1 August 2024,London,UK:US FDA expands Jemperli (dostarlimab) plus chemotherapy approval - oncology

The US Food and Drug Administration (FDA) has expanded its approval of Jemperli to all adult patients with primary advanced or recurrent endometrial (uterine) cancer as the first and only immuno-oncology based treatment to show an overall survival benefit.Jemperli approval now includes MMRp/MMS tumours,which represent a majority of endometrial cancer cases.Jemporli plus chemotherapy demonstrated a significant and clinically meaningful 31% reduction in risk of death versus chemotherapy alone.GlaxoSmithKline announced today that the FDA has approved Jemperli (dostarlimab) in combination with carboplatin and paditaxel (chemotherapy) followed by Jemperli as a single agent for adult patients with primary or recurrent endometrial cancer.Said Hesham Abdullah,Senior Vice President,Global Head Oncology,R and D,GlaxoSmithKline:We are thrilled this option is now available for more patients in the US,including the 70-75% with MMrp/MMS tumours whose treatment options have been limited.*Press release by GlaxoSmithKline and edited by Andrew Taylor*GlaxoSmithKline plc (LSE/NYSE:GSK)

Drug Companies Swap Units,Join Forces

Two pharma titans,GlaxoSmithKline and Novartis,are entering into a complex 25 billion dollar transaction.Novartis,based in Geneva,Switzerland,is buying GSK's oncology unit for 14.5 billion dollars;at the same time,Britain's GSK is buying Novartis' vaccine unit.Finally,the two firms are forming a joint venture that combines their over the counter drug businesses.
Today we announced we are focusing on our pharmaceutical,eye care,and generics businesses,said Novartis CEO Joseph Jimenez.We're gonna add probably one billion people on earth,and 50% of them will be over 50.It's gonna take innovation to deal with it.We've got these powerhouses that fit exactly with the demographic changes for the next 20 years-for example,GSK's two drugs for metastatic melanoma.
I believe increased technology is gonna allow new targets in cancer that we've never seen before.We're at the beginning of having new tools to combat this disease like never before.This deal with GSK changes the financial profile of Novartis,increasing our operating margin significantly.The whole portfolio review was to allow us to have great strength in that new world.I'll be able to feed these big engines a lot more.We're generating better leverage than we have in the past,explained Mr.Jiminez,who is an American.*
In addition,Novartis is selling its animal health business to Eli Lilly.Even when the deal with GSK is completed,Novartis will still be open to more bolt-on acquisitions that benefit its three lines of business.*
Novartis(NVS),Eli Lilly&Co(LLY),GlaxoSmithKline(GSK)

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)

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)

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)

Key Committee Recommends Lupus Drug Approval

On November 16,a key Food and Drug Administration committee recommended approval of Benlysta,the Human Genome Sciences/GlaxoSmithKline drug for the treatment of systemic lupus erythematosus.
The Arthritis Advisory Committee,which made the recommendation,provides the FDA with independent expert advice on rheumatology drug products such as Benlysta.Its nonbinding recommendation normally carries a great deal of weight in the FDA's deliberations.
Benlysta is the first new treatment expressly for lupus in 50 years.The vote to recommend approval was hailed by patient advocates as a sign of hope.Benlysta is also the first in a new class of drugs,the BLys-specific inhibitors.
Since 2006,Human Genome and Glaxo have been developing Benlysta together,with Human Genome having lead responsibility for conducting Phase 3 trials.The companies will share equally in development costs,sales,marketing expenses and any profits pending final FDA approval.Analysts consider Benlysta a prospective blockbuster,worth billions of dollars.
Lupus is a chronic inflammatory disorder most common in black,Hispanic and Asian women.It causes the immune system to attack the body's own organs and tissues,resulting in effects ranging from joint pain to kidney damage.The disease is potentially life-threatening.Like another autoimmune disorder,multiple sclerosis,lupus is hard to diagnose and varies from patient to patient.
Human Genome is located in Rockville,Maryland,and Glaxo is based in London,England.
Human Genome Sciences(HGSI),GlaxoSmithKline(GSK)

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)

Health Uncle:Businesses Asked to Prepare

The U.S. government is asking the business community to prepare now for what could be an autumn resurgence of the H1N1 virus,or swine flu.Businesses are being urged to administer the regular flu shot early this year,and to encourage vaccination of those at risk with the swine flu vaccine as soon as possible.At risk groups include pregnant women,younger workers and those with weakened immune systems.Businesses should also ask those with flu symptoms to stay home.Homeland Security Secretary Janet Napolitano said let's not play wait-and-see.We are asking the business community to be proactive.Should numerous workers fall ill,the economic impact would be substantial.Each business should develop unique contingency plans.
The government expects 45 million doses of swine flu vaccine,produced by GlaxoSmithKline,Novartis and others,to be available by mid-October.The vaccine is currently in clinical trials,some of them for children.One father remarked that his child might as well get the free trial shot now,rather than have to pay for it later.Two injections may be required,in addition to the regular flu vaccine.The pediatric trials are being held at 11 sites in 9 states.Each child gets a 40 dollar gift card for participating.
The World Health Organization is warning that the number of swine flu cases worldwide could double every three days for several months.The total could reach two billion cases.So far,more than 14,000 deaths from swine flu have been reported.