Wolters Kluwers Health acquired Lexi-Comp

Wow I just have to report this because I use Lexi-comp very frequently and although I have been introduced to Facts & Comparison, I find myself don't use it very often because of the unfriendly user-interface.  Lexi-comp tends to organize its information a little bit better and easier to find than Facts & Comparisons.  But Lexi-Comp has reported that Wolters Kluwer Health has acquired Lexi-Comp.  So now the company will have two products used to be competitive with one another under one roof. 

Even though Lexi-comp is more

The FDA approved Zytiga of Centocor Ortho BioTech

The FDA has approved Zytiga or abiraterone acetate of Centocor Ortho BioTech Inc to be used with prednisone in patients who have been diagnosed with late-stage castration-resistant prostate cancer that was previously treated with docetaxel.

The approval came before the assigned PDUFA date which was June 20, 2011. Patient support information has also been established.  See below for details.

Zytiga will be distributed through specialty pharmacy which means you can't get it at your regular pharmacy.

The decision made by the FDA came from clinical study evaluating the use of Zytiga in 1,195 patients with

MorphoSys received milestone payment from OncoMed

MorphoSys announced that the FDA has accepted the Investigational Drug Application (submitted by OncoMed who collaborated with Bayer in the project) for its HuCAL-derived fully human antibody (OMP-18R5) and hence triggered a milestone payment from OncoMed.

MorphoSys and OncoMed Pharmaceuticals signed a license agreement

Savient to release its financial earnings of first quarter 2011

Savient Pharmaceuticals announced that it would release the financial earnings of its first quarter 2011 on Thursday May 5, 2011 before the market opens.

The company will hold a conference call on the same date at 9:00 AM EST.

Based on the press release, the conference call can be accessed as follows:

• US residents: 888-357-3694
• International Residents: 973-890-8276
• Identification number: 61789535

Interested parties can also access the webcast through the company website.  Please follow this link.

Replay of the conference call will be available through

Merck released financial earnings of its first quarter

Merck released its financial earnings for its first quarter 2011.  The company reported a net income of 1.07B which is an increase of 0.64B compared to the same quarter of last year.

	First Quarter 2011	First quarter 2010	Difference
Net income (net loss)	1.07B	0.33B	0.64B
Research and Development	3.158B	2.051B	0.107B
Marketing and Administrative	3.146B	3.222B	0.084B
Sales	11.58B	11.422B	0.158B
Sales in Pharmaceutical Segment	9.82B	9.665B	0.155B
Sales in Animal Health Segment	0.758B	0.709B	0.049B
Sales in Consumer Care	0.517B	0.489B	0.028B

Highlights:

SCT: Nautic Partners Acquires Omnicare Clinical Research

Nautic Partners announced that it has acquired OmniCare Clinical Research which is a full-service, global clinical research organization.

This is the third acquisition of Nautic Partners since the starting of 2011.  Nautic Partners acquired AAVID Thermalloy in Jan 2011 and Reliant Hospital Partners in March 2011.

About OmniCare Clinical Research:

• The company often carries out early phase, phase II/III and late phase clinical trials for

Sanofi-Aventis reported its first quarter financial earnings

Sanofi-Aventis announced its earning (a previously reported) with a net income of 2.17B Euro which was a decline of 10.6% from the same quarter of last year.

in Euro	First Quarter 2011	First Quarter 2010	Difference
Net income	2.17B	2.427B	0.257B
Research and Development Expenses	1.1B	1.143B	0.042B
Net sales	7.779B	7.898B	0.019B
Selling and general expenses	1.93B	1.84B	0.09B
Net sales by Pharmaceuticals	6.583B	6.441B	0.142B
Net sales by Vaccines	0.602B	0.944B	0.342B
Net sales by Animal Health	0.594B	0.513B	0.081B

 News from Animal Health Product:

Radient Pharmaceuticals released positive results of the trial using ONKO-Sure

Radient Pharmaceuticals announced the results of the US clinical trial using ONKO-SURE as potential diagnostic tool for colorectal cancer.   The trial was done in collaboration with Mayo Collaborative Service.

The trial evaluated the use of Onko-Sure (DR-70) in combination with carcinoembryonic Antigen (CEA)  in the detection of colorectal cancer in all stages. The purpose of the trial was to validate the efficiency of using Onko-Sure in comparison to CEA in the diagnosis of colorectal cancer in patients who were not having the cancer and were having cancer at various stages.  The trial was done in 976 samples provided by the Mayo Collaborative Clinic.  These samples were tested using the standard CEA cancer screening test.  Onko-Sure upon received the samples performed the in-vitro Onko-Sure diagnostic test to compare it with the results obtained from the MCC.  The data were analyzed by the third party statistical analysis service.

