Infinity pharmaceuticals initiates the phase II trial of retaspimycin

Infinity Pharmaceuticals announced that it has initiated the phase II trial using retaspimycin hydrochloride (IPI-504) in combination with docetaxel as potential treatment in patient with non-small cell lung cancer.

The trial is an adaptive, randomized, placebo-controlled phase II study evaluating the anti-tumor activity, tolerability, and safety of retaspimycin in combination with docetaxel against docetaxel monotherapy in approximately 100  second or third-line NSCLC patients who have not received treatment with docetaxel previously.

The company will conduct an interim analysis to

The FDA allows initiation of phase I trial using RG3039

Repligen announced that the FDA has approved its plan to initiate the phase I trial using RG3039 as potential treatment for Spinal Muscular Atrophy (SMA), an inherited neurodegenerative disease often characterized by low levels of SMN protein caused by a defect in the SMN1 gene.  Patients affected by SMA often experience progressive damage to motor neuron, loss of muscle function and possible early death.

The planned phase I trial is a double-blind study evaluating

Onyx Pharmaceuticals provided updates on the phase 2b-003 A1 trial of carfilzomib

Onyx Pharmaceuticals released updates of the phase 2b 003-A1 trial using carfilzomib in patients with relapsed and refractory multiple myeloma.

The results showed that 37% of the 257 patients with evaluable results achieved a clinical benefit rate with a duration of response of 8.3 months. The study primary end point is overall response rate which was 24% with a median of the response was 7.8 months.  Patients participated in the study had a median of five prior lines of therapy which correlated to a median of 13 anti-myeloma agents.

The company plans to file the NDA

The FDA approves rilpivirine of Tibotec

FDA approved the use of Edurant or rilpivirine in combination with other antiretroviral drugs as potential treatment in patients with HIV-1 infection who have not been treated with any HIV therapy previously.

(Note: this didn't come as a surprise given the results released earlier)

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor which works by blocking the replication of HIV.  Edurant is going to be taken once a day.

Gilead has resubmitted the NDA for the combination product of Truvada and rilpivirine.  Tibotec signed an agreement with Mylan earlier this year.

The approval came from the phase III trials evaluating the safety and effectiveness of Edurant from the phase III trials in 1,368 adult patients diagnosed with HIV infection for 48 weeks and data from the 96-week with extension to 192 weeks trial.  The trials compared the effectiveness and safety of Edurant and efvirenz in combination with other antiretroviral therapy.  The results showed that Edurant was

Abbott issued statement about Trilipix

Abbott announced that the majority FDA Endocrinologic and Metabolic Drugs Advisory Committee recommends to retain the use of fenofibric acid (marketed as Trilipix in the US) used in combination with statin in patients with mixed dyslipidemia and at high risk of heart disease but at the same the committee requests more clinical data to support the use of use statin/fibrate combination.

The decision was made based on the ACCORD Lipid study. 

The NCEP or the National Cholesterol Education Program has issued guideline to consider

Merck announced recommended approval issued from the CHMP and launch of Victrelis

Merck announced that the Committee for Medicinal Products for human use (CHMP) of the European Medicines Agency has recommended the approval of Victrelis or boceprevir under the accelerated assessment for the treatment of chronic hepatitis C virus genotype 1 infection in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who have failed previous treatment or are not treated previously.

Victrelis has been approved in the US and the company has already made it

Auxilium received milestone payment from Pfizer

Friday the paycheck!

Auxilium pharmaceuticals announced that Pfizer has made a $7.5M in regulatory milestone payment following the first sale of Xiapex in Germany.  Xiapex was launched in Europe in April.  The product was approved in March of 2011 in Europe for the treatment of Dupuytren’s contracture and is marketed as Xiaflex.  The product has also been approved in the us for the same indication.

Xiapenex is priced at $1,000 to 1,400 per vial in Austria, Denmark, Norway, and the UK.

The company also announced that Xiapex is now available for prescribing in the United Kingdom, Germany, Denmark, Sweden, Finland, Normay, and Austria. 

Auxilium announced that it has received approximately

Isis Pharmaceuticals received milestone payment from GSK

Isis Pharmaceuticals announced that it has received a $5M milestone payment from GSK as the company initiated the phase 1 trial for ISIs-TTRRx which is being investigated for the treatment in patients with transthyretin amyloidosis. 

Both companies have recently expanded their agreement that was originally signed last year to discover medicines targeting rare diseases and infectious diseases.

