Nov. 24, 2014, 8:02 AM
- The European Commission approves AstraZeneca's (NYSE:AZN) Duaklir Genuair (aclidium bromide/formoterol fumarate 340/12 mcg) for the maintenance bronchodilator treatment in adults with chronic obstructive pulmonary disease (COPD).
- The product is a fixed dose combination of two approved long-acting bronchodilators with different mechanisms of action. Aclidium bromide is an anticholinergic or long-acting muscarinic antagonist that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a long-acting beta-agonist that stimulates the B2-receptors in the bronchial smooth muscle resulting in bronchodilation. Both are currently approved as stand-alone therapies for the maintenance treatment of COPD in the U.S. and Europe.
- Genuair is a multi-dose pre-loaded dry powder inhaler that utilizes optical and acoustic signals to inform the patient that the correct dose has been delivered.
- COPD-related tickers: (NYSE:GSK) (NYSE:NVS) (NASDAQ:THRX) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
Nov. 18, 2014, 10:52 AM
- AstraZeneca (AZN +1.2%) Chief Pascal Soriot will present his plan to deliver $45B in top-line revenues by 2023 to investors today at 1:30 pm ET.
- The company has 14 potential new medicines in Phase 3 development or registration, a potential 14 - 16 submissions and 8 - 10 approvals in the next two years. AZD9291 FDA submission expected in Q2 2015.
- It has 13 combination trials underway with 16 planned in its immuno-oncology portfolio.
- Five current platforms - Brilinta, diabetes, respiratory, Emerging Markets and Japan - account for more than 50% of global revenues. Oncology will be the sixth growth platform.
- Biologics account for almost half of its pipeline, growing focus on devices, portfolio balanced between primary and specialty care to boost profitability.
- Value to be created via partnerships and licensing in neuroscience and infection.
- Previously: AstraZeneca forecasts $45B in annual sales by 2023
Nov. 18, 2014, 4:35 AM
- Ahead of a six-hour investor meeting later today, AstraZeneca (NYSE:AZN) has reiterated that it expects annual sales to rise by three quarters and exceed $45B by 2023, a forecast it first gave after seeing off a $118B bid from Pfizer in May.
- "We have more than doubled the number of potential medicines in our late-stage pipeline since 2012 and we are on track to return to growth by 2017," says Chief Executive Pascal Soriot.
- AZN -1.1% premarket
Nov. 17, 2014, 4:06 AM
- Pfizer (NYSE:PFE) will pay $850M for rights to a cancer drug being developed by Merck KGaA (OTCPK:MKGAY), puncturing investor expectations of a renewed bid for AstraZeneca (NYSE:AZN).
- As a result of the upfront payment, Pfizer has lowered its forecast of 2014 EPS to $1.40-$1.49 from $1.50-$1.59.
- The agreement also calls for Pfizer to pay as much as $2B to Merck if the immunotherapy drug, known as MSB0010718C, meets commercial and regulatory goals.
Nov. 14, 2014, 10:38 AM
- Dow Chemical (DOW +1%) says it "fundamentally disagrees" with the position outlined by Dan Loeb's Third Point hedge fund in its latest statement and new website, which the company says reflect the views of "an activist investor that has little interest in anything that benefits [Dow's] many long-term shareholders."
- Jim Cramer is now a fan of Dow, citing the company as an example of a buyback done right; combining Dow's $5B increase in its buyback plan with its total repurchase authorization totals ~17% of market cap.
- Cramer also sees buyback opportunities in FLEX, JACK, M, DIS, KMB, VIA, DPS and AZN.
Nov. 12, 2014, 11:13 AM
- Advaxis (ADXS +1.8%) files an Investigational New Drug Application (IND) with the FDA to conduct a Phase 1/2 clinical trial of ADXS-HPV (ADXS-11-001) alone or in combination with MedImmune's (AZN -0.1%) investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, for the treatment of advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer.
- The Phase 1 portion will establish a recommended dose regimen of ADXS-HPV with MEDI4736 and the Phase 2 portion will evaluate the safety and efficacy of the combination. The study is expected to start in early 2015.
