Wed, Mar. 18, 7:45 AM
- Two 24-week Phase 3 trials (PINNACLE 1 & 2) evaluating AstraZeneca's (NYSE:AZN) PT003 in patients with chronic obstructive pulmonary disease (COPD) achieved their primary efficacy endpoints of statistically significant improvement in lung function compared to placebo.
- PT003 is a twice-daily fixed-dose combination of glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-2 agonist (LABA). It is the first LAMA/LABA combination to be delivered in a pressurized metered dose inhaler using the porous particle co-suspension technology developed by Pearl Therapeutics, which AZN acquired in 2013. The successful outcomes of the PINNACLE studies are the first from a series of pipeline candidates using Pearl's technology.
- PT003 was assessed in over 3,700 patients in over 275 study sites. The primary efficacy endpoint was trough forced expiratory volume in one second (FEV1). PT003 demonstrated statistically significant improvements in FEV1 versus placebo and the individual components glycopyrronium (PT001) and formoterol fumarate (PT005). PT001 and PT005 also showed statistically significant improvements in FEV1 compared to placebo.
- The company plans to file regulatory applications beginning this year. It will present the study results at a scientific meeting later this year.
- Related tickers: (NYSE:GSK) (NASDAQ:THRX) (NYSE:NVS) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
Sat, Mar. 14, 8:32 PMAstraZeneca's Brilinta plus aspirin reduces blood clot events in patients with a history of heart attack
- A large scale outcomes study investigating AstraZeneca's (NYSE:AZN) anti-clotting agent, Brilinta (ticagrelor), plus low dose aspirin compared to placebo plus low dose aspirin for chronic secondary prevention of artherothrombotic (hardening and narrowing of the arteries) events in patients who had a heart attack one to three years prior to the enrolling in the study showed a statistically significant reduction in blood clot-related cardiovascular (CV) events compared to placebo.
- Both doses of Brilinta used in the study significantly reduced CV death, myocardial infarction (heart attack) or stroke compared to placebo. The rate at three years for the ticagrelor 90 mg arm was 7.85%; 7.77% for ticagrelor 60 mg and 9.04% for placebo (p=0.0043). A numerical decrease in the secondary endpoints of CV death and all-cause mortality was observed, but did not reach statistical significance.
- As expected with an oral antiplatelet, TIMI (thrombolysis in myocardial infarction) bleeding was higher in the ticagrelor arms than placebo. TIMI major bleeding rates were: 2.60% for ticagrelor 90 mg; 2.30% for ticagrelor 60 mg and 1.06% for placebo (p<0.001).
- The study, called PEGASUS-TIMI 54, involved over 21,000 patients worldwide. It is the first prospective trial to evaluate longer term antiplatelet therapy in higher risk patients with a history of heart attack.
- The company intends to pursue regulatory approval for the expanded indication. Brilinta is currently cleared to reduce the rate of thrombotic CV events in patients with acute coronary syndrome (situations where the blood supply to the heart is suddenly blocked).
Tue, Mar. 10, 1:13 PM
- H.C. Wainwright maintains Buy rating on Acadia Pharmaceuticals (NASDAQ:ACAD) with $50 price target. Implied upside 19%.
- "Based on the clear beneficial safety profile for Nuplazid for PD+P over available atypical antipsychotics, we reiterate our bullish view regarding the PD+P indication and that the PD market alone (given the significant unmet need) is sufficient to support our $50 PT. We continue to see AD+P as a high risk, free call option potentially providing additional upside for investors," firm says.
- SA author Investing Healthcare calls ACAD "the biggest goldmine for acquirers in 2015." Potential buyers include AstraZeneca (NYSE:AZN), AbbVie (NYSE:ABBV), and Otsuka Pharmaceuticals.
Tue, Mar. 3, 7:08 AM
- AstraZeneca (NYSE:AZN) finalizes its acquisition of Actavis' branded respiratory portfolio in the U.S. and Canada. Under the terms of the deal, AZN paid $600M up front and agrees to pay low single-digit royalties above a certain sales threshold and an additional $100M for a number of contractual consents and approvals, including certain amendments to the ongoing collaboration agreements between the two firms.
