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	<title>Zogenix</title>
	<link>http://zogenix.com</link>
	<description>Zogenix</description>
	<pubDate>Mon, 30 Jan 2012 21:34:58 +0000</pubDate>
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		<title>Director, Regulatory Affairs</title>
		<link>http://zogenix.com/index.php/careers/director-regulatory-affairs-2/</link>
		<comments>http://zogenix.com/index.php/careers/director-regulatory-affairs-2/#comments</comments>
		<pubDate>Mon, 30 Jan 2012 21:34:58 +0000</pubDate>
		<dc:creator>zogenix</dc:creator>
		
		<category><![CDATA[careers]]></category>

		<guid isPermaLink="false">http://zogenix.com/index.php/careers/director-regulatory-affairs-2/</guid>
		<description><![CDATA[Job Title:  Director, Regulatory Affairs	
Position reports to: Vice President, Regulatory Affairs &#038; Product Quality/Safety
Location:  Emeryville, CA
Purpose of Position:
This Director, Regulatory Affairs is responsible for providing strategic and operational leadership in the area of advertising and promotion, labeling, and management of the Contact Center.  This position will serve as the company’s senior regulatory [...]]]></description>
			<content:encoded><![CDATA[<p>Job Title:  Director, Regulatory Affairs	</p>
<p>Position reports to: Vice President, Regulatory Affairs &#038; Product Quality/Safety</p>
<p>Location:  Emeryville, CA</p>
<p>Purpose of Position:<br />
This Director, Regulatory Affairs is responsible for providing strategic and operational leadership in the area of advertising and promotion, labeling, and management of the Contact Center.  This position will serve as the company’s senior regulatory liaison to the FDA’s OPDP, and works closely with representatives from medical, legal and commercial to support the interests of the business, and comply with applicable FDA regulations.  Represents Regulatory Affairs on the promotional review committee, and provides guidance to members regarding the current regulatory environment and regulatory considerations that may impact business activities.  </p>
<p>Leads the development of product labeling, and manages the submission of labeling changes to health authorities.   </p>
<p>This position will also provide leadership and management of the Contact Center for product information by HCPs and patients.  This activity includes the management of any vendors/CRO and consultants required to support this function. </p>
<p>Primary Responsibilities and Duties:<br />
•	Work through cross-function team to provide regulatory guidance on product promotional items.  Work closely with Medical, Legal and Commercial members to develop materials consistent with business needs and FDA compliance.  Manages the submission of materials to OPDP, and serves as regulatory liaison to OPDP.<br />
•	Leads and manages product labeling generation, and post-approval labeling changes.<br />
•	Provides leadership and organizational management of the Contact Center, including the generation and renewal of SRLs/FAQs, providing input on ad hoc questions, generation and summary of monthly activities via dashboard summaries. </p>
<p>Minimum Education Typically Required:<br />
BS/MS or equivalent in a relevant scientific discipline.</p>
<p>Amount of Experience Typically Required:<br />
Requires a minimum of 5 years experience (10+ years desired) with drug products in Regulatory Affairs, preferably in pharmaceuticals, biologics, or bio-pharmaceuticals.</p>
<p>Skills Required<br />
Possesses a thorough knowledge of current FDA regulations and guidances regarding advertising and promotional activities, labeling requirements, and medical information support.   </p>
<p>Possesses leadership skills and ability to interact with senior management </p>
<p>Excellent written and verbal communication abilities</p>
<p>Negotiation skills are essential</p>
<p>Expert knowledge of the pharmaceutical business, and proficiency at representing and interpreting the strategic business objectives of the company effectively is critical.</p>
<p>Travel:<br />
Willing to travel up to 20%</p>
]]></content:encoded>
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		</item>
		<item>
		<title>Associate Director, Non-Clinical Development</title>
		<link>http://zogenix.com/index.php/careers/associate-director-non-clinical-development/</link>
		<comments>http://zogenix.com/index.php/careers/associate-director-non-clinical-development/#comments</comments>
		<pubDate>Wed, 24 Aug 2011 20:06:05 +0000</pubDate>
		<dc:creator>zogenix</dc:creator>
		
		<category><![CDATA[careers]]></category>

		<guid isPermaLink="false">http://zogenix.com/index.php/careers/associate-director-non-clinical-development/</guid>
		<description><![CDATA[Associate Director, Non-Clinical Development
POSITION SUMMARY
The Associate Director of Non-Clinical Development will be responsible for developing and implementing non-clinical strategy for new drug product development at Zogenix.  This person will also oversee and manage non-clinical studies at contract research organizations, as well as be responsible for writing non-clinical sections of regulatory submissions.
MAJOR AREAS OF RESPONSIBILITY
•	In [...]]]></description>
			<content:encoded><![CDATA[<p>Associate Director, Non-Clinical Development</p>
<p>POSITION SUMMARY<br />
The Associate Director of Non-Clinical Development will be responsible for developing and implementing non-clinical strategy for new drug product development at Zogenix.  This person will also oversee and manage non-clinical studies at contract research organizations, as well as be responsible for writing non-clinical sections of regulatory submissions.</p>
<p>MAJOR AREAS OF RESPONSIBILITY<br />
•	In collaboration with Zogenix’ Senior Development staff, lead development of non-clinical strategy and execute a plan to enable rapid drug product approval for Relday™ (risperidone-SABER-DosePro) and future drug products<br />
•	Participate on drug product development teams by providing direction, oversight and management for all Zogenix non-clinical studies, and oversight for partner-conducted non-clinical studies, including Zohydro™, Relday™ and all future drug products.<br />
•	Work with Regulatory Affairs to write non-clinical sections of all regulatory submissions.</p>
<p>MINIMUM JOB QUALIFICATIONS<br />
•	Self-motivated individual with the ability to think and work independently<br />
•	Minimum of 9 years industrial experience in drug-device combination product development including experience managing a team and managing CRO’s<br />
•	Experience in CNS and Pain non-clinical product development required, some experience in parenteral or controlled release non-clinical product development preferred<br />
•	PhD in Toxicology, Pharmacology or a related discipline, or equivalent combination of education (MS or DVM) and drug product development experience.  DABT certification a plus<br />
•	Demonstrated success and experience working in a complex drug development environment<br />
•	Excellent communication skills with ability to clearly express themselves both verbally and in writing<br />
•	Strong understanding of ICH, FDA and EMEA guidelines pertaining to preclinical / nonclinical safety</p>
<p>PREFERRED JOB QUALIFICATIONS<br />
•	Demonstrated success working effectively outside defined scope of responsibility, when required.<br />
•	Have a bias for action and display a sense of urgency.<br />
•	Possess strong skills in leadership, communication, project management and budget management while maintaining high quality and efficiency standards.</p>
<p>SPECIAL WORKING CONDITIONS<br />
•	Up to 5-10% travel required</p>
<p>REPORTING RELATIONSHIP<br />
Reports to Sr. Director, Product Development</p>
<p>OFFICE SITE<br />
Emeryville, CA</p>
]]></content:encoded>
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		</item>
		<item>
		<title>Zogenix Receives 2010 Most Innovative Product Award for SUMAVEL DosePro</title>
		<link>http://zogenix.com/index.php/news/zogenix-receives-2010-most-innovative-product-award-for-sumavel-dosepro/</link>
		<comments>http://zogenix.com/index.php/news/zogenix-receives-2010-most-innovative-product-award-for-sumavel-dosepro/#comments</comments>
		<pubDate>Thu, 16 Dec 2010 16:03:04 +0000</pubDate>
		<dc:creator>zogenix</dc:creator>
		
