Download Advaxis, Inc

Survey
yes no Was this document useful for you?
   Thank you for your participation!

* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project

Document related concepts

Drug discovery wikipedia , lookup

Dental emergency wikipedia , lookup

Transcript
PharmacoFore, Inc.
BIO Member
Clinical Foci: CNS, Drug Discovery
Wesley D. Sterman, MD
Chief Executive Officer
75 Shoreway Road, Suite D
San Carlos, CA 94070
USA
www.pharmacofore.com
Incorporated: 2004
Employees:
25
Ownership:
Private
1-650-331-4010
HIGHLIGHTS
Recent
Upcoming
PF329 ER HM Bio-MD system: Achieved human proof-of-concept
demonstrating that our hydromorphone Bio-MD system is working as
designed; Supports application of our technology to codones, other
morphones, and amphetamines.
Advance additional product candidates leveraging our BioMD and MPAR technologies into development.
PF06 ER oxycodone Bio-MD and Bio-MD MPAR systems: Advanced our lead
product candidates into development. Human proof-of-concept of the
underlying Bio-MD technology demonstrated in PF329 clinical study.
Raised USD $10 million from Founders Fund in initial closing of recent
Series B round.
Enter partnership with leading pharmaceutical companies
to accelerate the development and commercialization of our
1) PF0713 IV sedative-hypnotic and antiemetic; and 2) our
opioid Bio-MD and MPAR programs.
Raise additional Series B equity capital in round led by
Founders Fund.
CORPORATE MISSION
PharmacoFore (P4) is a privately-held biopharmaceutical company focused on creating novel medicines to improve upon the therapeutic
utility of existing drugs, enhance patient care, and prevent the misuse, abuse, and overdose of prescription medications.
We pursue carefully chosen programs in which: 1) the targets of our compounds have known mechanisms-of-action; and 2) human proofof-concept (hPOC) can be achieved early in the development process. Consequently, commercial launch can be achieved more rapidly. Our
initial focus is on medicines that target the CNS and address unmet medical needs in areas such as sedation, pain management, and
attention deficit hyperactivity disorder.
As an innovator in the discovery of next-generation proprietary medicines, PharmacoFore applies insights and experience in medicinal
chemistry, applied biology, clinical pharmacology, and early stage development to create and advance a pipeline of lower-risk
development candidates. Our strategy is to leverage our expertise in these areas to generate data that demonstrate human clinical proofof-concept and support partnerships with leading pharmaceutical companies that have the capabilities to successfully develop and
commercialize our products.
We have achieved hPOC in our sedative-hypnotic program, demonstrating safety, efficacy and, importantly, competitive advantages which
support our target product profile. The development and regulatory path for this program could lead to a commercial launch in the 201516 time-frame. This program has multiple product opportunities as an IV sedative-hypnotic and antiemetic, with a combined worldwide
market of ~USD $3.6 billion.
In addition, we have demonstrated hPOC of our molecular-level delivery technology. Our technology is broadly applicable to known drugs
of abuse. Because our technology results in the release of known drugs systemically, the development risk and time to market are reduced,
with multiple NCEs expected in 2016-18.
PROPRIETARY TECHNOLOGY
P4 has created a novel Bio-Activated Molecular Delivery technology designed to effectively deter prescription drug abuse at a molecular
level. This technology does not a reformulation of existing opioids (1) in physical matrices that are easily circumvented by simple
extraction methods; or (2) with aversive agents or antagonists that may expose patients to additional risks. P4’s opioid Bio-MD systems are
designed to release clinically effective opioid drugs only when exposed to the correct physiologic conditions when orally ingested. P4's
complementary technologies (i) MPAR provides multi-pill abuse resistance – removes incentive to misuse by self-escalating the dose, and
protects from oral overdose; (ii) Polypharmacy protection against serious adverse events and deaths from polypharmacy.
CORPORATE ALLIANCES
To further develop our lead compounds, we aim to collaborate with global companies to accelerate the development and
commercialization of our products. We are currently seeking partners for multiple programs.
PF0713 Sedative-Hypnotic (human proof-of-concept – hPOC – achieved).
Moderate-to-Severe Pain –
Bio-Activated Molecular Delivery™ Systems and MPAR™ Technology for Abuse-Resistant Opioids:
PF03
•
Hydromorphone (hPOC achieved for hydromorphone Bio-MD™ system);
•
Oxymorphone;
•
Morphine
•
Oxycodone (advanced into development);
•
Hydrocodone.
PF06
14th Annual BIO CEO & Investor Conference
158
Company Profiles
PF16: Tapentadol.
PF05 Reduced Opioid-Associated Side Effects (including OIC).
PF0713 Antiemetic.
PF08 Attention Deficit Hyperactivity Disorder (ADHD).
Bio-MD Systems and MPAR Technology for Abuse-Resistant Amphetamine.
PRODUCTS
Name
Indication
Phase
Milestone
PF0713
IV sedative-hypnotic
Phase II, IIa,
IIb
Human proof-of-concept - safety, efficacy, and
competitive advantages - achieved.
PF0713
Antiemetic
Phase I
Demonstrated highly potent antiemetic in animal
studies.
PF03 Tamper- and abuse-resistant
hydromorphone
Moderate-to-severe
pain
Phase I
Human proof-of-concept of our prodrug's mechanismof-activation achieved.
PF06 Tamper- and abuse-resistant
oxycodone
Moderate-to-severe
pain
Preclinical
Product candidate advanced into development.
PF06 Multi-pill abuse-resistant
oxycodone
Moderate-to-severe
pain
Preclinical
Product candidate advanced into development.
PF08 tamper- and abuse-resistant
amphetamine
ADHD
Optimized
Lead
Expect to advance product candidate into development
in 2H11.
PF05 Opioid side effects
Opioid-Induced
Constipation
Lead Series
PF06 IR Hydrocodone Bio-MD MPAR
Moderate-to-severe
pain
Optimized
Lead
PF06 IR Oxycodone Bio-MD MPAR
Moderate-to-severe
pain
Lead Series
PF03 ER Morphine (and OM) Bio-MD
MPAR
Moderate-to-severe
pain
Lead Series
Expect to advance into development 1H12
SENIOR MANAGEMENT
Wesley D. Sterman, MD, Chief Executive Officer • A. Gregory Sturmer, Chief Financial Officer • Thomas E. Jenkins, PhD, Chief Scientific
Officer • Judy A. Magruder, Vice President • Narinder Banait, PhD, Vice President
SCIENTIFIC ADVISORY BOARD
David Alpers, MD, Washington School of Medicine • Douglas Gourlay, MD, Wasser Pain Management Centre, Mt. Sinai Hospital •
Cynthia McCormick, MD, Former FDA Division of Anesthetic, Critical Care and Addiction Drug Products Director • Steven Passik, PhD,
Memorial Sloan Kettering Cancer Center • Steven L. Shafer, MD, Columbia University and Editor-in-Chief, Anesthesia & Analgesia •
Lynn Webster, MD, Lifetree Pain Clinic
14th Annual BIO CEO & Investor Conference
159
Company Profiles