- Previously: Actavis sells U.S./Canada respiratory portfolio to AstraZeneca (Feb. 6)
Wed, Feb. 25, 5:34 PM
- The FDA approves Forest Laboratories subsidiary Forest Pharmaceuticals' (NYSE:ACT) Avycaz (ceftazidime-avibactam) for the treatment of adult patients with complicated intra-abdominal infections, in combination with metronidazole, and complicated urinary tract infections, including kidney infections, who have limited or no alternative treatment options.
- Avycaz contains ceftazidime, a previously approved cephalosporin antibacterial drug and avibactam, a non-beta lactam beta-lactamase inhibitor antibiotic to extend bacterial resistance. The addition of avibactam protects ceftazidime from being broken down by beta-lactamases that are produced by resistant bacteria.
- Avycaz is a Qualified Infectious Disease Product (QIDP) which adds a five-year period of market exclusivity to the five-year exclusivity period provided under the Food, Drug and Cosmetic Act. It is the fifth QIDP-tagged drug cleared by the FDA.
- The product was developed under a collaboration between Forest Labs and AstraZeneca (NYSE:AZN).
Thu, Feb. 19, 10:10 AM
- Facing ever-increasing pushback from payers over the high price of new treatments, some biotech firms are working on a new payment model that rewards them for the long-term performance of their drugs. Gene therapy developers, including BioMarin Pharmaceuticals (BMRN +0.4%) and Sangamo BioSciences (SGMO -0.1%), are leading the effort.
- The industry says that a one-time cure, even if priced greater than $1M, saves money over the long term but acknowledges that payers will balk at paying the cost upfront. The general consensus is that an upfront payment over $1M will be unacceptable.
- Under a pay-for-performance scheme, the annuity-like payments would cease if medical testing showed that the therapy was not working. Much work remains to be done, though, before this approach could be implemented. For example, legislation may be required to force insurers to pick up the tab for patients that switch coverage.
- Some proponents of the new scheme say that the payment streams could be securitized and sold to investors, like consumer debt.
- Gene therapies represent the highest priced treatments. Only one has cleared the regulatory hurdle to date, UniQure's (QURE +1.5%) Glybera, which costs 850K euros ($1M) in Germany. It will be sold for a one-time payment because it is too difficult to measure how well it works (this reasoning will undoubtedly pop up again).
- Previously: UniQure sets price record with Glybera (Nov. 26, 2014)
- Related tickers: (CELG +1.3%)(AMGN -0.2%)(BIIB +0.5%)(GILD +0.1%)(MRK -0.3%)(GSK -0.2%)(AZN +0.9%)(LLY +0.3%)(NVS +0.1%)(PFE -0.5%)(JNJ -0.3%)(OTCQX:RHHBY +1.4%)(BMY -0.4%)(ABT)(BAX -1.1%)
Tue, Feb. 17, 7:38 AM
- The U.S. District Court for the District of New Jersey rules that AstraZeneca's (NYSE:AZN) patent No. 7,524,834 (the '834 patent) protecting Pulmicort Respules is invalid. The patent, set to expire in 2018 and with pediatric exclusivity extending into 2019, will allow Actavis (NYSE:ACT) to release its generic version of the product. Teva Pharmaceutical Industries (NYSE:TEVA) has marketed a generic formulation for some time per a previous agreement with AstraZeneca.
- The court originally invalidated the '834 patent in April 2013 but the ruling was reversed and remanded in October 2013 by the U.S. Court of Appeals for the Federal Circuit.
- The company says the decision will not impact its 2015 guidance. Pulmicort generated $269M in sales in Q4 and $946M over the past 12 months. EVP, North America Paul Hudson says, "AstraZeneca strongly disagrees with the Court's decision. [The Company] has full confidence in the strength of its intellectual property rights protecting Pulmicort Respules. We are reviewing the decision and considering our legal options, including an appeal."
- Shares are down 1.5% premarket on light volume.
Fri, Feb. 6, 9:20 AM
- According to some observers, Pfizer's (NYSE:PFE) $17B takeout of Hospira (NYSE:HSP) is only a prelude to a bigger deal(s) considering that it was prepared to spend $120B for AstraZeneca (NYSE:AZN).
