role in the pathogenesis of fatty liver disease and fibrosis. The FDA designated it for Fast Track review for the treatment of NASH in August 2013.
- NASH is one of the "next big things" for drug makers. It affects as many as 5% of Americans.
- Related tickers: (TBRA +1.7%)(ICPT -1%)(DRRX +0.4%)(MNOV +1.9%)(GLMD)(RGLS -6.3%)(AZN +1.2%)(OTCPK:GNFTF)(CNAT +4.3%)(VBLT +0.2%)(RPTP +2.7%)(LJPC +10.4%)(MRK +1.3%)(SHPG +1.4%)(OTCQB:ISLT)(GILD -0.4%)
Fri, Jun. 26, 8:26 AM
- AstraZeneca (NYSE:AZN) changes the ratio of its American Depositary Shares (ADSs) from one per one ordinary share to two ADSs per ordinary share. The change will take effect on July 27 for ADS holders of record July 22. The new ADSs will be distributed on July 24.
- No action is required by ADS holders and there will be no change in the underlying ordinary shares.
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