SYDNEY, March 29, 2021
/CNW/ -- Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an
oncology-focused drug development company, is pleased to announce
that it has entered into a licensing agreement with Simcere
Pharmaceutical Group Ltd (Simcere)
(HKSE: 2096) to develop and commercialise Kazia's investigational
new drug, paxalisib, in Greater
China.
Key Points
- Simcere will assume responsibility for the development,
registration, and commercialisation of paxalisib in Greater China - a territory which includes
Mainland China, Hong Kong,
Macau, and Taiwan.
- Kazia retains rights to the development and commercialisation
of paxalisib in all other territories and will continue to drive
forward the GBM AGILE pivotal study as planned, including in
China.
- Under the terms of the agreement, Kazia will receive an upfront
payment of US$ 11 million (~AU$ 14.2
million), comprising US$ 7 million in
cash and a US$ 4 million equity
investment, priced at a 20% premium to recent trading. Kazia will
also receive contingent milestone payments of up to US$ 281 million (~AU$ 362 million) for
glioblastoma, with further milestones payable for indications
beyond glioblastoma. Simcere will additionally pay to Kazia
mid-teen percentage royalties on commercial sales.
- Transaction proceeds will be applied directly to the further
development of paxalisib.
- Simcere is one of China's
leading pharmaceutical companies, with over 40 marketed products
and an extensive development pipeline. It was incorporated in 1995
and is listed on the Hong Kong Stock Exchange (HKSE: 2096).
Simcere's primary areas of strategic focus are in oncology, central
nervous system disease, and autoimmune disease.
- Paxalisib is currently the subject of six additional studies in
other forms of brain cancer beyond glioblastoma.
Kazia CEO, Dr James Garner,
commented, "China is one of the
world's largest pharmaceutical markets, with specific requirements
and opportunities for innovative oncology products. We are
delighted to partner with Simcere to secure the commercial success
of paxalisib in this critical territory. Simcere's track record of
success is unrivalled, and they bring to paxalisib first-class
capabilities in clinical development, regulatory affairs, and
commercialisation. We look forward to working closely with our new
partners to make paxalisib available for Chinese patients as
swiftly as possible."
Dr Renhong Tang, Senior Vice President at Simcere, added, "we
are tremendously excited by the potential for paxalisib to make a
difference in this very challenging disease. The need for new
therapies in brain cancer is significant in China, and we share Kazia's commitment to
bringing forward new treatment options for patients."
Kazia has been advised in this transaction by Janette Dixon at JustPartnering and by Dragon
Financial Partners.
Simcere Pharmaceutical Group
Simcere Pharmaceutical Group is rapidly transitioning to an
innovation and R&D-driven pharmaceutical company, with a
mission of "providing today's patients with medicines of the
future." It has established a national key laboratory of
translational medicine and innovative pharmaceuticals. Simcere
focuses on oncology, central nervous system disease and autoimmune
disease therapeutic areas, with a diversified product portfolio and
industry-leading capabilities. Its vigorous in-house R&D
efforts and extensive R&D collaborations have made it a
strategic cooperation partner with world leading pharmaceutical
companies and biotechnology companies, in an effort to bring more
global life science breakthroughs to China.
For more information, please visit www.simcere.com.
Equity Issuance
Under the terms of the transaction, Simcere will make a
US$ 4 million (~AU$ 5.2 million)
equity investment in Kazia, priced at a 20% premium to recent
trading.
In relation to Kazia's 2016 purchase of Glioblast Pty Ltd, this
transaction satisfies the conditions for Milestone 4 of that
agreement and will therefore result in the issuance of escrowed
ordinary shares to Glioblast shareholders, under terms previously
disclosed by Kazia.
Paxalisib
Paxalisib is a brain-penetrant inhibitor of the PI3K / Akt /
mTOR pathway, which is disordered in the vast majority of patients
with glioblastoma, the most common and most aggressive form of
primary brain cancer.
In a phase II study in patients with newly diagnosed
glioblastoma with unmethylated MGMT promotor status, paxalisib has
shown highly encouraging signals of clinical efficacy. In
January 2021, patient recruitment
commenced for paxalisib in the GBM AGILE platform study, which is
expected to serve as the basis for registration in key
territories.
Investor Conference Call
Kazia is pleased to invite investors to attend a conference call
to further discuss the partnership with Simcere.
The call will be held on Tuesday 30 March
2021 at 8:00am, Sydney time (AEDT), which is 5:00pm on 29 March in New York (ET) and 2:00pm on 29 March in San Francisco (PT).
Participants will need to pre-register for the call via
the following link:
https://s1.c-conf.com/diamondpass/10013168-83hs6e.html
Click the 'Register Now' button and follow the prompts to
complete pre-registration. You will receive a calendar invite with
dial in numbers, passcode and PIN to join the conference call.
About Kazia Therapeutics Limited
Kazia Therapeutics Limited (ASX: KZA, NASDAQ: KZIA) is an
oncology-focused drug development company, based in Sydney, Australia.
Our lead program is paxalisib, a brain-penetrant inhibitor of
the PI3K / Akt / mTOR pathway, which is being developed to treat
glioblastoma, the most common and most aggressive form of primary
brain cancer in adults. Licensed from Genentech in late 2016,
paxalisib commenced recruitment to GBM AGILE, a pivotal study in
glioblastoma, in January 2021. Seven
additional studies are active in other forms of brain cancer.
Paxalisib was granted Orphan Drug Designation for glioblastoma by
the US FDA in February 2018, and Fast
Track Designation for glioblastoma by the US FDA in August 2020. In addition, paxalisib was granted
Rare Pediatric Disease Designation and Orphan Designation by the US
FDA for DIPG in August 2020.
For more information, please visit
www.kaziatherapeutics.com.
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SOURCE Kazia Therapeutics Limited