© 2017 Evestra, Inc.

2017

 

January, 24

Evestra Onkologia Sp. Awarded R&D Grant - $4.6 million supports endometriosis drug development

SAN ANTONIO – Evestra, Inc.’s wholly-owned Polish subsidiary, Evestra Onkologia Sp., has received a major research and development grant. The $4.6 million project, co-financed by the European Union Regional Development Fund, will support development of a drug – EC313 – designed to treat endometriosis.

Evestra is a San Antonio-based biopharmaceutical research and development company. Evestra Onkologia Sp. z o.o. is a Poland-based research and development company dedicated to oncology therapeutics.

Dr. Maciej Wierzbicki and an experienced R&D team in Lodz, Poland are spearheading Evestra Onkologia Sp. and the development of EC313. They will collaborate with Polish and international experts and opinion leaders.

“We are grateful to the Polish National Centre For Research and Development for awarding Evestra Onkologia this prestigious grant, and recognizing the innovative approach taken by Evestra to generate EC313 as a promising drug to treat endometriosis,” said Evestra President and CEO, Dr. Ze’ev Shaked. “This grant validates the strategic approach we have taken to drug development since we launched Evestra in 2008.” 

“EC313 was designed through intensive efforts in structure-activity relationships (SAR), which has led to a new generation of selective progesterone receptor modulator (SPRM) compounds and so-called mesoprogestins,” said Evestra’s Chief Scientific Officer, Dr. Klaus Nickisch. “These mesoprogestins have an optimal tailor-made ratio of agonistic to antagonistic activity, which is required for a particular gynecological treatment.”

EC313 has demonstrated significant superiority over other SPRMs, Shaked said. Evestra completed the discovery work on EC313 and holds an international patent covering EC313 and other new chemical entities (NCE). 

Endometriosis is a common gynecological condition affecting an estimated 10 percent of women of childbearing age. According to the Centers for Disease Control and Prevention, endometriosis is a condition that exist when the kind of tissue that normally lines the uterus grows somewhere else such as on the ovaries, behind the uterus, on the bowels, or on the bladder. This "misplaced" tissue can cause pain, infertility and other problems.

March, 1

Glenmark Pharmaceuticals Inc., USA, and Evestra, Inc. have completed a strategic development, license and commercialization agreement

Mahwah, NJ; March 1, 2017 – Glenmark Pharmaceuticals Inc., USA, and Evestra, Inc. have completed a strategic development, license and commercialization agreement to develop and market a generic version of Merck’s & Co.’s NuvaRing® product – an etonogestrel/ethinyl estradiol vaginal ring – designed to allow women access to a more affordable birth control option.

Development on the vaginal ring product is currently under way and the two companies expect to file an Abbreviated New Drug Application (ANDA) in fiscal 2019. 

Evestra will develop this product exclusively for Glenmark for the U.S. market, and will receive certain milestone payments during various stages of the product’s development, including royalties on net sales.

“This is an important U.S.-based strategic partnership for Evestra,” said President and CEO Ze’ev Shaked. “By aligning our efforts, we expect to make great strides in improving women’s healthcare and access to options that are significantly more accessible due to their lower costs. We are excited to work with Glenmark.” 

Glenmark has secured exclusive marketing and distribution rights for the product, including an option to commercialize two additional Evestra vaginal ring products, for the U.S. market. 

“Bringing high-quality and affordable options to market has been a core commitment for Glenmark since the beginning,” said Robert Matsuk, President – North America and Global API, Glenmark Pharmaceuticals Ltd. “The partnership with Evestra underscores that focus, and expands our portfolio into a leading non-daily contraceptive option prescribed to millions of women in the U.S.”

Merck’s IMS Health NuvaRing® registered sales of $768 million in 2016 in the U.S. market. NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy.

About Glenmark Pharmaceuticals 

Glenmark Pharmaceuticals is a research-driven, global integrated pharmaceutical company with operations in more than 80 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development primarily focused in the areas of oncology, respiratory disease, and dermatology. Glenmark has improved the lives of millions of patients by offering safe, affordable medications for nearly 40 years. For more information visit www.glenmarkpharma.com.

