Qnexa to be re-reviewed in April 2012

Vivus announced that the company had resubmitted the NDA for Qnexa for the treatment of obesity in obese men and women of non-child bearing potential. The US FDA accepted the resubmission on Nov 3, 2011 and recently set the review day on April 17, 2012.

After the initial submission, the US FDA issued a complete response letter saying that QNEXA couldn't be approved at that time due to the following areas:

Happy New Year!

Greetings to our readers!

It's been a pleasure having your support in the past year! PharmaPodia has been established for over a year and a half now. Over the last year, we have grown and we continue to do so. But it would not have been made possible without you, our reader.

With a new year on the horizon, we, at PharmaPodia, wish you a happy new year and may your wish come true this year!

Once again, thank you for your support and don't forget to come back and visit us again!

Best,

Team @ PharmaPodia

Prevnar 13 can now be used in people who are 50 years and older

The US FDA has expanded the use of Prevnar, a pneumococcal 13-valent conjugate vaccine to be used in people who are 50 years of age and older for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae.

The approval came from the results generated from randomized, multicenter studies conducted in the US and Europe in people who are 50 years of age and older evaluating Prevnar 13 or Pneumovax 23. The results showed that compared to Pneumovax 23, Prevnar induced similar antibody levels for the 12 common serotypes.

Prevnar's safety has been evaluated in about 6,000

Pegerine released preliminary data of the phase II trial evaluating bavituximab

Peregrine released preliminary data of the phase II study evaluating bavituximab's antiviral activity and safety profile in the treatment of HCV infection.

• Antiviral activity was defined as 12 week early virologic response

Patients in the trial were randomized into one of the following three arms:

• bavituximab 0.3 mg/kg
• bavituximab 3mg/kg
• pegylated inteferon alpha-2a

All patients were given ribavirin.

The preliminary data showed that bavituximab given in combination with ribavirin "appeared safe and well tolerated". Patients in this group reported fewer side effects when compared to the interferon-containing arm. Patients taking interferon with ribavirin achieved

Gentium to submit response to the EMA's Day 120 List of Questions by year end

Gentium announced that the company will submit the Day 120 List of Questions requested from the European Medicines Agency for the Marketing Authorization Application submitted for Defibrotide for the treatment and prevention of hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem-cell transplantation therapy by the end of December.

The MAA was submitted to the EMA in May 2011.  At the end of September 2011, the Committee for Medical Products for Human Use responded with a Day 120 List of Questions after the agency has accelerated the review process for defibrotide registration dossier. The review process will resume on day 121 and further communication will be made by Day 150

Infinity has extended its global strategic alliance with Mundipharma

Infinity has extended its global strategic alliance with Mundipharma. Under the extension, Mundipharma has agreed to provide Infinity over 50M in funding to continue the development of IPI-145and other candidates in 2013.

IPI-145 is a PI3K-delta and gamma inhibitors. Both PI3K-delta and gamma have been shown to play important roles in hematologic cancers in addition to other inflammatory and autoimmune diseases. IPI-145 is currently being investigated in two phase 1 trials.

The first trial is a double-blind, randomized, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-145 given as a single dose or multiple escalating doses in healthy adult subjects.

The second trial is an open-label, dose-escalation study

Emergent Biosolutions initiates the phase II study evaluating TRU-016

Emergent announced that the company initiates the phase II portion of the phase Ib/II study evaluating TRU-016 in combination with bendamustine in patients with relapsed chronic lymphocytic leukemia following the termination of the collaboration agreement with Abbott.

TRU-016 is an anti-CD37 monospecific protein therapeutic and is currently being investigated in the phase 1b study in patients with non-Hodgkin's lymphoma. 

The phase II portion of the study aims to evaluate and compare the safety and efficacy of TRU-016 in combination with bendamustine and

Mylan launched first generic of Teveten (eprosartan)

Mylan announced that it has launched the first generic version of Teveten (eprosartan mesylate ) tablets 400 mg and 600 mg.  Teveten tablets are currently marketed by Abbott Laboratories for the treatment of hypertension.   Mylan has 180 days of marketing exclusivity because the abbreviated new drug application filed by the company to the US FDA was the first one that was substantially complete and containing paragraph IV certification.

Teveten (eprosartan) is an angiotensin II

Geron initiates the phase II trial evaluating GRN1005

Geron recently announced that it has initiated the phase II trial evaluating the company's GRN1005 for the treatment of brain metastases arising from non-small cell lung cancer.

