Advisory Committee Says Relist AstraZeneca's FluMist Vaccine

The FDA'S Advisory Committee on Immunizations has recommended that pharma titan AstraZeneca's FluMist Quadrivalent (R) vaccine be added to the list of approved influenza vaccines for the 2018-19 flu season.It next goes to the CDC director's desk for final approval.The nasally administered vaccine had been suspended from the list when the CDC's annual data on flu vaccine efficacy did not indicate it was effective enough in children ages 2-17.The vaccine was still available in other countries,however,which had conflicting data on FluMist.*
FluMist is unique among flu vaccines in that it contains a live yet weakened influenza virus.It is also distinguished by its being administered at a prime source of influenza infection:the nostrils,perhaps giving it an immunological advantage.It is intended for use by the 2-49 age group.*
One reason for the relisting recommendation is that the current severe outbreak of flu in the US has taken about a hundred children's lives so far,some of whom may have skipped vaccination out of fear of injections.FluMist would give such persons an alternative.As well,AstraZeneca has been tweaking the vaccine to make it more targeted to the yearly influenza forecast,and the H1N1 strain in particular.*
Astra Zeneca is a multinational biotech and pharmaceutical company with headquarters in Cambridge,England.Its subsidiary MedImmune develops FluMist and the company's other biologics.AstraZeneca focuses its research on the areas of oncology;respiratory and autoimmune disorders;and cardiovascular and metabolic diseases.*
At time of publication,AstraZeneca stock was up 0.19 to 34.20,with a dividend yield of 4.09%.*
AstraZeneca (AZN)

MedImmune and 3M Partner in Cancer Drug Research

MedImmune,the biotech subsidiary of British pharma titan AstraZeneca,and 3M Drug Delivery Systems announced a research collaboration on 25 September 2015.It is focused on developing nextgen toll-like receptor agonists,which are agents that activate innate immune cells and enhance the visibility of cancer tumours.MedImmune has licensed MEDI9197 from 3M,which the US FDA recently accepted for an investigational drug application,allowing a Phase I study on its safety and tolerability as a potential treatment for solid tumour patients.*
Such TLR agonists activate antigen presenting cells such as dendritic cells,enhancing the visibility of a tumour to the immune system.MEDI9197 has been designed to activate a broad range of innate immune cells,leading to a more robust adaptive immune response.
Preclinial studies show MEDI9197 may inhibit tumour growth of both the injected and distant lesions in multiple types of cancer,including melanoma skin cancer.It is designed for intratumoural injection,allowing the compound to be retained in the tumour and provide specific immune activation,enhancing its safety and tolerability.*
MEDI9197 adds a unique mechanism to our growing portfolio,and supports our strategy of maximising anti-tumour immunity through scientifically rational combinations,said MedImmune Sr. Vice President and Head of Research Yong-Jun Liu,PhD.*
Everyone here at 3M's Drug Delivery Systems is very excited to collaborate with MedImmune,a world leader in cancer immunotherapy,according to Cindy Kent,President and General Manager of 3M DDS.We're very pleased with the progression of MEDI9197 to the clinic.*
Under the deal,MedImmune will be responsible for the clinical development and strategy for MEDI9197.3M will continue to develop more TLR agonists in oncology and other therapy areas,with MedImmune holding exclusive rights to conduct research on new molecules resulting from the collaboration,and to determine which to progress to clinical development.
MedImmune will make an upfront payment to 3M and must make developmental milestone payments for MEDI9197,as well as provide research funding to 3M.*
MedImmune is based in Gaithersburg,Maryland and is best known for its Flu-Mist influenza vaccines and its pediatric vaccine Synagis,which prevents the serious respiratory disease RSV.3M is a Saint Paul,Minnesota-based multinational corporation with 11 lines of business.It is famous for products such as the iconic Scotch Tape and Post-It Notes.*
AstraZeneca (AZN),3M (MMM)

