Connotia

30 New Medical Entities (NMEs): 24 New Chemical Entities and 6 New Biologics approved by FDA in 2011

2012-01-04T12:21:00.000-08:00

NEW CHEMICAL ENTITIES

DATSCAN
(IOFLUPANE I-123) by GE Healthcare

FDA Application number: NDA # 022454

Approval Date: 1/14/2011
DaTscan (Ioflupane I 123 Injection) is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS). DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson's disease, multiple system atrophy and progressive supranuclear palsy).
Prescribing Information:
http://us.datscan.com/wp-content/themes/main_site/pdf/prescribing-information.pdf
NATROBA
(SPINOSAD) by Parapro Pharmaceuticals

FDA Application number: NDA # 022408
Approval Date: 1/18/2011
Natroba™ Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in patients four (4) years of age and older.
Prescribing Information:
http://www.natroba.com/Full%20Prescribing%20Information.pdf
VIIBRYD
(VILAZODONE HYDROCHLORIDE) by Forest Labs

FDA Application number: NDA # 022567
Approval Date: 1/21/2011
VIIBRYD is indicated for the treatment of major depressive disorder (MDD).
Prescribing Information:
http://www.natroba.com/Full%20Prescribing%20Information.pdf
EDARBI
(AZILSARTAN MEDOXOMIL) by Takeda

FDA Application number: NDA # 200796 Approval Date: 2/25/2011

Edarbi is an angiotensin II receptor blocker indicated for the treatment of hypertension,to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Edarbi may be used, either alone or in
combination with other antihypertensive agents.
Prescribing Information:
http://general.takedapharm.com/content/file/pi.pdf?applicationcode=68E3872B-7993-4087-8929-05B4E4E0E6D2&FileTypeCode=EDARBIPI
DALIRESP
(ROFLUMILAST) by Forest Labs

FDA Application number: NDA # 022522
Approval Date: 2/28/2011
DALIRESP is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Prescribing Information: http://www.frx.com/pi/Daliresp_pi.pdf
GADAVIST
(GADOBUTROL) by Bayer

FDA Application number: NDA # 201277
Approval Date: 3/14/2011
GADAVIST™ is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.

Prescribing Information: http://labeling.bayerhealthcare.com/html/products/pi/gadavist_PI.pdf
HORIZANT
(GABAPENTIN ENACARBIL) by Glaxo SmithKline

FDA Application number: NDA # 022399
Approval Date: 4/6/2011
HORIZANT is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults.

Prescribing Information: http://us.gsk.com/products/assets/us_horizant.pdf
VANDETANIB
(VANDETANIB) by AstraZeneca

FDA Application number: NDA # 022405
Approval Date: 4/6/2011
CAPRELSA is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.

Prescribing Information: http://www.astrazeneca-us.com/cgi-bin/az_pi.cgi?product=caprelsa&country=us&popup=no
ZYTIGA
(ABIRATERONE ACETATE) by Janssen Biotech

FDA Application number: NDA # 202379
Approval Date: 4/28/2011
ZYTIGA is a CYP17 inhibitor indicated for use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who have received prior hemotherapy containing docetaxel.

Prescribing Information: http://www.zytiga.com/downloads/full_product_information.pdf#zoom=100
TRADJENTA
(LINAGLIPTIN) by Boehringer Ingleheim

FDA Application number: NDA # 201280
Approval Date: 5/2/2011
TRADJENTA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Prescribing Information: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Tradjenta/Tradjenta.pdf
VICTRELIS
(BOCEPREVIR) by Merck

FDA Application number: NDA # 202258
Approval Date: 5/13/2011
VICTRELIS is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (≥18 years of age) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.

Prescribing Information: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf
EDURANT
(RILPIVIRINE HYDROCHLORIDE) by Tibotec

FDA Application number: NDA # 202022
Approval Date: 5/20/2011
EDURANT® is a prescription HIV medicine that helps to treat HIV infection in adults. It contains the HIV drug rilpivirine. This is a type of HIV medicine called a non-nucleoside reverse transcriptase inhibitor, or NNRTI. EDURANT® is used in adults who have never taken HIV medicines before.