Included this earning, Isis Pharmaceuticals has received

Enzon discontinued the development of PEG-SN38 for the treatment of metastatic colorectal cancer

Enzon announced that it is to discontinue the development of PEG-SN38 program that was being evaluated for the treatment of metastatic colorectal cancer.  The company is currently conducting the phase II study and the complete discontinuation of PEG-SN38 for this indication will be in effect after the completion of the phase II study.

The company is currently developing PEG-SN38 as potential treatment of

Lantheus Medical Imaging released data of the phase II trial using Flurpiridaz F18

Lantheus Medical Imaging released the data of its phase II trial using PET myocardial imaging with Flurpiridaz F18 against single photo emission computed tomography myocardial perfusion imaging as potential method to detect non-invasive coronary artery disease.

The results showed that PET myocardial perfusion imaging with flurpiridaz F18 demonstrated suprior image quality, diagnostic certainty and diagnostic performance compared to SPECT MPI which is the current standard for non-invasive detection of CAD.

The company plans to initiate the phase III trial using flurpiridaz F18 in

Pfizer released positive results of the phase III trial using axitinib

Pfizer released results of the phase III trial using Axitinib as potential treatment in patients who have been previously treated with advanced renal cell carcinoma.

Patients treated with axitinib had significantly longer progression free survival compared to patients with sorafenib (6.7 months vs 4.7 months, HR: 0.665, 95%CI - not indicated).

Patients who progressed after receiving cytokine treatments had a significantly longer progression free survival in the axitinib group compared to the sorafenib group (12.1 vs 6.5 months,  p< 0.0001).

Patients who progressed after receiving sunitinib treatment also significantly longer

FDA clears Toxo Test

FDA has approved VIDAS TOXO IgG Avidity assay of bioMerieux Inc for its use to determine whether a pregnant woman or a person with swollen lymph nodes testing positive for toxoplasmosis which is often known as cat scratch disease.  The test is design to evaluate whether the approved population has been recently infected with toxoplasmosis parasite.

The test utilizes the Toxoplasma gondii present in the assay to detect the

Takeda acquired Nycomed

Despite numerous attempts to stir away the controversy, Takeda has announced that it is to acquire Nycomed with  its acquisition with 9.6B Euron on a cash-free, debt-free basis.  The transaction is expected to be completed within 90 to 120 days (be the end of September 2011).  Nycome is to become a wholly subsidiary of Takeda.  The purchase does not include Nycome's U excludes the US dermatology business which

Biothera initiates phase III trial using Imprime PGG

Biothera announced that it has initiated the phase III trial using Imprime PGG in combination with cetuximab (Erbitux) as potential treatment  in patients who have recurrent or progressive KRAS wild-type colorectal cancer.

About the trial:

• It's an open-label, randomized study evaluating Imrpime PGG used in combination with cetuximab in patients with current or progressive KRAS wild-type colorectal cancer.
• The company plans to enroll up to 795 patients who will be recruited in over 50 clinical sites worldwide.
• The study has two treatment groups: 
• Arm1: patients will be receiving Imprime PGG and cetuximab.  The company plans to enroll

Suven Life Sciences has completed all of the long term chronic toxicological studies of SUVN-502

Suven Life Sciences announced that it has completed all of the long term chronic toxicological studies of SUVN-502 in animals and are now ready to get the FDA approval to initiate the phase2a clinical trials in patients with Alzheimer's or Schizophrenia disease.  The company anticipates to file an Investigational New drug Application with the US FDA this year using the provided tox data to support the initiation of proof of concept clinical trial in the targeted populations. 

The chronic toxicological studies include

Northwest Biotherapeutics partnered with Fraunhofer Institute for Cell Therapy and Immunology

Northwest Biotherapeutics has partnered with the Fraunhofer Institute for Cell Therapy and Immunology to produce DCVax-L for brain cancer, for clinical trials and compassionate use cases in Europe.

Under the partnership, Fraunhofer Institute for Cell Therapy and Immunology IZI will use its manufacturing facility to produce DCVAx and will be helping NWBT with regulatory requirements for both clinical trials and compassionate use cases.  IZI will also be selecting and initiating connections with clinical centers

Shire acquired Advanced BioHealing

Shire announced that it has signed an agreement to acquire Advanced BioHealing with $750M in cash which financed from Shire's existing cash resources.

Upon acquiring Advanced BioHealing, Shire adds Dermagraft into its product line and enters the field of regenerative medicine.

