priority

Committee votes to back GSK/Ligand's Promacta

Mon, 02 Jun 2008 06:59:57 -0400

GlaxoSmithKline and Ligand Pharmaceuticals won a key endorsement for Promacta for the short-term treatment of people with chronic immune thrombocytopenic purpura, or ITP. An FDA expert committee voted unanimously to back the drug and a formal decision is expected June 19. The news on Friday provided a big boost to Ligand shares, which shot up almost 50 percent. The rise came after a big loss last week after FDA staffers raised doubts about the drug's ability to significantly lower bleeding.

The decision in favor of the drug came despite concerns that the developers have yet to produce a significant amount of data on the effects of the drug over a long period of use. That's likely to be a key concern for regulators, as ITP is a chronic condition. Glaxo, though, said it has more studies in the works and plans to file additional data later this year.

- here's the release
- read the Wall Street Journal's report
- check out the AP story

Talecris' antibody drug gets priority review

Fri, 09 May 2008 06:59:54 -0400

The FDA has granted priority review to Talecris' drug Gamunex, meaning the FDA will review its application in six months rather than the standard 10. Gamunex is an IGIV therapy that contains antibodies purified from the donated blood plasma of thousands of people. It's already approved to treat one autoimmune disease, and bring in about $650 million a year. The company is now pursuing an indication for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a rare neurological disorder in which patients suffer from weakness and impaired sensory function in the legs and arms. Gamunex previously received fast track and orphan drug status.

- here's the Talecris release
- read this report for more

Related Article:
Talecris backers design a $1 billion IPO

Alpharma withdraws painkiller NDA

Tue, 22 Apr 2008 06:59:57 -0400

Alpharma has withdrawn its NDA for Embeda, its extended-release painkiller. While the company's drug qualified for priority review, Alpharma said that "certain technical issues around data presentation" prevented the FDA from evaluating the drug in the six month review time. There were no details on exactly what those technical issues were. Alpharma said it plans to quickly resolve the issues, re-submit the NDA and launch the drug in the first quarter of 2009.

In its most recent Phase III trial, Embeda demonstrated significant pain relief. The painkiller is designed to be effective when taken as directed, but if tampered with by a drug abuser, the feeling of euphoria is dampened.

- see Alpharma's release

Celgene CEO outlines future plans, post-Pharmion buyout

Fri, 14 Mar 2008 07:59:56 -0400

In an interview with the Star-Ledger, Celgene CEO Sol Barer laid out some of the basics in how it will integrate operations with Pharmion, a biotech Celgene paid $2.9 billion for. After some consolidation, he says, the combined company will have operations around the globe. And while he expects some new collaboration deals with other developers, don't look for anything too big in the near term.

"A lot of these (deals) are driven by specific opportunities that often are difficult to predict," says Barer. "There will be a period of time subsequent to the Pharmion acquisition where a lot of integration will go on. While that will not affect the smaller deals, it probably will affect the larger collaborations, which would be a lower priority while we're integrating the new company."

- check out the Q&A from the Star-Ledger

Prasugrel gets priority review

Fri, 22 Feb 2008 06:59:56 -0500

The FDA has granted priority review to Eli Lilly and Daiichi Sankyo's prasugrel, an anti-clotting drug. The NDA for prasugrel was submitted to the agency in December. Now the drugmakers can expect an FDA ruling in just six months, rather than the 10 months is usually takes for a drug to receive approval. Lilly has a lot riding on prasugrel's approval, as many industry watchers say the company has no other blockbuster hopefuls in its pipeline. Both companies' shares rose on the news.

"We are greatly pleased to learn that the FDA has determined the application meets its criteria for such a review, and we look forward to working with the agency as it continues its review process," said Dr. J. Anthony Ware, Lilly vice president for cardiovascular/acute care.

- see this release
- check out the Wall Street Journal article for more

FDA to give Schering program priority review

Thu, 03 Jan 2008 06:59:54 -0500

Schering-Plough says the FDA will provide a priority review for sugammadex, which is being developed to reverse the effects of anesthesia used during surgery. Schering-Plough says the drug is significantly different than the meds already on the market for reversing the effects of anesthesia, saying the drug works for both mild and serious anesthesia induced by muscle relaxants. The priority review will cut the FDA's review process from 10 months to six.

