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Orphan Drugs: A Discussion With Dr. Timothy R. Coté

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Coté Orphan Consulting, LLC (COC), a regulatory affairs advisory firm in Silver Spring, Maryland, provides consulting services to companies that are developing or looking to develop orphan drugs. The company is founded in 2012 and led by Dr. Timothy R. Coté, former FDA Director of the Office of Orphan Products Development (OOPD). The COC team has provided regulatory consulting services including FDA orphan designation applications, breakthrough therapy designations, pediatric priority review vouchers, and regulatory strategic planning to over 150 major biotech and pharmaceutical companies. COC recently signed a $7 million contract resulting in the establishment of Coté Orphan Clinical Trials, a full-service clinical research organization.

The Orphan Druganaut Blog has the opportunity to interview Dr. Timothy R. Coté from COC about the services they provide and the state of the global orphan drug regulatory landscape.

1)   Can you please tell us a little about the Coté Orphan Consulting firm and what services you provide for companies interested in developing or are currently developing orphan drugs? Do you offer services globally or for specific geographic areas (EU, US, etc.)?

Coté Orphan Consulting provides valuable regulatory strategic planning to biotech and pharmaceutical companies seeking orphan status designation and marketing authorization for their orphan products. Services provided by the COC team include FDA orphan designation applications, regulatory strategic planning, breakthrough therapy designations, pediatric priority review vouchers, and clinical trials design and execution. COC caters to all major established regulatory markets.

2)   What role and impact do you see advocacy organizations and patients having on global regulatory agencies for orphan drugs ?

Patients are what this is all about. Previously, as chief medical officer for NORD I saw first-hand the critical role that patients play in orphan drug clinical trials, regulatory approvals, and eventually, marketing efforts. This is as it should be. Patients are the reason this endeavor exists.

3)   What changes would you like to see with global regulatory agencies to improve the speed of bringing orphan drugs to market and for providing faster access to patients ?

I was honored to serve as the director of FDA’s Office of Orphan Products Development and can state from first-hand knowledge that the OOPD as well as the many review divisions are committed to expedient review and licensing of orphan drugs. Sadly, the lapse is not theirs; they are a beleaguered, underfunded, bureaucratically constrained organization of dedicated public servants who, were it within their power, would indeed accelerate the licensure of therapies we all desire. To make this happen, Congress must appropriate the funds requisite to intelligent regulation of 25% of the US Economy. And the American people need to support the strivings of these selfless servants.

4)   Do you advise companies on the pricing of orphan drugs ? What do you see as the challenges for how insurance/government agencies will handle the high prices of orphan drugs ?

We do not advise on price points, but we recognize that orphan drugs merit higher price points for the 7 or 10 years of market exclusivity to which they are entitled. While some of the numbers may be eye-popping (e.g., $700,000 per patient per year) the knowledge is eternal and the exclusivity time-limited. For 32 years, the Orphan Drug Act has remarkably advanced capacity of the entire biotechnology industry. Therefore, it was no surprise when the Affordable Care Act (ACA)-the most radical revision of healthcare financing since 1776-left our system for incentivizing orphan drugs completely untouched. This was rational, given that orphan drugs represent less than 1% of the total healthcare budget. It is rare to see such rationality expressed by Congress, but this time we were lucky.

5)   Do you think collaborations/partnerships between different international regulatory agencies for orphan drugs will be the direction for the future ?

No, but I think they should be. For example, while I instituted regular monthly meetings between FDA and EMA offices responsible for orphan designation, and lobbied hard for a mutual recognition of such designation, I doubt it will occur in my lifetime. Drug regulation is the extension of the formal authority of States, and States are loathe to share authority.

6)   What do you see for the future of orphan drugs globally ?

Orphans are hot. They represent the great frontier in healthcare. We have 7,000 rare diseases but only about 400 licensed orphan products which together treat about only 200 rare diseases. That leaves 6,800 rare diseases without any form of treatment. We have work to do.

