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Medtech Subsector
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Medtech Phase of Development
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Timothy LaCroix

PharPoint Research Inc.
Vice President 

Gwen Lamar

Life Science Nation (LSN) is the premier sourcing platform for market intelligence and prospect pipeline development in the life science arena. LSN enables life science professionals to generate a list of qualified global targets that are a fit for their company’s products, services, and fundraising efforts. The ability to generate these Global Target Lists (GTLs) makes life science professionals more effective and efficient. 

Sector Interest
Biotech Subsector
Indication
Biotech Phase of Development
Medtech Phase of Development
Unique Capabilities

Life Science Investor Profiles, LSN has sourced validated and maintains the largest global database of investor profiles. LSN defined 10 categories of Life Science Investor;

·         Private Equity

·         Venture capital

·         Family Offices

·         Corporate VC

·         Angel Groups

·         Large Pharma/ Biotech

·         Alternative Institutional Investors: Pensions, Endowments

·         Endowments/Foundations

·         Hedge Funds

·         Government Grants

Marketing Services, LSN consults on branding, messaging, and outbound marketing strategies. This includes developing a tagline, elevator pitch, executive summary, corporate power point presentation, and new or updated website design to fit your brand and message. LSN will develop a Global Target List of prequalified candidates to target for marketing initiatives.

Life Science Nation

Tomas Landh

Novo Nordisk was founded in 1923 and is based in Bagsvaerd Denmark with additional R&D sites in Seattle WA Beijing China and Bangalore India. The firm is actively seeking to in-license assets and also forms research collaborations and co-marketing and distribution partnerships with other biotech companies. Novo Nordisk is focused on developing protein and peptide therapeutics and protein delivery devices. The firm has also in-licensed antibodies. Indications of interest include metabolic disorders blood and immune disorders growth disorders and inflammatory disorders. Within the inflammation fieldthe firm is particularly targeting therapies based on cytokines and on molecules on the surface of cells involved in immune regulation. The firm is interested in certain orphan conditions. In addition to partnering and in-licensing Novo Nordisk has a corporate venture fund Novo AS. The firm also offers research grants and resources for studies into Novo Nordisk's products.
Website:
www.novonordisk.com
Investor Type
Sector Interest
Biotech Subsector
Indication
Biotech Phase of Development
Capital Structure Preference
Investment Stage Preference
Novo Nordisk
Director 

David Larwood United States

We are focused on Valley Fever, an orphan disease that kills 150 people a year. Thousands are taking drugs for life, and many others have no effective drug therapy options. Nikkomycin-Z is a new, first in class antifungal ready for Phase II testing. Teliable animal models suggest NikZ will be effective. 

With our guidance, the NIH is funding two Phase II trials starting about late 2015. We would like to run a third, sweet-spot-of-market trial as soon as we secure funding. Our Chief Medical Officer is lead author on an NIH study on standard of care drugs for this disease. We plan to try NikZ under a simlar protocol as soon as we secure support. 

Valley Fever Solutions has made our API at pilot scale. The process is robust and repeatable. We are ready to make a large batch as soon as we secure funding. We expect the proof of concept trial can reach at least early readout within 18 months of funding. This can be achieved for less than $10M.

Website:
www.valleyfeversolutions.com
Year Founded
2007
Main Sector
Biotech Subsector
Indication
Biotech Phase of Development
Technology Overview
Nikkomycin-Z is a Nucleoside Peptide, first in class new anti fungal.
Alliance & Collaborations
Extensive NIH support
Supporting Metrics or Evidence
NikZ is fungicidal in mice, the best current drugs only limit further fungal growth (fungistatic). We have promising results in some dogs.
Current Financing Needs
$10M for Phase II proof of concept
Current Timeline
Ready to make API (8-12 months) for Phase II trials (following 8-12 months)
Current Investors
Founders
IP Status
12 years market exclusivity - OOPD, QIDP; new patents pending
Recent Milestones
RC3 grant brought our process to pilot scale API; NIH grants funded for Phase II trial, second parallel trial waiting for API (NIH sourcing)
Management Team Highlights
David Larwood (CEO) did early work on two $1B drugs, VP at two pre-Nasdaq companies (took one public, the other later reached $2B valuation); John Galgiani (CMO) is one of the most respected and well known clinicians in Valley Fever
David Larwood
Valley Fever Solutions
LinkedIn logo CEO 
BIO

