Esperion Completes Patient Enrollment in Global Pivotal Phase 3 Program for Bempedoic Acid

  • By Alta Partners
  • 03 Oct, 2017
— Pivotal Phase 3 Top-Line Results for Bempedoic Acid Expected in the Second and Third Quarters of 2018 —
— NDA Submission for LDL-C Lowering Indication for Bempedoic Acid Planned by First Quarter 2019 —

ANN ARBOR, Mich., Oct. 02, 2017 (GLOBE NEWSWIRE) -- Esperion Therapeutics, Inc. (NASDAQ:ESPR), the Lipid Management Company focused on developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today announced the completion of patient enrollment in the global pivotal phase 3 program for bempedoic acid. Top-line results from Studies 1, 3 and 4 are expected in the second quarter of 2018, with top-line results from Study 2 expected in the third quarter of 2018. The pivotal Phase 3 program for the bempedoic acid / ezetimibe combination pill remains on track to initiate this quarter, with top-line results expected by the fourth quarter of 2018. The four Phase 3 studies comprising the global pivotal Phase 3 program for bempedoic acid along with the single Phase 3 bridging study for the combination pill are expected to support two New Drug Application (NDA) submissions for LDL-C lowering indications for the bempedoic acid / ezetimibe combination pill and bempedoic acid by the first quarter of 2019.

"There are approximately 25 million patients living with hypercholesterolemia in the U.S. and Europe who are inadequately treated with current lipid-modifying therapies, including those patients who are unable to tolerate less than the lowest approved daily starting dose of statins or who are unable to access the therapies they need," said Tim Mayleben, president and chief executive officer of Esperion Therapeutics. "The tremendous progress made by our Lipid Management Team to rapidly enroll our global pivotal Phase 3 program for bempedoic acid is a significant step forward as we continue to progress toward the goal of providing these patients and their physicians with once-daily, oral options to lower LDL-C, especially for those whose therapeutic and economic needs are not currently being met, as we approach the most eventful and transformative year yet for Esperion in 2018."

Bempedoic Acid Global Pivotal Phase 3 Program

The ongoing Phase 3 program for bempedoic acid includes four global pivotal studies that enrolled almost 3,600 high cardiovascular disease (CVD) risk patients with hypercholesterolemia and atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH), or who are high risk primary prevention, on optimized background lipid-modifying therapy and with elevated levels of LDL-C. These patients are on two distinct types of background lipid-modifying therapy: 1) patients on their maximally tolerated statin therapy, and 2) patients only able to tolerate less than the lowest approved daily starting dose (e.g., patients considered statin intolerant).

Global Pivotal Phase 3 Study 1:This 52-week long-term safety and tolerability study fully enrolled 2,230 patients with ASCVD and/or HeFH whose LDL-C is not adequately controlled with current lipid-modifying therapies, and who are taking maximally tolerated statin therapy. Top-line results are expected to be announced by the second quarter of 2018.

Global Pivotal Phase 3 Study 2:This 52-week LDL-C lowering efficacy and safety study fully enrolled 779 patients with ASCVD and/or HeFH whose LDL-C is not adequately controlled with current lipid-modifying therapies, and who are taking maximally tolerated statin therapy. Top-line results are expected to be announced by the third quarter of 2018.

Global Pivotal Phase 3 Study 3:This 24-week LDL-C lowering efficacy study fully enrolled 345 high CVD risk patients with ASCVD and/or HeFH, or who are high risk primary prevention, whose LDL-C is not adequately controlled with current lipid-modifying therapies, and who are only able to tolerate less than the lowest approved daily starting dose of a statin and considered statin intolerant. Top-line results are expected to be announced by the second quarter of 2018.

Global Pivotal Phase 3 Study 4:This 12-week LDL-C lowering efficacy study fully enrolled 227 high CVD risk patients with ASCVD and/or HeFH, whose LDL-C is not adequately controlled with current lipid-modifying therapies, including ezetimibe, and who are only able to tolerate the lowest approved daily starting dose of a statin and considered statin intolerant. Top-line results are expected to be announced by the second quarter of 2018.

