Tekmira acquires worldwide exclusive license to MV-RNA

Tekmira announced that it has signed an agreement with Halo-Bio RNAi Therapeutics Inc to acquire worldwide exclusive license to novel RNAi platform called MV-RNA or multivalent RNA.

The companies will work together to design and develop MV-RNA molecules to target the gene of interests to Tekmira.  In addition, the company plan to combine MV-RNA molecules with its lipid nanoparticle technology to develop therapeutic products.

The MV-RNA technology works to silence multiple molecular targets with a single molecule and hence it has potential to work on multiple pathways to treat a certain disease. The company said MV-RNA can ind to the RNA induced silencing complex more efficiently and thus decreases the off target effects of the RNAi drugs. 

No financial term was disclosed.

Medivir sells generic division

Medivir announced that its subsidiary BioPhausia AB has entered into an agreement to sell its generic division to Bluefish Pharmaceuticals SB for Sek 26M in addition to the value of inventories which is approximated at Sek 12M. 

Staffs that have been working with the generic division BMM Pharma AB which is the generic division of BioPhausia will not be transferred to BlueFish Pharma.

BMM Pharma started selling generics since 2004 in the following countries: Sweden, Norway, Denmark and Finland.

The FDA approved Nucynta ER of Janssen

The FDA is on a roll here!  How many drugs have been approved in the past few days?  Wow! (Botox, Firazyr, Adcetris)

Janssen of Johnson and Johnson announced that the FDA has approved Nucynta or tapentadol extended-release tablets for the

Tradjenta is now approved in the EU

Lilly and Boehringer Ingelheim announced that the European Commission has approved the marketing authorization application submitted for linagliptin 5 mg tablet which will be marketed as Trajenta for the treatment of adults with type 2 diabetes.

The approval allows linagliptin to be used in combination with metformin or metformin plus sulfonylurea.  It can be used as monotherapy in patients who are not controlled by diet and exercise alone and in patients who could not tolerate intolerance or are contraindicated due to renal impairment.

Linagliptin has been approved in the US and

Firazyr of Shire is now approved in the US

Another drug is now approved for acute attacks of Hereditary angioedema in the US (the other two was Berinert and Kalbitor - both were approved in 2009).  

The US FDA has approved Firazyr or icatibant injection of Shire for the treatment of acute attacks of hereditary angioedema (HAE) in patients who are 18 and older

Firazyr has been given orphan drug designation in both

Dey Pharma of Mylan is to exclusively distribute EpiPen 2-Pak(R) and EpiPen Jr-2-Pak(R) Auto-Injector

Mylan's Dey Pharma has decided that it is to follow the National Institute of Allergy and Infectious Disease guidelines for the Diagnosis and Management of Food Allergy in the US by exclusively offer the EpiPen 2-Pak(r) and EpiPen Jr-2-Pak (epinephrine) Auto-Injector 0.3/0.15 mg in order to encourage physicians prescribing what is recommended in the guideline. 

Dey Pharma will no longer shipping single EpiPen Auto-Injector package configurations to US Pharmacy.  So what is available on the market now will be what

Pluristem's PLX Cells received orphan drug status for the treatment of Buerger's Disease

Pluristem announced that the US FDA has designated its PLX cells an orphan status for the treatment of thromboangiitis obliterans or Buerger's disease.

In addition, the company also announced that the application for orphan drug status has been submitted to the EMA's committee for Orphan Medicinal Product in Europe.

By having the orphan drug designation, the company

Catena of Santhera has been issued a patent from the US Patent and Trademark Office

Santhera announced that the company has received notice from the US Patent and Trademark Office stating that it has granted patent protection for the use of idebenone or Catena in the treatment of Duchenne Muscular Dystrophy and other muscular dystrophis.  A similar patent was granted in Europe in 2010.

The US patent is expected to last until 2027. 

Idebenone currently has orphan drug status in both the US and EU for the treatment of

Simcere received approval to market Iremod in China

Simcere pharmaceuticals announced that the State Food and Drug Administration has approved Iremod for the treatment of rheumatoid arthritis. 

This will make it the first Iguratimod medication on the market and is a new drug category of Disease Modifying Anti-rheumatic arthritis.