MedImmune,Hopkins Sign Research Pact

An R&D company and a research university have joined forces in the quest for new treatments for a number of serious illnesses,such as cancer,rheumatoid arthritis and infectious diseases.MedImmune,the Gaithersburg,Maryland biotech firm that is a subsidiary of pharma titan AstraZeneca,and Baltimore's The Johns Hopkins University signed the five year,6.5 million dollar research agreement on 11 December.*
The broad-scale,long-term partnership calls for both institutions to contribute funding,personnel and materials to the joint efforts and training programs.We believe this significant collaboration with JHU will create a new standard in how academia and inustry can work together,said Dr.Bahija Jallal,executive vice president at MedImmune.Our partnership with this prestigious research university will leverage each organisation's strength;advance research in critical therapeutic areas;and strengthen Maryland's presence as a growing hub in the bioscience industry.*
We are excited about the opportunity to collaborate with MedImmune researchers to accelerate the development of new therapies to treat a variety of serious diseases such as multiple sclerosis;rheumatoid arthritis;chronic obstructive pulmonary disease;and certain types of cancer,said Landon King,executive vice dean of The Johns Hopkins University School of Medicine.We believe that by working together to leverage the strength of each organisation,we can make significant advances.*
MedImmune focuses on the discovery,development and commercialisation of small molecule and biologic prescription medicines,pioneering innovative research and exploring novel pathways across its key therapeutic areas.It is best known for its vaccines FluMist and Synagis(R),which helps prevent respiratory syncytial virus infections in infants.*
AstraZeneca(AZN)

AstraZeneca Shops for Blockbuster Drug Replacements

British pharma titan AstraZeneca is attempting to solve its patent dilemma with cash.In late April,the company shelled out 1.26 billion dollars for San Diego biotech firm Ardea Biosciences.Ardea's main prospect is gout treatment Lesinurad.
According to AstraZeneca CEO David Brennan,this attractive Phase 3 program is an excellent opportunity to leverage Astra's global specialty and primary care sales and marketing capabilities.
Ardea is also developing combination treatments for pancreatic and liver cancer with Germany's Bayer AG,plus another gout drug in Phase 1 trials.
Astra is losing patent protection on many of its blockbuster products over the next few years.Billions in revenue will be lost as patents expire and generic competition cuts into sales of hypertension drug Atacand(2013);antipsychotic drug Seroquel and anti-cholesterol pill Crestor(2014);and gastroesophageal reflex disease pill Nexium in 2016.
This strategy was in place several years ago when Astra also acquired Gaithersburg,Maryland biotech firm MedImmune in 2007.
AstraZeneca(AZN),Ardea Biosciences(RDEA),Bayer AG(BAYRY)

MedImmune and Progenics Combat Deadly Bacteria

MedImmune,the biotech division of British pharma titan AstraZeneca,has signed an in-licensing agreement with Progenics Pharmaceuticals,Inc for Progenics' Clostridium difficile late stage preclinical program.Clostridium infections are the leading cause of hospital acquired infections in the US,resulting in 20,000 deaths and 1 billion dollars in health care costs annually.
Clostridium causes severe diarrhea and significantly lengthens hospital stays,leading to poorer outcomes.MedImmune will assess the efficacy and treatment of the disease with monoclonal antibodies that target toxins which mediate it.
MedImmune Senior Vice President and Infectious Disease iMed Head Steve Projan said the program fits strategically within our infectious disease portfolio and adds to our existing programs that aim to prevent and treat serious bacterial infections,particularly among high risk patients.Progenics CEO Mark R. Baker added that Progenics is pleased to have this potential candidate in MedImmune's hands,where it has the potential to improve human health.
About 500,000 cases of Clostridium are diagnosed in the US annually,mostly affecting hospital patients.Up to 28% of cases are community-acquired through contaminated soil,water,pets,cattle and foods.The bacteria not only damage the gut lining;but prevent the regrowth of normal,healthy bacteria in the gut as well. Progenics' antibodies are highly potent against most strains found in the US and Asia,and potent against hypervirulent strains,which are largely responsible for the disease's growth rate,preliminary findings suggest.
MedImmune,based in Gaithersburg,Maryland,employs about 3500 people worldwide.Progenics is a biotech firm located in Tarrytown,New York.
AstraZeneca(AZN),Progenics(PGNX)

