Immunex启动大型 Enbrel 试验(下)
Immunex plans to begin RADIUS 2 in 2002 when additional supplies of Enbrel become available following completion of the company's new Rhode Island manufacturing plant later this year. Patients in RADIUS 2 likewise will be followed for 2 years.
Enbrel is the only TNF inhibitor approved for use either with methotrexate or as a stand-alone therapy. It also is the only TNF inhibitor approved for use as a first-line therapy for RA.
The drug acts by inhibiting the binding of TNF molecules to the TNF receptor (TNFr) sites. TNF is one of the dominant cytokines or regulatory proteins that play an important role in both normal immune function and the cascade of reactions that cause the inflammatory process of RA and psoriatic arthritis.
Immunex claims that it is enrolling approximately 1,000 new patients per week to receive Enbrel, which is for now being manufactured in limited quantities. The company is seeking indications for the drug in psoriasis and psoriatic arthritis.
Meanwhile, Merrill Lynch analyst Eric Hecht said in a research note on Monday that Immunex has been making efforts to ensure that there is enough Enbrel on hand to meet demand this year, even before completion of the Rhode Island facility. Those efforts include a deal with Gaithersburg, Maryland-based MedImmune to allow unused manufacturing capacity for MedImmune's Synagis to be used to produce Enbrel.
Both drugs are currently manufactured by Boehringer Ingelheim Pharmaceuticals. The agreement with MedImmune calls for Immunex to make a payment to MedImmune if unused capacity is used for Enbrel production.
Hecht said that he believes Immunex could have enough Enbrel supply in 2002 to support $1 billion in sales of the drug. The company estimates that Enbrel will generate $750 million in revenues this year. Sales of the drug in the second quarter reached $183 million.
In Monday trade on the NASDAQ, shares of Immunex rose 0.97 to close at 16.84, while MedImmune shares climbed 2.62 to close at 36.79. Shares of American Home dropped 0.38 on the New York Stock Exchange to close at 56.61., http://www.100md.com
Enbrel is the only TNF inhibitor approved for use either with methotrexate or as a stand-alone therapy. It also is the only TNF inhibitor approved for use as a first-line therapy for RA.
The drug acts by inhibiting the binding of TNF molecules to the TNF receptor (TNFr) sites. TNF is one of the dominant cytokines or regulatory proteins that play an important role in both normal immune function and the cascade of reactions that cause the inflammatory process of RA and psoriatic arthritis.
Immunex claims that it is enrolling approximately 1,000 new patients per week to receive Enbrel, which is for now being manufactured in limited quantities. The company is seeking indications for the drug in psoriasis and psoriatic arthritis.
Meanwhile, Merrill Lynch analyst Eric Hecht said in a research note on Monday that Immunex has been making efforts to ensure that there is enough Enbrel on hand to meet demand this year, even before completion of the Rhode Island facility. Those efforts include a deal with Gaithersburg, Maryland-based MedImmune to allow unused manufacturing capacity for MedImmune's Synagis to be used to produce Enbrel.
Both drugs are currently manufactured by Boehringer Ingelheim Pharmaceuticals. The agreement with MedImmune calls for Immunex to make a payment to MedImmune if unused capacity is used for Enbrel production.
Hecht said that he believes Immunex could have enough Enbrel supply in 2002 to support $1 billion in sales of the drug. The company estimates that Enbrel will generate $750 million in revenues this year. Sales of the drug in the second quarter reached $183 million.
In Monday trade on the NASDAQ, shares of Immunex rose 0.97 to close at 16.84, while MedImmune shares climbed 2.62 to close at 36.79. Shares of American Home dropped 0.38 on the New York Stock Exchange to close at 56.61., http://www.100md.com