Advanced BioHealing focuses its resources to develop, manufacture, and commercialize living cell-based therapies that repair damaged human tissue and help the body heal itself. The company currently manufactures and markets Dermagraft which is a bio-engineered skin substitute that can be used to assist the restoration of damaged tissue and support the body's natural healing process.  Dermagraft has been approved by the FDA to treat diabetic foot ulcers.  It's currently being evaluated in the pivotal trial to assess its safety and efficacy in the patients with venous leg ulcers.  Data for the trials will be available in the fourth quarter of this year.  The company plans to file a US application in the first quarter 2012 with the FDA.

In addition, the regulatory filing has been submitted in Canada in March 2011.  The product is being reviewed by both the biologics and medical device divisions.  It has been approved in Israel, S. Africa, and Singapore but launch has not yet been announced.  The marketing application is planned for the following countries: Mexico, Saudi Arabia, United Arab Emirates and Malaysia.

Advanced Biohealing has three operation sites in the US including: a manufacturing facility in La Jolla, CA, its corporate offices in Westport, Connecticut, and research laboratories in Brentwood, Tennessee. 

Upon acquisition, the company plans to expand its existing manufacturing capability.  Shire will take pat in helping Advanced BioHealing's current manufacturing functions using Shire's manufacturing process and quality assurance expertise.

Pfizer completed the phase I/II study using ozoralizumab

Ablynx announced that the phase II trial conducted by Pfizer using ozoralizumab in patients with active rheumatoid arthritis has ben completed.

Ozoralizumab was originally developed by Ablynx and was licensed to Pfizer.  The original agreement was signed in 2006 between Ablynx and Wyeth Pharmaceuticals which was acquired by Pfizer.  Until now, the agreement has entered its third extension .  The originally agreement was estimated to possibly give Ablynx up to 212.5M in milestone payments.

Upon complete the proof of concept trial, the company is now working to determine

Watson released positive results of the phase II trial of Rapaflo

Watson released positive results of the phase II study evaluating Rapaflo(R) in 151 patients diagnosed with moderate to severe chronic prostatitis/chronic pelvic pain syndrome at the annual meeting of the American Urological Association.

The study found that patients treated with Rapaflo 4 mg  had a significantly decreased in total score assessed by the National Institutes of Health Chronic Prostatitis symptom index (NIH-CPSI) scale compared to placebo (-12.1 +/- 9.3 vs -8.5 +/- 7.2, p = 0.0224).

The study also found statistically significant decrease in

Watson launches Authorized Generic of Amrix

Watson announced that it has launched Generic Amrix (just a few days later than Mylan).

The company has launched the authorized generic version of Amrix (which is currently marketed by Cephalon) at the following strengths: 15 mg and 30 mg.  As with Amrix, the generic version is the cyclobenzaprine hydrochlodride extended release capsules.  The launch is made available due to an agreement with Watson signed with Anesta AG which is a subsidiary of Cephalon.

The companies have signed the non-exclusive sales agent agreement under which Anesta will manufacture and supply all dosage strengths of the authorized generic product to Watson.  In return, Watson on behalf of Anesta markets and distributes in the US.  Watson will receive payments from Anesta based on the sales of the generic version of Amrix.

About Amrix or cyclobenzaprine

• Amrix or cyclobenzaprine has been approved as

Roche is to promote Victrelis under a newly signed strategic agreement with Merck

Merck and Roche have signed strategic agreement to improve diagnosis, awareness and treatment of chronic hepatitis C infection in developed and emerging markets.  Under the agreement which was non-exclusive, Roche is to promote Victrelis of Merck which was recently approved by the FDA as part of a triple combination

Pfizer's NDA for critozinib has been accepted by the US FDA and new filing has been submitted in Japan

Pfizer announces that the New Drug Application for Crizotinib with the US FDA for the treatment of ALK-positive advanced non-small cell lung cancer has been accepted.  In addition, the company has also filed a the application for Crizotinib to the Japanese Ministry of Healthy, Labour and Welfare for

EnVivo released the results of the phase IIb trial

EnVivo announced that the phase IIb trial evaluating EVP-6124 in patients diagnosed with schizophrenia met the study primary endpoint.

 The company expects to have the full results released at the Medical Conference later this use.

 EnVivo also announcd that it will advance the program based on the results obtained from the phase IIb study.


About the phase IIb trial:

• It's a randomized, placebo-controlled clinical trial evaluating EVP-6124 against placebo in patients

Tekmira and Bristol-Myers Squibb expanded its multi-year contract

Tekmira announced that Tekmira and Bristol-Myers Squibb have expanded their collaboration to broader the applications of Tekmira proprietary lipid nanoparticle (LNP) formulation to evaluate its ability to deliver drug to tumors and other tissues that are not in the liver.

