AVI Biopharma reported delay in the initiatioin of the phase II trial

AVI BioPharma announced that the protocol for the phase II trial using eteplirsen being assessed for the treatment of Duchenne muscular dystrophy has not been approved by the Institutional Review Board of the Nationwide Children's Hospital in Columbus, Ohio.  The IRB request the company to modify

Ziopharm announced that the FDA has accepted the IND for ZIN ATI-001

Ziopharm Pharmaceutical announced that the Investigational New Drug Application for ZIN ATI-001 has been accepted to begin clinical study as potential therapy for melanoma.

The phase I study plans to evaluate the safety and the immunological and biological effects of the product in the targeted population. 


About ZIN ATI-001:

• ZIN ATI-001 utilizes the adenoviral vector to deliver the

Glenmark received approval for ANDA submitted for mupirocine 2%

Glenmark announced that its USA subsidiary of Glenmark Generics Limited has granted the company the approval for the ANDA submitted for mupirocin ointment USP 2%.

Mupirocin has been approved to be used

Galapagos initiates the phase II trial of GLPG0634

Galapagos announced that it has initiated the phase II trial evaluating the safety and efficacy of GLPG0634 for the treatment of infllammatory conditions such as rheumatoid arthritis.

The trial will enroll 36 subjects who are diagnosed with active rheumatoid arthritis but do not have sufficient response to the standard-of-care treatment with methotrexate.

The study will involve three groups of 12 subjects to receive

The FDA granted EPI-743 orphan drug status

Edison Pharmaceuticals announced that its EPI-743 product candidate has been given an orphan drug designation by the FDA.

The orphan drug designation is given to EPI-743 for the following indication: treatment of inherited mitochondrial respiratory chain diseases.

To be given an orphan drug status, the treatment has to target a disease that affects less than 200,000 people in the US.  In addition, by getting the orphan drug status, EPI-743 will be given accelerated review and a seven-year period of exclusivity upon FDA approval.

Edison Pharmaceuticals just announced that the FDA has granted Expanded Access to EPI-743 which is currently being investigated in the phase II trial.

About EPI-743

• EPI-743 is an orally available molecule that can cross the central nervous system readily.  The compound targets NADPH quinone oxidoreductase 1.  In addition, it works with the energy generated from the mitochondria to counter cellular redox stress.

The FDA allowed Expanded Access Program of Edison's EPI-743

Edison Pharmaceuticals announced that FDA has allowed an Expanded Access Program to provide EPI-743 to seriously  ill patients who had inherited respiratory chain diseases of mitochondria.  To be eligible, patients need to have their disease confirmed or in case when genetic confirmation is now allowed, patients can be given accessed to the medication if they meet specific clinical criteria.

EPI-743 has been used in 40

The FDA accepted the IND submitted by Adamis for APC-100

Adamis announced that the FDA has accepted the Investigational New Drug Application submitted by Adamis for APC-100 as potential therapy for prostate cancer.

The company plans to initiate the phase 1/2a clinical studies in men with castrate resistant prostate cancer.  The study will evaluate the toxicity, biochemical responses (through Prostate Specific Antigen), radiographic and clinical responses at the University of Wisconsin Carbone Cancer Center initially and will extend to the next clinical site Wayne State University Karmanos Cancer Institute.  Both of these cancer centers

Vertex released positive interim results of the phase 2 trial using combination VX-770 and VX-809

Vertex announced positive interim data using the combination of VX-770 and VX-809 as potential treatment in patients with defective protein that leads to cystic fibrosis in the first part of the phase 2 trial conducted by the company. The defective protein is the cystic fibrosis transmembrane conductance regulator that regulates the movement of chloride across the cell surface to help the hydration and clearing of the mucus from the airway.

Vertex shares drop approximately 8.8% in the early trading session.  The company is traded in the NASDAQ as VRTX.

At the time of the interim analysis, no serious adverse events were reported.

The results showed that a significant decrease in

The FDA approved the supplemental New Drug Application submitted by Lilly for Humalog

Eli Lilly announced that the FDA has approved the supplemental New Drug Application filed for Humalog and the label has been allowed to add the following updates:

• Humalog can now be used in continuous insulin infusion pump therapy in children who are 4 years and older with type 1 diabetes
• The maximum time-in-use of Humalog in the external pump reservoir is seven days.
• The maximum time-in-use of the infusion set and of the infusion set subcutaneous insertion site is three days.