- read the release for more info

ALSO: Schering-Plough plans to expand its manufacturing operations in Miami. Report

Related Articles:
Organon touts late-stage data for sugammadex. Report
A new 'religion' at Schering-Plough. Editorial
Schering-Plough: A good company to work for. Report

AEterna gets its ducks in a row

Wed, 03 Oct 2007 06:59:54 -0400

Executives at AEterna Zentaris have taken a good, long look at the company's pipeline and operations and have identified a number of changes that will take place.

Cetrorelix, currently in a Phase III program for benign prostatic hyperplasia, is AEterna's highest priority. The company also plans to move into Phase IIb trials for the endometriosis indication of the drug.
AEZS-108, a cytotoxic conjugate, is AEterna's highest earlier-stage priority, and will therefore. Phase II trials of the drug both endometrial and ovarian cancers will get underway this year. The company also prioritized early-stage drug candidates.
All projects will be developed internally through proof-of-concept in man, but non AEterna will look to unload non-core assets.
Asia (especially Japan) remains a market of interest for AEZS.

- see this release from AEterna

Related Articles:
AEterna files iNDA. Report
AEterna Zentaris announces ZEN-012 data. Report
AEterna regains rights to Cetrorelix. Report

Antisoma drug flunks ovarian cancer trial

Thu, 12 Jul 2007 06:59:57 -0400

The UK's Antisoma says that its experimental therapy for ovarian cancer has failed a clinical trial, triggering a swift loss of about one fifth of the company's share value. The mid-stage trial of ASA404 showed no increase in time to tumor progression when added to chemotherapy. Antisoma still has high hopes, though, that the therapy will prove convincingly effective against lung cancer. Novartis, which inked an $890 million pact on the drug in April, is preparing a Phase III study. "Based on these data, development in ovarian cancer will not be a priority," Antisoma said in a statement.

- see the release
- read the report on the trial results from MarketWatch

Related Articles:
Antisoma adds more positive data for AS1404. Report
Antisoma in licensing talks. Report
Antisoma trial delivers positive returns. Report

GAO: Improvements Needed in FDA’s oversight of Direct-to-Consumer Advertising

Maureen Martino — Thu, 14 Dec 2006 08:01:10 -0500

Drug company spending on DTC advertising—-such as that on television and in magazines-—of prescription drugs increased twice as fast from 1997 through 2005 as spending on promotion to physicians or on research and development. Over this period, drug companies spent less each year on DTC advertising ($4.2 billion in 2005) than on promotion to physicians ($7.2 billion in 2005) or research and development ($31.4 billion in 2005).

Studies GAO reviewed suggest that DTC advertising has contributed to increases in drug spending and utilization, for example, by prompting consumers to request the advertised drugs from their physicians, who are generally responsive to these requests. Evidence suggests that the effect of DTC advertising on consumers can be both positive, such as encouraging them to talk to their doctors, and negative, such as increased use of advertised drugs when alternatives may be more appropriate.

FDA reviews a small portion of the DTC materials it receives. To identify materials that have the greatest potential to impact public health, FDA has informal criteria to prioritize materials for review. However, FDA has not documented these criteria, does not apply them systematically to all of the materials it receives, and does not track information on its reviews. As a result, the agency cannot ensure that it is identifying or reviewing those materials that it would consider to be the highest priority.

FDA has taken longer to draft and review regulatory letters and the agency has issued fewer letters per year since 2002, when legal review of all draft regulatory letters was first required. From 2002 through 2005, from the time FDA began drafting a regulatory letter for a violative DTC material, it took the agency an average of 4 months to issue a regulatory letter, compared with an average of 2 weeks from 1997 through 2001. FDA has issued about half as many regulatory letters per year since the 2002 policy change.

