September 10, 2015​


Symplmed Launches Goal is Control Challenge to Motivate Patients to Reach and Maintain Blood Pressure Goals​


- Nearly 46 percent of hypertensive patients do not have their blood pressure under control -

-Symplmed launches Goal is Control Challenge in conjunction with NFL opening week, participants can win a trip to the Big Game -

Cincinnati, OH and Bend, OR — September 10, 2015 — Symplmed Pharmaceuticals, manufacturer of Prestalia® (perindopril arginine and amlodipine besylate), today announced the launch of the Goal is Control Challenge to motivate patients living with high blood pressure and reward them for getting their blood pressure under control. Participants earn lottery points for medication compliance, improvements in diet and exercise, and regular home monitoring of their blood pressure. Prize drawings will take place monthly through December. The January drawing will award winners with trips for two to the Big Game in Santa Clara, California on February 7, 2016.

The Goal is Control Challenge is a fun and interactive program that will encourage patients to better manage their high blood pressure, which can help reduce the risk of serious health conditions like heart attack or stroke, said Erik Emerson, President and CEO of Symplmed. Daily management of a chronic disease can be a struggle, and this program provides the tools, support, and incentives patients can use to stay on track and reach their health goals.

Symplmed is working through the NFL to promote the Goal is Control Challenge. Starting on September 10, 2015 and running through January 3, 2016, patients can enroll in the challenge by visiting www.thegoaliscontrol.com. To help drive awareness, Symplmed is advertising in the annual NFL team yearbooks. Winners of the Big Game prize will be announced in January 2016.  

Patients who participate in the Goal is Control Challenge can track their progress online and win monthly health-related rewards such as Apple Watches® and Fitbits®. Participants who choose to receive home delivery of their prescribed blood pressure medication through bpCareConnect,Symplmeds patient support program, will receive a free, one-month supply of their medication. Symplmed is also partnering with Omron Healthcare to provide free home monitors to patients who use bpCareConnect.

It comes down to providing the right tools and educating Americans about taking good care of their number one organ — the heart, said Ranndy Kellogg, CEO of Omron Healthcare, Inc. If we can get more people to start monitoring their blood pressure at home on a consistent basis, we can help save lives.

The Goal is Control message will also be shared with members of the American Heart Associations Check. Change. Control. Leadership Community, of which Symplmed is a member. The leadership community is a resource for organizations, clinics, and other institutions that work to help Americans reduce their risk for heart attack, stroke, and death by improving blood pressure control. According to the American Heart Association, multi-disciplinary community programs like the Goal is Control Challenge are effective in improving blood pressure results among participants.

To learn more about managing high blood pressure and the Goal is Control Challenge, visit www.thegoaliscontrol.com. See Official Rules for details. NO PURCHASE IS NECESSARY TO PARTICIPATE OR WIN. A PURCHASE WILL NOT IMPROVE CHANCES OF WINNING. VOID WHERE PROHIBITED. Must be 18 years of age or older to participate.

About Symplmed

Symplmed Pharmaceuticals is a private pharmaceutical company optimizing the value of its medicines and those of its industry partners by streamlining the prescription process, from fulfillment and payment to therapeutic compliance and outcomes monitoring. The Company’s patented 
technology platform, DyrctAxess™, enables direct delivery of medications to a patient’s home and addresses the problem of unfilled prescriptions. Symplmed is taking a therapeutic area approach, ensuring that medications necessary to manage a particular disease state are available through its DyrctAxess platform. The Company’s initial focus is high blood pressure (hypertension) with a proprietary ACE inhibitor ACEON® (perindopril erbumine) and Prestalia® a single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate. Symplmed also plans to expand its pipeline in multiple therapeutic areas. For more information, visit www.sympltech.com.​

Forward-Looking Statement

All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which Symplmed does business, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.

Media Contacts
Mike Beyer
Sam Brown, Inc.
mikebeyer@sambrown.com
312-961-2502

August 24, 2016


PuraCap brings new Eptex Acne Skincare Products to market through Symplmed and DyrctAxess™ Technology


SOUTH PLAINFIELD, NJ – August 24, 2016 - PuraCap Pharmaceuticals announced today their new — product Eptex®. The Eptex Acne Treatment line is pharmaceutical grade acne treatment utilizing cutting-edge delivery systems and proven ingredients to effectively treat acne for patients with sensitive skin. Eptex is now available for direct ordering through the Physician Direct Order portal. 

The Physician Direct program, powered by Symplmed’s patented DyrctAxess™ technology, provides Physician's a simple and secure method to order PuraCap products online and have them delivered directly to their office.  The new Eptex line is the third product available through our partnership with Symplmed. PuraCap will continue to add products to Symplmed’s DyrctAxess™ technology, as they are introduced.  

“We are pleased to continue growing our partnership with PuraCap and improving physician and patient availability to their array of dermatology products”, said Erik Emerson, CEO of Symplmed. “The physician direct order portal has been extremely well received, and we look forward to expanding on this technology platform to bring new opportunities in patient access.”