7)   Does COC have any upcoming meetings or special announcements to share ?

COC and the ERA Consulting Group (ERA) are pleased to announce the establishment of a strategic transatlantic alliance to provide comprehensive services to clients developing products for orphan indications.

The ERA Consulting Group, with offices in the UK, Germany, Washington, DC, and Brisbane, Australia, is a consulting organization in Europe and Australasia for biologics, including gene and cell therapy products, which are often developed for orphan indications. With more than 27 years of experience, the ERA team has successfully achieved orphan medicinal product status in the EU for many clients. Also, ERA has full electronic publishing capabilities to process electronic submissions both to FDA and EU authorities.

Together, COC and ERA can provide advice and practical assistance at all stages of development of orphan drugs, including concept, orphan designation, clinical trial applications, and BLAs/MAAs.

Thank you for your time.

COC Logo courtesy of COC.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

Europe’s July 2014 Products Recommended For Orphan Drug Designation

Erlenmeyer_Flasks

The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) held a meeting July 8 – 10, 2014. The EMA COMP July 2014 Meeting Report on the review of applications for orphan designation is published July 22nd.

At this meeting, there are 27 positive opinions recommending the following medicines for designation as orphan medicinal products. COMP’s opinions are forwarded to the European Commission (EC). The EC will then decide whether to grant an orphan designation for the medicines in question. Public summaries of the opinions will be available on the EMA website following adoption of the respective decisions on orphan designation by the EC.

Observations

•   27 ODDs are recommended

•   Vertex Pharmaceuticals’ Lumacaftor and Kalydeco (Ivacaftor) combination for Cystic Fibrosis

•   Genzyme Europe for Lysosomal Storage Disorder (LSD), Fabry Disease

•   Duchenne Muscular Dystrophy indication

•   3 Bleeding Disorder indications:

1.   Hemophilia A

2.   Hemophilia B

3.   Congenital Factor VII Deficiency.

EMA COMP July 2014 ODDs Recommended

Product Name Sponsor Company Indication
(3S)-1-azabicyclo[2.2.2]oct-3-yl{2-[2-(4-fluorophenyl)-1,3-thiazol-4-yl]propan-2-yl}carbamate Genzyme Europe BV Fabry Disease
17α,21-dihydroxy-16α-methyl-pregna-1,4,9(11)-triene-3,20-dione NDA Group AB Duchenne Muscular Dystrophy
Gevokizumab Les Laboratoires Schnitzler Syndrome
Lumacaftor and ivacaftor fixed-dose combination Vertex Pharmaceuticals (UK) Cystic Fibrosis
Recombinant factor VIIa modified with three terminal repeats derived from the β chain of human chorionic gonadotropin Richardson Associates Regulatory Affairs Ltd Congenital Factor VII Deficiency
Recombinant factor VIIa modified with three terminal repeats derived from the β chain of human chorionic gonadotropin Richardson Associates Regulatory Affairs Ltd Hemophilia A
Recombinant factor VIIa modified with three terminal repeats derived from the β chain of human chorionic gonadotropin Richardson Associates Regulatory Affairs Ltd Hemophilia B
Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain IDEA Innovative Drug European Associates Limited Myelodysplastic Syndromes
Recombinant human apolipoprotein A-I in a complex with phospholipids Cerenis Therapeutics Holding SA apolipoprotein A-I deficiency
Recombinant human apolipoprotein A-I in a complex with phospholipids Cerenis Therapeutics Holding SA ATP-binding cassette transporter A1 deficiency
Retinol Dr. Philipp Heinrich Novak bronchopulmonary dysplasia
Sodium ascorbate and menadione sodium bisulfite JJG Consultancy Ltd autosomal dominant polycystic liver disease
Ulinastatin BSV BioScience GmbH acute pancreatitis
2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethylsulfamide DualT pharma B.V. Small cell lung cancer
4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid Roche Registration Limited Acute Myeloid Leukemia
Adeno-associated viral vector serotype 8 containing the human UGT1A1 gene Fondazione Telethon Crigler-Najjar syndrome
Humanised IgG1 monoclonal antibody against human KIR3DL2 Innate Pharma S.A. cutaneous T-cell lymphoma
Lentiviral vector containing the human liver and erythroid pyruvate kinase (PKLR) gene Centro de Investigación Biomédica en Red (CIBER) pyruvate kinase deficiency
Macromolecular conjugate of heparin sodium on a polymer backbone Corline Systems AB prevention of ischaemia reperfusion injury associated with solid organ transplantation
Obinutuzumab Roche Registration Limited diffuse large B-cell lymphoma
Recombinant human diamine oxidase Medical University of Vienna Mastocytosis
S3,S13-cyclo(D-tyrolsyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-aspartyl-L-tryptophyl-N-methyl-L-glycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-N-methyl-L-isoleucinamide) Amyndas Pharmaceuticals paroxysmal nocturnal haemoglobinuria
Variant of recombinant human fibroblast growth factor 19 Diamond BioPharm Limited Primary biliary cirrhosis
Vector based on an adeno-associated virus serotype 2 backbone, pseudo-serotyped with a type 8 capsid, which carries the coding sequence of the human TYMP gene under the control of the humanthyroxine binding globulin promoter Vall d’Hebron Institute of Research mitochondrial neurogastrointestinal encephalomyopathy
(Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N’-(pyrazin-2-yl)acrylohydrazide Clinipace GmbH diffuse large B-cell lymphoma
(Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N’-(pyrazin-2-yl)acrylohydrazide Clinipace GmbH acute myeloid leukemia
[5-amino-1-(4-fluoro-phenyl)-1H-pyrazol-4-yl]-[3-(2,3-dihydroxy-propoxy)-phenyl]-methanone Synovo GmbH Pancreatic Cancer

