DUSA sets date to release its financial earnings

DUSA Pharmaceuticals announced that it will release its financial earnings in the fourth quarter and the fiscal year 2010 on Thursday, March 3rd at 6:30 AM EST.

The company will hold a conference call on the same date at 8:30 AM EST

To access the conference call

• North America Resident: 
• 800-647-4314
• International Callers: 
• 502-719-4466
• And you will need a password:
•  DUSA

If you happen to miss the conference call, the replay will be available 15 minutes after the conference call concludes

• North America Resident:
• 877-863-0350
• International Resident:
• 858-244-1268

 About DUSA Pharmaceuticals

•  DUSA Pharmaceuticals have several products on the market:
• Levulan Kerastick: It's 20% aminolevulinic acid HCl topical solution plus blue light illumination

IQ Therapeutics initiates the phase I trial for IQ-DAA

IQ Therapeutics initiates the phase I trial using its investigational product IQ-DAA for the treatment against anthrax.

About the clinical trial

• It's a randomized, placebo controlled, double blind, single dose-escalating trial.  The initial focus of the study will be safety and tolerability of IQNLF, a component of IQ-DAA (which will be described later). 
• The company plans to enroll 32 healthy volunteers.
• The study will be conducted by QPS Netherlands, BV.

About IQ-DAA (just a note from me: I love it how they name their product IQ-something... reminds me of intelligence test)

• IQ-DAA is a combination product of two monoclonal human antibodies which have abilities to neutralizing lethal toxin produced by Bacillus anthracis.  The antibodies do so by targeting the PA and LF components of the toxin.
• ID-DAA (stands for Dual Antibody Approach) consists of two antibodies against Protective Antigens and Lethal Factor  - both are parts of the toxin secreted by Bacillus anthracis.  
• Antibody directly acts against Protective Antigens is called IQNPA
• Antibody directly acts against Lethal Factor is called IQNLF.

IQ-Therapeutics

• IQ Therapeutics is a business of IQ Corporations.  The company plans to use its novel and proprietary human antibody-based technology to develop and deliver instant immunity to patients.
• IQ Therapeutics lead compound is IQ-DAA which is being investigated for the treatment of Anthrax Infections.
• The company technology: The Cloning the Human Response Technology uses resources from immunized donors to generate and develop fully human antibodies.
• The company strategic partner is DSM who invests as well as supplies the manufacturing capacity for monoclonal antibodies

My thought

• This is a neat concept.  It's probably not the first company has come up with the idea but the technology is interesting.  However, they might also need to consider how the body immune system will recognize the delivered treatment. 

Savient released its financial earnings of the fourth quarter and fiscal year 2010

In the same press release, Savient reported its financial earnings of the fourth quarter and the fiscal year 2010 ended on December 31, 2010.

	4th quarter 2010	4th quarter 2009	Change
Net income (loss)	(0.5M)	(0.2M)	0.3M
Revenue	1M	0.9M	0.1M
Research and Development	9.8M	9.7M	0.1M
Sellings & General Administrative expenses	8.2M	5.4M	2.8M

	Fiscal Year 2010	Fiscal Year 2009	Change
Net income (loss)	(73.1M)	(90.8M)	17.8M
Revenue	4M	3M	1M
Research and Development	32.4M	51.7M	19.3M
Selling & General Administrative expenses	25.M	30.8M	5.8M
At December 31, cash and short term investments	64.9M	108.2M	43.3M

About Savient:

• Savient is a specialty pharmaceutical company.  
• It's currently having two products on the market: Krystexxa (approved last year) and Oxandrin/

The company held a conference call on the same date and the replay can be accessed through March 11, 2011.

US:

• 1800-642-1687

International:

• 706-645-9291

Conference ID number: 45733606

The replay of the webcast is also available on the company archive for review

The FDA refused to approve taliglucerase alfa

The FDA refused to approve taliglucerase alfa for its use in the treatment of Gaucher disease.

Issues raised by the FDA:

• clinical and chemistry, manufacturing and controls: the FDA required additional testing specifications and assay validation
• Additional data from the switchover trial and long-term extension trial

Recently, Protalix has released its interim data in regard to the phase III trial  which was not

BioCryst received an additional $55M funding from the US Department of Health & Human Services to complete peramivir phase III program.

BioCryst received an additional $55M funding from the US Department of Health & Human Services to complete peramivir phase III program. The contract has also been extended through December 31, 2013. 

With the additional funding, the company plans to open more sites for the ongoing phase III study.  Recently, the FDA and HHS have recently agreed to change the study protocol recently.

