Tigris initiates phase II trial using AFP-464 in the treatment of estrogen receptor positive breast cancer

Tigris Pharmaceuticals announced that it has initiated the phase II trial using AFP-464 as potential therapy in Estrogen-Receptor Positive Cancer.

About the phase II trial:

• It's a randomized, open label phase II clinical trial using AFP-464 of Tigris evaluating its efficacy and safety in its use with or without Faslodex in Estrogen Receptor Breast Cancer Patients who have been treated with but continued to progress on Aromatase Inhibitor Therapy.
• Duration of therapy: patients will continue to receive treatment until disease progression is recorded.
• Treatment groups:

SCT: Pfizer formed partnership with ICON and PAREXEL

Pfizer announced that it has formed strategic partnerships with ICON and PAREXEL International Corporation who will be serving as strategic providers of clinical trial implementation services over a five-year period starting June 2011.

The partnership will give Pfizer ability to focus on developing clinical trial design and at the same time implementing the clinical development programs using the strength and scale of Icon and Parexel.

Icon is a global provider that outsources

SCT: Mylan is to rebrand Matrix Laboratories

Mylan announced that it is to rebrand Matrix Laboratories to extend global brand and prepare for commercial launch of prescription products in India as Mylan.

The name change is currently waiting for approval from the Registrar of Companies in India.  The company will retain the Matrix name for the institutionl ARV franchise, serving NGOs and other alliances.

Mylan purchased Matrix Laboratories in 2007. 

The FDA approved Dificid of Optimer!

The FDA announced that it has approved Difcid or fidamoxicin tablets to be used in the treatment of Clostridium difficile-associated diarrhea.   The NDA was accepted for review back in Jan.

Dificid is to be marketed by Optimer Pharmaceuticals. The company recently signed a license agreement with Astellas.  More information about the agreement can be found

AstraZeneca signed collaboration agreement with Daiichi Sankyo to market denosumab

AstraZeneca announced that it has entered into a co-promotion agreement with Daiichi Sankyo of Japan to promote denosumab for the treatment of bone diorders stemming from bone metastasis in Japan.

Daiichi Sankyo has acquired rights to market denosumab in Japan from Amgen in 2007.  The Japanese New Drug Application has been submitted

MAP Pharmaceuticals submitted the NDA for Levadex to the FDA

MAP Pharmaceuticals announced that it has submitted the new drug application for Levadex to the FDA as a potential medication for the treatment of migraine.

LEVADEX is available as an orally inhaled migraine medication.

The most common adverse event that has often been observed in the double-blind placebo controlled portion of the triad was after taste (6% vs 2% of placebo).  Another common adverse event that was often observed in the trial was nausea (5% vs 2% of placebo). 

MAP Pharmaceuticals has recently published the results of the phase III trial

The NIH stopped trial evaluating extended, high dose niacin in combination with statin

Because this might be practice changing...and the clinical side of me couldn't let this pass...

The NIH announced that it has stopped the clinical trial evaluating the combination of high dose, extended-release niacin in addition to statin therapy in patients with a history of cardiovascular disease who were taking a statin medication to keep their LDL cholesterol low in addition to having low HDL level and high triglycerides level. The trial was planned to end in 2012.  The Independent Data and Safety monitoring board recommended the trial to be stopped prematurely due to lack of efficacy.

The agency announced that "the combination of high dose, extended release niacin in addition to statin did not reduce fatal or non-fatal heart attacks, strokes, hospitalizations for acute coronary syndrome, or revascular procedures to improve blood flow in the arteries of the heart and brain".  This basically means that

The FDA approved the ANDA submitted by Teva for Combivir

Teva announced that the FDA has approved the Abbreviate New Drug Application submitted by Teva for the generic version of Combivr tablet which is currently marketed by Viiv Healthcare company.  Teva is to have a 180-day marketing exclusivity because it was the first company to file an ANDA containing paragraph IV.


