13F: Klingenstein Fields & Co LLC Has Cut Its Teva Pharmaceutical Industries (TEVA) Position by $4.04 Million as Stock Price Declined

Pharamaceutical | January 05, 2017

Klingenstein Fields & Co Llc decreased its stake in Teva Pharmaceutical Industries (TEVA) by 45.58% based on its latest 2016Q3 regulatory filing with the SEC. Klingenstein Fields & Co Llc sold 87,893 shares as the company’s stock declined 8.07% while stock markets rallied. The institutional investor held 104,954 shares of the major pharmaceuticals company at the end of 2016Q3, valued at $4.83M, down from 192,847 at the end of the previous reported quarter. Klingenstein Fields & Co Llc who had been investing in Teva Pharmaceutical Industries.

Spotlight

Cleaning validation is a necessary and time-consuming part of manufacturing pharmaceuticals. The validation process can be expedited and the cost reduced if the cleaner supplier can provide support — ultimately allowing pharmaceuticals to get to market faster and at a lower cost. This paper outlines the basics of cleaning validation and discusses the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.


Other News
PHARMACY MARKET

Astellas Announces Topline Results from Phase 3 Long-Term Safety Study of Fezolinetant in Mainland China

Astellas Pharma Inc. | September 05, 2022

Astellas Pharma Inc. announced topline results from the Phase 3 MOONLIGHT 3™ clinical trial in women in mainland China evaluating the long-term safety and tolerability of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause. MOONLIGHT 3 is a 52-week single-arm Phase 3 clinical trial investigating the long-term safety and tolerability of fezolinetant 30 mg taken once daily in 150 women in mainland China seeking treatment for relief of VMS associated with menopause. The study's primary endpoint is the frequency and severity of adverse events which were generally consistent with previous Phase 3 studies of fezolinetant. Detailed results will be submitted for publication in the near future. "The topline results from the MOONLIGHT 3 study are very encouraging and, upon initial review, further support the long-term safety of fezolinetant. We are evaluating the full MOONLIGHT data sets and remain committed to developing innovative treatments in this therapeutic area with the hope of delivering a first-in-class, nonhormonal treatment option for women with moderate to severe VMS." Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas Fezolinetant is an investigational selective neurokinin-3 receptor antagonist and is not approved anywhere in the world. In the U.S., a New Drug Application for fezolinetant for the treatment of moderate to severe VMS associated with menopause is under review. The NDA submission is based on results from two pivotal Phase 3 clinical trials, SKYLIGHT 1™ and SKYLIGHT 2™, and the Phase 3 long-term safety study, SKYLIGHT 4™. About the MOONLIGHT Phase 3 Clinical Trials MOONLIGHT 1™ is designed to investigate the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause in women in Asia. The study is double-blinded and placebo-controlled for the first 12 weeks, followed by a 12-week non-controlled extension treatment period. A total of 302 women with moderate to severe VMS associated with menopause were enrolled at nearly 60 sites in mainland China, Korea and Taiwan. MOONLIGHT 3™ is a 52-week single-arm Phase 3 clinical trial designed to investigate the long-term safety and tolerability of fezolinetant in women in mainland China with VMS associated with menopause. A total of 150 women were enrolled at 34 sites in mainland China. About the BRIGHT SKY™ Phase 3 Program The BRIGHT SKY pivotal trials, SKYLIGHT 1™ and SKYLIGHT 2™ enrolled over 1,000 women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4™ is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S., Canada and Europe. About VMS Associated with Menopause VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2 Worldwide, more than 50% of women 40 to 64 years of age experience VMS and, in East Asia, the prevalence of VMS has been estimated to be around 80% of women 40 to 65 years of age, with 55% having moderate to severe VMS.3,4 VMS can have a disruptive impact on women's daily activities and overall quality of life.1 About Fezolinetant Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS associated with menopause.5,6,7 The safety and efficacy of fezolinetant are under investigation and have not been established. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.

Read More

BUSINESS INSIGHTS

Cellusion and Celregen a member of Fosun Pharma, Enter into Exclusive License Agreement of CLS001 for a Corneal Endothelial Cell Regenerative