The product was independently developed by Simcere

Freedom-C2 trial of United Therapeutics failed to reach primary endpoint in preliminary analysis

United Therapeutics announced that the phase III trial (FREEDOM-C(2)) evaluating treprostinil diethanolamine for the treatment of pulmonary arterial hypertension did not meet the study primary endpoint in the preliminary analysis.

Treprostinil diethanolamine is a sustained-release oral formulation of treprostinil.

The phase III trial is a randomized, double-blind, placebo-controlled study enrolled 310 patients who were optimized on an endothelin receptor antagonist, a phosphodiesterase-5 inhibitor or both.  The trial was designed to evaluate the investigational product against placebo over the course of 16-week.  The result showed that no significant difference in a change of a 6-minute walk distance from baseline, the study primary endpoint, was observed between the treatment arm vs placebo.  The average dose of administered treprostinil was 3 mg +/- 1.9 mg given twice daily.

Even though the trial result is negative, the company still plans to submit the NDA in the first half of 2012.

Treprostinil is not a new drug itself because other formulation has been approved for the same indication.  The medication can be given intravenously, subcutaneously or via inhalation.

The company has conducted a conference call in regard to the results of this trial.  Interested parties can access the replay at the company website or call 1-855-859-2056 (for domestic caller) or 1-404-537-3406 (for international caller).  The conference code is 94755163.

Botox can now be used for the treatment of incontinence in specific population in the US

Botox  of Allergan is now approved for the treatment of specific form of urinary incontinence in patients who have neurologic conditions such as spinal cord injury and multiple sclerosis in the US.

Botox is to be administered directly into the bladder once in order to cause the relaxation of the bladder which will then increase the storage capacity and decrease urinary incontinence. In order to perform the injection, physicians need to perform a procedure called cystoscopy which allows doctor to visualize the interior of the bladder. (Once the effect of the medication has worn off, patients are eligible to receive additional treatment).

The FDA gave its nod of approval based on data collected in

Peregrine released additional results of the phase II single-arm trial

Peregrine announced positive results of the phase II trial evaluating bavituximab used in combination with docetaxel for the treatment of locally advanced or metastatic breast cancer. 

The study is a single-arm, multicenter phase II trial evaluating the use of weekly bavituximab and docetaxel in 46 patients who have had locally advanced or metastatic breast cancer who had received one prior chemotherapy regimen.  In today news, the company announced that the median overall survival of bevatixumab is 20.7 months which was about 9 months longer than treatment with docetaxel alone.

The study primary endpoint

Par is set to acquire Anchen Pharmaceuticals - Conference call today at 10:00 AM Eastern Time

Par Pharmaceuticals announced that it is to acquire a privately-held specialty company Anchen Pharmaceuticals ho focused on the development and commercialization of extended release and niche generic products for $410 in cash.

In the second quarter of 2011, the company had earned 224.2 M in revenues which represented a decrease of approximately 30M in the same quarter of last year.   Although the company had a net income of 9M in the second quarter of 2011, the company has a net loss of 99M in the six months ended on June 30, 2011.

As of June 30, 2011, the company had approximately

Simcere's manufacturing facility for Bigi passed EU-GMP inspection

Simcere pharmaceuticals announced that the manufacturing facility for diosmectite which comes in brand as Bigi for the treatment of diarrhea has passed the EU-GMP inspection.

The company has received the EU-GMP certificate after the audit was concluded in April 2011.

I think in the next few years or so, the FDA will be hiring a lots of inspectors (and will also be paying a lot for all the travelings that these will have to go).  Recent announcement has indicated that the FDA and the pharmaceutical manufacturing industry are

How much will Adcetris cost?

Just a quick update on Seattle Genetics' Adcetris pricing:

As mentioned, the company has an assistance program to help patients/providers obtain information on how to obtain the medication.

The conference call yesterday has indicated that Adcetris will be made available at $4500 per vial.  Each vial contains 50 mg and the first vial is ready for shipment as of Monday August 22, 2011.

The dosing information for

Seattle Genetics initiated phase II trial for Adcetris in new patient population

Boosted by the recent approval, Seattle Genetics has initiated the phase II trial evaluating Adcetris in patients with CD30-positive Non-Hodkin Lymphoma including diffuse large B-cell lymphoma, peripheral T-cell lymphoma and other less common lymphoma subtypes.

