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December 23, 1998
Baltimore-based Guilford Pharmaceuticals Inc. said yesterday that it has received government regulatory approvals to market its Gliadel treatment for malignant brain cancer in Canada and France.The Canadian Health Protection Branch and the French Drug Agency approved Gliadel for use in treating glioblastoma multiforme, a rapidly growing and one of the most fatal forms of brain cancer.Gliadel is a thin, dime-sized wafer that is loaded with a potent anti-cancer agent. Surgeons implant the wafers into cavities left in the brain after surgery to remove tumors.
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BUSINESS
By William Patalon III and William Patalon III,SUN STAFF | November 9, 2004
Guilford Pharmaceuticals Inc.'s revenue more than tripled during its third quarter, thanks in part to accelerating sales of its brain-cancer treatment, although the accompanying boost in expenses resulted in a widening loss for the Baltimore biotechnology company. For the three months that ended Sept. 30, Guilford reported a net loss of $14.5 million, compared with a net loss of $13.3 million for the comparable quarter last year. On a per-share basis the loss was 33 cents versus 46 cents a year earlier, when the company had 14.5 million fewer shares outstanding.
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BUSINESS
By Julie Bell and Julie Bell,SUN STAFF | November 10, 2000
Guilford Pharmaceuticals Inc. said yesterday that its cancer therapy Gliadel proved effective in extending the lives of brain cancer patients who got it along with initial surgery. Average survival for those who received the Gliadel treatment was 13.9 months compared with 11.6 months for patients receiving a placebo. The company plans to use the information, obtained in tests involving 240 patients in 14 countries, in applying to the Food and Drug Administration for permission to expand the uses of Gliadel, its only product on the market.
BUSINESS
August 4, 2004
In the Region Port coal terminal operator loses bid for tax exemption A port of Baltimore coal terminal operated by Consolidation Coal Sales Co., now known as CNX Marine Terminals Inc., is not entitled to an exemption from the state's personal property tax, the Maryland Court of Appeals said in an opinion yesterday. A favorable ruling from the court would have meant a refund of more than $8 million in taxes and interest from Baltimore. Consolidation Coal, a subsidiary of Pittsburgh-based Consul Energy Inc. that stores, ships and blends coal, had appealed personal property tax assessments of as much as $13.4 million a year from 1997 through 2000, saying its blending process makes it eligible for a tax exemption available to manufacturers in Maryland.
BUSINESS
By Julie Bell and Julie Bell,SUN STAFF | November 2, 2002
Guilford Pharmaceuticals Inc. said yesterday that it has formally submitted additional data to the Food and Drug Administration to support expanded use of its only marketed product, the brain cancer treatment Gliadel. The Baltimore company hopes the data - which appears to show improved long-term survival for certain patients who get Gliadel - prompts the FDA to reverse its earlier decision to reject expanded marketing of the chemotherapy-packed wafer. Gliadel is implanted in the cavity left when a brain tumor is surgically removed.
BUSINESS
By Julie Bell and Julie Bell,SUN STAFF | February 27, 2003
Guilford Pharmaceuticals Inc. said yesterday that the Food and Drug Administration approved the use of its Gliadel wafer as a first-time treatment for malignant brain tumors, handing the Baltimore company a major victory after a series of hard-luck rejections that had shaken the faith of investors. The ruling, which came 11 months after the FDA had turned down the company's initial application for expanded use, will allow Guilford to market Gliadel to newly diagnosed brain cancer patients - a population that makes up at least two-thirds of the limited market for the treatment.
BUSINESS
By Julie Bell and Julie Bell,SUN STAFF | December 7, 2001
Gliadel, Guilford Pharmaceuticals Corp.'s chemotherapy-packed wafer, benefits patients who receive it during initial surgery for brain cancer, an expert panel that makes recommendations to the Food and Drug Administration found yesterday. The $10,500 surgically implanted wafer currently is approved for use only with a certain kind of aggressive brain tumor that has recurred, requiring a second surgery. FDA approval of its use in initial surgeries would roughly triple the market for Gliadel, which generated nearly all of Guilford's $5.9 million in third-quarter revenue.