About Symplmed Technologies LLC
Symplmed Technologies is a private medical company improving the way manufacturers market, sell and distribute medical products by providing them directly to physicians, patients and care providers. Our patented technology platform, DyrctAxess™, enables direct order and delivery of our partner’s medications, eliminating issues of unfilled prescriptions while having a positive impact on compliance and outcomes. DyrctAxess further advances care by providing patients and doctors shared access to real-time information about medication use and its efficacy to help optimize care. For more information, visit www.symplmed.com.

About PuraCap Pharmaceutical LLC
PuraCap Pharmaceutical LLC is an emerging, fully integrated pharmaceutical company with expertise in product development, manufacturing and distribution, bringing high quality products & services to their customers.  PuraCap’s corporate structure supports a two-pronged approach for global growth in the areas of prescription brands (PuraCap Pharmaceutical LLC) as well as prescription generics and OTC and private label brands (PuraCap Laboratories).  Go to www.puracap.com for more information.

Forward-Looking Statement
All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which Symplmed does business, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.


Media Contact:
Tracy Wilken
wilken@symplmed.com
888-552-9769

January 13, 2014

Symplmed and Next IT Partner to Offer Transformative Virtual Health Assistant Powered by Alme for Healthcare


SPOKANE, Wash. — (BUSINESS WIRE)Next IT, developer of Alme, the world's most trusted virtual assistant platform, today announced a new partnership with Symplmed Pharmaceuticals LLC, a unique pharmaceutical company poised to simplify the prescribing and administration of essential medications through its patent pending technology, DyrctAxess. The two companies plan to launch a virtual health assistant, powered by the advanced Alme for Healthcare platform to empower clinicians and patients to achieve better clinical outcomes.

The new virtual health assistant will build on Symplmed’s already innovative medication access technology by assisting customers in tracking of their treatment plan. Alme for healthcare will support the DyrctAxess data gathering and monitoring technology as well as provide a personalized vehicle for patients to have questions answered 24 hours a day. And, when the need arises, the technology will be able to connect customers directly to the physician or customer service rep.

Symplmed, founded in 2013, is revolutionizing the way essential medications are prescribed and administered, focusing on making the process as efficient and effective as possible for the patient. Patients receive regular shipments of medications directly from the manufacturer, simplifying the experience and lowering costs. Symplmed’s patent pending DyrctAxess technology also connects physicians and patients via the web and mobile access so they can monitor treatment progress together.

“Symplmed is built with a singular focus on improving patient outcomes while minimizing physician and office burden. Through our DyrctAxess technology, we are revolutionizing how pharmaceuticals are commercialized,” said Symplmed CEO Erik Emerson. “Our partnership with Next IT is another step forward as we can now provide patients access to help and answers in a private, personalized, and nonjudgmental manner, 24 hours a day.”

By integrating the Alme for Healthcare-powered virtual health assistant into the DyrctAxess experience, patients and physicians will have the added benefit of Next IT’s industry leading A.I. software.

“Symplmed’s innovative approach to drug distribution and patient follow up is exactly the type of experience we wanted to foster when we launched Alme for Healthcare,” said Next IT CEO and founder Fred Brown. “Virtual health assistants have the power not only to increase patient engagement, but to revolutionize the entire treatment experience, bringing doctors and patients together as equal partners in an effective treatment plan.”

Symplmed and Next IT plan to launch the virtual health assistant to DyrctAxess users in Q3 2014.

About Symplmed

Symplmed is a unique pharmaceutical company aiming to simplify the prescribing and administration of essential medications - with a focus on helping patients consistently achieve treatment goals.

Symplmed’s combination of patent-pending technology and well-established pharmaceutical products integrate point-of-care and post-office-visit follow-up, allowing greater attention on patient, physician and payer benefits.

For more information, please visit 
www.sympltech.com

About Next IT

Founded in 2002, Next IT has been at the forefront of virtual assistant technology for over a decade. Alme, Next IT’s flagship product, is the world’s most trusted virtual assistant platform. Customer experience leaders including Aetna, Alaska Airlines, Amtrak, United Airlines and the U.S. Army all rely on Alme to provide their customers with remarkable experiences every day.

In 2013 Next IT launched Alme for Healthcare, a revolutionary new platform that delivers advanced virtual assistant capabilities to healthcare-specific environments across mobile, web and chat interfaces.

Next IT is proudly based in Spokane, Washington. For more information, please visit: 
www.NextIT.com.

Contacts
Jones-Dilworth, Inc.
Kevin LaHaise, 413-244-8994
kevin@jones-dilworth.com

July 18, 2014


Symplmed Completes Ownership of Perindopril Franchise with Acquisition of ACEON®

Cincinnati, OH – July 18, 2014 – Symplmed announced today that it has acquired U.S. rights to ACEON® (perindopril erbumine tablets), an angiotensin converting enzyme (ACE) inhibitor approved to treat patients with high blood pressure (hypertension) and reduce the risk of heart attack in patients with stable coronary artery disease. This acquisition completes Symplmed’s ownership of the perindopril franchise in the United States.