Bempedoic Acid / Ezetimibe Combination

Through the complementary mechanisms of action of inhibition of cholesterol synthesis (bempedoic acid) and inhibition of cholesterol absorption (ezetimibe), the bempedoic acid / ezetimibe combination pill is our lead, non-statin, orally available, once-daily, LDL-C lowering therapy. Inhibition of ATP Citrate Lyase (ACL) by bempedoic acid reduces cholesterol biosynthesis and lowers LDL-C by up-regulating the LDL receptor. Inhibition of Niemann-Pick C1-Like 1 (NPC1L1) by ezetimibe results in reduced absorption of cholesterol from the gastrointestinal tract, thereby reducing delivery of cholesterol to the liver, which in turn upregulates LDL receptors. Previously completed Phase 2 data demonstrated that this safe and well tolerated combination results in a 48 percent lowering of LDL-C, a 26 percent reduction in high sensitivity C-reactive protein (hsCRP), and may potentially be associated with a lower occurrence of muscle-related side effects.

Bempedoic Acid

With a targeted mechanism of action, bempedoic acid is a first-in-class, complementary, orally available, once-daily ACL inhibitor that reduces cholesterol biosynthesis and lowers LDL-C by up-regulating the LDL receptor, and may potentially be associated with a lower occurrence of muscle-related side effects. Completed Phase 1 and 2 studies conducted in approximately 1,200 patients and over 800 patients treated with bempedoic acid have produced clinically relevant LDL-C lowering results of up to 30 percent as monotherapy and an incremental 20+ percent when added to stable statin therapy.

Esperion's Commitment to Patients with Hypercholesterolemia

In the United States, 78 million people, or more than 20 percent of the population, have elevated LDL-C; an additional 73 million people in Europe and 30 million people in Japan also live with elevated LDL-C. Esperion's mission as the Lipid Management Company is to provide patients and physicians with convenient, complementary, cost-effective, once-daily, oral therapies to significantly reduce elevated levels of LDL-C in patients inadequately treated with current lipid-modifying therapies. It is estimated that 40 million patients in the U.S. are taking statins with approximately 5-20 percent of these patients only able to tolerate less than the lowest approved daily starting dose of their statin and are therefore considered to be statin intolerant. Esperion-discovered and developed, bempedoic acid is a targeted LDL-C lowering therapy in Phase 3 development. The company has two convenient, cost-effective, complementary, orally available, LDL-C lowering therapies in Phase 3 development: 1) a once-daily, oral bempedoic acid / ezetimibe combination pill, and 2) bempedoic acid, a once-daily, oral pill.

The Lipid Management Company

Esperion Therapeutics, Inc. is the Lipid Management Company passionately committed to developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated LDL-C. Through scientific and clinical excellence, and a deep understanding of cholesterol biology, the experienced lipid management team at Esperion is committed to developing new LDL-C lowering therapies that will make a substantial impact on reducing global cardiovascular disease; the leading cause of death around the world. Bempedoic acid and the company's lead product candidate, the bempedoic acid / ezetimibe combination pill, are targeted therapies that have been shown to significantly reduce elevated LDL-C levels in patients with hypercholesterolemia, including patients inadequately treated with current lipid-modifying therapies. For more information, please visit www.esperion.com  and follow us on Twitter at https://twitter.com/EsperionInc .

