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)

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)