About Evestra

Evestra, Inc. is an emerging San Antonio-based biopharmaceutical research and development company with a therapeutic focus in women’s healthcare. Evestra’s competitive advantage is based on its founders' extensive experience in pharmaceutical R&D, combined with a proven track record in commercializing women’s healthcare.

April, 6

Evestra, Inc. Signs Agreement With Gedeon Richter Plc

SAN ANTONIO – Evestra, Inc., today announced it has signed a collaboration partnership agreement with Hungarian company Gedeon Richter Plc. Under terms of the agreement, Evestra will perform certain research and development activities on a female urological product in exchange for licensing the commercialization rights for certain territories outside the U.S. to Gedeon Richter Plc. 

The deal consists of upfront payments for research and early development funding, as well as clinical development, regulatory and sales performance milestones, and royalty payments on net sales.

www.richter.hu

May, 15

Evestra to locate corporate office, new pharma   manufacturing facility in Schertz, Texas

SCHERTZ, Texas – Evestra, Inc., a biopharmaceutical research and development company, will move all its headquarters and manufacturing to Schertz, Texas beginning later this year, the company’s CEO said today. The company will receive a $200,000 incentive grant from the City of Schertz Economic Development Corp. to make the move and has retained an engineering firm to begin work on the facility, an existing, 12,900-square-foot building at 6410 Tri-County Parkway.

Evestra, launched nine years ago, is rapidly becoming a player in the global pharmaceutical industry. The company recently began a new collaboration agreement with Hungarian company Gedeon Richter Plc., the third project agreement between the two companies. Evestra also has an R&D agreement in place with India-based Glenmark Pharmaceuticals. In January, Evestra’s Polish subsidiary received a major European R&D grant for development of an endometriosis drug.

“We’re excited to be relocating our headquarters office to Schertz and to build our clinical and commercial manufacturing operation there,” said Evestra President and CEO, Dr. Ze’ev Shaked. “Over the next two years we will gradually establish Evestra’s presence in Schertz and join the city’s robust manufacturing community.  We believe this move will be great for Schertz and for our company.”

The Schertz Economic Development Corporation’s (SEDC) support for Evestra is part of a strategic effort to attract growing small businesses and to provide a long-term stability to the city’s tax base, said Kyle Kinateder, Executive Director of the SEDC. “Evestra is a great fit for our city because they build upon our local manufacturing base and introduce research and development operations into our city,” he said. 

Evestra’s phased move from southwestern Bexar County to Schertz will begin with the move of headquarters offices and the build-out of the manufacturing facility, including a quality control laboratory.  R&D is also expected to gradually move to the new location.  Brandt Engineering’s Schertz office is providing engineering, technical services and construction for the project. 

“Having Evestra joining our family of commercial enterprises marks a significant milestone in the history of our city,” said Schertz Mayor Michael Carpenter. “Perhaps most importantly, after the obvious economic benefit, is the clear cultural fit between the two organizations.  Like all businesses in Schertz, Evestra is our partner, neighbor, and friend.” 

About Evestra

Evestra, Inc. is a biopharmaceutical research and development company with a therapeutic focus in women’s healthcare. Evestra’s competitive advantage is based on its founders' experience in pharmaceutical R&D of steroidal drugs, combined with a proven track record in drug development and commercializing women’s healthcare products. For more information about Evestra, visit http://www.evestra.com/. 

About the Schertz Economic Development Corporation

The Schertz Economic Development Corporation is the local Type 4B corporation responsible for attracting new investment and businesses, promoting the expansion of existing industry and businesses, and creating new and improved employment in the City of Schertz. Schertz, Texas, has a current population of more than 38,000. Schertz is strategically located along Interstates 35 and 10 in the San Antonio-Austin Corridor, one of the nation’s fastest growing regions. Visit www.SchertzEDC.com for more information