ACEON is the first marketed product for Symplmed and is available through its proprietary web portal, DyrctAxess™, as part of a comprehensive hypertension-management offering. The Company anticipates adding to its perindopril franchise with FDA approval of its investigational drug Prestalia®, a single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate. If approved, this will be the first FDC of these two important medicines for the treatment of hypertension in the United States.

“The ACEON acquisition is an important milestone for Symplmed as we continue building our commercial presence in the United States," said Erik Emerson, President and CEO of Symplmed. “We look forward to supporting ACEON and its loyal patients while continuing to grow our product portfolio through the perindopril program and industry partnerships.”

About ACEON

ACEON is indicated for the treatment of patients with essential hypertension. ACEON may be used alone or given with other classes of blood pressure-reducing medications. Common adverse events (incidence greater than or equal to 5%) are cough, dizziness and back pain.

ACEON is contraindicated in patients with hereditary or idiopathic angioedema. Rare cases of angioedema, including intestinal angioedema, have been reported. ACEON is also contraindicated in patients known to be hypersensitive (including angioedema) to this product or to any other ACE inhibitor.

ACEON is indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. Common adverse events leading to discontinuation were cough, drug intolerance and hypotension. Rare cases of angioedema, including intestinal angioedema, have been reported. ACEON is contraindicated in patients known to be hypersensitive (including angioedema) to this product or to any other ACE inhibitor.

Important Safety Information for ACEON









About Symplmed

Symplmed Pharmaceuticals is a private pharmaceutical company optimizing the value of its medicines and those of its industry partners by streamlining the prescription process, from fulfillment and payment to therapeutic compliance and outcomes monitoring. The Company’s proprietary technology platform, which powers the DyrctAxess™ web portal, enables direct delivery of medications to a patient’s home and eliminates the problem of unfilled prescriptions. Symplmed is taking a therapeutic area approach with the goal of providing all the medications necessary to manage a particular disease state to its DyrctAxess members. The Company’s initial focus is high blood pressure (hypertension) with a proprietary ACE inhibitor ACEON® (perindopril erbumine tablets) and Prestalia®, a fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate that is currently under review by the FDA. Symplmed also plans to expand its pipeline in six additional therapeutic areas. For more information, visit www.symplmed.com.

Forward-Looking Statement

All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which Symplmed does business, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.

Media Contact:
Mariesa Kemble
Sam Brown, Inc.
mariesakemble@sambrown.com>
608-850-4745

February 24, 2016

Symplmed Pharmaceuticals Announces FDA Orange Book Listing for Two Prestalia Patents


Cincinnati, OH — February 24, 2016 — Symplmed Pharmaceuticals announced today that two patents covering Prestalia® (perindopril arginine and amlodipine besylate) are now listed in the U.S. Food and Drug Administration’s (FDA) publication Approved Drug Products withTherapeutic Equivalence Evaluations, commonly known as the Orange Book. The two Prestalia patents (6696481 and 7846961) offer product exclusivity until 2029.

The Orange Book identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug and Cosmetic Act.

About Prestalia
Prestalia contains perindopril arginine, an ACE inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, and is indicated for the treatment of hypertension to lower blood pressure. Prestalia may be used in patients whose blood pressure is not adequately controlled on monotherapy. Prestalia may be used as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine and the ACE inhibitor class to which perindopril principally belongs. There are no controlled trials demonstrating risk reduction with Prestalia.

Patients with moderate-to-severe hypertension are at a relatively high risk of cardiovascular events (e.g., stroke, heart attack, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. Consider the patient’s baseline blood pressure, target goal, and the incremental likelihood of achieving the goal with a combination product, such as Prestalia, versus a monotherapy product when deciding upon initial therapy. Individual blood pressure goals may vary based on the patient’s risk.

Important Safety Information for Prestalia








Prestalia is contraindicated in patients with hereditary or idiopathic angioedema, with or without previous angiotensin converting enzyme (ACE) inhibitor treatment, and in patients who are hypersensitive to perindopril, to ACE inhibitors, or to amlodipine. Rare cases of angioedema, including intestinal angioedema, have been reported in patients treated with ACE inhibitors. Do not co-administer aliskiren with ACE inhibitors, including Prestalia, in patients with diabetes.

Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of Prestalia, particularly in patients with severe obstructive coronary artery disease. In patients at risk of excessive hypotension, start Prestalia therapy under close medical supervision. Follow patients closely for the first 2 weeks of treatment and whenever the dose of Prestalia is increased or a diuretic is added or its dose increased. Monitor renal function periodically in patients treated with Prestalia. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function.

The most common adverse events associated with Prestalia include peripheral edema, cough, headache, and dizziness.

Please read the Prescribing Information about Prestalia at 
http://www.prestalia-us.com/.

About Symplmed
Symplmed Pharmaceuticals is a privately held pharmaceutical company optimizing the value of its medicines and those of its industry partners by streamlining the prescription process, from fulfillment and payment to therapeutic compliance and outcomes monitoring. The Company’s patented technology platform, DyrctAxess™, enables direct delivery of medications to a patient’s home and addresses the problem of unfilled prescriptions. Symplmed is taking a therapeutic area approach, ensuring that medications necessary to manage a particular disease state are available through its DyrctAxess platform. The Company’s initial focus is high blood pressure (hypertension) with a proprietary ACE inhibitor ACEON® (perindopril erbumine) and Prestalia® a single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate. Symplmed also plans to expand its pipeline in multiple therapeutic areas. For more information, visit www.symplmed.com.

