Archive for the ‘news’ Category

- European Pivotal Trial Confirms Bioequivalence -

SAN DIEGO, CA and Hamburg, Germany - (October 28, 2009): Zogenix, Inc. (“Zogenix”), a privately held pharmaceutical company, and Desitin Pharmaceuticals GmbH (“Desitin”), a privately held, mid-sized German pharmaceutical company, today announced that Desitin has filed for European regulatory approval of SUMAVEL DosePro (sumatriptan injection) needle-free delivery system. The announcement follows successful completion of a European pivotal bioequivalence trial comparing needle-free SUMAVEL DosePro to a traditional needle-based autoinjector, Imigran®-Inject, the European brand of Imitrex STATdose System®. In March 2008, Zogenix and Desitin entered into a license agreement granting exclusive rights in the European Union to Desitin Pharmaceuticals GmbH (“Desitin”) to develop and commercialize SUMAVEL DosePro.

SUMAVEL DosePro was recently approved by the U.S. FDA to treat acute migraine, with or without aura, and cluster headache, and will be launched by Zogenix in the U.S. in January 2010. SUMAVEL DosePro is a first-of-its-kind needle-free delivery system for subcutaneous sumatriptan, a treatment that provides migraine relief within 10 minutes for some patients. In clinical trials, the drug was shown to be absorbed rapidly, resulting in peak plasma concentrations within approximately 12 minutes. This rate of absorption of subcutaneous sumatriptan has been shown to correlate with rapid and complete relief of migraine symptoms, including migraine relief within 10 minutes for some patients and within 30 minutes for almost 50% of patients. Overall safety profiles were comparable for SUMAVEL DosePro and Imitrex STATdose System®.

“This filing demonstrates Desitin’s ability to move this product candidate through development and into the European regulatory approval process,” commented Dr. Martin Zentgraf, Desitin’s General Manager. “Subject to regulatory approval, we look forward to launching it with our CNS-focused sales representatives and partner companies in the major European countries, bringing this important product candidate to the market for the benefit of patients.”

“SUMAVEL DosePro is a unique new product which we believe has broad global appeal,” said Roger Hawley, chief executive officer and director of Zogenix. “With FDA approval and commercial manufacturing in place, Desitin’s achievement of this milestone in Europe with SUMAVEL DosePro will attract the attention of other companies who may be interested in our technology for delivery of their drugs in other therapeutic areas, including biologics.”

About Migraine
Migraine is considered the most common neurological condition in the developed world. It is typically characterized by severe, recurring head pain, usually located on one side of the head and one or more of the following associated symptoms: nausea; vomiting; and increased sensitivity to light, sound and/or smell. Oral and nasal treatment options are available but often do not work quickly enough for patients who experience migraine episodes associated with sudden onset, waking, nausea or vomiting. While needle-based treatment options are associated with faster onset of relief, some patients are deterred from use due to needle-aversion and complicated delivery systems.

About SUMAVEL DosePro
Zogenix plans to launch SUMAVEL DosePro in the US in January 2010, with their US co-promotion partner, Astellas.

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.

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.

IMPORTANT SAFETY INFORMATION
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 sensitivity 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. 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.

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.

MOST COMMON ADVERSE REACTIONS
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.

Please see full prescribing information click here.

About DosePro technology
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 ten 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 volunteers using the DosePro needle-free drug delivery system.

About Zogenix
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’s initial focus is the commercialization of SUMAVEL DosePro. Zogenix submitted a New Drug Application with the U.S. Food and Drug Administration for SUMAVEL DosePro in December 2007, and received FDA approval in July 2009. 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, visit www.zogenix.com.

About Desitin
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 2008/2009 of over $110 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.

Zogenix™, SUMAVEL™ and DosePro™ are trademarks of Zogenix, Inc.