MedImmune Joins Forces With Cancer Vaccine Collaborative

The structure of cancer research can be complex,even as the disease itself is.As a case in point,consider that MedImmune,the biotech division of British pharmaceutical titan AstraZeneca,has agreed to contribute three of its monoclonal antibodies to a research effort of the Cancer Vaccine Collaborative,or CVC.The CVC is in turn a project sponsored by a philanthropic organisation called the Cancer Research Institute and also by the Ludwig Institute for Cancer Research.The CVC is a network of clinical immunologists and oncologists with expertise in immunotherapy programs.
MedImmune's three antibodies will be incorporated into the CVC's portfolio of cutting edge clinical research and development,which utilises the expertise of its global network of clinicians and scientists to identify new immunotherapy combinations and launch clinical trials that help to bring the new treatments to cancer patients faster.
MedImmune's antibodies will be combined with other primary agents available to the CVC or accessed through additional partnerships to develop a more powerful generation of smarter immunotherapy drugs to better manage cancer patients' disease over the long term.Such combinations enable scientists to attack a particular cancer on multiple fronts,increasing the effectiveness of immune system response to cancer.
A monoclonal antibody is a protein produced from a single cell clone that can bind to substances such as tumor cells or other proteins,thus stimulating a person's immune system,modifying its regulatory checkpoints to make it more effective in responding to cancer.MedImmune intends to continue its research on these antibodies on an individual basis while the CVC combination studies proceed.
No financial terms of the joint effort with the CVC were revealed.
MedImmune employs about 3500 people worldwide.Its headquarters are in Gaithersburg,Maryland.
AstraZeneca(AZN)

Pfizer To Take Prescription Nexium Over the Counter-and possibly other drugs as well

British pharmaceutical titan AstraZeneca has sold Pfizer,the world's largest pharma company,the over the counter rights to its prescription heartburn treatment Nexium.Pfizer will pay Astra 250 million dollars up front.After that,Astra is eligible for milestone and royalty payments for product launches and sales of Nexium and any other Astra product Pfizer may take over the counter.
Pfizer projects a 2014 date for commercialising Nexium in the US,pending FDA approval,with other markets to follow.Nexium is currently prescribed for gastroesophageal reflex disease,or GERD,a severe form of heartburn that can damage the esophagus.
Tory Zook,Executive Vice President at Astra,said this agreement will help AstraZeneca realise the substantial,long term value of this brand and potentially other brands in our portfolio.Pfizer CEO Ian Read added that Pfizer Consumer Healthcare will have the opportunity to help more consumers better manage their health,while extending the value of certain important pharmaceutical brands.
AstraZeneca and Pfizer have also signed an agreement giving Pfizer right of first refusal for OTC rights to Rhinocort Aqua,a pump spray which is now prescribed for hayfever and house dust mite allergy,or non-infectious rhinitis.
AstraZeneca(AZN),Pfizer(PFE)

MedImmune Licenses Pfizer Cancer Care Candidate

MedImmune has licensed a Pfizer CTLA-4 monoclonal antibody,tremelimumab,for exploration in a number of potential cancer treatments.Under the agreement,Pfizer will retain the rights to use tremelimumab with specified types of combination therapies while MedImmune assumes global development rights of the antibody.
The acquisition for MedImmune's oncology pipeline exemplifies MedImmune's continued commitment to embracing this new era of cancer care,according to Dr.Bahija
Jallal,PhD,Executive Vice President of Research and Development.
CTLA-4 is a protein that has an important role in regulating the immune system.There is growing interest in potential therapeutic benefits of blocking this protein with antibodies such as Pfizer's tremelimumab,as a means of inhibiting immune system tolerance of carcinogenic tumors,thus providing a potential new immunotherapy for cancer patients.
MedImmune is a division of London-based pharma titan AstraZeneca.The Gaithersburg,Maryland biotech firm has a staff of around 3500 workers worldwide.MedImmune is the inventor of the iconic FluMist vaccine,as well as pediatric respiratory therapy Synagis.
AstraZeneca(AZN),Pfizer(PFE)