David Larwood has been a chemist for decades, most recently leading Valley Fever Solutions as CEO since it was founded in 2007. From 1997 to 2005 he was VP at two pre-NASDAQ companies, taking the second one public for four years until it was sold. The first later went public and reached $2B valuation.

His PhD research at UCSF supported the foundations for PEGylated liposomes, including Doxil. He was the first to make suitable PEGylated lipids and made some of the earliest of these novel liposomes.

He was the first to make Iotrolan, still produced by 12 companies decades later.

Eric Laub

Website:
www.corporateaccessadvisors.com
Medtech Subsector
Corporate Access Advisors
Principal 

Jason Laufer Israel

RDD Pharma, a clinical stage company with programs in:
1. Fecal incontinence (Phase 2a)
2. Chronic anal fissure (Phase 3 ready).
3. Pruritus Ani - preclinical development
4. Radiation Colitis - animal studies

- All rograms utilize a 505(b)2 strategy .
- Anal Fissure IP goes out to 2030.
Website:
www.rddpharma.com
Year Founded
2009
Main Sector
Biotech Subsector
Indication
Biotech Phase of Development
Medtech Phase of Development
Technology Overview

Company focused on ano-rectal diseases

Experienced management team

Lead product targets $600M market with poorly
addressed needs

Follow on product targets a $3B US market

Pipeline - Three clinical stage products:

  • PHASE III READY – ANAL FISSURE
  • PHASE IIa – FECAL INCONTINENCE ONGOING
  • PHASE II READY – PRURITUS ANI

De-risked 505(b)2 regulatory path

Supporting Metrics or Evidence

Fecal Incontinence - P1 Proof of Concecpt + Phase 2a Ongoing

Chronic Anal Fissure - completed two (2) Phase II studies evaluating Nifedipine in CAF.

  • RDD Study 104 - 20 Patients
  • RDD Study 112 - 33 Patients
Current Financing Needs

OrbiMed Israel (invested $4M in 2012) is a lead investor and has committed to $3M of a $15M Series B.

Current Timeline

Anal Fissure  - Phase 3 to commence 1Q2015

Fecal Incontinence - Phase 2a data read March/April 2015

Current Investors

OrbiMed

Ofakim Hi-Tech Ventures

Corporate Finance Holding GmbH

Mor Research

IP Status

Nifedipine Capository™ - Device for Treating the Anal Sphincter

–      Japan                         Granted (new)

–      Australia                   Granted

–      Korea          Allowed (new)

–      Israel           Allowed (new)

–      USA            Granted

–      Canada                     Allowed

Fecal Incontinence

–      US – National Phase

Radiation Colitis

–      Methods for Treating and Ameliorating Radiation-induced Gastrointestinal Tract Injury

Pruritus Ani

–      Method of Treating Anal Pruritus and Other Perianal Disorders

–      USA-issued patent: April 1, 2014

Recent Milestones

Chronic Anal Fissure - completed two (2) Phase II studies evaluating Nifedipine in CAF.

  • RDD Study 104 - 20 Patients
  • RDD Study 112 - 33 Patients
Management Team Highlights

Jason Laufer CEO 

•       Over 25 years in healthcare clinical and commercial operations

•       Global BD & Licensing at URL Pharma (acquired by Takeda for $800M), Managing Director at CELLGRO® (acquired by Corning , and CEO at Elutex

Nir Barak, MD CMO and Founder

•       More than 10 years as internal medicine physician

•       Career integrating R&D and clinical medicine

•       Formerly CSO/Founder of OBEcure Ltd.