		<category><![CDATA[news]]></category>

		<guid isPermaLink="false">http://zogenix.com/index.php/uncategorized/zogenix-receives-2010-most-innovative-product-award-for-sumavel-dosepro/</guid>
		<description><![CDATA[SAN DIEGO, Calif., December 13, 2010 — Zogenix, Inc. (“Zogenix”) (NASDAQ: ZGNX) today announced that CONNECT, a regional San Diego nonprofit organization,  selected SUMAVEL® DosePro™ (sumatriptan injection) Needle-free Delivery System as a 2010 Most Innovative Product (MIP) winner at the MIP Awards Luncheon on December 10, 2010. 
The 2010 CONNECT MIP Awards recognize the [...]]]></description>
			<content:encoded><![CDATA[<p><strong>SAN DIEGO, Calif.,</strong> December 13, 2010 — Zogenix, Inc. (“Zogenix”) (NASDAQ: ZGNX) today announced that CONNECT, a regional San Diego nonprofit organization,  selected SUMAVEL® DosePro™ (sumatriptan injection) Needle-free Delivery System as a 2010 Most Innovative Product (MIP) winner at the MIP Awards Luncheon on December 10, 2010. </p>
<p>The 2010 CONNECT MIP Awards recognize the emerging technologies and cutting-edge products that drive San Diego&#8217;s innovation economy.  SUMAVEL DosePro received top honors as the most innovative product for 2010 in the Life Sciences – Medical Products category.</p>
<p>SUMAVEL DosePro offers fast-acting, easy-to-use, needle-free subcutaneous administration of sumatriptan for patients suffering from migraine attacks, and has demonstrated consistent monthly growth in total prescriptions since its U.S. commercial launch in January 2010.  It is the first drug product approved by the U.S. Food and Drug Administration (FDA) which allows for the needle-free, subcutaneous delivery of medication.</p>
<p>Roger L. Hawley, Chief Executive Officer and Director of Zogenix said, “We are honored that CONNECT has recognized SUMAVEL DosePro, and by extension our proprietary DosePro delivery system, as a significant innovation.  San Diego is a rich source of new and exciting technologies, and we are proud to be distinguished in the region as the most innovative medical product within the life sciences category.” </p>
<p>SUMAVEL DosePro is currently approved in the United States and Denmark for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache.  SUMAVEL DosePro may offer a fast-acting and efficacious treatment alternative to oral and nasal triptans with simple, convenient administration when compared to traditional, needle-based sumatriptan injection. These unique attributes may be ideally suited for challenging migraine attacks, such as morning migraines, fast onset migraine and migraines with vomiting. </p>
<p>Zogenix and its co-promotion partner, Astellas Pharma US, Inc., launched SUMAVEL DosePro in the United States in January 2010.  Zogenix has a partnership with Desitin Arzneimittel GmbH to develop and commercialize SUMAVEL DosePro in the European Union.  Desitin plans to launch SUMAVEL DosePro in Denmark in early 2011.</p>
<p><strong>About SUMAVEL DosePro</strong><br />
SUMAVEL DosePro (sumatriptan injection) is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes.</p>
<p>SUMAVEL DosePro should only be used where a clear diagnosis of migraine or cluster headache has been established. SUMAVEL DosePro is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine and should not be administered intravenously. For a given attack, if a patient does not respond to the first dose of SUMAVEL DosePro, the diagnosis of migraine or cluster headache should be reconsidered before administration of a second dose. For more information about SUMAVEL DosePro, please visit www.SUMAVELDosePro.com.</p>
<p><strong>IMPORTANT SAFETY INFORMATION</strong><br />
SUMAVEL DosePro is contraindicated in patients with uncontrolled hypertension, in patients with history, symptoms or signs of ischemic heart disease, coronary artery vasospasm, cerebrovascular or peripheral vascular disease including ischemic bowel disease and in patients with other significant underlying cardiovascular diseases or known hypersensitivity to sumatriptan. SUMAVEL DosePro should not be given to patients in whom unrecognized coronary artery disease is predicted by the presence of risk factors without a prior cardiovascular evaluation. </p>
<p>Serious cardiovascular events, including death, have been reported when taking sumatriptan, including patients with no findings of cardiovascular disease. Considering the extent of use of sumatriptan in patients with migraine, the incidence of these events is extremely low. Cerebrovascular events, some fatal, have been reported in patients treated with sumatriptan. In a number of cases, it appears possible that the cerebrovascular events were primary, sumatriptan having been administered in the incorrect belief the symptoms experienced were a consequence of migraine when they were not. It is important to advise patients not to administer SUMAVEL DosePro if a headache being experienced is atypical.</p>
<p>SUMAVEL DosePro should not be used within 24 hours of other ergotamine-containing or ergot-type medications or other 5-HT1 agonists and is not generally recommended for use with MAO-A inhibitors. The development of a potentially life-threatening serotonin syndrome may occur with triptans, including treatment with SUMAVEL DosePro, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). SUMAVEL DosePro should be used during pregnancy only if the potential benefit justifies the potential risk.</p>
<p>In controlled clinical trials with sumatriptan injection, the most common adverse reactions were injection site reactions, tingling, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, feeling of tightness, numbness, feeling strange, tight feeling in head, flushing, tightness in chest, discomfort in nasal cavity/sinuses, jaw discomfort, dizziness/vertigo, drowsiness/sedation and headache.</p>
<p>For full prescribing information, go to http://www.zogenix.com/docs/SV0018.0709A_SDP_PI.pdf</p>
<p><strong>About DosePro Technology </strong><br />
The DosePro technology is an easy-to-use, pre-filled drug delivery system designed to enable self-administration of single doses of liquid drug formulations, subcutaneously, without a needle. The DosePro technology has undergone more than 10 years of design, process engineering, clinical evaluation and development work. DosePro is protected by more than 80 patents, issued and applied for, worldwide. Approximately 9,000 injections have been delivered in clinical trials in healthy volunteers using the DosePro needle-free drug delivery system.</p>
<p><strong>About Zogenix</strong><br />
Zogenix, Inc. (NASDAQ: ZGNX), with offices in San Diego and Emeryville, California, is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Zogenix’s first commercial product, SUMAVEL® DosePro™ (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix’s lead product candidate, ZX002, is a novel, oral, single-entity controlled-release formulation of hydrocodone currently in Phase 3 clinical trials for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy.</p>
<p>For additional information, please visit www.zogenix.com.</p>
<p>SUMAVEL and DosePro are trademarks of Zogenix.</p>
<p><strong>About CONNECT</strong><br />
CONNECT is a nonprofit organization dedicated to creating and sustaining the growth of innovative technology and life science businesses in San Diego. Since 1985, CONNECT has assisted in the formation and development of over 2,000 companies and is widely regarded as the world&#8217;s most successful regional program linking inventors and entrepreneurs with the resources they need for success. CONNECT focuses on research institution support, business creation and development, entrepreneurial learning, access to capital, public policy advocacy, awards, recognition and networking. There are more than 40 organizations in 18 countries that have adopted the CONNECT model, including New York City, the UK, Sweden, Norway, Denmark, Australia and India.<br />
For more information about CONNECT’s MIP Awards, please visit: http://www.connect.org/programs/most-innovative-products-award/ </p>
<p><strong>Forward Looking Statements</strong></p>
<p>Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as &#8220;believes,&#8221; &#8220;anticipates,&#8221; &#8220;plans,&#8221; &#8220;expects,&#8221; &#8220;indicates,&#8221; &#8220;will,&#8221; &#8220;intends,&#8221; &#8220;potential,&#8221; &#8220;suggests,&#8221; &#8220;assuming,&#8221; &#8220;designed&#8221; and similar expressions are intended to identify forward-looking statements. These statements are based on the company&#8217;s current beliefs and expectations. These forward-looking statements include statements regarding the attributes of SUMAVEL DosePro and the timing of Desitin’s planned launch in Denmark. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in the Zogenix’s business, including, without limitation: the market potential for migraine treatments, and Zogenix’s ability to compete within that market; inadequate therapeutic efficacy or unexpected adverse side effects relating to SUMAVEL DosePro that could delay or prevent commercialization, or that could result in recalls or product liability claims; the ability of Zogenix and Desitin to ensure adequate and continued supply of SUMAVEL DosePro to successfully launch commercial sales or meet anticipated market demand in the European Union; the scope, validity and duration of patent protection and other intellectual property rights for SUMAVEL DosePro; whether the approved label for SUMAVEL DosePro is sufficiently consistent with such patent protection to provide exclusivity for SUMAVEL DosePro; Zogenix and Desitin’s ability to operate its business without infringing the intellectual property rights of others; and other risks described in the company&#8217;s prior press releases and filings with the Securities and Exchange Commission. </p>
<p>You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.</p>
<p># # #</p>
<p>INVESTORS:<br />
Sara Pellegrino | The Ruth Group<br />
646.536.7002 | spellegrino@theruthgroup.com</p>
<p>MEDIA:<br />
Jason Rando | The Ruth Group<br />
646.536.7025 | jrando@theruthgroup.com</p>
]]></content:encoded>
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		</item>
		<item>
		<title>Zogenix and Desitin Announce First European Marketing Approval for SUMAVEL DosePro</title>
		<link>http://zogenix.com/index.php/news/zogenix-and-desitin-announce-first-european-marketing-approval-for-sumavel-dosepro/</link>
		<comments>http://zogenix.com/index.php/news/zogenix-and-desitin-announce-first-european-marketing-approval-for-sumavel-dosepro/#comments</comments>
		<pubDate>Thu, 16 Dec 2010 15:49:20 +0000</pubDate>
		<dc:creator>zogenix</dc:creator>
		
