Wednesday, January 5, 2005

GSK TO CO-PROMOTE ARIXTRA WITH ADOLOR

GlaxoSmithKline Plc signed a two-year agreement to co-market its anti-thrombotic agent Arixtra (fondaparinux sodium) in the United States with Adolor Corp.

Though financial terms have not been disclosed, Adolor said in a press release that GSK will reimburse the company for its costs associated with promoting Arixtra.

"Arixtra is an important medical option for the prevention and treatment of deep vein thrombosis and pulmonary embolism," said Kevin Lokay, vice president of GSK Oncology and Acute Care. "Aligning and integrating the Adolor and GSK sales forces will expand our reach with Arixtra while paving the way for future collaboration in the surgical market."

Adolor said it plans to hire 30 surgeon-focused sales representatives to work with GSK's sales team to co-promote Arixtra. Potentially, this combined sales team could promote Entereg (alvimopan) as well, Adolor said. Entereg is Adolor's investigational postoperative ileus therapy currently under review by the Food and Drug Administration. A decision on Entereg is expected in April.

Wednesday, September 15, 2004

IN BRIEF: THE AMERICAN COLLEGE OF CHEST PHYSICIANS

The American College of Chest Physicians released new guidelines for patients with thrombosis, which include a recommendation to use GlaxoSmithKline Plc's Arixtra (fondaparinux sodium) as a practical alternative to low-molecular-weight heparin. The drug also received "three of the strongest recommendations" for its use during the orthopedic procedures of hip and knee arthroplasty.

Monday, June 7, 2004

FDA APPROVES SANOFI-SYNTHELABO'S ARIXTRA FOR TWO NEW INDICATIONS

The Food and Drug Administration approved two new indications for Sanofi-Synthelabo's thrombosis prevention drug Arixtra (fondaparinux sodium).

The therapy is now approved for the treatment of acute deep venous thrombosis when administered in conjunction with warfarin sodium and for the treatment of acute pulmonary embolism in conjunction with warfarin sodium when initial therapy is administered in the hospital.

The approvals were based on results from two studies, according to a company statement. One open-label trial involved 2,213 patients with symptomatic pulmonary embolism and demonstrated a fixed once-daily subcutaneous dose of Arixtra 7.5 mg is at least as effective and safe as continuous intravenous and dose-adjusted unfractionated heparin (UFH). In addition, 15 percent of the participants received Arixtra on an outpatient basis after the first dose, compared with none in the UFH group.

In a separate study, which involved 2,205 patients with symptomatic deep venous thrombosis and without symptomatic pulmonary embolism, results showed that a once-daily 7.5 mg subcutaneous dose of Arixtra was at least as effective and safe as dose-adjusted low molecular weight heparin administered subcutaneously twice daily.

GlaxoSmithKline Plc is scheduled to acquire Arixtra from Sanofi-Synthelabo, but the transaction is dependent upon the successful acquisition of Aventis SA by Sanofi-Synthelabo, Reuters said.

Arixtra is already indicated for the prophylaxis of deep vein thrombosis.

Thursday, May 27, 2004

EU AUTHORITIES APPROVE GSK'S ACQUISITION OF TWO SANOFI THROMBOSIS DRUGS

The European Commission approved GlaxoSmithKline Plc's acquisition of Sanofi-Synthelabo's thrombosis pharmaceutical brands, Arixtra (fondaparinux sodium) and Fraxiparine (nadroparin) as well as a manufacturing facility in northern France, Dow Jones reported.

The two companies first announced the transaction, with an estimated value of $548 million, in April.

Dow Jones said Sanofi is divesting units to raise funds to pay for its recent takeover of Aventis SA. Meanwhile, GSK hopes to boost revenue throughout the next two years, when key drug patents will expire.

In 2003, sales of Arixtra were approximately $29.1 million and sales of Fraxiparine were $386.1 million.

Separately, Sanofi extended its U.S. takeover offer for Aventis from May 28 to June 30 as it waits for the French market authority to fix a closing date for Sanofi's improved offer.

Wednesday, April 14, 2004

GSK TO ACQUIRE GLOBAL RIGHTS FOR ARIXTRA, FRAXIPARINE FROM SANOFI IN $543.6 MILLION TRANSACTION

Sanofi-Synthelabo SA agreed to sell global manufacturing rights and a manufacturing facility for its Arixtra (fondaparinux sodium) and Fraxiparine (nadroparin) thrombosis therapies to GlaxoSmithKline Plc in an all-cash transaction valued at approximately $543.6 million, according to a Wall Street Journal report.