The study plans to recruit 55 patients at multiple centers in the US.  The study primary endpoint is to determine the antitumor activity of Adcetris as measured by objective response rate.

About Adcetris

Adcetris is an antibody-drug conjugate directed to CD30 that has been recently approved for:

• treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates
• treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen.

Nycomed sealed a deal with Norgine

Nycomed has signed a licensing agreement with Norgine to acquire exclusive rights to commercialize Moviprep in Russia, Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajukistan, Turkmenistan, Ukraine, and Uzbekistan.

Nycomed will be responsible to prepare necessary

NovaDel inked deal with Rechon

NovaDel announced that it has signed an exclusive license and distribution agreement with Rechon Life Science AB to manufacture and commercialize Zolpimist outside the US and Canada.

Zolpimist is the oral spray formulation of zolpidem tartrate that has been approved in the US in December 2008 for the treatment of insomnia characterized by difficulties with sleep initiation. 

Zolpidem is a hypnotic agent that is not

Incivek is now approved in Canada

Vertex Pharmaceuticals announced that it has received marketing approval for Incivek in Canada for the treatment of genotype 1 chronic hepatitis C with compensated liver disease including cirrhosis.  Incivek is to be used in combination with pegylated-interferon and ribavirin, both of which have been used in the treatment of hepatitis C.

Incivek was approved in the US for the same indication and has posed

Seattle Genetics drug's Adcetris got a nod of approval from the FDA!

The FDA has granted accelerated approval for Adcetris or brentuximab vedotin of Seattle Genetics for two indications:

• treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates
• treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen.

The drug was approved based on improvement in response rate.  Data for patient-reported outcomes or survival have not yet been made available (will this be another Avastin? Let's hope not!).  This however is the first drug approved for Hodgkin Lymphoma in the last 30 years!  This also marks the first drug to be approved for anaplastic large cell lymphoma!

Seattle Genetics announced that it is to make the drug available next week.

The company has already established SeaGen Secure (TM) to offer patients and providers access to ADCETRIS reimbursement support, benefit investgiation and patient assistance programs. 

SeaGen can be reached at 855-4SEAGEN or 855-473-2436 on Monday through Friday starting at 9 am to 8 pm Eastern Time.

Adcetris is a CD30-directed antibody-drug conjugate

The NDA for linaclotide has been submited to the FDA

Ironwood and Forest announced that the new drug application for linaclotide for the treatment of irritable bowel syndrome with constipation and chronic constipation has been submitted.

Included in the application are the efficacy and safety data from the phase III program that comprised of four double-blind, placebo-controlled trials in addition to two open-label long term safety studies.   The most common adverse events that lead to discontinuation of the product was diarrhea (which I think makes a lot of sense given how the drug works!).  The long-term safety studies are still on going with over 3,200 enrolled patients.

Linaclotide is a guanylate cyclase type C(GC-C) agonist that works on the guanylate cyclase type-C receptor located on the luminal surface of the intestine.  And because of its site of action, linaclotide is available orally (I don't think the intravenous form would work very well and it is not available intravenous anyway).  The preclinical model has shown that linaclotide is able to accelerate intestinal transit time as well as increase fluid secretion.

The agent has patent covering matter composition that lasts until 2025. 

If approved in the US, the product is to be co-promoted with Forest Pharmaceuticals.  The European development and commercialization have been outlicensed to Almirall SA.  Astellas Phara has rights to develop and commercialize the product in Japan, Indonesia, Korea, the Phillipine, Taiwan, and Thailand. 

About Forest and Ironwood (former Microbia)

The FDA clears Depuy Orthopaedics' Truematch

Johnson and Johnson announced that the FDA has approved the use of Trumatch (R) Personalized Solutions with JNJ's Sigma(R) Fixed-bearing knee system.

Trumatch(R) Personalize solution utilizes CT scans and computer software to guide the development and production of femoral and tibial cutting blocks.  The system is built to individualize to match actual bone surfaces of each patient.  The company said the use of Trumatch solutions can help reducing costs due to a decrease in operating time by an average of 35 minutes. 

The system has been approved and available in 12 other countries and it is to be distributed by DePuy.