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Please Note: “Erlenmeyer Flasks” From Argonne US National Lab  [Public domain in the US] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

FDA Breakthrough Therapy Designation: #49 For Pancreatic Cancer

FDA logo

Aduro BioTech, a California-based clinical-stage biotechnology company, announces July 21st that the company receives a FDA Breakthrough Therapy Designation (BTD). The BTD is for the company’s pancreatic cancer combination treatment that consists of CRS-207 and GVAX Pancreas immunotherapies. GVAX Pancreas is a “ … CRS-207 is one of a family of candidates based on Aduro Biotech’s live-attenuated, double-deleted (LADD) Listeria monocytogenes immunotherapy platform that induce a potent innate and T cell-mediated immune response …… GVAX vaccine derived from human cancer cell lines that are genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune-stimulatory cytokine.”

The BTD is based on results of a Phase II trial in metastatic pancreatic cancer patients which are presented at the beginning of 2014, at the ASCO Gastrointestinal Cancers Symposium conference. The clinical trial shows that the median overall survival of patients receiving the combination treatment is 6.1 months compared to 3.9 months for those patients receiving GVAX monotherapy. Aduro BioTech is planning on completing enrollment in a 240 patient Phase IIb clinical trial (ECLIPSE) by the end of 2015.

Please Note: FDA Official Logo from FDA website.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

FDA Breakthrough Therapy Designation: InterMune Joins The Idiopathic Pulmonary Fibrosis Race

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InterMune, a global biotechnology company focusing on the development and commercialization of therapies in pulmonology and orphan fibrotic diseases, announces on July 17th that the company receives the coveted FDA Breakthrough Therapy Designation (BTD). The BTD is for the investigational treatment, orphan drug Pirfenidone, an oral drug for adult patients with the rare lung disease, Idiopathic Pulmonary Fibrosis (IPF).

IPF is a chronic, progressive, severely debilitating and ultimately fatal lung disease – characterized by progressive permanent scarring of lung tissue. There are currently no FDA-approved treatment options.

This is the 48th FDA BTD announced by a sponsor company, the 1st BTD for InterMune, and the 2nd BTD for IPF.