Prescribing Information: http://www.edurant-info.com/sites/default/files/EDURANT-PI.pdf
INCIVEK
(TELAPREVIR) by Vertex

FDA Application number: NDA # 201917
Approval Date: 5/23/2011
INCIVEK is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated, in combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic hepatitis C (CHC) in adult patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have been previously treated with interferon-based treatment, including prior null responders, partial responders, and relapsers.
Prescribing Information:
http://pi.vrtx.com/files/uspi_telaprevir.pdf
DIFICID
(FIDAXOMICIN) by Optimer

FDA Application number: NDA # 201699
Approval Date: 5/27/2011
DIFICID is a macrolide antibacterial drug indicated in adults (18 years of age) for treatment of Clostridium difficile-associated diarrhea

Prescribing Information: http://www.dificid.com/upload/dificid.pdf
POTIGA
(EZOGABINE) by Valeant

FDA Application number: NDA # 022345
Approval Date: 6/10/2011
POTIGA is a potassium channel opener indicated as adjunctive treatment of partial-onset seizures in patients aged 18 years and older.

Prescribing Information: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022345s000lbl.pdf
ARCAPTA NEOHALER
(INDACATEROL MALEATE) by Novartis

FDA Application number: NDA # 022383
Approval Date: 7/1/2011
ARCAPTA NEOHALER is a long-acting beta2-adrenergic agonist indicated for the long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Prescribing Information: http://www.pharma.us.novartis.com/product/pi/pdf/arcapta.pdf
XARELTO
(RIVAROXABAN) by Janssen Pharmaceticals

FDA Application number: NDA # 022406
Approval Date: 7/1/2011
XARELTO is a factor Xa inhibitor indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing knee or hip replacement.
surgery

Prescribing Information: http://www.xareltohcp.com/sites/default/files/pdf/xarelto_0.pdf#zoom=100
BRILINTA
(TICAGRELOR) by Astra Zeneca

FDA Application number: NDA # 022433
Approval Date: 7/20/2011
BRILINTA is a P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) (unstable angina, non-ST elevation myocardial infarction, or ST elevation myocardial infarction). BRILINTA has been shown to reduce the rate of a combined endpoint of cardiovascular death, myocardial infarction or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with PCI, it also reduces the rate of stent thrombosis.

Prescribing Information: http://www1.astrazeneca-us.com/pi/brilinta.pdf
ZELBORAF
(VEMURAFENIB) by Roche

FDA Application number: NDA # 202429
Approval Date: 8/17/2011
ZELBORAF™ is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAFV600E mutation as detected by an FDA-approved test.

Prescribing Information: http://www.gene.com/gene/products/information/zelboraf/pdf/pi.pdf
FIRAZYR
(ICATIBANT ACETATE) by Shire

FDA Application number: NDA # 022150
Approval Date: 8/25/2011
FIRAZYR is a bradykinin B2 receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema in adults 18 years of age and older.

Prescribing Information: http://pi.shirecontent.com/PI/PDFs/Firazyr_USA_ENG.pdf
XALKORI
(CRIZOTINIB) by Pfizer

FDA Application number: NDA # 202570
Approval Date: 8/26/2011
XALKORI is a kinase inhibitor indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. (1) This indication is based on response rate. There are no data available demonstrating improvement in patient reported outcomes or survival with XALKORI.

Prescribing Information: http://labeling.pfizer.com/showlabeling.aspx?id=676
FERRIPROX
(DEFERIPRONE) by Apopharma

FDA Application number: NDA # 021825
Approval Date: 10/14/2011
FERRIPROX® (deferiprone) is an iron chelator indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.

Prescribing Information: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021825lbl.pdf
ONFI
(CLOBAZAM) by Lundbeck

FDA Application number: NDA # 202067
Approval Date: 10/21/2011
ONFI is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older

Prescribing Information: http://www.lundbeck.com/upload/us/files/pdf/Products/Onfi_PI_US_EN.pdf
JAKAFI
(RUXOLITINIB PHOSPHATE) by Incyte

FDA Application number: NDA # 202192
Approval Date: 11/16/2011
Jakafi is a kinase inhibitor indicated for treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis.

Prescribing Information: http://www.incyte.com/products/uspi_jakafi.pdf

BIOLOGICS
BENLYSTA
(BELIMUMAB) by Human Genome Sciences ($HGSI)

FDA Application number: BLA # 125370
Approval Date: 3/10/2011
BENLYSTA is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus

Prescribing Information: http://www.hgsi.com/images/Benlysta/pdf/benlysta_pi.pdf
YERVOY
(IPILIMUMAB) by Bristol Myers Squibb ($BMS)

FDA Application number: BLA # 125377
Approval Date: 3/25/2011
YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for the treatment of unresectable or metastatic melanoma.

