Attention Business Editors
YM BioSciences granted two US patents for AeroLEF(R)
§ - Additional AeroLEF patents granted in Europe, China and other
territories -
§ MISSISSAUGA, ON, Feb. 10 /CNW/ - YM BioSciences Inc. (NYSE Amex: YMI,
TSX:YM), announced that it has been granted two additional patents in the US
for AeroLEF(R), the Company's proprietary, inhaled-delivery composition of
free and liposome-encapsulated fentanyl in development for the treatment of
moderate to severe acute pain. US patent numbers 7,648,981 and 7,648,982
extend the life of YM's AeroLEF patent estate in the US to 2024. The Company
also announced that AeroLEF's patent estate has expanded to include other
territories with the issuance of European patent number 1,603,533 and several
patent allowances in China, India, Mexico and other territories.
§ "These patents strengthen and extend the patent protection for AeroLEF in
the US, and also expand the global market for this unique and potentially
first in class product," said David Allan, CEO of YM BioSciences. "The
scientific pedigree and unique advantages of this product have been
established and its safety and efficacy have been demonstrated in numerous
clinical trials. AeroLEF has met all endpoints in each of its trials including
a randomized Phase II trial and is currently being prepared for late-stage
development internationally."
§ US patent number 7,648,981 protects the self-medicating method of pain
management in which the pain sufferer inhales a formulation comprising free
and liposomal fentanyl in a dose ratio that provides rapid onset and sustained
relief from pain without attendant toxicity. Also claimed is a breath-actuated
device for delivering the fentanyl formulation.
§ US patent number 7,648,982 similarly covers a pain relief method and
device that delivers fentanyl formulations defined according to the particle
sizes and unit doses effective to manage pain by the route of pulmonary
delivery. European patent number 1,603,533 and other recently allowed patents'
coverage is similar in scope to the recently issued US patents.
§ AeroLEF's current patent estate in the US consists of three issued
patents and two pending patents.
§ About AeroLEF(R)
§ AeroLEF(TM) is a unique, inhaled-delivery composition of free and
liposome-encapsulated fentanyl in development for the treatment of moderate to
severe pain, including cancer pain. In contrast to fixed-dose approaches to
opioid delivery, where a significant titration period is often required to
determine the suitable dose for the patient, AeroLEF is being developed as a
non-invasive delivery system designed to enable patients to self-titrate.
Using AeroLEF, patients can identify and select a personalized dose for each
pain episode, achieving both rapid onset and extended duration of analgesia.
§ About YM BioSciences
§ YM BioSciences Inc. is a life sciences product development. Together with
the products from YM Australia (formerly Cytopia Limited), the Company is
currently developing four late-stage products: nimotuzumab, an EGFR-targeting
Affinity-Optimized Antibody(TM); CYT 387, a JAK 1/2 small molecule inhibitor,
CYT 997, a potent, vascular disrupting agent and AeroLEF(R), a proprietary,
inhaled-delivery composition of free and liposome-encapsulated fentanyl. YM
has proven regulatory and clinical trial expertise and a diversified business
model designed to reduce risk while advancing clinical products toward
international approval, marketing and commercialization.
§ Nimotuzumab is a humanized monoclonal antibody in development worldwide,
targeting multiple tumor types primarily in combination with radiation and
chemoradiation. It is importantly differentiated from all other currently
marketed EGFR-targeting agents due to its remarkably benign side-effect
profile. Nimotuzumab's anti-tumor activity has led to its approval for
marketing in 23 countries. In more than 9,000 patients reported as having been
treated with nimotuzumab worldwide to date, Grade IV incidents of radiation
dermatitis and incidents of severe rash have been only rarely observed and
reports of the other severe side-effects that are typical of EGFR-targeting
molecules have been equally rare. Nimotuzumab is licensed to YM's
majority-owned, Canadian subsidiary, CIMYM BioSciences Inc., by CIMAB S.A.,
and was developed at the Center of Molecular Immunology. The products
discovered by YM's recently acquired Australian subsidiary include the JAK 1/2
inhibitor CYT387, and the novel VDA molecule CYT997. Both were discovered
internally at Cytopia based on research led by Dr Andrew Wilks who identified
the JAK 1/2 kinase enzymes. Both products are currently in clinical
development. YM is developing AeroLEF for the treatment of moderate to severe
acute pain. The product is differentiated from other approaches using opioids
because patients are able to individually control the analgesia required for
their differing intensities of pain.
§ This press release may contain forward-looking statements, which reflect
the Company's current expectation regarding future events. These
forward-looking statements involve risks and uncertainties that may cause
actual results, events or developments to be materially different from any
future results, events or developments expressed or implied by such
forward-looking statements. Such factors include, but are not limited to,
changing market conditions, the successful and timely completion of clinical
studies, the establishment of corporate alliances, the impact of competitive
products and pricing, new product development, uncertainties related to the
regulatory approval process and other risks detailed from time to time in the
Company's ongoing quarterly and annual reporting. Certain of the assumptions
made in preparing forward-looking statements include but are not limited to
the following: that nimotuzumab will continue to demonstrate a competitive
safety profile in ongoing and future clinical trials; that JAK 1/2 and the VDA
molecule will generate positive efficacy and safety data in future clinical
trials; AeroLEF(R) will continue to generate positive efficacy and safety data
in future clinical trials; that and that YM and its various partners will
complete their respective clinical trials within the timelines communicated in
this release. We undertake no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise.
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