The results indicated that the use of Onko-Sure in combination with Carcinoembryonic Antigen showed

Cadence Pharmaceuticals to release its financial earnings

Cadence Pharmaceuticals announced that it is to release the first quarter financial results on May 5, 2011.

The company will host a conference and live webcast (simultaneously) on the same day at 8:30 AM Eastern Time (5:30 AM Pacific time).

Interested parties can join the conference call by dialing the following numbers:

• US residents: 877-303-9145
• International Residents: 760-536-5203

The webcast

The FDA Advisory Committee recommends the approval of telaprevir

A good day for Hepatitis C medication!

Upon waiting for the decision from the FDA Advisory Committee decision on the New Drug Application of telaprevir of Vertex, the trading of Vertex stock was halted and it may be for good.  The same thing happened to Optimer when the FDA advisory committee reviewed the NDA of fidamoxicin.  The reason is probably due to the over-reaction which happened not too long ago sending stocks of Salix down at least 20% after it announced that the FDA will not be approving the application submitted for Xifaxan

The result is....

The FDA approved the commencement of the phase I trial of OMP-18R5

OncoMed announced that the US FDA has allowed the commencement of the phase I trial using the company's anti-cancer stem cell therapeutic OMP-18R5 in patients with advanced solid tumors.

With the announcement, OncoMed received a $20M milestone payment from Bayer HealthCare Pharmaceuticals based on the signed strategic alliance agreement that occurred

The FDA Advistory Committee Recommends the Approval of Victrelis or boceprevir

mThe FDA Advisory Committee unanimously recommends the approval of Victrelis or boceprevir as potential treatment in patients with chronic HCV Genotype 1 Infection.

Although the FDA does not have to follow the FDA Advisory Committee, it often does.  The FDA will decide on the fate of Victrelis in mid-May (May seems to be a busy month!)

Boceprevir is a new class of hepatitis C virus protease inhibitor and has been granted a priority review status by the FDA (which is what Columbia Lab is seeking for its PROCHIEVE 8% recently).

The company has also submitted the Marketing Authorization Application

Columbia Laboratories filed the NDA for PROCHIEVE 8%

Watson announced that Columbia Laboratories has submitted the New Drug Application for Prochieve (R) Vaginal Progesterone Gel to the FDA to use in the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy.  (Let's hope if approved, this won't cause another Makena headache as KV Pharmaceutical did not too long ago)

Columbia Laboratories has requested the FDA to grant its NDA priority review.  If approved, the review process of the NDA for Prochieve can be completed in 6 months.

The company submitted data based on the positive results from the two phase III clinical trials evaluating the use of PROCHIEVE in the risk reduction of preterm birth in women.  The company also submitted pharmacokinetics studies supporting the use of PROCHIEVE in the indicated population.

Results from one of the phase III clinical trials (The PREGNANT Study)

• The trial evaluated the use of PROCHIEVE (8%) against placebo in patients who have cervical length between 10 to 20 mm measured by transvaginal ultrasound at mid-pregnancy.  The results showed that PROCHIEVE significantly reduce the rate of preterm birth that happened 33 weeks gestration) compared to placebo.  PROCHIEVE also significantly reduced the rate of preterm birth before 28 and 35 weeks against placebo. 

About the Agreement between Watson and Columbia Laboratories

Provectus Pharmaceuticals received orphan drug designation for PV-10

Provectus Pharmaceuticals received orphan drug designation from the FDA as potential treatment for liver cancer for Rose Bengal which is the active ingredient of PV-10.  This designation allows Provectus to exclusively market PV-10 for the treatment of hepatocellular carcinoma in the US for up to 7 years if it were to become the first company to receive approval to market the product in the US.  The company is also eligible to apply for the fee waiver for the Prescription Drug User Fee Act (PDUFA).

The company has completed enrollment for the phase I trial in Jan 2011 and is currently working on the design of the phase II trial for hepatocellular carcinoma.

The company has also completed the phase II

Johnson & Johnson acquired Synthes with 21.9B

Just hours before the company presents at its annual shareholder meetings (on April 28 @ 10 AM EST), Johnson and Johnson announced that it has entered into an agreement to merge with Synthes, a global manufacturer of orthopaedic devices.  The acquisition is estimated to be worth 21.9B.