The original contract was signed in 2010 in which Bristol-Myers Squibb is given permission to use Tekmira's SNALP formulation to validate the function of certain cellular targets.  Tekmira is to receive

Merck completes acquisition of Inspire

Merck announced that it has completed the acquisition of Inspire Pharmaceuticals.  As of May 16, 2011, Monarch Transaction Corp has merged with and into Inspire which will be acting as a wholly owned subsidiary of Merck.

Trading of Inspire shares have been ceased in the NASDAQ Global mmarket.

Merck reported back in April that it would acquire Inspire at $5 per share with a total estimated to be $430M.

About Inspire Pharmaceuticals

• Inspire Pharmaceuticals is a specialty pharmaceutical company

Isis Pharmaceuticals and GSK expand their collaborations

Isis Pharmaceuticals announced that Isis and GSK have expanded their collaboration as both initiate the sixth program under the collaboration signed to discover and develop drugs to treat rare and infectious diseases.  With the expansion, Isis Pharmaceuticals earns $3M from GSK.

In March 2010, both companies formed strategic alliance to develop RNA therapeutics.  Including the newly received $3M, Isis pharmaceuticals has received $38M in payment from GSK.  The company is eligible to receive up to

Mylan launches generic of Xibrom

Mylan just never stops producing generics. Just two days ago, the company launched cyclobenzaprine which is the generic of Amrix  and risperidone oral disintegrating tablet which is the generic of Risperdal M-tab.

Mylan has announced that it has just launched the generic version of Xibrom Ophthalmic solution which is the brand name of bromfenac ophthalmic solution 0.09% marketed by Ista for the treatment of postoperative inflammation in patients who have undergone cataract extraction.

Xibro Ophthalmic 0.09% is to be given twice daily.  According to the IMS health data, the sales of bromfenac

Lilly issued another response letter offering its perspective in regard to Amylin's lawsuit

Eli Lilly issued another response letter in regard to Amylin's lawsuit.

In the letter, Lilly stated that it has upheld its responsibility to and obligation in the alliance formed with Amylin.  Amylin has filed a suit stating that Lilly was not using "commercially reasonable efforts to support the success of Byetta or exenatide injection and ultimately Bydureon or exenatide extended-release for injectable suspension". 

Lilly also stated that its alliance with BI is to give more therapeutic options to diabetics in addition the alliance is to develop an oral medication not an injection and hence it is not a direct competition with the products developed under the alliance with Amylin. 

Lilly continues to say that

Sanofi and Glenmark Pharmaceuticals entered into a license agreement

Glenmark Pharmaceuticals and Sanofi have signed a license agreement to develop and commercialize GBR500 for the treatment of Crohn's disease and other chronic autoimmune disorders. 

Under the terms of the agreement, Sanofi will pay Glenmark an upfront payment of $50M.  However, the company won't be paying Glenmark in one single transaction.  The first $25M will be made upon closing of the transaction.  Sanofi will pay the other $25M after it has positively assessed certain data provided by Glenmark. 

Glenmark is also entitled to receive other regulatory and commercial milestone payments.  In addition, it is eligible to receive double-digit royalties on the net sales of commercialized products that are developed under the license signed between the two companies.  The agreement gives Sanofi exclusive marketing rights to

Cel-Sci initiates the phase III trial using Multikine in Poland

Cel-Sci announced that it has initiated the phase III trial using the company's flagship product Multikine in patients with head and neck cancer in Poland.  This will be the first clinical site in Poland and is also the first clinical site in Europe.

The trial has been initiated in the US and India.  The trial has been given an acronym: IT-MATTERS (I really like the creativity here and I wonder whether it's too obvious!)

Recently, the Taiwanese government has approved the

Amylin filed a lawsuit against Eli Lilly

Amylin filed a lawsuit against Eli Lilly with the Southern District of California in the United States District Court claiming that Lilly is engaging in "anticompetitive activity and breaching its strategic alliance agreements with Amylin to maximize commercialization of exenatide". 

Amylin stated that Lilly is "engaging in improper, unlawful, and anticompetitive behavior in the manner in which it plans to implement its recently announced global alliance agreement with BI to jointly develop and commercialize BI's linagliptin product". 

Lilly  has responded with the following statement saying that "the lawsuit is without merit" and the company will "vigorously defend" its position. 

