PharmaPodia: 2011-05-08

Saturday, May 14, 2011

Pro-Pharmaceuticals released first quarter earnings of 2011

Pro-Pharmaceuticals announced results of its first quarter 2011 with a net loss of 2.7M which was an increase of approximately 260K from the same quarter of last year.

As of March 31, 2011, the company had 6.9M in unrestricted cash and cash equivalents.

	First Quarter 2011	First Quarter 2010
Net income (Net Loss)	(2.4M)	(2.1M)
General and Administrative	1.27M	0.903M
Research and Development	744K	129K

About Pro-Pharmaceuticals
Pro-Pharmaceuticals is a

Ironwood pharmaceuticals sets date to give update for its first quarter 2011

Ironwood announced its financial earnings for the first quarter 2011 with a net loss of 18M which was an crease of 2M from the same quarter of last year.

As of March 31, 2011, the company had 220.57M in cash, cash equivalents and available-for-sale securities which was a decrease of approximately 24.458M from December 31, 2010.

The company had a total assest of 272.024M which was a decrease of 29.34M from December 31, 2010.

Update on linaclotide:

Shire to use Aegis Analytical's Discoverant for its manufacturing and production

Aegis Analytical announced that Shire Pharmaceuticals has chosen the company's Discoverant for its data analysis, management and reporting solution for product scale-up and production.

Discoverant is a manufacturing intellegence software platform developed at

The FDA approved Victrelis of Merck

Friday the 13th...and much later in the day..

Tthe FDA announced that it has approved Merck's boceprevir. Boceprevir will be marketed as Victrelis and can be used in combination with peginterferon alfa and ribavirin to treat patients who have been diagnosed with hepatitis C and have not been previously treated with any other therapy or have failed other therapy.

The approval came from the results of clinical trials conducted in 1500 adult patients showing that the use of Victrelis in combination with peginterferon alfa and ribavirin showed significantly improvement in sustained virologic response in two-thirds of patients receiving receiving the therapy compared to treatment of pegylated interferon and ribavirin alone. Patients treated with the triple-combination no longer had the virus RNA detected in their blood 24 weeks after stopping treatments. (My note:

Halozyme enters into a global licensing agreement with ViroPharma

Halozyme Therapeutics announced that it has entered into a global licensing agreement with ViroPharma to develop Cinryze which is a C1 human esterase inhibitor that is to be given subcutaneously for its used in the treatment of hereditary angioedema and three additional orphan indications.

Under the agreement, Halozyme received an upfront payment of $9M. The company has potential to earn an estimate of $74M in milestone payment in addition to 10% of royalty on future sales as Cinryze goes through regulatory and clinical development.

The agreement also stated that ViroPharm is

Sunesis Pharmaceutical released its first quarter earnings

Sunesis Pharmaceuticals released its financial earnings of the first quarter with a net income of 1.84M which was an significant increase from the net loss of the last quarter. Upon the release of its financial earnings, Sunesis’s stock has jumped about 13% as of May 12, 2011. (The company stock symbol: SNSS)

As of March 31, 2011, the company had 9.9M in cash and cash equivalents which was a decrease from 14.22M from December 31, 2010.

The company’s total assets amount to 54.67M which was a slight decrease of about 200,000 from December 31, 2010.

The company had recently signed a license agreement with

NanoBio & GSK announced initiation of two phase III multicenter trials

NanoBio and GSK announced that two phase III multicenter trials using NB001 as potential topical treatment for cold sores has been initiated.

About the two trials:
they company plans to conduct the trials in

An Update Statement from Takeda:

An Update Statement from Takeda:

The company issued a statement about various news articles circulating yesterday talking about a possible acquisition of Nycomed.

The company commented that it is not to comment about the circulating rumors regarding to its business at this point. The company is always evaluating and seeking opportunities to strengthen its business and bring value to its investor.

With this said, we will just have to wait and see how things pan out.

Thursday, May 12, 2011

Halozyme enters into a global licensing agreement with ViroPharma

The agreement also stated that ViroPharm is to fund all the development and commercialization expenses for the program. Clinical development is expected to begin later this year.

About Cinryze

Sucampo reported positive results form its phase III trial using lubiprostone in Japanese Patients

Sucampo released the results of the phase III trial using lubiprostone as potential treatment in chronic idiopathic constipation in 124 Japanese patients. In addition, the company also released the results collected from an additional 290 Japanese patients from its phase 3 long-term trial.