The news release announces the following implementations

• Change in primary efficacy analysis:  the study will focus on the subset of approximately 160 patients not treated with neuraminidase inhibitors as standard of

Savient Pharmaceuticals official launches Krystexxa

Savient Pharmaceuticals has officially launched Krystexxa in the US although it has been commercialized in December 2010.

Krystexxa or pegloticase has been approved for the treatment of chronic gout in adult patients refractory to conventional therapy.

The company plans to complete its EU submission in the first quarter 2011or sometimes after that.  The company also plans to file marketing application for Krystexxas in other countries around the

Nesina gained additional indications in Japan

Takeda's Nesina has received additional indication to be used in combination with sulfonylurea or biguanide for the treatment of Type 2 diabetes in JApan.

About Nesina:

• Nesina is a dipeptidyl peptidase-IV inhibitor.  IT was discovered by Takeda.  Its generic name is alogliptin
• It has been approved in Japan since June 2010.
• With the additional indications, Nesina can now be used when inadequate blood glucose cannot be achieved through
• treatment by diet and exercise only
• treatment by diet and exercise and an alpha-glucosidase inhibitor
• treatment by diet and exercise and a thiazolidinedione
• treatment by diet and exercise and sulfonylurea
• treatment by diet and exercise and biguanide
• DPP4 works to inhibit the degradation of incretin by inhibiting dipeptidyl peptidase enzyme. Incretin is

Takeda submits a New Drug Application for its new hypertension medication

Takeda announced that it has submitted the new drug application for the combination product of Azilsartan medoxomil and chlorthalidone to the US FDA.


About the new drug combination

• Azilsartan is angiotensin II receptor blocker.  Angiotensin II is an octapeptide hormone.  It is considered a vasopressin and works to induce vasoconstriction of the blood pressure.  As a result, it can increase the blood pressure and other cardiovascular conditions.  By blocking its receptor, angiotensin II can't bind to its receptor and as a result, it cannot exert its effect in the body.
• Chlorthalidone is a diuretic (it works to increase the excretion of sodium and chloride). 
• Azilsartan is an investigational product that was discovered by Takeda.  The company has submitted a

Synergy Receiced US Patent for its SP-333

Synergy Pharmaceuticals received US Patent for its SP-333. The patent number 7,879,802, covering Synergy’s novel drug candidate SP-333 to treat inflammatory bowel disease (IBD).  The patent title is: "Agonist of guanylate cyclase Useful for the Treatment of Gastrointestinal Disorders, Inflammation, Cancer and other Disorders".  The patent was granted on Feb 1, 2011.

SP-333 is a second generation guanylate cycalse (GC-C) agonist.   It is a synthetic analog of uroguanylin which is a natriuretic hormone naturally produced in the intestinal tract of a human body.  SP-333 is an orally available compound that can bind and activate guanylate cyclase located on the epithelial cells in the gastrointestinal mucosa. 


The company plans to submit the Investigational New Drug Application for SP-333 to the FDA in 2011.  The phase I trial

Salix articipated a complete response letter from the FDA

Salix anticipated to receive the complete response letter from the FDA for its sNDA submitted for Xifaxan (rifaximim) 550 mg tablet.

Salix was seeking to add additional indication to the already approved Xifaxan.  However, the FDA will probably refuse to approve Xifaxan 550 mg for the treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating.

The PDUFA date for the review is March 7, 2011


The company's stock plunged almost 23% (going from 41 to almost 32).  Salix is currently traded in the

Cytochroma has initiated the phase IIb tria

Cytochroma has initiated the phase IIb trial using its CTAP101 capsules in patients with chronic kidney disease.

About the trial

• It's a randomized, double-blind, placebo controlled, multi-site trial. 
• The study purpose is to evaluate the safety, efficacy, pharmacokinetics, pharmacodynamics, and tolerability of CTAP101 capsules when they are administered at various dose in patients having Vitamin D due to hyperparathyroidism (SHPT) and stage 3 chronic kidney disease.
• The study endpoints: vitamin D concentration, adverse events, physical and laboratory assessmens, and

Synta Pharmaceuticals set date for its financial earnings

Synta Pharmaceuticals announces that it will release financial earnings of its fourth quarter and fiscal year 2010 on Friday March 11, 2011 before the market opens.

The company will host a conference call on the same date at 10:00 AM EST.  In addition, a live webcast will also be available for view.