		<category><![CDATA[news]]></category>

		<guid isPermaLink="false">http://zogenix.com/index.php/uncategorized/zogenix-and-desitin-announce-first-european-marketing-approval-for-sumavel-dosepro/</guid>
		<description><![CDATA[SAN DIEGO, Calif., and Hamburg, Germany, December 2, 2010 — Zogenix, Inc. (NASDAQ: ZGNX) and Desitin Pharmaceuticals GmbH today announced that the Danish Medicines Agency of Denmark has approved the Marketing Authorization Application (MAA) for SUMAVEL® DosePro™ (sumatriptan injection) Needle-Free Delivery System. Denmark is the first country in Europe to grant marketing authorization for SUMAVEL [...]]]></description>
			<content:encoded><![CDATA[<p><strong>SAN DIEGO, Calif., and Hamburg, Germany,</strong> December 2, 2010 — Zogenix, Inc. (NASDAQ: ZGNX) and Desitin Pharmaceuticals GmbH today announced that the Danish Medicines Agency of Denmark has approved the Marketing Authorization Application (MAA) for SUMAVEL® DosePro™ (sumatriptan injection) Needle-Free Delivery System. Denmark is the first country in Europe to grant marketing authorization for SUMAVEL DosePro for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache. </p>
<p>SUMAVEL DosePro offers fast acting, easy-to-use, needle-free subcutaneous administration of sumatriptan. SUMAVEL DosePro may offer a treatment alternative to oral and nasal triptans, and simple, convenient administration when compared to traditional, needle-based sumatriptan injection. These unique attributes may be ideally suited for challenging migraine attacks, such as morning migraines, fast onset migraine and migraines with vomiting.</p>
<p>Roger L. Hawley, Chief Executive Officer and Director of Zogenix said, “The MAA approval of SUMAVEL DosePro in Denmark creates a point of entry into the E.U. market. We look forward to the upcoming E.U. commercial launch by our partner Desitin.”</p>
<p>Desitin plans to launch SUMAVEL DosePro in Denmark in early 2011 and is responsible for pursuing additional MAA approvals and broader commercialization on a country-by-country basis under the E.U. decentralized procedure.</p>
<p>Dr. Martin Zentgraf, Desitin’s General Manager, said, “We are pleased to announce the first MAA approval of SUMAVEL DosePro in Europe and anticipate commencing the commercial launch through our CNS-focused sales representatives and partner companies. We also have MAA submissions pending in other E.U. markets and look forward to gaining additional European approvals in the coming months.” </p>
<p>In March 2008, Zogenix and Desitin entered into a license agreement granting exclusive rights in the European Union to Desitin to develop and commercialize SUMAVEL DosePro. Zogenix and its co-promotion partner, Astellas, currently market SUMAVEL DosePro in the United States, where it has demonstrated consistent monthly growth in total prescriptions since its launch in January 2010.</p>
<p><strong>About SUMAVEL DosePro</strong><br />
SUMAVEL DosePro (sumatriptan injection) is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes.<br />
SUMAVEL DosePro should only be used where a clear diagnosis of migraine or cluster headache has been established. SUMAVEL DosePro is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine and should not be administered intravenously. For a given attack, if a patient does not respond to the first dose of SUMAVEL DosePro, the diagnosis of migraine or cluster headache should be reconsidered before administration of a second dose. For more information about SUMAVEL DosePro, please visit www.SUMAVELDosePro.com.</p>
<p><strong>IMPORTANT SAFETY INFORMATION </strong><br />
SUMAVEL DosePro is contraindicated in patients with uncontrolled hypertension, in patients with history, symptoms or signs of ischemic heart disease, coronary artery vasospasm, cerebrovascular or peripheral vascular disease including ischemic bowel disease and in patients with other significant underlying cardiovascular diseases or known hypersensitivity to sumatriptan. SUMAVEL DosePro should not be given to patients in whom unrecognized coronary artery disease is predicted by the presence of risk factors without a prior cardiovascular evaluation. </p>
<p>Serious cardiovascular events, including death, have been reported when taking sumatriptan, including patients with no findings of cardiovascular disease. Considering the extent of use of sumatriptan in patients with migraine, the incidence of these events is extremely low. Cerebrovascular events, some fatal, have been reported in patients treated with sumatriptan. In a number of cases, it appears possible that the cerebrovascular events were primary, sumatriptan having been administered in the incorrect belief the symptoms experienced were a consequence of migraine when they were not. It is important to advise patients not to administer SUMAVEL DosePro if a headache being experienced is atypical.</p>
<p>SUMAVEL DosePro should not be used within 24 hours of other ergotamine-containing or ergot-type medications or other 5-HT1 agonists and is not generally recommended for use with MAO-A inhibitors. The development of a potentially life-threatening serotonin syndrome may occur with triptans, including treatment with SUMAVEL DosePro, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). SUMAVEL DosePro should be used during pregnancy only if the potential benefit justifies the potential risk.</p>
