Gilead Sciences and Tibotec filed European Marketing Authorizations for TMC-278 separately

Gilead Sciences filed a European Marketing Authorization for TMC-278 and Truvada as the once a day treatment of HIV.  TMC278 or rilpivirine is a non-nucleoside reverse transcriptase inhibitor.  The company used data from its two pivotal phase III studies (THRIVE and ECHO) as evidence showing the efficacy, safety, and tolerability of rilpivirine in combination with two NRTIs in HIV patients. It was originally developed by Tibotec.  In 2009, Gilead and Tibotec entered into a development and commercialization agreement under which Gilead will develop the fixed-dose combination of TMC278 and emtricitabine and tenofovir for the treatment of HIV.    In addition, Tibotec also applied for a European Marketing Authorization separately for TMC-278. Source

The phase II trial using XToll for the treatment of rheumatoid arthritis has completed its enrollment.

The phase II trial using XToll for the treatment of rheumatoid arthritis has completed its enrollment. Xtoll is chaperonin10, a heat shock protein being developed by CBio.

September 2010 - Approvals

September 2010 - Drug Approvals!

The FDA backtracks its decision to withdraw midodrine from the market

• Recently, the FDA issued a letter stating that it would make mandatory withdrawal of midodrine (a medication that is used to treat low blood pressure) from the market if the parent company does not conduct clinical trial to prove its effectiveness.  Shire, the original marketer of midodrine as ProAmatine decided to not conduct clinical trial and will be withdrawing the drug from the market. 
• Hypotension or low blood pressure is not a common condition that you often see.  The drug market is probably not as big as the drug market for high blood pressure in which you have more than 10 or 20 medications that have been approved to treat the condition.  So if one medication is withdrawn, others are in line waiting.  On the other hand, medications that can be used to treat low blood pressure are just a handful.  As a result, taking one drug off the market might have a big effect in patients who rely on the medication to go about the day to day basis.  
• When I first read the news, my first reaction was what would happen to people who undergo dialysis.  If you are not familiar with the process, dialysis is a procedure that is used in patients whose kidneys are not functioning and as a result, the body would accumulate toxic and waste materials that could affect other organ systems.  The dialysis machine will act as the external kidney to remove most and hopefully all (although this sometimes might not be case) in the body.  As the blood travels through the machine, the patient often experiences hypotension or low blood pressure.  Doctors or nurses who administered the procedures often prescribe midodrine to help the patients from having big drop in blood pressure which could cause other damages. 
• A recent article from the New  York Times indicated that patients having heard about the FDA decision have started writing letters to request the reversal of the decision.  These patients utilize this medication to be able to function normally.  Activities such as school and work will be severely impacted when the medication is taken off the market.  In addition, due to limited choice, it is not the drug company that will suffer but the patient will.
• The article indicates the FDA has backtracked and allowed the medication to be remained on the market.  Such decision is lauded.  However, it does make one wonders about what happens if there is a recall about certain lots of this medication.  What will happen to our patients?
• Low blood pressure is not a blockbuster market and hopefully somewhere some other companies will try to develop a new medication to offer patients alternative.

Santhera pharmaceuticals and Ipsen entered into an exclusive agreement under which Ipsen will now have exclusive rights to fipamezole outside of the US, Canada and Japan.

Santhera pharmaceuticals and Ipsen entered into an exclusive agreement under which Ipsen will now have exclusive rights to fipamezole outside of the US, Canada and Japan. In addition, Ipsen will receive a 13 million EU upfront payment. Additional milestone payment can be worth up to 128 Million Eu. Fipamezole is being developed to treat levodopa induced dyskinesia. It was originally developed by Santhera and Juvanita which was acquired by Santhera. A partnership was formed between Santhera and Biovail to develop and commercialize fipamezole in the US and Canada. Source

Orexigen and Takeda entered into an exclusive partnership agreement

Orexigen Therapeutics entered an exclusive partnership agreement with Takeda under which they will develop and commercialize Orexigen's Contrave (naltrexone SR/bupropion SR) in the US, Canada, and Mexico.  Under the agreement, Orexigen will receive an upfront payment of $50M. In addition, Orexigen is subject to receive up to 1 billion in payment as the development reaches its milestones payment.  Contrave is being developed as the treatment of obesity. The New Drug Application has been submitted to the FDA.  The action date will be Jan 31, 2011.  Source

Phase II trial using Lispro, Aspart and rHUPH20 of Halozyme has been initiated

A phase II trial using Lispro, Aspart and rHUPH20 as the treatment of type 1 and type 2 diabetes has been initiated. rHuPH20 is hyaluronidase enzyme that is developed by Halozyme Therapeutics. The phase II clinical trial will be the crossover study and plan to enroll 110 patients. Source

Merck receives approval from the European Comission to market Sycrest!