Forward-Looking Statement
All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which Symplmed does business, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.

Media Contact
Mike Beyer
Sam Brown, Inc.
mikebeyer@sambrown.com
312-961-2502

Welcome to the Symplmed Newsroom. In this space, you will find all you need to know about Symplmed. For more information, follow us on Twitter at @symplmed.

NEWSROOM

January 7, 2015

Symplmed brings VAYA Pharma products into DyrctAxess Technology®


Second patient membership program to improve access to medications for individuals living with chronic diseases

Cincinnati, OH — January 7, 2015 — Symplmed Pharmaceuticals announced today that it has entered into an agreement with VAYA Pharma to distribute its medical food products — Vayarin®, Vayacog® and Vayarol® — through VAYA-Direct. The patient membership program, powered by Symplmed’s patented DyrctAxess technology, will provide prescribers and patients with a guaranteed price of $49.50 or less for each of VAYA’s products at the recommended daily dose as prescribed by physicians. VAYA-Direct will also accept insurance plans and provide delivery right to a patient’s home, as well as prompt refills.

“Partnering with VAYA Pharma to improve patient access to medications for chronic diseases through our DyrctAxess platform is validation of our technology and the support patients need to adhere to and fulfill their prescriptions,” said Erik Emerson, President and CEO of Symplmed Pharmaceuticals. “VAYA has an acute understanding of the business opportunities created by managing the prescription fulfillment activity for a patient, which is the fundamental concept of DyrctAxess.”

Symplmed and VAYA conducted a pilot during the second and third quarters of 2014 to evaluate operational implementation and patient acceptance. Upon completion of the pilot, it was clear that a strong patient need existed and that Symplmed’s DyrctAxess platform was fulfilling that need operationally.

“During the brief pilot phase with Symplmed, we learned a great deal about fulfillment habits and other various distribution insights that we can now implement to provide a better solution for both patients and prescribers,” said Yonatan Manor, Chief Operating Officer, VAYA Pharma. “We look forward to working with Symplmed to continue to meet the healthcare needs of patients who rely on medical food for disease management.”

VAYA-Direct is the second program to use the DyrctAxess technology to streamline the prescription process. bpCareConnect, owned by Symplmed, is a patient membership program that caps blood pressure medication costs, provides monitoring devices, offers online tracking tools and ships directly to the patient. Through the secure portal, patients can communicate treatment response data to prescribing physicians between office visits. Additionally, if approved by the U.S. Food and Drug Administration (FDA), Symplmed plans to offer Prestalia® (perindopril/amlodipine) through bpCareConnect.

About Symplmed

Symplmed Pharmaceuticals is a private pharmaceutical company optimizing the value of its medicines and those of its industry partners by streamlining the prescription process, from fulfillment and payment to therapeutic compliance and outcomes monitoring. The Company’s patented technology platform, DyrctAxess, enables direct delivery of medications to a patient’s home and addresses the problem of unfilled prescriptions. Symplmed is taking a therapeutic area approach, ensuring that medications necessary to manage a particular disease state are available through its DyrctAxess platform. The Company’s initial focus is high blood pressure (hypertension) with a proprietaryACE inhibitor ACEON® (perindopril erbumine) and Prestalia®, a single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate that is currently under review by the FDA. Symplmed also plans to expand its pipeline in multiple therapeutic areas. For more information, visit 
www.symplmed.com.

About VAYA Pharma

VAYA Pharma is a specialty pharmaceutical division of Enzymotec Ltd. (Nasdaq: ENZY) dedicated to the discovery, development, manufacture and marketing of innovative proprietary clinically tested lipid-based compositions familiar to the human body for addressing disorders that are impacted by lipid imbalances. VAYA Pharma’s medical food portfolio addresses three therapeutic segments: ADHD (Vayarin®), Early Memory Impairment (Vayacog®) and Hypertriglyceridemia (Vayarol®). Patients can access the benefits of Vayarin via 
www.vayarin.com and clicking on the “order button.” VAYA Pharma products are available in the U.S. only by prescription under the supervision of a physician. VAYA Pharma USA is headquartered in Greenville, South Carolina. For more information, visit www.vayapharma.com.

Forward-Looking Statement

All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which Symplmed does business, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.

Media Contact
Mariesa Kemble
Sam Brown, Inc.
mariesakemble@sambrown.com
608-850-4745

February 10, 2017


PuraCap Introduces Two New Acne Products to its Popular Eptex Intelligent, Physiologic Skin Repair Line Company officials say that the introduction of these new acne products to the Eptex line is a major boost to PuraCap's growing portfolio of dermatology products.