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INVESTOR CONTACTS
Zogenix, Inc.
David Nassif
Chief Financial Officer
858.436.8583
ir@zogenix.com

MEDIA CONTACTS
Zogenix, Inc.
Catherine O‘Connor
Sr. Director, Commercial Communications
858.436.3374
coconnor@zogenix.com

or

Edelman
Jackie Quintanilla
Vice President
323.202.1053
Jacqueline.Quintanilla@edelman.com

LICENSE CONTACTS EUROPE
Desitin Arzneimittel GmbH
Dr. Harald Jainta,
Director Business Development
jainta@desitin.de

- Data Published in Headache Highlights Bioequivalence, Safety and Ease of Use -

SAN DIEGO, CA and DEERFIELD, IL - (October 22, 2009): Zogenix, Inc. (“Zogenix”), a privately held pharmaceutical company, and Astellas Pharma US, Inc. (“Astellas”) announced that positive results from two clinical studies of new SUMAVEL DosePro (sumatriptan injection) needle-free delivery system will be published in the November 2009 issue of Headache. SUMAVEL DosePro, was recently approved by the FDA to treat acute migraine, with or without aura, and cluster headache. SUMAVEL DosePro is a first-of-its-kind needle-free delivery system for subcutaneous sumatriptan, a treatment that provides migraine relief within 10 minutes for some patients.

The first clinical study evaluated the pharmacokinetics, bioequivalence and safety of administering subcutaneous sumatriptan via the new SUMAVEL DosePro needle-free delivery system as compared to a traditional needle-based autoinjector, IMITREX® STATdose®. The study showed that the unique needle-free delivery system offered by SUMAVEL DosePro delivered subcutaneous sumatriptan in a manner bioequivalent to traditional needle-based technology when administered to the thigh and the abdomen, the most common sites of self-injection. The drug was absorbed rapidly, resulting in peak plasma concentrations within approximately 12 minutes. This rate of absorption of subcutaneous sumatriptan has been previously shown to correlate with rapid and complete relief of migraine symptoms, including migraine relief within 10 minutes for some patients and almost 50% of patients within 30 minutes. Overall safety profiles were comparable for SUMAVEL DosePro and IMITREX STATdose.

The second study evaluated the ease-of-use of SUMAVEL DosePro needle-free delivery system in 52 patients who used the drug at home to treat their migraine headaches. Because SUMAVEL DosePro is a first-of-its-kind product, and was designed to be easily self-administered in three simple steps (snap, flip, press), the study assessed whether the patients, using instructions supplied, could correctly use SUMAVEL DosePro during their first use during a migraine episode. An overwhelming majority of patients in the study - 98 percent - successfully used the new needle-free system during a migraine attack on their first attempt. The study also demonstrated a similarly high level of correct use over the remainder of the trial period (3 migraine attacks or 30 days, whichever occurred sooner).

“Until now, relatively fewer patients have benefited from the unique profile of subcutaneous sumatriptan as compared to the many patients who have taken triptan tablets. These data demonstrate that SUMAVEL DosePro is a unique new product which delivers subcutaneous sumatriptan in a way that will make physicians confident their patients will both get the full benefits of the medication and be able use it correctly,” said Roger Hawley, chief executive officer and director of Zogenix. “We believe SUMAVEL DosePro with its simple, needle-free delivery system will open the doors for many more patients to try and experience the benefits of rapid migraine relief from subcutaneous sumatriptan. We are excited to launch SUMAVEL DosePro with our co-promotion partner, Astellas, in January.”

About Migraine
Migraine affects nearly 30 million Americans and is considered the most common neurological condition in the developed world. It is typically characterized by severe, recurring head pain, usually located on one side of the head and one or more of the following associated symptoms: nausea; vomiting; and increased sensitivity to light, sound and/or smell. Oral and nasal treatment options are available but often do not work quickly enough for patients who experience migraine episodes associated with sudden onset, waking, nausea or vomiting. While needle-based treatment options are associated with faster onset of relief, some patients are deterred from use due to needle-aversion and complicated delivery systems.