The European Commission has given Merck its approval to market Sycrest or asenapine, an atypical antipsychotic medication, for the treatment of manic episodes in Bipolar I Disorder.  Merck is now able to market and distribute the drug in 27 European Member States.  Asanepine is marketed in the US as Saphris. Source

Pfizer to acquire FoldRX

Pfizer has entered into an acquisition agreement with FoldRx Pharmaceuticals under which Pfizer will acquire FoldRx.  FoldRX is a pharmaceutical company that have investigational compounds in clinical trials as well as pre-clinical programs.  Tafamidis of FoldRX has been filed for marketing authorixation in Europe with the European Medicines Agency.  The US and EU have given tafamidis orphan drug designation for the treatment of TTR amyloid polyneuropathy.  Source

Pharmapodia Podcast : 09 01.2010

Welcome September, Goodbye August!

Hope your week has been going well!  The long weekend is almost here so hang in there!

Highlight

Drugs on the Move

• The phase I trial of AGS-16M8F, an antibody-drug conjugate developed by Agensys to treat metastatic renal cancer,  has been initiated to study the safety and tolerability in renal cancer patients.
• An animal study using metformin, a commonly prescribed diabetes medication, in mice with lung cancer showed reductions in the number of tumor as well as tumor size.
• The result of a phase 2b trial using fenretinide or RT-101 of ReVision in patients with geographicatrophy showed a more than 50% reduction in incidence of choridal neovascularization.
• A study published in the New England Journal of Medicine showed Meridia or sibutramine often used to treat overweight or obese patients increased heart attack and strokes.

Deal Makers

• The National Institute of Allergy and Infectious Disease has awarded Emergent BioSolutions a 28.7 M contract to develop  the phase II clinical trial of its the third generation anthrax candidate.
• Biomedical Advanced Research And Development Authority has awarded Callerant Therapeutics a

Genzyme and Isis reported the result of mipomerson's phase III data

• Genzyme and Isis presented the result of the phase III study of mipomersen as the treatment of high cholesterol in patients with heterozygous familial hypercholesterolemia (patients have genetic predisposition to high cholesterol).  The study met its primary endpoint with a significant reduction in the level of LDL (bad cholesterol, 28%) compared to the placebo group (5% increase).  In addition, all secondary endpoints were also met.  the most common adverse events: reactions at injection site, flu-like symptoms, and an increase of liver transaminase.  Mipomersen is an apo-B synthesis inhibitor under the development of both Genzyme and Isis.

RapidVue of Quidel gets clearance from the FDA

The FDA approved RapidVue of Quidel to be used as the 3-min pregnancy diagnostic test.     the company plans to launch RapidVue this year.  Source

Pharmapodia Podcast : 08.31.2010

Welcome to Tuesday Podcast! (or the last day of August!)

Here are the highlights:

• The FDA has approved the use of Lumigan of Allergan in the treatment of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
• A phase II trial using Ovaprene of Ovatech, a non-hormonal intravaginal contraceptive showed its sperm killing agents were effective in achieving zero mobile sperm.
• The two year results of the pilot trial using a synthetic cornea of Eyegenix showed positive improvements in eye sight as well as nerve sensation in patients with visual impairment that were comparable to the traditional human allograft transplant group.
• Meda has signed an acquisition agreement in which it will acquire Alaven Pharmaceutical in a deal that was worth 350 million US dollar.
  
  

Radient Pharmaceuticals resumes collaboration with Mayo Collaborative Services

• The collaboration between Radient Pharmaceuticals and Mayo Collaborative Services has been resumed. The collaboration will focus on the clinical study to validate the use of Radient Pharmaceutical’s Onko-Sure in vitro diagnostic (IVD) cancer test in patients with colorectal cancer recurrence as well as treatment monitoring. Over 1000 samples will be used to compare Onko-Sure and Carcinoembryonic Antigen test. (Source)

PharmaPodia Podcast 08 30 2010

Welcome to our Monday podcast! 

Did you check out our Youtube channel?  If you haven't, you should!

Come back to the Monday topic! 

Here are the highlights!

• GRC-17538 of Glenbeck has completed its preclinical trial.  Phase I trial is expected.  It's being developed for the treatment of inflammatory and neuropathic pain.
• BMN-701 of Biomarin received orphan drug designation for the treatment of Pompe Disease.  The IND has been submitted and the company is waiting on the FDA's decision.
• The preliminary result of the phase II trial using cariprazine as the treatment of bipolar depression showed the drug did not give significant improvement in MADRS score compared to placebo.  It's being co-developed by Richter and Forest. Another phase II trial is planned.
• AAD-2004of  NeuroTech Pharma is now in the phase I trial as the treatment of Alzheimer's disease.
• Ivabradine demonstrated significant reduction in risk of death and hospitalization in patients with serious heart condition.  It was approved as the treatment of angina in Europe.
• Torezolid of Trius therapeutics is now in the phase III trial to treat acute bacterial skin and skin
  
  

Second Brand and Generic Quiz - Infectious Disease

Did you master the first quiz yet?

Here come the second quiz for you to try!