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic potential of, and clinical development plan for, the bempedoic acid / ezetimibe combination and bempedoic acid, including the Company's timing, designs, plans and announcement of results regarding its Phase 3 program and the Company's cash position and financial outlook. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion's actual results to differ significantly from those projected, including, without limitation, delays or failures in the Company's studies, the U.S. Food and Drug Administration may require additional studies or data, that Esperion may need to change the design of its Phase 3 program, that positive results from a clinical study of the bempedoic acid / ezetimibe combination and bempedoic acid may not necessarily be predictive of the results of future clinical studies, particularly in different or larger patient populations, that existing cash resources may be used more quickly than anticipated, that Esperion's global Phase 3 program for bempedoic acid may not produce positive results, or that other unanticipated developments or data could interfere with the scope of development and commercialization of the bempedoic acid / ezetimibe combination and bempedoic acid, and the other risks detailed in Esperion's filings with the Securities and Exchange Commission. Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

Media Contact:
Elliot Fox
W2O Group
212.257.6724
efox@w2ogroup.com

Investor Contact:
Mindy Lowe
Esperion Therapeutics, Inc.
734.887.3903
mlowe@esperion.com  

By Annie Criner 15 Dec, 2017

SAN CARLOS, Calif., Dec. 13, 2017 (GLOBE NEWSWIRE) -- Allakos Inc., a private, clinical-stage biopharmaceutical company focused on the development of antibodies for the treatment of allergic, inflammatory and proliferative diseases, today announced the successful completion of a $100 million Series B equity financing. The Series B was led by New Enterprise Associates (NEA) and included Redmile Group, Partner Fund Management, Rock Springs Capital, LifeSci Venture Partners, Samsara BioCapital, and a large institutional investor, as well as existing investors Alta Partners, RiverVest Venture Partners, Roche Venture Fund, and 3X5 Partners. Paul Walker, a Partner at NEA, will join the Company’s Board of Directors.

Proceeds from the financing will be used to advance Allakos’s development programs including the Company’s lead clinical candidate, AK002, which is being evaluated in patients with eosinophilic gastritis, indolent systemic mastocytosis (ISM), urticaria and severe allergic conjunctivitis. This investment also will support Allakos’s preclinical programs.

“We are excited to welcome a distinguished group of new investors to Allakos and appreciate the support of our existing investors,” said Robert Alexander, Ph.D., and Chief Executive Officer of Allakos. “The Allakos team is committed to developing antibodies to potentially treat a broad range of conditions for which there are no approved therapies or where treatment options come with undesirable side effects. We have made tremendous progress during 2017 and, with this financing, we look forward to continuing the development of AK002 and our preclinical programs.”

“Allakos’s highly differentiated approach has the potential to deliver first-in-class treatments for serious illnesses affecting both large and rare disease populations,” said Paul Walker. “I welcome the opportunity to work with the experienced leadership team at Allakos as they conduct clinical trials in several important disease indications.”

About Allakos  
Allakos is a privately held clinical-stage company developing antibodies that target immunomodulatory receptors present on the surface of immune effector cells involved in allergic, inflammatory, and proliferative diseases. The Company’s lead antibody, AK002, targets Siglec-8, an inhibitory receptor expressed on the surface of mast cells and eosinophils. AK002 has completed two Phase 1 studies, one in healthy volunteers and a single ascending dose study in patients with ISM. In addition, patients with ISM are currently being treated with AK002 for up to 12 months in a repeat dose study. In these studies, AK002 was well tolerated and demonstrated pharmacological activity on objective measures as well as patient reported symptoms.

For more information, please visit the Company's website at   http://www.allakos.com/

Source: Allakos, Inc.

By Annie Criner 04 Dec, 2017
“Founded in 2013, DispatchHealth is a provider of mobile urgent care. Our goal is to create an integrated, convenient, high touch triage and care delivery solution that extends the capabilities of the patient’s care team and provides definitive, quality care in the home while decreasing costs. Our skilled providers arrive with the tools necessary to provide advanced medical care and are supported by our technological infrastructure to ensure quality and improve outcomes.” Read more...
By Annie Criner 03 Dec, 2017

It may be time to give millennials the nickname, “The Now Generation”, because we seem to have, do, and want it all now. With just your mobile phone, you can get just about anything delivered right to your door, be picked up and dropped off, and source any piece of information your mind wonders about.

