AstraZeneca Group plcNYSE
Tue, Oct. 18, 9:58 AM
- The FDA accepts for review AstraZeneca's (AZN +1.5%) resubmitted New Drug Application (NDA) seeking approval of ZS-9 for the treatment of hyperkalemia (elevated potassium in the blood). The agency has categorized the refiling as a Class 2 Resubmission which means it may include a presentation to an advisory committee and requires a reinspection of its manufacturing facility. An action date (PDUFA) is not disclosed.
- In May, the company received a Complete Response Letter (CRL) regarding its original filing. The CRL cited deficiencies observed during an on-site inspection of the manufacturing facility and the receipt of new data that it had not had time to review.
- AstraZeneca acquired the rights to ZS-9 via its $2.7B takeover of ZS Pharma in December 2015.
- Previously: FDA rejects AstraZeneca's ZS-9 NDA; competitor Relypsa up 29% premarket (May 27)
Mon, Oct. 10, 12:22 PM
- The FDA grants tentative approval for Intellipharmaceutics' (IPCI +18.5%) generic version of AstraZeneca's (AZN -0.6%) Seroquel XR (quetiapine fumarate), an oral antipsychotic medicine indicated for the treatment of schizophrenia and manic/mixed episodes associated with bipolar disorder.
- The approval is tentative because the company cannot launch the product until November 1 pursuant to a July 2012 settlement agreement with AstraZeneca. Also, there are two other companies with first-to-file status that may launch their versions on the same date. There is a 180-day exclusivity period related to first-to-file so Intellipharmaceutics' launch may be delayed until after this period.
Fri, Oct. 7, 10:18 AM
- AstraZeneca (AZN -0.4%) inks an agreement with Johnson & Johnson (JNJ +0.3%) affiliate Cilag GmbH International divesting the ex-U.S. rights to Rhinocort Aqua, an OTC nasal spray for the treatment of allergic and non-allergic rhinitis and nasal polyps, for $330M in cash.
- The transaction, expected to close this quarter, does not include the transfer of any AZN employees or facilities and does not impact the company's 2016 financial guidance.
Wed, Oct. 5, 8:16 AM
- Insmed (NASDAQ:INSM) nabs exclusive global rights to AstraZeneca's (NYSE:AZN) AZD7686, an oral inhibitor of an enzyme called dipeptidyl peptidase 1 (DPP1) which plays a key role in the activation of neutrophil serine proteases, enzymes that mediate innate immune responses and play an important role in certain pulmonary diseases like non-cystic fibrosis bronchiectasis, chronic bronchial inflammation that can lead to respiratory failure.
- Insmed will pursue this disorder as the initial indication for the compound, renamed INS1007. A Phase 2 study should commence in 2017.
- Under the terms of the agreement, AstraZeneca will receive an upfront payment of $30M, up to $120M in milestones and tiered high-single-digit-to-med-teens royalties on net sales. AZN also has the option to negotiate a future agreement for commercializing AZD7986/INS1007 in chronic obstructive pulmonary disease or asthma.
Tue, Oct. 4, 8:29 AM
- Aralez Pharmaceuticals (NASDAQ:ARLZ), through its subsidiary Aralez Pharmaceuticals Trading DAC, enters into an agreement with AstraZeneca (NYSE:AZN) for the commercial rights to branded and authorized generic Toprol-XL (metoprolol succinate), a beta-blocker, for the control of high blood pressure, chest pain (angina) and heart failure.
- Under the terms of the deal, Aralez will pay AZN $175M for the U.S. rights to the branded product and the authorized generic version marketed by Par Pharmaceuticals. AZN will also receive up to $48M in milestones and mid-teens royalties on net sales. The transaction should close this quarter.
- In 2015, sales of branded Toprol-XL and AZN's share of generic sales totaled $89M.
- ARLZ is up 11% premarket on moderately higher volume.
Tue, Oct. 4, 7:34 AM
- Results from a 13,885-subject Phase 3 clinical trial, EUCLID, evaluating AstraZeneca's (NYSE:AZN) Brilinta (ticagrelor) against Bristol-Myers Squibb (NYSE:BMY) and Sanofi's (NYSE:SNY) Plavix (clopidogrel) for the prevention of atherothrombotic events (a composite of cardiovascular death, heart attack (MI) or ischemic stroke) in patients with symptomatic peripheral artery disease (PAD) failed to achieve its primary endpoint.
- The aim of the study was to determine if there was a treatment benefit (significantly improved prevention of clotting events) from ticagrelor over clopidogrel as measured by the difference in the time of first occurrence of any event in the composite. Participants received either Brilinta 90 mg twice daily or clopidogrel 75 mg once daily.
- Full results will be presented next month at the American Heart Association Scientific Sessions in New Orleans, LA.
- In March, the Brilinta failed to beat aspirin in a large-scale study, SOCRATES, in preventing major vascular events (stroke, MI, death) in patients with acute ischemic stroke or transient ischemic attack.