BUSINESS
By Mark Guidera and Mark Guidera,SUN STAFF | October 27, 1998
Guilford Pharmaceuticals Inc. reported yesterday that it had a $6.9 million loss, or 35 cents per share, on revenue of $3.8 million in its third quarter, which ended Sept. 30.In the third quarter of 1997, the Baltimore-based company booked a net profit of $6.3 million, or 32 cents a share, on revenue of $16.6 million. That quarter's earnings were driven by a $15 million one-time payment from Amgen Inc. for signing a licensing agreement that gave it rights to develop and market drug compounds discovered by Guilford that may have potential for treating a wide range of neuro-degenerative diseases.
BUSINESS
By Timothy J. Mullaney and Timothy J. Mullaney,SUN STAFF | November 2, 1995
Guilford Pharmaceuticals Inc. of Baltimore said yesterday that a successful clinical trial of its brain cancer implant in Europe paves the way for the company to ask federal regulators for permission to use the product to treat more of the 20,000 patients who have brain cancer surgery annually in the United States.The results, if they lead to a broader U.S. regulatory approval of the company's chemotherapy substitute, would expand the commercial potential of a product that analysts predict will make the 2-year-old biotech firm profitable by 1997 or 1998.
BUSINESS
By Mark Guidera and Mark Guidera,SUN STAFF | August 5, 1997
Guilford Pharmaceuticals Inc. yesterday reported a net loss of $5.3 million, or 29 cents a share, for its second quarter, compared with a net profit of $2.8 million, or 18 cents a share, in the corresponding period last year.The Baltimore bio-pharmaceuticals company said last year's profit for the three months ended June 30 was the result of a payment of $7.5 million from Rhone-Poulenc Rorer for the rights to market Gliadel, a chemotherapy-loaded implantable wafer for the treatment of brain cancer following surgery.
BUSINESS
By William Patalon III and William Patalon III,SUN STAFF | May 18, 2004
Guilford Pharmaceuticals Inc. has signed a licensing deal to distribute its Gliadel brain-cancer therapy in Europe, an agreement that could generate up to $2.5 million in fees and royalty payments while helping the Baltimore company boost its presence in that overseas market. In its announcement yesterday, Guilford said it had granted United Kingdom-based Link Pharmaceuticals Ltd. exclusive rights to market Gliadel in Germany, France, Belgium, the Netherlands, Luxembourg, Austria and Switzerland.
BUSINESS
By Julie Bell and Julie Bell,SUN STAFF | February 27, 2003
Guilford Pharmaceuticals Inc. said yesterday that the Food and Drug Administration approved the use of its Gliadel wafer as a first-time treatment for malignant brain tumors, handing the Baltimore company a major victory after a series of hard-luck rejections that had shaken the faith of investors. The ruling, which came 11 months after the FDA had turned down the company's initial application for expanded use, will allow Guilford to market Gliadel to newly diagnosed brain cancer patients - a population that makes up at least two-thirds of the limited market for the treatment.
BUSINESS
By Julie Bell and Julie Bell,SUN STAFF | February 14, 2003
Guilford Pharmaceuticals Inc. said yesterday that its fourth-quarter loss widened to $15.1 million as sales of its Gliadel brain-cancer treatment fell. The Baltimore company said the loss, equivalent to 50 cents per share, expanded from $13.8 million, or 46 cents per share, in the 2001 quarter. Revenue plummeted to $1.6 million from $6.8 million after buyers, who had overstocked Gliadel earlier in the year, let inventories fall back in line with demand. Analysts had expected even worse results, predicting a loss of 59 cents a share, according to the average estimate of five analysts surveyed by Thomson Financial/First Call.
BUSINESS
By Scott Banerjee and Scott Banerjee,SUN STAFF | December 4, 2002
David P. Wright, Guilford Pharmaceuticals Inc.'s president and chief business officer, said yesterday that he is leaving the Baltimore-based company after two years. Wright's sales responsibilities will be taken over by Michael Kelly, formerly of ViroPharma Inc., who will become vice president of sales and marketing. A Guilford spokeswoman said Craig R. Smith, chairman and chief executive, will also assume the role of president. Wright joined Guilford as vice president of sales and marketing in November 2000 from Gaithersburg-based MedImmune Inc., where he helped oversee sales of Synagis, that company's hugely successful infant respiratory drug.
