SA News • Thu, Dec. 11
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- On Tuesday, AstraZeneca announced the EU approval for Moventig (naloxegol) for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to laxatives.
- I reiterate my bull thesis on AstraZeneca.
- As expected, Astra continues to enhance its growth prospects as an independent pharmaceutical company. Also, as expected, the EC aligned its decision on Moventig with the EMA.
Update: AstraZeneca On A Hot Streak, Announces Positive Data From The Phase 3 Study Of Brodalumab
- AstraZeneca announced yesterday positive Phase 3 data from the AMAGINE program on brodalumab.
- I reiterate my bull thesis on AstraZeneca. The development of brodalumab represents a significant revenue opportunity.
- As expected, Astra continues to enhance its growth prospects independent of Pfizer. Yesterday's announcement corroborates this position.
Update: AstraZeneca Wins EC Marketing Authorization For Duaklir GenuairTrevor Lowenthal • Tue, Nov. 25
- AstraZeneca announced EU Marketing Authorization for Duaklir Genuair on Monday.
- I reiterate my bull thesis on AstraZeneca.
- As expected, AstraZenca continues to improve its growth prospects as an independent pharmaceutical company. Monday's announcement corroborates this position.
Update: AstraZeneca Q3 Earnings Fail To Impress, But Long-Term Prospects Remain IntactTrevor Lowenthal • Fri, Nov. 7
- Astra reported Q3 earnings on Thursday.
- I reiterate my bull thesis on Astra.
- As expected, Astra remains fully capable of earnings growth independent of Pfizer. The latest earnings report corroborates this position.
- AstraZeneca may not receive a fresh offer from Pfizer in the wake of new tax rules announced by the Treasury.
- AstraZeneca though looks attractive even without a bid from Pfizer.
- The company recently received approval for Xigduo XR in the U.S. and has also sealed the Almirall transaction.
- AstraZeneca’s oncology portfolio also looks promising, with olaparib recently receiving positive recommendation in the European Union.
- There is 10%-12% upside potential in AstraZeneca shares in the near-term.
- AstraZeneca announced today FDA approval for its diabetes combo pill Xigduo XR.
- I reiterate my bull thesis following the approval.
- As expected, AstraZeneca continues to enhance its growth prospects, thus supporting my thesis that it can thrive independent of Pfizer.
Update: AstraZeneca Receives Positive EMA Recommendation For Olaparib
- AstraZeneca announced Friday the EU recommendation for approval for Olaparib.
- I reiterate my bull thesis, as Astra continues to increase its growth prospects.
- As expected, the company continues to demonstrate its viability independent of Pfizer. The positive EU recommendation corroborates this position.
Update: AstraZeneca Moves Closer To EU Approval For Moventig
- AstraZeneca announces a positive EMA opinion for Moventig.
- I reiterate my bull thesis on AstraZeneca given the market potential in the EU for this opioid-induced constipation drug.
- The positive EMA opinion follows the recent FDA approval for Moventig.
- AstraZeneca announced today a licensing agreement with Eli Lilly for AZD3293 to target Alzheimer's disease.
- I reiterate my bull thesis on AstraZeneca given the value proposition of this arrangement.
- I didn't anticipate this agreement in my initial report.
AstraZeneca Has 30% Upside As A Takeover Candidate
- Pfizer's last bid for AstraZeneca is a 27% premium over the current stock price.
- Talks may resume as early as this month if AstraZeneca is interested, but are more likely to resume in November.
- This deal is beneficial to AstraZeneca's shareholders over the short-term, but is likely to hinder innovation at the combined company over the long-term.
- AstraZeneca has an attractive drug pipeline and is expecting to grow revenues 7.5% annually as a result of this pipeline.
- Pfizer has been slashing R&D spending and is in desperate need of a drug pipeline to carry its company into future success.
Update: AstraZeneca's Earnings Beat Reaffirms Bull Thesis
- AstraZeneca is attempting to make an earnings comeback after being hindered by a series of patent expirations, which has taken a toll on revenues.
- Pfizer isn't budging with respect to unveiling whether it still has plans to acquire AstraZeneca after the 3-to-6-month waiting period.
- Regardless, AstraZeneca is proving that it can exceed expectations independent of Pfizer, pursuant to the latest earnings report. Thus, I reaffirm my bull thesis in light of strong earnings performance.
- AZN is a solid company with a fine management team, but is a poor investment choice at its current stock price given its uncertain future.
- Unfavorable politics and negative sentiment in the US and UK make another offer for AZN by Pfizer unlikely in 2014.