My note: Although I understand Amylin's point of view and without inside knowledge able the details of its agreement with Lilly, it might have gone a bit over for Amylin to suit Lilly when it tries to collaborate with another company to promote another product.  The same company can develop different products for the same therapeutic area.  Unless in the agreement specifically stated that Lilly is not allowed to collaborate with another company to develop a therapeutic product in the same class as Amylin's product, I can see how the breach of agreement can occur.  But then again, it all depends on how the wording in the agreement stated.

Oncolytics initiated phase I trial using Reolysin and signed a commercial supplies agreement with SAFC

Oncolytics Biotech Inc announced that it has signed a commercial supplies agreement with SAFC which is a division of Sigma-aldric Corporation.  Under the agreement, SAFC will manufacture Reolysin which is Oncolytics proprietary reovirus.  SAFC will perform process validation of the product and continue to supply clinical requirement to Oncolytics.  Upon approval, SAFC will also be responsible for the commercial material of Reolysin.

In addition, Oncolytic Biotech has also initiated the phase I trial

Teva is to acquire Taiyo Pharmaceuticals

Teva announced that it has acquired Taiyo Pharmaceuticals for $460M in cash that is to be paid to private shareholders. This constitutes approximately 57% of the shares of Taiyo Pharmaceutical Industry.  Taiyo is a privately-held company.  This acquisition positioned Taiyo at a value of $1.3B.  Teva also offers to purchase all remaining outstanding shares of Taiyo. 

Taiyo Pharmaceutical is a third generic pharmaceutical company in Japan whose sales reached

Novartis released results of the two phase III trials using indacaterol

Novartis announced the results of the two phase III trials evaluating the combination of Onbrez Breezehaler and tiotropium against tiotropium monotherapy in patients with Chronic Obstructive Pulmonary Disease (COPD).

Novartis has submitted the NDA for indacaterol to the US FDA and the review date has been set to be in

Ziopharm filed an investigational new drug application for Ad-RTS-IL-12 developed in partnership with Intrexon

Ziopharm oncology announced that it has filed an investigational new drug application for Ad-RTS-IL-12 which is being developed as potential treatment for melanoma.

The company plans to move Ad-RTS-IL-12 to clinical study in which Ad-RTS-IL 12 iwwll be as administered intratumoral injection.

Agreement between Intrexon and Ziopharm

The initiation of Lu AA21004 of Takeda and Lundbeck in Japan

Takeda Pharmaceuticals and H. Lundbeck A/S (will be referred to as Lundbeck) have initiated the phase III trial using Lu AA21004 as potential treatment of major depressive disorder in Japan.

Lu AA21004 is currently being evaluated in for ongoing short-term studies and two long-term safety studies.

About the trial:
It is a randomized, double-blind, multi-center phase III trial evaluating the efficacy and safety of Lu AA21004 (5 mg and 10 mg) against placebo in approximately 360 patients diagnosed with MDD.

The primary endpoint of the study is the change in Montgomery-Asberg Depression Rating Scale or MADRS from baseline until after eight weeks of treatment.

About the agreement between Takeda and Lundbeck:

Mylan launches Generic of Amrix

Mylan announced that it has launched the first generic version of Amrix Capsules which is the brand name of Cyclobenzaprine hydrochloride Extended Release capsules marketed by Cephalon at the following strengths: 15 mg and 30 mg.

Mylan was the first company that filed a substantially complete ANDA which included paragraph IV certification of cyclobenzaprine HCl ER Capsules.  As a result, the company has been awarded an exclusive marketing opportunty of 180 days.  During this period, the company will be the sole generic provider of Amrix.

Based on IMS health data, the sales of Amrix Capsules were estimated to be approximately $125M in the 12 months ended on March 31, 2011. 

Teva has recently

Mylan launches generic Risperdal M-Tab

Mylan announced that it has launched the generic version of Risperdal M-tab which is the brand name of Risperidone Orally Disintegerating Tablets at the following strengths: 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg.

The brand name version is currently being marketed by Ortho-McNeil for the treatment of schizophrenia.

According to IMS Health data, risperidone ODT had a sale of $61M in the 12 months ended on December 31, 2010.

About Risperdal or Risperidone

• Risperidone is a selective monoaminergic antagonist that has high affinity for the serotonin Type 2 receptor, dopamine Type 2 dreceptor, alpha 1 and alpha 2 adrenergic receptors and H1 histaminergic receptors.  
• Besides being available in oral disintegrating tablet, risperidone also is available

Siga Technologies signed contract with BARDA

Siga Technologies announced that it has signed a contract with the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services to supply two million courses of the ST-246, the company's smallpox antiviral, to the Strategic National Stockpile. 

The five-year contract is estimated to be worth approximately