<p>In controlled clinical trials with sumatriptan injection, the most common adverse reactions were injection site reactions, tingling, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, feeling of tightness, numbness, feeling strange, tight feeling in head, flushing, tightness in chest, discomfort in nasal cavity/sinuses, jaw discomfort, dizziness/vertigo, drowsiness/sedation and headache.</p>
<p>For full prescribing information, go to http://www.zogenix.com/docs/SV0018.0709A_SDP_PI.pdf</p>
<p><strong>About DosePro Technology </strong><br />
The DosePro technology is an easy-to-use, pre-filled drug delivery system designed to enable self-administration of single doses of liquid drug formulations, subcutaneously, without a needle. The DosePro technology has undergone more than 10 years of design, process engineering, clinical evaluation and development work. DosePro is protected by more than 80 patents, issued and applied for, worldwide. Approximately 9,000 injections have been delivered in clinical trials in healthy volunteers using the DosePro needle-free drug delivery system.</p>
<p><strong>About Zogenix</strong><br />
Zogenix, Inc. (NASDAQ: ZGNX), with offices in San Diego and Emeryville, California, is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Zogenix’s first commercial product, SUMAVEL® DosePro™ (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix’s lead product candidate, ZX002, is a novel, oral, single-entity controlled-release formulation of hydrocodone currently in Phase 3 clinical trials for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy.</p>
<p>For additional information, please visit www.zogenix.com.</p>
<p><strong>About Desitin</strong><br />
Desitin Pharmaceuticals GmbH, based in Hamburg, Germany is an independent, private, fully integrated, German pharmaceutical company focused on the development, manufacturing and distribution of products for the treatment of central nervous system disorders. Desitin, with turnover in 2009/2010 of over $115 million, is one of the leading European companies in the field of epilepsy with additional expertise in Parkinson’s disease and psychiatric disorders. With their pharmaceutical and clinical development capabilities, the company develops innovative products such as controlled-release and high-dose antiepileptics. Desitin’s sales infrastructure offers comprehensive coverage in Germany, Switzerland, Northern and Eastern Europe. The company also has strategic partnerships with other companies covering nearly all of the remaining countries in Europe. For additional information, visit www.desitinpharma.com. </p>
<p>Zogenix™ and DosePro™ are trademarks of Zogenix, Inc.<br />
SUMAVEL ® is a registered trademark of Zogenix, Inc.</p>
<p>Forward Looking Statements<br />
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as &#8220;believes,&#8221; &#8220;anticipates,&#8221; &#8220;plans,&#8221; &#8220;expects,&#8221; &#8220;indicates,&#8221; &#8220;will,&#8221; &#8220;intends,&#8221; &#8220;potential,&#8221; &#8220;suggests,&#8221; &#8220;assuming,&#8221; &#8220;designed&#8221; and similar expressions are intended to identify forward-looking statements. These statements are based on the company&#8217;s current beliefs and expectations. These forward-looking statements include statements regarding the attributes of SUMAVEL DosePro,  the commercial potential of the product and the prospects for the MAA submissions in other E.U. markets. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in the Zogenix’s business, including, without limitation: the ability of Zogenix and Desitin to ensure adequate and continued supply of SUMAVEL DosePro to successfully launch commercial sales or meet anticipated market demand in the E.U.; the scope, validity and duration of patent protection and other intellectual property rights for SUMAVEL DosePro; whether the approved label for SUMAVEL DosePro is sufficiently consistent with such patent protection to provide exclusivity for SUMAVEL DosePro; Zogenix and Desitin’s ability to operate its business without infringing the intellectual property rights of others; the market potential for migraine treatments, and the companies’ ability to compete within that market; inadequate therapeutic efficacy or unexpected adverse side effects relating to SUMAVEL DosePro that could delay or prevent commercialization, or that could result in recalls or product liability claims; Zogenix’s reliance on Desitin for the commercial sales success and regulatory approval and compliance of SUMAVEL DosePro in the E.U.; and other risks described in the company&#8217;s prior press releases and filings with the Securities and Exchange Commission. </p>
<p>You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.</p>
<p>INVESTORS:<br />
Sara Pellegrino | The Ruth Group<br />
646.536.7002 | <a href="mailto:spellegrino@theruthgroup.com" title="spellegrino@theruthgroup.com" target="_blank"> spellegrino@theruthgroup.com</a></p>
<p>MEDIA:<br />
Jason Rando | The Ruth Group<br />
646.536.7025 | <a href="mailto:jrando@theruthgroup.com" title="jrando@theruthgroup.com" target="_blank"> jrando@theruthgroup.com</a></p>
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		<title>Zogenix Announces Completion of Enrollment in ZX002 Phase 3 12-Month Safety Study</title>
		<link>http://zogenix.com/index.php/news/zogenix-announces-completion-of-enrollment-in-zx002-phase-3-12-month-safety-study/</link>
		<comments>http://zogenix.com/index.php/news/zogenix-announces-completion-of-enrollment-in-zx002-phase-3-12-month-safety-study/#comments</comments>
		<pubDate>Thu, 02 Dec 2010 21:56:30 +0000</pubDate>
		<dc:creator>zogenix</dc:creator>
		