- Conservative estimates of revenues in 2023 are $31 billion vs. company estimates of $45 billion.
- At the current price of $73, investors are paying for hope on a pipeline that won't deliver significant revenues for at least 5 years.
- AstraZeneca tumbled after rejecting Pfizer's "final" bid, and considerable risks remain.
- Nevertheless, both its impressive dividend yield of 5.30% and extensive pipeline keep me interested.
- To take advantage of its high yield, I have constructed a conservative yield-enhancing strategy that reduces risk and provides investors with peace of mind.
AstraZeneca Continues To Benefit From Pfizer Courtship
- Pfizer made a generous new offer to acquire AstraZeneca for $106 billion in cash and shares.
- Pfizer CFO Frank D'Amelio revealed that every option, including a hostile takeover, remains on the table when it comes to buying AstraZeneca.
- Pfizer’s attention, in addition to strong fundamentals and innovation at AstraZeneca, will likely continue to be a boon for AstraZeneca shares.
Pfizer And AstraZeneca: Innovation Will Not Follow Acquisition
- PFE is unsuccessfully courting AZN to the tune of $100 billion and may soon invest in a hostile bid.
- R&D productivity is declining for the pharmaceutical industry in general and is worse for larger than smaller companies.
- Consolidation is a common strategy to stave off slowing growth but is seen to further decrease R&D productivity.
- PFE's acquisition of AZN will result in large tax savings but will also stifle innovation, which is the chief driver of growth.
- Pfizer recent overture to acquire Astra Zeneca makes financial sense.
- The combined companies would be still be facing immediate difficulty in increasing revenues.
- The combination is a long term play as the pipeline should bear fruit in the 2017 time frame.
- AstraZeneca’s diabetes drug Symlin may one day enter the $6 billion Alzheimer’s drug market.
- There are over 5 million Americans suffering from Alzheimer’s.
- AstraZeneca is in need of a blockbuster drug to offset its patent cliff.
- AstraZeneca offers one of the best dividends on the market.
Thu, Dec. 11, 10:38 AM
- Today is shaping up to be another session of positive money flow into AstraZeneca (AZN +0.5%). Shares are up a fraction on turnover of 3M compared to the average daily volume of 2.1M. Yesterday, shares rose 2.2% on a 3x surge in volume.
- Investors appear to like the potential of Moventig (naloxegol) in Europe.
- Previously: Moventig cleared in Europe for OIC (Dec. 9, 2014)
Tue, Dec. 9, 7:14 AM
- The European Commission approves AstraZeneca's (NYSE:AZN) Moventig (naloxegol) for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to laxatives. It is the first once-daily oral peripherally -acting mu-opioid receptor agonist (PAMORA) approved in the EU.
- Moventig is part of an exclusive worldwide license agreement initiated in 2009 with Nektar Therapeutics (NASDAQ:NKTR). The product utilizes Nektar's oral small molecule polymer conjugate technology.
- Previously: Ad Comm supports approval of Moventig for OIC (Sept. 26, 2014)
- Previously: FDA clears OIC drug (Sept. 16, 2014)
- OIC-related tickers: (NASDAQ:PGNX) (NASDAQ:CBST) (NASDAQ:SLXP) (NASDAQ:SGYP)
Mon, Dec. 8, 12:37 PM
- Biotech investors are giving Seattle Genetics (SGEN -8.4%) the cold shoulder today on increased volume. It appears that all the love is being directed to the potential of competitors' PD-1 inhibitors in fighting cancer despite the company's presentations at the American Society of Hematology meeting of positive results for Adcetris (brentuximab vedotin), an antibody-drug conjugate directed to CD30 in Hodgkin lymphoma (HL).
- Long-term data from a Phase 1 trial of Adcetris combined with AVD (adriamycin, vinblastine, dacarbazine) demonstrated a 100% overall survival rate at year three and 92% failure-free survival rate at year 3 in frontline HL.
- Adcetris in combination with bendamustine as a second-line therapy demonstrated an objective response rate of 96% and a complete remission rate of 83% in patients with relapsed or refractory HL.
- In a Phase 2 trial in previously untreated HL patients aged 60 and older, Adcetris showed a 93% objective response rate.
- The company is collaborating with Takeda Pharmaceutical Co. (OTCPK:TKPHF) (OTCPK:TKPYY) on the development of the product.
