Development of almorexant of GlaxoSmithKline (GSK) and Actelion has been discontinued

The phase III trial using almorexant for the treatment of sleep disorders has been discontinued due to results in regard to its clinical profile and tolerability profiles.

Almorexant is a dual orexin receptor antagonist being co-developed by both GlaxoSmithKline (GSK) and Actelion under the Orexin Alliance formed in July 2008 (See below for more information).

Informatin about Orexin and almorexant:

• Orexin is a neural peptide modulators often seen in the brain.  They are produced in the hypothalamic neurons.  Its functions include regulating the sleep and wake states in human body. Orexin receptor is G-protein coupling receptor.  Once orexin binds to its receptor, its effects have been demonstrated to increase wakefullness.  When a deficiency of orexin signals occurred, narcolepsy has been observed. 

 

• Almorexant works to stop the orexin receptor from interaction with orexin which will lead to alertness and wakefullness.  As a result, by stopping this interaction, less orexin neuron will be activated and

Study with Pharmapodia Series - Caduet - amlodipine and atorvastatin

Happy Saturday!

I've uploaded a new video on youtube!

You can either go to youtube to check it out or you can watch it below!

Study with Pharmapodia Series introduce Caduet!

Plexxikon initiates the phase I trial using PLX5622

Plexxikon initiates the phase I clinical trials using PLX5622 as a potential treatment for rheumatoid arthritis.

• PLX5622 is a novel, oral and highly selective Fms inhibitor.  It works by inhibiting the Fms kinase which plays a role in several inflammatory mediators and cells such as macrophages, osteoclasts and T-cells. The inhibition of this process will lead to the depression of inflammation.

• Thirty-two healthy volunteers will be given PLX5622 in single-ascending dose in the first phase 1 trial.
• Thirty-two patients with rheumatoid arthritis will be given PLX5622 in multiple-ascending dose once the first phase 1 trial is complete and safety has been verified.
• In pre-clinical study, PLX5622 has demonstrated its ability to suppress arthritis in animal models including advanced models of collagen-induced arthritis.  A significant improvement in grip strength and clinical scores were observed.
• Plexxikon is bsed in Berkeley, CA.

Update on Remoxy and Pain Therapeutics!

 

• After resubmitting the new drug application for REMOXY (an oral controlled-release oxycodone) in December, Pain Therapeutics announced that the FDA has accepted its resubmission and classified it as a Class 2 resubmission.  In addition, the FDA has assigned the Prescription Drug User Fee Act date for Remoxy.  Its PDUFA date will be on  June 23, 2011.

• After the FDA acceptance of its resubmission was announced, King Pharmaceuticals made a $5M payment to Remoxy.

More information about Remoxy, Pain Therapeutics and its Partner King Pharmaceuticals are presented as below:

About Remoxy(R):

• REMOXY(R) is a twice-a-day long-acting formulation of oral oxycodone that can be used to relieve moderate to severe pain. It was originally developed by Pain Therapeutics using ORADUR technology belonging to DURECT Corporations. 
• Oxycodone is an opioid that works to relieve pain in many conditions. However, current marketed formulations do not offer protection against abusive use. ORADUR technology claims to provide a

Endo Pharmaceuticals and Orion Corporation entered into a collaboration agreement

Endo Pharmaceuticals and Orion Corporation entered into a collaboration agreement to discovery, develop and commercialize oncology products.

Under the agreement, Orion will have rights to market assets resulting from this collaboration in Europe including Russia.  Endo will have marketing rights for these assets in North America.  Both companies will also have rights to exclusively license compounds of the other company's development-ready programs at pre-determined stages and will share all development costs.

In addition, the agreement has allowed Endo to license Orion's lead product, a novel andreogen-receptor antagonist for the treatment of advanced prostate cancer.  Endo exercises its rights to codevelop the lead product originated from Orion.  The compound will be jointly developed by both companies.  The compound is expected to enter into phase I clinical trials in the future.

Each company will receive cross royalties to each other depending on sales from the respective territories.  

