With FDA Approval Of Zolgensma, Regenxbio Sets Out For First Revenue Stream

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Regenxbio expects to obtain royalty payments from Novartis for Zolgensma after it was approved by the FDA to treat patients with spinal muscular atrophy.

To date, Regenxbio has taken in about $190 million in payments for Zolgensma, with a lot more expected as the drug starts being sold on the market.

Regenxbio has a robust NAV technology platform and about 100 or more AAV vectors in its arsenal to target a host of different types of diseases.

The most promising treatment stemming from the biotech would be RGX-314 which is being developed to treat patients with wet age-related macular degeneration.

Regenxbio (RGNX) announced that a gene therapy developed based on its technology was approved by the FDA. This gene therapy product is known as Zolgensma, which Novartis (NVS) now owns after acquiring AveXis for $8.7 billion back in 2018. While Novartis does own Zolgensma, it will have to pay royalties to Regenxbio on net sales for it. That means Regenxbio can start earning revenue for one of its very first products. The company is in good shape because it has many other gene therapy programs in its pipeline. The most notable one would be RGX-314, which is being developed to treat patients with wet age-related macular degeneration.

Click here to read more via Seeking Alpha.

Johns Hopkins founded medical research firm LifeSprout gets financing boost

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A Baltimore-based regenerative medicine firm called LifeSprout, which makes synthetic products used to restore soft tissue, has secured $6.5 million in financing.

LifeSprout, a private company founded out of Johns Hopkins University, said Wednesday it closed on seed-stage financing to develop the first products using its Regenerative Matrix technology, which uses materials designed to look and feel like natural tissues. The injectable material is designed to prevent scarring.

Hopkins researchers said in a scientific paper this month that the technology could help patients suffering soft tissue losses from tumor removal, trauma or aging.

LifeSprout’s first product is an aesthetic dermal filler called Lumina. The financing will allow the company to develop additional regenerative medicine products targeting rare diseases.

“In a few years we have taken the technology from inception at Johns Hopkins to pre-clinical manufacturing of our first products in aesthetic medicine,” said Dr. Sashank Reddy, co-founder and president of LifeSprout, in an announcement.

Read more via the Baltimore Sun.

Qiagen launches companion test for Novartis breast cancer treatment

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Dive Brief:

  • Qiagen said it has launched the first FDA-approved companion diagnostic for identifying breast cancer patients who may benefit from treatment with Novartis’ Piqray (alpelisib).
  • Novartis last week announced FDA approval of the kinase inhibitor designed specifically for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative​ advanced breast cancer patients with a PIK3CA mutation.
  • Qiagen said it has a worldwide co-exclusive license from Johns Hopkins University for PCR-based companion diagnostics based on mutations in the PIK3CA gene.

Click here to read more via Med Tech Drive.

Viela Bio Enters Strategic Collaboration with Hansoh Pharma to Develop and Commercialize Inebilizumab for Autoimmune Diseases and Hematologic Cancers in China

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Partnership accelerates access to inebilizumab in China and supports the mission of both companies to bring transformative therapies to more patients around the world

Viela Bio is eligible to receive an upfront collaboration fee and milestone payments of more than $220 million plus royalties on product sales

GAITHERSBURG, Md. & SHANGHAI–(BUSINESS WIRE)–Viela Bio, Inc. (“Viela”) and Hansoh Pharmaceutical Group Company Limited (“Hansoh Pharma”) today announced a collaboration focused on development and commercialization of inebilizumab – Viela’s humanized anti-CD19 monoclonal antibody – in China for neuromyelitis optica spectrum disorder (NMOSD), as well as other potential inflammation/autoimmune and hematologic malignancy indications.

“Our collaboration with Hansoh Pharma strengthens our ability to commercialize inebilizumab throughout the world,” commented Bing Yao, Ph.D., Viela’s Executive Chairman and Chief Executive Officer. “Their significant commercial, regulatory and clinical development infrastructure gives us a strong strategic partner in China and also may provide support for our global product expansion and lifecycle plans.”

Under terms of the collaboration, Viela will receive an up-front collaboration fee and additional payments contingent on certain development, regulatory, and commercial milestones, totaling potentially more than $220 million, plus tiered royalties on net sales. Hansoh Pharma will be responsible for leading development and commercialization of inebilizumab in China.

