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Lilly and TransPharma Medical Announce Licensing and Development Agreement
Lilly Gains Access to Transdermal PTH Program for Osteoporosis
INDIANAPOLIS, IN and LOD, ISRAEL– Eli Lilly and Company (NYSE:LLY) and
TransPharma Medical Ltd. today announced that the two companies have entered
into a licensing and development agreement related to TransPharma's ViaDerm-hPTH
(1-34) product for the treatment of osteoporosis. The product, which is
administered transdermally using TransPharma's proprietary technology, is
currently in Phase II clinical testing.
Under the terms of the agreement, Lilly will obtain exclusive worldwide
rights to TransPharma's ViaDerm-hPTH (1-34) product and will also gain
non-exclusive access to TransPharma's ViaDerm drug delivery system. TransPharma
will receive a $35 million upfront payment, and may also receive development and
sales milestones, as well as royalties on sales if a transdermal PTH product is
successfully commercialized. TransPharma and Lilly will both fund and
participate in Phase II clinical development activities. Thereafter, Lilly will
be responsible for further development activities and the potential
commercialization of any transdermal PTH products. Other terms of the deal were
not disclosed.
The transaction is expected to become effective in either June or July of
2008, contingent upon clearance under the Hart-Scott-Rodino Anti-Trust
Improvements Act. At closing, Lilly would expect a $0.02 per share charge to
earnings for acquired in-process research and development.
"This agreement expands the scope of our osteoporosis program with a novel,
patient-centered approach that builds upon our success with Evista and Forteo,"
commented Dr. Gwen Krivi, vice president of Lilly Research Labs and global brand
development platform leader for musculoskeletal and Cialis platform. "As we
focus on developing a transdermal PTH product with TransPharma, we will leverage
our combined expertise, with the goal of providing patients with a product that
meets their desire for an alternative to injection for PTH."
"We are extremely pleased to partner with Lilly, a leading player in the
osteoporosis market," said Dr. Daphna Heffetz, CEO of TransPharma Medical. "This
collaboration is an excellent example for how our transdermal ViaDerm-based
products may deliver added value to promising drug compounds. We are confident
that Lilly's experience and outstanding drug development capabilities together
with our innovative technology could propel our joint ViaDerm-PTH (1-34) product
as an improved therapy for people suffering from osteoporosis."
About ViaDerm Drug Delivery System
TransPharma’s ViaDerm drug delivery system incorporates a handheld electronic
control unit, which creates microscopic passageways through the outer layer of
the skin allowing for transdermal delivery of a wide variety of drugs from a
patch. The system provides a cost-effective, easy-to-use, self-administered
solution that enables the safe, reproducible and accurate delivery of a broad
range of product candidates, including hydrophilic small molecules peptides and
proteins.
About Osteoporosis
Osteoporosis is a debilitating disease that affects an estimated 75 million
people in Europe, the U.S. and Japan. Osteoporosis, which means “porous bone,”
is a disease in which the density and quality of bone are reduced. As the bones
become more porous and fragile, the risk of fracture is greatly increased. The
loss of bone occurs “silently” and progressively and no symptoms are apparent
until the first fracture occurs.
The most common fractures associated with osteoporosis occur at the hip,
spine and wrist. The incidence of these fractures, particularly at the hip and
spine, increases with age in both women and men.
Vertebral fractures can result in serious consequences, including loss of
height, intense back pain and deformity.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers – through medicines and information –
for some of the world's most urgent medical needs. Additional information about
Lilly is available at www.lilly.com.
About TransPharma Medical
Established in 2000, TransPharma Medical Ltd. is a specialty pharmaceutical
company focused on the development and commercialization of drug products
utilizing a proprietary active transdermal drug delivery technology. TransPharma
aims to develop multiple drug products through strategic partnerships with
leading pharmaceutical companies and through independent product development.
For more information, visit the Company's website at www.transpharma-medical.com.
This news release contains forward-looking statements. These statements are
subject to known and unknown risks and uncertainties that may cause actual
future experience and results to differ materially from the statements made.
Factors that might cause such a difference include, among others, the completion
of clinical trials, the FDA and other foreign review processes and other
governmental regulation, Lilly's and TransPharma's abilities to successfully
develop and commercialize drug candidates, competition from other pharmaceutical
companies, the ability to effectively market products, and other factors
described in Lilly's most recent filings with the Securities and Exchange
Commission. Lilly undertakes no duty to update forward looking statements.
For Release: Immediately
Refer to: Lilly: Mark E. Taylor (317) 276-5795
TransPharma: Tsipi Haitovsky +972-52-5989892
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