Lixisenatide of Zealand Pharma showed positive reduction in A1C level in phase III trial

The top of the line results of the phase III trial showed significant reduction in A1C level when lixisenatide was used in combination with basal insulin as the treatment of type II diabetes compared to placebo.  Lixisenatide is a glucagon-like peptide-1 agonist developed by Zealand Pharma.  Additional results are expected in the second quarter 2011. Source

GSK halted the development of Simplirix after the failed phase III trial

 

• The phase III trial using Simplirix (Herpes Simplex Vaccine) developed by GSK did not meet its primary endpoint which was the prevention of genital herpes disease.  The phase III trial was conducted in collaboration with the US National Institute of Allergy and Infectious Disease (NIAID).  Over 8000 women were vaccinated at sites located in the US and Canada. While Simplirix had a good safety profile, its efficacy was not high as expected.  GSK decided to stop further develop of Simplirix. Source

First dose of ACH-1625, a HCV protease inhibitor, has been given to a patient participating in its phase II clinical trial

The first dose of ACH-1625 of Achillion has been given to a hepatitis C patient participating in the phase II clinical trial.  ACH-1625, a hepatitis C virus inhibitor developed by Achillion, is now being evaluated for its safety, tolerability and antiviral activity in combination with pegylated interferon alpha-2a and ribavirin.  HCV protease is an essential enzyme that is required for viral replication.  The company anticipates to have the results available by the end of next year.  Source

Acucela and Otsuka entered into a definitive agreement to co-develop and co-promote OPA-6566

Acucela and Otsuka entered into a definitive agreement to co-develop and co-promote OPA-6566, an adenosine A2a receptor agonist originally discovered by Ako Research Institute of Otsuka, as the Glaucoma treatment. Under the agreement, Acucela will perform early clinical development of OPA-6566 in the US.  In addition, Acucela will have the opportunity to opt-in right to co-develop and co-promote the compound with a pre-determined opt-in fee as well as milestone payments.  OPA-6566 has been shown to lower intraocular pressure by activating adenosine A2a receptor. Source

Seattle Genetics and Millenium announced positive result from the pivotal trial using brentuximab vedotin, an antibody-drug conjugate targeting CD30, for the treatment of relapsed or refractory Hodgkin lymphoma (HL) patients.

 Seattle Genetics and Millenium announced positive result from the pivotal trial using brentuximab vedotin, an antibody-drug conjugate targeting CD30, for the treatment of relapsed or refractory Hodgkin lymphoma (HL) patients. Early result showed that 75% of the patients achieved an objective response, which was the primary endpoint of the trial. The company intended to file the biologics license application (BLD) to the US FDA in the first half of 2011. A Marketing Authorization Application to European Medicines Agency is planned in 2011. the Brentuximab is also being studied as the treatment of relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) in the phase II trial which results will be announced in the next few weeks. Source

MDV3100 moves into phase III trial as the treatment of advanced prostate cancer

The phase III trial using MDV3100 developed by Medivation as the treatment of advanced prostate cancer has been initiated.  In 2009, Medivation and Astellas signed a global agreement to co-develop and commercialize MDV3100 as the treatment of early and advanced prostate cancer under which Medivation received a 110 million up-front payment.  Medivation is also eligible for additional milestone payments.  MDV3100 is a novel, triple-acting, oral androgen antagonist that has been shown to slow growth and induce cell death in bicalutamide-resistant cancer via 3 mechanisms: block testosterone binding to androgen receptor, reduce the movement of androgen receptor to the nucleus of prostate cancer cells and inhibit the receptor from binding to DNA. Source

Relistor prefilled syringes of Progenics have been approved to be used in the US, EU, and Canada

The US FDA, European Medicines Agency (EMA) of the European Union (EU), and Health Canada, the Canadian Regulatory Agency have approved the use of prefilled Syringes for Relistor of Progenics in the US, EU, and Canada for the treatment of opioid-induced constipation (OIC) in palliative-care patients with advanced illness. 
Relistor or methylnaltrexone bromide antagonizes the peripheral mu-opioid receptor and displace opioid at the same receptor to reduce the associated constipation side effect.

