Adventrx met with the FDA

Adventrx announced that it has met with the US FDA to review the development plans for ANX-188 (purified poloxamer 188) for the treatment of sickle cell patients who experienced vaso-occlusive crisis. 

The company and the FDA have discussed on the study design of the phase III trial of ANX-188 but additional meetings are required in the next several weeks and months in order to finalize ANX-188 development plans.  The company said it will continue to manufacture and prepare clinical trial material for the phase III trial which it hopes can be initiated in 2012.

ANX-188 is a novel, purified, rheologic and antithrombotic compound.

Eisai commenced operations of a new research facility at H3 Biomedicine

Eisai held a ceremony to commence the operations of a new research facility at H3 Biomedicine Inc.  H3 Biomedicine Inc is the company’s US research subsidiary and located in Cambridge, Massachusetts.  H3 Biomedicine will be focusing on the development of anticancer medication by integrating genetic information with synthetic organic chemistry.  

H3 Biomedicine was established in

NPS Pharmaceuticals completed the submission of the new drug application for Gattex

NPS Pharmaceuticals announced that it has completed the submission of the new drug application for Gattex® (teduglutide) for the treatment of adults with short bowel syndrome.

The company is requesting the FDA to give the NDA a priority review.  Teduglutide has been given orphan drug designation for the treatment of SBS in both the US and EU.

Gattex (teduglutide) is a recombinant analog of human glucagon-like peptide 2 which has been shown to be involved in gastrointestinal regeneration and repair. 

Included in the NDA are data from 14 completed and one ongoing clinical study.  The medication had been studied in 566 patients.  Of these 566 patients, the safety and efficacy of teduglutide was tested in 173 subjects with short bowel syndrome.

The Marketing Authorization Application has been submitted to the European Medicines Agency by Nycomed, a Takeda company, since the end of September 2011 for the treatment of short bowel syndromes.  NPS Pharmaceuticals and Nycomed entered into an agreement in 2007 allowing Nycomed to develop and commercialize teduglutide outsides of the US, Canada and Mexico. 

Arbor Pharmaceuticals submitted a new drug application for its clinical compound

Arbor Pharmaceutical announced that it has submitted a new drug application for one of its clinical candidates to the US FDA.

The product has just recently been granted an orphan drug designation by the US FDA.  The designation will allow the company to market the product exclusively for six year if the drug is approved for the designated indication .

While the company did not disclose the product name, a search has

Aveo signed contract manufacturing agreement with Boehringer Ingelheim

Aveo signed a contract manufacturing agreement with Boehringer Ingelheim for large-scale process development and clinical manufacturing of ficlatuzumab.

Ficlatuzumab is a novel HFG inhibitory antibody that is being investigated in phase 2 trial as potential treatment for non-small cell lung cancer.

Boehringer Ingelheim will be manufacturing ficlatuzumab for clinical trials at its site in Fremont, CA (USA).

Both companies did not disclose financial terms of the agreement.

Merrimack initiated phase I trial evaluating MM-121

Merrimack announced the initiation of the phase I trial evaluating its MM-121 in combination with one of the multiple standard treatment regimens in patients with advanced solid tumor.

The phase I study aims to evaluate the safety and pharmacokinetics of MM-121  when given with other chemotherapy. 

The first patient has been enrolled at Fox Chase Cancer Center in Philadelphia, PA.  The company expects additional clinical trial sites will be open in both North America and European Union.

The compound is currently being developed under the signed exclusive

Eisai has officially entered the Canadian market

Eisai has officially entered into the Canadian healthcare market with Eisai Limited (Eisai Canada) on November 30.

Eisai Canada was originally established in April 2010 and has launched two products in Canada: Banzel (an antiplatelet agent) and Gliadel Wafer (a chemotherapeutic agent).  The company has filed a New Drug Submission (similar to New Drug Application in the US) for Halaven with the Canadian regulatory authorities.

The expansion to Canadian market is part of the company's mid-term strategic plan "HAYABUSA".  The company plans to increase the number of patients it serving from 200M during the period of 2006 to 2010 to more than 500M during the period of 2011 and 2015. 