Teva announced that it plans to put the product on the market in the fourth quarter of 2011.

According to IMS sales data, Combivir has an

SCT: Eli Lilly issued statement in regard to the temporary restraining order issued by the US District Court

Before Amylin released the press release in regard to the temporary restraining order related to the lawsuit involving the collaboration between Lilly and Amylin, Lilly issued the statement saying that it is disappointed with the decision made by the US District Court but it will work to abide to the ruling.

The company also said that the allegation made by Amylin against Lilly was entirely without merit and the company will work to fight the lawsuit filed against the company.

Arena released the results of the meta-analyses of the phase III trial program

Arena announced the results of the meta-analyses of the phase III trial program using lorcaserin in obese and overweight patients for its effect in weight loss against placebo.

Arena has submitted the New Drug Application for lorcaserin to the US FDA in December and has received a Complete Response Letter in October 2010.  The company plans to submit a response

Sinovac Biotech reports positive results of the phase I trial using EV71 vaccine

Sinovac Biotech announced positive results of the phase I trial using EV71 vaccine as the potential therapy against hand, foot, and mouth disease.

The results showed that the agent has good safety and tolerance profiles.  In addition, the preliminary immunogenicity study results showed that good immune responses were demonstrated when the vaccine was administered.

The company plans to initiate the phase

Glenmark settled the US patent infringement suit with Triax and Astellas

Glenmark, Triax Pharmaceuticals and Astellas Pharma entered into a settlement and license agreement to settle the US patent infringement suit related to the abbreviated new drug application filed for 0.1% hydrocortisone butyrate cream by Glenmark.

According to the IMS Health Data, sales of Locoid Lipocream was approximately 38M in 2010.

Under the settlement agreement, Glenmark is to market and distribute

Amylin obtained a temporary restraining order against Lilly

Just when you thought it can't get any uglier, Amylin announced it has "obtained" a temporary restraining order against  Eli Lilly to block Lilly form using the same sales force to market both exenatide and linagliptin.

In addition, the court has also blocked Lilly from disclosing any confidential information about

Achillion initiated the phase I trial using ACH-2684, a potential therapy for HCV infection

Achillion announced that it has initiated the phase I trial using ACH-2684 as potential treatment for hepatitis C.

The company plans initiate the phase II, 12-week trial of ACH-1725 protease inhibitor in the near future.

About the phase 1 trial:

• It's a randomized, double-blind, placebo-controlled trial evaluating the safety, tolerability, pharmacokinetic profile and antiviral activity of ACH-3684 in both healthy volunteers and

Centella Therapeutics partnered with Cancer Resarch UK to develop CEN-209

Centella Therapeutics announced that it has partnered with Cancer Research UK to develop, manufacture, and trial its new acquired drug CEN-209 (from Auckland Uniservices) for the treatment of solid tumor in cancer patients.

Under the agreement signed between the two organizations, the Cancer Research UK's Drug Development Office will complete the preclinical development of CEN-20 in addition to taking

Centella Therapeutics acquired exclusive rights to CEN-209

Centella Therapeutics announced that it has entered into a licensing agreement with Auckland UniServices Ltd based in Auckland, New Zealand to acquired exclusive rights to CNE-209 as potential agent to be used in hypoxic tumor therapy.

CEN-209 is a novel investigational product that is designed to increase the effectiveness of radiotherapy and chemotherapy which are often used to target hypoxic solid tumor, a form of tumor that is often resistant to standard radiotherapy and chemotherapy.

CEN-209 is only activated

Anavex Life Sciences provided updates on ANAVEX 2-73

Anavex Life Sciences provided positive updates on its ongoing phase I trial evaluating ANAVEX 2-73 as potential therapy for patients with Alzheimer's disease.

The phase I trial is a randomized, placebo-controlled study determining the maximum tolerated single dose, safety, pharmacokinetics and pharmacodynamics of ANAVEX 2-73 given orally in ascending dose.  The trial is set to initiate the dosing of the next higher dose cohort after the data from the lower dose cohort has been shown to be safe in treated subjects.