The latest convenience app that can save you time is in the healthcare space. When you are sick, the last thing you want to do is get in your car, sit in traffic, and interact with more people than absolutely necessary while you wait in a crowded waiting room.

A New Way To Get Well

DispatchHealth   is a relatively new service that is bringing the health care to your door. “DispatchHealth is an on-demand, in-home, care delivery platform designed to address the healthcare needs of the on-demand consumer, as well as the needs of the consumer that struggles with access to care,” said Mark Prather, CEO of DispatchHealth.

While the service doesn’t cover something as serious as a broken arm, it does cover most common illnesses that would be an expensive use of an emergency room or urgent care.

“Consumers can access the service via an app on their mobile phones, the DispatchHealth website or simply call directly to request medical care,” said Prather. “Using its proprietary risk-stratification technology, patients are screened to make sure it is appropriate to assign a medical team. Once cleared, board-certified, ER-trained professionals are then dispatched to the home, senior care facility or workplace.”

Millennials Want Convenient Health Care

Some busy millennials may find it easier to have a medical professional meet them at their workplace instead of home, because they need to see someone as soon as possible, but can’t afford to stay home for the day.

An important piece about DispatchHealth is that the service is also great for senior citizens who have difficulty getting to the doctor when they are sick. For millennials though, the convenience factor is key.

According to a recent survey by   The Capital Group , millennials consider health insurance to be one of their top three “must have” benefits, signaling the importance of having available and affordable health care when they need it. This priority translates into on demand services for health care too.

“We live in an on-demand culture,” said Prather. “We all want the right care at the right price at the right time. Our service aligns well with millennial expectations and the shift toward consumer-directed healthcare. DispatchHealth's Net Promotor Score (NPS) has never dropped below 90, indicating the high customer satisfaction and loyalty that millennials are known to be so fond of. Far above the healthcare industry average of 30.”

Millennials Can’t Afford An Emergency Room Visit

Another major perk of DispatchHealth when it comes to millennial preference is cost. Millennials know all too well how expensive it is to be an adult, especially with the rising cost of health care.

“The providers have the ability to perform procedures such as laceration repair, rapid infectious disease testing and even deliver IV fluids and medications,” shared Prather. “They also have access to their own on-scene laboratory and mobile imaging. The average cost of an emergency room visit can run $2200, while a DispatchHealth visit can cost approximately a tenth of that.”

Speaking from experience as a millennial parent, I know how expensive an emergency room bill can be when bringing my child in for care. Since most new parents are now millennials, they will be more cost conscious where possible when it comes to health care and this gives them another choice for themselves and their children.

The cost is usually cheaper for this type of in home care, compared to an emergency room. Another area that is a benefit is the comfort factor. Have you ever felt stuffy in a doctor’s office from the smells, sounds, and sights?

“We have had mothers write to tell us how their children had a laceration repaired on the kitchen table and never even cried,” said Prather. “There is just something different about care in the home. The patients are more comfortable and the providers have an insight into the social circumstances of a patient’s life. We believe that this insight gives us a better chance at producing a care plan that truly works for our patients.”

If you are reading this with a stuffed nose, headache, or other common ailment and want to give it a test run, make sure to check their covered cities. They are currently active in Phoenix, AZ, Richmond, VA, Denver, CO, and Colorado Springs, CO.

The good news is that DispatchHealth will be spreading throughout the United States soon, as they have received a $30.8 million Series A investment, which will allow them to expand. Clearly on demand health care is a valuable resource that millennials and others alike will use.

DispatchHealth has begun to disrupt the health care industry, much like other emerging companies have upended the norm in their own niche. Millennials are likely to get behind their mission as they look to craft their lives from convenience and the ability to save money.

See original article here .

By Annie Criner 30 Nov, 2017

Luhan Yang

CO-FOUNDER, EGENESIS

Using Crispr gene-editing technology, EGenesis overcame a major hurdle on the path to animal-to-human organ transplantation, removing 62 viruses that humans are susceptible to from 40 pig embryos.