Biotech Together:MedImmune Finds French Research Partners

MedImmune,the biotech division of pharma titan AstraZeneca,has been selected as a strategic research partner by Inserm,the French National Institute of Health and Medical Research.The three-year collaboration seeks to advance research in oncology,respiratory,inflammatory and autoimmune diseases.
The research aims to move discoveries from bench to bedside,helping patients with unmet medical needs through exploring disease mechanisms and potential candidate drugs.
Also involved in the research is the private subsidiary of Inserm,Inserm Transfert.Inserm Transfert manages research projects,supporting studies from the preclincal to the postmarketing,and providing seed financing for biotech projects.
Inserm has 10 strategic research partners and 500 collaborators in total.It is closely associated with university hospital personnel and foreign research scientists.
Inserm's CEO,Professor Andre Syrota,said they are confident they will benefit from MedImmune's strong support of their efforts to foster discovery of new targets in therapy areas with high unmet medical needs.
MedImmune is based in Gaithersburg,Maryland.It is perhaps best known for its FluMist vaccine product.
AstraZeneca(AZN)

MedImmune's Oncology Portfolio Advances

MedImmune,the biologics business of British pharma titan AstraZeneca,is perhaps best known for its FluMist product,but it is also quite active in oncology innovation.They are using insights and understanding of cancer to discover breakthrough biologic therapies that can be used to treat specific cancers for the individual patient,according to Jerry McMahon,PhD,Senior Vice President and Oncology Innovative Medicines Unit Leader.
MedImmune's pipeline is focused on eliminating cancer cells in more effective and targeted ways.They are currently researching their products MEDI-575,an antibody with promise in treatment of solid tumors;and the immunotoxin moxetamomab pasudotox(CAT 8015),which is being evaluated for therapeutic potential against certain leukemias.
These are early phase studies,but MedImmune is excited about the oncology portfolio's progress and looks forward to advancing oncology products into expanded clinical studies in the near future,Dr.McMahon indicated.
MedImmune,based in Gaithersburg,Maryland,employs about 3500 people worldwide.Jerry McMahon,who assumed his position in October,received a doctorate in Biochemistry and Genetics from Rensselaer Polytechnic Institute in Troy,New York.
AstraZeneca(AZN)

Biotech's Respiratory Virus Treatment:FDA Dissatisfied

The Food and Drug Administration has requested that biotech firm MedImmune conduct further study of its respiratory virus treatment motavizumab.MedImmune recieved a complete response letter from the FDA asking for an additional clinical trial of motavizumab that supports a satisfactory risk/benefit profile.MedImmune,the biologics unit of British drugmaker AstraZeneca,said it will thoroughly review the letter and make a decision in due course about motavizumab,which it says it continues to believe in.It was the second complete response letter it had recieved from the FDA in the course of seeking approval for the treatment.
Motavizumab is being investigated to treat respiratory syncytial virus,which poses a threat to certain infants and adults.RSV typically causes a mild cold-like illness that clears up within a few weeks,but can be more severe,causing pneumonia or bronchitis in young babies,premature babies or adults,especially those with chronic heart or lung problems-possibly leading to death and requiring hospitalization.
Motavizumab is a monoclonal antibody,which is an antibody produced by a cloned cell that binds to a targeted cell,potentially stimulating the patient's immune system to attack the target cell.
Based in Gaithersburg,Maryland,MedImmune employs about 3300 people worldwide.It also has facilities in Frederick,Maryland and Cambridge,U.K.
AstraZeneca(AZN)