Prescribing Information: http://packageinserts.bms.com/pi/pi_yervoy.pdf
NULOJIX
(BELATACEPT) by Bristol Myers Squibb ($BMS)

FDA Application number: BLA # 125288
Approval Date: 6/15/2011
NULOJIX is a selective T-cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant.

Prescribing Information: http://packageinserts.bms.com/pi/pi_nulojix.pdf
ADCETRIS
(BRENTUXIMAB VEDOTIN) by Seattle Genetics ($SGEN)

FDA Application number: BLA # 125399
Approval Date: 8/19/2011
ADCETRIS is a CD30-directed antibody-drug conjugate indicated for:
• The treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT)
•HL in patients who are not ASCT candidates after failure of at least 2 multiagent chemotherapy regimens
• Systemic anaplastic large cell lymphoma (sALCL) after failure of at least 1 multiagent chemotherapy regimen

Prescribing Information: http://www.adcetris.com/_pdf/Adcetris_USPI_2011.pdf
ERWINAZE
(asparaginase Erwinia chrysanthemi) by Eusa Pharmaceuticals

FDA Application number: BLA # 125359
Approval Date: 11/18/2011
ERWINAZE (asparaginase Erwinia chrysanthemi) is an asparagine-specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli derived asparaginase.

Prescribing Information: http://www.erwinaze.com/pdf/PI_18-Nov2011.pdf
EYLEA
(AFLIBERCEPT) by Regeneron ($REGN)

FDA Application number: BLA # 125387
Approval Date: 11/18/2011
EYLEA is indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD).

Prescribing Information: http://www.regeneron.com/EYLEA-fpi.pdf

Farma M&A and involuntary outbursts of crying and laughing

2011-11-04T14:58:00.000-07:00

Do you have difficulty imagining what's next in Pharma M&A? You are not alone. Many of us suffer from the bouts of irresistible urge to comment on 'Farma' and 'Phinance'. It is ironical because the two seldom make sense together and adverse side-effects are significant. For instance, big mergers invariably end up in long-term debt, useless goodwill, and endless questions about the vision of decision-makers. On the other hand, smaller and mid-size Pharma companies (biotechs included) have such symptomatically large cash-burn rates and little revenues that we wonder why CFOs and investors do not line up as patients for new trials for cardiovascular drugs. They must be getting heart attacks, right?

As comes November, so do we begin to conjecture about the M&A activity in the Pharma space that is left for the remaining year. Heart begins to pace faster every friday anxious about the news that 'Merger Monday' may bring. There are some obvious candidates that we have been watching. First, why doesn't GlaxoSmithKline just buy out Human Genome Sciences ($HGSI) already? The rumor engine has run past its warranty on that one. Then there is Vertex ($VRTX) with a HCV drug so great that even Merck ($MRK) may be drooling. The HCV wave has also popped the stocks of Pharmasset ($VRUS) and, today, Inhibitex ($INHX). Don't you miss days when Pfizer ($PFE) made acquisitions, big and small, without thinking twice? Finally, there is Dendreon ($DNDN) - now trading at $6 plus change per share. Would it have to be a penny-stock again to become attractive?

The new pharma flavor-of-the-year has to be neurology. Everyone is beating their brains out figuring what new neurology drug companies can they add to their pipelines. There are those who get what they want. Case in point - Teva ($TEVA) swallowing Cephalon. And the rest like Valeant Pharma ($VRX) are left behind holding onto their nerves and their wads of cash - $1 billion to be exact. Biotech analysts are scratching their own brains wondering what will be the next hot buys before Christmas. Acorda ($ACOR) has Ampyra - the new MS drug, and Avanir ($AVNR) seems to be attracting attention for Nuedexta - its drug to treat pseudobulbar affect (PBA). What?

The answer seems that there are many ways to spend billion-plus dollars on Pharma M&A in a nervous society and depressed economy. In our feeble minds, question remains, 'If it is a Monday, will we be able to regain control of involuntary outbursts of crying or laughing?'

