Zogenix Inc. Who is Zogenix?. Filed March21, 2008 to come public via an $86 million IPO Specialty pharmaceutical company with two proprietary product candidates in late-stage development for the treatment of central nervous system disorders and pain. Sumatripan DosePro™, Lead product
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Who is Zogenix? • Filed March21, 2008 to come public via an $86 million IPO • Specialty pharmaceutical company with two proprietary product candidates in late-stage development for the treatment of central nervous system disorders and pain. • Sumatripan DosePro™, Lead product • needle-free subcutaneous delivery of sumatriptan for the treatment of acute migraine. • NDA submitted December 2007, and accepted for filing by the FDA in March 2008. • Plan to launch the product in the first quarter of 2009. • ZX002 - second product • novel controlled release formulation of hydrocodone for the treatment of chronic pain. • has completed Phase 2 clinical trials, initiating the Phase 3 clinical program in the second half of 2008.
Dose Pro TM • A novel drug delivery system that subcutaneously delivers a pre-filled, single dose injection of a drug through an easy-to-use, needle-free device that can be self-administered. • Preliminary pre-clinical and clinical studies demonstrate that DosePro can be used with small molecules and biological products, including protein therapeutics and monoclonal antibodies. • This technology may have significant market potential across a broad range of therapeutic areas, including those typically treated with small volume injectable products, such as hepatitis, infertility, multiple sclerosis and rheumatoid arthritis.
Zogenix will build their internal product pipeline by investigating proven drugs that can be paired with DosePro to enhance their benefits and commercial attractiveness. • Will focus on marketed compounds whose commercial potential has been limited by safety concerns, relative efficacy or patient adherence. • Will out-license Dose Pro to potential partners seeking to enhance, differentiate, or extend the life cycle of their own injectable products.
Lead Compound: Sumatripan Dose Pro TM • Migraine affects approximately 30 million people in the United States • Characterized by four major symptoms: • pain, • nausea • abnormal sensitivity to both sound and light. • Triptans are the class of drugs most often prescribed for treating migraines. They are believed to effect migraine relief by binding to serotonin (5-hydroxy-tryptamine) receptors in the brain, where they act to induce vasoconstriction of extracerebral blood vessels and also reduce neurogenic inflammation.
Sumatripan Dose Pro TM • Sumatriptan was the first Triptan compound to be developed, and offered improved efficacy and tolerability over ergot-derived compounds. • The development of sumatriptan was quickly followed by a number of “second generation” triptan compounds, characterized by improved pharmacokinetic properties and/or tolerability profiles. • Although the pharmacological mechanism of the triptans is similar, their pharmacokinetic properties are distinct. • bioavailability of oral formulations ranges between 14% (sumatriptan) and 74% (naratriptan), and their elimination half-life ranges from 2 hours (sumatriptan and rizatriptan) to 25 hours (frovatriptan). • Sumatriptan has been in clinical use for over 15 years for the safe and effective treatment of migraine and cluster headache and is currently available by • tablet, nasal spray and subcutaneous injection.
Market • Triptan drugs generated $2.8 billion in the United States (2007 sales- average wholesale price data published by Wolters Kluwer Health) • Injectable sumatriptan provides the fastest onset and most complete migraine relief of any form of migraine therapeutic, including all oral and nasal triptans. Competition • Imitrex (GlaxoSmithKline) is the leading triptan brand • $1.6 billion in the US (2007 sales) • Injectable forms of Sumatriptan accounted for $274 million, of which Imitrex STATdose accounted for $242 million. • DosePro is expected to compete for approximately $550 million annually in the five major countries of Europe: Germany, France, Italy, Spain, and the UK, according to IMS Health MIDAS
Commercialization of Sumatripan outside the US • March 17, 2008: Entered into a license agreement to grant exclusive rights in the European Union to Desitin Pharmaceuticals, to develop and commercialize Sumatriptan DosePro. • Under the terms of the agreement, Desitin will oversee, and be responsible for the expenses related to, all clinical development, regulatory approvals and commercialization efforts required to market and sell sumatriptan DosePro across Europe. • Zogenix will be responsible for the manufacture and supply of commercial product, and will receive a transfer price payment on manufactured product and royalty payments based on sales of the product upon commercialization. • Zogenix retains full commercial rights to sumatriptan DosePro in the U.S., Canada, Asia and certain other countries.