About the phase 3 double-blinded, placebo-controlled, efficacy clinical trial:

The study enrolled 124 Japanese patients diagnosed with CIC.
Patients received either 24 mcg capsules or placebo capsules that were to be taken twice a day for 28 days.
The results showed that:

Update from Nycomed: Agreement and Possible Acquisitions?

Nycomed recently entered into a commercialization agreement with Almirall for roflumilast in Spain. Under the agreement, Almirall is to launch roflumilast in Spain in 2011.

Nycomed has received an undisclosed upfront payment.

Roflumilast is an oral phosphodiesterase 4 enzyme inhibitor that has been approved for

Teva released earnings of first quarter 2011

Teva Pharmaceuticals released its financial earnings for the first quarter 2011 with a net income of 761M.

The company had 1.1B in cash and marketable securities as of March 31, 2011.

	First Quarter 2011	First Quarter 2010	Difference
Net Income (Net Loss)	761M
Research & development	239M	207M	32M
Selling and Marketing Expenditures	825M	744M	81M
General & Administrative	221M	182M	39M
Operating income	867M
Net sales	4.1B

Some other key figures:

Inovio released its earnings of first quarter 2011

Inovio released its first quarter financial earnings with an increase revenue of approximately 1.8M and with a net loss of 2.4M in the fiscal year 2011.

	First Quarter 2011	First Quarter 2010	Difference
Net Income (Net Loss)	(2.4M)	(2.3M)	0.1M
Revenues	3.1M	1.4M	1.7M
Research & Development	4.4M	2.7M	1.7M
General Administration	3.32M	3.05M	0.27M
Operating Expenses	7.7M	5.8M	1.9M

As of March 31, 2011, the company had 40.8M in cash and cash equivalents plus short-term investments in certificates of deposit. This is an increase of 19M from December 31, 2010.
The company attributed the increase in assess due to a purchase agreement signed with a single investor under which more than 21M shares of the company common stocks were purchased and more than 10M shares of common stocks were exercised at $1.4 per share. The agreement was worth approximately 24.3M. The net profit resulted from the transaction was 23 million.

Some highlights in its first quarter:

Acetylon Pharmaceuticals formed alliance with Leukemia and Lymphoma Society

Acetylon Pharmaceuticals announced that it has formed a business alliance with Leukemia & Lymphoma Society (LLS) under which both businesses will support the development of phase I/II trials using Acetylon's ACY-1215, an oral selective HDAC66 inhibitor, as potential treatment in patients with multiple myeloma.

Both entities will form a joint clinical oversight committee for the development of this compound.

Under the alliance, LLS will provide Acetylon up to $4.85M in milestone-tranched funding. Acetylon will perform a three-part Phase I/II clinical trial using ACY-1215 in adult patients with relapsed and relapsed/refractory multiple myeloma.

Acetylon plans to

Fluzone Intradermal is now approved in the US!

Sanofi-Aventis announced the FDA has approved the supplemental biologics license application submitted by Sanofi-Avantis for the licensure of Fluzone Intradermal.

Fluzone is an influenza virus vaccine that is now indicated for the active immunization against influenza disease that can be caused by viruses with subtypes A and B in adult patients 18 through 64 years of age.

The company plans to make it available

Nymox initiated the short safety trial for NX-1207

Earning season seems to occupy all the news outlet recently...here is a new clinical trial that has just been initiated

Nymox has announced that it has initiated the small, open-label, short-term safety trial using NX-1207 in patients with benign prostatic hyperplasia.

The study plans to enroll approximately 100-200 subjects who have participated in trials that used NX-1207.
The study aims to evaluate the safety of repeat injection of the drug.
The company plans to enroll patients in approximately 70 US clinical sites. The study is called NX02-0020. Duration of the study is expected to be 90 days.

Agreement with Recordati:

Inspire Pharmaceuticals released first quarter earnings

Inspire Pharmaceuticals announced its earnings for the first quarter 2011 with a net loss of 17.6M

Due to recent merger agreement with Merck under which Merck is to acquire Inspire at $5 a share, the company does not provide guidance for the year of 2011.