To access the webcast live or its archive, please log-in at this website

To access the conference call at 10:00 AM EST.  You can dial one of the following number

• 877-407-8035 (I think this is for US individual but the company does not clarify)
• 201-689-8035  (I think this is for international individual but again the company does not distinguish the two)

Replay of both the webcast and phone conference will be available from March 11 to March 17.  To access the replay, you can dial

• 877-660-6853 (For US?)
• 201-612-7415 (for international probably?)
• Enter the account number: 286
• Enter the conference ID: 366916

About Synta Pharmaceuticals

• Synta Pharmaceuticals is a biopharmaceutical company.  The company focuses its resources to develop medicines for the following medical condition:  cancer and inflammatory disease. 
• Synta Pharmaceuticals' pipeline:
• Ganetespib (Hsp90 inhibitor)
• Currently being studied in phase II trials for the treatment of: non-small cell lung cancer, Gastrointestinal Stromal Tumors, colorectal Cancer, Gastric CAncer, Small Cell Lung Cancer, Ocular Melanoma, Hematologic, Pancreatic, Prostate Cancer, Breast canccer, HCC
• It's being studied in phase 1 trials in solid tumor and its effect in combination with docetaxel.
• Elesclomol (mitochondria metabolism inhibitor): being developed for the treatment of ovarian cancer, other solid tumors, AML
• STA-9584 (vascular disrupting agent)
• IL-12/23 inhibitor: currently being developed preclinially
• Oral CRACM Ion Channel Inhibitor: currently being developed preclinically

The FDA has approved Ridascreen Norovirus 3rd Generation EIA assay

The FDA has approved Ridascreen Norovirus 3rd Generation EIA assay to be used as preliminary identification of norovirus.

The assay can be used when a group of people concurrently experienced contracted gastroenteritis and a clear avenue of virus transmission is identified.

About Ridascreen Norovirus 3rd Generation IEA assay

• The assay is produced and will be marketed by R-BioPharm AG (headquarter in Darmstadt, Germany).  
• The test was approved by the FDA under the de novo pathway.  In the past, medical device needs to go through regular regulatory process in order to be approved and marketed in the US.  The de novo pathway offers an alternative method to get the device to the market faster.  In order to be qualified

Addex released its financial earnings

Addex has released its financial results

The conference call has taken place at 10 AM EST. The archive can be accessed here

The brief information is as followed:

in CHF	2nd half  2010	2nd half 2009	Change
Net income (loss)	(16.3M)	(23.1M)	6.8M
Income	1.3M	1.69M	0.39M
Research and Development	14.47M	21.4M	6.93M
General Administrative expenses	3.1M	3.4M	0.3M

Oncolytics Biotech has initiated the enrollment of the phase II trial

Oncolytics Biotech has initiated the enrollment of the phase II trial using Reolysin as part of the treatment regimen in patients with pancreatic cancer.

About the trial:

• The phase II trial is an open-label, multi-institution, 2-arm, randomized trial in patients with metastatic pancreatic cancer.  The company plans to enroll 70 patients in the trial.
• Intervention: 2 treatment groups
• Treatment Arm A: carboplatin, paclitaxel plus Reolysin
• Treatment Arm B: carboplatin and paclitaxel.

• Treatment design
• On day one: All patients will receive intravenous administration of paclitaxel and carboplatin.

Pharming and Santarus initiate the phase IIIb trial using Rhucin

The international, multicenter, randomized, placebo-controlled phase IIIB clinical trial using Rhucin in the treatment of acute attacks of angioedema in patients with hereditary angioedema (HAE) has been initiated.

About the trial

• As stated, the trial is an international, multicenter, randomized, placebo-controlled phase IIIb study. 
• The company plans to enroll 50 patients.
• Dose: 50 U/kg 
• Duration: the company plans to complete the study in 12 to 18 months.
• The company has completed registrational clinical trials which data have been submitted to the FDA.  The purpose of this trial is to provide additional validation of the use of visual analog scale used in other trials to measure the effects of Rhucin.

About Rhucin or Ruconest (its brandname in European Countries)

• Rhucin is recombinant version of the human protein C1 inhibitor and is produced/engineered using

kyowa hakko kirin is to acquire ProStrakan

Kyowa Hakko Kirin has agreed to purchase ProStrakan with approximately 292M pounds (about 130 pence per ProStrakan's share) in cash.  Kyowa Hakko Kirin hopes the acquisition will facilitate its entry into the EU and US markets in which ProStrakan has established  sale forces through its subsidiaries to market its approved products.