Hedging our Bets? • Recent high profile setbacks to the inhalable drugs sector, including the market failure of Pfizer's Exubera (inhalable insulin) and recent decisions by NovoNordisk and Eli Lilly to abandon similar development projects, are likely to increase the demand for effective needle-free delivery methods. • The recent development of needle-free delivery systems has accelerated considerably in response to the generally-held opinion that patients dislike traditional syringe-administered medications. • In addition, the renewed focus on patient compliance as a way of improving therapeutic outcomes has seen companies with successful needle-free systems begin to attract considerable investor attention. • Dose Pro system has potential application in indications ranging from hepatitis to rheumatoid arthritis, has already been examined as a method of delivering agents including the anaemia drug erythropoietin (EPO) as well as a variety of targeted therapeutic antibodies. Future looks good for Zogenix!
Chronic Pain • The American Pain Society estimated in 1999 that 9% of the U.S. adult population suffers from moderate to severe non-cancer related chronic pain. • Chronic pain is treated with both immediate release and extended release opioids. Market • Target market as prescription non-injectable codeine-based and extended release morphine-based pain products. • 2007 U.S. sales of approximately $9.7 billion, based on average wholesale price, on approximately 185 million prescriptions (data published by Wolters Kluwer Health). • During the same period, existing hydrocodone products, the most commonly prescribed opioid pain products, generated $2.5 billion in sales representing growth of 18.3% since 2006.
ZX002 - oral hydrocodone • Controlled release profile that combines immediate release and extended release properties, using Elan Pharma International Ltd.'s proprietary Spheroidal Oral Drug Absorption System, or SODAS. • SODAS: The extended-release beads are prepared using sugar/starch spheres upon which a drug/excipient layer is coated, followed by an ammonio-methacrylate copolymer coating • After rapid dissolution of the hard gelatin capsule shell, the permeability of the ammonio-methacrylate copolymer coating allows GI fluid to enter the beads and solubilize the drug. • After dissolving, morphine may then diffuse out of the beads at a predetermined rate. This entire process prolongs the in vivo dissolution of the drug and extends its absorption into the body. • Zogenix in-licensed exclusive U.S. rights to ZX002 from Elan Pharma International Ltd. in November 2007 (makers of Avinza).
Competition • Current competitors in the opioid pain therapeutics space include • Abbott Laboratories (Vicodin and Vicoprofen) • Alpharma Inc. (Kadian) • Endo Pharmaceuticals Holdings Inc. (Opana, Percocet) • Johnson & Johnson, (Tylox, Tramadol) • King Pharmaceuticals, Inc. (Avinza) • Mallinckrodt Inc., (Magnacet) • Purdue Pharma L.P. (MS Contin C-II, OxyContin C-II, OxyIR C-II) • Teva Pharmaceutical Industries Limited • Watson Pharmaceuticals, Inc. (Maxidone) • There are at least fifteen opioid product candidates, including abuse and diversion resistant formulations of currently available opioids, novel opioids and alternative delivery forms of various opioids under development at other pharmaceutical companies, including an extended release version of Vicodin being developed by Abbott Laboratories, and an extended-release hydrocodone product candidate being developed by Alpharma, Inc. • ZX002 also faces competition from non-opioid product candidates including new chemical entities, as well as alternative delivery forms of NSAIDs.
So what does Zogenix offer? • Presently, hydrocodone is only available in immediate release product forms that are commonly dosed four to six times per day to provide pain relief. • Existing hydrocodone products, (Vicodin, Lortab and Vicoprofen), and their generic equivalents, contain analgesic combination ingredients such as acetaminophen or NSAIDs, which if taken in high quantities over time can lead to serious side effects such as liver toxicity and gastrointestinal damage. • Eliminating the combination analgesic ingredient and by having a controlled release profile, ZX002 removes the potential limitations of existing hydrocodone combination formulations and allows for less frequent dosing.