The Safety Review Committee after reviewing the data in

Mylan announced that it has launched the generic version of Roxicodone tablets marketed by Xanodyine at the following strengths: 5 mg, 15 mg, 30 mg under the development and supply agreement with Coastal Pharmaceuticals.

Roxicodone is the brand name of oxycodone which is a schedule II medication.

As of March 31, 2011, the annual sales of Oxycodone HCl Tablets in the

Watsons Acquired Specifar Pharmaceuticals

Joining a recent string of acquisition, Watson announced that it has acquired Specifar Pharmaceuticals with 400 M Euro or $562M in cash and certain contingent consideration.

Reported within the last few days, Cilag of JNJ has acquired JB Chemical and Pharmaceuticals (an Indian-Based company), Valeant acquired Sanitas, and Par Pharmaceuticals acquired Edict Pharmaceuticals, Watson has joined the group to expand its access to emerging and European market.

Specifar's pipeline has the generic tablet version of

Alcon (Now Novartis) won a patent infringement lawsuit filed against Apotex

Alcon announced that The US district Court has ruled in favor of Alcon Laboratories and Alcon Research (both of which are now part of Novartis) in regard to a US patent infringement lawsuit filed along with Kyowa against Apotex and Apotex Corp.

The lawsuit was brought forward by Alcon in response to the ANDA submitted by Apotex to the US FDA for the generic version of Patanol or olopatadine hydrochloride ophthalmic solution currently marketed by Alcon.  Patanol has been granted US patent number 5,641,805 which is co-owned by

Sandoz filed ANDA for Vyvanse marketed by Shire

Shire announced last week that it received the paragraph IV notice letter from Sandoz notifying that Sandoz has filed an abbreviated new drug application for the generic version of Vyvanse, the brand name of lisdexamfetamine dimesylate capsules.  The ANDA submitted by Sandoz included all available strengths currently on the market.

Vyvanse currently has sixteen patents listed in the FDA Orange Book and they are set to expire

Provectus completes patient recruitment for the phase 2c tiral using PH-10

Provectus announced that it has completed patient recruitment for its phase 2C clinical trial using PH-10 for the treatment of psoriasis. 

About the Phase 2C trial:

• It's a multicenter, randomized vehicle controlled phase 2C trial that enrolled over 90 subjects at four different clinical sites.  The study is designed to evaluate the efficacy and safety of PH-10 given topically once a day to areas that have been affected with mild to moderate plaque psoriasis.
• The four clinical sites currently participating in the studies are

Ampio completed analysis of data from phase III trials of Zertane or tramadol and planned to present the data in the future

Ampio Pharmaceuticals announced that it has completed the analysis of the data collected from the phase III trials using Zertane for the treatment of premature ejaculation.

Ampio Pharmaceutical has also recently debuted in the NASDAQ stock exchanged under the symbol: AMPE.  The company started its trading session on May 19, 2011.  As of May 23, 2011, its value at closing time was 7.58 per share.

Although the report announced that the results were positive, no data were released! The company said more data comparing Zertane and other marketed drugs for the investigative indication will be presented in the future.

However, the company plans to file a marketing authorization application to several selected European countries for Zertane as the treatment of premature ejaculation.

Zertane was acquired by Ampio Pharmaceuticals after it merged with DMI Biosciences in March 2011. The tested formulation in the phase III trial was the fast dissolving oral tablet. 

Zertane which has the active ingredient as tramadol has been approved and used for over 30 years.  Tramadol is frequently used for pain relief.

Mylan launches the generic version of Depakote Sprinke Capsules

Mylan announced that it has launched the generic version of Depakote Sprinkle Capsules 125 mg which is currently marketed as monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures and adjunctive therapy in patients with multiple seizure types that include absence seizures.