7 New Medical Entities Approved by FDA in Q1 2010

2010-04-13T19:05:00.001-07:00

ACTEMRA (Tocilizumab) by Genentech
FDA Application number: BLA # 125276; Approval Date: 1/8/2010
ACTEMRA (tocilizumab) is an interleukin-6 (IL-6) receptor inhibitor indicated for treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
Dosage: Once every 4 week as 60 m intravenous drip of 4 or 8 mg/Kg.
Prescribing Information: http://www.gene.com/gene/products/information/actemra/pdf/pi.pdf
AMPYRA (Dalfampridine) by Acorda Therapeutics
FDA Application number: NDA # 022250; Approval Date: 1/22/2010
AMPYRA (dalfampridine) is a potassium channel blocker indicated to improve walking in patients with multiple sclerosis (MS).
Dosage: 10 mg twice daily.
Prescribing Information: http://www.ampyra.com/local/files/PI.pdf
VICTOZA (Liraglutide) by Novo Nordisk
FDA Application number: NDA # 022341; Approval Date: 1/25/2010
VICTOZA is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Dosage: Once daily 0.6, 1.2 or 1.8 mg subcutaneous injection.
Prescribing Information: http://www.victoza.com/pdf/PI_(1_Column_Format).pdf
XIAFLEX (Collagenase clostridium histolyticum) by Auxilium Pharmaceuticals
FDA Application number: BLA # 125338; Approval Date: 2/2/2010
XIAFLEX is indicated for the treatment of adult patients with Dupuytren's contracture with a palpable cord.
Dosage: 0.58mg per intralesional injection.
Prescribing Information: http://www.xiaflex.com/docs/pi_medguide_combo.pdf
VPRIV (Velaglucerase alfa) by Shire
FDA Application number: NDA # 022575; Approval Date: 2/26/2010
VPRIV (velaglucerase alfa for injection) is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for pediatric and adult patients with type 1 Gaucher disease.
Dosage: 60U/kg administered every other week as a 60 min intravenous infusion.
Prescribing Information: http://medicuslb.com/dev/vpriv/staging/VPRIV_Full_Prescribing_Info.pdf
CARBAGLU (Carglumic acid) by Recordati
FDA Application number: NDA # 022562; Approval Date: 3/18/2010
CARBAGLU (Carglumic acid) is a Carbamoyl Phosphate Synthetase 1 (CPS 1) activator is indicated as an adjunctive therapy for the treatment of acute hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS).
Dosage: 100 mg/kg/day to 250 mg/kg/day.
Prescribing Information: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022562lbl.pdf
ASCLERA (Polidocanol) by Chemische Fabrik Kreussler
FDA Application number: NDA # 021201; Approval Date: 3/30/2010
ASCLERA (Polidocanol) is a sclerosing agent indicated to treat uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity.
Dosage: Up to 10 ml of 0.5-1.0% solution by intravenous injection.
Prescribing Information: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021201lbl.pdf

Centralized Coordination of Decentralized Research

2010-03-15T11:31:00.001-07:00

Truth be told, it is tough out there for pharmaceutical scientists. Mega-mergers means mega-lay-offs. Outsourcing means research jobs going to India and China. Large supply of basic scientists by academia means slower job growth. So where does one conduct the next world-changing research project, which tour of duty can make your efforts rewarding, and where does one find bread and cheese?

There was a time that a research job at a big pharmaceutical company was considered the most cushy and secure for a scientist. Not so anymore. The mantra at Big Pharma is that they want to be more like small biotechs. That is both in terms of higher productivity and quicker decision-making. They are already becoming an ensemble of small franchises such that each can focus on a key therapeutic area and feed the drug pipeline for the sake of its own survival. Similarly, pride in ownership of technology is disappearing as more and more work is done through external contract research organizations (CROs) - hand-picked for their expertise in given areas.

What about the smaller biotechs and pharmaceuticals now? What are they doing? Sadly enough, many of the start-ups cannot even afford to have bare-bone working laboratories. But that does not stop innovation or research. They too, like the big pharma, are relying on external decentralized resources to conduct research and achieve their objectives. Except that some of them do not even have enough centralized expertise to pull it all together

As the globalization is tearing down the national boundaries for outsourcing, those CROs who can deliver in time and cost are flourishing. The decentralization is successful so far there is in-house expertise to coordinate, manage and direct all the external efforts. But not every company has the required central research coordinator with right expertise.

Thus working as a global strategic research project coordinator has become the new emerging role for scientific consultants who choose to facilitate the extremely decentralized research environment of today. Between the vision of getting a drug to the clinic and the tedious experimental work required to accomplish it, lies the domain of these scientists and their focus to get projects done and get them done right.

Shakespeare would have said -

All the world's a laboratory,
And all the men and women merely scientists;
They have their experiments and they have their results,
And one scientist in one time leads many projects,
his research being done at seven CROs.