Humalog is the brand name

Covidien filed a counterclaim against Applied Medical Corporation

Covidien announced that the company's subsidiary has filed a counterclaim against Applied Medical Corporation, who previously filed a lawsuit against Covidien for alleged infringement of a reissue patent in regard to unspecified Versaport Plus trocar products, for patent misuse, non-infringment and invalidity . 

Covidien obtained a reissue patent based on the US patent Number

Eli Lilly won the latest round of the lawsuit filed by Amylin

Amylin announced that the Court has vacated the temporary restraining order issued previously against Lilly.  In addition, the court has also rejected Amylin's request for Preliminary Injunction that was supposed to put restriction on the Lilly Diabetes sales force and other relief.

The lawsuit was filed by Amylin against Lilly claiming Lilly has breached its contract with Amylin by entering into a collaboration with Boerhinger Ingelheim and did not fully maximize its ability to promote the full potential of exenatide.

As I've mentioned previously, it is likely to be an uphill battle that Amylin is going to fight. 

Somaxon and Paladin entered into commercialization agreement

Somaxon announced that it and Paladin have entered into an exclusive collaboration under which Paladin is to commercialize Silenor in Canada, South America and Africa for the treatment of insomnia characterized by difficulty with sleep maintenance.

Under the terms of the agreement, Paladin is to make a $500,000 up-front payment in addition to purchasing 2.184.769 shares of Somaxon's common stocks which is estimated to be worth $5M.

Somaxon is entitled to receive additional

APP launches Letrozole

APP announced that it has received the FDA approval to market 2.5 mg Letrozole tablets, the generic version of Femara, and is ready to launch the product immediately. APP is not the first company to market generic Femara.  The generic version has been put on the market by other company such Teva and Mylan to name a few..

Femara is currently marketed by

Takeda announced results of trials using Velcade

Another update from Takeda

Takeda announced results from the two clinical studies evaluating Velcade or bortezomib in patients with relapsed or refractory multiple myeloma at the annual meeting of the American Society of Clinical Oncology in Chicago, Illinois.

The first trial:

• The phase I trial evaluating bortezomib in combination with LY2127399 as potential therapy in 20 patients previously treated for multiple myeloma in 20 subjects of whom 65% had received Velcade previously.  The study was to evaluate

Seattle Genetics and Takeda announced update on brentuximab

Seattle Genetics and Takeda Oncology have announced update of brentuximab used in the pivotal trial as potential therapy in relapsed or refractory Hodgkin lymphoma patients and the phase II trial as potential therapy in relapsed or refractory systemic anaplastic large cell lymphoma.

About the Pivotal trial:

• The trial enrolled 102 subjects diagnosed with relapsed or refractory Hodgkin lymphoma but failed previous autologous stem cell transplant.  The independent review facility

Mylan received approval to market generic Aricept

Mylan announced that its subsidiary Matrix Laboratories Limited has been given a nod of approval from the FDA to market Aricept or donepezil hydrochloride tablets 5 mg and 10 mg.  Aricept is the brand name marketed by Eisai for its use in the treatment of dementia associated with Alzheimer's disease.

Mylan is said to launch the product immediately.  Recently

Elite Pharmaceuticals signed a contract manufacturing agreement with Mikah Pharma

Elite Pharmaceuticals announced that it has signed a commercial manufacturing and supply agreement with Mikah Pharma to perform laboratory stability studies, manufacturing, and packaging for two generic products: 2.5 mg and 5 mg Isradipine Capsules and 35 mg Phendimetrazine Tartrate Tablets.

Elite is to receive a 10% royalty on net profits of the finished product

The phase III trial of United Therapeutics evaluating treprostinil posted positive preliminary results

United Therapeutics announced that the phase III trial FREEDOM-M evaluating treprostinil diethanolamine sustained release formulation in patients with pulmonary arterial hypertension met the study endpoints after the company conducted a preliminary analysis.