Pirfenidone Global Regulatory History

The global regulatory history of Pirfenidone is interesting, as the drug has been on the global market for a few years, but is not currently approved in the US. InterMune resubmits its Pirfenidone New Drug Application (NDA) to the FDA in May 2014, in response to a Complete Response Letter (CRL) the company receives in May 2010. In the CRL, the FDA recommends an additional Phase III clinical trial to support the efficacy of Pirfenidone. InterMune conducts the Phase III ASCEND clinical trial and results are presented at the May 2014 meeting of the American Thoracic Society and is also published on-line in the New England Journal of Medicine. In a Press Release in May 2014, Dan Welch, Chairman, CEO, and President of InterMune says that :

“If the FDA grants approval of our NDA within the 6-month review period of an NDA resubmission, we would be ready to launch Pirfenidone in the 1st quarter 2015”.

The European Commission (EC) grants marketing authorization in February 2011, in all 28 EU member states, for Esbriet (Pirfenidone) for the treatment of adults with mild to moderate IPF. Esbriet also receives approval for marketing in Iceland and Norway. Commercial sales of Esbriet in the EU include the key markets of Germany, France, Italy, and the UK.

Other global markets include:

•   2008 launch of Pirespa (Pirfenidone) in Japan

•   2012 launch of Pirespa in South Korea

•   January 2013 Esbriet launch in Canada

•   Approval in China, India, Argentia, and Mexico.

US IPF Race To Market

In an online 2013 PharmaTimes article, the following data is presented from GlobalData on the IPF global market :

•   Expects IPF therapy sales across US, France, Germany, Italy, Spain, and the UK to increase dramatically from $49 million in 2012 to over $1.1 billion by 2017

•   US IPF therapy sales is expected to increase from a value of $6.5 million in 2012 to $696 million in 2017

•   European IPF therapy sales is expected to increase from $43 million in 2012 to $419 million in 2017

•   The anticipated launch in the US of InterMune’s Esbriet and BI’s Nintedanib in 2015, in a market that currently has no therapeutic options, will cause the US market to exponentially grow to about $500 million in 2015.

Only a day before announcing this latest BTD, Boehringer Ingelheim (BI) announces on July 16th, that the company’s investigational orphan drug Nintedanib receives a BTD for the same indication. Nintedanib has FDA Priority Review and Fast Track status.

It will be interesting to watch over the next year the neck-to-neck race between InterMune’s Pirfenidone and BI’s Nintedanib, to see which product will launch first in the US market, what strategies both companies will use, and what market share each IPF drug will take. This is a great time for the US IPF community, as both of these two investigational drugs compete and are brought to market.

FDA IPF Workshop Announced

As part of the FDA’s Patient-Focused Drug Development (PFDD) initiative, a September 26, 2014 meeting is scheduled for IPF.

PFDD is a platform for patients, families, and caregivers to express their feelings and opinions about their particular disease and everyday living, the impacts of the disease on themselves and others, and to provide feedback on current treatments. It is a great way to start a conversation between patients and the FDA about this rare disease.

The timing of the FDA meeting and the two FDA BTDs this past week, suggest a positive regulatory outcome and new publicity for a rare disease.

References

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart

Coalition For Pulmonary Fibrosis

Pulmonary Fibrosis Foundation.

Please Note: “Swimmers at the 2007 Kingdom Games in Den Haag” by Knurftendans (Own work) [Public domain] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

Orphan Drugs And Rare Diseases: SAGE Therapeutics IPO

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SAGE Therapeutics, a Cambridge, Massachusetts-based biopharmaceutical company launched in 2010, is developing treatments for rare Central Nervous System (CNS) disorders. The company announces on July 17th in an amended S-1 Form, the pricing of its Initial Public Offering (IPO) of 5.75 million shares (includes .75 million over-allotment shares that underwriters will have the option to purchase), at a public offering price of $17 – $18/share (before underwriting discounts). SAGE Therapeutics’ shares are expected to begin trading on the NASDAQ Global Market on July 18th under the ticker symbol “SAGE”. J.P. Morgan and Goldman Sachs are the joint bookrunners on the deal.