About Sumavel DosePro
Zogenix and Astellas plan to launch SUMAVEL DosePro in January 2010 in the US.

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.

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.

IMPORTANT SAFETY INFORMATION
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 sensitivity 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. 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.

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.

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.

Please see full prescribing information click here.

About DosePro technology
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 ten 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 volunteers using the DosePro needle-free drug delivery system.

About Zogenix
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’s initial focus is the commercialization of Sumavel DosePro. Zogenix submitted a New Drug Application with the U.S. Food and Drug Administration for Sumavel DosePro in December 2007, and received FDA approval in July 2009. 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, visit www.zogenix.com.

About Astellas
Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. In the US, Astellas markets products in the areas of Immunology, Urology, Anti-Infectives, Cardiovascular and Dermatology. For more information about Astellas Pharma US, Inc., please visit our website at www.us.astellas.com.

Zogenix™, Sumavel™ and DosePro™ are trademarks of Zogenix, Inc.

# # #

INVESTOR CONTACTS
Zogenix, Inc.
David Nassif
Chief Financial Officer
858.436.8583
ir@zogenix.com

MEDIA CONTACTS
Zogenix, Inc.
Catherine O‘Connor
Sr. Director, Commercial Communications
858.436.3374
coconnor@zogenix.com

or

Edelman
Jackie Quintanilla
Vice President
323.202.1053
Jacqueline.Quintanilla@edelman.com

Astellas
Jenny Keeney
Sr. Communications Associate
847-317-5405
Jenny.Keeney@us.astellas.com

SAN DIEGO, Calif., (September 23, 2009): Zogenix, Inc. (“Zogenix”), a privately held pharmaceutical company, announced today that it has completed a $51 million Series B preferred stock financing. Clarus Ventures and Domain Associates, current investors in Zogenix, co-led the round with participation from all existing investors, including Scale Venture Partners, Thomas, McNerney & Partners, and Abingworth Management as well as new investor, Oxford Finance Corporation. The first tranche of $36 million has been closed; the remaining $15 million is callable by the company’s board of directors between December 2009 and February 2010.

The capital will be used to finance the launch of SUMAVEL DosePro (sumatriptan injection) needle-free delivery system, the company’s first product, which recently received FDA approval. Funds will primarily support the production of inventory and building the Zogenix commercial organization of over 105 people. The launch is planned for January 2010 as part of a co-promotion effort with Astellas Pharma US, Inc. which was announced last month.

“Obtaining FDA approval of our first product, validating our DosePro subcutaneous needle-free delivery system, manufacturing SUMAVEL DosePro at commercial scale, and concluding the primary care co-promotion agreement were major milestones we achieved after securing our Series A funding just three years ago,” said Roger Hawley, chief executive officer and director of Zogenix. “Despite the challenging economic and capital markets environment, the strong support from our entire group of venture capital investors validates our accomplishments. The Series B funding will now allow us to bring this unique product to migraine sufferers and establish our US commercial organization.”

About SUMAVEL DosePro
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.

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.

IMPORTANT SAFETY INFORMATION
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 syndromes and in patients with other significant underlying cardiovascular diseases. 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. 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.

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.

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.

Please see full prescribing information click here.

About DosePro technology
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 ten 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.

About Zogenix
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’s initial focus is the commercialization of Sumavel DosePro. Zogenix submitted a New Drug Application with the U.S. Food and Drug Administration for Sumavel DosePro in December 2007, and received FDA approval in July 2009. 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, visit www.zogenix.com.

Zogenix™, Sumavel™ and DosePro™ are trademarks of Zogenix, Inc.

