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)

Pfizer Breast Cancer Drug Gets Breakthrough Designation

A Pfizer investigational compound,palbociclib,an oral drug,has received Breakthrough Therapy designation by the FDA for the potential treatment of patients with a form of breast cancer.The designation expedites the development and review of the compound,as it is intended to treat a serious or life-threatening disease and preliminary evidence indicates the drug may demonstrate substantial improvement over existing therapies.
Pfizer has initiated a Phase 3 study evaluating palbociclib in combination with letrozole versus letrozole alone as a first line treatment for post-menopausal patients with ER+,HER2- locally advanced or metastatic breast cancer.The study is currently open and enrolling.
Preliminary Phase 2 data show that women treated with the combination of palbociclib with letrozole achieved statistically significant improvement in median survival compared to those treated with letrozole alone(26.1 months versus 7.5 months.)
Palbociclib is an inhibitor of cyclin dependent kinases,or enzymes that serve as on and off switches in tumour cells.The drug was shown to inhibit cell growth and supress DNA replication.Pfizer,the world's largest pharmaceutical company,is also investigating the drug's potential for treating other cancers.
Pfizer(PFE)

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)

Pfizer's New Rheumatoid Arthritis Pill Approved

Pfizer's new rheumatoid arthritis(RA) drug XELJANZ(R) has gotten FDA approval for adults with moderate to severe RA who had a poor response to methotrexate.It is the first RA treatment approved in a new class of medicines called JAK inhibitors,and the first new oral disease-modifying anti-rheumatic drug(DMARD) approved in more than 10 years.
The new pill was approved for a 5mg twice daily dosage.It may be used alone or in combination with methotrexate or other non-biologic DMARDs.
Xeljanz is a second-line medication,meaning that pre-treatment with a biologic is not required.It is an important new option that could potentially change the way rheumatologists treat this serious autoimmune disease,according to Pfizer CEO Ian Read.The discovery and development of Xeljanz by Pfizer scientists reflects our commitment to R and D innovation and our dedication to bringing important and meaningful medications to patients.
Xeljanz is specifically designed to inhibit JAK pathways,which are signaling pathways within the cell that play an important role in RA inflammation.Many patients do not adequately respond to,or are intolerant of,currently available RA treatments,said Stanley Cohen,MD,study investigator.Xeljanz significantly reduced the signs and symptoms of RA and improved physical function.
Possible side affects include increased risk of certain infections and cancers,as the drug changes the way the immune system works.
Pfizer(PFE)

Pfizer Leukemia Pill Approved

Pfizer,the world's largest pharmaceutical company,has announced FDA approval of its new oral medication BOSULIF(R) for adults previously treated for chronic myelogenous leukemia,or CML,with the Philadelphia chromosome abnormality.There will be an estimated 5400 cases of CML diagnosed in 2012,resulting in 610 deaths.
Bosulif is described as an important new addition to the CML treatment landscape by a Pfizer lead investigator,Jorge Cortes,MD,professor of medicine at the University of Texas MD Anderson Cancer Care Center in Houston and Chief,CML Section,Department of Leukemia.Bosulif is one of a series of CML drugs called tyrosine kinase inhibitors that inhibit production of the tyrosine kinase enzyme by the bone marrow.They are based on a better understanding of the molecular basis of CML.
In clinical trials,about 55% of patients previously treated with other CML drugs returned to normal blood counts within the first 48 weeks of treatment with Bosulif,with a major response to treatment of at least 18 months.Novartis' GLEEVEC(R) is one of the main first line treatments for CML.
Up to 26,000 Americans are living with CML today.An unmet need remains for many CML patients,Dr.Cortes pointed out.Bosulif offers a distinct adverse event profile and a convenient once-daily dosing regimen,said Marc Rothenberg,MD,Pfizer vice president of Clinical Development and Medical Affairs.
Although it cannot be described as being a cure,Bosulif is indeed another step forward in the treatment of chronic myelogenous leukemia.
Pfizer(PFE),Novartis AG(NVS)