Status Epilepticus (SE)

SAGE Therapeutics’ programs are aimed at treating different stages of the rare disease Status Epilepticus (SE). SE is:

“ … a life-threatening form of epilepsy or seizures that occurs in approximately 150,000 US patients each year, with a mortality rate of 20%. Refractory SE, in which currently available treatment options are not effective, occurs in approximately 1/3 of SE patients…”.

SAGE Therapeutics’ lead product candidate is SAGE-547, an intravenous (IV) agent in clinical development as an adjunctive therapy for patients with Super-Refractory Status Epilepticus (SRSE). There are currently no therapies approved for SRSE. In April 2014, SAGE-547 receives a FDA Orphan Drug Designation (ODD) for SE. In June 2014, SAGE Therapeutics presents preliminary SAGE-547 clinical data at the Epilepsy Pipeline Project Conference in San Francisco.

SAGE-547 FDA ODD Database Record

Generic Name: allopregnanolone
Trade Name: n/a
Date Designated: 04-20-2014
Orphan Designation: Treatment of status epilepticus
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sponsor: Sage Therapeutics 215 First Street Suite 220 Cambridge, MA 02142 The sponsor address listed is the last reported by the sponsor to OOPD.

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Per the amended S-1, SAGE Therapeutics estimates that the net proceeds from the sale of shares of common stock in this offering will be approximately $79.1 million, or $91.3 if the underwriters fully exercise their option to purchase additional shares, assuming the offering price of $17.50/share (midpoint of the per stock price range). The majority of the proceeds will be used for a Phase I/II study for SAGE-547 for SRSE. This study is an open-label study with the objective to evaluate the safety, efficacy, and pharmacokinetics of SAGE-547 injection as adjunctive therapy for the treatment of adults with SRSE. This study is currently enrolling patients at five centers in the US.

Other products in SAGE Therapeutics’ Pipeline for acute and orphan CNS indications are:

•   SAGE-689 (IV) in preclinical development for adjunctive SE

•   SAGE-217 in preclinical development for maintenance therapy for SE.

Please Note: “HERO (Human Epilepsy Research Opportunities) Badge” courtesy of the HERO website.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

FDA Breakthrough Therapy Designation: Boehringer Ingelheim Gets A 3rd

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Boehringer Ingelheim (BI) announces on July 16th, that the company’s investigational orphan drug Nintedanib receives the coveted FDA Breakthrough Therapy Designation (BTD) for the treatment of the rare disease Idiopathic Pulmonary Fibrosis (IPF).

IPF is a chronic, progressive, severely debilitating and ultimately fatal lung disease – characterized by progressive permanent scarring of lung tissue. According to the BI Press Release, there are as many as 132,000 Americans with IPF. There are currently no FDA-approved treatment options.

This is the 47th FDA BTD announced by a sponsor company and the 3rd BTD for BI:

Num Drug Name Indication
1 Volasertib Acute  MyeloidLeukemia(AML)
2 Idarucizumab Antidote for Pradaxa
3 Nintedanib Idiopathic Pulmonary Fibrosis (IPF)

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Nintedanib Global Regulatory Activity

Regulatory Date Regulatory Agency & Action Taken
June 2011 FDA Orphan Drug Designation
April 2013 European Commission (EC) Orphan Designation
June 2013 FDA Fast Track Designation
June 2014 FDA Priority Review Designation
June 2014 EMA validates application for marketing authorization & grants accelerated review
July 2014 FDA BTD

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Nintedanib FDA Orphan Drug Designation Database Record

Generic Name: nintedanib
Trade Name: n/a
Date Designated: 06-29-2011
Orphan Designation: Treatment of patients with idiopathic pulmonary fibrosis.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sponsor: Boehringer Ingelheim 900 Ridgebury Rd. Ridgefield, CT 06877 The sponsor address listed is the last reported by the sponsor to OOPD.

