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Mon, Jan. 11, 8:37 AM
- AstraZeneca (NYSE:AZN) enters into a new collaboration with Moderna Therapeutics to discover, co-develop and commercialize messenger RNA (mRNA) therapeutic candidates for the treatment of a range of cancers. This new partnership adds to their 2013 collaboration to develop mRNA candidates in cardiovascular, metabolic and renal diseases, in addition to selected targets in cancer.
- The collaboration will leverage AstraZeneca unit MedImmune's protein engineering and cancer biology know-how with Moderna's mRNA platform.
- Under the terms of the deal, the companies will collaborate on two specific immuno-oncology programs. Moderna, through its oncology-focused venture, Onkaido, aims to deliver one Investigational New Drug (IND) application-ready molecule for each of the programs. AstraZeneca will be responsible for early clinical development, led by MedImmune, while both AstraZeneca and Moderna will share the costs of late-stage development. They will co-commercialize the products in the U.S. on a 50:50 profit sharing basis. AstraZeneca will lead ex-U.S. commercialization with Moderna receiving tiered royalties up to the high double digits on ex-U.S. sales.
- Under their original strategic agreement, AstraZeneca has exclusive access to any target of its choice in the cardiometabolic space, as well as specific cancer targets, for up to five years. Several projects are progressing toward clinical development with the first in-human study expected to commence by the end of the year.
Tue, Jan. 5, 8:01 AM
- Ardelyx (NASDAQ:ARDX) completes its open label pharmacodynamic study of hyperkalemia candidate RDX022 in healthy adult volunteers. The results showed that RDX022 effectively binds to potassium in the gastrointestinal tract. All doses (up to 27.5 g/day) were generally well-tolerated.
- According to the company, RDX022 overcomes the limitations of other drugs used to treat hyperkalemia (abnormally high levels of potassium in the blood) due the absence of sodium as a counter-ion while being better tasting.
- A Phase 3 trial is planned for H2 2016.
- Hyperkalemia-related tickers: (NASDAQ:RLYP)(NYSE:AZN)
Dec. 22, 2015, 9:29 PM
- The FDA approves AstraZeneca's (NYSE:AZN) Zurampic (lesinurad), in combination with a xanthine oxidase inhibitor (XOI), for the treatment of hyperuricemia (elevated levels of uric acid in the blood) associated with gout.
- Lesinurad inhibits the function of transporter proteins involved in uric acid resorption in the kidneys, thereby helping them excrete uric acid.
- An XOI, such as Takeda's Uloric (febuxostat), reduces the level of uric acid in the body by inhibiting xanthine oxidase, an enzyme that catalyzes xanthine to uric acid.
- The approval requires the company to conduct a postmarketing study to assess the renal and cardiovascular safety of Zurampic. Its labeling includes a boxed warning about the risk of kidney failure, which is more common when it is used without an XOI or if dosed above approved levels.
- The FDA's Advisory Committee voted 10-4 in favor of approval two months ago.
- Previously: FDA Ad Comm backs AstraZeneca's lesinurad for gout-associated hyperuricemia (Oct. 24)
Dec. 18, 2015, 9:37 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issues three positive opinions for AstraZeneca (NYSE:AZN) marketing applications.
- It backs approval of lesinurad 200 mg tablets, in combination with a xanthine oxidase inhibitor (XOI), for the adjunctive treatment in adults with gout (with or without tophi) who have failed to achieve target serum uric acid levels with a XOI alone.
- It backs approval of TAGRISSO (osimertinib) 80 mg once-daily tablets for the treatment of adults with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M-positive non-small lung cancer.
- It backs approval of BRILIQUE (ticagrelor) 60 mg for the treatment of patients with a history of heart attack who are at high risk of a further atherothrombotic event. It is currently cleared (90 mg dose) to reduce the rate of cardiovascular death, myocardial infarction and stroke in patients with acute coronary syndrome.
- A final decision by the European Commission usually takes ~60 days.
Dec. 17, 2015, 12:45 PM
Dec. 17, 2015, 3:16 AM
- AstraZeneca (NYSE:AZN) has agreed to buy a 55% stake in biotech firm Acerta Pharma for $4B, giving it access to acalabrutinib, a new kind of drug for fighting blood cancers.