		<category><![CDATA[news]]></category>

		<guid isPermaLink="false">http://zogenix.com/index.php/news/zogenix-announces-completion-of-enrollment-in-zx002-phase-3-12-month-safety-study/</guid>
		<description><![CDATA[SAN DIEGO, Calif., November 30, 2010 — Zogenix, Inc. (NASDAQ: ZGNX) today announced completion of enrollment in its open-label Phase 3 safety study (Study 802) of ZX002. ZX002 is a novel, oral, single-entity, controlled-release formulation of hydrocodone for the treatment of moderate to severe pain in patients requiring around-the-clock opioid therapy for an extended period [...]]]></description>
			<content:encoded><![CDATA[<p><strong>SAN DIEGO, Calif., </strong>November 30, 2010 — Zogenix, Inc. (NASDAQ: ZGNX) today announced completion of enrollment in its open-label Phase 3 safety study (Study 802) of ZX002. ZX002 is a novel, oral, single-entity, controlled-release formulation of hydrocodone for the treatment of moderate to severe pain in patients requiring around-the-clock opioid therapy for an extended period of time. The goal of this 12-month study of ZX002 is to evaluate overall safety in at least 300 patients for six months and at least 100 patients for one year. With successful conclusion of the enrollment of 450 patients for this study, the top-line long-term safety results are anticipated to be available in the second half of 2011. </p>
<p>Zogenix is concurrently conducting a pivotal Phase 3 efficacy study (Study 801) of ZX002. Study 801 is a randomized, 12-week, double-blind, placebo-controlled trial that is continuing to enroll opioid-experienced adult subjects with moderate to severe chronic lower back pain. The primary efficacy endpoint is the mean change in average daily pain intensity scores between ZX002 and placebo. Study 801 is expected to be fully enrolled in early 2011. Initial top-line data from Study 801 are also anticipated in the second half of 2011. </p>
<p>Pending positive Phase 3 clinical results, Zogenix expects to submit an NDA for ZX002 with U.S. Food and Drug Administration (FDA) by early 2012. If approved, ZX002 has the potential to be the first controlled-release version of hydrocodone and also the first hydrocodone product that is not combined with another analgesic.</p>
<p>Stephen J. Farr, Ph.D., President and Chief Operating Officer said, “With the completion of enrollment in our Phase 3 safety study, we believe ZX002 is on track to be the first potential single-entity, controlled-release hydrocodone formulation. Most marketed hydrocodone products contain acetaminophen, an analgesic which can cause liver toxicity at high doses over time. ZX002 is not combined with any other analgesic, and may be suitable for both patients who are using immediate-release opioid products on a chronic basis and patients already using extended-release opioids.”</p>
<p>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 can be treated with both immediate-release and extended-release opioids. Marketed hydrocodone products are the most commonly prescribed pharmaceuticals in the United States, generating $3.1 billion in U.S. sales during the 12 months ended June 2010 (Wolters Kluwer Pharma Solutions, Source®: PHAST Retail). Most of these products contain the analgesic combination ingredient acetaminophen. When used in high dosages over time, acetaminophen can cause liver toxicity.</p>
<p><strong>About ZX002</strong><br />
ZX002 is a novel, oral, single-entity controlled-release formulation of hydrocodone currently in Phase 3 clinical trials for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy for an extended period of time. ZX002 uses Elan Pharma International Limited’s proprietary Spheroidal Oral Drug Absorption System, or SODAS® Technology. The SODAS technology serves to enhance the release profile of hydrocodone to provide consistent 12-hour pain relief relative to existing immediate-release combination formulations.</p>
<p>If approved, ZX002 may represent the first available controlled-release version of hydrocodone and also the first hydrocodone product that is not combined with another analgesic. The Phase 3 clinical development program for ZX002 was initiated in March 2010 and initial top-line data are anticipated in the second half of 2011. Pending positive Phase 3 clinical results, Zogenix expects to submit a new drug application (NDA) for ZX002 with U.S. Food and Drug Administration (FDA) by early 2012.</p>
<p><strong>About Zogenix</strong><br />
Zogenix, Inc. (NASDAQ: ZGNX), with offices in San Diego and Emeryville, California, is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Zogenix’s first commercial product, SUMAVEL® DosePro™ (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix’s lead product candidate, ZX002, is a novel, oral, single-entity controlled-release formulation of hydrocodone currently in Phase 3 clinical trials for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy.</p>
<p>For additional information, please visit <a href="http://www.zogenix.com/">www.zogenix.com</a>.</p>
<p>Forward Looking Statements<br />
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as &#8220;believes,&#8221; &#8220;anticipates,&#8221; &#8220;plans,&#8221; &#8220;expects,&#8221; &#8220;indicates,&#8221; &#8220;will,&#8221; &#8220;intends,&#8221; &#8220;potential,&#8221; &#8220;suggests,&#8221; &#8220;assuming,&#8221; &#8220;designed&#8221; and similar expressions are intended to identify forward-looking statements. These statements are based on the company&#8217;s current beliefs and expectations. These forward-looking statements include statements regarding the timing of results from Study 802, the enrollment and timing of results from Study 801 and the timing of an NDA filing. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in the Zogenix’s business, including, without limitation: the progress and timing of the company&#8217;s clinical trials; the potential that earlier clinical trials may not be predictive of future results; the potential for ZX002 to receive regulatory approval on a timely basis or at all; the potential for adverse safety findings relating to ZX002 to delay or prevent regulatory approval or commercialization, or result in product liability claims; the ability of Zogenix and its licensors to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its products and product candidates; and other risks described in the company&#8217;s filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.</p>
<p>INVESTORS:<br />
Sara Pellegrino | The Ruth Group<br />
646.536.7002 | <a href="mailto:spellegrino@theruthgroup.com" title="spellegrino@theruthgroup.com" target="_blank"> spellegrino@theruthgroup.com</a></p>
<p>MEDIA:<br />
Jason Rando | The Ruth Group<br />
646.536.7025 | <a href="mailto:jrando@theruthgroup.com" title="jrando@theruthgroup.com" target="_blank"> jrando@theruthgroup.com</a></p>
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		<title>Zogenix Announces Pricing of Initial Public Offering</title>
		<link>http://zogenix.com/index.php/news/zogenix-announces-pricing-of-initial-public-offering/</link>
		<comments>http://zogenix.com/index.php/news/zogenix-announces-pricing-of-initial-public-offering/#comments</comments>
		<pubDate>Mon, 22 Nov 2010 22:00:23 +0000</pubDate>
		<dc:creator>zogenix</dc:creator>
		