- Brilinta is the #3 seller in AstraZeneca's Cardiovascular & Metabolic Disease unit, generating $739M in sales over the most recent four quarters (#1 is Crestor with $4,622M and #2 is Onglyza with $797M).
- Previously: AstraZeneca's Brilinta/Brilique flunks late-stage study for prevention of vascular events in stroke patients (March 23)
- Update: Shares are off 1% premarket on light volume.
Mon, Oct. 3, 4:40 AM
- AstraZeneca (NYSE:AZN) has signed a deal with Allergan (NYSE:AGN) where the latter will pay up to $1.52B for rights to an antibody for Crohn's disease.
- Allergan pays $250M up front, but it might also make payments worth up to $1.27B over a period of up to 15 years, tied to potential sales of the antibody, MEDI2070 -- an anti-IL-23 monoclonal antibody, currently in Phase IIb clinical development.
- That includes launch milestone payments of up to $435M and sales-based milestones of $725M along with tiered royalties. The deal comes via AstraZeneca's global biologics research and development unit.
- AZN is up 0.5% premarket.
Thu, Sep. 29, 5:35 PM
Fri, Sep. 16, 12:07 PM
- C.R. Bard (NYSE:BCR) upgraded to Outperform from Market Perform by Wells Fargo.
- DexCom (NASDAQ:DXCM) upgraded to Buy from Hold by Desjardins. Downgraded to Neutral from Buy with a $92 (1% downside risk) price target by BTIG Research.
- Alimera Sciences (NASDAQ:ALIM) upgraded to Outperform from Market Perform by Cowen & Company.
- Seattle Genetics (NASDAQ:SGEN) upgraded to Neutral from Sell by Goldman Sachs. Price target raised to $47 (13% downside risk) from $30.
- Akorn (NASDAQ:AKRX) upgraded to Overweight from Neutral by Piper Jaffray. Price target raised to $34 (19% upside) from $33.
- Community Health Systems (NYSE:CYH) upgraded to Positive from Neutral by Susquehanna. Price target raised to $18 (66% upside).
- AstraZeneca (NYSE:AZN) upgraded to Buy from Hold by Jefferies. Price target raised to GBX 5,800 (14% upside) from GBX 5,400. Downgraded to Neutral from Outperform with a GBX 5,200 (2% upside) price target by BNP Paribas.
- McKesson (NYSE:MCK) downgraded to Neutral from Buy by Goldman Sachs. Price target lowered to $189 (15% upside) from $210.
- Cardinal Health (NYSE:CAH) downgraded to Neutral from Buy by Goldman Sachs. Price target lowered to $83 (8% upside) from $90.
- Novavax (NASDAQ:NVAX) downgraded to Neutral from Outperform by Wedbush. Price target lowered to $2 (44% upside) from $14. Downgraded to Neutral from Buy by Citigroup. Price target lowered to $1.50 (8% upside) from $12. Downgraded to Neutral from Overweight by JPMorgan and Piper Jaffray.
- Raptor Pharmaceutical (NASDAQ:RPTP) downgraded to Market Perform from Outperform by Cowen & Company.
- Vitae Pharmaceuticals (NASDAQ:VTAE) downgraded to Market Perform from Outperform by BMO Capital.
- Atara Biotherapeutics (NASDAQ:ATRA) downgraded to Sell from Neutral by Goldman Sachs. Price target lowered to $16 (18% downside risk) from $23.
- GlaxoSmithKline (NYSE:GSK) downgraded to Underperform from Neutral with a GBX 1,520 (6% downside risk) price target by BNP Paribas.
- Applied Genetic Technologies (NASDAQ:AGTC) downgraded to Neutral from Buy by Roth Capital. Price target lowered to $12 (34% upside) from $34. Downgraded to Hold from Buy by Cantor Fitzgerald. Price target lowered to $15 (68% upside) from $32.
- Cepheid (NASDAQ:CPHD) downgraded to Neutral from Outperform by Baird.
Fri, Sep. 16, 10:38 AM
- AstraZeneca (AZN +1.3%) announces the successful outcome of a Phase 3 clinical trial, DURATION-8, evaluating the combination of once-weekly 2 mg injections of BYDUREON (exenatide extended-release) and once-daily oral 10 mg pills of FARXIGA (dapagliflozin) compared to the individual medicines in type 2 diabetics inadequately controlled on metformin. The data were presented today at the 52nd Annual Meeting of the European Association for the Study of Diabetes in Munich, Germany.
- The study met its primary endpoint of significantly reducing HbA1c levels from baseline with the combination compared to standard-of-care therapy with the individual drugs. The specific reductions in HbA1c in patients receiving the combination, exenatide alone once/week and dapagliflozin alone once/day were -2.0%, -1.6% and -1.4%, respectively; p<0.01.
- Patients treated with the combination also experienced statistically significantly greater weight loss and reduction in systolic blood pressure than those receiving standard of care therapy.
