Jazz Pharmaceuticals to release first quarter earnings

Jazz Pharmaceuticals announced that it will release its first quarter earnings on May 3, 2011.

The company will host a conference call on the same day at 4:30 pm Eastern Time. The live webcast will also be streaming simultaneously via the company website.

To access the conference call:

• US resident: 1-866-510-0712

• International Resident: 1-617-597-5380
• Passcode: 13279408

Vanda to release financial earnings of 1st quarter

Vanda Pharmaceuticals announced that it is to release the financial earnings of first quarter on May 5, 2011 before the market opens.

The company will also hold a conference call at 10:00 AM Eastern time on the same day.

• US caller can dial: 1-866-383-7998
• International caller can dial: 1-617-597-5329
• Passcode:44118664

The replay can be accessed until May 12, 2011 by calling:

• US: 1-888-286-8010
• International: 1-617-801-6888
• Passcode: 73214212

The company will also hold a webcast on the same day.  The webcast be accessed here

Recent News:

Cumberland to release earnings of first quarter 2011

Cumberland announces that it will release the financial earning of its first quarter on May 4, 2011 after the market closes.

The company will also hold a conference call and live Internet webcast on the same date at 5:00 PM EST to discuss the earnings.

To participate in the conference call:

• US callers: 877-303-1298
• International Callers: 253-237-1032

For the reply of the conference call which will be available for approximately one week after the live conference call concluded:

• US Callers: 800-642-1687
• International Callers: 706-645-9291
• Conference ID for the reply: 62581136

The live webcast can be accessed through this link

Recent News: 

Bristol-Myers Squibb to release its financial earnings of first quarter

Bristol-Myers Squibb announces that it would release its earnings in the first quarter 2011 on April 28, 2011.

The conference call will take place on the same day at 10:30 AM Eastern Time.

Interested parties can participate in the conference call by following the instruction below:

• Interested parties should dial: 913-312-0670 and enter the passcode 5540965

• The conference call will be available for access until midnight May 12, 2011.  To access the replay please dial: 402-280-9013 and enter the password: 5540965

The company will also hold a webcast simultaneously that can be accessed through this website

Recent notable news:

Idera pharmaceuticals delayed the initiation of the phase II trial of IMO-2125

Idera Pharmaceuticals announced that it has delayed the initiation of the phase II trial using IMO-2125 as potential treatment in treatment-naive HCV patients.

The results came after the announcement of the preliminary data from the 26-week nonclinical toxicology study using IMO-2125 in rodents.    The data showed instances of atypical lymphocytic proliferation has been observed.  The full results will be available in the second half of 2011.

The delayed phase II trial

The FDA approved the sNDA for Fusilev

Spectrum Pharmaceuticals announced that the FDA has approved the Supplemental New Drug Application submitted by Spectrum for Fusilev to be used in patients with osteosarcoma after being treated with high-dose methotrexate.

The newly approved Fusilev is a different formulation of the already approved Fusilev.  The new formulation is the ready to use Fusilev which has been formulated so that reconstitution is not necessary before administration.  The solution has a higher strength than the currently available Fusilev which is available as powder for for solution for injection.

In addition, Spectrum has also submitted another supplemental new drug application

Drug Approval Updates!

When did March go and is April really ending this soon?

I finally find time to update the new drug approval for the month of March.  Will be working meticulously this weekend to update the April List!

The March Approval can be accessed through here

March in Summary:

Pfizer to host annual meetings of shareholders

Pfizer to host the annual meeting of shareholders on Thursday, April 28.
The webcast will be made available on the company website at 8:30 Central Daylight at the company website.

All interested parties are invited to attend the webcast!

The webcast can be viewed via this link

For registration, please fill out the form here

Information about the company's annual report can be found here

The physical address of where the meeting is going to take place is:  Renaissance Dallas Hotel, 2222 Stemmons Freeway, Dallas, Texas.


Recent News:

Pfizer to collaborate with Shanghai Pharmaceuticals in China

Not too long after SciClone announced that it is to acquire NovaMed Pharmaceuticals to expand its access to the Chinese Market, Pfizer signed a memorandum of understanding with Shanghai Pharmaceuticals to pursue potential business opportunities in China.

Under the new corporation, the companies plan to explore option to register, commercialize,

Gilead releases first quarter earnings

Gilead released financial earnings of its first quarter 2011 with a net income of 651M, a decrease of 200M from the same quarter of last year (651 M vs 854M).