Competitive Survival in The Googloid World of Networks: Eat, Excrete and Procreate

2009-12-11T08:40:00.000-08:00

Thanks to Charles Darwin for explaining the Origin of Species, and to Herbert Spencer for coining the mantra for evolution - Survival of the fittest.

But how do we understand the 'extinction of species' and the 'mantra for survival'?

The harsh reality of nature is that survival mainly depends on the food supply. The ecobiologists call it a food web - a vast network consisting of predators and preys. Till recently there was really no good way to study the co-dependences in the food supply chain. Simply put, if the survival of one species is important for the survival of the second, it has to be ranked higher than others as a survival factor.

Stefano Allesina of the University of Chicago and Mercedes Pascual of the University of Michigan wondered if the laws for survival in the food web are similar to those for survival in the world-wide web of internet. See Googling Food Webs: Can an Eigenvector Measure Species' Importance for Coextinctions?

They took a cue from PageRank, an algorithm Google’s search engine uses to rank importance of websites by analyzing its links. If a page feeds another page it gains importance for survivability on the planet web. Similarly, Allesina and Pascual found their modified algorithm was more effective than existing models in identifying the species that are important for the survival of other species on the food web. Recognized as one of the great ideas of 2009, The Google Algorithm as Extinction Model could be useful in analyzing other networks too. World is full of them. Think social networks, communication networks, financial networks, satellite networks and energy networks. Do you remember the great Northeast Blackout of 2003 caused by extinction of a single bottom-of-the-chain power grid?

In pharmaceuticals, consider intracellular networks and signal transduction networks. More and more examples of new therapies indicate that just like a disease can be caused by a small disruption in a critical link molecule, a cure can be obtained by reverting the balance back to normal. Survival requires controlled tweaking of the networks rather than a complete disruption and reinstatement of a specific component.

Food is however, only one part of the equation. The balance of species is also determined by the relative rate of reproduction and the disposal of excrements. These two factors definitely contributed to Google's escalation to the top of information web. While feeding off other's bytes, the world of information is having a population explosion and generating lot more garbage to be buried and lot more sewage to be disposed. Consider, for instance, the 'information overload' numbers reported in a new study from the University of California at San Diego's Global Information Industry Center that in 2008, Americans consumed about 34 gigabytes of information for an average person on an average day.

To a piece of information today, therefore, Google is not only a foster parent that asks to eat spinach, but also a teacher that grades its performance, and a God that decides its vital existence. Google is - the hospital, the nursery, the university, the restaurant, the waste management company, the utlity company and the funeral home.

Survival on Google and other PageRanked networks of life will rely on three basics activities that together, as Actor Dustin Hoffman once pointed out, is the main purpose of why God sent us to the earth - "Eat, Excrete and Procreate". You can be happy like fish in the Lake Michigan, but your survival still depends on these three activities of the Asian Carp. As we apply PageRank model to science, business and life, new Googloids will emerge that will determine the survivability of its network constitutents. Competitive Intelligence will entail identifying reproductive behavior, personal hygeine and, of course, dietary patterns of those constituents.

If you believe Dustin, make note of his other suggestion - "The two basic items necessary to sustain life are sunshine and coconut milk."

Incyte outlicenses Ex-US rights of INCB18424, an oral JAK1/JAK2 inhibitor to Novartis for 150M upfront, 60M for Eurotrials and up to 1.1 B total

2009-11-25T03:42:00.000-08:00

What Happened?
Incyte Corporation (NASDAQ: INCY) announced today that it has entered into a collaboration and license agreement with Novartis for two of its investigational hematology-oncology therapies: INCB18424, an oral JAK1/JAK2 inhibitor that is in Phase III development for myelofibrosis.

How does it benefit patients?
It would accelerate the ex-US, specifically Europian, development of the drug for myelofibosis. The major Myelofibrosis is a serious life-threatening neoplastic condition characterized by varying degrees of bone marrow failure, splenic enlargement and debilitating constitutional symptoms.

How does it help Incyte?
Incyte gets to keep the US rights, gets Novartis to pay for the European trials and according to Paul A. Friedman, Incyte’s president and CEO, this would give Incyte "sufficient resources to continue to advance other promising compounds in our pipeline".

How does it help Novartis?
Novartis gets the rights and responsibility for the future development and commercialization of INCB18424 in all hematology–oncology indications outside of the US. Novartis also gets rights to future worldwide development of INCB28060 a cMet cancer inhibitor with Incyte retaining rights to co-develop.

What were the terms?