		<category><![CDATA[news]]></category>

		<guid isPermaLink="false">http://zogenix.com/index.php/news/zogenix-announces-pricing-of-initial-public-offering/</guid>
		<description><![CDATA[SAN DIEGO, Nov 22, 2010 (GlobeNewswire via COMTEX) &#8211;
Zogenix, Inc. (&#8221;Zogenix&#8221;) (Nasdaq:ZGNX) announced today the pricing of its initial public offering of 14,000,000 shares of its common stock at $4.00 per share, before underwriting discounts and commissions. All of the common stock is being offered by Zogenix. In addition, the underwriters have a 30-day option [...]]]></description>
			<content:encoded><![CDATA[<p>SAN DIEGO, Nov 22, 2010 (GlobeNewswire via COMTEX) &#8211;</p>
<p>Zogenix, Inc. (&#8221;Zogenix&#8221;) (Nasdaq:ZGNX) announced today the pricing of its initial public offering of 14,000,000 shares of its common stock at $4.00 per share, before underwriting discounts and commissions. All of the common stock is being offered by Zogenix. In addition, the underwriters have a 30-day option to purchase up to an additional 2,100,000 shares of common stock from Zogenix to cover over-allotments, if any.</p>
<p>Shares of Zogenix&#8217;s common stock will trade on the NASDAQ Global Market under the symbol &#8220;ZGNX.&#8221; The offering is expected to close on November 29, 2010, subject to customary closing conditions.</p>
<p>Wells Fargo Securities, LLC and Leerink Swann LLC are acting as joint book-running managers for the offering, and Oppenheimer &#038; Co. and Stifel Nicolaus Weisel are acting as co-managers for the offering. A registration statement relating to these securities was declared effective by the SEC on November 22, 2010. This offering is being made only by means of a prospectus, copies of which may be obtained from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, or by calling toll-free 800-326-5897 or emailing a request to cmclientsupport@wellsfargo.com and from Leerink Swann LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, or by calling toll-free 800-808-7525 or emailing a request to Syndicate@Leerink.com.</p>
<p>This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.</p>
<p>About Zogenix</p>
<p>Zogenix, Inc. (Nasdaq:ZGNX), with offices in San Diego and Emeryville, Calif., is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Zogenix&#8217;s first commercial product, SUMAVEL(R) DosePro(TM) (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix&#8217;s lead product candidate, ZX002, is a novel, oral, single-entity controlled-release formulation of hydrocodone currently in Phase 3 clinical trials for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy.</p>
<p>For additional information, please visit www.zogenix.com.</p>
<p>This news release was distributed by GlobeNewswire, www.globenewswire.com</p>
<p>SOURCE: Zogenix</p>
<p>CONTACT:  The Ruth Group<br />
INVESTORS:<br />
Sara Pellegrino<br />
646.536.7002<br />
spellegrino@theruthgroup.com<br />
MEDIA:<br />
Jason Rando<br />
646.536.7025<br />
jrando@theruthgroup.com</p>
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		<title>Zogenix Files Registration Statement for Proposed Initial Public Offering</title>
		<link>http://zogenix.com/index.php/news/zogenix-files-registration-statement-for-proposed-initial-public-offering/</link>
		<comments>http://zogenix.com/index.php/news/zogenix-files-registration-statement-for-proposed-initial-public-offering/#comments</comments>
		<pubDate>Tue, 07 Sep 2010 15:38:33 +0000</pubDate>
		<dc:creator>zogenix</dc:creator>
		
		<category><![CDATA[news]]></category>

		<guid isPermaLink="false">http://zogenix.com/index.php/news/zogenix-files-registration-statement-for-proposed-initial-public-offering/</guid>
		<description><![CDATA[SAN DIEGO, Calif., September 7, 2010 — Zogenix, Inc. (“Zogenix”) announced today that it has filed a registration statement with the Securities and Exchange Commission (”SEC”) relating to the proposed initial public offering of shares of its common stock. The number of shares to be offered and the price range for the offering have not [...]]]></description>
			<content:encoded><![CDATA[<p><strong>SAN DIEGO, Calif., September 7, 2010</strong> — Zogenix, Inc. (“Zogenix”) announced today that it has filed a registration statement with the Securities and Exchange Commission (”SEC”) relating to the proposed initial public offering of shares of its common stock. The number of shares to be offered and the price range for the offering have not yet been determined. All shares of the common stock to be sold in the offering will be offered by Zogenix.</p>
<p>Wells Fargo Securities, LLC and Leerink Swann LLC are acting as joint book-running managers for the offering, and Oppenheimer &#038; Co. and Stifel Nicolaus Weisel are acting as co-managers for the offering.  This offering will be made only by means of a prospectus. Once available, copies of the prospectus relating to this offering may be obtained from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, or by calling toll-free 800-326-5897 or emailing a request to equity.syndicate@wellsfargo.com and from Leerink Swann LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, or by calling toll-free 800-808-7525 or emailing a request to <a href="mailto:Syndicate@Leerink.com" title="Syndicate@Leerink.com" target="_blank"> Syndicate@Leerink.com.</a></p>
<p>A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.</p>
<p><strong>About Zogenix</strong><br />
Zogenix, Inc., with offices in Emeryville and San Diego, Calif., is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Zogenix’s first commercial product, Sumavel™ DosePro™ (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix’s lead product candidate, ZX002, is a novel, oral, single-entity controlled-release formulation of hydrocodone currently in Phase 3 clinical trials for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy.</p>
<p># # #</p>
<p>CONTACTS:<br />
Catherine O‘Connor | Zogenix, Inc.<br />
858.436.3374 | <a href="mailto:coconnor@zogenix.com" title="coconnor@zogenix.com" target="_blank"> coconnor@zogenix.com</a></p>
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		<title>Zogenix Secures $35 Million Debt Facility And Raises $15 Million Investment Capital</title>
		<link>http://zogenix.com/index.php/news/zogenix-secures-35-million-debt-facility-and-raises-15-million-investment-capital/</link>
		<comments>http://zogenix.com/index.php/news/zogenix-secures-35-million-debt-facility-and-raises-15-million-investment-capital/#comments</comments>
		<pubDate>Tue, 13 Jul 2010 06:05:06 +0000</pubDate>
		<dc:creator>zogenix</dc:creator>
		