The acquisition is subject to ProStrakan's shareholders decision. The company expects the voting will be held at the Shareholder Meetings in April 2011.  In order for the acquisition to go through, at least 75% votes are needed.  If approved, the acquisition can be completed as early as June 2011.

About ProStrakan:

• ProStrakan is a specialty pharmaceutical company that has over 30 products on the market in both the

Update: Abstral, Paladin Labs and its future plan

Paladin Labs received approval Health Canada to market Abstral for its use in the management of episodes of breakthrough pain in cancer patients who have already received opioid analgesics for chronic pain.

About Abstral

• Abstral is a novel, rapidly-disintegrating, sublingual formulation of fentanyl. 
• ProStrakan has received approval from the FDA to market Abstral in the US as reported here
• The company plans to launch Abstral in Canada in the the next quarter when its availability in the US is expected in the first quarter of 2011.
• Abstral has been available throughout Europe via ProStrakan sale forces.

Agreement:

• Abstral was developed by Orexo AB from whom it has licensed rights for the product in Europe and North America.  In 2008, Paladin Labs obtained license from ProStrakan to market Abstral in Canada

Ista sets date to release its earnings (4th quarter and full-year)

Get busy with conference calls tomorrow!

Adding to Addex, Ista has announced that it will release its fourth quarter and full-year 2010 financial results on Wednesday, Feb 23, 2011.

The conference call will take place on the same date at 4:30 PM EST

You can either access the conference call via the company website by clicking here
Or
You can call in

• US
• 1-866-770-7120
• International 
• 617-213-8065

• You will need to enter the password for access: 668727832

If by chance you have to run and miss the conference call, a replay will be made available after the conference call/webcast until March 23, 2011.

To access the replay

• US & Canada
• 1-888-286-8010
• International
• 1-617-801-6888
• Passcode (different from the one above): 11293297

About Ista:

• Ista is public company that focuses on the developing of prescription eye care products in the US.  It

Gilead acquires Calistoga for $375 M

Gilead announced that it has entered a definitive agreement to acquire Calistoga Pharmaceuticals for $375M. 

The company plans to complete the acquisition of Calistoga by the end of the second quarter of 2011.  

About the agreement:

• In addition to the $375M, an additional $225M could be paid toward Calistoga as its drug candidates achieved certain milestones. 

About Calistoga

• Calistoga is a privately-held company that has its headquarter located in Seattle, Washington, US.  Its pipeline includes products focusing on the treatment of cancer

Patheon set date to release its financial results of the first quarter of the fiscal year 2011

Patheon announces that it would release the financial results of its first quarter of the fiscal year 2011 on Thursday, March 10, 2011 at approximately 8 am EST.

The company will hold a conference call in conjunction with a live audio on the same date at 10:00 AM EST.

To access the conference call:

• US (including Puerto Rico)
• 1- 888-231 - 8191

• Canada and International

Update on TMC435 of Tibotec and Medivir: New trials initated and results from its phase IIb trial

Tibotec initiates the registrational phase III trials using TMC435 in adult patients who had chronic genotype 1 HCV.  Patient recruitment has started.

Medivir has also just recently announced the positive results of the phase IIb trial using TMC435 in conjunction with Peginterferon - 2a and ribavirin in HCV infected patients.  The results showed that TMC435 treatment group had a higher percentage of patients achieved virological response at week 4.  However, the results did not show whether it was significantly higher than Peg-2a and ribavarin group.  Based on the number at week 4, 71% of patients in the standard of care group achieved virological response (it's about

Azelis acquired S&D Group Limited

Azelis acquired S&D Group Limited but the acquisition excludes the following companies (belong toe S&D groups) companies provide pharmaceutical finished dosage (S&D), chemical synthesis and laboratory supply markets (Chemog) and parts of the personal care active business (S&D Chesham GmbH and Protec Ingredia).  The acquisition is expected to be completed in the first quarter of 2011.

Azelis had a total sale of 1.15B pounds with a total assets of 589M pounds.