Cellusion and Celregen | September 12, 2022

Cellusion Inc. a Japanese regenerative medicine startup aiming to solve the global corneal transplant waiting list problem with a unique differentiation induction method from iPS cells to Corneal Endothelial Cell Substitute from iPS Cells for bullous keratopathy novel treatment and Hangzhou Celregen Therapeutics Ltd. a member of Shanghai Fosun Pharmaceutical Co., Ltd. and focus on regenerative medicine and cell therapy and incubated by New Drug Fund of Fosun Health Capital announced an exclusive license agreement in the Greater China region for Celregen to develop, manufacture and commercialize CLS001. Under the Agreement, Celregen will have the exclusive right to develop, manufacture and commercialize CLS001 for bullous keratopathy in the Greater China region, including Mainland China, Hong Kong, Macau and Taiwan. On the other hand, Cellusion retains the rights of development, manufacturing and commercialization of CLS001 in other regions including Japan, the USA, and EU. Under the terms of the agreement, Cellusion will potentially receive over 100 million US dollars including upfront payment, development milestones and sales milestones as well as tiered royalties. “We are very enthusiastic about combining our knowledge of the underlying iPS cellular biology with Celregen and Fosun Pharma in the development and commercialization of innovative medicine in China. Together, we are committed to make best efforts on launching CLS001 for the patient suffering from bullous keratopathy due to the cornea donor shortage in the greater China region.” Shin Hatou, M.D. Ph.D., CEO of Cellusion “Today’s announcement with a global industry leader in iPS cells derived corneal endothelial regenerative therapy such as Cellusion, is an important and strategic step to build a long-term foundation for cell therapy in China,” said Cui Zhiping, the Chairman of Celregen, Fosun Global Partner, Chief Consultant of VC investment of Fosun Pharma and CEO of Fosun New Drug Fund. “This partnership, which leverages each company’s respective strengths, will help us bring novel regenerative medicine products to patients in greater China.” According to reports, there are about millions of people in China who are blind due to corneal diseases, and this number is increasing at a rate of 100,000 per year. Most of the patients with corneal blindness need corneal transplantation to restore their sight, but only less than 20,000 corneal transplants are conducted due to severe donor cornea shortage issues. Cellusion has already announced that the patient recruitment began for the First-in-Human Investigator-Initiated Study of CLS001 to initiate in 2022 at the Keio University Hospital and has been preparing to start Cellusion initiated clinical trial in Japan within a few years followed by global studies in the US and EU region. Cellusion is developing CLS001, CECSi cells for Corneal Endothelial regeneration to cure Bullous Keratopathy which is applied to more than half of all cases of corneal transplantation. CLS001 is expected to replace the current supply limitations by combining “CECSi Cells made from iPS cells with excellent proliferative properties” and “a simple injection cell delivery procedure without needs of human expertise.” About Celregen Celregen, incubated by New Drug Fund of Fosun Health Capital, focuses on stem cell and transformed cellular regenerative medicine. This platform adopts a variety of modes of cooperation with leading biotech and scientists. It is expected to be a head biotech in regenerative medicine in China. About Fosun Pharma Founded in 1994, Fosun Pharma is a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China. Fosun Pharma directly operates businesses including pharmaceutical manufacturing, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and clinical needs-oriented. The company enriches its innovative product pipeline through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma has formed technological platforms for innovative small molecule drugs, antibody drugs, and cell therapy with a focus on key disease areas including oncology and immunomodulation, metabolism and digestive system, and central nervous system. About Fosun New Drug Fund New Drug Fund, under the management of Fosun Health Capital, is the first VC established by Fosun Pharma. The Fund focuses on innovative biopharmaceutical-based drug fields at the start-up and expansion stages, including gene therapy, cell therapy, bio-conjugate drugs, and medical aesthetics, etc. The Fund has committed to incubate cutting-edging science and revolutionary technologies from world top universities, research institutes and biotech, through which path we can establish and adopt a variety of models of cooperation.