 

Robert Niecestro PhD Regulatory Affairs

  • Over 25 years of experience in the healthcare industry
  • Managing Director of Accelapharm, VP Reg. of Axsome Rx and EVP of Clinical & Reg. Affairs at TG Rx
  • VP Clinical & Reg. Affairs at Keryx Biopharma

 

Monil Shah, PharmD MBA Clinical Advisor

  • VP, Clinical Affairs at Ventrus Biosciences
  • Over 15 years in clinical management roles at BMS, Celgene, Amgen, and Novartis

RDD Pharma
CEO 

Albert Lauritano

BD (Becton Dickinson and Company) based in Franklin Lakes NJ is a leading medical technology company that partners with customers and stakeholders to address many of the world?s most pressing and evolving health needs. Their innovative solutions are focused on improving drug delivery enhancing the diagnosis of infectious diseases and cancers supporting the management of diabetes and advancing cellular research. The firm has nearly 3 associates in 5 countries who strive to fulfill our purpose of ?Helping all people live healthy lives? by advancing the quality accessibility safety and affordability of healthcare around the world. For more information please visit www.bd.com. BD partners with companies from their formation through to commercialization including expansion of operations and channel access. BD considers a variety of engagement models including research collaborations licenses investments and acquisition when partnering with companies aligned with BD?s core businesses and new areas of strategic interest seeking opportunities from around the globe.
Website:
www.bd.com
Investor Type
Sector Interest
Biotech Subsector
Indication
Biotech Phase of Development
Medtech Phase of Development
Capital Structure Preference
Investment Stage Preference
Becton Dickinson (BD)
Director Strategic Technology Partnerships 

Mr Charles Leahy United States

Amorphex Therapeutics is an early clinical stage company that was founded to develop products for sustained ophthalmic drug delivery using patented TODDD™ technology. Topical ophthalmic pharmaceuticals are a $5+Billion market, but inaccurate and inefficient delivery systems, poor compliance and excessive side effects undermine their clinical benefits and true sales potential. TODDD™ is a soft, non-invasive device that is completely concealed under the eyelid and continuously delivers therapeutic levels of drug 24/7 over several months. While TODDD™ is soft and flexible, unlike soft contact lenses, it doesn’t contain appreciable water and avoids the surface drying and resulting deposits that irritate and deter many contact lens wearers. In recognition of the potential benefits and their developmental progress, the company’s founders have been awarded three National Institutes of Health (NIH-SBIR) grants for the TODDD™ technology totaling $2.5 million.

TODDD™ has issued patents in major markets and has been successfully tested in safety studies, animal trials with drugs and without drug in humans.

Amorphex is seeking to fund small, 30 - 40 subject, human clinical trials of TODDD™ delivering timolol, prostaglandin and both drugs simultaneously. This funding will also support pre-clinical development of TODDD™ for ocular allergy and inflammation applications.  These milestones will drive dramatic increases in valuation and corporate partner interest.

Website:
http://www.amorphexusa.com/
Year Founded
2010
Main Sector
Biotech Subsector
Medtech Subsector
Indication
Biotech Phase of Development
Medtech Phase of Development
Supporting Metrics or Evidence
Successful safety studies, animal trials and human proof of concept studies.
Current Financing Needs
$1.1M to regulatory milestone, $2.1M to clinical milestone, $4.6+ M to complete plan
IP Status
Patents issued in US, Europe, Japan and Canada
Amorphex Therapeutics
VP of Clinical Affairs 

Anton Leighton United States

Year Founded
2010
Main Sector
Biotech Subsector
Indication
Biotech Phase of Development
Current Financing Needs
Initial
IP Status
Issued US patents
Recent Milestones
Identification of novel MOA
Management Team Highlights
Founder experienced in drug development
Rhamnopharma, Inc.
CEO 

Michael Leonard

Website:
www.trigemina.com
Trigemina
CFO