Sanofi's decision to sell the rights to the two blood thinners is a concession to antitrust authorities, according to the Journal, as the French firm attempts to take over Aventis SA, whose second-highest-selling product, Lovenox (enoxaparin), is also an anticoagulant.

A source familiar with Sanofi told the Journal that the U.S. Federal Trade Commission selected GSK as the "most qualified" purchaser among many interested parties, including Roche Holding AG.

In the agreement, GSK disclosed its intention to initiate clinical trials that could expand Arixtra's indications. Currently, the drug is only approved for use among patients undergoing hip fracture surgery or hip- or knee-replacement surgery.

The transaction is subject to approval of U.S. and European competition authorities.

Friday, June 20, 2003

CORRECTION

In the June 19 issue of Health Care Business Daily, FWI reported erroneous data about the Food and Drug Administration approval of a new indication for Sanofi-Synthelabo Inc. and Organon Inc.'s Arixtra (fondaparinux). Arixtra received a new indication for extended prophylaxis of deep venous thrombosis, which may lead to pulmonary embolism in hip fracture surgery patients. The drug is already approved for the prophylaxis of deep vein thrombosis.

Thursday, June 19, 2003

FDA APPROVES NEW INDICATION OF ARIXTRA

The Food and Drug Administration approved a new indication for Sanofi-Synthelabo Inc. and Organon Inc.'s Arixtra (fondaparinux) for the treatment of deep vein thrombosis that may lead to pulmonary embolism in hip fracture surgery patients, including extended prophylaxis, the companies said.

The therapy has already been approved for treating deep venous thrombosis potentially leading to pulmonary embolism in hip fracture surgery patients, hip replacement surgery patients and patients undergoing knee replacement surgery.

The FDA approval was granted after Arixtra was given a six-month priority review in March, the second such review the drug has received.

The regulatory agency examined data from a recent study in which hip surgery patients were treated with Arixtra 2.5 mg once daily for seven days, followed by three weeks of extended prophylaxis treatment.

Results showed that Arixtra was associated with a rate for venous thromboembolism events, or VTEs, of 1.4 percent as compared with a rate of 35 percent in patients treated with placebo. The rate of symptomatic venous VTEs was 0.3 percent for Arixtra as compared with 2.7 percent for placebo.

Arixtra is the only anti-thrombotic treatment in the United States indicated for the extended prophylaxis of deep venous thrombosis in patients who require hip fracture surgery, Sanofi-Synthelabo said in a statement.

Wednesday, June 11, 2003

EXTENDED ARIXTRA TREATMENT SIGNIFICANTLY REDUCES RISK OF DVT AND PULMONARY EMBOLISM IN HIP FRACTURE PATIENTS, STUDY SHOWS

Hip fracture patients treated with Organon N.V. and Sanofi-Synthelabo's Arixtra (fondaparinux) for four weeks are 96 percent less likely to develop deep-vein thrombosis and pulmonary embolism than patients administered the same treatment for one week, according to a new study.

The randomized study of 656 hip fracture patients was the largest of its kind to examine the benefits associated with four-week treatment with an antithrombotic to prevent DVT and pulmonary embolism after hip fracture surgery.

In the Phase III study, patients were administered a daily 2.5 mg dose of Arixtra following surgery for one week. Patients were then randomized to either continue receiving Arixtra treatment or to receive placebo for an additional 21 days.

Results showed that extending Arixtra treament for three weeks reduced the incidence of venous thromboembolism after hip surgery from 35 percent to 1.4 percent and the incidence of symptomatic venous thromboembolism from 2.7 percent to 0.3 percent.

Measures of venous thromboembolism included both proximal and distal DVT and pulmonary embolism.

"The results of Phase III studies in orthopedic surgery have demonstrated that [Arixtra] has superior efficacy compared with current low molecular weight heparin therapy and a prolonged period of treatment is beneficial in hip fracture patients," said Dr. Bengt Eriksson, orthopaedic surgeon at Sahlgrenska University in Ostra, Sweden.

"The effectiveness of [Arixtra] could change treatment strategies in patients undergoing orthopedic surgery where the risk of thromboembolic complications remains high for at least four weeks after surgery," he noted.