Under the terms of the agreement, shareholders of Synthes are entitled to receive CHF 55.65 in cash and CHF 103.35 of Johnson & Johnson stock per each share that they own.

As of April 26, 2011, Synthes has approximately 119.5M fully diluted shares outstanding and an approximately 2B in cash.

The acquisition is expected to be completed in the second half of 2012. 

The company anticipates the acquisition will bring:

• product development capabilities and robust pipelines 
• expand both companies' portfolio orthopaedics solutions worldwide
• commitment to improve patient care and quality of life.

The company held a conference call

Aergerion Pharmaceuticals announced that the US Patent and Trademark Office has issued the patent number 7,932,268 covering the methods for treating disoders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects for lomitapide.

The patent is expected to last until August 2027

Watson released financial earnings of the first quarter 2011

As reported earlier, Watson Pharmaceuticals released its financial earnings of the first quarter of 2011.

The company recorded a net income of 44.8M which is a decrease of 25.0M compared to the same quarter of last year (44.8 M vs 69.8M).

The company also reported that Columbia Laboratories has submitted the NDA for PROCHIEVE (R) Vaginal Gel.

 The company had $514.8M

Sanofi-Aventis to report its first quarter earnings

Sanofi-Aventis is to release its financial earnings for first quarter 2011 on April 28, 2011

The press release of the financial results will be available at 7:30 AM Central European Time (which mean it is going to be 1:30 AM Eastern Time - for the night owls)

The Presentation will be available at 2:30 PM Central European Time.

The live webcast will be held at 3:00 PM Central European Time and can be accessed through the company website.

Recent News:

Sanofi-Aventis and Regeneron announced positive results in trial using aflibercept

Sanofi-Aventis and Regeneron announced positive results from the phase III trial using aflibercept as potential treatment in second-line metastatic colorectal cancer.

The trial showed that Zaltrap or aflibercept (VEGF-TRAP) when used with FOLFIRI (a combination chemotherapeutic regiment of folinic acid - leucovorin, 5-fluorouracil and irinotecan) showed improvement in overall survival. (I don't know why no data was reported)

The most commonly observed adverse events associated with aflibercept and FOLFIRI combination were diarrhea, asthenia, fatigue, stomatitis, and ulceration, nausea, infection, hypertension, gastrointestinal and abdominal pains, vomiting, decreased appetite, decreased weight, epistaxis, alopecia and dysphonia.

Upon releasing the data, Regeneron shares' price

Lexicon to release its financial earnings for first quarter 2011

Lexicon announced that it is to release the first quarter earnings of 2011 on May 3, 2011 before the market opens.

The company will hold a conference call with simultaneous webcast on the same day at 11:00 AM Eastern Time.  The reply of the conference call will be available through the company website until May 31, 2011.

To access the conference call:

• US and Canadian Residents:
• 888-220-1244
• International Residents:
• 706-679-5615
• The conference call ID: 62216935

Recent News:

Vertex Pharmaceuticals to release its financial earnings

Vertex announced that it will release its first quarter financial results on May 3, 2011 after the market closes.

The company will host a conference call at 5:00 PM Eastern Time,

The live webcast will be available through the company website.  You can follow this link!

Recent News:

Mylan launches letrozole (generic of Femara)

Mylan announced that it has launched the generic version of Femara 2.5 mg.

Femara is currently marketed in by Novartis.  Mylan was the first to file the ANDA to the FDA.  In December 2008,  Novartis and Mylan reached an agreement to allow Myland markets the generic version of Femara, letrozole 2.5 mg, before the US Patent Expiration of the Patent Number 4,978,672.  Other terms were not disclosed and remained confidential.

About Femara

Horizon Pharmaceuticals received FDA approval for Duexis

Horizon announced that the FDA has approved Duexis which is the combination of ibuprofen and famotidine for the relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis as well as its use in the risk reduction of developing upper gastrointestinal ulcers.

The company plans to make the drug available in the US in the second half of 2011.

Duexis was studied in two multicenter, double-blind, active controlled trials that lasted 24 weeks in patients who require daily administration of non-steroidal anti-inflammatory drug for at least 6 months for one of the following conditions: osteoarthritis, rheumatoid arthritis, chronic low back pain, chronic regional pain syndrome, and chronic soft tissue pain (REDUCE-1 and REDUCE-2).   Patients were given

XenoPort to conduct phase III trial using arbaclofen under the SPA

XenoPort announces that the FDA and the company have agreed on the Special Protocol Assessment that is going to be used in the pivotal phase III trial using arbaclofen placarbil as potential treatment for spasticity in multiple sclerosis patients.  The data from the phase III trial will be used to support the new drug application that will be submitted by XenoPort to the FDA for arbaclofen approval.

