Approvable letter

FDA delays approval of AMAG anemia drug

John Carroll — Mon, 20 Oct 2008 11:36:39 -0400

Shares of AMAG Pharmaceuticals were dinged by the news that the FDA is asking for more information on its experimental anemia drug ferumoxytol. The stock slid 13 percent after the company announced the delay. AMAG--which filed for the NDA last December--declined to say exactly what the FDA is looking for. But the company adds that it won't have to mount new trials for the drug, which is intended to treat in chronic kidney disease patients. And AMAG also says it will continue to make plans to launch the therapy in the first quarter of next year.

"We believe that we will be able to provide the information requested by the FDA in an expeditious manner," said CEO Brian Pereira in a statement.

- check out AMAG's release

FDA delays Roche's blockbuster Actemra

John Carroll — Fri, 19 Sep 2008 10:20:25 -0400

The FDA is delaying approval of Roche's new rheumatoid arthritis drug Actemra, saying that it wants to see more information on the therapy. The news swiftly hit the share price of Chugai, Roche's partner on the drug. The FDA is looking for more information on manufacturing and the final label. But significantly the agency is not looking for more safety or efficacy data and is not asking for any time-consuming clinical trials.

Analysts widely expect Actemra to compete for blockbuster status with more than a billion dollars in annual revenue. The therapy is one of Roche's most promising new drugs. It blocks the IL-6 protein, which plays a role in inflammation. Despite the delay, analysts voiced their confidence of a pending approval.

- here's Roche's release on Actemra
- read the story from the Wall Street Journal

Cardiome shares plunge on approvable letter

John Carroll — Mon, 11 Aug 2008 11:41:46 -0400

After riding high on the news of positive data from a recent Phase IIb trial, shares of Cardiome Pharma swiftly sank 30 percent after investors heard that the FDA's "approvable" letter for Kynapid (vernakalant)--co-developed with Astellas--included a request for more information on the drug's impact on a subset of patients in trials and a safety update on users.

"Astellas will be in contact with the FDA within the next few days to discuss next steps, and we expect that several months may be required to assemble a complete and appropriate response," stated Bob Rieder, CEO and chairman. "While this action letter could result in the need for an additional clinical study, Cardiome is optimistic that the questions raised can be satisfactorily addressed from currently available data."

- check out the Cardiome's release
- read the report from the Globe and Mail

FDA goes neutral with new response letters

John Carroll — Thu, 10 Jul 2008 11:33:49 -0400

For years now investors in the biopharma field have often had to spend a considerable amount of time scratching their heads over what the FDA really meant when the agency issued an "approvable" or "not approvable" letter--often over-reacting to the headlines. So now the FDA says that it will issue "complete response" letters for drugs that aren't approved for sale in the hope that more neutral language can calm jittery nerves. These new letters are intended to tell developers what is missing from their application and if possible how they can cure the fault.

Several analysts, though, noted that the FDA's quest for neutrality is likely to lead only to greater confusion about the prospects of an experimental therapy.

"While this new plan may provide more detailed information to the company regarding issues that need to be addressed, investors will likely be kept in the dark on the status of a drug's approvability," noted analyst Jon LeCroy. "Investors will no longer know whether a drug is dead in the eyes of the FDA."

- read the story from eNews

ALSO NOTED: Medicines Company gets not approvable letter; Sun, Taro merger called off; and much more...

Wed, 28 May 2008 06:59:50 -0400

> The Medicines Company got a not approvable letter on an sNDA for an additional dosing regimen for Angiomax, a treatment of acute coronary syndromes initiated in the emergency department. Release

> A planned merger between Sun Pharmaceuticals and Taro Pharmaceuticals has been canceled. Taro's board decided that it wasn't in the best interest of the company. Taro release

> NeoStem execs say they don't know why the company's stock has declined over the last four days. NeoStem release

> New research has highlighted a brain protein called DARPP-32 which bolsters the well-documented dopamine response. It could alter long-lasting responses to drugs of abuse, and decreases motivation for food reward. Report

> Networking tools like Facebook and Twitter will soon be de rigeur for pharma marketing, replacing blogs as the must-use online tools. Report

> New U.K. guidelines for heart-attack prevention could be a major windfall for statin-makers. Report

> Say hello to Pfizer's new general counsel, Amy Schulman (photo), a top litigator who's served as lead attorney on the company's Celebrex and Bextra cases. Report

And Finally... Here's a quandary: You're a good-sized drugmaker, but not a behemoth able to throw your weight around the industry's big trade associations. So how do you get your voice heard in our nation's capital? Form your own association, of course. Report

Discovery secures $60M financing deal

Tue, 27 May 2008 06:59:54 -0400

Struggling Discovery Labs signed a three year, $60 million financing deal with Kingsbridge Capital, a U.K.-based investment group. Kingsbridge will provide the capital through the purchase of newly issued shares of Discovery's common stock. The company said the deal "significantly improves the company's financial flexibility to support the potential commercialization of Surfaxin," as well as the rest of its respiratory pipeline.