The company expects to have the preliminary data from the second phase III trial FREEDOM - C(2) in 313 patients evaluating treprostinil in PAH subjects in September 2011.

The FREEDOM-M trial:

• It's a randomized, double-blind, placebo-controlled trial evaluating 0.25 mg of treprostinil sustained release formulation against placebo in patients with pulmonary arterial hypertension. 
• The trial enrolled 349 subjects who were randomized into either the placebo group or the active group for a duration of 12 weeks. 
• The study primary endpoint was change in 6 minute-walk-distance test at week 12.
• Data at week 12 are available in 228 patients.
• The trial results showed that subjects treated with treprostinil had an improvement in median of 6MWD by 23 meters compared subjects received placebo (p = 0.0125)

About Treprostinil

• Treprostinil is a prostacyclin modulator wchi works to directly vasodilate the pulmonary and systemic arterial vascular beds.  In addition, it also inhibits platelet aggregation (which could potentially increase risk of bleeding)
• Treprostinil has been developed and approved in the US.  Treprostinil is available in two formulations:
• Tyvaso Inhalant
• It is available in 2.9 mL clear LDPE ampules.  The vial contains 1.74 mg treprostinil per ampule at a concentration of 0.6 mg/mL
• Tyvaso is manufactured by Catalent Pharma Solutions (PI 2011) and is jointly marketed by Lung Rx and United Therapeutics.
• Remodulin for Injection
• It's available in 20 mg, 50 mg, 100 mg, and 200 mg contained in 20-mL vial.
• The product is manufactured by Baxter Pharmaceutical Solutions and Jubilant HollisterStier LLC (PI 2011)

SCT: Ofirmev has been added to the US Military's Joint Deployment Formulary

Cadence Pharmaceuticals announced that  Ofirmev or acetaminophen intravenously formulation has been added to the US Military's Joint Deployment Formulary.

Ofirmev has been approved in the US in November 2010 for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics and the reduction of fever.

GTx is to initiate the phase III trials evaluating ostarine

GTx announced that it has reached an agreement with the FDA to initiate the phase III trial evaluating ostarine or GTx-024 for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer.

The company plans to initiate two phase III trials in July called POWER 1 and POWER 2 (POWER - Prevention and Treatment of Muscle Wasting in CanCER).

Both studies are expected to finish subject enrollments in one year

The FDA approved generic version of Lybrel

Watson announced that the FDA has approved the ANDA submitted by its subsidiary Watson Laboratories for Lybrel, a contraceptive agent, which is currently marketed by Pfizer.

Lybrel is a combination product of Levonorgestrel and Ethinyl Estradiol tablets containing 0.09 mg of levonorgestrel and 0.02 mg of ethinyl estradiol.

Watson expects to launch the product shortly.

Based on data from the IMS, the total US sales for Lybrel for the 12 months ending on April 30, 2011 was a little under $12M.

Sanofi is to submit NDA and MAA following the results of the phase III trial evaluating aflibercept

Regeneron and Sanofi announced that patients treated with Zaltrap or aflibercept incombination with FOLFIRI in patients who were previously treated for metastatic colorectal cancer showed significant improvement in survival compared to patients treated with placebo and FOLFIRI. (The trial was called VELOUR)

Sanofi plans to submit the NDA and the MAA to the US FDA and European Medicines Agency respectively in the second half of the year.

FOLFIRI Regimen includes the following agents:

Sound Pharmaceuticals initiated study evaluating SPI-1005 in the prevention of hearing loss

Sometimes I thought research at university can have interesting topics (or I must say sometimes very unconventional) but the below trial is quite different from what we often hear or read about.

Sound Pharmaceuticals announced that it has initiated a new clinical trial evaluating SPI-1005 in the prevention of hearing loss due to loud music. 

Healthy young adult will be recruited to listen to music that is stored in personal music players.  Subjects will be randomized to take either placebo or SPI-1005 starting two days before they are instructed to listen to music in the personal music players for four hours to induce mild temporary auditory threshold shift.


About SPI-1005:

takeda launched Sonias in Japan

Takeda announced that it has launched Sonias LD and Sonias HD in Japan for the treatment of type 2 diabetes.


Sonias is a combination product of pioglitazone (Actos) and glimepiride.