I’m on a mission to create a world where there are no organ shortages. In the U.S., over 100,000 people are on a waiting list, and only about 20 percent to 30 percent will get one.  

The idea of xenotransplantation, or cross-species transplantation, has been around for decades. In the 1990s, there was a huge failure to overcome the compatibility issues that arise with trying to put a pig organ in a human body. Because of public health concerns, the WHO and USDA shut down all clinical trials, and the field has been silent.

There are two major barriers to xenotransplantation using pigs. One is viruses known as PERVs. PERVs reside in the pig genome and can integrate into the human genome. In 2015 we showed that we could use Crispr gene editing to eradicate 62 PERVs in pig cells. But one of the biggest questions was whether the PERVs played a crucial function in the pig. For the first time, in 2017, we answered the question: They’re dispensable.

It took hundreds of trials to get to a viable, “PERV-inactive” pig. Too many edits to a pig’s cells will stress out the cells, leading them to essentially commit suicide. We created a chemical cocktail to tell the cell, “It’s OK, don’t worry.” The first pig was born in China in March. We’re testing them to see if they have normal physiology and can produce offspring that preserve the genetic modification.

The other barrier is that, even though we know how to remove PERVs, there’s still the possibility that a human host could reject a pig organ. It’s still early days. We’re talking with the FDA about how to test our organs’ compatibility. We’ve just finished raising a $38 million Series A, and while we don’t have a clear path to market, we always keep our goal in mind: to deliver an organ. We’re not doing science for intellectual purposes.

—As told to Caroline Chen

´╗┐Read full article here .

By Alta Partners 28 Nov, 2017
Currently Edward Mallinckrodt Professor and Chair, Department of Pathology & Immunology, Washington University School of Medicine

Appointment Effective January 1, 2018
By Alta Partners 03 Nov, 2017

Trevena, Inc. (NASDAQ:TRVN) today announced that it has recently submitted its New Drug Application (NDA) for OLINVO™ (oliceridine injection) to the U.S. Food and Drug Administration (FDA). OLINVO is the first G protein biased ligand of the mu opioid receptor, a new class of opioid receptor modulator, and the first pain program to receive Breakthrough Therapy designation from the FDA.

The submission includes data showing that intravenous OLINVO demonstrated analgesic efficacy in all three dosing regimens tested in the two Phase 3 APOLLO pivotal efficacy studies. These trials were designed to support an indication for the management of moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted.

The filing also includes safety and tolerability data for over 1,100 patients administered OLINVO across Phase 2 and Phase 3 studies, including the ATHENA open label safety study. Additional pharmacokinetic data, clinical pharmacology data, and results from five randomized controlled trials with head to head comparisons to morphine support potential differentiation of OLINVO.

“OLINVO was designed to fill a major gap in the set of medicines available for managing moderate to severe pain in the hospital,” said Maxine Gowen, Ph.D., chief executive officer. “Despite availability of non-opioid analgesics and advances in multimodal analgesia, tens of millions of patients still require IV opioids following surgery, during severe illness, or after trauma. Millions of these patients remain at risk for opioid-related adverse events, including respiratory depression or postoperative vomiting. We look forward to working with the FDA during the review process and to a potential NDA approval of OLINVO in 2018.”

By Alta Partners 02 Nov, 2017

SAN DIEGO, Nov. 01, 2017 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq:LIFE), a biotherapeutics company engaged in the discovery and development of immunology-based protein therapeutics to treat patients suffering from severe, rare immune-mediated diseases, as well as various cancers, announced that today Sanjay Shukla, M.D., M.S., who joined aTyr Pharma as Chief Medical Officer in March 2016, will succeed John Mendlein, Ph.D., as President and Chief Executive Officer. Dr. Shukla will also join aTyr’s Board of Directors. Dr. Mendlein, who has served as Chief Executive Officer since September 2011 and as a member of the Board of Directors since July 2010, will continue to serve on the Board of Directors of aTyr Pharma.