Upfront payment of $150 million from Novartis to Incyte.
Milestone payment of $60 million from Novartis to Incyte for initiation of the European Phase III trial of INCB18424, COMFORT-II.
Additional milestones payments of up to approximately $1.1 billion from Novartis to Incyte.
Double-digit royalty payments on future ex-US INCB18424 sales from Novartis to Incyte.
Royalties on sales of INCB28060 from Novartis to Incyte.

Who else has a similar compound?

Phase III:
No other compound
Phase II:
Cephalon: CEP-701
Phase I
AstraZeneca: AZD1480
Exelixis: XL019
S*BIO: SB1518
Cytopia Research: CYT387

California leads in lacklustre 3Q biopharma VC financing

2009-11-16T23:38:00.000-08:00

Biopharma companies raised about
$755.7M in 3Q of 2009. This number is approximately 70% of the amount raised in the same quarter last year. West coast companies led the funding by raising 329.4M, all of it in California.

International:

arGen-X http://www.argen-x.com/ 13.8M
PharmAbcine http://www.pharmabcine.com/ 6M
ProFibrix http://www.profibrix.com/ 11M
Novacta Biosystems http://www.novactabio.com/ 21.6M
Allostera Pharma http://www.allostera.com/ 15.4M
Enobia Pharma http://www.enobia.com/ 50M
Novast Pharmaceuticals http://www.novast.com/ 25M

Mid-Atlantic:

Arginetix http://www.arginetix.com/ 4.6M
Profectus BioSciences http://profectusbiosciences.com/ 19M

Mid-West:

NewLink Genetics http://www.linkp.com/ 7.5M
Akebia Therapeutics http://www.akebia.com/ 16M
ProCertus Biopharma http://www.procertus.com/ 2.1M

North-East

Kolltan Pharmaceuticals http://www.kolltan.com/ 5M
NanoBio http://www.nanobio.com/ 10M
Cerulean Pharma http://ceruleanrx.com/ 10M
Constellation Pharma http://constellationpharma.com/ 17.2M
Gloucester Pharma http://gloucesterpharma.com/ 29M
Acetylon Pharmaceuticals 7.2M
Avila Therapeutics http://www.avilatx.com/ 30M
Seaside Therapeutics http://seasidetherapeutics.com/ 30M
Curemark http://www.curemark.com/ 6.5M
Small Bone Innovations http://www.totalsmallbone.com/ 35M
Cognition Therapeutics http://www.cogrx.com/ 1.2M

South-East

Quantum Immunologics http://quantumimmunologics.com/ 2.2M
Alimera Sciences http://www.alimerasciences.com/ 5M
Union Springs http://clynsbrands.com/ 5M
Chimerix http://www.chimerix-inc.com/ 16M
Viament Pharmaceuticals http://www.viamet.com/ 18M
Liquidia Technologies http://www.liquidia.com/ 7M

West

DNAnexus http://www.dnanexus.com/ 1.5M
Intellikine http://www.intellikine.com/ 51M
Limerick Biopharma http://www.limerickbio.com/ 15M
3-V Biosciences http://www.3vbio.com/ 30M
Jennerex Biotherapeutics http://www.jennerex.com/ 5.1M
Juvaris Biotherapeutics http://www.juvaris.com/ 12.5M
Celladon http://www.celladon.net/ 21.8M
aTyr Pharma http://www.atyrpharma.com/ 12M
Adamas Pharmaceuticals http://www.adamaspharma.com/ 40M
Alvine Pharmaceuticals http://www.alvinepharma.com/ 21.5M
Presidio Pharmaceuticals http://www.presidiopharma.com/ 27M
Helicon Therapeutics http://helicontherapeutics.com/ 50M
Oraya Therapeutics http://www.orayainc.com/ 42M

Deep-sea crab is no Panda!

2009-11-13T06:07:00.000-08:00

Those who know me know that I care deeply about the planet earth ... especially life on earth.

That is why when Matt Walker, the editor of BBC's earth news that takes pride in 'Reporting life on earth', reported that 'The deep-sea crab that eats trees', I was worried. We can't have some deep-sea crab called Munidopsis andamanica eating our trees. Before we go start hugging our beloved trees, let us make sure it is true?

Since there is no photographic evidence of the accused committing the crime, I used my own imagination (and Google Images) to come up with a snapshot shown on the right.

How was deep-sea crab caught red-handed? Caroline Hoyoux, a Belgian Marine Biologist, put a piece of wood in a cage trap at the bottom of the ocean. One year later, "Voilà!", she found a squatting crab.