 February 10, 2017 – PISCATAWAY, N.J. – According to Dahai Guo, CEO of PuraCap Pharmaceutical LLC (www.puracap.com), an emerging, fully-integrated pharmaceutical company that brings affordable, world-class quality products to the market, the company recently added two new acne products to its Eptex™ line of intelligent, physiologic skin repair formulations. The products include Eptex Controlled Release Acne Wash and Eptex Controlled Release Acne Relief Lotion.

 “These new Eptex products offer acne treatment utilizing cutting-edge delivery systems and proven ingredients to effectively treat acne in patients suffering from sensitive skin,” explains Guo. “When added to our existing line, which currently includes the popular EpiCeram® Controlled Release Skin Barrier Emulsion, a leading prescription product indicated for atopic dermatitis and related skin conditions, PuraCap’s portfolio of dermatology products continues its steady growth.”

 According to Elise Geiger, Vice President and General Manager of PuraCap's Branded Rx division, both of the new Eptex acne treatment products utilize a controlled release Intelli-Target™ technology that delivers treatment where it's needed and most effective, minimizing the side effects typically associated with acne treatments.

 “Each product also contains MultiSal Neolipids™, which are foundational lipids for skin barrier repair, and are ideal for both teens and adults,” Geiger says. “Eptex is available exclusively throughparticipating healthcare professionals and directly from www.eptexskincare.com.”

 Gao said, “We are proud of PuraCap’s strong, growing portfolio of dermatology products and we are committed to continuing to offer innovative solutions to meet the needs of people with dermatological conditions with our Eptex skin care product line.”

 According to Geiger, these new acne alternatives enable patients to reap the benefits of benchmark treatments while minimizing any potential side effects typically associated with acne treatments.


We look forward to partnering with physicians to provide these intelligent acne products to patients," she said.


About Puracap

 PuraCap Pharmaceutical LLC is an emerging, fully-integrated pharmaceutical company with expertise in product development and manufacturing, bringing affordable, world-class quality products to their customers.  The PuraCap corporate structure supports a two-pronged approach for global growth with dedicated companies in the areas of prescription and OTC private label brands (PuraCap Pharmaceutical) as well as prescription generics (Puracap Laboratories).   PuraCap Pharmaceutical continues to innovate using soft gel expertise and developing other oral solid dosage options. For more information, visit the company’s website at www.puracap.com.


About Symplmed Technologies LLC

Symplmed Technologies is a private medical company improving the way manufacturers market, sell and distribute medical products by providing them directly to physicians, patients and care providers. Our patented technology platform, DyrctAxess™, enables direct order and delivery of our partner’s medications, eliminating issues of unfilled prescriptions while having a positive impact on compliance and outcomes. DyrctAxess further advances care by providing patients and doctors shared access to real-time information about medication use and its efficacy to help optimize care. For more information www.sympltech.com.

January 26, 2015

Symplmed announces FDA approval of Prestalia® for treatment of hypertension


Approval expands unique product offerings available through bpCareConnect

Cincinnati, OH and Bend, OR — January 26, 2015 — Symplmed Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Prestalia® (perindopril arginine and amlodipine) tablets, licensed from Servier (Suresnes, France), for the treatment of hypertension. Prestalia, the first fixed-dose combination of these two medications, may be used in patients whose blood pressure is not adequately controlled on monotherapy. Prestalia may be used as initial therapy if a patient is likely to need multiple drugs to achieve their blood pressure goals.

“This is a significant milestone for Symplmed and for our development partner Servier as it is the first product from our perindopril pipeline to receive FDA approval,” said Erik Emerson, President and CEO of Symplmed Pharmaceuticals. “With ACE inhibitors and calcium channel blockers being two of the most highly prescribed products for the treatment of cardiovascular disease, we are excited to be able to provide physicians and patients these two therapeutic classes in a single pill combination right from the start of the treatment for hypertension.”

“The burden of hypertension remains very high in all countries and the combination therapy is often the only treatment option for many patients,” said Dr. Isabelle Tupinon-Mathieu, Vice President R&D, Head of the Center for Therapeutic Innovation in Cardiology at Servier. “This new combination of perindopril arginine with amlodipine besylate will definitely contribute to help these patients.”

FDA approval of Prestalia was based on data from the 837-patient Phase III PATH trial (Perindopril Amlodipine for the Treatment of Hypertension). The study demonstrated that the fixed-dose combination of perindopril arginine with amlodipine besylate in a single pill was significantly better than either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment. It also suggested that the combination may provide a better benefit/risk ratio than either treatment alone. There are additional clinical studies that demonstrate use of these classes of drugs together may reduce cardiovascular events.

“We now have another great combination of two drugs each with an evidence based outcome history that are combined in a single pill,” said George Bakris, MD, former president of the American Society of Hypertension and principal investigator for the PATH trial.

Symplmed plans to make Prestalia available to physicians and patients within the first quarter of 2015 through its hypertension management program, bpCareConnect. Powered by Symplmed’s DyrctAxess™ technology, bpCareConnect is a patient membership program that caps blood pressure medication costs, provides monitoring devices, offers online tracking tools and ships directly to the patient. To enroll in bpCareConnect,
visit www.bpcareconnect.com.

