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)

Roche Subsidiary Genentech Wins FDA Approval for MS Treatment Ocrevus | GEN Genetic Engineering & Biotechnology News - Biotech from Bench to Business | GEN

Genentech Wins FDA Approval for MS Treatment Ocrevus | GEN Genetic Engineering & Biotechnology News - Biotech from Bench to Business | GEN


















Roche Holding AG ADR (OTC:RHHBY)

Biogen IDEC Changes Name,But Gets Downgrade Anyway

Biogen has dropped the IDEC from its name as of today,Monday 23 March,and is getting a new logo as well.It added IDEC when it merged with IDEC Pharmaceuticals 12 years ago.*
Today we are a new company,distinct from either parent,and we hope to not only carry on our heritage of excellence,but to forge new ground,said CEO Dr.George Scangos.0ur name is intended to acknowledge our heritage,but also to create a new image to reflect our new reality.*
The Cambridge,Massachusetts-based firm has a market cap of around 112 billion dollars and a staff of 7550.Last week the company announced a successful early stage trial for a drug that slows the progression of early stage Alzheimer's disease.A third of the patients with a gene that makes them susceptible to developing Alzheimer's had to discontinue the treatment because of brain swelling,however.Still,Biogen is going directly to a late stage trial,aiming to have the drug on the market by 2020.It has been estimated the new drug,BIIB037,could bring in more than 10 billion dollars at peak revenue.
Biogen is already known for its effective multiple sclerosis therapies,but now aims to find a cure for the ailment,and even for ALS,or Lou Gehrig's disease.It sees itself as a neurodegenerative disease specialist.
Biogen is also working on a number of biofamiliar drugs,the equivalent of generics for off-patent biotech drugs.It is seeking European approval for biofamiliars it ha developed for Amgen's Enbrel and Johnson and Johnson's Remicade,both of which are rheumatoid arthritis treatments.
Biogen stock was downgraded by Stiefel Financial from buy to hold on concern that it is overvalued because definitive data for the Alzheimer's drug will not be in before 2018.Citi maintained its buy rating on the firm,and Barclays maintained its overweight on the company,although Biogen's price targets have already been exceeded.The expensive stock was going for 469.71 this morning,down 1.34%.*
Biogen (BIIB),iShares Biotechnology ETF (IBB)

Pharma Flash:AbbVie Continues To Court Shire PLC

AbbVie,the Chicago-based biopharma concern,is continuing its courtship of Ireland's Shire PLC,despite repeated rejections on the grounds that AbbVie made an inadequate offer.It has made a third offer of 46 billion dollars,also promising a plan to buy back shares and offer shares as well as cash to Shire shareholders.*
Shire has several ADHD drugs in its portfolio,such as Adderall.The deal would also be an inversion for AbbVie,i.e.,by being Ireland-based,it would lower AbbVie's tax rate to 13% and free up overseas cash.That's significantly less taxes than US competitors pay.*
AbbVie was formerly part of Abbott Laboratories.It was spun off on 1 January 2013 as a global biopharma firm.With 25,000 workers,AbbVie has launched a Phase III study of Veliparib for Advanced Breast Cancer.
AbbVie claims the proposed combination is strategically compelling to AbbVie and Shire and would create a larger and more diversified biopharmaceutical company with multiple leading franchises and significant financial capacity for future acquisitions,investment and enhanced shareholder distribution and value creation.It offers attractive free cash flow and an enhanced return of capital policy.The new company would be listed in both London and on the NYSE.*
AbbVie(ABBV),Shire PLC(SHPG)