Matrix Laboratories (of Mylan) signed agreement with Tibotec to manufacture its rilpivirine

Matrix Laboratories Limited, a subsidiary of Mylan, has signed a non-exclusive agreement with Tibotec to manufacture, market and distribute the generic version of rilpivirine hydrochloride, an investigational compound being developed by Tibotec. Rilpivirine is being investigated for its use in the treatment in patients with HIV-infection.

Agreement:

• Under the agreement, Matrix will have rights to market the product in sub-Saharan Africa, certain developing countries and India.  In addition, Matrix will become the manufacturer of the once-daily 25 mg rilpivirine as a single agent.  It also has a license to develop the fixed-dose combination product. 

Teva and APP announced launch of gemcitabine

Teva and APP announced launch of gemcitabine, an oncology medication marketed as Gemzar by Eli Lilly. 

Gemcitabine is a nucleoside metabolic inhibitor.  It works to inhibit DNA synthesis which is an important process for cell replication.  It specifically works to inhibit the S-phase.  As a result, the cells that have taken up gemcitabine will not be able to replicate and die.  

Gemcitabine has been approved in the US to be used in combination with chemotherapy to treat ovarian cancer (with carboplatin), breast cancer (with paclitaxel), non-small cell lung cancer (with cisplatin).  It is also the first line treatment to be used in patients with locally advanced (nonresectable Stage II or stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas.

Teva and APP have signed an agreement under which APP will manufacture Gemcitabine HCl for injection.  In addition, it will be able to market the productive in the US within Teva’s 180-day exclusivity due to a license receive from Teva.  Teva, in return, will receive royalty during the manufacturing term.

Gemzar is the brand name of gemcitabine and is marketed by Eli Lilly and had a sale of $785 M in the US last year according to the IMS sales data.

My note: the introduction of generic gemcitabine might drive the price down a bit but I wouldn't expect its drug price will be down much.  This will add some earning values to Teva and might cut Lilly's profit a bit. 

The FDA granted an orphan status to BioSante's melanoma vaccine

The FDA granted an orphan status to BioSante's cancer vaccine which is being developed for the treatment of stage IIb to IV melanoma.

Orphan Drug Designation is often given to pharmaceutical products that are intended to be used in disease which has less than 200,000 patients being affected per year in the US.  Once granted, the medication often has market exclusivity for 7 years and tax credits.

BioSante's cancer vaccines have been given orphan drug status for the following indications:

• Pancreatic Cancer
• Acute Myeloid Leukemia
• Chronic Myeloid Leukemia

Products that have been approved and currently marketed:

• Elestrin: a 0.06% estradiol gel that is indicated for the treatment of moderate-to-severe hot flashes associated with menopause.

Other products in development at BioSante and its partners

• LibiGel: a testosterone gel that is currently being studied in phase III trials.  The company plans to submit the NDA to the FDA in late 2011.
• The Pill-plus: a combination product of estrogen, progestin and another androgen that has been licensed out to Pantarhei Bioscience B.V.  Pantarhei has rights to develop and market The Pill-Plus in the US.  BioSante retains rights to develop and market the transdermal formulation of Pill-Plus. 
• Bio-T-Gel: is testosterone transdermal formulation.  It is currently being developed by Teva Pharmaceuticals US who will also be marketing the product once approved.  It's being developed for the treatment of male hypogonadism or low testosterone levels
• In addition, BioSante is working to develop some Aesthetic Medicine (BioLook(TM)) using its CaP technology.    The company plans to initiate trial in human in the next 12 months.

Ligand Acquired CyDex Pharmaceuticals

Are you ready for another acquisition?  Firms are purchasing left and right!

Ligand has acquired CyDex Pharmaceuticals , a company based on Lenexa, Kansas, with both cash and contingent payment. 

An upfront cash of 31.2 M will be paid to CyDex Shareholders who will also be receiving a 4.3M payment as the acquisition celebrates its one year anniversary of closing.  CyDex Shareholders are also entitled to receive contingent cash payment as deemed appropriate (in term of certain transaction and revenue share plan).  In order to adjust for working capital, Ligand also paid an approximately 800K at close.