Pharmacokinetics?!? • In single and multiple dose pharmacokinetic evaluations, ZX002 demonstrated detectable plasma concentrations of hydrocodone within 15 minutes. • ZX002 also demonstrated a sustained release effect significantly longer than currently available hydrocodone combination products such as Vicodin, dose proportional pharmacokinetics and an acceptable safety profile. SOMEWHAT VAGUE!!! • In a Phase 2 chronic pain study, ZX002 demonstrated a reduction in pain intensity for chronic moderate to severe osteoarthritis pain patients across multiple dosage strengths and a clinically acceptable safety profile.
Meet the Board • Cam Garner - Founder of Dura Pharmaceuticals (Co-founder and Chair) • local industry members have called the most successful specialty pharmaceutical company in San Diego history. Dura specialized in respiratory and pulmonary therapies and was acquired by Dublin, Ireland-based Elan Corp. for $1.8 billion in 2000. • The mastermind behind San Diego-based Verus Pharmaceuticals Inc., which last year introduced the first major competitor to the 20-year-old EpiPen to treat severe allergic reactions. • Founding member of the first San Diego biotech firm, former Hybritech - acquired in 1986 by Eli Lilly & Co. For $500 million. • Co-founder of specialty pharmaceutical companies, Cadence Pharmaceuticals, Inc., Evoke Pharma, Elevation Pharmaceuticals, DJ Pharma and Xcel Pharmaceuticals, Inc. • Kurt Wheeler - Managing Director of Clarus Ventures, a venture capital firm • Clarus Ventures and Domain Associates LLC led the $60 million round for Zogenix. • Additional investors included BA Venture Partners, Thomas, McNerney & Partners and Life Science Angels Inc.
James Blair PhD • board memberships include Cadence Pharmaceuticals, Cell Biosciences, Five Prime Therapeutics, GenVault, NeuroPace, Novacea and Pharmion. • served as a director of over 40 life sciences ventures • Louis Bock - Managing Director of Scale Venture Partners, a venture capital firm • Alex Zisson - Partner at Thomas, McNerney & Partners. • Roger Hawley - Chief Executive Officer and Director • Stephen Farr PhD - President and Chief Operating Officer • he played a key role in identifying and acquiring the DosePro™ technology
Follow the Cash • http://www.secinfo.com/dVut2.t335.htm - 1stPage
Effective Doses • At marketed doses, all oral triptans are effective and well tolerated. Differences among them are in general relatively small, but clinically relevant for individual patients. Rizatriptan 10 mg, eletriptan 80 mg and almotriptan 12.5 mg provide the highest likelihood of consistent success. Sumatriptan features the longest clinical experience and the widest range of formulations. All triptans are contra-indicated in the presence of cardiovascular disease. • Current triptan retail prices (per unit) include: Amerge 1 and 2.5 mg, 17.78 dollars; Axert 6.25 and 12.5 mg, 16.31 dollars; Frova 2.5 mg, 13.89 dollars; Imitrex 50 mg, 14.96 dollars; Imitrex 100 mg, 14.41 dollars; Imitrex Nasal Spray 20 mg, 21.61 dollars; Imitrex SQ 6 mg, 50.26 dollars; Maxalt 5 and 10 mg, 15 dollars; Maxalt-MLT 5 and 10 mg, 15 dollars; Relpax 40 mg, 13.58 dollars; Zomig 2.5 mg, 13.67 dollars; Zomig 5 mg, 15.89 dollars; Zomig-ZMT 2.5 mg, 13.67 dollars; and Zomig-ZMT 5 mg, 15.89 dollars. • The mean therapeutic gain with subcutaneous sumatriptan 6mg (51%) was more than that for all other dosage forms of triptans (oral sumatriptan 100mg 32%; oral sumatriptan 50mg 29%: intranasal sumatriptan 20mg 30%; rectal sumatriptan 25mg 31%; oral zolmitriptan 2.5mg 32%; oral rizatriptan 10mg 37%; oral eletriptan 40mg 37%; oral almotriptan 12.5mg 26%). Compared with oral sumatriptan 100mg (32%), the mean therapeutic gain was higher with oral eletriptan 80mg (42%) but lower with oral naratriptan 2.5mg (22%) or oral frovatriptan 2.5mg (16%). The few direct comparative randomised clinical trials with oral triptans reveal the same picture. Recurrence of headache within 24 hours after an initial successful response occurs in 30 to 40% of sumatriptan-treated patients.