Lipitor goes generics

Watson announced the launch of the authorized generic version of Lipitor (atorvastatin) currently marketed by Pfizer.  Under the terms of the exclusive supply and distribution agreement, atorvastatin will be manufactured and supplied to Watson through Pfizer.  Watson is allowed to market and distribute the products in the US.  Pfizer in return will receive a portion of the net sales from Watson's sales of the product.  The agreement is valid until November 30, 2016.

In the twelve months ending September 30, 2011, sales of Lipitor were estimated to be $7.8B according to IMS data.

Atorvastatin is an HMG-reductase inhibitor  that works to decrease cholesterol in the blood.

Mylan received approval to market dexrazoxane

Mylan announced that the abbreviated new drug application subttmited for dexrazoxane for injection has been approved by the US FDA.  The product has been shipped immediately to pharmacy after the approval was received.

The US sales of dexrazoxane in the 12 months ending

Eisai will launch warfarin granule in Japan

Eisai will launch warfarin granules 0.2% in Japan on December 1.  Warfarin granules 0.2% has been approved in Japan since July of this year.  On November 28, the medication was listed on Japan's National Health Insurance drug price list. 

Vestura of Watson has been approved by the FDA

The FDA approved Watson's abbreviated new drug application for Vestura, which is the generic name of Yaz marketed by Bayer.

Vestura like Yaz contains 3 mg drospirenone and 0.02 mg ethinyl estradiol.  According to IMS data, the sales of Yaz reached $173M in the twelve months ending September 30, 2011. 

Vestura has been approved for the prevention of

BioMarin expands its manufacturing facility

BioMarin got approval from the FDA to expand its biologics manufacturing facility in Novato, CA.  The expansion will support the manufacturing of the company’s enzyme replacement therapy portfolio which constitutes of complex glycoprotein products produced by mammalian cells.

Manufacturing facilities will produce the company’s commercial products in addition to material for clinical trials for its pipeline protein products including GALNS for MPS IV, PEG-PAL for PKU, CNP analog for Achondroplasia and a new undisclosed biologic.  The Novato manufacturing facility was initially licensed to produce Aldurazyme for MPS I in 2003.  In 2005, the facility was allowed to manufacture Naglazyme for MPS VI.  The expansion which is adjacent to the current plant will also be used to manufacture Nalgazyme.

The company’s CEO Jean-Jacques Bienaime said the company plans to add its manufacturing capabilities to its recently acquired facility in Ireland.

Nalgazyme (galsulfase) has been approved for the treatment of mucopolysaccharidosis VI (MPS VI).

Aldurazyme (laronidase) has been approved for the treatment of mucopolysaccharidosis I (MPS I): jointly developed with Genzyme Corporation

Kuvan (saproterin dihydrochloride) tablets has been approved for the treatment of phenylketonuria: developed in partnership with Merck KGaA.

Firdapse (amifampridine) has been approved for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS) in Europe.

The company’s GALNS (N-aceylgalactosamine-6-sulfatase) is currently being studied in phase III trial for the treatment of mucopolysaccharidose IVA.

The company’s amifampridine phosphate is currently being studied in phase III trials for the treatment o Lambert Eaton Myasthenic Syndrome in the US.

The company also has other clinical products in phase various development phases.

Regeneron and Bayer take Eylea to China

After gaining the US approval, Regeneron and Bayer’s Eylea is going to China.  The companies have initiated the phase III trial evaluating the use of Eylea for the treatment of wet age-related macular degeneration in China.  Even though China has one of the youngest population in the world, the country also has one of the biggest aging population.  With the exploding market, the move is appropriate and probably necessary.  

The phase III clinical trial will evaluate the efficacy and

Takeda submitted the NDA for a new fixed dose combination containing alogliptin and metformin to the US FDA

Takeda announced that it has submitted the new drug application of its fixed-dose combination product containing alogliptin and metformin to the US FDA for the treatment of type 2 diabetes.