- The drugmaker also has the option to buy the rest of Acerta for a further $3B subject to certain milestones.
- After spurning a $120B takeover bid from Pfizer last year, AstraZeneca CEO Pascal Soriot said he would consider small and midsize deals to further boost the company's drug pipeline.
- AZN -0.8% premarket
- Previously: AstraZeneca confirms talks with Acerta Pharma (Dec. 14 2015)
- Previously: WSJ: AstraZeneca in talks to buy cancer drug developer Acerta for $5B (Dec. 11 2015)
- Update: Under the terms of the agreement, AstraZeneca will make an upfront payment of $2.5B and a conditional payment of $1.5B to be paid on the receipt of the first regulatory approval for aclalabrutinib in the U.S. for any indication or the end of 2018, whichever is first.
Dec. 16, 2015, 9:50 AM
- WuXi AppTec and AstraZeneca's (AZN +0.8%) MedImmune form a strategic alliance to develop biologics in China in the areas of respiratory, inflammation, autoimmunity, cardiovascular, metabolic disorders and oncology. Under the terms of the agreement, which is light on the details, AstraZeneca has the option to acquire WuXi's biologics manufacturing facility in Wuxi city.
- The alliance builds on the existing joint venture between MedImmune and WuXi, formed in 2012, to develop and commercialize MEDI5117, a monoclonal antibody that binds to interleukin 6 (IL-6), for the treatment of autoimmune and inflammatory diseases. The IND was accepted by the China Food and Drug Administration (CFDA) in March for the treatment of rheumatoid arthritis.
Dec. 16, 2015, 4:36 AM
- AstraZeneca (NYSE:AZN) has agreed to buy Takeda Pharmaceutical's (OTCPK:TKPYY) respiratory business for $575M, including expanded rights to roflumilast (Daliresp), a treatment for chronic obstructive pulmonary disease.
- Annual global sales of the three core medicines acquired, excluding sales of Daliresp in the U.S., were $198M for the period ending in March 2015.
- AZN +0.4% premarket
Dec. 15, 2015, 1:34 PM
- In a regulatory filing, AstraZeneca (AZN +0.9%) reports that it has completed its divestment of Entocort (budesonide) with the finalization of its agreement with Perrigo (PRGO +0.6%) for the U.S. rights to the Crohn's disease medicine, for which Perrigo paid $380M.
- Zeria Group's Tillotts Pharma AG owns the rights outside of the U.S. for which it paid $215M.
- Previously: AstraZeneca, Perrigo sign deal for rights to Entocort (Nov. 23)
- Previously: AstraZeneca divests non-U.S. rights to Entocort for $215M (July 9)
Dec. 14, 2015, 4:28 AM
- AstraZeneca (NYSE:AZN) has confirmed that it's in talks with privately held Acerta Pharma, after WSJ reported on Friday it was looking to acquire the Dutch firm for more than $5B.
- Although there is no certainty a deal will be reached, AstraZeneca's interest is closely tied to Aceta's potential blockbuster medicine for blood cancers called acalabrutinib.
- Previously: WSJ: AstraZeneca in talks to buy cancer drug developer Acerta for $5B (Dec. 11 2015)
Dec. 11, 2015, 5:37 PM
- AstraZeneca (NYSE:AZN) is in advanced talks to buy privately held cancer drug developer Acerta Pharma for more than $5B, WSJ reports.
- Acerta does not yet have any drugs on the market, but its acalabrutinib compound is similar to a blood-cancer drug from AbbVie and Johnson & Johnson that analysts expect to be a multibillion-dollar seller, and has shown promise in early clinical trials.
- The drug reportedly works in a similar way as AbbVie's Imbruvica, and Acerta is testing it in various leukemias, lymphomas and other cancers; analysts expect Imbruvica will become one of the world’s top-selling cancer drugs, exceeding $5.5B in yearly sales by 2020.
Dec. 4, 2015, 12:01 PM
- Relypsa (RLYP +16.6%) jumps on increased volume in response to rumors that Merck (MRK +0.5%) may be eyeing the company. Actelion Pharmaceuticals (OTCPK:ALIOY -0.4%) is another rumored suitor considering AstraZeneca's (AZN +0.4%) recent takeover of ZS Pharma (ZSPH -0.1%).