About Azelis
Azelis is a pan-European specialty chemical distributors.  It was created in 2001 through the merging of Novorchem and Arnaud (an Italian company and French company respectively).  It has expanded in sizes and services through a series of acquisition with the most recent acquisition one was Finkochem d.o.o. of Serbia.  Azelis provides services in the following domains

• Animal nutrition: providing products to the agricultural and animal feed industry
• Pharma:  provides finished preparations and APIs to the pharmaceutical, veterinary and health care industries.  The company also has offices in Shanghai (China) and India.
• Chemical industries
• Coatings: products include additives, pigments and fillers and resins
• Composites: provides over 2000 products in the following categories: additives, ancillaries,

Kancera (AB) has acquired iNovacia

Kancera (AB) has acquired iNovacia

About iNovacia AB

• Founded in May 2006 from a team of professionals originated from Pharmacia Corporation, GlaxoSmithKline, Drug Discovery Partners International and Biovitrum.  
• The company is owned by different entities: 
• Biovitrum AB: 10%
• Asinex Ltd: 20%
• Employees and founders: 70%
• The company has formed strategic alliance with Provid Pharmaceuticals and Asinex

Antisense Therapeutics is in the final preparation for the first human clinical trial for ATL1103

Antisense Therapeutics is in the final preparation for the first human clinical trial for ATL1103 which is being developed as potential treatment for particular growth and sight disorders as well as some forms of cancer.

The company plans to initiate the clinical trial to demonstrate the safety and tolerability of ATL1103 in health volunteers in the third quarter of 2011 and expects to complete the trial by the end of 2011.

About ATL1103 and Agreement:

• ATL1103 is a second generation antisense medication that is designed to inhibit growth hormone receptor expression.  As the expression of this receptor is being reduced, it could cause a

Protalix provides update on taliglucerase

Protalix released the interim analysis from the phase III trial using taliglucerase alfa in the treatment of Gaucher disease.

About the clinical trial

• The phase III trial is a multicenter, open-label, switchover trial which is designed to evaluate the safety and efficacy of taliglucerase alfa in patients currently treated with imiglucerase for Gaucher disease. 
• The trial enrolls both adults and pediatrics.  Twenty-five adult patients have been enrolled and this completed the adult portion of the study.  The study is still currently enrolling pediatric patients for the study.
• All patients in the trial started out by taking imiglucerase (dose 10-60 U/kg every other week).  Once patients' diseases have been stable.  They would be eligible to switch over to taliglucerase alfa and be

Drug Approval Updates!

I finally find time to update the FDA approval lists!

Jan - 2011 is now complete:

• In Jan 2011:  the FDA approved 38 medications
• Of these 38 medications: 10 are NDA and BLA ( 9 NDA and 1 BLA)
• Abstral - Fentanyl of ProStrakan
• Argatroban - Sandoz
• Datscan - ioflupane I 123 - GE healthcare
• Nithiodote - Sodium nitrite, sodium thiosulfate - Hope Pharma
• Natroba - Spinosad - Parapro Pharms
• Viibryd - vilazodone hydrochloride  - Trovis Pharma LLC
• allegra allergy , allergra hives - fexofenadine hydrochloride - Sanofi ventis US
• Sodium fluoride F 18 - National Cancer Institute
• Gralise - - Gabapentin - Abbott Prods
• Rituxan - Rituximab - Genetech
• 28 ANDA were approved in the first month of 2011

Feb - 2011 is in progress

Warner Chilcott sets date to announce its fourth quarter and full year 2010 financial results

Warner Chilcott is set to announce the financial results of its fourth quarter and full year 2010 on Friday, Feb 25, 2011.

The company plans to hold a conference call and webcast on the same date at 8:00 AM EST.

To access the conference call, dial the following number:

Corifact of CSL Behring is approved in the US

CSL Behring got a nod from the FDA to market Corifact in the US.



About Corifact:

• Corifact is a brand name for Factor XIII human concentrate.  It is a fibrin-stabilizing factor concentrate.  It's derived from human plasma and has undergone virus inactivation and removal in order to ensure safety upon administration.  However, this does not completely eliminate the risk.  In addition, because it is human derived product, a chance of patient developing antibody to the product

Intrinsic Therapeutics enrolls first patient in its phase III study

Intrinsic Therapeutics enrolled first patient for the phase III trial using Barricaid(R) Device to prevent reherniations following lumbar discectomy.

About the trial

• It's a prospective, randomized, superiority study evaluating the use of Barricaid and the traditional limited discetomy in the prevention of reherniations following lumbar discectomy.
• The trial intends to enroll up to 800 patients. 

About Barricaid

• Barricaid, developed by Intrinsic Therapeutics, is an anular closure device that surgeons could use to

BioMarin and its earnings in 2010

BioMarin released its financial earnings of the 2010 fiscal year ended on December 31, 2010.

The company had a net income of $205M (mostly due to the following reason: in its third quarter, the company reversed its deferred tax asset valuation allowed and was given a credit of $224.1M).  This was definitely an increase from a net loss of 0.5M of the last fiscal year. 


The company currently has 4 products on the market:

• Naglazyme
• Aldurazyme (marketed by Genzyme)