New Drug Application

ALSO NOTED: Adolor shares rise on NDA news; Indevus plans Phase III; Exelixis earns milestone; and much more...

Thu, 29 Nov 2007 06:59:50 -0500

> Shares of Adolor surged on the news that the FDA's Gastrointestinal Drugs Advisory Committee will review the new drug application for the pain drug Entereg on Jan. 23. Report

> Backed by a fresh batch of positive, mid-stage data for its experimental therapy to treat a rare hormone condition, Indevus says it will launch Phase III by mid-2008. Release

> Exelixis has earned a $5 million milestone payment from Bristol-Myers Squibb. Report

> Belgium's Galapagos wins up to $2.4 million in upfront fees and research funds in a development deal with Cystic Fibrosis Foundation Therapeutics. Up to $5.7 million in milestones is also on the table. Report

> Protein therapy company Medgenics has raised £3.28 million from a share placing with investors. Report

> AstraZeneca got a bit of a windfall today from the FDA, which granted six extra months of exclusive marketing rights to its Arimidex cancer drug. Report

> New warnings and warning recommendations are flying out of the FDA this week like geese flying south for the winter, partly because of an FDA advisory panel is meeting. Report

> Talk about an outpouring of adverse-event reports. After WFAA-TV in Dallas reported musician Carter Albrecht's violent death--perhaps under the influence of Pfizer's smoking-cessation drug Chantix--more than 5,000 complaints about the med's side effects poured into the FDA. Report

And Finally… Hospital superbugs that can break down antibiotics are so widespread throughout Europe that doctors increasingly have to use the few remaining drugs that they reserve for emergencies. Release

ALS sees strong data in Phase III antibiotic trial

Thu, 15 Nov 2007 06:59:54 -0500

Advanced Life Sciences is touting data from a recent trial of its antibiotic cethromycin. The therapy produced positive data that it can fight pneumonuia effectively and safely and demonstrated an ability to combat the MRSA superbug as well. ALS officials told the Chicago Tribune that the data was good enough to pursue FDA approval. In the trial, cethromycin essentially matched the efficacy of a standard of care in fighting community-acquired pneumonia. Flavin added that the company planned an NDA next year with marketing to commence in 2009.

"We are very excited to have met all of our endpoints in Trial CL-05, and we are pleased to have successfully completed the clinical development program of cethromycin. The results attained in this trial, along with the positive results achieved in Trial CL-06 reported in June of this year, will form the core of our New Drug Application submission and positions us well with prospective commercial partners," said Dr. Michael Flavin, chairman and CEO of Advanced Life Sciences.

- see the release for more
- here's the report from the Chicago Tribune

Related Articles:
Advanced Life Sciences raises $36M. Report
Clues shed light on fighting lethal MRSA strain. Report

MediQuest touts Phase III Raynaud's data

Fri, 09 Nov 2007 06:59:57 -0500

MediQuest Therapeutics is reporting positive results from a Phase III trial of MQX-503, a topical therapy for Raynaud's Disease. Raynaud's--a stinging constriction of blood flow to hands, feet and other extremities that affects mostly women--has an estimated market potential of more than $300 million. Patients taking MQX-503 showed significant improvements in their condition.

"With the conclusion of this clinical study, MediQuest is one step closer to submitting the MQX-503 New Drug Application to the FDA," said Dr. Frederick Dechow, MediQuest president and CEO. "Our proprietary drug delivery technology provides a unique platform to deliver active therapeutic agents to specific problem areas. MQX-503 is a new therapy specifically designed to treat this unmet clinical need."

- check out the release from MediQuest
- see this Emerging Drug Developer profile for more

Positive Phase III results for Cephalon's Treanda

Wed, 24 Oct 2007 06:59:57 -0400

Cephalon is touting Phase III results of its non-Hodgkin's lymphoma drug Treanda. In the trial, 100 patients who were not responding to Genentech and Biogen Idec's Rituxan were given Treanda. The overall response rate was 75 percent and the median duration of response was 40 weeks (9.2 months). The study met its primary endpoints of overall response rate and median duration of response, while demonstrating a manageable tolerability profile.

"We are encouraged that these results replicate those seen in our Phase 2 study, confirming the substantial efficacy in this difficult to treat population," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "Based on these positive results, we are on track to file a New Drug Application in the fourth quarter for Treanda in patients with indolent NHL who have failed treatment with rituximab." Treanda is also being studied as a treatment for chronic lymphocytic leukemia.