XenoPort plans to initiate the phase III trial in the second quarter of 2011. 

The company has recently completed the end of phase II meeting with the FDA and will be conducting additional studies that will be used as supporting materials for the NDA that it plans to submit to the FDA (see below)

About the planned phase III trial:

Merck and Sanofi Aventis initiated phase III trial

Merck and Sanofi Aventis initiated the phase III trial evaluating the safety and efficacy of the combination vaccine comprising the following components DtaP5-IPV-Hib-HepB (stand for: Diptheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B vaccine) in infants in the US. The combination is being evaluated to protect infants from the following disases: diphtheria, tetanus, whopping cough, polio (types 1,2,3), invasive disease caused by Haemophilus influenza type b, and hepatitis B.

The trial is a randomized, open-label

HemaQuest enrolls first patient in phase II trial evaluating HQK-1001

HemaQuest Pharmaceuticals announced that it has enrolled the first patient in the phase II trial evaluating HQK-1001 in patients with sickle cell disease.

The company expect to have interim results available late 2011 and full results available in the first quarter of 2012.

About the Phase II trial:

• It's a randomized multi-dose phase II trial evaluating the safety and tolerability of HQK-1001 in

Wockhardt to market generic Aricept

Wockhardt announced that it has received the US FDA approval to market the generic version of Aricept tablets.   Wockhardt is said to manufacture the active pharmaceutical ingredient and the tablet.   According to the press release, the Active Ingredient will be

Daiichi Sankyo receives marketing approval for edoxaban

Daiichi Sankyo announced that the Ministry of Health, Labor and Welfare has granted the marketing approval for Lixiana or edoxaban to be used for the prevention of venous thromboembolism after major orthopedic surgery.  The approved doses were 15 mg and 30 mg.  Edoxaban can be used once daily.

Besides being studied for the prevention of thromboembolism after major orthopedic surgery, the molecule is also being investigated for use as

The FDA has approved to expand the use of menactra meningococcal conjuvate vaccine of Sanofi Pasteur in infants.

Menactra is a polysaccharide diphtheria toxoid conjugate vaccine. It covers serogroups A, C, Y and W-135. Infants and children whose ages range from 9 months to 23 months will be given a total of 2 doses of Menactra that are administered three months apart.

Menactra has been approved in the US previously

ISIS Pharmaceuticals to release first quarter earnings

Earning Season is in full swing!

Isis Pharmaceuticals announced that it will host webcast upon releasing its financial earnings for first quarter 2011 on May 5, 2011.

The webcast will take place at 4:30 PM Eastern Time or

Ganaxolone receives US Patent

The US Patent and Trademark Office has issued Patent Number 7,858,609 to cover solid formulations and methods of the making and use thereof for ganaxolone of Marinus.

The patent will provide ganaxolone coverage until the end of 2026. 

A second patent application covering a new synthesis method for ganaxolone has also been submitted.  The patent application asks for protection covering the decrease of number of process steps thus increasing cost efficiency.

About Ganaxolone: 

Pfizer to release first quarter earnings

Pfizer to release the its earnings of the first quarter on May 3, 2011.

The company invites all interested parties to attend the webcast and conference call with analyst at 10 am EST on the same date.

To access the conference call:

• US and Canada Residents: 1-866-246-2525
• International Residents: 706-634-2365
• Passwords: First Quarter Earnings

To access the webcast:

• Registration is required and can be accessed here
• More information can be found here

Recent News: 

Bayer and newly published data on drospirenone and levonorgestrel

Recent studies have shown association between incidence of non-fatal venous thromboembolism and the use of drospirenone-containing oral contraceptives in women.  The two studies were:

• Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel: nested case-control study based in UK General Practice Research Database by Lianne Parkin et al published in the British Medical Journal (international edition) on April 21, 2011. (1)
• Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using US Claims Data by Susan S. Jick et al published in the British Medical Journal on April 21, 2011. (2)

Here is the brief information about each trial:

FDA Approval - April

After updating the March Approval, it's April's Turn!

You can see an update of April Approval here!

Enjoy!

Pharmapodia

Update Pharmapodia

Hi all,

In case you haven't noticed, I've added on the side bar recent releases of financial earnings of different companies.

Enjoy & Happy Easter! :)

Pharmapodia