As of March 31, 2011, the company had 6.36B in cash, cash equivalents and marketable securities which is an increase of $1B from December 31, 2010.  The company had 820.5M cash flow in the first quarter of the fiscal year 2011.

	1st quarter 2011	1st quarter 2010	Difference
Net Income (Net loss)	651M	854M	203M
Revenues	1.92B	2.08B	0.04B
Administrative and selling expenses	295M	265M	30 M
Research and Development	254 M	215M	32M

 The company had an increase in 4% of product sales in

Salix to release financial earnings of first quarter

It's earning season everyone!!

Salix Pharmaceuticals announced that it would report the financial earnings of the first quarter of 2011 on Thursday May 5, 2011.

The company will hold a conference call at 5 PM Eastern time.  In addition, the company will simultaneously webcast at the time the conference call takes place.

To access the conference call, interest parties can dial

• US and Canada residents: 888-267-6301
• International residents: 719-325-2392

The company will also have the replay of the conference call be available via the following numbers

• US and Canada Residents: 888-203-1112
• International Residents: 719-457-0820
• Access Code: 5125681

Recent News:

Amgen and UCB announced results of the phase II study of AMG785

Amgen and UCB announced that the preliminary results of the phase II trial using AMG785/CDP7851 as potential treatment of postmenopausal osteoporosis in postmenopausal women who have low bone mineral density met the trial primary endpoint which is defined as the increase in lumbar spine bone mineral density at month 12.

About the trial: 

• The phase 2 study is a 12-month multi-center, international, randomized, placebo-controlled, parallel-group trial evaluating the effect of AMG 785/CDP7851 against placebo in women with low BMD.  In addition, the trial aims to characterize the safety and tolerability of the tested compound. 
• Enrollment: 400 postmenopausal women with low BMD (having T-score between -2.0 to -3.5)
• Route of administration

Watson filed ANDA for Welchol and confirms the patent challenge

Watson announced that it has submitted an Abbreviated New Drug Application to seek the US FDA approval to market Colesevelam HCl 625 mg tablets which is the generic name of Welchol marketed by Daiichi Sankyo.

On April 18, 2011 Daiichi Sankyo and Genzyme Corporation have filed a lawsuit against Watson to the  US District Court of the District of Delaware to prevent Watson from getting the approval to commercialize Colesevelam before the expiration of the US Patent Nos 5.607,669 and 5,693,675 which cover colesevelam.

The suit was filed under the provisions of the Hatch-Waxman Act which prevents the FDA from approving the ANDA submitted by Watson until September 25, 2013 or the resolution of the matter before court whichever occurs earlier.

According  to the IMS data, the sales

Mylan received FDA approval for generic version of Famvir

Mylan Inc announced that it has received the FDA approval to market the generic version of famciclovir tablets in the following strengths: 125 mg, 250 mg and 500 mg.

Based on the information from IMS health, famiclovir tablet sales in the US was approximately $196M in the year of 2010.

About famciclovir:

Furiex acquired full rights to JNJ-Q2 of Janssen

On the same date that Cumberland announced that it has acquired ifetroban, Furiex acquired full exclusive rights to develop and commercialize JNJ-Q2 from Janssen Pharmaceutical NV.

No financial information was disclosed except that Janssen is entitled to receive payments as JNJ-Q2 reaches certain regulatory milestones and sale milestones.  In addition, Janssen is also eligible to receive royalties from sales once the compound is approved and commercialized.

Furiex is working to in future development of JNJ-Q2 by

AM152 receives orphan drug designation

Amira Pharmaceuticals announced that the FDA has granted AM152 an orphan drug status as potential treatment of idiopathic pulmonary fibrosis.

About AM152:

• AM152 is a lysophosphatidic acid (LPA) receptor 1 antagonist.  Lysophosphatidic acid has been shown to be involved in

Taro Received FDA approval for generic of Aldara

Taro Pharmaceuticals announced that it has received the FDA approval to market the generic Imiquimod cream 5% which has been approved as Aldara for the treatment of actinic keratosis and external genital warts.

Aldara is currently marketed by Graceway Pharmaceuticals who has earned $340M in Aldara's annual sales.