For more information or to register for updates on availability of Prestalia, visit 
www.prestalia-us.com.

About Prestalia

Prestalia contains perindopril arginine, an angiotensin converting enzyme inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, and is indicated for the treatment of hypertension, to lower blood pressure. Prestalia may be used in patients whose blood pressure is not adequately controlled on monotherapy. Prestalia may be used as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine and the ACE inhibitor class to which perindopril principally belongs. There are no controlled trials demonstrating risk reduction with Prestalia.

Patients with moderate-to-severe hypertension are at a relatively high risk of cardiovascular events (e.g., stroke, heart attack, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. Consider the patient’s baseline blood pressure, target goal and the incremental likelihood of achieving the goal with a combination product, such as Prestalia, versus a monotherapy product when deciding upon initial therapy. Individual blood pressure goals may vary based on the patient’s risk.

Prestalia tablets are contraindicated in patients with hereditary or idiopathic angioedema, with or without previous ACE inhibitor treatment, and in patients who are hypersensitive to perindopril, to any other ACE inhibitor, or to amlodipine. Do not co-administer aliskiren with ACE inhibitors, including Prestalia, in patients with diabetes.

Important Safety Information for Prestalia









About Symplmed

Symplmed Pharmaceuticals is a private pharmaceutical company optimizing the value of its medicines and those of its industry partners by streamlining the prescription process, from fulfillment and payment to therapeutic compliance and outcomes monitoring. The Company’s patented technology platform, DyrctAxess™, enables direct delivery of medications to a patient’s home and addresses the problem of unfilled prescriptions. Symplmed is taking a therapeutic area approach, ensuring that medications necessary to manage a particular disease state are available through its DyrctAxess platform. The Company’s initial focus is high blood pressure (hypertension) with a proprietary 
ACE inhibitor ACEON® (perindopril erbumine) and Prestalia®, a single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate. Symplmed also plans to expand its pipeline in multiple therapeutic areas. For more information, visit www.sympltech.com.

About Servier

Servier is an independent French pharmaceutical research company. Its development is based on the continuous pursuit of innovation in the therapeutic areas of cardiovascular, metabolic, neurologic, psychiatric, bone and joint diseases as well as cancer. With a strong international presence in 146 countries, Servier employs more than 21,400 people worldwide. More information is available at 
www.servier.com.

Forward-Looking Statement

All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which Symplmed does business, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.

Media Contacts
Mariesa Kemble
Sam Brown, Inc.
mariesakemble@sambrown.com
608-850-4745

Servier Communication Department
presse@servier.fr
+33 1 5572 6037

July 9, 2015


Symplmed Launches Prestalia® for Treatment of Hypertension​


- First fixed-dose combination of perindopril arginine and amlodipine besylate available in U.S. -

- Available through bpCareConnect and at pharmacies nationwide -

Cincinnati, OH and Bend, OR — July 9, 2015 — Symplmed Pharmaceuticals today announced that Prestalia® (perindopril arginine and amlodipine besylate) tablets are now available by prescription in the United States. Prestalia is the first fixed-dose combination of an angiotensin converting enzyme (ACE) inhibitor and a calcium channel blocker that is indicated in patients not adequately controlled with monotherapy, and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

“This is the first time these two proven medications are available in a single pill, establishing a simple regimen for the more than three million patients who currently take an ACE inhibitor and a calcium channel blocker to control their blood pressure,” said Erik Emerson, President and CEO of Symplmed. “By making Prestalia available through bpCareConnect, we are also giving physicians the opportunity to provide enhanced support for these patients beyond the exam room by lowering their prescription drug costs, actively monitoring their progress, and receiving treatment feedback in real time.”

Prestalia adds to the drug offerings already available through bpCareConnect and continues to build on the variety of products leveraging Symplmed’s patented DyrctAxess™ technology.

To learn more about bpCareConnect and to enroll,
visit www.bpcareconnect.com.

About Prestalia

Prestalia contains perindopril arginine, an ACE inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, and is indicated for the treatment of hypertension to lower blood pressure. Prestalia may be used in patients whose blood pressure is not adequately controlled on monotherapy. Prestalia may be used as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine and the ACE inhibitor class to which perindopril principally belongs. There are no controlled trials demonstrating risk reduction with Prestalia.

Patients with moderate-to-severe hypertension are at a relatively high risk of cardiovascular events (e.g., stroke, heart attack, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. Consider the patient’s baseline blood pressure, target goal, and the incremental likelihood of achieving the goal with a combination product, such as Prestalia, versus a monotherapy product when deciding upon initial therapy. Individual blood pressure goals may vary based on the patient’s risk.

Important Safety Information for Prestalia









Prestalia is contraindicated in patients with hereditary or idiopathic angioedema, with or without previous angiotensin converting enzyme (ACE) inhibitor treatment, and in patients who are hypersensitive to perindopril, to ACE inhibitors, or to amlodipine. Rare cases of angioedema, including intestinal angioedema, have been reported in patients treated with ACE inhibitors. Do not co-administer aliskiren with ACE inhibitors, including Prestalia, in patients with diabetes.

Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of Prestalia, particularly in patients with severe obstructive coronary artery disease. In patients at risk of excessive hypotension, start Prestalia therapy under close medical supervision. Follow patients closely for the first 2 weeks of treatment and whenever the dose of Prestalia is increased or a diuretic is added or its dose increased. Monitor renal function periodically in patients treated with Prestalia. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function.

The most common adverse events associated with Prestalia include peripheral edema, cough, headache, and dizziness.

Please read Prescribing Information about Prestalia at 
http://www.prestalia-us.com/.

About Symplmed

Symplmed Pharmaceuticals is a private pharmaceutical company optimizing the value of its medicines and those of its industry partners by streamlining the prescription process, from fulfillment and payment to therapeutic compliance and outcomes monitoring. The Company’s patented technology platform, DyrctAxess™, enables direct delivery of medications to a patient’s home and addresses the problem of unfilled prescriptions. Symplmed is taking a therapeutic area approach, ensuring that medications necessary to manage a particular disease state are available through its DyrctAxess platform. The Company’s initial focus is high blood pressure (hypertension) with a proprietaryACE inhibitor ACEON® (perindopril erbumine) and Prestalia®, a single-pill, fixed-dose combination of perindopril arginine and amlodipine besylate, both available through the DyrctAxess hypertension portal, bpCareConnect. Symplmed also plans to expand its pipeline in multiple therapeutic areas. For more information, visit www.symplmed.com.

Forward-Looking Statement

All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which Symplmed does business, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.

Media Contacts
Mike Beyer
Sam Brown, Inc.
mikebeyer@sambrown.com
312-961-2502

​September 27, 2016


​Astavita Brings AstaMed(R) MYO, Prescription Medical Food for Clinical Dietary Management of Sarcopenia, Into Symplmed DyrctAxess Technology(R) - New Patient Membership Program to Improve Access to Medications for Individuals Living With Sarcopenia


​BELLEVUE, WA--(Marketwired - Sep 27, 2016) - AstaMed, a division of Astavita, Inc., and a biotech leader in the development and commercialization of natural astaxanthin prescription medical foods, today announced that it has entered into an agreement with Symplmed Technologies to distribute its medical food product -- AstaMed MYO -- through www.AstaMed-Direct.com. The patient membership program, powered by Symplmed's patented DyrctAxess Technology, will provide patients with a guaranteed price of $60 or less for a 30-day supply of AstaMed MYO at the recommended daily dose as prescribed by physicians. AstaMed-Direct will also accept insurance plans and provide delivery directly to a patient's home and automate reminders and refills. The program with launch October 1, 2016 in parallel with the new effective date of the ICD-10 diagnosis code for sarcopenia -- M62.84.

October 1, 2015​


Symplmed and PuraCap Pharmaceutical LLC partner to distribute new EpiCeram‑L™ Lip Care through DyrctAxess Technology


Cincinnati, OH–October 1, 2015 – Symplmed announced today that it has entered into an agreement with PuraCap® Pharmaceutical LLC to distribute a new product, EpiCeram-L™ Lip Care, through Symplmed’s patented DyrctAxess technology. The program is designed to provide physicians with easy access to PuraCap’s growing portfolio of dermatology products.

From PuraCap Pharmaceutical LLC, the makers of EpiCeram® Controlled Release Skin Barrier Emulsion, comes a unique lip care formulation with an exclusive delivery system developed specifically for severely chapped, dry, or cracked lips. EpiCeram-L Lip Care uses patented MultiSal™ technology to deliver 3 essential lipids – ceramides, free fatty acids and cholesterol in an all-natural, fragrance-free, and color-free formulation. EpiCeram-L Lip Care is available exclusively through prescribing healthcare professionals.

“Partnering with PuraCap to accelerate their product distribution through our DyrctAxess platform is continued validation of our technology,” said Erik Emerson, President and CEO of Symplmed Pharmaceuticals. “PuraCap has a strong, growing portfolio of dermatology products which we’re excited to offer in their own customized execution of DyrctAxess.”

“Symplmed demonstrated a strong understanding and history of success in the execution of direct ordering and fulfillment,” said Elise Klein, Vice President and General Manager of PuraCap’s Branded Rx division. “We look forward to working with Symplmed to continue to meet the needs of our physicians and patients through the introduction of EpiCeram-L Lip Care.”

PuraCap is the third execution of Symplmed’s DyrctAxess technology which is designed to streamline the product fulfillment process.

About Symplmed

Symplmed Pharmaceuticals is a private pharmaceutical company optimizing the value of its medicines and those of its industry partners by streamlining the prescription process, from fulfillment and payment to therapeutic compliance and outcomes monitoring. The Company’s patented technology platform, DyrctAxess™, enables direct delivery of medications to a patient’s home and addresses the problem of unfilled prescriptions. Symplmed is taking a therapeutic area approach, ensuring that medications necessary to manage a particular disease state are available through its DyrctAxess platform. The Company’s initial focus is high blood pressure (hypertension) with a proprietary ACE inhibitor ACEON® (perindopril erbumine) and Prestalia® a single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate. Symplmed also plans to expand its pipeline in multiple therapeutic areas. For more information, visit www.sympltech.com.