“This is an excellent time for aTyr as we are well-positioned for future growth with strong leadership to drive forward our shared vision to develop meaningful medicines for patients with rare muscle and lung diseases, as well as to serve cancer patients with products based on our new immuno-oncology platform, ORCA,” said John Mendlein, outgoing-CEO of aTyr Pharma. “After six incredible years as CEO, I am very pleased to pass the leadership torch to Sanjay and continue to advise him as a board member. Having worked extensively with Sanjay, I am confident he will continue to elevate aTyr to greater heights for patients and all stakeholders alike. I would like to express my immense gratitude to all our amazing employees, board, patients, and investors for all that we have accomplished so far at aTyr.”

“We are truly grateful for John’s leadership in guiding aTyr through several key milestones, including bringing the first Physiocrine-based therapeutic into the clinic, building a well-capitalized, NASDAQ-traded company, growing a robust pipeline of three biologic programs and solidifying aTyr’s intellectual property estate for an entire new class of proteins,” said John Clarke, chairman of aTyr Pharma’s board. “We thank John for his leadership and accomplishments at aTyr and wish him well in all his future endeavors. Looking forward, we are excited about this transition and confident that under Sanjay’s leadership, aTyr will continue to grow and successfully deliver upon its important mission.”

Dr. Shukla will continue aTyr’s mission to develop innovative new protein therapeutics based on its knowledge of Physiocrine biology. Dr. Shukla served as aTyr’s Chief Medical Officer since March 2016and has over twenty years of leadership experience in both large pharma and biotech companies. Since joining aTyr, Dr. Shukla led the completion of three Phase 1b/2 Resolaris™ clinical trials and two long-term safety extension studies for the treatment of rare muscular dystrophies and has advanced the iMod.Fc program for the treatment of interstitial lung diseases towards the clinic with a Phase 1 trial expected to commence this quarter.  

“I am excited for the opportunity to lead aTyr at such a productive time for the company,” said Sanjay Shukla, President and CEO of aTyr Pharma. “Our team has made tremendous progress in elucidating the biology and laying the groundwork for the potential therapeutic applications of this groundbreaking new science, under John’s leadership. I am ready to lead our team forward to continue to build on this strong foundation of success. Our mission remains steadfast and during this quarter we intend to bring a second Physiocrine-based therapeutic candidate into the clinic with an iMod.Fc Phase 1 trial and select an antibody to develop as an IND candidate from our ORCA program.”

By Alta Partners 31 Oct, 2017

NEWARK, Calif., Oct. 31, 2017 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ:CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need, today announced the appointment of Sujal Shah as its President and Chief Executive Officer, effective November 1, 2017. Mr. Shah has been serving as the Interim President and Chief Executive Officer since March 2017.

“I am delighted to announce the appointment of Sujal as Chief Executive Officer,” said Robert Wills, Ph.D., Chairman of the Board of Directors. “Sujal has the vision and leadership needed to guide CymaBay through its next stage of growth. During his tenure as CFO, and over the last six months as interim CEO, he has played a key role in strategy, finance and operations at the company, and I believe he is uniquely qualified to lead CymaBay.”

“I am honored to be named Chief Executive Officer and to have the opportunity to lead such a talented team as the company enters one of the most important periods in its history,” said Sujal Shah, President and Chief Executive Officer of CymaBay. “Our lead candidate seladelpar has the potential to significantly advance the treatment of patients with primary biliary cholangitis, or PBC, and nonalcoholic steatohepatitis, or NASH.  Just last week, positive interim results from a phase 2 study in PBC were presented as an oral, late-breaking presentation at the Liver Meeting® 2017. Our goals for 2018 are to initiate a phase 3 study in PBC as well as a phase 2 study in NASH. All of us here at CymaBay are focused on improving the lives of patients with liver disease, and I feel fortunate to be part of that effort.”

