BioTime and Processa Announce Their Intention to Enter into a HyStem® Sublicense for Drug Delivery
Processa is led by a management team with a proven track record in
drug development and drug delivery
ALAMEDA, Calif.--(BUSINESS WIRE)--Oct. 11, 2017--
BioTime, Inc. (NYSE American: BTX), a late stage clinical biotechnology
company focused on developing and commercializing products addressing
degenerative diseases, today reached agreement on terms to sublicense
certain HyStem® rights to Processa Pharmaceuticals, Inc.
(“Processa”) for the creation of a sustained-release delivery platform.
“We are excited to form this new relationship with Processa. Dr. David
Young and the team at Processa have a strong background in drug
development, particularly with drug delivery platforms, and have been
instrumental in more than 30 FDA approvals,” said Adi Mohanty, Co-Chief
Executive Officer of BioTime. “This initiative will combine the
expertise and experience of the Processa team with our HyStem platform,
and together we hope to leverage the technology beyond the local
delivery programs we are pursuing at BioTime. I believe that securing
this potential sublicensing arrangement further validates and supports
BioTime’s key strategic initiatives.”
“The Processa team and I are excited about accessing the HyStem
technology platform as a way to address the numerous challenges that
exist within drug delivery. This technology has the potential to be
beneficial for many drugs. We are keen to make progress on the
development of the HyStem platform for drug delivery,” said Dr. David
Young, CEO of Processa. “I look forward to completing the agreement
quickly and building a strong and long-lasting partnership with the
HyStem® is BioTime’s cell and drug delivery platform. HyStem®
technology includes a family of unique, biocompatible hydrogels designed
to effectively deliver cells or bioactive compositions for therapeutic
benefit. HyStem® was designed to enable the effective
transfer, engraftment and metabolic support for cells and is the basis
of BioTime’s Renevia® program. The flexible chemistry of the
HyStem® also allows for hydrogel optimization in the delivery
of drugs and therapeutics. BioTime is actively pursuing local delivery
aspects of this platform technology.
About BioTime, Inc.
BioTime is a late stage clinical biotechnology company focused on
developing and commercializing products addressing degenerative
diseases. The Company’s current clinical programs are targeting three
primary sectors, aesthetics, ophthalmology and cell and drug delivery.
Its clinical programs are based on two platform technologies:
pluripotent cells, which can become any type of cell in the human body,
and cell/drug delivery. Renevia®, a cell delivery product,
met its primary endpoint in an EU pivotal clinical trial for the
treatment of facial lipoatrophy in HIV patients earlier this year.
Submission for approval of Renevia® is expected later this
year, with an anticipated commercial launch in 2018. OpRegen®,
a retinal pigment epithelium transplant therapy, is in a Phase I/IIa
multicenter trial for the treatment of dry age-related macular
degeneration, the leading cause of blindness in developing countries.
BioTime also has significant equity holdings in two publicly traded
companies, Asterias Biotherapeutics, Inc. (NYSE American: AST) and
OncoCyte Corporation (NYSE American: OCX), and one private company, AgeX
BioTime common stock is traded on the NYSE American and TASE under the
symbol BTX. For more information, please visit www.biotime.com or
connect with the company on Twitter, LinkedIn, Facebook, YouTube,
To receive ongoing BioTime corporate communications, please click on the
following link to join the Company’s email alert list: http://news.biotime.com.
About Processa Pharmaceuticals, Inc.
Processa Pharmaceuticals, Inc was founded with a mission to develop
products that can improve the survival and/or quality of life for
patients who have a high unmet medical need. The company has assembled a
proven management team, Board of Directors and product development team.
The Processa Team are experts in developing drug products from IND
enabling studies to NDA submission. The company's combined scientific,
development and regulatory experience has resulted in more than 30 drug
approvals by the U.S. Food and Drug Administration (FDA) and more than
50 drug development programs, including drug products targeted to orphan
Certain statements contained in this release are “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. Statements pertaining to future financial and/or
operating results, future growth in research, technology, clinical
development, and potential opportunities for BioTime, Inc. and its
subsidiaries, the ability BioTime and its licensees to obtain additional
FDA and foreign regulatory approval to market BioTime’s products,
ability of the parties to reach a definitive agreement based on the term
sheet, along with other statements about the future expectations,
beliefs, goals, plans, or prospects expressed by management constitute
forward-looking statements. Any statements that are not historical fact
including, but not limited to statements that contain words such as
“will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”
should also be considered forward-looking statements. Forward-looking
statements involve risks and uncertainties, including, without
limitation, risks inherent in the development and/or commercialization
of potential products, uncertainty in the results of clinical trials or
regulatory approvals, need and ability to obtain future capital whether
the parties can reach a definitive agreement based on the term sheet,
and maintenance of intellectual property rights. Actual results may
differ materially from the results anticipated in these forward-looking
statements and as such should be evaluated together with the many
uncertainties that affect the business of BioTime, Inc. and its
subsidiaries, particularly those mentioned in the cautionary statements
found in more detail in the “Risk Factors” section of its Annual Reports
on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC
(copies of which may be obtained at www.sec.gov).
Subsequent events and developments may cause these forward-looking
statements to change. BioTime specifically disclaims any obligation or
intention to update or revise these forward-looking statements as a
result of changed events or circumstances that occur after the date of
this release, except as required by applicable law.
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Source: BioTime, Inc.
David Nakasone, 510-871-4188
JQA Partners, Inc.
Jules Abraham, 917-885-7378