“We are thrilled to partner with Viela. They have shown that targeting CD19 to achieve sustained B cell depletion is a compelling monotherapy strategy that brings profound benefits to patients with NMOSD, for whom there is no approved therapy,” said Aifeng Lyu, Ph.D., President of Hansoh Pharma. “Viela is a leader in researching and developing breakthrough treatments for inflammation and autoimmune diseases. Together, we will endeavor to advance inebilizumab as quickly as possible for patients in China, as well as seek to broaden the potential of inebilizumab via combination therapies.”

Viela recently presented positive results from a pivotal study of inebilizumab in patients with neuromyelitis optica spectrum disorder (NMOSD) – a rare autoimmune disease characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis. Inebilizumab is not yet approved for sale in either the United States or China. Viela expects to file for a Biologics License Application with the U.S. Food and Drug Administration (FDA) in mid-2019.

Click here to read the entire release.

The Catalyst: Creating Innovation in Health Care – United Therapeutics’ Martine Rothblatt at Healthy Returns

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There are few, if any, more innovative, more daring, and more iconic health care executives. We’ll hear about the process that drives groundbreaking invention, and her dream of permanently alleviating the shortage of transplantable organs.Martine Rothblatt, founder and CEO of United Therapeutics presents her organization’s latest innovation, followed by a conversation with “Fast Money” Host and “Power Lunch” co-anchor, Melissa Lee.

Click here to watch the video interview via yahoo.com and CNBC

Regenxbio building Maryland AAV plant to support gene therapies

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Regenxbio will construct a GMP facility in Maryland to produce adeno-associated viral vectors for its gene therapy programs using its NAV technology-based platform.

The good manufacturing practice (GMP) plant will be integrated into Regenxbio’s 132,000 square-foot headquarters in Rockville, Maryland, currently under construction. Financial details have not been disclosed but the manufacturing plant is expected to be operational in 2021.

“The creation of this additional manufacturing capacity using our platform suspension cell culture process will allow us to more efficiently advance our development programs from research stage to the clinic and ultimately to patients, while ensuring manufacturing capacity availability,” chief technology officer Curran Simpson said in a statement.

The plant will support the firm’s multiple gene-therapy programs through the production of Regenxbio’s NAV Technology-based vectors at scales up to 2,000 liters.

“Regenxbio’s novel and unique approach to gene therapy focuses on enabling cells in the body to produce therapeutic proteins or antibodies and targeting and correcting genetic defects,” Kenneth Mills, CEO of Regenxbio, said earlier this month during a financial conference call.

“Our NAV Technology serves as a backbone gene therapy research and is widely utilized gene therapy platform across diverse disease applications.”

The technology consists of over 100 adeno-associated viral (AAV) vectors including AAV7, AAV8, AAV9 and AAVrh10, which deliver engineered genes to cells. It has so far been used to treat over 200 patients in clinical trials for Regenexbio and its licensee partners.

Click here to read more via BioProcess International

QIAGEN’s QuantiFERON®-TB Access development program gains recognition from United Nations initiative for health innovation

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HILDEN, Germany & GERMANTOWN, Md.–(BUSINESS WIRE)–May 21, 2019–

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that QuantiFERON ® -TB Access, a new solution under development for diagnosis of latent tuberculosis (TB) infection in low-resource regions with a high disease burden of tuberculosis, will be recognized by the Joint United Nations Programme on HIV/AIDS (UNAIDS) at the organization’s Health Innovation Exchange from May 21-23 in Geneva, Switzerland. The event will be held during the World Health Assembly and brings together ministers of health, nonprofits and industry to spotlight innovations with potential to change the world’s health landscape and benefit sustainable development.

QuantiFERON-TB Access (QFT ®  Access) is a proprietary new test designed to advance tuberculosis control in areas with limited infrastructure, including countries in Asia, Africa and Latin America. The World Health Organization (WHO) has classified 30 countries in these regions as high-burden, representing an estimated 85% of the global TB burden. QFT Access pairs highly sensitive digital detection with a complete workflow created to deliver cost-efficient results quickly and with unmatched simplicity. It eliminates the need for an extensive laboratory infrastructure while providing best-in-class QuantiFERON technology. Clinical trials are being conducted in 2019, and commercialization of QFT Access is expected to begin in 2020.