# # #

MEDIA CONTACTS
Zogenix, Inc.
Catherine O‘Connor
Sr. Director, Commercial Communications
858.436.3374
coconnor@zogenix.com

INVESTOR CONTACTS
Zogenix, Inc.
David Nassif
Chief Financial Officer
858.436.8583
ir@zogenix.com

— Novel Product Recently Approved by the FDA
for Treatment of Acute Migraine and Cluster Headache —

SAN DIEGO, CA, and DEERFIELD, IL (August 3, 2009): Zogenix, Inc. (“Zogenix”), a privately held pharmaceutical company and Astellas Pharma US, Inc. (“Astellas”), announced today their exclusive co-promotion agreement for Sumavel DosePro (sumatriptan injection) needle-free delivery system. Sumavel DosePro received FDA approval in July 2009 and is a first-of-its-kind needle-free delivery system for subcutaneous sumatriptan, a treatment that provides migraine relief within 10 minutes for some patients.

“Partnering with Astellas is a significant milestone for Zogenix which will allow us to bring this cutting edge treatment to a broader number of people suffering from migraines,” said Roger Hawley, CEO and director of Zogenix, Inc. “It was essential that we found the right partner for the introduction of our first product, Sumavel DosePro. Astellas will bring significant sales and marketing experience to our promotional efforts and help ensure the successful launch of Sumavel DosePro.”

According to the National Headache Foundation, acute migraines affect nearly 30 million Americans, primarily women between the ages of 25 and 40, who are treated by primary care physicians and neurologists. Tablets are a treatment option for some of these migraine sufferers, but not all patients are satisfied with tablet therapy. Fast-acting, non-oral options are needed particularly for those who experience migraine episodes associated with sudden onset, waking, nausea or vomiting.

“Part of Astellas’ corporate strategy is to continue establishing successful partnerships, so we are especially pleased to bring Sumavel DosePro to market with Zogenix,” said Seigo Kashii, president and CEO of Astellas. “We believe this innovative product will have a broad appeal which complements our current primary care efforts and enriches our local portfolio. We look forward to our collaboration with Zogenix to further meet the needs of patients.”

Sumavel DosePro is expected to be commercially available in January 2010. Under the terms of the agreement, the companies will collaborate on the promotion and marketing of Sumavel DosePro with Zogenix focusing their sales activities primarily on the neurology market while Astellas will focus mostly on primary care physicians. Zogenix will have responsibility for manufacturing and distribution of the product. Product sales will be booked by Zogenix and Astellas will be compensated based on sales performance within their prescriber audience.

About Sumavel DosePro
Sumavel DosePro (sumatriptan injection) needle-free delivery system is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes.

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.

Important Safety Information
Sumavel DosePro is contraindicated in patients with ischemic heart disease or those with symptoms consistent with ischemic heart disease. It should not be administered to patients with cerebrovascular syndromes, peripheral vascular disease or in patients with uncontrolled hypertension. Very rarely, serious cardiac adverse events 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.

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 selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors SNRIs or MAO inhibitors. Sumavel DosePro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The most common adverse events observed in controlled clinical trials with sumatriptan injection were injection site reactions, atypical sensations (such as feelings of tingling, warm/hot sensations), dizziness and flushing. Most side effects lasted for only a short time. In clinical trials comparing the safety and tolerability of Sumavel DosePro to sumatriptan injection, most injection site reactions resolved spontaneously.

For full prescribing information, click here.

About DosePro technology
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 ten 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.

About Zogenix
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’s initial focus is the commercialization of Sumavel DosePro. Zogenix submitted a New Drug Application with the U.S. Food and Drug Administration for Sumavel DosePro in December 2007, and received FDA approval in July 2009. The company’s pipeline also includes ZX002, a novel oral controlled-release formulation of hydrocodone without acetaminophen for the treatment of chronic pain, expected to enter Phase 3 clinical trials in 2009. Zogenix also plans to license the patented DosePro needle-free drug delivery system to other companies. For additional information, visit www.zogenix.com.

About Astellas
Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. In the US, Astellas markets products in the areas of Immunology, Urology, Anti-Infectives, Cardiovascular and Dermatology. For more information about Astellas Pharma US, Inc., please visit our website at www.us.astellas.com.

Zogenix™, Sumavel™ and DosePro™ are trademarks of Zogenix, Inc.
.