BUSINESS
By Julie Bell and Julie Bell,SUN STAFF | November 7, 2002
Guilford Pharmaceuticals Inc. said yesterday that its third-quarter loss widened to $14.6 million, a result largely of a layoffs-related charge and a decline in sales of its Gliadel treatment for brain cancer. The company's results were better than analysts had expected. The Baltimore company said its third-quarter revenue, nearly all of which came from Gliadel, fell to $3.3 million from $5.9 million a year earlier. Guilford described use of Gliadel by brain-cancer patients as "flat," but Chief Executive Officer Craig R. Smith said sales to distributors rose in last year's third quarter as the company stockpiled the chemotherapy-packed wafer on the incorrect assumption that the Food and Drug Administration was about to approve expanded use of it. Guilford said the loss amounted to 49 cents a share.
BUSINESS
By Julie Bell and Julie Bell,SUN STAFF | November 2, 2002
Guilford Pharmaceuticals Inc. said yesterday that it has formally submitted additional data to the Food and Drug Administration to support expanded use of its only marketed product, the brain cancer treatment Gliadel. The Baltimore company hopes the data - which appears to show improved long-term survival for certain patients who get Gliadel - prompts the FDA to reverse its earlier decision to reject expanded marketing of the chemotherapy-packed wafer. Gliadel is implanted in the cavity left when a brain tumor is surgically removed.
BUSINESS
By Julie Bell and Julie Bell,SUN STAFF | November 7, 2001
Guilford Pharmaceuticals Inc. said yesterday that its third-quarter loss grew to $13.8 million despite a more than 20-fold increase in revenue from its chemotherapy-packed Gliadel wafer for brain cancer. The Baltimore-based company, rocked by Amgen Inc.'s recent decision to quit a drug-licensing deal under which Guilford stood to gain millions, also said it would narrow its research focus to cut costs. For the quarter, the company's quarterly loss amounted to 46 cents a share on revenue of $5.9 million.
BUSINESS
By William Patalon III and William Patalon III,SUN STAFF | May 18, 2004
Guilford Pharmaceuticals Inc. has signed a licensing deal to distribute its Gliadel brain-cancer therapy in Europe, an agreement that could generate up to $2.5 million in fees and royalty payments while helping the Baltimore company boost its presence in that overseas market. In its announcement yesterday, Guilford said it had granted United Kingdom-based Link Pharmaceuticals Ltd. exclusive rights to market Gliadel in Germany, France, Belgium, the Netherlands, Luxembourg, Austria and Switzerland.
BUSINESS
By Julie Bell and Julie Bell,SUN STAFF | May 10, 2002
Guilford Pharmaceuticals Inc. said yesterday that its first-quarter loss narrowed as sales of its Gliadel treatment for brain cancer grew. The Baltimore-based company also told investors in a conference call that it was discontinuing development of its Lidomer treatment for post-surgical pain and narrowing the focus of its efforts to develop the cancer treatment Paclimer as part of cost-cutting moves. Guilford reported a net loss of $13.5 million, or 45 cents a share, on revenue of $6.2 million.
BUSINESS
By Julie Bell and Julie Bell,SUN STAFF | March 21, 2002
Guilford Pharmaceuticals Inc. said yesterday that the Food and Drug Administration had rejected its request to expand the use of its Gliadel brain-cancer treatment, providing the latest setback for the company and pushing its shares down 15 percent. The stock of the Baltimore-based company traded as low as $6.50 yesterday before rallying to close at $8.14 on the Nasdaq stock market, down $1.49 for the day. The closing price, a six-month low, left the stock nearly 45 percent below its six-month high of $14.76 on Nov. 20. Chief Executive Officer Craig R. Smith said in a conference call that Guilford is seeking a meeting with the FDA about the agency's decision to reject the use of Gliadel in initial brain-cancer surgeries.
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