About Aldara

• Aldara is the brand name for imiquimod cream.  Based on its package insert, Aldara has been approved for

Cumberland Pharmaceuticals acquired compound from Vanderbilt University

Cumberland Pharmaceuticals announces that it has acquired Hepatoren or ifetroben injectioini which is being investigated as potential treatment of critically ill hospitalized patients experiencing Hepatorenal Syndrome from Vanderbilt University.

Ifetroben was initially developed by Bristol-Myers Squibb as potential treatment for different cardiovascular diseases.  After being studied in the phase II trial, BMS decided to donate the proram to Vanderbilt University.  Since then, researchers at the school has studied and evaluated the compounds for other indications.

Cumberland Pharmaceuticals plans to develop ifetroben for many indications besides the treatment of hepatorenal syndrome in critically ill

Johnson and Johnson released its earnings of 1st quarter 2011

Johnson and Johnson reported financial earnings of its first quarter 2011 with a decrease of 23.2% in net earnings compared to the same period of last year ($3.476B vs $4.526B).

The company has increased its earning guidance to 5.00 from 4.9 per share for the full year 2011.

After a series of recall due to manufacturing problems, Johnson and Johnson has experienced a set back in US market.  Its US sales has experienced a 13.8% decrease (1.345B vs 1.560B) from the same period of last year.  In contrast, its international sales experienced an increase of 5.9% compared to the same quarter of last year (2.337B vs 2.206B). 

Of the major segment, Johnson and Johnson sees a significant decrease in US sales of Over-the-counter and nutritional products compared to the same quarter of last year, 26.8%

Anthera to continue enrolling patients in the phase III VISTA-16 trial

Anthera Pharmaceuticals announced that it will continue enrolling patients for the phase III VISTA-16 trial evaluating the use of varespladib in patients with Acute Coronary Syndromes (ACS) after the reviewing the positive outcome from the interim biomarker analysis and safety data.

The company stocks increase after the announcement by 18%.  Anthera Pharmaceuticals stocks are traded in the NASDAQ as ANTH

A collection of biomarkers that are used in the analysis were: secretory phospholipase A2 (sPLA2), low density lipoprotein cholesterol (LDL-C), C-reactive protein (CRP), interleukin-6  (IL-6), and a composite responder endpoint (defined as having LDL-C < 70 mg/dL and CRP < 1.0 mg/L).

 About VISTA-16:

SciClone acquires NovaMed Pharmaceuticals

SciClone announced that it has acquired NovaMed Pharmaceuticals, a Chinese Pharmaceutical company to expand its product portfolio and presence in Chinese Market.

Under the terms of the agreement, SciClone will pay NovaMed shareholders an upfront payment of $24.7M in cash, and approximately $37.1M worth of shares of SciClone common stocks.  In addition, the shareholders are eligible to receive up to $43.0M in payments as certain revenue and earnings achieve targets set in 2011 and 2012 fiscal years.

About NovaMed

The FDA approved new manufacturing process of Oncaspar

Sigma-Tau Pharmaceuticals announced that the FDA has approved the new manufacturing process of the primary ingredient of Oncaspar, L-asparaginase. 

The new manufacturing process was seek due to the ceasing in production of L-asparaginase from previous supplier.

About Oncaspar:

• Oncaspar is the brand name for pegaspargase

Regeneron announced that the US FDA accepted the Biologics License Application (BLA) submitted by Regeneron for VEGF Trap-Eye as potential treatment of Wet Age-related Macular Degeneration.  It has also granted priority review for the molecule with the target review date is August 20, 2011.

If you want to learn more about VEGF Trap-Eye, I have posted

Amylin releases its financial earnings

Amylin releases the earnings of its first quarter 2011 with a net loss of 37.3M, a decrease of 0.9M in net loss compared to the same period of last year.

The company had 475.3M in cash, cash equivalents, short-term investments and restricted cash as of March 31, 2011.

The company sales of Byetta and Symlin has decreased from 172.4M to 150.8 in the first quarter 2011 when compared to the first quarter 2010.  The decrease primarily came from the a decrease in sale of Byetta which went from 172.3M in the first quarter 2010 to

Eli Lilly released its earnings

Eli Lilly released its first quarter earnings today and the stock market has been down and down and down.

The company reported a net income in the first quarter but it was lower than the net income of the same quarter of last year.