Why does a deep-sea crab turn vegetarian and eat a tree? Because it wanted a high-fiber diet? No, not really. Can it be because there aren't many appealing entrees in the deep sea menu? Or because when stuck in a cage at the bottom of the ocean all your life, you will eat anything to survive, e.g. deadwood. Given, that there were other choices like worms, bivalves and other crustaceans. But what if you are allergic to seafood? Or may be you like seafood but then it is cooked with lots of vegetables in it. Just like how we trick our kids to eat broccoli.

I am glad that the story has a happy ending. There is really no threat to the trees. Apologies to Matt's hyped up title ... its not trees, just deadwood. I say, let the crabs eat it. They are no Panda.

A panda walks into a cafe. He orders a sandwich, eats it, then draws a gun and proceeds to fire it at the other patrons. "Why?" asks the confused, surviving waiter amidst the carnage. The panda pauses on his way out, produces a badly punctuated wildlife manual, and tosses it over his shoulder. "Well, I'm a panda," he says at the door. "Look it up." The waiter turns to the relevant entry and, sure enough, finds an explanation: "Panda. Large black-and-white bear-like mammal, native to China. Eats, shoots and leaves."

Company sequences whole human genome for $1,700. Fellow Americans, let us sequence our national genome.

2009-11-05T19:02:00.000-08:00

Well, I admit it upfront that it is another case of media exaggeration.

Reuters just ran a story with a catchy title "Company sequences whole human genome for $1,700". Sounds incredible, doesn't it? Especially because just a few years ago we spent hundreds of millions, if not billions, of dollars to sequence the first human genome. So what's the catch?

Well, I thought reading the article will explain it all. It did not. The best it offers is that a privately held company Complete Genomics says it can do a "usable genome map for about $4,400". So we all agree that whatever we get for $1,700 is useless. Still there is big difference between the 'usable genome map' and 'complete genome sequence'. Perhaps as much difference as exists between 'the physical map of the world showing the continents and geographic features' and a 'High resolution satellite map of the world showing individual streets and corners'.

A visit to Complete Genomics' website reveals that their claims are honest. In a recent issue of the prestigious journal Science, the company published three genomes sequenced by a novel method. The article entitled, "Human Genome Sequencing Using Unchained Base Reads on Self‐Assembling DNA Nanoarrays" is definitely scientifically and technologically a great step forward. But commercially, what are we getting and at what cost? A related press release on the company website elaborates, "The consumables cost for these three genomes sequenced on the proof-of-principle genomic DNA nanoarrays ranged from $8,005 for 87% coverage to $1,726 for 45% coverage for the samples described in this report."

Now we are getting somewhere. So it does not include the cost of equipment, facilities and personnel, etc. After adding all that the most optimistic cost estimate may be closer to reasonable $100,000. A lot for an average american, but not too much for Complete Genomics that just secured $45M in venture financing and might be currently looking as much for sequencing next 100 genomes as for an IPO exit strategy making use of all the media attention.

So what is all this fuss about. Of course, it is about reducing the cost of genome sequencing so that one day it becomes a diagnostic tool to identify each individual's genetic Achille's heel(s). This would change how we would treat diseases, how treatment would be personalized, and how preventive therapies will be done way before the onset of the disease.

But till we get there, for now it is all about the bragging rights and raising more capital. Intrestingly, every sequencing company has to now advertise a more outrageously discounted cost just so that they can be heard above the noise.

A big carrot in the corner is a $10M X-prize offered by Archon to the winner of a major sequencing milestone . The recent post on their website boasts A $10 MILLION PRIZE FOR THE FIRST TEAM TO SUCCESSFULLY SEQUENCE 100 HUMAN GENOMES IN 10 DAYS . Seems like a challenging task. More so, considering that the goal of the contest was only '10 human genomes' just a few months ago.

I do not know at what point this elastic will break. For now we are stretching it thin with contenders claiming lower costs at one end and visionaries raising the bar higher on the other. I say, that if it indeed is so cheap, let us give $2000 tax rebate to every american and have our national genome sequenced. Let us do it before the elastic snaps and the ends are free.

