Directive Ranks #1 in Clutch’s Top B2B Marketing Service Providers

Directive Consulting | March 06, 2019

Directive, the leading B2B and enterprise search marketing agency, has recently been honored as the number one B2B marketing and advertising service provider in Los Angeles, according to Clutch. Clutch is a B2B research, ratings and reviews site that identifies leading IT and marketing service providers and software. Recently, Clutch has announced over 260 B2B companies that embody industry leadership in Los Angeles based on their market presence, respective expertise, verified client feedback, and their past and current clientele. Directive was awarded the leading spot on the advertising and marketing list. “We are thrilled for this opportunity to be recognized as the go-to service provider for B2B marketing,” said CEO and Co-founder Garrett Mehrguth. “This is a testament to our team’s dedication and unwavering focus on excellence and to deliver premier services to our clients.” Since its establishment in 2014, Mehrguth has led Directive in its expansion of five global offices including Orange County, California; Austin, Texas; Los Angeles; New York City; and London. Directive has increased by a year-over-year growth rate of 300 percent, and now is celebrating as the number one B2B marketing and advertising service provider in Los Angeles.

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Oramed Completes Patient Enrollment in Phase 2 Oral Insulin NASH Trial

Oramed Pharmaceuticals Inc. | March 17, 2022

Oramed Pharmaceuticals Inc. a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced it has completed enrollment of all patients in a Phase 2 trial of its oral insulin capsule ORMD-0801 for the treatment of non-alcoholic steatohepatitis. An estimated 1.5% to 6.5% of adults in the U.S., or between 4 million and 17 million people, have NASH and about half of these also have diabetes, according to the National Institute of Diabetes and Digestive and Kidney Diseases. The double-blind, multi-center trial with clinical sites in the U.S. and Israel is assessing the safety and potential efficacy of ORMD-0801 in Type 2 diabetes patients with NASH. Efficacy endpoints including safety and percentage change in liver fat content, liver fibrosis, and liver steatosis from baseline are measured via MRI-PDFF following 12 weeks of dosing. "There is currently no drug approved to treat this disease, leaving NASH with a serious unmet medical need. With direct action on the liver, we believe that ORMD-0801 has the potential to address over 50% of people with diabetes who also suffer from NASH, a population with unfortunately increased mortality. We look forward to analyzing and reporting topline data, which we expect will confirm our prior pilot study's efficacy and safety results," Oramed Chief Executive Officer, Nadav Kidron The global market for drugs to treat NASH is expected to reach $84 billion by 2029, according to a publication by Research and Markets on the Global Non-Alcoholic Steatohepatitis (NASH) Drugs Market. About NASH Non-alcoholic steatohepatitis is a serious, progressive liver disease caused by a buildup of fat in the liver and accompanied by inflammation, liver cell damage, and in some cases, scarring of the liver. Over time, NASH may progress to cirrhosis, liver cancer, liver failure, and even death. Currently, no pharmacotherapy is globally approved for the treatment of NASH, and people with NASH are left with very few treatment options. About Oramed Pharmaceuticals Oramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which is being evaluated in two pivotal Phase 3 trials and has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. In addition, Oramed is developing an oral GLP-1.

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Breckenridge Signs New-Product Agreement with PTS Pharma

Breckenridge Pharmaceutical, Inc. | April 23, 2022

Breckenridge Pharmaceutical, Inc. announces today that it has signed a new-product agreement with PTS Pharma, LLC. under which PTS will support a technology transfer to Towa Pharmaceutical Europe, S.L. of a complex "For Suspension" product developed by PTS. The remainder of development and commercialization will be performed at the Towa facility. According to industry sales data, the product and its generics had annual sales of approximately $75 million during the twelve months ending February 2022. The companies are actively negotiating and look forward to collaborating on additional complex formulations under the same business model. About Breckenridge Breckenridge Pharmaceutical, Inc., a subsidiary of Towa Pharmaceutical, partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients. With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we improve the health and quality of life of the patients we and our customers serve. About PTS Pharma, LLC PTS Consulting, LLC and PTS Pharma LLC., is a formulation development, clinical trial production, regulatory services and analytical control laboratory based in Kansas. PTS Consulting is actively involved in regulatory consulting services. PTS Pharma operations include the capability and expertise to develop complex formulations of tablets, capsules, granules, modified dosage forms, topical dosage forms, suppositories, film products, solution, and suspension formulations and sterile injectables, with involvement in multiple aNDA and NDA filings over the years. The activities are housed in dedicated GMP suites in the facility in Kansas City, USA. PTS Pharma is also involved in active raw material clinical production by fermentation technology processes. The firm was founded in 2003 by Paul Sudhakar, an industry veteran who is the Owner, President, and CEO of the firm.