Read More

BUSINESS INSIGHTS

Ex-Biocon team Symbio Generrics completes capital raise from Ascent Capital

Symbio Generrics | November 25, 2022

Symbio Generrics India Private Limited a specialized Active Pharmaceutical Ingredients & Intermediates manufacturing and marketing organization, announced that it has completed an equity capital raise from Ascent Capital, a leading growth-capital focused private equity fund. Symbio was founded by pharmaceutical professionals, Salim Shaikh and Abhijit Kale. They were soon joined by the third promoter, Akash Puranik; all of whom possess decades of experience in the global pharmaceutical industry. Symbio's journey from a sales and marketing organization to a full-fledged vertically integrated manufacturer of specialized APIs has been exemplary. Through a well-developed customer ecosystem, the highly experienced & skilled team at Symbio has established a global footprint for its APIs. Ascent Capital's sizeable investment in Symbio will further accelerate the company's expansion plans and sets the company enroute to emerge as a top-10 manufacturer of APIs in India. The funds raised from Ascent will be utilized towards undertaking strategic acquisitions, establishing a best-in-class R&D facility and ramping up manufacturing capacity. The company's R&D Centre is housed in Bengaluru while the manufacturing plant is located at Dobbaspet, Bengaluru. The Company is in the process of acquiring another manufacturing facility in India. The team is focused on building a high-potential generics API portfolio for the global markets and to this effect, will work towards getting US FDA and other SRA approvals for their recently acquired facilities. "We are glad to be associated with Ascent Capital which has a reputation of partnering with entrepreneurs to build leading businesses in India. The sizeable investment from Ascent Capital will add power to our next growth spurt and enable us to emerge as a top-10 API company in India. We are setting ourselves a medium-term goal of growing rapidly into a sizeable company by leveraging the strength of our team and expanding our horizons to actively serve the global API market." Commenting on the fund raise, Salim Shaikh, Executive Chairman & Founder of Symbio Generrics Akash Puranik, Promoter, MD& CEO of Symbio Generrics, says, "The latest feather in our cap is the influx of resources from Ascent Capital. We have carved strategic alliances and relationships spanning over two decades with leading pharmaceutical entities in regulated and semi-regulated markets and are now keen to expand these synergies further in the global arena. With a well-developed infrastructure, both on the manufacturing and R&D front, we are keen to engage with potential partners for CDMO Business." Mr. Raja Kumar, Founder and MD of Ascent Capital, said, "Ascent Capital has been known to support highly qualified professional teams in niche domains. Continuing with this tradition, we are delighted to partner with the first-generation technocrat founders at Symbio. Collectively, the team at Symbio is one of the best multi-disciplinary teams in the Indian pharma space and has shown an exemplary track record of building global relationships. We look forward to working collaboratively with the Company to ensure that we have another category leader from the Ascent stable, akin to BigBasket, Sequent, Skanray, to name a few." IC Universal Legal's Chennai team led by Senior Partner, Sameena Chatrapathy represented Symbio as the legal counsel for the fund raise from Ascent Capital as well as the follow-on acquisitions. About Symbio Symbio Generrics India Private Limited founded in the year 2010 is a specialized Active Pharmaceutical Ingredients & Intermediates manufacturing and marketing organization with headquarters in Bengaluru. The Company was founded by first generation entrepreneurs coming from a leading pharmaceutical organization, with a combined experience of over 40 years. About Ascent Capital Ascent Capital is a leading India-focused Independent Private Equity Fund Manager. The team at Ascent is one of the most experienced investment teams in India with 150+ years of collective experience in Indian PE and capital markets. Thus far, Ascent has helped more than 60 entrepreneurs build leading businesses across diverse sectors such as Technology, Healthcare, Financial Services, Consumer Brands, etc. It typically invests USD 10-30 MM in fast growing businesses, led by outstanding entrepreneurs, that have the potential to emerge as leaders in its segment thereby delivering exceptional exit outcomes. Ascent is backed by marquee investors, who include long term institutional investors like pension funds, foundations, endowments, fund of funds and large corporations - a vote of confidence in the team's ability to excel and deliver results.

Read More

PHARMA TECH

Bluestar Genomics Receives CAP Accreditation for Its Clinical Laboratory

Bluestar Genomics | October 11, 2022

Bluestar Genomics, Inc., an early cancer detection company leading the development and commercialization of next-generation liquid biopsy tests focused on non-invasive detection of high-mortality cancers in high-risk patient populations, today announced it received accreditation for its clinical laboratory from the College of American Pathologists (CAP). The certification enables the company to serve physicians and patients globally as it works towards broad commercialization of its first test for the detection of pancreatic cancer. CAP Accreditation is an internationally recognized program that awards laboratories that meet stringent requirements of quality, accuracy, and consistency. This milestone further solidifies Bluestar Genomics’ commitment to providing the highest standards of testing results. The company’s proprietary approach to detecting cancer early is anchored in epigenomic process of tracking dynamic changes in cells in the body by measuring levels of the biomarker 5-hydroxymethylcytosine (5hmC) in a person’s blood. “This accreditation—on the heels of our CLIA certification and combined with our growing body of scientific evidence supporting the utility of our 5hmC-based epigenomic testing—positions us to become the first cancer detection company to offer non-invasive epigenomic blood-based testing for early pancreatic cancer detection. These milestones are a testament to our focus on preparing our company to serve customers around the world, helping millions of patients avoid late-stage, untreatable cancer diagnosis.” David Mullarkey, chief executive officer of Bluestar Genomics Bluestar Genomics’ pancreatic cancer early detection test has been analytically validated and previously received FDA Breakthrough Device Designation. It is designed to analyze a person’s changing biology and uses novel 5hmC-based epigenomic analysis to detect when cells become cancerous. The company has a prospective, large clinical validation study underway to further study its test. About Bluestar Genomics Bluestar Genomics is an early cancer detection company focused on the development and commercialization of non-invasive epigenomic tests to detect cancer through a standard blood draw, earlier than existing methods and when the disease is still treatable. The company uses its one-of-a-kind epigenomic platform that combines best-in-class bioinformatics and genomic technologies to analyze individuals’ changing biology that is yet to produce symptoms. Leveraging its novel liquid biopsy technology, Bluestar Genomics is initially focused on high-mortality cancers with the greatest need for early detection, starting with pancreatic and women’s cancers. With locations in San Diego and the San Francisco Bay Area, Bluestar Genomics collaborates with top research institutions and is supported by multiple global healthcare and technology investors and pharmaceutical collaborations.

Read More

Spotlight

Cleaning validation is a necessary and time-consuming part of manufacturing pharmaceuticals. The validation process can be expedited and the cost reduced if the cleaner supplier can provide support — ultimately allowing pharmaceuticals to get to market faster and at a lower cost. This paper outlines the basics of cleaning validation and discusses the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.

Resources