Abbott withdraws Meridia from the Market

Abbott voluntarily withdraws Meridia or sibutramine, which is indicated to help overweight or obese patients to lose weight in addition to low-calorie diet, after the FDA's request.  The request stemmed from the results of the trial studying sibutramine effect in cardiovascular outcomes of over 10,000 patients spanning over 6 years.  Abbott advises patients taking sibutramine to discontinue using the medication.  Some of serious side effects were: increase blood pressure, heart rate, serotonin syndrome, seizure and bleeding.
Source

Update from Pfizer: tasocitinib, acquisition of FoldRx, and possible divestiture of Capsugel

• Pfizer reported positive results from the phase II trial using tasocitinib as the treatment of moderate to severe plaque psoriasis: tasocitinib significantly reduce the Psoriasis Area and Severity index when compared to the placebo.  The study had 4 treatment groups: 2, 5, 15 mg tasocitinib and placebo.  The positive result in health-related quality of life outcomes was seen as early as week 4 in the 5 mg and 15 mg treatment groups compared to the placebo.  Tasocitinib is an investigational oral Janus Kinsae inhibitor.  Source
• Pfizer has completed its acquisition of FoldRx  Source 
• Pfizer reviews the future of its business Capsugel. Divestiture might be a possibility.  In 2009, this business unit generated 740 M in revenue.  Capsugel offers a wide range of service: providing different innovative dosage forms and solutions such as: hard gelatin, liquid-filled, vegetarian capsules, innovative R&D equipment and liquid formulation.  Source

October 2010 - Approvals

October 2010 - Drug Approvals!

Par Pharmaceutical shipped Generic Tussionex (R)

• The FDA has approved the generic version of Tussionex (R) - hydrocodone polistirex and chlorpheniramine polistirex (CII) extended release (ER) oral suspension of Tris Pharma, a licensing partner of Par Pharmaceuticals.  Tussionex(R) is being used to relieve cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age and older.  Hydrocodone is a semisynthetic narcotic antitussive and analgesic.  Chlorpheniramine is an H1 receptor agaonist that has anticholinergic and sedative effects.  Par Pharmaceutical has announced that it has started shipping limited shipment of Generic Tussionex (R).  Tussionex (R) is currently marketed by UCB and had an annually sale of approximately $226 M.  Source

Novartis discontinues the developments of albinteferon alfa-2b and efunguban

• Novartis decides to discontinue the development of 2 investigational compound:albinterferon alfa-2b (co-develop with Human Genome Sciences) and Mycograb (darifenacin)
• Albinterferon alfa-2b was being developed as the treatment of chronic hepatitis C.  Efungubam is an antifungal that was being investigated for the treatment of invasive candidiasis in adult patients.
• The discontinuations of these program will incur an intangible asset impairment of approximately 590 M (230 M for albinteferon alfa-2b and 400 M for darifenacin or Mycograb) Source

Watson signed an agreement with Moksha8 of Brazil to expand its presence in Latin America

Watson signed an agreement with Moksha8 of Brazil to expand its presence in Latin America.  Under the agreement, Watson made an initial 30 M investment to Moksha8 and gained significant minority ownership position next to other existing investors TPG Biotechnology and Montreux Equity Partners.   Additional 20 million investment is expected to be matured in the next year.   Watson will also be responsible for the manufacturing and supplying selected products that will be marketed exclusively in Brazil and Mexico by Moksha8.  For these products, Watson will have marketing authorization rights while Moksha8 will be responsible for sales, marketing and commercializing expenses. Watsons already has products marketed in Brazil  through its Brazilian subsidiary. Moksha8 currently has 21 products in the markets. Source

Kapvay, clonidine hydrochloride extended releas tablet, has been approved to treat ADHD

• The FDA has given its approval to Shionogi’s Kapvay – clonidine hydrochloride, a centrally acting alpha-2 adrenoceptor agonist and a non-stimulant agent – to be used as monotherapy for treat attention deficit disorder in children and adolescents aged 7 to 17 years old.  In addition, it is also the first and only medication that can added to other stimulant medications.  According to the company’s press release, the most common and drug related adverse reactions are: somnolence, fatigue, upper respiratory tract infection, and others.  Source

The FDA’s Critical Path Initiative awarded nearly 3 M for TB research

·         The  FDA for  following groups which focus on Tuberculosis Research: (For more information about The Critical Path Initiative please see below!)

o   Michael Brennan, Ph.D., Aeras Global TB Vaccine Foundation – Discovery of biological and immunological biomarkers for TB vaccines

o   Ann Ginsberg, M.D., Ph.D., Global Alliance for TB Drug Development – Frozen trials, developing a repository of clinical trial specimens

o   Khisimuzi Mdluli, Ph.D., Global Alliance of TB Drug Development – Qualifying new preclinical models for the development of tuberculosis drug combinations

o   Fred Quinn, Ph.D., the University of Georgia Research Foundation Inc. – Development of a diagnostic for latent TB

o   John T. Belisle, Ph.D., Colorado State University – Small molecule biomarkers for tuberculosis treatment, relapse, and cure

o   Marc D. Porter, Ph.D., the University of Utah – Development and validation of point-of-care tests for tuberculosis (ultrasensitive SERS detection technology for low concentration antigens).

·         The Clinical Path Initiative was launched in 2004.  It is the FDA’s national strategy to transform how FDA-regulated products were developed, evaluated and manufactured. FDA’s regulated products include: human drugs, biological products, medical dievices, and veterinary drugs. 

