Merck’s Pneumococcal Vaccine for Babies Looks Good in Trial

biospace | May 09, 2019

Merck & Company announced that its investigational 15-valent pneumococcal conjugate vaccine was “noninferior” to a currently available 13-valent pneumococcal conjugate vaccine in healthy babies 6 to 12 weeks of age. The Phase II study, called V114-008, met its primary endpoint, showing noninferiority for the 13 serotypes seen in both vaccines. V114 also caused an immune response in infants for two additional disease-causing serotypes, 22F and 33F, which aren’t in PCV13.
Pneumococcal disease is caused by Streptococcus pneumoniae, and includes non-invasive illnesses like pneumonia, sinusitis, and middle ear infection. It also causes invasive diseases such as bacteremia, bacteremic pneumonia, and meningitis. Everyone is at risk for pneumococcal disease, but the most vulnerable populations are children under the age of 2, adults 65 years and older, and people with suppressed immune systems or chronic diseases.

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Camargo Pharmaceutical Services is the most experienced global strategist providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and global equivalent processes. By assessing the scientific, medical, regulatory and commercial viability of product development opportunities.

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PHARMACY MARKET

Eirion Therapeutics Announces Strategic Agreement for HTL Biotechnology to Become Eirion's Exclusive Botulinum API Manufacturer

Eirion Therapeutics, Inc. | September 09, 2021

Eirion Therapeutics, Inc., an aesthetic dermatology company headquartered in Woburn, Massachusetts, announced that HTL Biotechnology, the worldwide leader in biotechnology solutions using hyaluronic acid and other biopolymers, will become Eirion's exclusive botulinum active pharmaceutical ingredient (API) manufacturer. Botulinum is the active ingredient in Eirion's lead product candidate ET-01, a topical neuromodulator being developed for Crow's Feet wrinkles and primary axillary hyperhidrosis (excessive sweating) that is currently in Phase 2 clinical trials, as well as in their liquid injectable neuromodulator product candidate being developed for glabellar wrinkles, AI-09. As part of the agreement, HTL will build, validate and operate a botulinum manufacturing facility in the US. In the future, HTL expects to apply to the CDC to have the facility certified to manufacture botulinum and later apply to the FDA to have it certified as a GMP plant. Under the agreement, HTL will pay for the construction, the validation and the operation of the US manufacturing facility, which is expected to become operational in 2022. In exchange, Eirion will begin paying manufacturing fees to HTL in 2023, with HTL also later sharing in the potential commercial success of ET-01 and AI-09, if approved. "This agreement marks an important expansion of HTL's biotechnology platform beyond our already industry-leading work in hyaluronic acid and bio-polymer manufacturing, as well as a key milestone in HTL's expanding footprint in North America," commented HTL CEO Yvon Bastard. "HTL believes that Eirion's products could be game-changers in the aesthetic field thanks to their substantial benefits for patients. Providing leading, innovative companies with the solutions that will empower them to change the lives of patients is our core purpose, which explains why we are particularly excited by this partnership" added Charles Ruban, HTL deputy CEO. About Eirion Therapeutics, Inc. Eirion Therapeutics, Inc. is a privately held, clinical stage biopharmaceutical company that is developing next-generation prescription products for aesthetic dermatology. Eirion currently has a rich pipeline of products focusing on treatments for wrinkles, primary axillary hyperhidrosis, androgenic alopecia, and hair greying. In the future, Eirion plans to also pursue additional indications that address other major unmet clinical needs for physicians and their patients. Earlier this year, Eirion closed a $40 million investment and licensing deal with Shanghai Haohai Biological Technology Ltd in China.

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PHARMA TECH

Invitae to Acquire Ciitizen to Strengthen its Patient-Consented Health Data Platform to Improve Personal Outcomes and Global Research