The effectiveness of FDA’s regulatory letters at halting the dissemination of violative DTC materials has been limited. The 19 regulatory letters FDA issued in 2004 and 2005 were issued an average of 8 months after the materials were first disseminated. By the time FDA issued these letters, companies had already discontinued use of more than half of the violative materials. When the cited materials were still being disseminated, drug companies complied with FDA’s requests to remove the materials, and identified and removed other materials with similar claims. FDA’s issuance of regulatory letters did not always prevent drug companies from later disseminating similar violative materials for the same drugs. These issues are not new. In 2002, GAO reported that, by delaying the issuance of regulatory letters, the 2002 policy change had adversely affected FDA’s ability to enforce compliance. At that time, GAO recommended, and FDA agreed, that letters be issued more quickly. GAO continues to believe this is necessary in order to limit consumers’ exposure to false or misleading advertising.

Why GAO did this study

The Food and Drug Administration (FDA) is responsible for overseeing direct-to-consumer (DTC) advertising of prescription drugs. If FDA identifies a violation of laws or regulations in a DTC advertising material, the agency may issue a regulatory letter asking the drug company to take specific actions. GAO was asked to discuss (1) trends in drug company spending on DTC advertising and other activities; (2) what is known about the relationship between DTC advertising and drug spending and utilization; (3) the DTC advertising materials FDA reviews; (4) the number of regulatory letters that cited DTC materials and FDA’s process for issuing those letters; and (5) the effectiveness of these letters at limiting the dissemination of violative DTC advertising. GAO reviewed research literature, analyzed FDA’s processes, and examined FDA documentation.

What GAO recommends

GAO recommends that FDA (1) document criteria for prioritizing DTC materials for review, (2) systematically apply its criteria to materials it receives, and (3) track which materials it reviews. In its comments on a draft of this report, HHS disagreed with the recommendations, stating that they would require vastly increased staff. GAO believes that FDA already has most of the information that would be required to establish a systematic process for screening DTC materials.

SPOTLIGHT: Tykerb gains priority review

Wed, 15 Nov 2006 19:01:33 -0500

Analysts applauded today's announcement that the FDA will provide a priority review for GlaxoSmithKline's cancer therapy Tykerb. Report

SPOTLIGHT: FDA to give Humira priority review for Crohn's

Thu, 26 Oct 2006 20:01:33 -0400

Abbott Laboratories says that the FDA will give its anti-inflammatory drug Humira a priority review as a treatment for Crohn's disease. The priority review will move up a decision on Humira into early March, cutting four months off the timetable. To back up its application for Humira, Abbott submitted data from a trial of volunteers who had not responded to the monoclonal antibody Remicade (infliximab) made by Centocor. In Crohn's disease inflammation of the digestive tract causes pain and diarrhea. Humira has already been approved for rheumatoid arthritis and other conditions. Report

Gestiva gets approvable letter

Sun, 22 Oct 2006 20:01:36 -0400

Adeza Biomedical has received an approvable letter for Gestiva, a long-acting form of a naturally occurring progesterone designed to prevent preterm birth. The FDA granted priority review for the drug, as it would be the first therapy to prevent preterm delivery. In August, an FDA expert advisory panel recommended approval of Adeza BioMedical's Gestiva but said that the agency should require a post-marketing study to monitor the safety of the drug. Now, the agency has informed Adeza that approval of the drug is subject to the completion of an additional animal study and certain other conditions. The drug developer said it would meet with the FDA to determine what steps need to be taken for approval.

- read this BusinessWeek report

Related Articles:
Committee votes in favor of Adeza's Gestiva. Report
FDA to give Gestiva priority review. Report

SPOTLIGHT: PDI loses GSK contract

Mon, 25 Sep 2006 20:01:33 -0400

PDI says that GlaxoSmithKline isn't renewing its contract sales deal for 2007, ending an arrangement that was worth $65 million to $70 million a year in revenue, a big chunk of its income. PDI's total revenue last year was $319 million. PDI CEO Michael Marquardt said the company's immediate priority is finding new opportunities for the sales force that had been deployed for GSK products. Report

Velcade wins priority review from FDA

Tue, 08 Aug 2006 20:01:36 -0400

The FDA has granted a priority review for Millennium's Velcade for relapsed mantle cell lymphoma. Velcade is currently approved for patients with multiple myeloma who have failed at least one standard therapy. "Receiving priority review is a significant step forward in accelerating and expanding the potential of Velcade in cancers beyond multiple myeloma," said Deborah Dunsire, Millennium's president and CEO.