·         The focuses of the initiative are as bellow

o   Develop better evaluation tools: identify better marker and develop better assay

o   Ensure the safety and efficiency of clinical trials by modernizing it

o   Encourage the use of bioinformatics

o   Focus on advanced manufacturing tools: process analytic technology and nanotechnology

o   Work to develop products that meet urgent public health needs

o   pay better attention to special or at-risk populations such as pediatrics.

For more detail information you can visit the Critical Path Initiatives

Update from Mylan: Atazanavir, fludarabine and bupropion

• Under the President's Emergency Plan for AIDS Relief (PEPFAR), the FDA has tentatively approved the generic version of Reyataz capsules developed by a subsidiary of Mylan, Matrix, to be used in combination with other medications to control HIV infection.  Reyataz or atazanavir is marketed by Bristol Myers Squibb.  Atazanavir 150 mg and 300 mg capsules of Matrix will be available to developing countries outside of the US once approved. Atazanavir is a protease inhibitor that works to inhibit the processing of Gag and Pol protein which lead to the formation of non-mature virion. Source

• The FDA has approved the generic version of Fludarabine phosphate injection of Mylan packaged in a 2 ml vial with 50 mg of fludarabine to be used as a chemotherapy medication for B-cell chronic lymphocytic leukemia. Fludarabine is a fluorinated nucleotide analog that is resistant to deamination by adenosine deaminase. Source

• Mylan launched Bupropion Hydrochloride Extended-release 150 mg and 300 mg tablets, the generic version of Wellbutrin XL marketed by GSK.  Bupropion is a selectively serotonin reuptake inhibitor.  It's being marketed to treat Major Depressive Disorder and Season Affective Disorder. Source 
• Currently, the FDA has issued boxed warnings in regard to the use of bupropion:
• Increase risk of suicidality when it is used to treat psychiatric patients
• Wellbutrin XL was not approved to be used in smoking cessation however Zyban (another trade name for bupropion) does.  Psychiatric disturbances and changes in mood and behavior (suicidal attempt) have been reported in patients using bupropion for smoking cessation. 
• Discontinuation of bupropion and contact with healthcare professional were advised if patient exhibited unusual changes in moods and behaviors that were not typical
• For more information, please look at package insert for more information

The FDA extended PDUFA date for Xifaxan 550 mg of Salix

The Prescription Drug User Fee Act (PDUFA) goal date for XIFAXAN (rifaximin) 550 mg tablet of Salix has been extended to March 7, 2011.  Rifaximin is a gut-selective antibiotic that has limited systemic absorption and has broad-spectrum activity in vitro against both gram negative and gram positive pathogen.  The proposed additional indication is: treatment of non-constipation irritable bowel syndrome and IBS-related bloating.

• Rifaximim or XIFAXAN 550 mg has been approved to be used as a risk reduction agent for over hepatic encephalopathy recurrence in patients 18 or older. 
• Rifaximim or XIFAXAN 200 mg has been approved to be used in patients who are 12 years or older to treat traveler's diarrhea that are caused by Non-invasive strains of E. coli.  

 Source

Trial used CINATRA (drug coated stent system) with voclosporin did not demonstrate clinical efficacy

The CONFRIM1 trial using Atrium Medical Corporation's CINATRA TM Drug coated Coronary Stent System coated with voclosporin of Isotechnika did not demonstrate clinical efficacy over bare metal stent in angiographic late lumaen loss.  The program is co-developed with Isotechnika Pharma.

Voclosporin, a calcineurin inhibitor, is developed by Isotechnika Pharma.  It's currently being evaluated in different trials as treatment of moderate to severe psoriasis and dry eye syndrome with Isotechnika partner's Lux Biosciences.  Source

The FDA ordered halt to manufacturing, marketing, shipping, and selling of unapproved single-ingredient oral colchicine.

The FDA ordered halt to manufacturing, marketing, shipping, and selling of unapproved single-ingredient oral colchicine.


Colcichine is a medication that has been approved to treat inflammatory conditions:

• gout flares (prophylaxis and treatment)
• Familial Mediterranean fever (FMF): in adults and children 4 years or older

A combination formulation of colchicine and Probenecid is currently being marketed by Watson Laboratories.  And it is being used to treat: chronic gouty arthritis.

Currently, Colcrys or colcichine marketed by AR Scientific is the only FDA approved single-ingredient tablet.  Other colchicine single-ingredient products currently marketed in the US have not been approved.  Colcrys is currently being manufactured by Mutual Pharmaceuticals/URL Pharma.  The manufacturer has established a Patient Assistance Program (PAP) and a Co-Pay Assistance Program (CAP) to ensure the availability and affordability of colchicine. 

• PAP will cover: Patient without insurance, patient with insurance, and Medicare beneficaries enrolled in part D who do not want to use Colcrys payment to contribute toward their true out-of-pocket expenditures part D.
• CAP: eligible patients will not be required to pay more than $25 per prescription
• For more information please visit: www.colcrys.com, www.needymeds.org, or call 1-888-811-8423

Source

Mymetics to use Vivalis' EB66 cell lines to test investigational vaccine

Vivalis and Mymetics Corporation have signed a research license agreement under which Mymetics will utilize Vivalis EB66 cell line to evaluate the replication of an undisclosed vaccine developed by Mymetics.

EB66 cell line is an avian embryonic stem cells that have long-term genetic stability, immortality and cell growth up to high cell densities in suspension using serum-free media.  These are some of the unique industrial and regulatory characteristics.  

Vivalis has filed a Biologics Master File (BMF) for the EB66 cell lines with the US FDA on June 27, 2008. Source