USC Norris Doctors Advance Cancer Research

A number of physician researchers from the USC Norris Comprehensive Cancer Center in Los Angeles were collaborators on more than 70 research projects presented at the 2012 annual meeting of the American Society of Clinical Oncology.About 30,000 oncologists from around the world attend the meeting to review the latest developments in their field.Advances in the treatment of cancer and patient care were set forth in more than 4500 abstracts presented or published at the gathering.Topics of the papers included targeted therapy;clinical trial results for a wide rage of cancers;and patient quality of life.The meeting took place at McCormick Place in Chicago from June 1-5.
One of the more promising studies presented was collaborated on by Heinz-Josef Lenz,associate director for clinical research and co-leader of the gastrointestinal cancers program at the USC Norris CCC.It was an international phase III trial of regorafenib,a candidate drug that has been found to significantly improve overall survival in metastatic colorectal cancer patients who are unresponsive to other approved therapies.It is believed that the drug,pending FDA approval,will raise the standard of care for these patients.
Regorafenib is an oral drug developed by Bayer AG.Its stock trades on the OTC pink sheets in the U.S. under the ticker symbol BAYRY.The company is well known as the maker of Bayer aspirin products.Indeed,Bayer AG was the first producer of aspirin tablets.

Commentary:The Primatene Mist Controversy Still Swirls

The Primatene Mist controversy is far from over.People are genuinely suffering from the withdrawal of this effective respiratory band-aid from the market by the FDA at the end of 2011.What is clear is that no one knows just when a reformulated product will be available.It apparently must be subjected to the full FDA approval process,including patient trials.That could take years.What is more,you're starting from a baseline of professional reservations about the product to begin with.Allergists point out that Primatene only treats symptoms of a potentially life-threatening disease.They do not regard it as a sufficient approach to dealing with asthma.Such a complex and dangerous ailment requires a personal,formal treatment plan drawn up and supervised by medical professionals.Inhaling Primatene often masks the real problem of chronically inflamed lungs which are sustaining damage over time from the underlying condition,bronchial asthma.That is why the National Institutes of Health doesn't recommend use of Primatene.It is considered to be an easy way out that has serious long term consequences for the patient's health.That being said,the lack of adequate health care for the poor and underserved,including those in rural areas,has been once again pointed up by the withdrawal of Primatene,a medication which is really only appropriate for those with occasional,mild asthma.It also illustrates a degree of bungling and foot-dragging on the part of both regulators and industry,who failed to come up with an entirely satisfactory substitute propellant in time.Some interesting articles by other authors on this topic have been posted below.Rest assured,this blog will stay on this very important case.

Focus on Pharma:Drugmaker Looks To Pipeline,Divestitures

In its recent earnings report,Pfizer,the world's largest pharmaceutical company,posted 6% profit growth on cost-cutting and share buybacks.Sales declined 5% on patent expirations of cholesterol drug Lipitor and others taking effect.
Despite the loss of patent protection,Pfizer isn't giving up promoting its cardiovascular blockbuster.Lipitor is still being marketed with a 4 dollar copay card and television advertising.Sales of the drug dropped 40% in Q4 when its patent expired.The company says it hasn't yet decided whether the ad campaign will continue long term.Liptior was advertised on television more than any other prescription drug last year.
Pfizer has promising new drugs in its pipeline,such as lung cancer treatment Xalkori,rheumatoid arthritis drug tofacitinib,and atrial fibrillation medicine Eliquis.
Eliquis was granted priority review by the Food and Drug Administration.Morninstar Associates projects an 80% chance of approval for the medicine,with a potential for 3 billion dollars in sales.Profits from it would be shared with Bristol-Myers Squibb.
Pfizer continues its aggressive cost-cutting,and is well on the way to its goal of 4 billion dollars annually.The company is expected to finalize the divestiture of its animal health and nutritional segments later in 2012.Morningstar values these businesses at 11 and 7 billion dollars,respectively,says Damien Conover,CFA,Associate Director at Morningstar.
Pfizer(PFE),Bristol-Myers Squibb(BMY)