Sonias comes in two different strengths:

• Sonias LD: Low dose: 15 mg of pioglitazone and 1 mg of glimepiride
• Sonias HD: High Dose: 30 mg of pioglitazone and 3 mg of glimepiride

About pioglitazone and glimepiride

• Pioglitazone is a thiazolidinedione that works through the peroxisome proliferator-activated receptor-gamma found in adipose tissue, skeletal muscle and liver.  By activating the PPAR receptors, pioglitazone decreases insulin resistance in the periphery and in the liver which lead to an increase in increased insulin-dependent glucose disposal and decrease the production of hepatic glucose.
• The mechanism of how glimepiride works is still unknown.  

Acura Received Notice of Allowance for the third Aversion Technology Patent

Acura Pharmaceuticals announced that it has received a receipt of a Notice of Allowance from the US Patent and Trademark Office related to the non-provisional patent application submitted for Aversion Technology platform. 
The company indicates that the patent will be issued

GSK to offer steep discount of Rotarix to developing countries

Just because I like to post good news for the opening of the week!

GSK announced that it is to provide up to 125M doses of Rotarix to developing countries at an approximately $2.5 per dose over the next five year.  This is a 95% decrease in price compared to how much the product is marketed in Western Countries.  The company aims to expand Rotarix access to over 40 countries by 2015.

The offer was made in response to the request from UNICEF for rotavirus vaccines after the company consulted with the Bill & Melinda Gates Foundation and the

Merck and Ariad announced positive results form the phase III SUCCEED study of ridaforolimus - ARIAD is to hold a conference call

Merck and Ariad announced positive results from the phase evaluating the safety and efficacy of ridaforolimus as potential treatment in metastatic soft-tissue or bone sarcomas patients who previously had favorable responses to chemotherapy.

Merck plans to file a NDA for ridaforolimus to the US FDA and the EU EMA later this year.

Ariad plans to conduct a conference call from 5:45 to 6:45 PM central time (6:45 to 7:45 PM Eastern Time) on June 6, 2011 to discuss the comprehensive data from the phase III SUCCEED trial.

• To attend the conference call:
• US Dialers: 800-265-0241
• International Dialers: 617-847-8704
• The webcast will also be available live at http://investor.ariad.com
• The passcode: 91808133

About Merck and Ariad agreement:

The FDA accepted the NDA submitted by Sunovion for ciclesonide

Nycomed announced that the FDA has accepted the New Drug Application submitted by Nycomed's licensing partner Sunovion Pharmaceuticals for ciclesonide nasal aerosol in a hydrofluoroalkane formulation.
The NDA is seeking to market ciclesonide nasal aerosol in HFA 74 mcg once daily with 37 mcg available in one spray in one nostril for the treatment of symptoms of Seasonal Allergic Rhnitis (SAR) and Perennial Allergic rhinitis (PAR) in populations of 12 years and older.

The NDA included data from three randomized, double-blind, parallel-group, multi-center, placebo-controlled trials evaluating ciclesonide administered from 2 to 6 weeks in the US in adolescent and adult subjects suffering from allergic rhinitis.  The three trials consisted of 2,488 subjects in which 761 received 74 mcg once a day.  The trial primary endpoint was difference in changes from baseline of the average morning and evening reflective total nasal symptom scores between the treatment group and the placebo group.  Data from other clinical trials were also included in the NDA.

About the agreement:

Impax Lab hosts conference call to discuss Warning Letter from the FDA

Impax to host a conference call to address warning letter issued by the FDA.  The conference call is to take place at 9:00 AM Eastern Time. 

Dial in the US: 877-273-1376
Dial outside of the US: 702-800-7095
Webcast can be viewed at: www.impaxlabs.com

Impax Lab announced that the FDA has issued a warning letter to its manufacturing facility in Hayward, CA due to the site's deviation from sampling and testing of in process materials and drug products, production record review and process for investigating the failure of certain manufacturing batches (or portion of batches) to meet specifications.

The company is to conduct a voluntary recall of five lots of fenofribate capsules 200 mg at wholesale level in March 2011.