		<category><![CDATA[news]]></category>

		<guid isPermaLink="false">http://zogenix.com/index.php/news/zogenix-secures-35-million-debt-facility-and-raises-15-million-investment-capital/</guid>
		<description><![CDATA[SAN DIEGO, Calif., July 13, 2010 — Zogenix, Inc. (“Zogenix”), a privately held pharmaceutical company, announced that it has secured a $35 million debt facility led by Oxford Finance Corporation which also included Silicon Valley Bank.  The facility consists of a $25 million term loan and a $10 million revolving line of credit.  [...]]]></description>
			<content:encoded><![CDATA[<p><strong>SAN DIEGO, Calif., July 13, 2010</strong> — Zogenix, Inc. (“Zogenix”), a privately held pharmaceutical company, announced that it has secured a $35 million debt facility led by Oxford Finance Corporation which also included Silicon Valley Bank.  The facility consists of a $25 million term loan and a $10 million revolving line of credit.  Concurrently, all existing Zogenix investors, including Clarus Ventures, Domain Associates, Scale Venture Partners, Thomas, McNerney &#038; Partners, Abingworth Management, and Chicago Growth Partners, have provided an additional $15 million investment.</p>
<p>The financing will be used to satisfy working capital needs in the commercial launch of SUMAVEL™ DosePro™ (sumatriptan injection) needle-free delivery system, the company’s first FDA-approved product, and the ongoing Phase 3 clinical development program  of ZX002, a novel oral controlled-release formulation of hydrocodone without acetaminophen for the treatment of chronic pain.  Proceeds will also be used to fully repay the outstanding balance of an existing term loan.</p>
<p>“This funding enhances our financial strength as we continue to focus on the successful launch of our first product, SUMAVEL DosePro,” said Ann Rhoads, chief financial officer at Zogenix.  “The additional support from our investors represents their commitment to the growth of our company and the development of our pipeline.”</p>
<p> “Oxford is pleased to participate in the financing package Zogenix has secured to further the growth of its company,” said Chris Herr, managing director of Oxford Finance Corporation. “Zogenix has a strong management team that is leading their FDA-approved product to commercial success.” </p>
<p>“The financing we are providing Zogenix will offer the flexibility the company needs to continue to meet its strategic objectives,” said Michael White, senior relationship manager, Life Sciences, from Silicon Valley Bank in San Diego. “We are pleased to help Zogenix and many other life science companies in the San Diego market meet their goals.”</p>
<p><strong>About Zogenix</strong><br />
Zogenix, Inc., with offices in Emeryville and San Diego, Calif., is a privately held pharmaceutical company focused on the development and commercialization of medicines to treat neuroscience disorders and pain. The company is commercially focused on SUMAVEL™ DosePro™ (sumatriptan injection) needle-free delivery system, which launched in January 2010, for the acute treatment of migraine and cluster headache. The company’s pipeline includes ZX002, a novel oral controlled-release formulation of hydrocodone without acetaminophen for the treatment of chronic pain, which entered Phase 3 clinical trials in March 2010.  Zogenix also plans to license the patented DosePro needle-free drug delivery system to other companies. For additional information, please visit <a href="http://www.zogenix.com/">www.zogenix.com</a>.</p>
<p><strong>About Oxford Finance Corporation</strong><br />
A subsidiary of Sumitomo Corporation, Oxford is a specialty finance firm providing senior secured loans to public and private life science and healthcare services companies worldwide. For over 20 years, Oxford has delivered flexible financing solutions to its clients, enabling these companies to maximize their equity by leveraging their assets. In recent years, Oxford has originated over $1.5 billion in loans, with lines of credit ranging from $500 thousand to $40 million. Oxford is headquartered in Alexandria, Virginia, with additional offices in California and Massachusetts. For more information visit <a href="http://www.oxfordfinance.com/">www.oxfordfinance.com</a>.</p>
<p><strong>About Silicon Valley Bank</strong><br />
Silicon Valley Bank (SVB) is the premier commercial bank for companies in the technology, life science, venture capital, private equity and premium wine industries. SVB provides a comprehensive suite of financing solutions, treasury management, corporate investment and international banking services to its clients worldwide. Through its focus on specialized markets and extensive knowledge of the people and business issues driving them, Silicon Valley Bank provides a level of service and partnership that measurably impacts its clients’ success. Founded in 1983 and headquartered in Santa Clara, Calif., the company serves clients around the world through 26 US offices and international operations in China, India, Israel and the United Kingdom. Silicon Valley Bank is a member of global financial services firm SVB Financial Group (Nasdaq: SIVB) and a member of the FDIC and the Federal Reserve System. More information on the company can be found at <a href="http://www.svb.com/">www.svb.com</a>.</p>
<p>SUMAVEL and DosePro are trademarks of Zogenix, Inc.</p>
<p># # #</p>
<p><strong>INVESTORS: </strong><br />
Ann Rhoads | Zogenix, Inc.<br />
858.436.8583 | <a href="mailto:ir@zogenix.com" title="ir@zogenix.com" target="_blank"> ir@zogenix.com</a></p>
<p><strong>MEDIA: </strong><br />
Catherine O‘Connor | Zogenix, Inc.<br />
858.436.3374 | <a href="mailto:coconnor@zogenix.com" title="coconnor@zogenix.com" target="_blank"> coconnor@zogenix.com</a></p>
<p>Shelly Davis | Oxford Finance Corporation<br />
888.471.0174| <a href="mailto:sdavis@oxfordfinance.com" title="sdavis@oxfordfinance.com" target="_blank"> sdavis@oxfordfinance.com</a></p>
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		<title>Zogenix Initiates Pivotal Phase 3 Clinical Trial for Novel Formulation of Oral Controlled-Release Hydrocodone</title>
		<link>http://zogenix.com/index.php/news/zogenix-initiates-pivotal-phase-3-clinical-trial-for-novel-formulation-of-oral-controlled-release-hydrocodone/</link>
		<comments>http://zogenix.com/index.php/news/zogenix-initiates-pivotal-phase-3-clinical-trial-for-novel-formulation-of-oral-controlled-release-hydrocodone/#comments</comments>
		<pubDate>Wed, 17 Mar 2010 13:56:15 +0000</pubDate>
		<dc:creator>zogenix</dc:creator>
		