Pfizer,Cellectis Ink Cancer Immunotherapy Pact

Pfizer,the world's largest pharmaceutical company,has signed a deal with French biotech firm Cellectis to develop and commercialise CAR-T immunotherapies in the field of oncology directed at several targets.Cellectis' CAR-T technology utilises engineered T-cells from a single donor for use in multiple patients,rather than engineering a patient's own T-cells to target tumour cells.*
Cellectis' CAR-Ts are off-the-shelf products which can be industrialised and standardised.They may be shipped in advance and would be accessible to cancer centers all over the world without the need for a local CAR-T processing facility,which is an enormous advantage.*
Cellectis plans to open a US site for this collaboration with New York-based Pfizer.Cellectis CEO Andre Chulika,PhD,said we look forward to working closely with the team at Pfizer on researching and developing novel CAR-T therapies that could potentially change the way cancer is treated.
Mikael Dolsten,MD,PhD,Pfizer President of R&D,added that combining the innovation and scientific expertise of Cellectis with Pfizer's deep oncology and immunology experience creates a world-class partnership designed to deliver a new generation of CAR-T immunotherapies for cancer patients with urgent medical needs.*
Cellectis will receive an upfront payment of 80 million dollars plus R&D costs.It will also receive development,regulatory and commercial milestone payments of 185 million per Pfizer product,as well as tiered roylaties on net sales.Pfizer will also purchase about 10% of Cellectis capital through newly issued shares of Cellectis,pending shareholder approval.*
Pfizer(PFE),Cellectis(ALCLS:EN Paris)

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)

GlaxoSmithKline Submits New Melanoma Therapies

GlaxoSmithKline has submitted a Marketing Authorisation Application to the European Medicines Agency for trametininb as a monotherapy,and in combination with dabrafenib,for adult metastatic melanoma with a BRAF V600 mutation.The EMA granted GSK's request for accelerated assessment of the application.
The application contains data from two clinical trials of the therapies.
GSK initiated a randomised study early in the development programme to ascertain whether the combination therapy could circumvent resistance to single agent anti-BRAF melanoma therapy and were encouraged by trial results,said Dr.Rafa el Amado,Head of Oncology R and D.We are planning further submissions based on these data in the US and other countries in the coming months.
GSK had submitted applications for dabrafenib monotherapy to the EMA,and for trametinib monotherapy  to the US FDA,for BRAF V600 metastatic melanoma in August 2012.
Melanoma is the deadliest form of skin cancer and even kills numerous young people annually.
GlaxoSmithKline is one of the world's leading pharmaceutical and healthcare companies.London-based,it employs over 97,000 in more than 100 countries.
GlaxoSmithKline(GSK)

GlaxoSmithKline Submits New Diabetes Treatment

On January 14,London-based GlaxoSmithKline,a leading pharmaceutical and health care company,submitted albiglutide BLA,an investigational once-weekly treatment for adult type 2 diabetes,to the FDA.The drug will also be submitted to the European Union in early 2013.
Albiglutide is a GLP-1 agonist,a biotech drug that is designed for once-weekly subcutaneous dosing.GLP-1 is a peptide,a short chain of amino acids, normally secreted from the gastrointestinal tract during eating which helps release insulin to help control blood sugar.GLP-1 secretion is absent or reduced in those with type 2 diabetes.
While GLP-1 rapidly degrades,the new treatment,albiglutide,has been engineered to have a longer duration of action.It is comprised of two copies of modified human GLP-1 fused in series to human albumin,a protein made by the liver,the company said.
Shares of GlaxoSmithKline closed flat at 44.83 in Thursday trading.
GlaxoSmithKline(GSK)