 Quiz 2

• Miscellaneous:
• nitrofurantoin : Macrodantin/macrobid
• Sulfonamide
• trimethoprim/sulfamethoxazole: Bactrim, Cotrim, Septra, Sulfatrim
• Quinolone or Respiratory Fluorquinolone
•  levofloxacin : Levaquin
• moxifloxacin: Avelox, Vigamox
• *Boxed Warning*: tendon inflammation and/or rupture w/ quinolone antibiotics, risks may be increased w/ concurrent corticosteroids, organ transplant recipients, and in pts > 60 years of age.
• Quinolone
• ciprofloxacin : Cipro, Cipro XR
• *Boxed Warning*: Tendon inflammation and/or rupture w/ quinolone antibiotics, risks may be increased w/ concurrent corticosteroids, organ transplant recipients, and in pts > 60 years of age.
• Macrolide:
• azithromycin: Zithromax
• clarithromycin: Biaxin, Biaxin XL

Enjoy!


Pharmapodia

Another new Introduction...

Hello again!

It's Monday!  So quick so fast so soon!

Well, I've been thinking about posting the podcast on youtube... and now we have the channel set and ready. This is still in its infancy as I'm still trying to work out and see what will be the best method.

Until then, I hope you enjoy the new addition, a different venue for you to get update on the news!

Subscribe, wouldn't you?

Genzyme rejects Sanofi Offer

After reporting a 18 billion buyout of Genzyme from Sanofi-Aventis, Genzyme rejected the offer claiming the offer undervalued the company! Source

Portola Pharmaceuticals released result of phase II INNOVATE-PCI of elinogrel

• The result of the phase II INNOVATE-PCI comparing the use of oral and IV elinogrel compared to clopidogrel in addition to standard of care in patients undergoing non-urgent PCI showed that oral and IV elinogrel exerted greater antiplatelet effect than clopidogrel.  in addition, the antiplatelet activity was also noted to be greater in elinogrel during the transition from IV dose to oral dose than clopidogrel.  elinogrel is a competitive, reversible P2Y12 ADP receptor antagonist that is licensed to Novartis Pharma by Portola Pharmaceuticals. Source

China Pharmaceuticals reported second quarter financial earnings

• China Pharmaceuticals reported a net income of 5.3 M, a 208% increase from the same quarter of last year. The company had revenues of almost a 10.5 M, a 100% or more increase from the same quarter of lat year. The company had 6.7 M in cash as of June 30, 2010. Source

First Brand and Generic Quiz - Infectious Disease

Hello and welcome to our new experimental project!

On this page is the link to Quizlet page in which you can find the quiz that has been made in order to help you learn about the brand and generic drugs (just in case you want to know them!).  I might add therapeutic classes in the future but for now, I hope you enjoy our new update!  As most of us might have known, brand names come in many different flavors, the brand name listed here are the commonly used ones. 

Quiz 1 (follow the link!)

• Drug included in this set:
• Penicillin
• Penicillin (Pen VK)
• Amoxicillin (Amoxil)
• Amoxicillin + Clavulanate (Augmentin, Augmentin XR)
• Piperacillin + tazobactam (Zosyn)
• ampicillin
• Penicillinase-resistant penicillin
• dicloxacin (Dynapen)
• Cephalosporin
• 3rd generation
• Ceftriaxone (Rocephen)
• Cefpodoxime (Vantin)
• Ceftazidime (Fortaz, Tazicef)
• Cefdinir (Omnicef)
• 1st generation
• Cephalexin (Keflex)

Enjoy!

Pharmapodia!

Pharmapodia Introduces...Brand and Generic Quizzes!

Pharmapodia introduces....

Brand and Generic (top 200 or possibly more) quizzes!

Using Quizlet, a free flashcard maker, Pharmapodia will be posting quiz related to brand and generic (possibly other things on the way, as time allows)....

If you have an iphone (not sure if the droid will do), you can download it to your iphone using certain iphone software such as Cram.  The set is public so feel free to share it with your friends. 

We will try to group them by general indication such as : infectious disease, cardiovascular, diabetes etc.  

This is an ongoing project and changes might be made as we continue to develop this.

In a mean time, we hope you enjoy the new update!

• First Quiz! (terms involved: amoxicillin, cefdinir, penicillin, amoxicillin + clavulanate, cefpodoxime, dicloxacillin, piperacillin + tazobactam, ampicillin, cephalexin, ceftazidime, ceftriaxone)
• 2nd Quiz! (term involved: nitrofurantoin, trimethoprim/sulfamethoxazole, levofloxacin, moxifloxacin, ciprofloxacin, clarithromycin, azithromycin)

Thanks and Enjoy!

A 18.5 million offer from Sanofi-Aventis to Genzyme Corp

• Sanofi-Aventis announced a 18.5 billion or $69 per share offer to take over Genzyme Corp. It's been reported that Genzyme would like to have an offer of at least $75 per share.