- Previously: Positive results in Adcetris Phase 3 label expansion trial (Sept. 29, 2014)
- PD-1 inhibitor-related tickers: (BMY +0.2%)(FPRX +4.8%)(MRK -0.2%)(CELG +4.2%)(OTCQX:RHHBY -0.5%)(AZN -0.6%)
Mon, Dec. 8, 10:55 AM
- Funded by collaboration partner AstraZeneca (AZN +0.1%), Dynavax (DVAX +2.9%) will initiate a Phase 2a study in 1H 2015 to evaluate AZD1419 in asthmatic patients. Dynavax will earn a milestone payment from AZN when this occurs. Remaining milestones could be as much as $100M.
- AZD1419 is a second-generation TLR9 agonist CpG oligodeoxynucleotide for inhalation use.
Fri, Dec. 5, 3:44 PM
- The FDA's Anti-Infective Drugs Advisory Committee voted as follows in its review of Cerexa's (ACT -0.7%) NDA for ceftazidime/avibactam:
- Question 1: 11 - 1 that CAZ-AVI NDA demonstrated substantial evidence of safety/efficacy in complicated intra-abdominal infections.
- Question 2: 9 - 3 that CAZ-AVI NDA demonstrated substantial evidence of safety/efficacy in complicated urinary tract infections.
- Question 3: 12 - 0 that CAZ-AVI NDA failed to show evidence of safety/efficacy in aerobic Gram-negative infections where patients had limited or no alternatives.
- Question 4: 11 - 1 that CAZ-AVI NDA failed to show evidence of safety/efficacy in aerobic Gram-negative infections when no adequate treatments are available.
- Previously: Ad Comm review approaches for Actavis anti-infective combo (Dec. 3, 2014)
- Related ticker: (AZN -0.3%)
Fri, Dec. 5, 12:56 PM
- A jury in the U.S. District Court for the District of Massachusetts returns a verdict in favor of AstraZeneca (AZN -0.2%) in a lawsuit brought by various purchaser groups challenging its settlement of Nexium patent litigation with Ranbaxy Laboratories (OTC:RBXLY) (OTC:RBXZF).
- Two similar cases in Pennsylvania are still pending.
- Previously: AstraZeneca could face hefty damages in Nexium case (Dec. 3, 2014)
Wed, Dec. 3, 1:46 PM
- The FDA's Anti-Infective Drugs Advisory Committee meets on Friday, December 5 to review the New Drug Application (NDA) submitted by Cerexa for the combination of ceftazidime/avibactam (CAZ-AVI) for the treatment of complicated intra-abdominal infections, complicated urinary tract infections and acute pyelonephritis. The NDA also includes a limited use indication for patients with aerobic Gram-negative infections with limited treatment options.
- The FDA designated CAZ-AVI a Qualified Infectious Disease Product (QIDP) in March 2013. Among the benefits of the tag is a five-year period of market exclusivity if approved.
- Cerexa was acquired by Forest Labs in 2006 for $480M. Forest was acquired by Actavis (ACT +0.5%) for $25B this year.
- Briefing doc and addendum
- Related ticker: (AZN +1.6%)
- Previously: AstraZeneca reports top-line results from Phase 3 antibiotic trials
Wed, Dec. 3, 7:36 AM
- AstraZeneca (NYSE:AZN) could be on the hook for substantial damages if it loses a trial in Boston involving Ranbaxy Laboratories Ltd. (OTC:RBXLY) (OTC:RBXZF) and their pay-to-delay agreement that blocked generic competition to Nexium. This is first such trial since the U.S. Supreme Court ruled that companies can be sued over these deals if the payments are large and unjustified.
- The suit challenges a 2008 settlement of a patent dispute between the two companies that postponed the entry of generic competition until this year. Plaintiffs argue that the $1B+ that Ranbaxy received violated antitrust law and was excessive for a patent case.
- Teva Pharmaceutical Industries (NYSE:TEVA) was also a defendant in the case but it reached a settlement with the plaintiffs after four weeks of testimony.
- If the plaintiffs win, there will be another trial to determine the amount of damages. A win, though, is far from certain because the drug buyers have failed to show that they were harmed by the deal. Two weeks into the trial, AstraZeneca filed a motion to throw out the claims on the basis that the plaintiffs' experts failed to offer evidence of what they regard as proper royalty rates for drugs, a stipulation made by the court for the trial to proceed. Judge William Young denied the motion without elaborating.
- Nexium generated almost $4B in sales last year.
Tue, Dec. 2, 11:50 AM
- The FDA accepts for review AstraZeneca's (AZN -1.5%) New Drug Application (NDA) for Iressa (gefitinib) as a monotherapy for the first-line treatment of patients with advanced or metastatic epidermal growth factor mutation-positive (EGFRm) non-small cell lung cancer (NSCLC). The PDUFA date will be in Q3 2015.