	First Quarter 2011	First quarter 2010	Difference
Net Income (Net Loss)	(17.6M)	(14.8M)	2.8M
Revenues	21.1M	22.1M	1M
Research & Development	3.6M	9.583M	5.983M
Selling & general administrative	12.841M	13.694M	0.853M
Operating Expenses	38.8M	36.5M	2.3M

In the first quarter of 2011, the company announced

Avanir reported its first quarter 2011

Avanir released its earnings for the second quarter 2011 with a net loss of 14.5M. This makes the company incurred a net loss of 26.6M in the first six months of its fiscal year.

As of March 31, 2011, the company had 103.047M in cash and cash equivalents.

	Second Quarter 2011	Second Quarter 2010	Difference
Net income (net loss)	(14.5M)	(6.4M)	7.9M
Revenues	1.4M	1.0M	0.4M
Research & development	2.519	3.815	1.3M
Selling and Administrative	13.28M	3.62M	9.66M
Operating Expenses	15.8M	7.4M	8.4M

The company launched Nuedexta in early

Pfizer announced results of phase III trials using Prevnar 13

Pfizer announced that its phase III pivotal trial evaluating Prevnar 13, a pneumoccal 13-valent conjugate vaccine), in adults who were 50 years and older met the study primary endpoints.

The results showed that Prevnar 13 was as immunogenic as the currently licensed nonconjugated pneumococcal polysaccharide vaccine for the 12 serotypes that were common in both vaccines in patients who either were pneumococcal vaccine-naive or previously immunized with PPSV.

The secondary endpoints showed that

Johnson and Johnson released positive results of the phase IIb data

Johnson and Johnson announced the results of the phase IIb trial evaluating the use of Stelara or ustekinumab as potential treatment with moderate to severe Crohn's disease but failed or were intolerant to other treatment of tumor necrosis factor antagonist.

The results showed that 40% of patients taking STELARA 6 mg/kg achieved clinical response in the study. Clinical response was defined as a 100 point reduction in the Crohn's Disease Activity index at week 6. This was also the study primary endpoint.

In addition, a significantly higher percentage of patients who continued to be treated with STELARA through week 22 achieved clinical response and clinical remission when compared to patients receiving placebo.

The company plans to move forward with

AcelRx received European Patent covering NanoTab

AcelRx Pharmaceuticals announced that opposition period granted by the European Patent Office in regard to NanoTab dosage forms has expired. Up until the date of expiration which was April 21, no opposition has been recorded.

AcelRx was granted European Patent number EP2114383 coverings small-volume NanoTa dosage forms that can be used to administer opioid sufentanil transmucosally. The patent is expected to last until 2027. AcelRx Pharmaceuticals has exclusively rights to the patent which has been used in the following products ARX-01, ARX-02, and ARX-03. The patent has been registered in England, Germany, France, Spain, Italy, Switzerland/Lichtenstein, Denmark, Netherlands, Portugal, and Sweden.

The patent protection cover

Depomed received Paragraph IV notification from Sun in regard to Glumetza

Depomed Inc announced that it has a Paragraph IV certification notice from Sun Pharmaceuticals notifying Depomed that Sun Pharmaceutical has filed an Abbreviated New Drug Application with the US FDA for the generic version of Glumetza or metformin hydrochloride extended release tablets at 2 different strengths: 500 mg and 1000 mg.

Sun Pharmaceuticals said that the patent expiration dates listed in the FDA Orange Book for Glumetza would not be infringed by the products for which Sun has submitted the ANDA. The expiration dates for Glumetza listed in the Orange Book ranging

AstraZeneca released economic health data comparing ticagrelor and clopidogrel

In the time where money savings is essential, AstraZeneca has conducted a substudy of its Plato trial which evaluated the use of Brilique or ticagrelor as treatment of broad spectrum of acute coronary syndrome evaluating the cost-effectiveness gained in quality-adjusted life year between Brilique and clopidogrel.

The company has also announced that the Scottish Medicines Consortium has agreed to reimburse

Epicept filed a phase III protocol for Ceplene with the US FDA

Epicept announced that it has filed the phase III protocol with the US FDA for Ceplene or histamine dihydrochloride. The FDA will review the protocol under the Special Protocol Assessment. This means the FDA will provide a formal guidance to Epicept in regard to the trial's design, clinical endpoints, statistical analysis and labeling claims. The company expects to hear back from the US FDA in the next 45 days. It also hopes to reach an agreement with the FDA in regard to all major protocol elements in late 2011.