Nov. 11, 2014, 4:52 PM
- A Phase 3 study evaluating Amgen's (NASDAQ:AMGN) brodalumab versus Janssen's (NYSE:JNJ) Stelara (ustekinumab) and placebo at week 12 in patients with moderate-to-severe plaque psoriasis met its primary endpoints. Brodalumab was superior to ustekinumab in achieving total clearance of skin disease as measured by PASI-100. Compared to placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75% improvement from baseline in disease severity at week 12 (measured by PASI-75). All key secondary endpoints were also met.
- Proportion of patients achieving total clearance of disease: brodalumab-210 mg: 36.7%; brodalumab-140 mg: 27.0%; Stelara: 18.5%; placebo: 0.3%.
- Proportion of patients achieving PASI-75: brodalumab-210 mg: 85.1%; brodalumab-140 mg: 69.2%; Stelara: 69.3%; placebo: 6.0%.
- Amgen plans to present the complete results at a future medical conference.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NASDAQ:CELG) (NYSE:NVS) (NASDAQ:DERM) (NASDAQ:IDRA) (NYSE:HSP) (NYSE:PFE) (NYSEMKT:CANF) (NYSE:MRK)
Nov. 11, 2014, 7:44 AM
- Dupilumab, a fully-human monoclonal antibody being co-developed by Sanofi (NYSE:SNY) (OTCQB:SNYNF) and Regeneron Pharmaceuticals (NASDAQ:REGN), showed showed positive results in a 776-patient Phase 2b dose-ranging clinical trial in adults with moderate-to-severe uncontrolled asthma.
- The three highest doses of dupilumab in combination with standard-of-care therapy met the primary endpoint of a statistically significant improvement from baseline in forced expiratory volume over one second (FEV1) at week 12 in patients with high blood eosinophils (>= 300 cells/microliter) compared to placebo in combination with standard-of-care therapy. Also, two doses of dupilumab (200 mg every other week and 300 mg every other week) showed a statistically significant improvement in mean percent change in FEV1 and a reduction in severe exacerbations, both in the high eosinophils group and the overall study population.
- Dupilumab blocks IL-4 and IL-13, two cytokines required by the Th2 immune response. Some researchers believed that targeting the Th2 pathway would limit the benefit in asthmatics with high eosinophils, but this study demonstrated that it could be effective. Final results from the trial will be presented at a future medical conference.
- Sanofi plans to proceed to Phase 3 development.
- Asthma-related tickers: (NYSE:GSK) (NYSE:TEVA) (NYSE:AZN) (OTCQX:RHHBY) (NASDAQ:AMGN) (NYSE:MRK) (NYSE:NVS) (NASDAQ:THRX)
Nov. 10, 2014, 1:46 PM
- San Francisco, CA-based FibroGen (Pending:FGEN) is on deck for its IPO of 7.1M shares of common stock at $16 - 19.
- The biopharmaceutical company focuses on fibrosis and hypoxia-inducible factor (HIF) biology. Its lead product is roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylases currently in Stage 3 development, for the treatment of anemia in patients with chronic kidney disease. Its second product candidate is FG-3019, a monoclonal antibody in Phase 2 development for the treatment of idiopathic pulmonary fibrosis.
- The company's development and commercialization partners for roxadustat are Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY) (Japan, Europe, CIS, Middle East, South Africa) and AstraZeneca (AZN +0.6%) (U.S., China, ROW ex. Astellas territories).
- 2013 Performance ($M): Revenues: 102.2 (+55.1%); Operating Expenses: 110.1 (+18.1%); Net Loss: (14.9) (+54.3%); CF Ops: 25.9 (+562.5%).
- 2014 Performance (9 mo.): Revenues: 121.5 (+35.3%); Operating Expenses: 123.6 (+69.8%); Net Loss: (8.9) (-175.4%); CF Ops: 46.2 (-4.9%).