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)

Asthma Med Primatene Mist Being Reformulated

Because its propellant is a chloroflourocarbon,Primatene Mist is being reformulated by Armstrong Pharmaceuticals.As of December 31,2011,the Food and Drug Administration is banning the production and sale of epinephrine metered dose inhalers containing CFCs to protect the atmosphere's ozone layer.
Primatene Mist,introduced in 1964,is the only inhalable over the counter medication for the temporary relief of occasional symptoms of bronchial asthma.Although Primatene Mist will have a new,non-CFC propellant,its active ingredient will remain epinephrine.
Primatene Mist relieves wheezing,tightness of chest and shortness of breath in as little as 15 seconds.It is the number one OTC brand for physician-diagnosed bronchial asthma.
The Primatene brand is also applied to OTC tablets,sold since 1954,which ease breathing for asthma patients by reducing spasms of bronchial muscles,loosening phlegm and thinning bronchial secretions.Highly regarded by patients,Primatene tablets are a product of Pfizer Consumer Healthcare and have different active ingredients than Primatene Mist.
Pfizer(PFE)

Pfizer Acquires Biotech Firm

Pfizer,a world-leading drug producer and marketer,is to acquire FoldRx,a privately held company that specializes in innovative oral medicines to treat diseases caused by protein misfolding.Protein misfolding is increasingly considered an underlying cause of many chronic degenerative conditions.FoldRx's main candidate,tafamidis,is registered as an oral therapy for TTR amyloid polyneuropathy,or ATTR-PN,a progressively fatal genetic neurological disorder.The biotech firm has filed a marketing application for tafamidis with the European Medicines Agency,and the drug has been fast-tracked by the FDA.
To this point,only liver transplants have been available to treat ATTR-PN.Liver transplants are not uniformly effective and are often fatal in their own right.At least 8,000 patients worldwide have ATTR-PN,most of them in the European Union.
TTR is a liver protein that,when defective,gets lodged in peripheral nerve tissue,causing neurological disorders such as ATTR-PN.
FoldRx's small molecule therapeutics,based on proprietary expertise,are also being applied to a discovery program in cystic fibrosis,Parkinson's and Huntington's diseases.Pfizer sees the acquisition of FoldRx as a way to bolster its rare disease portfolio and assist the patients with its medical,administrative,manufacturing and marketing proficiencies.
Pfizer(PFE)

Lupus Drug Made Priority

The FDA has granted a priority review designation to the lupus drug Benlysta,a joint project of Human Genome Sciences and its partner GlaxoSmithKline.Benlysta is the first medicine for systemic lupus erythematosus,the most common form of the disease,to complete Phase 3 trials with positive results,said Dr.Carlo Russo,Senior Vice President,Biopharm Development with GSK.The priority review designation is given to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists.European marketing authorization is also being sought for Benlysta.
Lupus is an autoimmune disease that is most common among women of Asian,African or Hispanic heritage.It is a chronic inflammatory disorder caused by the body's immune system attacking its own organs and tissues.Like multiple sclerosis,lupus has a wide variety of symptoms and is difficult to diagnose.Most cases are mild with episodic flare-ups.Symptoms range from fatigue and fever to joint pain and skin lesions.Lupus can be fatal,damaging the kidneys,causing atherosclerosis,or hardening of the arteries,and possibly even the cancer non-Hodgkin's lymphoma.The American College of Rheumatology has compiled a checklist of 11 clinical and laboratory criteria to assist with diagnosis.
HGSI and GSK entered into a co-development and commercialization agreement for Benlysta in 2006.They will share equally in development costs,sales,marketing expenses and profits,pending approval.
Human Genome Sciences is based in Rockville,Maryland and GlaxoSmithKline is a British firm.
Human Genome Sciences(HGSI),GlaxoSmithKline(GSK)