Proteolix, Inc. to be Acquired By Onyx Pharmaceuticals
Publicado: Lun Oct 12, 2009 9:44 pm
Proteolix, Inc. to be Acquired By Onyx Pharmaceuticals
Mon Oct 12, 2009 7:00am EDT
http://www.reuters.com/article/pressRel ... RN20091012
Cita:
"Acquisition Provides Onyx with a Late-Stage Next-Generation Therapy for
Multiple Myeloma and a Leading Proteasome Inhibition Platform
SOUTH SAN FRANCISCO, Calif., Oct. 12 /PRNewswire/ -- Proteolix, Inc. today
announced that it has signed a definitive agreement to be acquired by Onyx
Pharmaceuticals, Inc. (Nasdaq: ONXX). Proteolix is a privately-held
biopharmaceutical company focused on discovering and developing novel
therapies that target the proteasome for the treatment of hematological
malignancies and solid tumors. Proteolix's lead compound, carfilzomib, is a
proteasome inhibitor currently in multiple clinical trials, including an
advanced Phase 2b clinical trial for patients with relapsed and refractory
multiple myeloma.
"Proteolix has succeeded in pioneering a new class of potent proteasome
inhibitors, as demonstrated by the promising data achieved in multiple studies
of our lead candidate, carfilzomib. We believe Onyx truly shares our vision
for carfilzomib as an important new therapy in oncology and recognizes
Proteolix's scientific leadership in proteasome inhibition," said John A.
Scarlett, M.D., President and Chief Executive Officer of Proteolix. "Onyx's
proven track record and commercial resources in oncology are impressive. We
are excited to join forces and together we are poised to advance carfilzomib
through regulatory approval and achieve our ultimate objective of helping
patients."
Under the terms of the transaction, Onyx will make a $276 million cash payment
upon closing of the transaction. Additional payments include $40 million
payable in 2010 based on the achievement of a development milestone and up to
$535 million contingent upon the achievement of anticipated approvals for
carfilzomib in the U.S. and Europe. Of the potential $535 million, a payment
of $170 million is based upon the achievement of accelerated U.S. Food and
Drug Administration approval. The transaction is expected to close in the
fourth quarter of 2009, subject to the receipt of clearance under the
Hart-Scott-Rodino Act and customary closing conditions.
Proteolix is a leader in developing therapeutics that inhibit the cellular
proteasome, a validated and well-characterized approach to treating certain
hematologic cancers. Carfilzomib is the first in a new class of selective and
irreversible proteasome inhibitors. To date, carfilzomib has demonstrated
strong response rates in multiple studies and a potentially more tolerable
safety profile than currently approved agents. An ongoing accelerated
approval Phase 2b trial in patients with relapsed and refractory multiple
myeloma is expected to complete enrollment in 2009 with data anticipated in
the second half of 2010. Carfilzomib is also being evaluated in a companion
Phase 2 trial in relapsed multiple myeloma. A Phase 3 trial evaluating
carfilzomib in combination with lenalidomide and dexamethasone as a potential
treatment option for patients with multiple myeloma is expected to begin in
2010. Carfilzomib is also being evaluated in a Phase 1b/2 study for solid
tumor cancers. In addition, Proteolix has discovered additional
next-generation proteasome inhibitors to which it holds worldwide development
and commercialization rights, including an oral proteasome inhibitor and a
selective immunoproteasome inhibitor.
"Treatment options in multiple myeloma have historically been limited, and
there is a tremendous need to expand the treatment paradigm with agents
offering an improved efficacy and safety profile," said Michael Kauffman,
M.D., Ph.D., Chief Medical Officer at Proteolix. "Carfilzomib is in multiple
ongoing clinical studies and has revealed clear single-agent activity in a
heavily pre-treated multiple myeloma patient population, as well as being well
tolerated alone, or in combination with Revlimid. Upcoming data for
carfilzomib could support the potential near-term introduction of a novel
therapy for this debilitating disease."
Cooley Godward Kronish LLP acted as legal advisor to Proteolix on this
transaction.
About Multiple Myeloma
Multiple myeloma (MM) is the second most common hematologic cancer and results
from an abnormality of plasma cells, usually in the bone marrow. In the
United States, more than 50,000 people are living with MM and approximately
20,000 new cases are diagnosed annually(i). Worldwide, more than 180,000
people are living with MM and approximately 86,000 new cases are diagnosed
annually(ii).