- Iressa is an EGFR tyrosine kinase inhibitor that blocks the transmission of signals involved in the growth and spread of tumors. It is currently approved in 90 countries. In the U.S., it is working with Qiagen (QGEN +0.3%) to develop a companion diagnostic test to guide the use of Iressa in patients with advanced NSCLC.
Mon, Dec. 1, 4:30 AM
- After teaming up in September to develop its experimental Alzheimer's drug, AstraZeneca (NYSE:AZN) and partner Eli Lilly (NYSE:LLY) have begun a large trial for the product, known as AZD3293 or LY3314814.
- The pivotal Phase II/III clinical trial will involve more than 1,500 patients with early Alzheimer's and is expected to be completed in 2019.
Fri, Nov. 28, 9:23 AM
- The European Commission approves Boehringer Ingelheim's Vargatef (nintedanib), in combination with docetaxel, for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology, after first-line chemotherapy. Adenocarcinoma is the most common form of lung cancer.
- Nintedanib is an oral angiokinase inhibitor which simultaneously inhibits endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR) signalling pathways. It is currently being investigated in various other cancers.
- Earlier this month, Europe's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion supporting approval of nintedanib, branded as Ofev, for the treatment of ideopathic pulmonary fibrosis (IPF). The FDA approved it for IPF in October.
- Previously: Europe Ad Comm supports approval for BI pulmonary fibrosis drug
- Previously: BI begins enrollment in Phase 3 CRC trial
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Lung cancer-related tickers: (NYSE:BMY) (NYSE:MRK) (NASDAQ:CLVS) (NASDAQ:FPRX) (NASDAQ:BIND) (NYSE:GSK) (NASDAQ:ARIA) (NASDAQ:ECYT) (NYSE:AZN) (OTC:MKGAF) (OTCPK:MKGAY) (NASDAQ:ONTY) (NYSE:PFE) (NASDAQ:HTBX) (OTCQX:RHHBY) (NASDAQ:INCY)
Fri, Nov. 28, 4:54 AM
- Pfizer's (NYSE:PFE) attempt to gain control of AstraZeneca (NYSE:AZN) through a £69.4B ($110B) takeover bid in May would have collapsed on changes to U.S. tax inversion laws, announced Astrazeneca's chief exec, cooling off speculation of another bid for the U.K. pharmaceutical company.
- "If we had agreed to a deal at the time, probably that deal would have fallen apart by now, just like the AbbVie/Shire deal, and created enormous destruction and disruption in our company," said Pascal Soriot in an interview with CNBC.
Tue, Nov. 25, 4:47 PM
- Amgen (AMGN -1.2%) and development partner AstraZeneca (AZN -0.6%) announce that the Amagine-2 Phase 3 trial evaluating two doses (210 mg and 140 mg every two weeks) of brodalumab in patients with moderate-to-severe plaque psoriasis met its primary endpoints compared to J&J's (JNJ -0.1%) Stelara (ustekinumab) and placebo at week 12. The 210 mg arm and the weight-based analysis group both demonstrated superiority to Stelara on achieving total skin clearance as measured by the Psoriasis Area Severity Index (PASI 100 or 100% reduction in score).
- 44.4% of patients in the brodalumab 210 mg group, 33.6% in the brodalumab weight-based group, 25.7% of patients in the brodalumab 140 mg group, 21.7% of patients in the Stelara group and 0.6% of patients in the placebo group achieved PASI 100. PASI 75 (75% reduction in score) scores for the same groups were: 86.3%, 77.0%, 66.6%, 70.0% and 8.1%, respectively.
- All secondary endpoints comparing brodalumab to placebo were also met. The first major secondary endpoint comparing PASI 100 for brodalumab 140 mg against Stelara at week 12 was numerically greater but not statistically significant (p=0.078). The remaining secondary endpoints for the 140 mg group versus Stelara were also numerically greater (all p values<0.05) but could not be considered statistically significant due to the sequential testing method.
- Previously: Positive Phase 3 results for brodalumab
- Previously: Amgen's brodalumab beats Stelara in Phase 3 trial
Tue, Nov. 25, 8:18 AM
- Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
- Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
- Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (NYSE:NVS) (NYSE:AZN) (NASDAQ:AMGN) (NASDAQ:BIIB) (NASDAQ:CELG) (NYSE:LLY) (NYSE:SNY) (NYSE:ABT) (NYSE:ABBV) (NYSE:BMY) (NYSE:MRK) (NYSE:GSK)
Mon, Nov. 24, 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)
Tue, Nov. 18, 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
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