-Vivek for Connotia (http://www.connotia.com/)

16 New Medical Entities (NMEs) Approved by FDA in 2009

2009-11-05T15:40:00.000-08:00

Savella (Milnacipran hydrochloride) http://www.savella.com/
Cypress bioscience
Savella is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia. Savella is not approved for use in pediatric patients.
Uloric (Febuxostat) http://www.uloric.com/
Takeda pharmaceuticals
Uloric is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout. Uloric is not recommended for the treatment of asymptomatic hyperuricemia.
Afinitor (Everolimus) http://www.afinitor.com/
Novartis
Afinitor is a once-daily oral inhibitor of mTOR (mammalian target of rapamycin) for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib.
Coartem (Artemether & lumefantrine) http://www.coartem.com/
Novartis
Coartem (artemether and lumefantrine) are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum.
Fanapt (Iloperidone) http://www.fanapt.com/
Vanda pharmaceuticals
Fanapt is an atypical antipsychotic agent indicated for the acute treatment of schizophrenia in adults.
Samsca (Tolvaptan) http://www.samsca.com/
Otsuka America Pharmaceuticals
Samsca is a selective vasopressin C2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium less than 125 per l or less marked hyponatremia that is symptomatic and has resisted correction with fluidrestriction], including patients with heart failure, cirrhosis, and syndrome of inappropriate antidiuretic hormone (SIADH).
Besivance (Besifloxacin hydrochloride) http://www.besivance.com/
Bausch and Lomb
Besivance (besifloxacin ophthalmic suspension) 0.6% for the treatment of bacterial conjunctivitis.
Multaq (Dronedarone hydrochloride) http://www.multaq.com/
Sanofi Aventis US
Multaq is an antiarrhythmic drug indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥50 mm or left ventricular ejection fraction [LVEF] less thn 40%), who are in sinus rhythm or who will be cardioverted.
Effient (Prasugrel hydrochloride) http://www.effient.com/
Eli Lilly and Co.
Effient is a P2Y12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with PCI as follows: patients with unstable angina or, non-ST-elevation myocardial infarction (NSTEMI) or patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI.
Livalo (Pitavastatin calcium) http://www.livalo.com/
Kowa
Livalo is a HMG-CoA reductase inhibitor indicated for patients with primary hyperlipidemia and mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B),triglycerides (TG), and to increase high-density lipoprotein cholesterol.
Saphris (Asenapine) http://www.saphris.com/
Organon USA Inc.
Saphris is an atypical antipsychotic indicated for acute treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar disorder in adults.
Sabril (Vigabatrin) http://24.249.12.134/
Lundbeck Inc.
Sabril is an antiepileptic drug (AED) indicated for refractory complex partial seizures in adults. It should be used as adjunctive therapy in patients who have responded inadequately to several alternative treatments.
Bepreve (Bepotastine besilate) http://www.bepreve.com/
ISTA Pharmaceuticals
Bepreve (bepotastine besilate ophthalmic solution) 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms allergic conjunctivitis.
Vibativ (Telavancin hydrochloride) http://www.vibativ.com/
Theravance Inc.
Vibativ is a lipoglycopeptide antibacterial indicated for the treatment of adult patients with complicated skin and skin structure infections (CSSSI) caused by susceptible gram-positive bacteria.
Votrient (Pazopanib hydrochloride) http://www.votrient.com/
GlaxoSmithKline
Votrient is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma.
Istodax (Romidepsin) http://www.istodax.com/
Gloucester Pharmaceuticals
Istodax is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

- Vivek Sharma for Connotia (http://www.connotia.com/)

To be or not to "Be well"...is that a choice?

2009-11-04T05:05:00.000-08:00

Well, if you were wondering what New Merck's new motto gonna be, wait no more. In sickness or in health, Merck wishes you "Be well". Not "Get well" or "Feel better"or even "Become well"... just "Be well".

When I first heard "Bee well", I thought they were talking about some hornet's nest. Like how it may be to work for the New Merck (or some call it Schmerck) at the moment. It was easy to say that Old Merck was a place "Where patients come first" or that Schering-Plough was "Earning trust everyday". But saying that "Where patients come first everyday" would have been neither good for 'earnings' nor truthful advertising. And nowhere as terse as Be well.

A bigger question is about our health options. No, I do not mean Obama's healthcare plan or Pelosi's public option. What I wonder is whether we have the option to Be well? Moreover, if we really choose to Be well, would we need medicines, pharma and healthcare? Do we need drugs to Be well, when we are already taking dietary supplements from GNC to Live Well.

The reality is that we are a sick nation. Suffering from diseases like obesity, erectile dysfunction, restless legs, anxiety, attention deficit, depression and swine flu. We are so used to being sick, that we forget that we have a choice. Choice to Be well.

Thanks for reminding us Merck.