About Carfilzomib
Carfilzomib is the first in a new class of highly specific proteasome
inhibitors. Carfilzomib produces specific and sustained inhibition of the
proteasome, leading to apoptosis in cancer cells with minimal off-target
effects. In Phase 1 and Phase 2 clinical trials, carfilzomib has demonstrated
single-agent activity in hematologic and solid tumors, including multiple
myeloma and renal cancer. Proteolix is currently conducting a comprehensive
clinical development program evaluating carfilzomib for the treatment of
multiple myeloma, including two ongoing Phase 2 clinical trials of
single-agent carfilzomib, one in heavily pre-treated relapsed and refractory
patients with progressive disease who have failed to respond to prior
treatment, and a second in relapsed patients stratified by prior treatment
with bortezomib. A Phase 1b clinical trial of carfilzomib in combination with
lenalidomide and dexamethasone in patients with relapsed multiple myeloma is
also ongoing. In addition, based on promising Phase 1 results, Proteolix is
conducting a single-agent Phase 1b/2 clinical trial of carfilzomib in patients
with recurrent or advanced solid tumors. For the latest information regarding
ongoing carfilzomib clinical trials, please visit http://www.clinicaltrials.gov.
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to
improving the lives of people with cancer. The company, in collaboration with
Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar®,
a small molecule drug. Nexavar is currently approved for the treatment of
liver cancer and advanced kidney cancer. Additionally, Nexavar is being
investigated in several ongoing trials in a variety of tumor types. For more
information about Onyx, visit the company's website at http://www.onyx-pharm.com.
About Proteolix, Inc.
Founded in December 2003, Proteolix, Inc. is a privately-held
biopharmaceutical company, headquartered in South San Francisco, dedicated to
discovering, developing and commercializing novel therapeutics that target
protein degradation pathways for cancer and autoimmune diseases. Proteolix's
lead product, carfilzomib, is the first in a new class of highly specific
proteasome inhibitors, and is currently in multiple Phase 2 clinical studies
to evaluate its safety and efficacy in multiple myeloma and other
malignancies. Proteolix is also developing a pipeline of novel proteasome
inhibitors, including an oral proteasome inhibitor and a selective
immunoproteasome inhibitor.
Venture capital investors in Proteolix include U.S. Venture Partners, Advanced
Technology Ventures, Latterell Venture Partners, Delphi Ventures, The Vertical
Group, Nomura Phase4 Ventures and Westfield Capital Management."
Fin de la cita.
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.Saludos
Mon Oct 12, 2009 7:00am EDT
http://www.reuters.com/article/pressRel ... RN20091012
Cita:
"Acquisition Provides Onyx with a Late-Stage Next-Generation Therapy for
Multiple Myeloma and a Leading Proteasome Inhibition Platform
SOUTH SAN FRANCISCO, Calif., Oct. 12 /PRNewswire/ -- Proteolix, Inc. today
announced that it has signed a definitive agreement to be acquired by Onyx
Pharmaceuticals, Inc. (Nasdaq: ONXX). Proteolix is a privately-held
biopharmaceutical company focused on discovering and developing novel
therapies that target the proteasome for the treatment of hematological
malignancies and solid tumors. Proteolix's lead compound, carfilzomib, is a
proteasome inhibitor currently in multiple clinical trials, including an
advanced Phase 2b clinical trial for patients with relapsed and refractory
multiple myeloma.
"Proteolix has succeeded in pioneering a new class of potent proteasome
inhibitors, as demonstrated by the promising data achieved in multiple studies
of our lead candidate, carfilzomib. We believe Onyx truly shares our vision
for carfilzomib as an important new therapy in oncology and recognizes
Proteolix's scientific leadership in proteasome inhibition," said John A.
Scarlett, M.D., President and Chief Executive Officer of Proteolix. "Onyx's
proven track record and commercial resources in oncology are impressive. We
are excited to join forces and together we are poised to advance carfilzomib
through regulatory approval and achieve our ultimate objective of helping
patients."
Under the terms of the transaction, Onyx will make a $276 million cash payment
upon closing of the transaction. Additional payments include $40 million
payable in 2010 based on the achievement of a development milestone and up to
$535 million contingent upon the achievement of anticipated approvals for
carfilzomib in the U.S. and Europe. Of the potential $535 million, a payment
of $170 million is based upon the achievement of accelerated U.S. Food and
Drug Administration approval. The transaction is expected to close in the
fourth quarter of 2009, subject to the receipt of clearance under the
Hart-Scott-Rodino Act and customary closing conditions.