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ClinChoice Raises $150 mm Series E Round Financing, Further Strengthening its Global Services Capabilities

ClinChoice | July 05, 2022

Recently, ClinChoice announced the successful completion of its $150 mm Series E round financing. The investment was led by Legend Capital, and co-invested by Taikang Life Insurance, Sherpa Healthcare Partners and existing shareholders, including Lilly Asia Ventures and Apricot Capital. Proceeds of the financing will be used to fund the Company's continued business expansion and innovative service offering worldwide. Recently, ClinChoice announced the successful completion of its $150 mm Series E round financing. The investment was led by Legend Capital, and co-invested by Taikang Life Insurance, Sherpa Healthcare Partners and existing shareholders, including Lilly Asia Ventures and Apricot Capital. Proceeds of the financing will be used to fund the Company's continued business expansion and innovative service offering worldwide. As a full service clinical-stage CRO, ClinChoice serves the global market by providing integrated one-stop clinical development services to emerging biopharmaceutical, medical device and consumer health clients around the world. ClinChoice has over 3000 employees worldwide covering most of drug development hotbeds in US, China, multiple countries in Europe and Southeast Asia. With over 25 years of high-quality services, ClinChoice has completed more than 1,000 Phase I-IV full-service clinical projects and supported over 100 innovative drug registrations, clinical design and development. ClinChoice strictly adheres to GCP and ICH standards and has developed robust SOPs recognized by more than 50 large multinational companies, all of which have passed multiple inspections and audits by major regulatory agencies around the world. "We thank the investors for their trust in ClinChoice. This round of capital investment fully validates ClinChoice's rapid growth and future potential in the field of clinical CRO. With the new round of financing, we will further enhance our innovative service offering and continue business expansion by organic growth and M&A, in order to better serve our clients worldwide." Global Chairman and CEO of ClinChoice, Mr. Ling ZHEN Dr. Hongbin ZHOU, Co-Chief Investment Officer of Legend Capital, said, "We would like to express our gratitude for trusting in Legend Capital and we are excited to be part of ClinChoice, together with the Management Team and the existing shareholders, including Lilly Asia Ventures, Goldman Sachs. We are very positive on the growth outlook of the CRO industry. As a rapidly growing CRO, ClinChoice has built an excellent platform combining global expertise with deep knowhow across key local markets, to support innovation. Going forward, we will work closely with the management team to improve its existing business, attract industry talent and launch new strategic initiatives." About ClinChoice ClinChoice is a global clinical CRO, providing high-quality Integrated One-stop Service Offerings for new bio-pharmaceutical and medical device clients worldwide. Our Service Offerings cover Clinical Operation, Project Management, Biostatistics, Data Management, Biostatistical Programming, Regulatory Affairs, Medical Affairs, Feasibility Research, HGRAC Submission, Clinical Safety Management, Site Management Organization, Nature Medicine/Traditional Chinese Medicine and Phase I Clinical Research, etc. Now, ClinChoice has over 3,000 employees worldwide covering most of drug development hotbeds in US, China, multiple countries in Europe and Southeast Asia. Since its inception, ClinChoice has completed multiple rounds of financing, with investments from renowned institutional investors including Goldman Sachs, Lilly Asia Ventures, and DFJ Dragon Fund. About Legend Capital In April 2001, Legend Capital was established as a fund manager under Legend Holdings, focusing on the early-stage VC and growth-stage PE investment. Since its establishment, Legend Capital has been adhereing to internationally accepted standards to create best practices in fund management and operation. With a proven track record of more than 20 years, it now has full experience in fund management and operation and has built an extensive partner ecosystem across the entire investment chain.

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Iktos Announces Collaboration With Galapagos in AI For Drug Design

Iktos, | June 29, 2022

Iktos, a company specialized in Artificial Intelligence for new drug design, announced a collaboration with Galapagos, a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines, to apply Iktos’s generative modelling artificial intelligence (AI) technology in one of Galapagos drug discovery programs. Under the agreement, Iktos will apply its de novo ligand and structure-based generative modelling technologies and software Makya™, its AI-based retrosynthesis analysis and planning tool Spaya™, and its know-how in computational drug design to expedite the identification of potential pre-clinical candidates and to identify additional novel chemical matter with suitable properties. Galapagos scientists will benefit from direct access to Makya™ and Spaya™ as part of the collaboration. Iktos’s AI technology, based on deep generative models, helps to bring new insights and directions into the drug discovery process based on a comprehensive data-driven chemical structure generation technology. This technology automatically designs virtual novel molecules with all of the characteristics of a successful drug molecule. This approach, validated through multiple collaborations, is a novel solution to one of the key challenges in drug design: rapid identification of molecules that simultaneously satisfy multiple parameters, such as potency, selectivity, safety, and project-specific properties. This approach uniquely enables the exploration of chemical space and produces innovative molecule designs with greater freedom to operate. Iktos has also diversified its R&D efforts into the development of an AI technology for retrosynthesis and has developed the AI-based retrosynthesis analysis and planning tool Spaya™ enabling systematic exploration and prioritisation of synthetic routes for a desired compound in minutes. “We are thrilled and proud to join forces with Galapagos with the aim to discover optimised lead compounds for one of Galapagos undisclosed small molecule drug discovery projects. Pleased to have earned Galapagos trust, we are confident that together with Galapagos established R&D team, we will be able to identify promising novel chemical matter and solve complex multiparametric optimisation problems. The insights and feedback from Galapagos research team will be highly valuable to guide us into improving our technology and products.” Yann Gaston-Mathé, President and CEO of Iktos About Iktos Incorporated in October 2016, Iktos is a French start-up company specialized in the development of artificial intelligence solutions applied to chemical research, more specifically medicinal chemistry and new drug design. Iktos is developing a proprietary and innovative solution based on deep learning generative models, which enables, using existing data, to design molecules that are optimized in silico to meet all the success criteria of a small molecule discovery project. The use of Iktos technology enables major productivity gains in upstream pharmaceutical R&D. Iktos offers its technology both as professional services and as a SaaS software platform, Makya™. Iktos is also developing Spaya™, a synthesis planning software based upon Iktos’s proprietary AI technology for retrosynthesis.

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