Monday, November 29, 2004

FDA REJECTS CONNETICS' SKIN TREATMENT EXTINA

The Food and Drug Administration issued Connetics Corp. a non-approvable letter for pharmaceutical brand Extina (ketoconazole 2%) in the treatment of seborrheic dermatitis.

The federal agency determined that Extina is not effective for seborrheic dermatitis because it was not superior to placebo foam in a Phase III trial, according to a Connetics press release. In the Phase III study, Extina demonstrated non-inferiority to Johnson & Johnson's Nizoral Cream (ketoconazole 2%).

"The FDA's decision is disappointing and surprising," said Connetics Chief Executive Officer Thomas Wiggans. "Based on discussions with the FDA regarding the requirements for the Phase III trial, we believe Extina met the study endpoints and that the New Drug Application was approvable."

Wiggans added that he expects any potential lost revenue for Extina in 2005 will be offset by expense savings since the company will not incur the planned commercialization costs for Extina.

However, as a result of the FDA letter, Connetics now expects its fourth-quarter revenue and earnings per share to be at the low end of its previous guidance ranges. The firm had projected revenue of $43 million to $46 million and earnings of $0.16 to $0.18 per diluted share.

Seborrheic dermatitis is a skin condition characterized by loose, greasy or dry scales, with or without associated reddened skin.

Shares of Connetics closed at $21.72, down $4.63, or 17.6 percent, in heavy trading on the Nasdaq. Tuesday, September 28, 2004 IN BRIEF: CONNETICS CORP. Connetics Corp. initiated a Phase III trial of Desilux (desonide 0.05%) for the treatment of atopic dermatitis in children aged 3 months to 17 years. Connetics plans to submit a New Drug Application to the Food and Drug Administration by the end of 2005 if the firm's Phase III program produces positive results. Friday, April 16, 2004 IN BRIEF: CONNETICS CORP. Connetics Corp. said it expects to earn between $0.02 and $0.03 per diluted share in the first quarter of 2004 compared with previous guidance predicting a net loss of $0.02 to $0.03 per share. The company anticipates receiving higher-than-expected royalty and contract revenue in addition to generating between $19.5 million and $20.5 million from sales of its Soriatane (acitretin) psoriasis treatment. Monday,

April 12, 2004

IN BRIEF: CONNETICS CORP.

Connetics Corp. announced that the Food and Drug Administration accepted the firm's New Drug Application for Extina (ketoconazole foam 2%) with a user fee goal date of Sept. 24. The investigational drug is a potential new treatment for seborrheic dermatitis and would be delivered via the company's proprietary VersaFoam delivery system.

Thursday, March 25, 2004 CONNETICS' VELAC EFFECTIVE AT TREATING ACNE, STUDIES FIND Connetics Corp.'s Velac gel (clindamycin 1% and tretinoin 0.025%) is superior to clindamycin or tretinoin gel alone for treating acne vulgaris, according to data released by the company.

The firm's two double-blind, placebo-controlled, Phase III studies involved a total of 2,200 patients with mild to moderate acne. The patients were treated with Velac, clindamycin gel, tretinoin gel or placebo once daily during a period of 12 weeks.

The trials had two primary efficacy endpoints--lesion count and the proportion of patients who were clear or almost clear of lesions at the end of treatment.

In patients treated with Velac, the mean reduction in total lesion count was 49 percent versus 38 percent in the clindamycin group, 40 percent in the tretinoin group and 23 percent among those who received placebo.

Additionally, 37 percent of Velac-treated patients were clear or almost clear of lesions at the end of the trials compared with 27 percent, 25 percent and 14 percent in the clindamycin, tretinoin and placebo groups, respectively.

Connetics said it plans to submit a New Drug Application for Velac, which combines the two most commonly used acne agents into one vehicle, during the third quarter of this year.

"The breakthrough formulation technology to stabilize the two active ingredients along with the significantly superior clinical results seen in the pivotal trials has the potential to result in a new paradigm in acne therapy," said Dr. Lincoln Krochmal, executive vice president of research and product development for Connetics.

Connetics licenses U.S. rights to Velac from Yamanouchi Europe B.V.

Friday, April 25, 2003

PHASE III TRIAL RESULTS SHOW CONNETICS' EXTINA MAY BE SUPERIOR TO NIZORAL FOR DERMATOLOGICAL TREATMENT

Connetics Corp.'s foam product Extina (ketoconazole) is not inferior to Johnson & Johnson's cream agent Nizoral (ketoconazole) in treating the fungal infection seborrheic dermatitis, according to Phase III study results.

In the four-week, placebo-controlled trial, the severity of the skin condition was assessed in 619 patients who were treated with Extina, Nizoral, a placebo foam or a placebo cream.

There was a 50 percent response rate among Extina-treated patients, a 44 percent response to Nizoral, a 40 percent response in the placebo foam group and a 26 percent response to the placebo cream.

Based on the improvement in signs of the disorder, such as scaling, erythema and plaque thickness, Extina produced a median improvement of 80 percent, while Nizoral resulted in 67 percent improvement. Placebo foam treatment resulted in 57 percent improvement, while placebo cream produced 54 percent improvement.

The Palo Alto, Calif. company said it intends to submit a New Drug Application to the Food and Drug Administration in the middle of this year.