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ZOGENIX MEDIA CONTACTS:
Zogenix, Inc.
Catherine O‘Connor
Sr. Director, Commercial Communications
858.436.3374
coconnor@zogenix.com

ZOGENIX INVESTOR CONTACTS:
Zogenix, Inc.
David Nassif
Chief Financial Officer
858.436.8583
ir@zogenix.com

ASTELLAS CONTACTS:
Astellas US LLC
Maribeth Landwehr
Director, Corporate Communications
(847) 317-8988

Astellas US LLC
Jenny Keeney
Sr. Communications Associate
(847) 317-5405

First Product Featuring Novel DosePro Needle-Free Delivery System

SAN DIEGO, Calif., (July 16, 2009): Zogenix, Inc. (“Zogenix”), a privately held pharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Sumavel DosePro (sumatriptan injection) needle-free delivery system to treat acute migraine, with or without aura, and cluster headache. Sumavel DosePro is a first-of-its-kind needle-free delivery system for subcutaneous sumatriptan, a treatment that provides migraine relief within 10 minutes for some patients.

“In my 28 years treating migraine patients, a consistent challenge has been delivering fast relief in a patient acceptable form,” said Roger K. Cady, M.D., director of the Headache Care Center in Springfield, Mo. “Sumavel DosePro will be a welcome treatment option because it combines key benefits – the rapid efficacy of subcutaneous sumatriptan and a simple to use needle-free delivery system.”

Triptans, the most commonly prescribed class of drugs for the treatment of migraine, are a $3.3 billion market in the U.S (Source: Wolters Kluwer Health, Source® Pharmaceutical Audit Suite (PHAST). Based on AWP for U.S. retail prescriptions of drugs in the triptan market, May 2008 —April 2009.) According to the National Headache Foundation, acute migraines affect nearly 30 million Americans. Tablets are a treatment option for some migraine sufferers, but not all patients are satisfied with tablet therapy. Fast-acting, non-oral options are needed particularly for those who experience migraine episodes associated with sudden onset, waking, nausea or vomiting.

The FDA approval of Sumavel DosePro is based on extensive efficacy and safety data from original filings for needle-based sumatriptan injection (IMITREX®), in addition to clinical studies conducted by Zogenix on bioequivalence, usability and safety specific to the Sumavel DosePro combination drug/needle-free delivery system.

“We are pleased to receive approval from the FDA for Sumavel DosePro, our first commercial product. We believe our DosePro technology represents a ground-breaking advancement in the self-administration of subcutaneous medications without a needle,” said Stephen Farr, Ph.D., president, chief operating officer and director of Zogenix. “We fully expect this FDA approval to catalyze DosePro licensing discussions in several other therapeutic areas.”

“During market research sessions with health care providers and migraine patients,‛cool’ was one of the most common responses to Sumavel DosePro – that’s a very unusual description in this industry,” said Roger Hawley, chief executive officer and director of Zogenix. “We believe our novel DosePro delivery system could transform the future of subcutaneous drug delivery of pharmaceuticals. This first approval was made possible by years of dedication and shared entrepreneurial spirit of our Zogenix team, our business partners and our investors.”

Zogenix plans to launch Sumavel DosePro with its own sales force and a co-promotion partner, and will make the product commercially available as soon as possible.

About Sumavel DosePro
Sumavel DosePro (sumatriptan injection) needle-free delivery system is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes.

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.

Important Safety Information
Sumavel DosePro is contraindicated in patients with ischemic heart disease or those with symptoms consistent with ischemic heart disease. It should not be administered to patients with cerebrovascular syndromes, peripheral vascular disease or in patients with uncontrolled hypertension. Very rarely, serious cardiac adverse events 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.