About Cydex Pharmaceuticals:

• It's a specialty pharmaceutical company.  The company has developed an advanced drug formulation technology called Captisol. 
• Captisol: is developed to enhance the solubility ,stability, bioavailability, safety and dosing of active pharmaceutical ingredients (APIs) using modified cyclodextrin molecules.  
• The two drugs that are currently in the market using Captisol technology are Vfend IV and

Teva is to acquire Corporacion Infarmasa, a Peruvian pharmaceutical company

Teva announced its acquisition of Corporacion Infarmasa, a Peruvian pharmaceutical company.  Corporacion Infarmsa belongs to the Rohatyn Group and Altra Investments.

Corporacion Infarmsa belongs to the top ten pharmaceutical companies in Peru.  Corporacion Infarmsa has over 500 products on the market.  This represents a over 80% of its registered products.  In addition to manufacture and commercialize branded products, it also does so to generic medications.  Its products' therapeutic areas are primary corticosteroids, antihistamines, analgesics and antibiotics.

Corporacion Infarmsa will be incorporated into Corporacion Medco which currently represents Teva in Peruvian market.

Two recent acquisitions have been Theramex (a European-based women' health business belong to Merck KGaA) and Ratiopharm.  I think the acquisition of Corporacion Infarmsa will help increase Teva's market shares in Peru with possible expansion in Latin America.

New Drug Approval for 2011

New Drug Approval for January 2011 has been updated!

Enjoy! :)

Pharmapodia

The FDA granted MuDelta of Furiex Fast Track Designation

The FDA granted MuDelta of Furiex Fast Track Designation.

MuDelta is a mu-opioid receptor agonist and a delta-opioid antagonist.  It's being developed for the treatment of Diarrhea-Predominant Irritable Bowel Syndrome.  MuDelta is currently being studied in phase II clinical trials.

Under the Fast Track Designation Program, MuDelta is eligible to have expedite review process.

Partnership:

MuDelta was developed in collaboration with Janssen-Cilag Pharmaceuticals.  Under the development and license agreement, Janssen-Cilag has rights to continue to develop and commercialize MuDelta after Furiex completes the phase II development.  If Janssen-Cilag exercises its right, it will be accountable for the cost associated with the development, manufacture and marketing of MuDelta.  Furiex would be eligible to receive up to $90M  as MuDelta reaches regulatory milestones.  In addition, up to $75M would be paid to Furiex based on the product sale-milestones.   Furiex would also be eligible to receive other royalties.  However, if Janssen-Cilag decided not to exercise its rights and Furiex decides to continue the product development, Furiex will need to pay Janssen-Cilag certain milestones and royalties as the drug moves forward with its clinical development.

Furiex is a spin-off of PDD, a global contract-research organization.  The process took place in June 2010.

Clinical Development:

The results of the phase I study showed that MuDelta had a favorable safety and pharmacokinetic profile.
The ongoing phase II trial is investigating the clinical efficacy of the oral formulation of Mu Delta.  It is being compared against placebo.  The study is designed to be an adaptive study design - this means the investigators are able to modify the study design as new information coming forward.

Abbott reported its sales in fhe 4th quarter of 2010 with an increase in total sale of 13.4%

Abbott reported its earning in the fourth quarter ended on December 31, 2010.

• The company reported a fourth quarter sales of 9.968 billion (a 13.4% increase in sale compared to the 4th quarter of 2009)  with total US sales accounted for 4.287B (an increase of 6.3% compared to the 4th quarter of 2009).  

• The US pharmaceutical sales accounted for 2.655B ( about 0.629B less than the international pharmaceutical sales which posted an increase of 19.4% in total sales when compared to the same quarter of 2009.).
• Of the total sales reported in the 4th quarter 2009, segments that experienced a decrease in sales

The FDA completed the review of TEVA's ANDA for the generic version of Lovenox: Shares rose

The FDA has completed the review of the ANDA for the generic version of Lovenox or enoxaparin sodium submitted by Teva.  A Minor Deficiency letter was issued indicating that Teva needs to provide some answers to the list of questions requested by the FDA.  This indicates that there is potential for the generic product of Lovenox to be approved once Teva has responded to the FDA's request.