Biotech Firm Dismisses GlaxoSmithKline Offer

Rockville,Maryland biotech firm Human Genome Sciences has rejected a 13 dollar a share bid by British pharma titan GlaxoSmithKline,with whom it has a partnership in the promotion of lupus drug Benlysta.The offer is inadequate,the company says in a letter to shareholders,because it doesn't capture HGS' inherent value and growth opportunities.HGS listed one of these opportunities as Benlysta,which is not only a treatment for lupus;but shows promise for treating other autoimmune diseases as well.The initial market opportunity for Benlysta is approximately 7 billion dollars in the U.S. alone,the company says.HGS goes on to cite its robust pipeline of new products as underpinning its future prospects,including cardiovascular drug darapladib and diabetes treatment albiglutide.Its early stage pipeline includes potential cancer,autoimmune and Alzheimer's disease medications as well.Glaxo was opportunistically trying to purchase HGS at a low point of the company's share price,HGS said.The Board has authorized management to seek strategic alternatives such as sale to another party to increase HGS' shareholder value.Human Genome's financial advisors,Credit Suisse and Goldman Sachs,both recommended against accepting the GSK offer as being inadequate. Human Genome Sciences(HGSI),GlaxoSmithKline(GSK)

The Heart of Biogen Idec

Just what is biotech titan Biogen Idec really about?We are a science-based business,according to CEO George Scangos,PhD.Making science-based decisions is the best thing we can do for our patients and shareholders.The company is a leading maker of multiple sclerosis therapies such as the established MS treatment Tysabri.Our new MS drug is oral;the first generation drug was injectable.Novartis also has an oral MS drug. There's a lot of innovation going on in the neurodegenerative field.There is a Phase III trial on an ALS drug-a drug for Lou Gehrig's disease.There are earlier programs on Alzheimer's and Parkinson's diseases.You need to find out what type of neurodegenerative disease they have in order to treat them,and more advanced imagery is helping that. Biogen has one of the most robust late stage pipelines.All of the research is associated with protein folding and plaques,understanding the pathology.There's huge potential.I'm very excited about the potential to treat these poor patients with better drugs in the next couple of years,Dr.Scangos said. Biogen Idec is based in Weston,Massachusetts. Biogen Idec(BIIB),Novartis(NVS)

Biotech Drugs Used To Fight Non-Hodgkin Lymphoma

Among treatments used for the blood cancer non-Hodgkin lymphoma,which claimed the life of Merseyside footballer Gary Ablett,are several biotech drugs.These include Genentech's Rituxan;Genzyme's Campath;Spectrum Pharmaceutical's Zevalin;and GlaxoSmithKline's Arzerra.Genentech is a division of Roche Pharmaceuticals.
Other treatments for the ailment are radiation therapy and chemotherapy.There is growing interest in stem cell transplants as a treatment as well.
Non-Hodgkin lymphoma,or NHL,is a cancer that starts in lymphocytes,a type of white blood cell found in the lymph nodes and other lymphoid tissues such as the spleen,bone marrow,tonsils and adenoids.The lymphatic system is spread throughout the body to fight infection.
There are no screening tests for NHL.Symptoms may include enlarged lymph nodes;swollen abdomen;a feeling of fullness;chest pain or pressure;shortness of breath or coughing;fever;weight loss;night sweats;and fatigue.A range of diagnostic procedures are used to identify NHL,from ultrasound and biopsy to PET scans.
The five year survival rate for NHL ranges from 53-91%,based on factors such as how far the cancer has spread and the patient's age.Those over age 60 tend to have a harder time surviving NHL.
Roche Holding AG(RHHBY),Spectrum Pharmaceuticals(SPPI),Genzyme(GENZ),GlaxoSmithKline(GSK)

A Successful Partnership:GlaxoSmithKline and Human Genome Sciences

British pharma titan GlaxoSmithKline is building on research carried out by Rockville,Maryland biotech firm Human Genome Sciences.Two of GSK's pipeline projects are based on HGS technology.
Darapladib is an inhibitor of the Lp-PLA2 enzyme,which is believed to be a risk factor for coronary heart disease and ischemic stroke.It is a potentially important new treatment for prevention of cardiovascular events.The candidate drug discovered by GSK using an HGS technology is in a Phase 3 trial for efficacy and safety of treatment.
Albiglutide is a biological product created by HGS and licensed by GSK IN 2004.It is designed to act throughout the body to help maintain blood glucose levels and control appetite.This potential long term treatment for type 2 diabetes is also in a Phase 3 trial.
HGS has a substantial financial interest in both of these GSK products which its research has had a formative influence on.
GlaxoSmithKline and Human Genome Sciences are also co-owners and developers of Benlysta,the first new lupus treatment approved in the U.S. in 50 years.
GlaxoSmithKline(GSK),Human Genome Sciences(HGSI)