Discovery has been on the ropes since receiving a third approvable letter for Surfaxin, a treatment for premature infant respiratory distress syndrome. The most recent approvable letter did not call for a new trial of the drug and execs said they hope to quickly respond to the FDA's concerns.

- here's Discovery's release for more

Wyeth gets approvable letter for bazedoxifene

Fri, 23 May 2008 06:59:58 -0400

The FDA handed Wyeth a third approvable letter for bazedoxifene, a treatment for postmenopausal osteoporosis. In the letter, the FDA said it needed more information concerning the incidence of stroke and venous thrombotic events. Wyeth said the delay was expected. "In our conference with the Agency earlier this year, they stated their desire to convene an advisory committee to review the pending new drug applications for both treatment and prevention of postmenopausal osteoporosis," said Gary L. Stiles, M.D., Wyeth's CMO. The company expects to file a response by the end of 2008. A recent IMS report predicted that bazedoxifene could become a much-needed blockbuster for Wyeth if approved.

- see this release
- here's the IMS report

Related Articles:
Wyeth's reports strong Phase III bazedoxifene data
Wyeth to slash another 1,200 jobs

Merck shelves study of cholesterol drug

Wed, 21 May 2008 06:59:57 -0400

Saying it had the wrong patient population, Merck has discontinued its ACHIEVE imaging study for its cholesterol drug MK-0524A. Its steering committee recommended a new imaging study that included a "more appropriate patient population." The ACHIEVE trial was intended to gauge the drug's impact on the thickness of artery walls.

Merck emphasized that the decision to discontinue the trial was not related to a recent Not Approvable letter from the FDA and that all other studies would proceed as planned. The FDA turned thumb's down on MK-0524A last April. The drug is a combination of the B vitamin niacin and the drug laropiprant.

- here's the release
- read the report from Hemscott

ALSO NOTED: Salix gets approvable letter; Intermune drug hits the fast track; and much more...

Mon, 19 May 2008 06:59:50 -0400

> Should Fred Hassan (photo) give back his bonus? That's what Forbes is asking this week, saying that the Schering-Plough CEO's 2007 compensation package was probably artificially inflated by the fact that sales-damaging study results were held back until early January 2008. Report

> Salix says it has received an approvable letter from the FDA for balsalazide tablet studied as a treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older. The company says it should be able to provide a complete response to the letter in a matter of days. Release

> The FDA has put Intermune's drug pirfenidone--for idiopathic pulmonary fibrosis--on the regulatory fast track. Story

> Holmes Biopharma announced that its clinical research operations in Omaha, Nebraska have been disrupted due to a working capital deficiency. Release

> MorphoSys has extended its research contract with Schering-Plough by a year. Report

> Biophage Pharma has sold the assets of its Immunotox Labs Division to Validapro BioSciences Inc. for $400,000 in cash and the assumption by Validapro Biosciences of certain liabilities. Release

> In a deal with the U.S. Department of Justice, the Canadian drugmaker agreed to pay almost $25 million to settle claims that it paid docs and their office managers to get patients onto its Cardizem heart drug. Report

> The FDA is warning doctors again that organ-transplant drugs CellCept (from Roche) and Myfortic (Novartis) have been linked to miscarriages and birth defects when taken by pregnant women. Report

And Finally... A simple gene test may soon be available that will eliminate up to half of the potential patients for the therapy. Report

FDA delays Entereg decision

Fri, 09 May 2008 06:59:58 -0400

GlaxoSmithKline and Adolor's seemingly never-ending effort to win approval for Entereg has hit yet another delay. The FDA informed the companies that it would not make a decision by Saturday, the drug's PDUFA date. No date was given but the FDA said it would provide further details soon in an action letter.

GSK and Adolor have been attempting to gain FDA approval for Entereg since 2006, when the agency issued an approval letter and asked the companies for additional safety data. If approved, Entereg will be used to treat postoperative ileus in bowel resection.

- here's the release

Battered Discovery Labs tries to reassure investors

Mon, 05 May 2008 06:59:56 -0400

Discovery Laboratories is signaling investors to hang on for a few weeks more. After seeing its stock price go into meltdown mode Friday on the FDA's third approvable letter for Surfaxin, Discovery execs announced that they believe they can respond to the agency in six to eight weeks and may get another review in as few as 60 days.

"Discovery Labs firmly believes that this recent approvable letter reflects notable progress towards gaining FDA approval for Surfaxin," the company said on Monday. There is no requirement for a new trial of the drug, which treats respiratory distress syndrome in premature babies. Discovery Labs may be making an impact. Its stock price climbed more than 10 percent this morning.