Here is the proposal:

Epicept released its financial earnings of first quarter 2011

Epicept reports its first quarter earnings with a net loss of 2.466M in the fiscal year 2011.

	First Quarter 2011	First Quarter 2010	Difference
Net Income (Net Loss)	(2.466M)	(4.508M)	2.042M
Revenues	0.2M	0.2M	0
Research & development	1.684M	2.039M	0.355M
Selling, General and Administrative	1.394M	2.057M	0.663M

As of March 31, 2011, the company had 10.2M in cash and cash equivalents which is an increase of 7.765M from the same quarter of last year.

Other updates:

Cephalon released results of the phase IV trial using Nuvigil

Cephalon released the results of the phase IV trial evaluating Nuvigil or armodafinil tablets in subjects with shift work disorders.

The trial was a six-week, double-blind, placebo-controlled study enrolling 383

Valeant released first quarter earnings

Valeant released its financial earnings in first quarter of 2011.

As of March 31, 2011, the company had 401.75M in cash and cash equivalents which about 7M

Merrimack acquired rights to MM-398 from PharmaEngine

Merrimack Pharmaceuticals announced that it has acquired European and Asian Rights to MM-398 or nanoliposomal irinotecan from PharmaEngine with a 10M upfront payment. PharmaEngine is eligible to receive up to an additional $210M as MM-398 reaches certain development, regulatory and sales milestones in addition to tiered royalties on sales of MM-398 in Europe and Asia.

MM-398 was originally developed by Hermes BioSciences, a company that Merrimack acquired in 2009. MM-398 is a very stable nanoliposomal formulation of irinotecan. MM-398 when under the development of Hermes Biosciences was licensed to PharmaEngine to develop and commercialize the product in Europe and Asia.

As this agreement comes forward,

Salix confirmed lawsuit filed by Napo regarding crofelemer

Salix Pharmaceuticals confirmed a lawsuit from Napo Pharmaceuticals claiming that Salix Pharmaceutical has breached its commitments under the Collaboration Agreement between Napo and Salix in regard to the development of crofelemer.

Salix Pharmaceuticals announced that the suit against Salix is baseless and the company plans to defend itself and continue to develop and commercialize crofelemer in accordance to the Collabration Agreement with Napo.

The phase III trial using crofelemer as potential treatment for chronic diarrhea in patients with HIV/AIDS. Three doses of crofelemer (125 mg, 250 mg, 500 mg) were compared to placebo.
Agreements:

SCT: Taro Pharmaceutical updated on its Canadian Manufacturing Facility

Taro Pharmaceutical Industries announced that the re-inspection from the US FDA in Feb 2011 was satisfactory and the problems noted by the US FDA on Feb 5, 2009 has been resolved. The inspection was done in July 2008.

The facility mentioned is its Canadian Manufacturing Facility located at

Aceto released Third Quarter Earnings of the fiscal year 2011

Aceto announced a net income of 3.8M in third quarter 2011 which is equivalent to the what the company had in the third quarter 2010.

	Third Quarter 2011	Third Quarter 2010	Difference
Net income (Net loss)	3.846M	3.841M0.005M	0.005M
Selling, General & Administrative	13.281M	10.063M	3.218M
Net sales	117.881M	99.347M	18.534M

In the third quarter 2011:

Inhibitex released its financial earnings

Inhibitex announced a net loss of 7.48M in its first quarter 2011.

As of March 31, 2011, the company had 3M in cash and cash equivalents which was decresae from 11M from December 31, 2010.

	First Quarter 2011	First quarter 2010	Difference
Net Income (Net Loss)	(7.48M)	(4.79M)	2.69M
Revenues	287,500	999,167	711,667
Research & Development	6.57M	4.79M	1.78 M
General & Administrative	1.2M	1.02M	0.98M

Future plans:

The company plans to initiate

SCT: The FDA approved KeyPath MRSA/MSSA Blood Culture Test

The FDA has approved KeyPath MRSA/MSSA Blood Culture Test of MicroPhage Inc.

KeyPath MRSA/MSSA Blood Culture Test was developed to determine whether the presence of MRSA or MSSA in patient's positive blood culture. The advantage of the test is its quick turn-around time. The test can be completed within 5 fives after the bacterial growth is detected in the sample.

The approval came from a clinical study involving 1,116 blood samples