As indicated by the FDA in its warning letter, until the company completes its remedial process and the FDA agrees with the cGMP compliance after re-inspection, the FDA may withhold the approval of all pending and new applications listing the Hayward facility as a manufacturing location of finished dosage forms.

The company said it has been working in the past three months to address issues relating to the manufacturing systems and standards.  It has reduced the production level at the Hayward facility but currently produces products at a normal space and does not anticipate to reducing its manufacturing capacity or hold shipments of finished products.

The company plans to work with the FDA to address the issues posted in the warning lette.

Novartis released positive results of the phase imatnib III trial

Novartis announced positive results of the phase III trial evaluating Glivec in patients with resected CD117-positive gastrointestinal stromal tumors. The trial compared the difference in the duration of Glivec treatment in target population.

The phase III trial was conducted in 400 patients by the Scandinavian Sarcoma Group and the Sarcoma Group of Arbeitsgemeinscharft Internistische Onkologie. 

The results showed that:

•  A significantly higher number of patients taking Glivec for three years had free of cancer recurrence compared to patients taking Glivec for one year after five year (66% vs 48%, HR 0.46, 95% CI - 0.32 - 0.65, p < 0.0001).
• A significantly higher number of patients remained alive in the three year treatment compared to the one year treatment (92% vs 82%, HR 0.45, 95%CI 0.22 - 0.89, p = 0.019).

About Glivec or Gleevec (US brandname) or imatinib

• Glivec has been approved and used in more than 110 countries for the treatment of all phases of Philadelphia + chronic myeloid lymphoma.  
• In addition to the above indications, in the US, the EU and other countries, it has also been approved as treatment for patients with CD117-positive gastrointestinal stromal tumors that cannot be removed surgically or have already spread to other parts of the body.
• In the US and EU, Glivec has also been approved and used in part of post-surgery treatment in adults who have undergone complete surgical removal of CD117-positive gastrointestinal stromal tumors.
• Imatinib is a protein-tyrosine kinase inhibitor that works by inhibiting the BCR-ABL tyrosine kinase which was the resultant of the Philadelphia chromsome abnormality in chronic myeloid lymphoma. 

Tekmira filed an amended complaint against Alnylam

Tekmira announced that it has filed an amended complaint against Alnylam Pharmaceuticals with the Busiesness Litgiation Session of the Massachusetts Superior Court.  The complaint consists of a new claim stating that Alnylam has committed the breach of contract, breach of the implied covenant of good faith and fair dealing, tortious interference with contract relationship, and civil conspiracy.  Tekmia has also stated that Alnylm has breached the license and manufacturing agreements signed between the two companies.

Tekmira also added AlCana Technologies Inc as a defendant in the complaint claiming that there have been a misappropriation of trade secretes, tortious interference with contractual relations, unjust enrichment, unfair and deceptive acts and trade practices and civil conspiracy.

Tekmira filed the amended compalint to seek relief inform of damages including royalties and profits that made by improperly use of Tekmira's technology and termination of Alnylam's license to Tekmira's technology from Alnylam and AlCana.

Seaside Therapeutics initiated the phase III trial using STX209

Seaside Therapeutics announced that it has initiated the pivotal phase III study evaluating STX209  as a potential treatment in social impairment in adolescents and adults (12 to 25) with Fragile X Syndrome.

The trial is planned to be conducted at approximately 20 clinical sites in the US and to enroll approximately 120 subjects.  Subjects will be randomized into either STX209 group or placebo group for a duration of 8 week-treatment period with a maximum of 28 days of titration.  The study plans t

Amylin announced positive results in patients taking metreleptin

Amylin announced that the trial evaluating metreleptin as potential treatment of lipodystrophy  in patients who have one or more metabolic abnormalities showed improvement in A1C level in addition to triglycerides.  The results were presented at the 93rd Annual Meeing and Expo of The Endocrine Society in Boston.

The trial was being conducted under a treatment Investigational New Drug authorized by

Ligand and The Medicines Company entered into a license agreement

Ligand and The Medicines Company announced that they have entered into a worldwide license agreement for Captisol ® which is an intravenous formulation of clopidogrel or Plavix ®. 

Under the agreement, Ligand will receive a $1.75M upfront payment in addition to a potential 422M in milestone payments and up to double digit royalties on