Citing results that were not compelling enough to proceed, Bind Therapeutics (BIND -3.4%) and Amgen (AMGN +0.6%) notify each other that they will not be exercising their options to develop an Accurin incorporating the Amgen therapeutic payload.
The collaboration began in January 2013 with the goal of developing a nanomedicine for treating solid cancer tumors based on Bind's platform for targeted and programmable nanomedicines and Amgen's undisclosed proprietary cancer compound.
Bind CEO Scott Minick says that his company will proceed undeterred with its collaborations with AstraZeneca (AZN +2%), Roche (RHHBY -0.6%) and Pfizer (PFE +1%).
The FDA's Oncologic Drugs Advisory Committee votes 11-2 in favor of requiring AstraZeneca (AZN +0.9%) to submit additional clinical data demonstrating the efficacy of olaparib as a treatment for ovarian cancer before it will consider recommending approval. The panel's opinion was that the data the company submitted in its application was not robust enough to prove it could be reproduced. Committee members also voiced concern about a potential risk of secondary cancers in patients receiving the drug.
The FDA's Oncologic Drugs Advisory Committee meets Wednesday to decide if AstraZeneca's (AZN -1.2%) cancer drug olaparib should be given an accelerated approval or wait for the final results of the ongoing SOLO-2 clinical trial. The panel will discuss the results of Study 19 where olaparib demonstrated an 83% reduction in risk of progression or death in patients with ovarian cancer. There appears to be questions regarding the validity and reproducibility of the magnitude of the treatment effect, however. The committee will decide if the treatment benefits outweigh the side effects risk.
If the panel votes to wait until the completion of the SOLO-2 study, U.S. approval will not happen until 2016 considering the trial's mid-2015 final data collection date.
The company forecasts olaparib peak sales of $2B which places it in the top six pipeline candidates that it included in its recent investor presentation.
Shire emphasizes its accelerating top-line growth, enhanced profitability, rich pipeline and total shareholder returns as proof that current management is on the right track and that Shire's future is bright continuing as an independent company.
India's Dr. Reddy's Laboratories (RDY) recalls 13,560 bottles of metoprolol succinate, a drug for high blood pressure, after it failed a dissolution test, a measure to check the amount of time it takes the active ingredient to release into the body which helps predict the drug's performance inside the body. The FDA classifies the recall as Class II which means that use or exposure may cause temporary or medically reversible health consequences.
Metoprolol succinate extended release is a generic form of AstraZeneca's (AZN) Toprol XL. Wockhardt Ltd recalled 109,744 bottles of the same drug last month also for failing a dissolution test.
In March, Dr. Reddy's recalled 58,656 bottles of the heartburn drug lansoprazole due to microbial contamination. Indian drug makers have been hit by numerous quality issues this year which has prompted increased scrutiny from regulators.
Nektar Therapeutics (NKTR) +9.2% AH after a long trading halt, as an FDA advisory panel recommended against requiring cardiovascular outcome trials for a certain class of drugs - including NKTR's Movantik - in the treatment of constipation caused by opioid medicines (earlier).
The drug treatment, being developed by NKTR partner AstraZeneca (AZN), also is being reviewed by health agencies in the European Union and Canada.
The FDA is expected to make a decision on Movantik by Sept. 16.
Amgen (AMGN +0.2%) and collaboration partner AstraZeneca (AZN -0.2%) announce the results of a 168-patient Phase 2 clinical trial evaluating the safety and efficacy of their human mAb brodalumab as a treatment for psoriatic arthritis. At 12 weeks, the therapeutic significantly improved signs and clinical symptoms of the disease as measured by a 20% improvement in the American College of Rheumatology response criteria (ACR20). In addition, many patients continued to improve and sustained their improvements through 52 weeks.
The study achieved its primary endpoint of demonstrating superiority vs placebo in ACR20 responses at week 12. 37% of patients treated with 140 mg of brodalumab and 39% treated with 280 mg of brodalumab achieved ACR20 compared to 18% in the placebo group. 14% of patients in both test groups achieved ACR50 (50% improvement) vs 4% in the control group. Patients achieving ACR70 were not significantly higher in the test groups vs placebo.
Brodalumab blocks the binding of IL-17 to its receptor and thus inhibits inflammatory signalling.
The firms have initiated two Phase 3 studies evaluating brodalumab for psoriatic arthritis.