Invitae | September 07, 2021

Invitae , a leading medical genetics company, today announced it has entered into a definitive agreement to acquire Ciitizen, a patient-centric consumer health tech company. Backed by a16z, Section 32 and Verily, Ciitizen is working to build a global platform to help patients collect, organize, store and share their medical records digitally. The acquisition would enhance Invitae's platform by providing patients an easy-to-use, centralized hub for their genomic and clinical information, which together comprise a powerful dataset with the potential to drive research and improve healthcare decision making. "Invitae is relentlessly pursuing a day when genetics is used routinely to improve healthcare for billions of people around the globe. We believe combining Ciitizen's state-of-the-art, transparent and patient-consented platform with our technologies and services will accelerate our evolution into a genome information company that informs healthcare throughout one's life. This would give us the ability to engage patients, create an innovative patient-centered data ecosystem and deliver better outcomes for everyone. Invitae views the acquisition of Ciitizen as an important part of its strategy to be the industry leader across the genetic testing, software and health information technology spaces," said Sean George, Ph.D., co-founder and CEO of Invitae. "Ciitizen has already helped patients take ownership of their medical records to optimize therapy for themselves and contribute their data towards a variety of goals, including research on rare diseases," said Anil Sethi, CEO and founder of Ciitizen. "Patients leave a breadcrumb trail of records behind them, and we believe access to this real-world data is key to personalized therapeutics in the future. The combination of lifelong health history together with Invitae's world-class genetic and data services would enable a digital ecosystem of personalized services for each patient. Democratization of patient-consented data is expected to improve outcomes by providing access to third-parties for whom the patient has granted consent. Unlike many health data companies, we operate on the premise that it's the patient's data, not ours." Invitae is working to aggregate results from the world's genetic tests into a single, easy-to-use service that makes genetic information accessible to all who can benefit from it - always with patient consent. Over the past five years, Invitae has completed 13 acquisitions that have expanded its testing menu, lowered the cost of its tests, improved its customer experience and enhanced its ability to attract partners. Invitae raised more than $1.4 billion since the beginning of 2021, in part to identify and acquire key assets that bring the company closer to delivering on its vision. The addition of Ciitizen is expected to empower Invitae to more quickly extend its platform, adding a complementary patient service that streamlines the process of collecting and organizing health information from any source and uses machine learning to transform the unstructured (and largely untapped) health information to enable better care decisions, find clinical trials, and power research using real-world evidence. In addition, as the use of Invitae testing and the Ciitizen service expands, third-party access to consented genomic and other clinical data can be democratized to power a variety of applications that can enhance Invitae's business and growth strategy. About Invitae Invitae Corporation is a leading medical genetics company, whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. About Ciitizen Ciitizen is a patient-centric consumer health technology platform that enables patients to collect, store and share their medical records in a single location. Ciitizen developed proprietary machine learning and AI technologies to abstract critical information from unstructured health records to advance the understanding of diseases, match patients with potentially life-saving clinical trials, and enable better care decisions. Ciitizen also provides valuable big data analytics and data quality technologies to the network of Health Information Exchanges (HIEs) to produce research-ready, regulatory-grade data within minutes, instead of hours or days, and ensure HIEs can comply with the Information Blocking regulations.

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Jubilant Radiopharma and SOFIE Biosciences Ink Strategic Collaboration Agreement to Further Advance the Field of Molecular Imaging & Therapeutics

SOFIE Biosciences, Inc. | November 05, 2020

SOFIE Biosciences, Inc. ("SOFIE"), an established radiopharmaceutical supplier and worldwide radiopharmaceutical contract manufacturing organization, and Jubilant Radiopharma, a business division of Jubilant Pharma Limited, announced that both the organizations have entered into a strategic partnership. Under the terms of the partnership, Jubilant Pharma, via one of its wholly owned subsidiaries, with 25% of equity holding shall be a strategic partner to SOFIE, enabling SOFIE to continue to grow production capacity, advance its theranostic pipeline, and support novel PET diagnostic manufacturing and distribution within the U.S. "SOFIE is a beacon of innovation, and with Jubilant's deep experience, uncompromised quality and customer-centric operations, we will bring game-changing theranostic solutions to nuclear medicine," stated Sergio Calvo, President of Jubilant's Radiopharmaceuticals Division. "With this new relationship, SOFIE achieves another milestone in our innovation strategy," Philipp Czernin, SOFIE's Chief Revenue Officer, remarked. "By engaging a well-established industry partner such as Jubilant Radiopharma, SOFIE will leverage the combined market presence and astute organizational structure to deliver breakthrough compounds to the nuclear medicine community. With respective distribution capabilities and the highly complementary product portfolio of SPECT and PET radiopharmaceuticals, both companies are well poised to create a single-vendor opportunity in select geographies." As part of the agreement, Jubilant Radiopharma will invest US $25m into SOFIE Biosciences. This funding will help accelerate the readiness timelines for SOFIE's state-of-the-art Theranostics Center of Excellence Manufacturing Facility in Totowa, New Jersey, as well as advance the development of their Fibroblast Activation Protein Inhibitor (FAPI) program. Patrick Phelps, SOFIE's President and Chief Executive Officer stated, "Under this strategic partnership, SOFIE is excited to meet the growing need to manufacture highly specialized radiopharmaceuticals, as well as become the first theranostic production center for FAPI in the US. FAPI has received worldwide acclaim for its value as a key next-generation theranostic agent with the ability to greatly enhance the detection and treatment of a wide variety of oncology diseases, and we believe with Jubilant Radiopharma's investment and support, we can accelerate the development and commercialization of this exciting family of compounds." "This agreement is yet another demonstration of Jubilant Radiopharma's long term commitment to the global Nuclear Medicine community. Our teams are dedicated to bringing to market the next generation of breakthrough products and industry-leading services to healthcare providers across the globe as part of our mission of improving lives through Nuclear Medicine," stated Pramod Yadav, CEO Jubilant Pharma Limited. About SOFIE Biosciences, Inc SOFIE's vision is to improve patient outcomes by developing and delivering molecular diagnostics and therapeutics (Theranostics). With its robust radiopharmaceutical production and distribution network, mature contract manufacturing services, and now, high value Theranostic intellectual property, SOFIE is poised to deliver on the promise of nuclear medicine.

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