About PuraCap Pharmaceutical LLC

PuraCap Pharmaceutical LLC is an emerging, fully integrated pharmaceutical company with expertise in product development, manufacturing, and bringing affordable, world-class quality products to their customers. The PuraCap corporate structure supports a two-pronged approach for global growth with dedicated companies in the areas of prescription brands (PuraCap Pharmaceutical) as well as prescription generics and OTC and private label brands. PuraCap Pharmaceutical continues to innovate using our soft gel expertise and developing other soft gel options. Go to
www.puracap.com for more information.

Forward-Looking Statement

All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which Symplmed does business, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.

Media Contacts
Symplmed
Mike Beyer
Sam Brown, Inc.
mikebeyer@sambrown.com
312-961-2502

PuraCap Pharmaceutical LLC
Elise Klein
Vice President and General Manager
Branded Rx Products
Elise.klein@puracappharma.com
908-941-5456

April 2, 2015

#50Startups: Symplmed, Working to Streamline Healthcare

As featured in BendTECH, Symplmed works to reduce friction for patients and physicians dealing with chronic conditions like hypertension. They create new medicines, tools, and technology to simplify treatments – and deliver the prescriptions and equipment needed directly to manage care more efficiently.

June 17, 2014

FDA Accepts New Drug Application for Symplmed’s Prestalia® for the Treatment of Hypertension


First fixed-dose combination of ACE inhibitor, perindopril arginine, and calcium channel blocker, amlodipine besylate, to be reviewed in the U.S

Symplmed to Streamline Prescription Delivery Process through Proprietary DyrctAxess™


Cincinnati, OH − June 17, 2014 – Symplmed announced today that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for investigational drug Prestalia®, the first single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate for the treatment of hypertension in the U.S. Symplmed filed the application under section 505(b)(2) consistent with FDA’s guidance. The Prescription Drug User Fee Act (PDUFA) goal date for Prestalia is January 21, 2015.

Perindopril is a well-known, long-acting angiotensin-converting enzyme (ACE) inhibitor indicated for hypertension and stable coronary artery disease. Amlodipine, the number one prescribed anti-hypertensive, is a calcium channel blocker indicated for the treatment of hypertension and coronary artery disease. Servier, a leading French private pharmaceutical research company and development partner to Symplmed, currently markets a single-pill combination treatment as Coveram® in 84 countries outside the United States. Prestalia is the first and only single-pill, fixed-dose combination of these two important medicines to be reviewed by the FDA to date.

“Acceptance of our NDA is an important corporate milestone for Symplmed as Prestalia will be our first proprietary product with regulatory exclusivity,” said Erik Emerson, president and CEO of Symplmed. “Phase III data showed that Prestalia provided rapid and sustained blood pressure control in one convenient pill. We look forward to working with the FDA throughout the review process.”

The Prestalia NDA is primarily supported by data from the 837-patient Phase III PATH trial (Perindopril Amlodipine for the Treatment of Hypertension) which demonstrated that the single pill of perindopril arginine combined with amlodipine besylate was significantly better than either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment.

“The clinical outcomes from the Phase III PATH study suggest that Prestalia could offer an effective as well as convenient option for patients,” said George L. Bakris, MD, former president of the American Society of Hypertension and principal investigator for the PATH trial. “The clinical study also indicated that the combination may provide a better benefit/risk ratio than either treatment alone. A single-pill, fixed-dose combination of perindopril arginine and amlodipine besylate would be a welcome addition to our treatment options.”

DyrctAxess: The Next Step in Optimizing Care
If approved, Symplmed would offer Prestalia through its proprietary web portal, DyrctAxess, as part of a comprehensive hypertension-management offering. Symplmed is revolutionizing the process in which life-saving and health-promoting medications are obtained from its own growing pipeline, as well as from industry partners. DyrctAxess unifies all elements of the prescription process including claims adjudication, fulfillment, compliance and outcomes tracking. The portal offers enhanced efficiency, control and information to empower patients, physicians and payers and help achieve optimal care. For more information, visit 
www.bpcareconnect.com.

About Servier

Founded in 1954, Servier is an independent French pharmaceutical research company. Its development is based on the continuous pursuit of innovation in the therapeutic areas of cardiovascular, metabolic, neurologic, psychiatric, bone and joint diseases as well as cancer.

With a strong international presence in 140 countries, Servier employs more than 21,000 people worldwide. For more information, visit
www.servier.com.

About Symplmed

Symplmed is a new pharmaceutical company revolutionizing the delivery of life-saving and health-promoting medications, from its own growing product line and from industry partners, through the company’s proprietary DyrctAxess web portal. Symplmed is launching in high blood pressure (hypertension) with a proprietary ACE inhibitor ACEON® (perindopril erbumine) and a fixed-dose combination (FDC) of perindopril/amlodipine that is currently under review by the FDA. The company also has development plans for DyrctAxess in six additional therapeutic areas. For more information, visit 
www.sympltech.com.

Forward-Looking Statement

All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which Symplmed does business, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.