- The development of the combination is ongoing.
Fri, Sep. 16, 7:55 AM
- The European Medicines' Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Pfizer's (NYSE:PFE) IBRANCE (palbociclib) for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer. CHMP's opinion specifies that IBRANCE be used in combination with an aromatase inhibitor [i.e., AstraZeneca's (NYSE:AZN) Arimidex (anastrozole)] and in combination with fulvestrant (AZN's FASLODEX) in women who have received prior endocrine therapy.
- Palbociclib is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6, downstream signaling pathways which lead to cellular proliferation. When combined with an antiestrogen, it inhibits the growth of breast cancer by interfering with these pathways and promoting the deterioration of cancer cells (senescence).
- A final decision by the European Commission usually takes ~60 days.
- The FDA approved IBRANCE in 2015.
Mon, Sep. 5, 3:39 PM
- Two Phase 3 clinical trials, SIROCCO and CALIMA, assessing two dosing regimens of AstraZeneca's (NYSE:AZN) interleukin-5 inhibitor, benralizumab, as add-on therapy in patients with severe eosinophilic asthma met their primary and secondary endpoints. The data were presented at the European Respiratory Society International Congress in London. Detailed results were published today in The Lancet.
- A total of 2,511 patients (1,205 in SIROCCO and 1,306 in CALIMA) who were receiving standard-of-care therapy, including inhaled corticosteroids and long-acting beta 2 agonists, were randomized to receive either 30 mg of benralizumab every four weeks; 30 mg of benralizumab every four weeks three times followed by 30 mg every eight weeks; or placebo for 48 weeks.
- The eight-week benralizumab regimen showed a reduction in the annual rate of asthma exacerbations of up to 51% and an improvement in lung function (measured by FEV1 of up to 159 mL) after four weeks of therapy that was sustained throughout the treatment period. Improvement in asthma symptoms was also observed.
- No additional benefit was seen with the 4-week regimen which supports less-frequent dosing.
- The incidence of adverse events was similar between the benralizumab-treated cohorts and placebo.
- The data from both studies will be included in regulatory submissions in the U.S. and EU later this year.
- Previously: AstraZeneca's asthma candidate benralizumab successful in two late-stage studies (May 17)
Fri, Sep. 2, 8:06 AM
- Boston Scientific (NYSE:BSX) upgraded to Buy from Hold with a $33 (36% upside) price target by Argus Research.
- Novo Nordisk (NYSE:NVO) upgraded to Hold from Reduce by HSBC.
- Karyopharm (NASDAQ:KPTI) upgraded to Buy from Hold by Jefferies. Price target raised to $12 (8% upside) from $9.
- AstraZeneca (NYSE:AZN) upgraded to Buy from Hold with a $38 (17% upside) price target by Argus Research.
- Quest Diagnostics (NYSE:DGX) downgraded to Neutral from Buy with an $86 (4% upside) price target by Mizuho Securities.
Thu, Sep. 1, 7:58 AM
- Results from a five-year 11,693-subject safety study comparing AstraZeneca's (NYSE:AZN) asthma med SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol to budesonide (an inhaled corticosteroid) alone showed a comparable risk of serious asthma-related events and lower risk of asthma exacerbations. Specifically, the trial showed statistical non-inferiority (7.3% higher risk) of SYMBICORT to budesonide in the time to first asthma-related event (hazard ratio: 1.073) and a 16.5% lower risk (hazard ratio: 0.835) of asthma exacerbations versus budesonide.
- Complete results are available in the The England Journal of Medicine. The study, started in 2011, was a post-marketing requirement by the FDA. All manufacturers of LABA- (long-acting beta2-adrenergic agonist) containing products for asthma in the U.S. are required to conduct similar safety studies when the LABAs are used in combination with an inhaled corticosteroid. The company has shared the data with the FDA and will soon be discussing the next steps in its post-marketing requirements with the agency.
- SYMBICORT was first approved in the U.S. in July 2006.
Wed, Aug. 31, 5:03 AM
- AstraZeneca (NYSE:AZN) will pay $5.5M to resolve a foreign bribery probe into improper payments by its sales and marketing staff to state-employed healthcare officials in China and Russia.
- The SEC detailed the settlement with AstraZeneca in an order instituting an administrative proceeding arising out of violations of provisions in the Foreign Corrupt Practices Act.
Wed, Aug. 24, 3:10 AM
- AstraZeneca (NYSE:AZN) has agreed to sell its small-molecule antibiotics operations to Pfizer (NYSE:PFE) in a transaction that could eventually be worth $1.575B.
- The deal will allow AstraZeneca to focus on three main therapy areas and realize value "from the strong portfolio of established and late-stage small molecule antibiotics."
- Pfizer will pay $550M upfront plus $175M in January 2019 and as much as $850M in milestones and sales-related payments.
- The U.S. company will receive approved antibiotics Merrem, Zinforo and Zavicefta, and clinical-development treatments ATM-AVI and CXL. (PR)