Proteolix is a leader in developing therapeutics that inhibit the cellular
proteasome, a validated and well-characterized approach to treating certain
hematologic cancers. Carfilzomib is the first in a new class of selective and
irreversible proteasome inhibitors. To date, carfilzomib has demonstrated
strong response rates in multiple studies and a potentially more tolerable
safety profile than currently approved agents. An ongoing accelerated
approval Phase 2b trial in patients with relapsed and refractory multiple
myeloma is expected to complete enrollment in 2009 with data anticipated in
the second half of 2010. Carfilzomib is also being evaluated in a companion
Phase 2 trial in relapsed multiple myeloma. A Phase 3 trial evaluating
carfilzomib in combination with lenalidomide and dexamethasone as a potential
treatment option for patients with multiple myeloma is expected to begin in
2010. Carfilzomib is also being evaluated in a Phase 1b/2 study for solid
tumor cancers. In addition, Proteolix has discovered additional
next-generation proteasome inhibitors to which it holds worldwide development
and commercialization rights, including an oral proteasome inhibitor and a
selective immunoproteasome inhibitor.
"Treatment options in multiple myeloma have historically been limited, and
there is a tremendous need to expand the treatment paradigm with agents
offering an improved efficacy and safety profile," said Michael Kauffman,
M.D., Ph.D., Chief Medical Officer at Proteolix. "Carfilzomib is in multiple
ongoing clinical studies and has revealed clear single-agent activity in a
heavily pre-treated multiple myeloma patient population, as well as being well
tolerated alone, or in combination with Revlimid. Upcoming data for
carfilzomib could support the potential near-term introduction of a novel
therapy for this debilitating disease."
Cooley Godward Kronish LLP acted as legal advisor to Proteolix on this
transaction.
About Multiple Myeloma
Multiple myeloma (MM) is the second most common hematologic cancer and results
from an abnormality of plasma cells, usually in the bone marrow. In the
United States, more than 50,000 people are living with MM and approximately
20,000 new cases are diagnosed annually(i). Worldwide, more than 180,000
people are living with MM and approximately 86,000 new cases are diagnosed
annually(ii).
About Carfilzomib
Carfilzomib is the first in a new class of highly specific proteasome
inhibitors. Carfilzomib produces specific and sustained inhibition of the
proteasome, leading to apoptosis in cancer cells with minimal off-target
effects. In Phase 1 and Phase 2 clinical trials, carfilzomib has demonstrated
single-agent activity in hematologic and solid tumors, including multiple
myeloma and renal cancer. Proteolix is currently conducting a comprehensive
clinical development program evaluating carfilzomib for the treatment of
multiple myeloma, including two ongoing Phase 2 clinical trials of
single-agent carfilzomib, one in heavily pre-treated relapsed and refractory
patients with progressive disease who have failed to respond to prior
treatment, and a second in relapsed patients stratified by prior treatment
with bortezomib. A Phase 1b clinical trial of carfilzomib in combination with
lenalidomide and dexamethasone in patients with relapsed multiple myeloma is
also ongoing. In addition, based on promising Phase 1 results, Proteolix is
conducting a single-agent Phase 1b/2 clinical trial of carfilzomib in patients
with recurrent or advanced solid tumors. For the latest information regarding
ongoing carfilzomib clinical trials, please visit http://www.clinicaltrials.gov.
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to
improving the lives of people with cancer. The company, in collaboration with
Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar®,
a small molecule drug. Nexavar is currently approved for the treatment of
liver cancer and advanced kidney cancer. Additionally, Nexavar is being
investigated in several ongoing trials in a variety of tumor types. For more
information about Onyx, visit the company's website at http://www.onyx-pharm.com.
About Proteolix, Inc.
Founded in December 2003, Proteolix, Inc. is a privately-held
biopharmaceutical company, headquartered in South San Francisco, dedicated to
discovering, developing and commercializing novel therapeutics that target
protein degradation pathways for cancer and autoimmune diseases. Proteolix's
lead product, carfilzomib, is the first in a new class of highly specific
proteasome inhibitors, and is currently in multiple Phase 2 clinical studies
to evaluate its safety and efficacy in multiple myeloma and other
malignancies. Proteolix is also developing a pipeline of novel proteasome
inhibitors, including an oral proteasome inhibitor and a selective
immunoproteasome inhibitor.
Venture capital investors in Proteolix include U.S. Venture Partners, Advanced
Technology Ventures, Latterell Venture Partners, Delphi Ventures, The Vertical
Group, Nomura Phase4 Ventures and Westfield Capital Management."
Fin de la cita.
si quereis el texto en castellano:
Traductor Google:
http://translate.google.com/?hl=es#
.Saludos