- Relypsa's sole product is Veltassa (patiromer for oral suspension) for the treatment of hyperkalemia (abnormally high levels of serum potassium), cleared by the FDA on October 21.
- Previously: Good news is bad news for Relypsa; shares down 26% premarket after approval of Veltassa (Oct. 22)
- Previously: ZS Pharma take out by AstraZeneca puts the spotlight on Relypsa; shares rise 17% premarket (Nov. 6)
Dec. 4, 2015, 8:23 AM
- Mallinckrodt (NYSE:MNK) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target raised to $88 (22% upside) from $74.
- AstraZeneca (NYSE:AZN) upgraded to Overweight from Underweight by Morgan Stanley. Price target set at ₤53 ($80) (138% upside).
- Wright Medical (NASDAQ:WMGI) upgraded to Buy from Hold by Jefferies. Price target raised to $29 (32% upside) from $23.
- Pfizer (NYSE:PFE) upgraded to Neutral from Reduce by SunTrust Robinson Humphrey. Price target raised to $37 (5% upside) from 34.
- Perkin Elmer (NYSE:PKI) downgraded to Neutral from Outperform by Wedbush. Price target maintained at $56 (10% upside).
- OncoGenex Pharmaceuticals (NASDAQ:OGXI) downgraded to Hold from Buy by Stifel. $7 price target removed.
- Aduro Biotech (NASDAQ:ADRO) downgraded to Perform from Outperform by Oppenheimer. Price target is $30 (1% upside).
Dec. 2, 2015, 11:10 AM
- Key points from AstraZeneca's (AZN -0.5%) conference call this morning to update investors on its late-stage pipeline:
- Product development will focus on three therapy areas (Respiratory, Inflammation & Autoimmunity/Cardiovascular & Metabolic Disease/Oncology) with a shift toward more targeted specialty care programs.
- 2015 key milestones: U.S. approvals of Tagrisso (osimertinib), Iressa (gefitinb) and Brilinta post-MI. Regulatory submissions in the U.S. for lesinurad (gout) and PT003 (COPD), in the EU for cediranib (ovarian cancer), saxa/dapa (type 2 diabetes)(CRL rec'd from FDA) and CAZ AVI (serious infections) and Japan for Brilinta ACS, post-MI.
- FDA clearance of PT003 and ZS-9 expected in H1 as well as Tagrisso approval for lung cancer in the EU and Japan. Expected approvals in H2 in the EU are saxa/dapa, cediranib and CAZ AVI.
- Resp/Inflam/Auto: Key products in late-stage development: Benralizumab, an IL-5 inhibitor, in Phase 3 development for severe asthma and COPD. Regulatory submissions expected in H2 2016. Anifrolumab, a fully human IgG1 K monoclonal antibody, in Phase 3 for systemic lupus erythematosus. Final data expected in 2018, regulatory submissions to follow in 2019.
- Cardio/Meta: New indications for Brilinta (stroke/transient ischemic attack, peripheral arterial disease, diabetes) expected to launch in 2017 and 2018. Key pipeline products: Roxadustat (stokes production of red blood cells), ZS-9 (hyperkalemia).
- Oncology: Key pipeline products: durvalumab (PD-L1+ NSCLC and other cancers), expanded indications for Lynparza (olaparib).
- Slide presentation
Dec. 2, 2015, 9:00 AM
- In a regulatory filing, AstraZeneca (NYSE:AZN) announces that EVP, Global Medicines Development and Chief Medical Officer Sean Bohen will host a conference call today at 11:00 am ET to update investors on its late-stage pipeline, including progress made this year and expected news flow in 2016. No new material information will be presented. The aim of the event is to provide additional color on the pipeline.
Nov. 23, 2015, 3:56 AM
- AstraZeneca (NYSE:AZN) has finalized plans to divest its Crohn's disease drug Entocort by selling U.S. rights to the medicine to Perrigo (NYSE:PRGO) for $380M.
- The move is part of AstraZeneca's "externalization" drive, which aims to sell non-core products to help it fill a short-term revenue gap caused by older drugs, while investing in a pipeline of new medicines.
- Entocort had U.S. sales of $89M in the first nine months of 2015.
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