Sujal Shah joined CymaBay as Chief Financial Officer in December of 2013. Prior to that he served as a consultant and acting Chief Financial Officer since June 2012. From 2010 to 2012, Mr. Shah served as Director, Health Care Investment Banking Group for Citigroup, where he was responsible for managing client relationships and executing strategic and financing related transactions for clients focused in life sciences. From 2004 to 2010, Mr. Shah was employed with Credit-Suisse, last serving as Vice President, Health Care Investment Banking Group. Mr. Shah received a MBA from Carnegie Mellon University Tepper School of Business and B.S. and M.S. degrees in biomedical engineering from Northwestern University. Mr. Shah currently serves on the Executive Advisory Board of the Chemistry of Life Processes Institute at Northwestern University.

By Alta Partners 31 Oct, 2017

IRVINE, Calif.--(BUSINESS WIRE)-- Aerie Pharmaceuticals, Inc. (NASDAQ: AERI ), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of glaucoma and other diseases of the eye, today announced the appointment of John Maltman, Ph.D., as Vice President of Medical Affairs, reporting to Theresa Heah, M.D., M.B.A., Aerie's Vice President of Clinical Research and Medical Affairs. Dr. Maltman will be responsible for leading the strategic efforts of Aerie's Medical Affairs Department across a broad spectrum of product-related activities. He previously held several related positions at Allergan, Inc.

In connection with his acceptance of the position as Vice President of Medical Affairs, Dr. Maltman will receive awards totaling 46,500 stock options and 4,000 shares of restricted stock. The stock options will vest over 4 years, with 25% vesting on the first anniversary of the hire date and the remainder vesting ratably on each of the subsequent 36 monthly anniversaries of the hire date; the restricted stock will vest over a period of 4 years in four equal annual installments on each anniversary of the hire date. This award was made outside of Aerie's stockholder-approved equity incentive plan and was approved by the Company's independent directors as an inducement material to Dr. Maltman entering into employment with the Company in reliance on NASDAQ Listing Rule 5635(c)(4), which requires this public announcement.

By Alta Partners 27 Oct, 2017

Prolacta Bioscience, the pioneer in human milk-based neonatal nutritional products for premature infants, will participate in the 2017 Infant Health Policy Summit , hosted by the National Coalition for Infant Health  and the Institute for Patient Access , on Oct. 26, 2017, in Washington, D.C.
 

The Summit, titled “Diversity & Disparity: Breaking Down Access Barriers,” provides a collaborative platform for health care providers, patient advocates, parents and policymakers to discuss patient access issues facing vulnerable premature infants and their families. The panel on “Milk Matters: Diversity, Quality & Safety,” will include:
 

  • Dr. Mitchell Goldstein, Medical Director of the National Coalition for Infant Health, practicing neonatologist and Professor of Pediatrics at Loma Linda University;
  • Dr. Martha Dawson, Historian and Chair of the National Black Nurses Association Finance Committee and Assistant Professor and Coordinator of Nursing at the University of Alabama at Birmingham School of Nursing; and
  • Scott Eaker, Vice President of Quality and Regulatory Affairs at Prolacta Bioscience.


“The National Coalition for Infant Health’s agenda is to make exclusive human milk the standard of care for all infants, and especially those born weighing less than 1,500 grams (3 pounds 5 ounces),” Goldstein said. “We are simultaneously raising awareness on this issue and working to ensure access to an exclusive human milk diet for low-income families through Medicaid reimbursement.”
 

“Prolacta is proud to support the 2017 Infant Health Policy Summit, as we share a mutual commitment to making an exclusive human milk diet accessible to all vulnerable premature infants in the NICU,” Eaker said.
 

Now in its third year, the Policy Summit also explores issues related to maternal nutrition; nutritional practices in the neonatal intensive care unit (NICU), including infant tube feeding safety; respiratory health; and the potential risk of Hepatitis C transmission. The annual event draws attendees including individual health care providers, congressional leaders and staff, representatives from national nursing and physician organizations and national and regional preemie parent organizations.

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