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Nintedanib’s Competition

InterMune’s competing IPF orphan drug Pirfenidone is resubmitted to the FDA in May 2014 after being rejected in 2010. InterMune expects to win FDA approval within 6 months and to be launched in the 1st quarter of 2015. In Europe, Pirfenidone has been on the market for 2 years.

With the June 2014 EMA accelerated review of BI’s Nintedanib, the IPF drug will now try to catch up to its rival, InterMune’s Pirfenidone in Europe.

Analysts, patients, and the media are closely watching the race in the US of both IPF drugs to see which makes it first to market.

References

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “Kalymnos 2005 022” by David Bolius [CC By-SA 2.5] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

Rare Diseases: BioBlast Pharma IPO

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BioBlast Pharma, a Tel Aviv, Israel-based clinical-stage biotech founded in 2012, is developing a platform of products for rare and ultra-rare genetic diseases. The company files an F-1 Form in February 2014, with the US Securities and Exchange Commission (SEC), to raise up to $37.5 million in an IPO. On July 7th, BioBlast Pharma files an amended F-1 Form with an increase in the amount the company is attempting to raise – up to $46 million. BioBlast Pharma plans to list on the NASDAQ with the symbol “ORPN”. Oppenheimer and Roth Capital are the joint bookrunners.

BioBlast Pharma’s most advanced product Cabaletta, a mutant protein stabilizing platform, is in a Phase II clinical trial (HOPEMD) for the treatment of Oculopharyngeal Muscular Dystrophy (OPMD). Cabaletta is an IV formulation of Trehalose, which the company says enables the drug to reach muscles. Trehalose prevents aggregation of proteins in cells. OPMD is a rare genetic condition and form of muscular dystrophy that begins usually after age 40. It effects the muscles of the eyelid first, resulting usually in droopy eyelids (ptosis), followed by problems with swallowing (dysphagia). Patients with OPMD can also have weakness in the muscles near the center of the body (proximal muscles).

Other Cabaletta Preclinical Rare Disease Development Programs

•   Spinocerebellar Ataxia Type 3 (SCA3) or Machado Joseph Disease

•   Spino Bulbar Cerebellar Ataxia (SBMA) or Kennedy’s Disease.

SCA3 is a genetic disease where patients have memory deficits, difficulty with swallowing and speech, and other muscular disorders. SCA3 begins in early adolescence and progresses over time. It is an incurable disease with no currently approved treatment.

SBMA results in the degeneration and loss of lower motor neurons in the brainstem and spinal cord. There is currently no approved treatment.

Cabaletta FDA Orphan Drug Designation Database Record

Generic   Name: Trehalose
Trade   Name: Cabaletta
Date   Designated: 10-25-2013
Orphan   Designation: Occulopharyngeal Muscular Dystrophy
Orphan   Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan   Indication
Sponsor:   BIOBLAST PHARMA LTD. 35 Achad Haam Tel Aviv ISRAEL

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Other BioBlast Pharma Preclinical Rare Disease Pipeline Candidates

•   Spinal Muscular Atrophy (SMA)

•   Friedrich’s Ataxia (FA)

•   Ornithine Transcarbamylase Deficiency (OTCD).

Use of Some Net Proceeds From IPO

•   $6 million for completing clinical program for OPMD

•   $3.5 million for completing Phase II and pivotal clinical study for SCA3

•   $4.2 million for initiating and completing Phase II/III clinical study for SBMA

•   $4.5 million for completing pre-clinical program for FA and Phase I clinical study

•   $7.8 million for completing pre-clinical program for OTCD and initiation and completion of Phase I and IIA/B clinical studies

•   $2.2 million for initiating and completing Phase I/II clinical program for SMA.

Please Note: “Wall Street & Broadway” by Fletcher6 (Own work) [CC-BY-SA-3.0] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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