- here's the UPI report on Velcade

Novelos cancer drug hits FDA's fast track

Sun, 06 Aug 2006 20:01:36 -0400

The FDA has put Novelos Therapeutics' experimental drug NOV-002 on the fast track. Researchers are studying it in combination with chemotherapy for the treatment of advanced non-small cell lung cancer. The move makes it more likely that the drug can get a priority review, which would shave six months off the approval process.

"Obtaining fast track for NOV-002 is a further validation of Novelos' development progress, as we commence a pivotal Phase III NSCLC trial under a SPA," said Harry Palmin, president and CEO of Novelos. "It recognizes that Novelos' clinical and non-clinical data demonstrated NOV-002's potential to address significant unmet medical need in advanced lung cancer patients."

- here's the release on the FDA action

ALSO NOTED: Serono files sBLA for Rebif; Germany's Ingenium raises €9.2M in VC; and much more...

Mon, 03 Apr 2006 20:00:50 -0400

> Switzerland's Serono has filed a supplemental BLA for a new formulation of its MS drug Rebif. According to Phase III data, the new formulation is more easily tolerated by patients. Report

> Achillion Pharmaceuticals has filed for a $75 million IPO. Report

> Germany's Ingenium has raised €9.2 million in its fourth round of venture capital. Release

> Unhappy Chiron shareholders were won over by Novartis' newly sweetened bid offer, paving the way for a merger. Report

> The FDA has granted a priority review for Avanir Pharmaceuticals' Neurodex, a drug for under-treated emotional disorder. Report

> The FDA has granted priority review for Remicade as a treatment for pediatric Crohn's disease. Report

> Chutes & Ladders: SIGA Technologies' CEO Kasten Bernard has resigned. Report

> Canada's Bioniche Life Sciences announced that the FDA has given its approval for a second Phase III trial of an experimental bladder cancer therapy. Article

> ArQule is reporting positive Phase I data for ARQ501, its lead cancer therapy. Release

> Halozyme Therapeutics says that preclinical and Phase I data for Chemophase supported the safety profile of the enzyme-chemo combination for bladder cancer. Release

> Biosite and Oxford Genome Sciences have announced a collaboration to evaluate protein-based disease markers for colorectal cancer. Release

> In a preclinical data presentation Antisoma said that data showed that a combination of its AS1404 and Avastin performed markedly better than Avastin alone in inhibiting the growth of human colon and lung tumour xenografts. Release

And Finally... California plays a leading role in the spread of influenza, and researchers are struggling to find out why. Article

Pfizer's Champix gains priority review status

Wed, 21 Dec 2005 19:01:36 -0500

Pfizer's closely watched smoking cessation drug Champix has been granted a six-month priority review by the FDA. According to Pfizer, the number of people who die from smoking-related illnesses is set to climb from 5 million to 10 million a year by 2020. The potential market for Champix is huge, as only 7 percent of smokers can quit on their own.

- read this report from TheDay for more information

Elan, Biogen Idec get priority review for Tysabri application

Thu, 17 Nov 2005 19:01:38 -0500

Elan and Biogen Idec got a major boost Thursday evening when the FDA said it would provide a priority review for their request to bring Tysabri back onto the market for multiple sclerosis. The notification also confirmed the FDA's opinion that the biotech companies' application was complete. The accelerated review process cuts the FDA's response time from 10 months to six months. Tysabri was pulled from the market last February after it was linked to a lethal brain disease. It had been approved for marketing only months before and was expected to quickly emerge as a blockbuster drug.

- read this AP report for more

FDA to accelerate Exjade review

Tue, 21 Jun 2005 20:01:35 -0400

The FDA has agreed to give Novartis a priority review for Exjade, an experimental treatment that removes excess iron in the blood. And analysts say the move may allow the drug giant to start marketing the drug by the end of this year. Potential sales estimates range from $200 million to $700 million a year.

- read this story from MarketWatch for more