- check out the Discovery release

FDA delays Discovery Labs approval

Fri, 02 May 2008 06:59:56 -0400

Discovery Labs has been dealt another blow in its quest to gain approval for Surfaxin, a treatment for premature infant respiratory distress syndrome. The FDA issued an Approvable Letter yesterday, saying that it needed more information on the drug before it could be approved. Discovery says it will review the letter and discuss its next steps with the FDA. The company did not provide details regarding what additional information the FDA is seeking. This is the third approvable letter issued for the drug.

- here's the release

Drug work completed, Theravance cuts 40% of staff

Wed, 23 Apr 2008 06:59:57 -0400

Theravance announced that it is cutting 40 percent of its workforce now that it has finished work on its antibiotic telavancin. Telavancin is currently undergoing FDA review: in March the FDA accepted the company's response to the approvable letter Theravance received in October. Telavancin is a once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections, such as MRSA.

The company's net loss for the first quarter of 2008 was $29.8 million compared with $49.5 million for the same period of 2007, a decrease of $19.7 million. Completing Phase III work on Telavancin contributed to the narrower loss. Rick Winningham, Theravance's CEO, said that the company will prioritized development TD-5108, a treatment for GI motility dysfunction. "During the second quarter, we will be making certain workforce changes to focus support on these key activities and our discovery programs and to reduce our cash burn rate in 2008 and beyond," noted Winningham.

- check out this release from Theravance
- and see this Forbes report

Endo pulls Frova app after mulling FDA response

Tue, 08 Apr 2008 06:59:54 -0400

Endo Pharmaceuticals says a close reading of a non-approvable letter from the FDA for Frova prompted officials to pull their request to gain approval for the short-term relief of menstrual migraine. The Chadds Ford, PA-based developer has already won approval for the use of Frova against acute migraine for patients with a clear diagnosis. And without explanation Endo says it will return the rights to Chronogesic to Durect.

"The decision to withdraw the unapproved supplemental application was complex; however, after a lengthy and detailed evaluation of the points raised in the FDA 'not approvable' letter, we have determined the withdrawal to be the appropriate course of action at this time," said Endo CEO Dave Holveck (photo).

- here's the release
- read the report in the Philadelphia Business Journal

Related Articles:
Endo, Vernalis get FDA rejection for Frova. Report
Endo plans for the future. Report

Avanir gets $40 to wrap new Phase III for Zenvia

Thu, 27 Mar 2008 07:59:55 -0400

A group of venture firms led by ProQuest Investors is providing Avanir Pharmaceuticals with $40 million to fund a confirmatory late-stage trial of Zenvia and a full response to the FDA's request for more data. Avanir will issue an aggregate of approximately 35 million shares at a price of $1.14 per share unit--the market closing bid price as of March 26, 2008 plus a nominal amount for warrants--with 35 percent warrant coverage. The warrants, which represent the right to acquire up to approximately 12.2 million shares, are exercisable at 125 percent of the offering price and have a 5-year exercise term.

Avanir has had a hard time developing Zenvia, an experimental drug for involuntary emotional expression disorder. The FDA handed the biotech an approvable letter for the drug in late 2006 which outlined a demand for new data on the drug.

- read the press release

ALSO: Germany's Pieris has raised $38 million in its second round of venture financing led by OrbiMed Advisers. Pieris is developing a novel class of targeted human protein therapeutics. Release

PLUS: Durham, NC-based Scynexis has raised $13.5 million from a group of investors that include a lineup of Big Pharma companies. Report

Related Articles:
Avanir shares soar on positive Zenvia data. Report
CEO heads for exit after Avanir stocks plunge. Report
Avanir pockets $10M with AstraZeneca deal. Report
Avanir slashes jobs, puts Zenvia on ice. Report
Avanir slashes costs as it mulls asset sale. Report

Basilea shares plunge on antibiotic delay

Tue, 18 Mar 2008 07:59:58 -0400

Switzerland's Basilea took its turn on the public markets' whipping post, shedding 27 percent of share value after announcing that its antibiotic ceftobiprole had failed to quickly win over FDA regulators. The agency said that it would need more information on the antibiotic--which is partnered with Johnson & Johnson. In an approvable letter, the FDA outlined its requirements: more information on the drug's impact on diabetic foot infections, more time to assess the data submitted, and a review of the study sites used to test the therapy. Ceftobiprole is intended to treat complicated skin infections, including MRSA.

In a phone call with analysts, Basilea CEO Anthony Man declined to offer a timeline for an approval, but noted that the agency isn't asking for more studies. Researchers are also testing the drug as a possible therapy for pneumonia.