Some financial updates: financial earnings (Shengtai, Bohai), and Rigel milestone payment from AstraZeneca

• Upon starting the phase III trial using fostamatinib (R788), AstraZeneca has initiated a 25 M milestone payment to Rigel.  R788 is an oral sleen tyrosine kinase (syk) inhibitor, originally developed by Rigel, and is currently being developed by AstraZeneca as the treatment of rheumatoid arthritis.  In Feb 2010, AstraZeneca acquired exclusive rights to future development and commercialization of fostamatinib.  Source

 

• Shengtai Pharmaceutial reported a net profit of almost 3.2 M in the fiscal year of 2010 ended on June 30, 2010, a significant increase from a net loss of 2.6 M at the end of the fiscal year in 2009.  The company had a net caseh of 9.5 M, an almost 8 M increase from the last year.  Source

 

•  Bohai pharma reported a net income of 9.5 M at the end of its fiscal year 2010 ended on June 30, an increase of 1.6 M compared to the same period of last year.  Bohai Pharmaceuticals is a Chinese pharmaceutical based company specialized in production, manufacturing and distribution of traditional Chinese medicine in China. Source

A few updates from J&J

•  J&J has published the result of its phase 3 trial comparing the effects of tapentadol extended release tablet and oxycodone CR as the treatment of chronic low back pain to placebo group in the journal of Expert Opinion of Pharmacoptherapy.   
• The result showed that both tapendatol ER and oxycodone CR provided significantly higher percentages of patients achieved improvement in pain intensity compared to the placebo.
• Treatment discontinuations due to adverse events were 16.7% for tapentadol ER, 32.3% for oxycodone CR, and 4.7% for placebo.  In addition, 5.7% patient in the tapentadol group, 2.7% patients in the oxycodone CR group, and 20.7% patients in the placebo group experienced lack of efficacy.  No statistical analysis was given for these analysis.  
• A new drug application for tapentadol ER has been submitted to the FDA in 2009.  ]
• Tapentadol immediate release, a centrally acting oral analgesic that binds to mu-opioid receptors and inhibitors norepinephrine re-uptake, was approved in 2008 to relief of moderate to severe acute pain in patients over 18 years and older. Source

• Centocor Ortho Biotech Inc has submitted a supplemental Biologics License Application for Simponi, a human monoclonal antibiody that can act to neutralize excess TNF-alpha,  to address its efficacy in inhibiting the progression of structural damage, including major clinical response and maintenance of reducing  signs and symptoms and improving physical function in the treatment of moderately to severely active rheumatoid arthritis.  Simponi has been approved by the FDA in 2009 as the treatment of adults with moderately to severely active RA, active psoriatic arthritis and active ankylosing spondylitis.  Source

• Johnson and Johnson has completed the acquisition of Micrus Endovascular, a global developer and manufacturer of minimally invasive devices for hemorrhagic and ischemic stroke.Micrus Endovascular will operate under Johnson and Johnson's Codman Neurovascular, a business unit of Codman & Shurtleff.  Source

Clinical trial updates from Polymedix and Galapagos

Clinical trial updates from Polymedix and Galapagos

• PMX-30063, a novel small molecule that mimics the host defense immune protein, developed by Polymedix is now being studied for its safety and efficacy as the initial treatment for acute bacterial skin and skin structure infection caused by Staphylococcus aureus in the phase II clinical trial.  The trial plans to enroll 200 patients diagnosed with ABSSSI.  The company plans to release an un-blinded interim analysis of approximately 80 patients who have completed the treatment before the expected full study results will be announced in mid-2011.  Source

•  The phase II trial using GLPG0259 of Galapagos has been initiated as the treatment of rheumatoid arthritis.  GLP0250 is developed by Galapagos internally under an option agreement with Janssen Pharmaceutical.  Janssen pharmaceutical has exclusive rights to license the program for 60 million pounds in addition to potential milestones payments that could be worth up to 776 million pounds and other royalties.  GLPG0259 inhibits the MAPKAPK5 protein in human cell.  MAPKAP5 has been shown to play a key role in inflammation and the breakdown of collagen in human cartilage through research conducted by Galapagos.  Source

Endo Acquired Qualitest for 1.2 B in cash

Endo announced that it has signed a definitive agreement to acquire Qualitest for 1.2 Billion in cash.  Qualitest is one of the leading generic makers in the US.  The purchase will add significant generic product lines into Endo current portfolio (especially pain medications) in addition to increase Endo's revenues and earning growth.  Source

Terminations of Phase III Trials for advanced castration-resistant prostate cancer from AstraZeneca and Pfizer!

Within the same day, both AstraZeneca and Pfizer terminated their phase III clinical trials!