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 selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors SNRIs or MAO inhibitors. Sumavel DosePro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The most common adverse events observed in controlled clinical trials with sumatriptan injection were injection site reactions, atypical sensations (such as feelings of tingling, warm/hot sensations), dizziness and flushing. Most side effects lasted for only a short time. In clinical trials comparing the safety and tolerability of Sumavel DosePro to sumatriptan injection, most injection site reactions resolved spontaneously, with no apparent difference between Sumavel DosePro and sumatriptan needle injection.

For full prescribing information, click here.

About DosePro technology
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 ten 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.

About Zogenix
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’s initial focus is the commercialization of Sumavel DosePro. Zogenix submitted a New Drug Application with the U.S. Food and Drug Administration for Sumavel DosePro in December 2007, and received FDA approval in July 2009. The company’s pipeline also includes ZX002, a novel oral controlled-release formulation of hydrocodone without acetaminophen for the treatment of chronic pain, expected to enter Phase 3 clinical trials in 2009. Zogenix also plans to license the patented DosePro needle-free drug delivery system to other companies.

Zogenix™, Sumavel™ and DosePro™ are trademarks of Zogenix, Inc.
IMITREX® is a registered trademark of GlaxoSmithKline.

MEDIA CONTACTS
Zogenix, Inc.
Catherine O‘Connor
Sr. Director, Commercial Communications
858.436.3374
coconnor@zogenix.com

INVESTOR CONTACTS
Zogenix, Inc.
David Nassif
Chief Financial Officer
858.436.8583
ir@zogenix.com

- Potential Final Approval July 2009 -

SAN DIEGO, Calif. – (February 18, 2009): Zogenix, Inc. (“Zogenix”), a private, specialty pharmaceutical company, announced that the U.S. Food & Drug Administration (FDA) has provided a target date of July 15, 2009 for completion of its review of the NDA for Sumavel DosePro (sumatriptan injection) needle-free delivery system. Zogenix is seeking marketing approval of Sumavel DosePro for the acute treatment of migraine attacks with or without aura, and the acute treatment of cluster headache episodes.

In October, the company received a Complete Response letter from the FDA citing the need for a single additional in vitro test to be conducted. Zogenix recently submitted this information to the FDA. The FDA has accepted this resubmission as a complete response, providing the new Prescription Drug User Fee Act (PDUFA) review date of July 15, 2009.

Sumavel DosePro uses the novel, proprietary DosePro drug delivery system to subcutaneously administer sumatriptan, a medication that has been used to treat migraines effectively and safely for over fifteen years, but without many of the issues associated with needle delivery. Sumavel DosePro has the potential of offering migraine relief beginning in as little as ten minutes, in a system sufferers can self administer in three easy steps. Given the unique attributes of Sumavel DosePro, Zogenix believes it has the potential to be used as a replacement for needle-based injectable forms of sumatriptan, as well as to replace tablet and nasal spray triptans for challenging migraine episodes.

Migraine affects approximately 30 million people in the United States. Patients suffer with extreme pain, nausea, vomiting, and sensitivity to light and sound, making it difficult to undertake work or other activities. Because of this, speed of relief is a key attribute identified by migraine patients when choosing a medication.

“We look forward to working with the FDA to help make this important alternative treatment available to patients who suffer from migraines,” said Roger L. Hawley, Chief Executive Officer of Zogenix. “We are building commercial inventory and our launch plans are in place. It is our intention to launch the product following FDA approval in the second half of 2009.”

About Zogenix
Zogenix, Inc., with offices in Emeryville and San Diego, Calif, is a private, specialty pharmaceutical company with two proprietary product candidates in late-stage development for the treatment of central nervous system disorders and pain. The company’s lead product candidate, Sumavel DosePro, enables needle-free subcutaneous delivery of sumatriptan for the treatment of acute migraine and cluster headache. Zogenix submitted a New Drug Application with the U.S. Food and Drug Administration for Sumavel DosePro in December 2007. The company also plans to license the patented DosePro needle-free drug delivery system to other companies. The company’s second product candidate, ZX002, is a novel, oral controlled release formulation of hydrocodone for the treatment of chronic pain. This product candidate has completed Phase 2 clinical trials and is ready to begin Phase 3. For additional information, visit www.zogenix.com.