While analysts suggested that a 9 to 12-month delay was likely, at least one was pleased to see that the FDA was willing to go with Basilea's non-inferiority trial, which could have proved to be a sticking point.

- here's the release
- read the article from MarketWatch

Related Articles:
J&J files Ceftobiprole in Switzerland. Report
Basilea reports positive Phase III antibiotic data. Report
Basilea shares jump on antibiotic data. Report
Basilea gets fast track for antifungal drug. Report

FDA to review Theravance's telavancin response

Thu, 06 Mar 2008 06:59:54 -0500

More news in Theravance's ongoing battle to win approval for its antibiotic telavancin: the FDA has accepted the company's response to the approvable letter Theravance received in October. Telavancin is a once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections, such as MRSA.

The FDA's approvable letter included a request for more clinical data or reanalyzed clinical data, revised labeling and a resolution of good manufacturing practices. Last week Theravance was scheduled to meet with the FDA, but that meeting was canceled because the agency wanted review the monitoring of study sites following data integrity concerns. Further action on the NDA won't be taken until the FDA is finished its evaluation. Theravance was a 2003 Fierce 15 company.

"We are pleased that the FDA has accepted for review our complete response, which we submitted on January 21st," said Rick E Winningham, CEO of Theravance. "We are committed to working with the FDA to resolve the remaining issues on our cSSSI NDA."

- check out Theravance's release

Related Articles:
Blog divines new FDA standard on data integrity. Report
FDA wants more data on Theravance antibiotic. Report
Theravance trumpets positive results of mid-stage trial. Report
Astellas take a pass on Theravance's drugs. Report

ALSO NOTED: Amgen analysts bearish; FDA hands Kyowa not-approvable letter; Valeant plans review; and much more...

Thu, 28 Feb 2008 06:59:50 -0500

> Oh, the curse of duplication. Schering-Plough embarked on a company-wide downsizing yesterday, eliminating hundreds of jobs in nearly all departments, including finance, research, information technology, and marketing. Report

> Faced with what they see as the likelihood of some significant restrictions on the use of Amgen's anemia drugs--as well as new data on risks associated with the drugs--analysts have been turning distinctly bearish on the biotech giant's stock. Report

> Kyowa Pharmaceutical has received a not-approvable letter from the FDA for istradefylline (KW-6002), its investigational drug for the treatment of Parkinson's disease. Release

> Valeant Pharmaceuticals says it will undertake a strategic review after reporting weak results for the fourth quarter. Release

> The U.S. Patent office has upheld the validity of Geron's patent for human embryonic stem cells. Report

> Any attempt to track down the source of problems with the blood thinner heparin are likely to run into trouble following a convoluted supply trail in China. Report

> The FDA has nixed Eli Lilly's plans for a long-acting formulation of its antipsychotic Zyprexa. Report

> GSK's secret vaccine adjuvant is drawing attention. Report

And Finally... The CDC has greatly expanded the population of people it's recommending for an annual flu shot, saying everyone aged six months to 18 should get the an annual jab. Report

Blogster sees lessons in FDA approvable letters

Thu, 21 Feb 2008 06:59:54 -0500

The blogster Eye on FDA has tracked down and posted every approvable letter he's heard about for 2007. The crop of letters highlights some particular challenges for new drugs targeting ADHD, pain and depression. The 29 letters marked a record for the FDA, particularly for multiple letters covering the same therapy. "And even though we are in a severe "risk-averse" environment, one could say that efficacy was every bit as much a factor as safety in the 2007 crop of letters."

- read the blog report

Related Articles:
2007 FDA approvals. Report
FDA more friendly to approvable than approved. Report
'07 drug approval record raises worries. Report
Dry spell or parched desert for NME approvals? Report
New drug approval lags in 2007. Report

GSK, Adolor face another Entereg delay

Mon, 11 Feb 2008 06:59:58 -0500

The FDA has told Adolor and GSK that it will take three more months to review Entereg, a anti-constipation drug candidate. The agency is now expected to announce its decision on May 10. Recently, an FDA advisory committee narrowly endorsed the drug, saying that the benefits of the drug outweigh the potential risk of heart attacks that has been associated with Entereg. Adolor also submitted an updated risk management plan for the drug today.

GSK and Adolor have been attempting to gain FDA approval for Entereg since 2006, when the agency issued an approval letter and asked the companies for additional safety data.

- see this release for more

Related Articles:
Entereg wins key FDA advisory committee vote. Report
Adolor shares rise on NDA news. Report
Investors cheer FDA's acceptance of Entereg response. Report
FDA wants more safety data on Entereg. Report
Adolor shelves Entereg studies; shares plunge. Report
FDA needs more data on Adolor drug. Report
Adolor hit by FDA's approvable letter for Entereg. Report