Alogliptin is a selective dipeptidyl peptidase IV inhibitor that has not yet been approved for the treatment of type II diabetes in the US.  The agent works by inhibiting the degradation of dipeptidyl peptidase IV which plays role in breaking down two of the important

Glenmark Generics to market generic Singulair in 2012

Glenmark Generics has received tentative approval to market montelukast sodium 10 mg tablets, the generic version of Singulair of Merck, from the US FDA.

The sale of Singular in the 12 month period ending on September 2011 was $3.2B based on IMS health data. 

Montelukast inhibits the physiologic actions of several of cysteinyl leykotrienes which are released from various cells such as mast cells and eosinophils by inhibiting the leukotriene receptor (often found in the airway).  These cells are often involved with inflammatory processes.  As a result, by inhibiting the receptors for these markers, it will help decreasing the inflammatory process.  One of the resulting effect is the decrease in bronchoconstriction.  As a results, montelukast has been approved for the following indications:

• prophylaxis and chronic treatment of asthma in patients 12 months of age and older
• acute prevention of exercise-induced bronchoconstriction in patients 15 years of age and older
• Relief of symptoms of allergic rhinitis: seasonal allergic rhinitis in patients 2 years of age and older, and perennial allergic rhinitis in patients 6 months of age and older

 Glenmark plans to market montelukast in August 2012 when the patent of Singular expires.

Singulair is available as 4 mg, 5 mg, 10 mg tablets.

Tekmira receives approval from the FDA to initiate phase I trial evaluating TKM-Ebola

Tekmira Pharmaceuticals has received a green light from the FDA to initiate the phase I trial evaluating TKM-Ebola for the treatment of Ebola infection.  The company plans to commence the trial in early 2012.

The phase I trial is a placebo-controlled, single-blind, single-ascending dose study evaluating TKM-Ebola in healthy volunteers who will be divided into different cohorts.  The trial aims to assess the safety and tolerability of TKM-Ebola as well as the pharmacokinetics and systemic exposure of the medication after being given as both a single-ascending dose and multiple-ascending doses.

TKM-Ebola is developed using Tekmira's lipid nanoparticle delivery technology.  The results from preclinical studies published in the medical

Rasitrio of Novartis has been approved in Europe

Novartis announced that the European Commission has approved Rasitrio, which is a triple combination therapy containing aliskiren, amlodipine and hydrochlorothiazide, for the treatment of high blood pressure.

Quick info about the component of Rasitrio:

• aliskiren which represents a relatively new class of high blood pressure medication is a renin inhibitor.  Renin works to produce an inactive decapeptide angiotensin I which is then converted to angiotensin II by angiotensin-converting enzyme (ACE).  Angiotensin II is a vasoconstrictor and can promotes aldosterone secretion and

The FDA approved Intermezzo

After several rejections, Transcept has finally been given a green light to market Intermezzo (zolpidem tartrate sublingual tablet) for the treatment of insomnia in patients who have difficulty returning to sleep after waking up in the middle of the night. 

Intermezzo is the brand name for zolpidem which is a hypnotic agent that is not structurally related to a benzodiazepines barbiturates or other medications that have similar properties. 

Intermezzo can be given to patients at

Tasly Pharmaceuticals selected Icon Clinical Research to conduct its phase III trial

Tasly Pharmaceuticals selected Icon Clinical Research to conduct the phase III t89 trial for the treatment of chronic stable angina pectoris due to coronary heart disease.  T89 (Dantonic) is a Chinese botanical product that has been approved by the State Food and Drug Administration of China in 1993.  The medication has been used in over 10 million patients.

If things go smoothly, T89 will become the first traditional Chinese medicine approved in the State. 

Tasly Pharmaceutical is a fully-owned subsidiary of Tasly Pharmaceuticals Co. Ltd which is based in Tianjin China.  Tasly has businesses in modern traditional Chinese Medicines, chemical and biological drugs, healthcare products and functional foods.  The company is able to conduct its own product development, manufacturing, commercial sales as well as distribution.

Tasly has also entered into a drug-wholesaling venture with the UK's Co-operative group in 2007.