Zogenix™, Sumavel™, and DosePro™ are trademarks of Zogenix, Inc.

MEDIA CONTACT:
Zogenix, Inc.
Catherine O‘Connor
858.436.3374
coconnor@zogenix.com

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SAN DIEGO, Calif. - (April 17, 2008): Zogenix, Inc. (”Zogenix”), a private, specialty pharmaceutical company, today announced that Cynthia “Candy” Robinson has joined the company as Chief Development Officer (CDO), and Mark Thompson has joined as Vice President, Sales and Managed Markets.

Before joining Zogenix, Dr. Robinson had served as a consultant to the company. She also served as Senior Vice President, Development Operations at InterMune, from 2004 to 2007. Prior to InterMune, Inc., Dr. Robinson spent fifteen years at Elan Pharmaceuticals, Inc., where, in her culminating position as Vice President, Project Management, she oversaw a portfolio of 14 global development programs from pre-clinical through commercialization, including multiple products in the therapeutic areas of CNS and pain. These efforts resulted in nine U.S. New Drug Applications (NDAs), four European Marketing Authorization Applications (MAAs), and four U.S. product launches. Dr. Robinson holds a B.S. in Chemistry and a Ph.D. in Organic Chemistry from the University of Alabama.

Mr. Thompson brings nearly 30 years of pharmaceutical sales and senior management experience to Zogenix. He previously served as Vice President, Sales at Valeant Pharmaceuticals, Inc., where he led both the hepatology and neuroscience sales teams, as well as the management of sales operations, analytics and training. Prior to Valeant, Mr. Thompson was the Vice President, Sales, at InterMune for two years, and Vice President, Sales, at SkinMedica for two years. He also served as Senior Director, National Sales for Elan Biopharmaceuticals, Inc., Primary Care Division, leading a sales team of approximately 500. Mr. Thompson began his pharmaceutical career at Glaxo, Inc., and over a 21-year career there rose to the level of Regional Vice President, where his responsibilities included sales of Imitrex^® and other CNS products.

“Both Candy and Mark are welcome additions to complete our management team,” said Roger Hawley, Chief Executive Officer of Zogenix. “Candy will immediately focus on driving our clinical development activities for ZX002, which we expect to enter Phase 3 clinical trials in the second half of this year. Mark will play a key role as we build our sales and managed markets organization in preparation for a potential launch of sumatriptan DosePro™ in early 2009, subject to the receipt of FDA approval. We believe their expertise in CNS products, migraine and pain, from both the clinical and commercial perspectives, will further strengthen our strategic and implementation capabilities.”

About Zogenix

Zogenix, Inc., with offices in Emeryville and San Diego, CA, is a private, specialty pharmaceutical company with two proprietary product candidates in late-stage development for the treatment of central nervous system(CNS) disorders and pain. The company’s lead product candidate, sumatriptan DosePro™ (previously Intraject^®), enables needle-free subcutaneous delivery of sumatriptan for the treatment of acute migraine and cluster headache. Zogenix submitted a New Drug Application with the U.S. Food and Drug Administration for sumatriptan DosePro in December 2007, and it was accepted for filing by the FDA in March 2008. Zogenix’s second product candidate, ZX002, is a novel, controlled release formulation of hydrocodone for the treatment of chronic pain. This product candidate has completed Phase 2 clinical trials, and the company anticipates initiating the Phase 3 clinical program in the second half of 2008. The company also plans to license the patented DosePro drug-delivery system to other companies. For additional information, visit www.zogenix.com.

Zogenix, DosePro™ and INTRAJECT^® are trademarks of Zogenix, Inc.
Imitrex^™ is a registered trademark of GlaxoSmithKline.

CONTACT:
Zogenix, Inc.
David Nassif
Chief Financial Officer
858.436.8583

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