		<category><![CDATA[news]]></category>

		<guid isPermaLink="false">http://zogenix.com/index.php/news/zogenix-initiates-pivotal-phase-3-clinical-trial-for-novel-formulation-of-oral-controlled-release-hydrocodone/</guid>
		<description><![CDATA[SAN DIEGO, Calif., March 17, 2010 — Zogenix, Inc. (“Zogenix”), a privately held pharmaceutical company, announced that it has initiated a pivotal Phase 3 clinical trial with ZX002, a novel, oral, controlled-release formulation of hydrocodone without acetaminophen.  ZX002 is being developed for the treatment of moderate to severe pain in individuals who require around-the-clock [...]]]></description>
			<content:encoded><![CDATA[<p><strong>SAN DIEGO, Calif., March 17, 2010</strong> — Zogenix, Inc. (“Zogenix”), a privately held pharmaceutical company, announced that it has initiated a pivotal Phase 3 clinical trial with ZX002, a novel, oral, controlled-release formulation of hydrocodone without acetaminophen.  ZX002 is being developed for the treatment of moderate to severe pain in individuals who require around-the-clock opioid therapy for the control of pain.  Hydrocodone is the most widely prescribed drug in the United States, but there are currently no products available with hydrocodone only, or with controlled-release formulations.  ZX002, which incorporates Elan’s proprietary SODAS® technology, offers a unique controlled-release profile which utilizes both immediate release and extended release properties designed to enable twice daily dosing. </p>
<p>“We are pleased to be initiating this pivotal Phase 3 trial of ZX002 as the first single-entity, controlled-release hydrocodone formulation,” said Cynthia Robinson, Ph.D., chief development officer of Zogenix.  “We believe this hydrocodone therapy could offer significant benefits to both the patient and the practicing physician by allowing for less frequent dosing with a customized controlled-release profile and the ability to titrate to higher hydrocodone doses than currently recommended for hydrocodone products burdened by combination formulations. Further, we believe ZX002 may offer patients an option for the treatment of their chronic pain that potentially avoids some of the serious side effects that can accompany chronic use of combination opioids that contain acetaminophen, or other non-steroidal anti-inflammatory drugs (NSAIDs).”</p>
<p><strong>ZX002 Phase 3 Clinical Trial Design</strong><br />
This Phase 3 efficacy trial for ZX002 is designed to enroll approximately 600 patients with chronic low back pain. The trial is a US-based multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of ZX002.  For further information regarding this study contact: <a href="http://www.clinicaltrials.gov">www.clinicaltrials.gov </a>and reference NCT01081912.</p>
<p><strong>About Zogenix</strong><br />
Zogenix, Inc., with offices in Emeryville and San Diego, Calif., is a privately held pharmaceutical company focused on the development and commercialization of medicines to treat neuroscience disorders and pain. The company is commercially focused on SUMAVEL™ DosePro™ (sumatriptan injection) needle-free delivery system, which launched in January 2010. The company’s pipeline includes ZX002, a novel oral controlled-release formulation of hydrocodone without acetaminophen for the treatment of chronic pain, which entered Phase 3 clinical trials in March 2010.  Zogenix also plans to license the patented DosePro needle-free drug delivery system to other companies. For additional information, please visit <a href="http://www.zogenix.com">www.zogenix.com</a>.</p>
<p><strong>About Elan Drug Technologies and SODAS® Technology</strong><br />
Elan Drug Technologies (EDT), a leader in drug delivery, is a business unit of Elan Corporation, plc (NYSE:ELN). EDT developed the controlled release formulation of hydrocodone, using one of its Oral Controlled Release Technologies, the SODAS® (Spheroidal Oral Drug Absorption System) technology, which has been accepted by regulatory authorities worldwide including approvals for SODAS-based products in the US for Avinza®, Ritalin LA® and Focalin® XR. A number of other compounds are in late stage development utilizing Elan Drug Technologies SODAS® technology.  Elan Drug Technologies offers clients drug delivery expertise with a suite of commercially launched, proprietary, technology-driven solutions. More information is available at <a href="http://elandrugtechnologies.com">www.elandrugtechnologies.com</a>.</p>
<p>SODAS is a registered trademark of Elan Pharma International Ltd<br />
AVINZA is a registered trademark of King Pharmaceuticals Research and Development, Inc.<br />
FOCALIN and RITALIN LA are registered trademarks of Novartis AG</p>
<p># # #</p>
<p><strong>INVESTORS:</strong><br />
Ann Rhoads | Zogenix, Inc.<br />
858.436.8583 | <a href="mailto:ir@zogenix.com" title="ir@zogenix.com" target="_blank"> ir@zogenix.com</a></p>
<p><strong>MEDIA: </strong><br />
Catherine O‘Connor | Zogenix, Inc.<br />
858.436.3374 | <a href="mailto:coconnor@zogenix.com" title="coconnor@zogenix.com" target="_blank"> coconnor@zogenix.com</a></p>
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		<title>ZOGENIX APPOINTS NEW CHIEF FINANCIAL OFFICER</title>
		<link>http://zogenix.com/index.php/news/zogenix-appoints-new-chief-financial-officer/</link>
		<comments>http://zogenix.com/index.php/news/zogenix-appoints-new-chief-financial-officer/#comments</comments>
		<pubDate>Wed, 03 Mar 2010 21:23:16 +0000</pubDate>
		<dc:creator>zogenix</dc:creator>
		
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		<description><![CDATA[SAN DIEGO, Calif., March 1, 2010 — Zogenix, Inc. (“Zogenix”), a privately held pharmaceutical company, announced the appointment of Ann D. Rhoads to serve as the company’s chief financial officer (CFO).  In addition to overseeing the day-to-day financial operations, Ms. Rhoads will be responsible for the financial strategy of the company as it begins [...]]]></description>
			<content:encoded><![CDATA[<p><strong>SAN DIEGO, Calif., March 1, 2010</strong> — Zogenix, Inc. (“Zogenix”), a privately held pharmaceutical company, announced the appointment of Ann D. Rhoads to serve as the company’s chief financial officer (CFO).  In addition to overseeing the day-to-day financial operations, Ms. Rhoads will be responsible for the financial strategy of the company as it begins to accumulate sales of its first product, SUMAVEL™ DosePro™ (sumatriptan injection) needle-free delivery system, which launched at the beginning of this year.</p>
<p>Ms. Rhoads was previously the chief financial officer and senior vice president for Premier, Inc., a $600 million dollar healthcare service company where she had responsibility for all areas of financial management, strategic planning, business development, information technology, ethics and compliance.  Ms. Rhoads joined Premier in August 1998 as vice president for strategic initiatives responsible for overseeing strategic investments, including a $30 million venture capital fund, as well as assisting Premier operating divisions with long range strategic planning. She was promoted to chief financial officer in 2000.  Prior to joining Premier, Ms. Rhoads held various positions at Sprout Group, a venture capital affiliate of Donaldson, Lufkin &#038; Jenrette (now part of Credit Suisse First Boston), Bain &#038; Company and Merrill Lynch Capital Partners (now known as Stonington Partners).  Ms. Rhoads received a Masters in Business Administration from the Harvard Graduate School of Business Administration and a B.S. from the University of Arkansas.</p>
<p>“Dynamic times call for exceptional leadership talent and a strong team. We are extremely pleased to have attracted Ann to join the Zogenix executive team in this key position.  The depth and breadth of her expertise in healthcare, finance and business strategy will be a significant asset to Zogenix as we continue to expand our development pipeline, execute our commercial strategies and plan our future growth,” said Roger Hawley, chief executive officer of Zogenix. </p>
<p>“This is a great opportunity to bring my experience in strategic planning as well as financial management to a young company with innovative products,” said Ann.  “I am eager to work with the entire team at Zogenix as we expand the string of successes that have taken place since the approval of SUMAVEL DosePro last summer.”</p>
<p><strong>About Zogenix</strong><br />
Zogenix, Inc., with offices in Emeryville and San Diego, Calif., is a privately held pharmaceutical company focused on the development and commercialization of medicines to treat neuroscience disorders and pain. The company&#8217;s initial focus is the commercialization of SUMAVEL DosePro, which launched in January 2010. The company’s pipeline also includes ZX002, a novel oral controlled-release formulation of hydrocodone without acetaminophen for the treatment of chronic pain, preparing to enter Phase 3 clinical trials.  Zogenix also plans to license the patented DosePro needle-free drug delivery system to other companies. For additional information, please visit <a href="http://www.zogenix.com/">www.zogenix.com</a>.</p>
<p>Zogenix™, SUMAVEL™ and DosePro™ are trademarks of Zogenix, Inc.</p>
<p># # #</p>
<p>INVESTORS: <br />  858.436.8583 | ir@zogenix.com </p>
<p>MEDIA:  <br /> Catherine O‘Connor | Zogenix, Inc. <br /> 858.436.3374 | coconnor@zogenix.com </p>
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