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)

Lupus Patients,Maryland Firm Have Big Day

Lupus,a complex autoimmune disorder that pits the body's own defenses against itself,faced its first new adversary in more than 50 years Wednesday when the Food and Drug Administration approved Benlysta.The drug,a product of Rockville,Maryland biotech firm Human Genome Sciences and British business partner GlaxoSmithKline,carries a caution on the label that the medication has not been proven effective for treating African Americans to the FDA's satisfaction.
Nonetheless,it is believed the drug could garner billions of dollars for the two pharmaceutical companies,launching Human Genome into the major leagues of the industry.There is no competition for Benlysta at this point,being the first of a new class of drugs,the BLYS-specific inhibitors.
In its trials,Benlysta was found to help about 35% of those who suffer from the chronic inflammatory disease,which can be life-threatening.The FDA approval is seen as a win for Maryland's I-270 corridor as a whole,where the D.C. Metro Area's biotech industry is concentrated.It may well encourage more capital flow to the corridor as entrepreneurs and investors respond to the elevation in stature.
Human Genome's stock gained 13.05% on Thursday in the face of a broader market selloff.
Human Genome Sciences(HGSI),GlaxoSmithKline(GSK)

Human Genome Sciences Sets Cancer Goals

Human Genome Sciences has set its oncology and immunology goals for 2011.The therapies at the center of these goals are in the mid and early stage pipelines.The firm's oncology portfolio is centered around its expertise in the programmed cell death approach.
Human Genome's monoclonal antibody mapatumumab is being studied in combination with Nexavar as a treatment for advanced hepatcellular cancer.At the same time,The company's HGS1029 is being evaluated as a treatment for solid and advanced lymphoid tumors.
HGS1029 is one of a new class of compounds that block IAP proteins from protecting cancer cells.HGS1029 will be studied both alone and in combination with other agents,such as mapatumumab.HGS will initiate and continue the clinical trials of these oncology therapies in 2011.
CEO Thomas H. Watkins announced these and other goals on January 10 at the 29th Annual JP Morgan Healthcare Conference in San Francisco.Human Genome Sciences is based in Rockville,Maryland and has more than a billion dollars of cash and investments in its war chest.That is considered a lot for a young biotech concern such as Human Genome.
Human Genome Sciences(HGSI)

Frontiers In Medicine:Genentech's Cancer Treatment Approved

The FDA has approved Genentech's biotech medicine Herceptin,in combination with chemotherapy,as a treatment for certain stomach cancers-metastatic ones with the protein HER2 on tumor cells.
Early studies suggest Herceptin may block signals that cause tumor cells to grow and divide,and also signals the immune system to destroy the cancer cells.
About 21,000 Americans will be diagnosed with stomach cancer in 2010,and more than 10,500 will die of it.Often,symptoms of the disease do not appear until the late stages,when it has become metastatic,or spreading,or cannot be surgically removed.
The latest analysis shows that median overall survival with the Herceptin/chemotherapy regimen was 13.1 months,versus 11.7 months with chemotherapy alone.Herceptin is also used to treat HER2+ metastatic breast cancer.
Hal Barron,M.D.,executive vice president of Product Development and chief medical officer,said the FDA approval provides an important new personalized medicine for people with the life-threatening disease who have few treatment options.
Formerly an independent firm,Genentech became a member of Switzerland's Roche Group in March 2009.Considered the original biotech company,Genentech uses human genetic information to discover,develop,manufacture and commercialize medicines for gravely ill patients.
The Roche Group is traded on the over the counter pink sheets in the U.S.,under the ticker symbol RHHBY.

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)