The phase II trial is set to assess the efficacy, safety and tolerability in the intended population. The company plans to enroll 50 patients in the trial. GRN1005 will be administered at a dose of 650 mg/m2 via intravenous infusion every three weeks. The company's primary efficacy

Mylan received approval to market generic Keppra XR Extended Release tablets

Mylan announced that the company has received approval for the abbreviated new drug application filed for levetiracetam extended-release tablets from the US FDA.

The submitted ANDA is first-to-file generic Generic Keppra XR Extended-Release tablets. As a result, the company has exclusive marketing rights to the product on all strengths for 180 days.  The company said it will ship the product immediately.

The approved strengths are 500 mg and 750 mg.

Based on the data from IMS Health, the total US sales for levetiracetam ER tablets reached 162.8M in the 12 months ending on Sept. 30, 2011.

Keppra XR has been approved as adjunctive therapy in the treatment of partial onset seizures in epileptics whose age are 16 years and older.  Keppra XR tablets are currently being marketed by UCB.

Eisai resubmitted the new drug application for Perampanel

Eisai announced that it has resubmitted the new drug application for the company AMPA Receptor antagonist perampanel to the US FDA for the treatment of partial-onset seizures associated with epilepsy on December 22, 2011.

The US FDA has issued the Refusal to File letter for the original NDA that was submitted in May 2011 in July 2011.  The FDA has requested the company to reformat and reanalyze some of the datasets in the ossier.

Perampanel is novel chemical compound discovered by

Veloxis formed alliance with Athena Drug Delivery Solutions

Veloxis Pharmaceuticals (formerly known as LCP) has formed an alliance with Athena Drug Delivery Solutions Pvt. Ltd to develop, manufacture and commercialize the company's investigational drug AtorFen (Fenofirbate-atorvastatin fixed dose combination).

Under the agreement, Athena will have exclusive rights to manufacture, develop, register, and commercialize AtorFen with third parties in certain emerging market territories.  Based on the press release, it looks like Athena will be manufacturing the product in India through its partnerships with regional and country level pharmaceutical companies.  Athena will have all the technology for manufacturing AtorFen transferred from Veloxis who will have 70% of all revenues generated from AtorFen. Veloxis also has rights to reclaim rights in certain territories or regions where Athena has not established partnership within the certain time interval.

AtorFen is a combination product of fenofibrate and atorvastatin, 

Veloxis licenses Fenoglide to Santarus

Veloxis Pharmaceuticals announced that it has transfer the US commercial rights of Fenoglide from Shore Therapeutics to Santarus Inc.

Under the agreement, Shore will receive an upfront payment of $11M from Santarus. Shore will also be eligible to receive tiered royalties on netsales of Fenolgide (fenofibrate). Santarus will also be responsible for the commercialization of Fenoglide (fenofibrate) 40 mg and 120 mg tablets in the US.

Veloxis has also settled the patent litigation between the company Veloxis and Impax Laboratories. The company said Impax has been given sublicense to begin selling generic version of Fenoglide starting October 1, 2015 or earlier depending on the situation.

Gilead's NDA for QUAD submitted to the FDA has been accepted

Christmas present for Gilead!

The company recently announced that the FDA has accepted the New Drug Application submitted for the Quad, a quadruple anti-HIV regimen.

The Quad contains the following ingredients: elvitegravir, cobicistat, emtricitabine and tenofovir.

The Company submitted the NDA on Oct 27, 2011.  The target review date will be on August 27, 2012.

Elvitegravir is an integrase inhibitor. It was originally developed by Japan

A new face of the FDA website

It's almost the new year...and the FDA website just got a new facelift!

It definitely looks a lot cleaner than what it used to look in the past. It's also looking sleeker as well.

Now if they can organize the contents in such a way that they are easy to find, I would say this might have been the best Christmas present!

Helix Biopharma filed a clinical trial application in Germany and the UK

Helix Biopharma announced that it has filed a clinical trial application with the Bundesinstitue fur Arzneimittel und Medizinprodukte (in Germany) and the Medicines and Healthcare Regulatory Authority (in the UK) to seek permission to initiate the phase III trial evaluating the company's interferon alpha-2b in patients with low-grade cervical lesions.

The clinical trial application process involves the initial screening that requires typically 2 weeks (although the duration can be extended). Once the initial screening is

Merry Christmas and Happy New Year

Merry Christmas and Happy New Year!

We wish you and your family a warm Christmas filled with joy and wonderful presents.

May the coming year bring you good fortune and good health :)

Warmly,

Pharmapodia Team