AstraZeneca (AZN) licenses SNG001, an inhaled inteferon beta (IFN-beta), from U.K. firm Synairgen Plc. It supports the immune system by correcting a deficiency which makes patients more susceptible to respiratory tract infections. The product has a broad spectrum anti-viral effect. It acts by delivering IFN-beta to the lungs when an infection begins to take hold in the upper airways. It is in clinical development as a treatment for respiratory tract infection in patients with severe asthma.
Under the terms of the agreement, AZN will pay Synairgen an upfront fee of $7.5M and development, regulatory and commercial milestones of up to $225M. Once commercially available, it will be pay tiered royalties in the range of single-digit to mid-teens. AZN will be responsible for future development costs. It will initiate a Phase 2a clinical trial in patients with severe asthma in early 2015.
Yesterday it was Biogen (BIIB). Today it's AstraZeneca (AZN). Isis Pharmaceuticals (ISIS) earns a $15M milestone payment from AZN by virtue of its initiation of a Phase 1 clinical trial for ISIS-ARrx, an antisense drug for the treatment of prostate cancer that works by inhibiting the production of the androgen receptor. Isis has now earned $57M to date on its development and is eligible for additional milestone payments as the product progresses through clinical trials.
Cancer Genetics (CGIX) inks a deal with AstraZeneca (AZN) CAMCAR, S.A. to provide biomarker-based diagnostic testing services for cancer patients in Central America and the Caribbean. The initial focus will be lung cancer but will eventually expand to other cancer categories.
Roche's (RHHBY -0.2%) Ventana Medical Systems and AstraZeneca's (AZN) MedImmune will jointly develop a PD-L1 immunohistochemistry assay to screen patients for MedImmune's clinical trials for MEDI4736, an anti-PDL1 therapy for non-small cell lung cancer. Financial terms are not disclosed.
AstraZeneca (AZN +0.2%) and Cigna (CI) -0.1%) ink a deal whereby the insurer will use predictive modeling software to authorize paying for Crestor instead of relying on prior authorization. Cigna says that it will lower drug costs because the Big Data-based model will flag patients most at risk for atherosclerosis and will approve the immediate use of Crestor instead of following the traditional "step therapy" rule requiring the patients to try cheaper drugs first. It is also a win for AZN because it will be CI's brand-name statin. The initiative should help support sales before the product goes off patent in 2016.
At this week's American Society of Clinical Oncology meeting in Chicago, cancer immunotherapies are all the rage. Using the body's immune system to battle cancer is significantly extending survival times for a variety of cancers and has created the next frontier for blockbusters. Bristol-Myers Squibb (BMY), Merck (MRK), Roche (RHHBY) and AstraZeneca (AZN) are all racing to bring their offerings to market.
Some caution is warranted, however. The drugs work for only a minority of patients and they frequently have significant side effects, especially when a combination of therapies is used. For example, in a trial of BMY's Yervoy for advanced lung cancer, half of the 46 patients in the trial suffered serious side effects and three died from the drugs themselves.
Actavis (ACT +0.3%) files an ANDA for a generic version of AstraZeneca (AZN -0.3%) and Bristol-Myers Squibb's (BMY +0.2%) Onglyza (saxagliptin hydrochloride), a treatment for glycemic control in adults with type 2 diabetes.
AZN filed suit against ACT on May 23, 2014 to prevent it from commercializing its generic version prior to the expiration of the '400 patent. The court instituted a stay of final FDA approval of the ANDA until January 31, 2017 or final resolution of the suit, whichever occurs sooner. ACT believes it is the first filer so it will be entitled to 180 days of generic market exclusivity upon regulatory clearance.
According to IMS Health Data, U.S. Onglyza sales were ~$532M for the 12-month period ending February 28, 2014.
As expected, Pfizer (PFE) has abandoned its attempt to acquire AstraZeneca (AZN) for £69.4B ($117B), saying that "it does not intend to make an offer" for the U.K. company after the latter rejected Pfizer's latest proposal.
Under British law, the U.S. giant can not make another bid for AstraZeneca for three-to-six months. (PR)
Pfizer (PFE) is on the brink of halting its attempt to acquire AstraZeneca (AZN) for £69.4B ($117B), Bloomberg reports.
Under British law, Pfizer has until 5 pm in the U.K. to make a firm offer, but it is expected to say that it won't make one. The company would then have to wait three-to-six months to make another proposal.
Pfizer hopes that AstraZeneca shareholders will use the time to pressure their company to engage with the U.S. firm.