- ETFs: IBB, BIB, BIS (NYSEARCA:IPO)
Nov. 6, 2014, 8:51 AM
- AstraZeneca (NYSE:AZN) Q3 results ($M): Revenues: 6,542 (+4.7%); Gross Profit: 5,127 (+2.3%); Operating Income: 541 (-68.3%); Net Income: 253 (-79.7%); EPS: 0.20 (-79.8%); CF Ops (9 mo.): 5,216 (+6.0%).
- Revenue by region: U.S.: 2,528 (+7.1%); Europe: 1,648 (+1.1%); Established ROW: 898 (-4.6%); Emerging Markets (incl. China): 1,468 (+11.3%); China: 558 (+19.5%).
Nov. 6, 2014, 8:31 AM
- Aegerion Pharmaceuticals (NASDAQ:AEGR) acquires Myalept (metreleptin for injection) from AstraZeneca (NYSE:AZN) for $325M. The drug is indicated for the treatment of leptin deficiency in patients with generalized lipodystrophy. It is the first and only product approved in the U.S. to treat the disease.
- Myalept has Orphan Drug status in the U.S., European Union and Japan.
Nov. 6, 2014, 8:03 AM
- In a setback for India's generic drug firm Ranbaxy Laboratories Ltd., the FDA revokes its previously granted tentative approvals for its lower cost versions of AstraZeneca's (NYSE:AZN) heartburn med Nexium and Roche's (OTCQX:RHHBY) antiviral Valcyte.
- The agency informed the company that while there were no data integrity issues related to its filings, its decisions granting the approvals were "in error."
- The revocation also terminates its six-month first-to-file market exclusivity.
- Management says in a statement, "Ranbaxy is disappointed with this development and is actively evaluating all available options to preserve its rights."
Nov. 6, 2014, 4:54 AM
- AstraZeneca (NYSE:AZN) raised its 2014 sales forecast for the second quarter in a row, as the delayed arrival of Nexium generics in the U.S. kept cash flowing from the heartburn and ulcer pill.
- The company said full-year revenue was now expected to increase in low single-digits, compared with previous guidance for sales to be in line with 2013.
- However, profit excluding certain items fell during the quarter, declining 13% Y/Y to $1.77B from $2.03B.
- AstraZeneca also announced a $325M upfront payment from Aegerion Pharmaceuticals, after agreeing to sell its rare disease drug Myalept.
- AZN -1.4% PM
Nov. 5, 2014, 5:30 PM
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Nov. 4, 2014, 9:28 AM
- AstraZeneca (NYSE:AZN) establishes a clinical trial collaboration with Pharmacyclics (NASDAQ:PCYC) and Janssen Research & Development LLC (NYSE:JNJ) to evaluate the safety and efficacy of AZN's anti-PDL1 immune checkpoint inhibitor, MEDI4736, in combination with Imbruvica (ibrutinib) for the treatment of hematologic cancers including diffuse large B-cell lymphoma and follicular lymphoma.
- MEDI4736 blocks the signals that enable tumors to avoid detection by the immune system thus countering the tumor's immune-evading tactics.
- The Phase 1 clinical trial to establish a dose regimen will be conducted by Pharmacyclics. Financial terms of the collaboration are undisclosed.
- Other MEDI4736 collaborations are ongoing.
- Previously: Incyte and MedImmune collaborate on cancer immunotherapies
- Previously: Ventana and MedImmune collaborate
- Previously: Advaxis and MedImmune team up in cancer immunotherapy
Nov. 4, 2014, 7:21 AM
- AstraZeneca (NYSE:AZN) unit MedImmune acquires privately-held Definiens, the developer of Tissue Phenomics, an imaging and data analysis technology that dramatically improves the identification of biomarkers in tumor tissue.
- Under the terms of the transaction agreement, MedImmune will make an upfront payment of $150M for 100% of Definiens' shares plus future predetermined milestones.
- The acquisition will strengthen MedImmune's focus on the discovery of novel biomarkers in immuno-oncology. The use of biomarkers has already demonstrated great promise in potentially shortening clinical trial times and increasing patient response rates. About 80% of AstraZeneca's small molecule and biologics pipeline has a personalized healthcare approach.
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