“We are pleased that UNAIDS selected QuantiFERON-TB Access for recognition at the Health Innovation Exchange. QIAGEN’s drive to develop QFT Access springs from the need for a modern, accurate test for TB infection screening in areas where the disease burden is high but resources and infrastructure are scarce,” said Thierry Bernard, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN. “QFT Access builds on the success of QuantiFERON ® -TB Gold Plus, the modern gold standard for detection of latent TB infection. We have created a field-friendly Sample to Insight solution using a simple test to reduce costs and labor and avoid the need for cold chain, a computer or continuous power supply.”

Click here to read the entire press release.

Navitas Life Sciences Announces Acquisition of KAI Research, US-based Full-service Contract Research Organisation (CRO)

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PRINCETON, N.J.May 21, 2019 /PRNewswire/ — Navitas Life Sciences, a TAKE Solutions Enterprise today announced the acquisition of US based niche full service CRO and health research company, KAI Research Inc.

KAI Research brings on board top of class offerings in 3 key areas – Clinical Trial Management, Clinical Research Consultation, and Data Management & Standardization. Through this acquisition, Navitas Life Sciences expands Phase II and Phase III capabilities in North America adding to its current capabilities in Europe and APAC. KAI strengthens Navitas’ therapeutic expertise in mental health, musculoskeletal diseases, neurological disorders, pain, diabetes, infectious diseases and oncology for Pharma and medical devices. The company has differentiated offerings in the areas of patient registries and e-clinical solutions as well as long-standing relationships with clinical sites and trusted network of service providers across the United States and Africa.

Srinivasan H R, Managing DirectorNavitas Life Sciences said, “We are on track in terms of our acquisitions, KAI Research will further strengthen our capabilities in clinical services and expand our therapeutic expertise. Through this acquisition, we also gain a unique standpoint in serving Federal agencies like FDA, NIH, CDC, Department of Defense etc. Together, we intend to create a world class enterprise making meaningful strides in our ability to deliver improved trial outcomes to the bio pharma landscape. The addition of KAI’s capabilities translates to global trial capabilities across North AmericaEurope and APAC markets. Combining these operational and TA capabilities with our proprietary AI driven OneClinical platform allows us to be a great partner to small and mid-tier customers as well as to large pharma.”

Kathy Dimeo, President, KAI Research Inc said, We are happy to share that we have been acquired by Navitas Life Sciences. The complementary synergies between our companies will increase service offerings and capacity to serve our current and prospective clients and improve the quality of our service delivery, while opening our services to the global community.”

Click here to read the entire press release.

Montgomery County Economic Development Corporation (MCEDC) Launches New Bio Lab Pilot

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Helps Fund Wet Lab Space for Small Biotech Companies

The Montgomery County Economic Development Corporation (MCEDC) launches a year-long pilot program designed to help small biotech companies fund wet lab space in Montgomery County, Maryland. The Bio Lab Pilot project will assist the County’s growth-stage life sciences companies with their infrastructure needs.

The successful applicant must agree to be headquartered in the County for three years, and lease wet lab space that is 5,000 SF or less. The grant award will provide $10 per SF of lab fit-out costs, up to $30,000 per company.

“Young BioHealth companies are not always able to obtain conventional financing. These grants are designed to help fill the funding gap associated with wet lab costs,” said David Petr, President and CEO of MCEDC.

MCEDC will fund the pilot project with $250,000 from its FY19 budget, which includes $50,000 in funding from the Maryland Department of Commerce.

“Maryland Commerce is pleased to support this project, which will help offset the cost of wet lab space and encourage more small biotech companies to grow in Montgomery County,” said Kelly M. Schulz, Maryland’s Commerce Secretary.

Expanding local companies, new start-up companies, and relocating companies are eligible to apply for Bio Lab Pilot funds to fit-out newly leased lab space. Developers and building owners are ineligible to receive pilot program grants. The threshold criteria for a pilot award will be the demonstrated evidence of a funding gap that prevents the company from completing its new lab fit-out.

Click here to read the entire press release.

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