The company stock is traded on the NYSE as LLY

Operating Results - Unaudited

	First Quarter 2011	First Quarter 2020	Difference
Net Income (loss)	1.055 Billions	1.248 Billions	0.193
Revenues	5.839 Billions	5.485 Billions	0.354
Research and Development	1.124 Billions	1.039 Billions	0.085
Marking, Selling and Administrative	1.785 Billions	1.161 Billions	0.624

Compared to the same quarter of last year, the company experienced a significant reduction in sales of Gemzar (going from 287.8 millions to 156.1 millions, 46% decrease).  This is due to competition from generic competitor.  The company animal health sector sees a growth of 28% compared to the same quarter.

Recent News: 

GSK and Valeant submit the response to the FDA in regard to ezogabine

GSK and Valeant announced that they had submitted a response to the FDA's Complete Response Letter that was issued on November 30, 2011 in regard to the New Drug Application for ezogabine which is being studied as a potential adjuctive treatment of partial-onset seizures in adults.

In the Complete Response Letter, the FDA indicated that the application can't be approved at the current form.

Ezogabine is called retigabine in  Europe and it was recently

Baxter acquired Prism Pharmaceuticals

Baxter announced that it and Prism Pharmaceuticals have entered into the definitive agreement that is estimated to be worth up to $338M which include $170M of cash in upfront payment and possibly an additional $168M based on future sales and milestones.

The company expected to complete the transaction in the second quarter of 2011.

Prism Pharmaceutical is a specialty pharmaceutical company that has its headquarter in Prussia, PA.  The company has

Gilead Sciences sets date to release earnings

Gilead announces its first quarter financial results 2011 will be released on Wednesday April 20, 2011 at 4:05 PM Eastern Time (I wonder why it's not 4:00 or 4:30 or 5:00 but it has to be 4:05!)

Gilead announced that it would hold a conference call to discuss the financial results on the same day at 5:30 PM Eastern Time (I'm glad it's not 5:03!).

Interested parties can connect to the conference call via the internet by going to the company website  Additional software installations might be needed to have access to the conference call via the internet.  Please arrive at least 15 minutes early for preparation.

To Dial in for live conference call

• US resident: 1-877-299-4454
• International: 1-617-597-5447
• Passcode: 45089365

To dial in for the replay which is available 2 hours after the conference call ends and will be available until April 23, 2011 (8:00 PM Eastern Time)

• US residents can call: 888-286-8010
• International residents can call: 1-617-801-6888
• The conference passcode: 41368400

The webcast will be made available for up to 1 year after the conclusion of the conference call.
 
Recent news:

Galapagos discontinues the phase II trial of GLPG0259

Galapagos announced that it has discontinued the phase II development of GLPG02529 which was originally developed as potential treatment for rheumatoid arthritis.  

The decision cam after the company reviewed the interim reported of the phase II trial using GLPG0259 in patients with rheumatoid arthritis.  Data in the first 30 patients in which 20 patients received GLPG0259 and 10 patients received placebo showed that limited efficacy observed in patients treated with GLPG0259 compared to placebo after 12 weeks of treatment.

The company plans complete the data analysis of the trial and determine the next step for GLPG0259.

As of now, the company will utilize its resources to development other compounds for the treatment of rheumatoid arthritis, cancer metastasis and cachexia.

Galapagos and Janssen Pharmaceuticals NV

Pfizer announced top of the line results for tofacitinib

The top of the line data of the phase III trial using tofacitinib of Pfizer as potential treatment in patients with active rheumatoid arthritis showed positive results.

The two-year study expected to have full results in 2012.

The study showed that compared to the placebo group patients in the 10 mg group showed

• significant reduction in signs and symptoms of rheumatoid arthritis (measured by the ACR20) at six month 
• significant reduction in the progression of structural damages (measured by the modified Total Sharp Score) at six months
• Significant improvement in physicial function (measured by the mean change in HAQ DI) at three months

The study also showed that compared to the placebo group, patients in the 5 mg group showed

JDP Therapeutics initiates phase I trial for JDP-205

JDP Therapeutics announced that it has initiated the phase I trial using JDP-205 in healthy volunteers.

The company has enrolled and given JDP-205 to health volunteers.

About the trial:

• It is a single dose, randomized, 4-way crossover study designed to

J&J to host an analyst conference call to discuss its first quarter 2011

Johnson and Johnson announced that it will host a conference call with financial analysts on April 19 to discuss the first quarter earnings of the fiscal year 2011.

The webcast will also be transmitted online for interested parties and investors.  To access the webcast, please visit here!