- According to Gabelli analyst Kevin Kedra, Actavis Plc (NYSE:ACT) is an attractive target, especially since nabbing Allergan (NYSE:AGN) and its fast-growing drug portfolio. A Pfizer takeover would be big enough to overcome the U.S. Treasury's stricter rules on inversions and lower its tax bill.
- John Boris of SunTrust Banks says GlaxoSmithKline (NYSE:GSK), AbbVie (NYSE:ABBV), Bristol-Myers Squibb (NYSE:BMY) and Mylan (NASDAQ:MYL) may be on the radar as well.
- Pfizer had $33B in cash at the end of September which it will use a portion of plus debt to pay for Hospira.
Fri, Feb. 6, 8:16 AM
- In an effort to sharpen its focus on its core therapeutic areas, Actavis (NYSE:ACT) divests its branded respiratory assets for the treatment of chronic obstructive pulmonary disease (COPD) in the U.S. and Canada to AstraZeneca (NYSE:AZN). Under the terms of the agreement, AZN will pay ACT $600M plus low single-digit royalties above a certain revenue threshold.
- AstraZeneca will own the development and commercial rights to Tudorza Pressiar (aclidinium bromide inhalation powder) and Daliresp (roflumilast). Sales for both products last year were $230M. AZN will also secure the development rights in the U.S. and Canada for LAS40464, which it sells in the E.U. under the brand name Duaklir Genuair.
- Actavis will receive an additional $100M from AstraZeneca on the basis of certain amendments to the firms' ongoing collaboration agreements.
- The transaction should close this quarter.
Thu, Feb. 5, 7:20 AM
Thu, Feb. 5, 4:32 AM
- AstraZeneca (NYSE:AZN) reported a fourth-quarter loss this morning, but stressed that it was on track to return to growth by 2017.
- The company's fourth-quarter net loss came in at $321M, down 38% from $524M a year earlier, while sales for the last three months of the year fell 2% to $6.68B.
- Actavis (NYSE:ACT) also confirmed that AstraZeneca would buy its branded respiratory business in the U.S. and Canada for an initial $600M.
- ACT -1.7% premarket
Wed, Feb. 4, 5:30 PM
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Wed, Feb. 4, 8:57 AM
Mon, Feb. 2, 11:41 AM
- Thinly-traded relatively-recent IPO Ardelyx (ARDX -30.9%) heads south on a 4x surge in volume albeit on turnover of only 325K shares. The company reported results from a Phase 2b clinical trial sponsored by development partner AstraZeneca (AZN -1%) that assessed tenapanor in hyperphosphatemic patients with chronic kidney disease on hemodialysis.
- The study met its primary efficacy endpoint of a statistically significant dose-related decrease in serum phosphate levels in patients treated with tenapanor compared to placebo (p=0.012). The overall safety profile did not change, but the rate of diarrhea, the most frequent adverse side effect, was much higher than expected.
- Ardelyx intends to evaluate the future development plans for tenapanor with AstraZeneca for this indication as well as irritable bowel syndrome. The study results will be presented in a future peer-reviewed forum.
- Previously: Tenapanor successful in Phase 2 trial (Oct. 1, 2014)
Mon, Jan. 26, 3:30 PM
- The FDA approves the Abbreviated New Drug Application (ANDA) from Teva Pharmaceutical Industries (TEVA -1.8%) subsidiary Ivax Pharmaceuticals for a generic version of AstraZeneca's (AZN -0.2%) Nexium (esomeprazole magnesium delayed-release capsules). Esomeprazole is a proton pump inhibitor that reduces stomach acid.
- The primary indication is the treatment of gastroesophageal reflux disease (GERD) in adults and children at least one year old. It is also cleared for the reduction in risk of gastric ulcers associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), the treatment of stomach infection from Helicobactor pylori in conjunction with certain antibiotics and the treatment of conditions where the stomach produces excess acid, including Zollinger-Ellison syndrome.
- It is the first generic esomeprazole to gain regulatory clearance in the U.S.
Mon, Jan. 26, 8:47 AM
- Citing its lack of abuse and dependence potential, the U.S. Drug Enforcement Agency (DEA) removes naloxegol from its list of Schedule II drugs.
- Naloxegol was developed by Nektar Therapeutics (NASDAQ:NKTR) for the treatment of opioid-induced constipation. It is marketed under the brand name Movantik by AstraZeneca (NYSE:AZN).
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