Depakote is the brand name for divalproex sodium capsule which has an approximate

Valeant acquired AB Sanitas

Second day of the week and here comes the third major acquisition. JNJ has recently announced it is to acquire JB Chemical and Pharmaceuticals while Par pharmaceuticals announced it is to acquired an Indian-based company, Edict Pharmaceuticals.

Valeant has agreed to acquire AB Sanitas, a publicly-traded specialty pharmaceuticals company baesd in Kaunas, Lithuania, for approximately 314M Euro in cash.  Valeant is to acquired 87.2% Sanitas's outstanding shares from its major shareholders.  Once this acquisition is complete, Valeant is to commence

The FDA has scheduled a Dermatologic and Ophthalmic Drugs Advisory Committee Meeting for the BLA of VEGF Trap-Eye

Regeneron announced that the FDA has scheduled a Dermatologic and Ophthalmic Drugs Advisory Committee Meeting to discuss the Biologics License Application submitted for VEGF Trap-Eye submitted by the company on June 17, 2011.

The application seeks the approval of VEGF Trap-Eeye for the treatment of neovascular form of age-related macular degeneration (wet AMD).

The submission was filed in February and granted a Priority Review Designation.  The PDUFA date has been

Par Pharmaceuticals acquired Edict Pharmaceuticals

Par Pharmaceuticals announced that it has signed a definitive agreement to acquired Edict Phramaceuticals for up to $37.1M in cash and Par's repayment of certain additional pre-close indebtedness.

The transaction is expected to be completed by the end of 2011.

The acquisition will expand its manufacturing sites which will potentially increase its capacity.  Par Pharmaceutical Companies has two divisions: Par Pharmaceuticals (the generic drug division) and Strativa Pharmaceuticals (a proprietary product division).  The company is based in Woodcliff Lake, New Jersey US.

Edict Pharmaceuticals is privately-held Indian developer and manufacturer of generic pharmaceuticals.  The company specialized in producing

Cilag of Johnson and Johnson is to acquired JB Chemical and Pharmaceutical's Russia/CIS OTC business

Johnson and Johnson announced that its wholly-owned subsidiary Cilag GmbH International has signed definitive agreement to acquired JB Chemcical & Pharmaceutical's Russia/ Common Wealth of Independent States (CIS) Over-the counter business with approximately $260M in cash (according to JNJ's report).

Details of the transaction is as follow:

• JB Chemical & Pharmaceutical is to sell its Russia/CIS OTC Business to Cilag (Johnson and Johnson subsidiary) for INR 9,385M (which is approximately 206M US dollars, I wish they just wrote 9.385B instead of 9 thousand something million). 
• In addition, the company has also agreed to sale

Actelion released the results of the phase II trial using its CRTH2 antagonist

Actelion announced that the phase II trial using CRTH2 antagonist met the primary endpoint in patients with seasonal allergic rhinitis.

The company reported significant reduction in mean change from baseline in Daytime Nasal Symptom Score over the entire treatment period was observed in patients treated with CRTH2 antagonist compared to placebo.

The company plans to continue the development of CRTH2 and the results of the trial will be published in scientific journal in the future.

About the trial:

• It was a prospective, multi-center, double-blind, placebo-controlled, active-reference, multiple-dose levels, randomized, parallel-group phase II study (very very very very long description) enrolled 579 patients with seasonal allergic rhinitis.  Subjects were treated for two weeks.  

About CRTH2 antagonist:

• CRTH2 antagonist works by blocking the effect of prostaglandin D2 which has been shown to play role in allergic reaction. 
• The compound is also being tested in the phase II trial in patients with asthma.

Pfizer released the results of the subanalysis of the EMPHASIS HF trial using Inspra

Pfizer keeps putting out news in the past a couple days...