Teva announced that it intends to answer the FDA's questions in the near future.

Upon the announcement, shares of Momenta, dropped from almost $16 to 12.5 (about 21% decrease).  (NASDAQ:MNTA).
Meanwhile, shares of Teva rose from 52.7 to about 54.5 (about 3.4-3.5% increase) after the announcement was made.  (NASDAQ:TEVA)

You might wonder why Momenta shares dropped when the branded Lovenox is marketed by Sanofi-aventis (which benefited from a 4.2B in sales from Lovenox worldwide!)

The generic version of Lovenox called M-enoxaparin, co-developed by both Sandoz and Momenta, actually has been approved in the US by the FDA in July, 2010.  The drop in its stock price is due to the introduction of a new competitor.  (See the agreement segment below for more details)

About Lovenox or enoxaparin

• Enoxaparin is a low molecular heparin that is indicated to be used in the prevention and treatment of deep vein thrombosis. In addition, it can also be used in the prophylaxis of ischemic complications in patients with unstable angina and non-Q-wave myocardial infarction.  It can also be used to treat acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention.
• Enoxaparin was originally approved in 1993 (according to its package insert).  It amazes me that it takes 17-18 years for a generic product to come out. 

About Sandoz and Momenta Agreement

• In 2003, Sandoz and Momenta entered into a co-development agreement to exclusively work together to develop and commercialize injectable enoxaparin for all major indications in the US.  Under the agreement, Sandoz was granted an exclusive license to develop and commercialize the stated injectable enoxaparin for all medical indications.  An upfront payment was made to Momenta.  In addition, Momenta was eligible for other milestone payments.  However, its share of profits from the sales of M-enoxaparin would be affected when there was an introduction of another generic maker.  Instead of getting a 40 to 50% profit from sales of M-enoxaparin, it will only receive a royalty on net sales which could be a substantial reduction from the share of 40 to 50% sale profits. 
• In 2006, both companies agreed to an expansion of the agreement which allowed for the development and commercialization of M-enoxaparin in European Union.

Novartis has signed a definitive agreement to acquire Genoptix

Novartis has signed a definitive agreement to acquire Genoptix in cash at the price of 25 USD per share which was about 25% over Genoptix's stock price as of yesterday.  Its stock closed at about $20 and since  jumps to over 24 after the announcement was made publicly this morning.

Genoptix will be integrated into Novartis Molecular Diagnostics (MDx) unit belonging to the Novartis Pharmaceuticals Division.

Genoptix was founded in 1999 in Carlsbad, California.  It's a specialized laboratory service prodiver which operate: COMPASS Compressive Assessment, CHART (Comprehensive Hematopathology Assessment and Review Over Time), NexCourse (launched in 2010).  Its diagnostic services are used to diagnosing: bone marrow, blood and lymph node cancers. 

Genoptix went public in 2007 and is listed on the NASDAQ Global Select Market.  It's also a member of S&P SmallCap 600 Index and the Russell 2000 Index.

At the end of 2009, the company had a net income of 30.6M (a 1.71 earning per share).  It was a decrease of 0.8 M from the net income of 2008.

COMPASS: Comprehensive Assessment provides its services mainly to hematologists and oncologists.  It conducts diagnostic tests and determine the performance of these tests.  In addition, a summary of the results will be presented after it has been evaluated and synthesized.

CHART also provides its services mainly to hematologists and oncologists.  Using reports generated from its sister COMPASS servces, it will analyze disease progression after cerain clinical actions have been executed.  You can think of it as a tracking service in some ways.

NexCOURSE was recently launched.  Its services are dedicated to the evluation of colorectal carcinoma (colon cancer).  NexCourse is one of the newer services that Genoptix offered to expand its services to solid tumor territory.  NexCourse plans to predict patient response to certain treatments.

Ok I'm getting more fascinated with this company and will provide more information about its clinical service in the very near future!