 

• AstraZeneca terminate the phase III trial using Zibotentan, an oral endothelin pathway blocker, as the treatment of advanced castration-resistant prostate cancer.  The preliminary result showed that zibotentan did not offer significant improvement in the overall survival which was the study’s primary endpoint in the study population.  The company does not plan have any regulatory submission for zibotentan at the present time.  Source

 

• Pfizer discontinued the phase III trial using Sutent as the treatment of advanced castration-resistant prostate cancer.  The interim analysis showed that it is unlikely that the trial will meet its primary endpoint, an improvement in overall survival compared to prednisone alone.  Sutent or sunitinib, an oral multi-kinase inhibitor, was approved to be used in treatments of gastrointestinal stromal tumor after disease progression on intolerance to imatinib mesylate and advanced/metastatic renal cell carcinoma (RCC). Source

The phase 1b trial using KAI-4169 developed by KAI Pharmaceuticals as the treatment of secondary hyperparathyroidism has enrolled its first patient

The phase 1b trial using KAI-4169 developed by KAI Pharmaceuticals as the treatment of secondary hyperparathyroidism has enrolled its first patient.  The study will assess the safety and tolerability of KAI4169 as the single ascending dose given intravenously to end-stage renal disease patients with hyperparathyroidism undergoing hemodialysis.  Source

The Russian Federal Agency approved clinical trial using Multikine of Cel-Sci

Cel-Sci announced that the Ethical Council Ministry of Healthcare and Social Development of Russian Federation has approved its phase III trial using Multikine as the treatment of head and neck cancer in Russia . Multikine is a developed by Cel-Sci and the phase III trial is expected to be the largest trial to study the head and neck cancer and will be involved 9 countries around the world.  Source

Transition Therapeutics reported its financial result of 2010 fiscal year with a decrease in net loss compared to the same time of last year

It's been awhile since I posted anything about financial result.  Here it is:

• Transition therapeutic reports its end of fiscal year 2010 that ended on June 30, 2010 with a net loss of about 19 million dollars, a decrease of 3 million Canadian dollar at the end of last year.  The company reported an increase in revenue of almost 2 million dollar compared to the same time of last year to 4.5 M.  The company had 49.6 M Canadian dollar in cash and cash equivalents, short term investment, and others at the end of its fiscal year. Source

OncoGenex has initiated the phase II trial using OGX-427 which is the second-generation antisense drug as the treatment of advanced prostate cancer (in men).

OncoGenex has initiated the phase II trial using OGX-427 which is the second-generation antisense drug as the treatment of advanced prostate cancer (in men).  OGX-427 is targeting the Heat Shock Protein 27 which has been shown to be overexpressed in certain types of cancer.  The trial will study the effects of OGX-427 on prostate specific antigen (PSA) levels, time to progression by PSA or measurable disease, and others. Source

From the FDA desk: Approval of new contraceptive & New treatment of Uveitis

• Allergen announced that it has received the US FDA approval to market Ozurdex (dexamethasone), intravitreal implant as the treatment of uveitis or infecitous ocular inflammation.  Dexamethasone is a corticosteroid that can act to reduce inflammation. Ozurdex is developed using Allergan's proprietary and innovative NOVADUR solid polymer delivery system.  Currently, treatment of uveitis is limited.  The other implant has been approved to treat uveitis is Retisert of Bausch& Lomb. Source

• The FDA has approved a new contraceptive called Beyaz of Bayer Healthcare Pharmaceuticals.  Beyaz contains estrogen, progestin and folate acid.  The product indicates that while it is a contraceptive medication, it will decrease the risk of neural tube defect in children who are conceived after discontinuation of contraceptive products due to the addition of folate in the medication.  Source

Recall from Amgen: Epogen and Procrit

Recall!!!

Amgen initiates nationwide recall of Epogen and Procrit due to glassware contamination. Both Epogen and Procrit are being marketed as treatment of anemia related to HIV therapy, chronic renal failure, and chemotherapy. 

Epogen and Procrit are manufactured by Amgen and distributed by Centocor Ortho Biotech Products. Source

Prucaloride of Movetis is now in the phase III trial for the treatment of chronic constipation in men

Prucalopride, or Resolor of Movetis, a selective high-affinity 5HT4 receptor agonist, is now being studied as the treatment of chronic constipation in men in the phase III trial.  The result is anticipated to be available late 2012 and early 2013.  Prucalopride is being marketed in over 30 European countries as the treatment of chronic constipation in women.  Switzerland recently has approved its used in the treatment of idiopathic chronic constipation in adults when dietary  measures and laxatives do not improve clinical outcomes. Source