Pfizer has recently announced that the results of the pre-specified sub-analysis of the EMPHASIS HF (HF stands for Heart Failure..trademark of any heart failure study almost!) using Inspra or eplerenone in adition to standard recommended therapy showed significant reduction in the incidence of new onset atrial fibrillation or flutter (AF/F) in patients having systolic heart failure and mild symptoms when compared to placebo when given with standard recommended therapy.  (Note: Eplerenone has not been approved for use in the population tested in the study in any countries).

The trial has stopped recruiting patients since

The FDA approved telaprevir of Vertex

It's bound to be the month for Hepatitis!!!

The US FDA has approved telaprevir with the trade name Incivek to be used in combination with peg interferon alfa and ribavirin to treat certain adults who have been diagnosed with hepatitis C infection.  Incivek just like with Victrelis (how I love these names...!) can be used in patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to prior treatments.

The company has already stationed 200 field-based employees across the US, including a 115-person sales team who are ready for the introduction of INCIVEK to the medical community.

The company has already launched a program to help patients getting Incivek.  The proram will help

GSK and Human Genome Sciences received positive recommendation from the CHMP

GlaxoSmithKline and Human Genome Sciences announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of the marketing authorization of the companies' application for Benlysta or belimumab as an add-on therapy in adult patients who have active autoantibody-positive systemic lupus erythematosus that is not controlled under standard therapy.

Benlysta or belimumab has been approved recently in

The European Commission approved Apixaban or Eliquis, an Oral Direct Xa inhibitor

Pfizer announced that the European Commission has approved apixaban or Eliquis to be used in the prevention of venous thromboembolism after elective hip or Knee replacement.

Apixaban is developed in collaboration with Bristol-Myers Squibb.  Bristol-Myers Squibb and Pfizer entered into a worldwide collaboration program in 2007 to develop and commercialize Apaxiban. For more information about the agreement

Progenics released the results of the phase III trial using methylnaltrexone and plans for submission

Progenics released the results of the phase III trial evaluating methylnaltrexone bromide given as subcutaneous injection as potential therapy for patients who experienced non-malignant pain and opioid-induced constipation.

The results showed that 34.1% of patients receiving methylnaltrexone 12 mg subcutaneously experienced bowel movements within 4 hours during the treatment period.  A significant improvement in patient subjective assessments when compared to baseline were recorded.  Patients experienced significant reduction in straining and the the number of bowel movements accompanied by the sensation of complete evaluation.

Progenics plans to submit the data from this study to the US FDA for

StarPharma released positive results of the phase II trial using VivaGel

StarPharma, an Australian company, releases the results of the phase II trial using the company product's VivaGel for the treatment of bacterial vaginosis.

The study met its primary endpoint which was significant increase clinical Cure in patients treated with VivaGel 1%  given once a day for seven days when compared to placebo in two to five days (74% vs 22%, p = 0.0002).

StarPharma has filed a new patent application for VivaGel relating to its use in

Metabolex initiated phase II trial using arphalofenate

Metabolex announced that it has initiated the phase II trial using arphalofenate as a potential therapy for the management of hyperuricemia in patients with gout.

Metabolex also announced that it is to initiate the study using arphalofenate in combination with allopurinol (standard of treatment for gout disease) in patients who are refractory to allopurinol.  In addition, it plans to initiate another study using arphalofenate in combination with febuxostat in patients with gout.

About the trial:
It's a randomized, double-blind, placebo-controlled trial evaluating the safety and

Alvine was issued US Patents covering ALV003

Alvine Pharmaceuticals announced that the US Patent and Trademark Office has issued four key patents protecting various aspects of ALV003, an enzyme that is being studied as potential treatment of Celiac Disease.

The four key patents are: 7,943,312; 7, 928, 056; 7, 923, 532; and 7, 910, 541. 

The compound was originally developed at Stanford University.  Alvine Pharmaceuticals acquired

The FDA approved Sutent for additional indication

Pfizer announced that the FDA has approved the use of Sutent as the first anti-VEGF therapy for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease.

The FDA approved Sutent based on the data from the