- see this release for more

PLUS: Anthera Pharmaceuticals has reported positive results from a Phase II clinical trial of its first compound, A-002, for the treatment of cardiovascular disease. Release

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Cephalon takes heat for off-label narcotic promotion. Report
Cephalon shares tank after Sparlon rejection. Report

Wyeth's reports strong Phase III bazedoxifene data

Thu, 20 Sep 2007 06:59:56 -0400

At the American Society for Bone and Mineral Research Annual Meeting, Wyeth presented strong Phase III data for its osteoporosis drug. Bazedoxifene 20 mg and 40 mg significantly reduced the risk of new vertebral fractures by 42 percent and 37 percent, respectively, in a three-year study. Bazedoxifene has already been submitted to the FDA and is awaiting final approval. Earlier this year, Wyeth received an FDA approvable letter for bazedoxifene for the prevention of postmenopausal osteoporosis. In July 2007, Wyeth submitted a separate new drug application to the FDA for bazedoxifene for the treatment of postmenopausal osteoporosis. This new data comes as much-needed good news for Wyeth, which has struggled with its drug development programs as of late.

- see Wyeth's release for more on bazedoxifene

Related Articles:
Wyeth stumbles badly trying to develop new drugs. Report
Wyeth stock down after several setbacks. Report
Novartis drug cuts hip-fracture deaths. Report

GSK nixed on Advair application

Wed, 08 Aug 2007 06:59:54 -0400

Analysts were surprised to hear that GlaxoSmithKline was handed a "not approvable" letter for the supplemental drug application for the 500/50 strength of Advair Diskus for patients with chronic obstructive pulmonary disease. The company expressed surprise as well.

"The FDA questioned how Advair 500/50 compared to the currently approved 250/50 strength in order to allow for appropriate dosing recommendations," says the company's statement. "GSK will be meeting with FDA to discuss this request in more detail and determine next steps, including discussion of data GSK has recently generated on the reduction of exacerbations with the Advair 250/50 strength."

- check out the release on the rejection

Related Articles:
Advair fails to hit goal in COPD trial. Report
New research highlights dangers of bronchodilators. Report

ALSO NOTED: Osgood promoted at ThermoGenesis; ImClone expects CEO announcement; OVATION expands pipeline; and much more...

Tue, 31 Jul 2007 06:59:50 -0400

> ThermoGenesis has promoted COO William Osgood to the CEO's post. The transition was triggered by founder Phil Coelho's move to the new position of chief technology architect. Report

> ImClone said it expects to name a new CEO within a month as net income slid on flat revenue. Report

> Ovation Pharmaceuticals has expanded its central nervous system development pipeline with the initiation of a pivotal clinical trial to support a new drug application of intravenous carbamazepine in adult patients with epilepsy. Release

And Finally... A new study attempts to explain what motivates feelings of guilt. Report

SPOTLIGHT: Stiefel wins FDA OK

Tue, 17 Jul 2007 06:59:53 -0400

Stiefel Laboratories announced that the FDA has approved its new drug application for Extina Foam, 2 percent for the treatment of seborrheic dermatitis. The approval, which the company received June 12, clears the way for the product to be sold and marketed in the United States. Release

Arpida shares soar on late-stage superbug data

Mon, 16 Jul 2007 06:59:58 -0400

Shares of Switzerland's Arpida soared more than 25 percent this morning after the company announced that its superbug drug iclaprim performed as well as a competing drug from Pfizer in a late-stage trial. Arpida says that a regulatory filing for the therapy--designed to fight MRSA and other tough infections--is on track for later this year.

"We look to discuss the data with the regulatory authorities to define the path forward for the filing of a New Drug Application which we expect to take place in the course of this year," said Arpida CEO Khalid Islam.

- for more on the data, see this release
- here's the Dow Jones report on the study

Related Articles:
Study finds alarming spread of MRSA. Report
MRSA-CA danger to healthcare workers. Report

Momenta sees delay in generic Lovenox development

Thu, 28 Jun 2007 00:01:38 -0400

Shares of Momenta took a hit after the company warned that its development of a generic version of Sanofi's blood thinner Lovenox is likely to take longer than expected. Shares slid 15 percent on the news that the regulatory review of its abbreviated new drug application would take longer than the 18 to 24 months originally expected. Momenta is developing M-Enoxaparin with Sandoz, the generic arm of Novartis. Momenta is considered one of the key players in the development of a new generation of follow-on biologics. Sanofi has argued that its blockbuster Lovenox is too complex to be copied. But a judge opened the door to a competing therapy last February with a ruling invalidating the patent on the injectable. Momenta is competing with Amphastar Pharmaceuticals and Teva to do just that.

- read the AP report on Momenta's worries

Analysis: A bipartisan group of Senators is forming to back a new bill that would grant four years of exclusive sales to a biologic before it faced generic competition. The bill also would allow follow-on drugs to be marketed as interchangeable and that generic developers would have to mount at least one clinical trial for approval--with a proviso that the FDA could waive that requirement. Report

Related Articles:
Sanofi loses Lovenox patent protection. Report
Lovenox reduces cardio risks but can cause bleeding. Report
Sandoz takes big stake in Momenta. Report