Ajinomoto Bio-Pharma Services and Revance Therapeutics Announce Manufacturing Agreement for Supply of DaxibotulinumtoxinA for Injection
Revance Therapeutics (Nasdaq: RVNC) has partnered with Ajinomoto Bio-Pharma Services to establish a strategic commercial manufacturing agreement for DaxibotulinumtoxinA for Injection. This product is currently undergoing review for Biologics License Application (BLA). Ajinomoto will provide drug product manufacturing services at their San Diego facility, enhancing Revance’s supply chain resilience. Clinical trials have shown success in treating glabellar lines, and the company is also exploring additional indications. The partnership aims to meet growing demand in the aesthetic and therapeutic markets.
- Strategic partnership with Ajinomoto Bio-Pharma enhances manufacturing capabilities for DaxibotulinumtoxinA.
- DaxibotulinumtoxinA has completed Phase 3 trials for glabellar lines, indicating potential market approval.
- Regulatory approval for DaxibotulinumtoxinA is still pending, posing uncertainty for commercial launch.
- Potential delays in approval process due to COVID-19 related restrictions, impacting timelines.
SAN DIEGO and NEWARK, Calif., Dec. 22, 2020 /PRNewswire/ -- Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), a leading provider of biopharmaceutical contract development and manufacturing services, and Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, are pleased to announce a strategic commercial manufacturing agreement for the supply of DaxibotulinumtoxinA for Injection.
DaxibotulinumtoxinA for Injection is currently under Biologics License Application (BLA) review. Aji Bio-Pharma will serve as a dual supply source and provide drug product manufacturing services for Revance at the company's aseptic manufacturing facility in San Diego, California.
"We are excited to partner with Revance and their efforts to establish a new standard in aesthetic and therapeutic neuromodulator offerings," said Jean-Baptiste Agnus, VP of Sales at Ajinomoto Bio-Pharma Services. "This partnership underscores our commitment to be a leading, trusted, innovative partner to our clients and reinforces our company mission to improve the health of humankind."
"We are delighted to be partnering with Aji Bio-Pharma for the production of our innovative product and bolstering our supply chain resiliency," said Brian Blagg, Vice President, Engineering & Supply Chain at Revance. "Aji Bio-Pharma's manufacturing infrastructure, long-standing experience and customer-centric service, were important to this collaboration."
About Ajinomoto Bio-Pharma Services
Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India, providing comprehensive development, cGMP manufacturing, and aseptic fill finish services for small and large molecule APIs and intermediates. Ajinomoto Bio-Pharma Services offers a broad range of innovative platforms and capabilities for pre-clinical and pilot programs to commercial quantities, including Corynex® protein expression technology, oligonucleotide synthesis, antibody drug conjugations (ADC), high potency APIs (HPAPI), biocatalysis, continuous flow manufacturing and more. Ajinomoto Bio-Pharma Services is dedicated to providing a high level of quality and service to meet our client's needs. Learn more: www.AjiBio-Pharma.com
About Revance Therapeutics, Inc.
Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.
"Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.
Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.
BOTOX® is a registered trademark of Allergan, Inc.
Forward-Looking Statements
Any statements in this press release that are not statements of historical fact, including statements about the therapeutic and commercial potential of DaxibotulinumtoxinA for Injection; Revance's ability to obtain, and the timing relating to, regulatory approval with respect to DaxibotulinumtoxinA for Injection in glabellar lines; Revance's development of a biosimilar to BOTOX®; Revance's business strategy, timeline and other goals for its anticipated products and its plans and prospects, including its manufacturing and commercialization plans; and potential benefits of Revance's drug product candidates, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although Revance believes that the expectations reflected in the forward-looking statements are reasonable, Revance cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from Revance's expectations. These risks and uncertainties relate to, but are not limited to: delays in the approval of Revance's biologics license application for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines, including as a result of COVID-19-related policies and travel restrictions currently in place at the FDA; the impact of the COVID-19 pandemic on Revance's or Aji Bio-Pharma's manufacturing operations or supply chain, end user demand for Revance's products, or Revance's commercialization efforts, business operations, clinical trials and other aspects of its business; Revance's or Aji Bio-Pharma's ability to manufacture supplies for Revance's product candidates; the results, timing, costs, and completion of Revance's research and development activities; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results; the applicability of clinical study results to actual outcomes; Revance's plans to research, develop, and commercialize its drug product candidates; Revance's ability to obtain regulatory approval of its drug product candidates; Revance's ability to successfully commercialize its drug product candidates, if approved, and the timing and cost of commercialization activities; Revance's ability to obtain funding for its operations; Revance's ability to continue obtaining and maintaining intellectual property protection for its drug product candidates; and Revance's financial performance, including future revenue, expenses and capital requirements. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance's periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" on Revance's Form 10-Q filed with the SEC on November 9, 2020. The forward-looking statements in this press release speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.
View original content to download multimedia:http://www.prnewswire.com/news-releases/ajinomoto-bio-pharma-services-and-revance-therapeutics-announce-manufacturing-agreement-for-supply-of-daxibotulinumtoxina-for-injection-301197277.html
SOURCE Ajinomoto Bio-Pharma Services; Revance Therapeutics, Inc.
FAQ
What is the recent partnership made by Revance Therapeutics (RVNC)?
What is DaxibotulinumtoxinA for Injection used for?
What clinical trials has Revance conducted for DaxibotulinumtoxinA?
What are the potential risks mentioned for Revance Therapeutics (RVNC)?