My thoughts: this is a good move for Novartis to acquire Genoptix.  Cancer incidence is on the rise.  Targeted therapy has become pretty hot recently.  With this service, Novartis might be able to expand its horizon!

The FDA accepted the NDA of fidaxomicin of Optimer for review and the PDUFA date has been set

Fidaxomicin of Optimer has been accepted for review for the treatment of Clostridium diffcile infection. In addition, it has granted priority review for fidaxomicin. The FDA has also issued a Prescription Drug User Fee Act (PDUFA) date which lands on May 30, 2011. The Anti-infective drugs Advisory Committee will meet on April 5, 2011 to deliberate its recommendation to the FDA in regard to the drug approval. (My take on this is included at the bottom)

This post addressed:

• Information about fidaxomicin as a drug
• Clinical trial information
• General patent information
• Regulatory information
• Quick look at C. diff
• My take

About fidaxomicin:

Fidaxomicin is a novel antibiotics belong to a class called macrocycles. Macrocycles works to inhibi the bacterial enzyme RNA polymerase which plays an important role in bacterial survival. In this case, fidaxomicin inhibits the enzyme RNA polymerase of Clostridium difficile which results in the killing of Clostridium difficile.

The company also develops the oral suspension formulation to go with the existing fidamoxicin tablet.

Clinical Information:

• Two large phase III clinical trials were conducted comparing the use of fidaxomicin to Vancocin (vancomycin – one of the more powerful antibiotics are currently on the market). The results were available in 2008 and 2009.

• The first phase III trial was a multicenter, randomized, double blind study enrolling 629 adults who had confirmed CDI. Patients were treated with 200 mg of OPT-80 (fidaxomicin) orally twice a day or 125 mg of Vancocin (vancomycin) orally four times a day. 
• The primary endpoint of the study was clinical cure in infected patients. 

The FDA approves vilazodone for the treatment of major depressive disorders in adults!

On Friday Jan 21, 2011, the FDA approves Viibryd, the brand name of vilazodone hydrochloride) for the treatment of major depressive disorder in adults.  Vilazodone is manufactured by PgXHealth, the main operating bussiness of Clinical Data.  I expect the press release and conference call will happen tomorrow.

About vilazodone

• Vilazodone was originally developed by Merck KGaA which licensed vilazodone to Genaissance Pharmaceuticals in 2004.  Clinical Data acquired Genaissance Pharmaceuticals in 2005 and came with it vilazodone. 
• Vilazodone works as a serotonin reuptake inhibitor and serotonin receptor 1A partial agonist.  Serotonin has been observed to be deficient in patients who suffer from depression.  As a

Study with Pharmapodia Series - Humira or adalimumab

Come and learn about Humira or adalimumab with us on our YouTube channel!



:)

Have a great week!

Pharmapodia

Ridaforolimus of Ariad performed well in its phase III trial studying its safety and efficacy in patient with metastatic Soft-Tissue or Bone Sarcomas.

Ridaforolimus of Ariad performed well in its phase III trial studying its safety and efficacy in patient with metastatic Soft-Tissue or Bone Sarcomas

About Ridaforolimus:

• Ridaforolimus I an oral mTOR inhibitor originally developed by ARIAD. mTOR is an important protein in the regulation of protein synthesis, cell proliferation, cell cycle progression, and cell survival. It works closely with other signaling proteins such as PI3K, AKT and PTEN in these processes.

Agreement:

• In July 2007, Merck and ARIAD entered into a collaboration agreement under which a $75M upfront payment from Merck was made to ARIAD. Ever since 2007, more than $50M has been made toward the development of ridaforolimus as it progresses through the phase II and III clinical trials.
• In May 2010, both companies restructured the partnership. Under the new agreement, Merck now has an exclusive license to develop, manufacture and commercialize ridaforolimus as an oncology product. Merck will now also be responsible for all activities in regard to ridaforolimus. This includes performing clinical trials and submitting regulatory filings. Another

Orencia - abatacept - Learn with Pharmapodia!

Learn with us about Orencia or abatacept!

A new youtube video has been added!




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