Posts Tagged ‘biopharmaceuticals’

Transcept Pharmaceuticals Inc. (TSPT) nearly doubles on drug review

Thursday, September 15th, 2011

Transcept Pharmaceuticals Inc. (Nasdaq: TSPT) shares rose 93.7% to $6.47 a day after the drug developer said U.S. regulators might finish a new review of its sleep drug within two months. Volume for the stock exceeded 3.8 million, towering above a daily average of only 235,000.

A news release out Sept. 14 noted that the company, headquartered in Point Richmond, Calif., plans to resubmit to the U.S. Food and Drug Administration (FDA) its New Drug Application (NDA) seeking approval of Intermezzo® (zolpidem tartrate sublingual tablet) for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

The plan to resubmit the Intermezzo® NDA results from a meeting today with the FDA during which the FDA generally agreed with a Transcept proposal to reduce the recommended Intermezzo® dose for women from 3.5 mg to 1.75 mg, and to keep the recommended Intermezzo® dose for men at 3.5 mg. The Transcept proposal also includes new instructions stating that Intermezzo® should only be taken if patients have at least four hours of bedtime remaining, and that patients should refrain from driving for at least one hour after arising and until five hours after dosing Intermezzo®.

In the same release, Transcept CEO Glenn A. Oclassen was quoted as saying “We are pleased that the FDA has expressed general agreement with our proposal to address the concerns expressed in the July 2011 Intermezzo® Complete Response Letter. We look forward to working with the FDA to complete the review of this important new treatment strategy for insomnia characterized by middle of the night awakening.”

Transcept is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience.

Vermillion Inc. (VRML) jumps on patent news

Wednesday, September 14th, 2011

Vermillion Inc. (Nasdaq: VRML) shares climbed 23.7% to $3.03 after the diagnostics company said it had been issued a patent called “serum biomarkers in lung cancer.” Volume for the stock totaled more than 826,000 shares, compared to an all-day average of less than 153,000.

A press release out Sept. 6 announced that the United States Patent and Trademark Office (USPTO) had issued to the Company patent number 8,014,952 for the serum.

Said Vermillion CEO Gail Page, “This patent highlights on-going progress in expanding our intellectual property portfolio. Beyond our core focus areas of ovarian cancer and peripheral artery disease, we now have patents in lung cancer, breast cancer, and Alzheimer’s disease. It is our goal to explore business opportunities to leverage this growing and valuable asset of the Company.”

Based in Austin, Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic tests that help physicians diagnose, treat and improve outcomes for patients.

Pharmasset Inc. (VRUS) jumps on drug findings

Tuesday, September 6th, 2011

Pharmasset Inc. (Nasdaq: VRUS) shares rose 5.2% to $67.55 after the drug developer released preliminary findings from a study of its Hepatitis C treatment. Volume for the stock was 658,000 shares, or about half its daily average.

A news release out September 6 noted that the Princeton, New Jersey-based company announced today sustained virologic response (SVR) results from its phase 2b PROTON study with PSI-7977 400 mg dosed once daily in combination with peginterferon alfa 2a and ribavirin (Peg-IFN/RBV) in subjects with hepatitis C virus (HCV) genotype 1 who have not been treated previously.

In all, 95 treatment-naive patients with HCV genotype 1 were enrolled into two open-label arms of the PROTON trial, receiving either PSI-7977 200 mg QD (N=48) or 400 mg QD (N=47) for 12 weeks. Individuals in both arms received Peg-IFN/RBV for 24 weeks and were followed post-treatment to assess SVR12.

What’s more, 26 subjects were enrolled in a placebo control arm and are receiving 48 weeks of Peg-IFN/RBV. Results from this study through the SVR12 endpoint are scheduled to be presented as part of a Presidential Plenary Session at the American Association for the Study of Liver Diseases (AASLD) meeting on Tuesday, November 8, 2011.

“I am very pleased with the results of this study which clearly demonstrate the benefit of the 400 mg dose of PSI-7977 with only 24 weeks of interferon for all subjects,” Dr. Eric Lawitz, the study’s principal investigator, was quoted in the release as saying. “HCV therapy is becoming overly complex, and the elimination of 24 weeks of interferon and ribavirin as well as all response guided criteria for patients with HCV genotype 1 would be a welcomed simplification.”

Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections.

DARA Biosciences Inc. (DARA) prospers from new pain drug

Thursday, August 18th, 2011

DARA Biosciences Inc. (Nasdaq: DARA) shares climbed 23.3% to $2.81, on word of a fast-tracking for its new pain drug. Volume for the stock topped 835,000 shares Thursday morning, crushing its all-day average of 28,000.

A news release out August 18 revealed that the Raleigh, North Carolina-based DARA announced today that its investigational drug KRN5500 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of chemotherapy-induced neuropathic pain in patients with cancer.

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address the unmet medical need (Fast Track Drugs). The purpose of the program is to get important drugs to the patient earlier.

New Drug Applications (NDA) for products in the Fast Track program normally receive priority review.

The same release quoted DARA CEO Richard Franco as saying, “the FDA Fast Track designation for KRN5500 is a significant positive step for the thousands of cancer patients who suffer this unremitting pain from a number of causes including from their chemotherapy.

“This is a most serious condition in need of new treatment options,” Franco continued. “Current estimates show as many as 40-50% of cancer patients receiving chemotherapy endure this condition and a certain portion of these patients endure relentless chronic pain requiring treatment even after they recover from their cancer. CIPN is also a dose limiting side effect of many commonly used chemotherapeutics. We are very encouraged by the initial clinical results, our partnership with the National Cancer Institute (NCI) and now the FDA Fast Track Drug status,” he added.

Icagen Inc. (ICGN) takes flight on hint of Pfizer takeover

Monday, June 27th, 2011

Icagen Inc. (Nasdaq: ICGN) shares rocketed 113.8% to $5.13 after drug manufacturer Pfizer Inc. (NYSE: PFE) said in a regulatory filing late Friday that it was looking at a possible strategic alliance with the biopharmaceutical company. Volume for Icagen totaled 1.8 million shares in the early trading hours of Monday, compared to an all-day average of 71,000.

A news release was issued soon after the market closed on Friday, June 24. In the release, Icagen put out a statement in which it acknowledged that it is currently engaged in preliminary discussions with Pfizer regarding a potential strategic transaction, but, quote “no definitive agreement has been reached.

“There can be no assurance that any agreement will be reached,” the statement continued, “or that a transaction will be consummated. Icagen does not plan to make future announcements with respect to this matter unless and until its Board of Directors has approved a specific transaction or an extension or other modification of the existing collaboration agreement and it has entered into a definitive agreement or the current discussions have terminated.”

Icagen, Inc. is a biopharmaceutical company based in Research Triangle Park, North Carolina, focused on the discovery, development and commercialization of novel orally-administered small molecule drugs that modulate ion channel targets. Utilizing its proprietary know-how and integrated scientific and drug development capabilities, Icagen has identified multiple drug candidates that modulate ion channels.