Melinta Therapeutics, Inc., a privately held company developing and
commercializing novel antibiotics to treat serious bacterial
infections, and Cempra, Inc. (Nasdaq:CEMP) today announced the
executive leadership team for the combined Melinta and Cempra
business, which will keep the name Melinta Therapeutics upon the
closing of the merger.
As previously announced, Dan Wechsler will lead the
senior management team of the combined company as president and
chief executive officer (CEO). He will be joined by an executive
management team with a proven track record of successful execution,
including:
Executive Officers
- Sue Cammarata, MD, Chief
Medical OfficerDr. Cammarata, current chief medical officer of
Melinta, has more than 20 years of clinical experience in the
development, approval and launch of pharmaceuticals, including
several anti-infective brands such as Cubicin (daptomycin) in the
EU, and Zyvox (linezolid) globally. Since joining Melinta in
2014, she has led the successful Phase 3 clinical development of
Baxdela, which was approved by FDA in June, and is also responsible
for medical affairs. Prior to joining Melinta, Dr. Cammarata served
as vice president of clinical research at Shire HGT, where she was
responsible for clinical development and post approval commitments
for novel therapies in rare and orphan diseases. Earlier, she held
several senior positions at Novartis, most recently as vice
president and global program head for the company’s immunology and
infectious disease franchises. In this role, she managed the
integration of Chiron’s infectious disease portfolio after its
acquisition by Novartis in 2006. In addition, she managed the EU
approval process for Cubicin’s endocarditis and bacteremia
indications. Before joining Novartis, Dr. Cammarata held several
positions at Pharmacia Upjohn (later Pfizer) where she was an
integral member of the team that led the Phase 3 and subsequent
global regulatory programs for Zyvox, a first-in-class antibiotic
for gram-positive infections, including those resistant to
vancomycin. Dr. Cammarata received her M.D. from Michigan
State University, completed her residency in internal medicine and
her fellowship in pulmonary and critical care medicine at Henry
Ford Health Systems and was a pulmonary and critical care medicine
specialist for several years in private practice before entering
the pharmaceutical industry. Dr. Cammarata earned her B.S. in
pharmacy from Purdue University.
- Erin Duffy, PhD, Chief Scientific OfficerDr.
Duffy, current chief scientific officer of Melinta, has more than
21 years of pharmaceutical research experience and has been
responsible for translating Melinta’s Nobel
Prize-winning ribosome technology platform into the discovery
and early-stage development of novel antibiotic candidates. She
joined the company in 2002 and has become one of the world’s
leading experts on the structure and function of the bacterial
ribosome and the interaction of antibiotics with their ribosomal
targets. Dr. Duffy has led Melinta’s ESKAPE Pathogen Program from
its infancy and has been instrumental in advancing the platform
while also contributing to the development programs for other drug
candidates. The ESKAPE Pathogen Program is Melinta’s most advanced
preclinical initiative, focused on using a discrete, novel binding
site within the bacterial ribosome to design and develop completely
new classes of antibiotics to treat some of the deadliest
multi-drug resistant gram-positive and gram-negative infections.
Prior to joining Melinta, Dr. Duffy served as associate director of
innovative discovery technologies at Achillion Pharmaceuticals,
Inc. Dr. Duffy began her scientific career as a computational
chemist with Pfizer Global Research and Development in Groton,
Connecticut. Dr. Duffy trained at Yale University, where she
received her Ph.D. in physical-organic chemistry and was a Howard
Hughes postdoctoral fellow. She holds a B.S. in chemistry from
Wheeling Jesuit University.
- Paul Estrem, Chief Financial OfficerPaul
Estrem, current chief financial officer (CFO) of Melinta, has more
than 27 years of financial leadership experience in the
pharmaceutical industry. Prior to joining Melinta, Mr. Estrem
held several senior positions at Baxter International, most
recently vice president of integration for Baxter’s Medical
Products, where he held a lead role in the $4 billion acquisition
of Gambro and oversaw the integration of their products, facilities
and 8,000 employees. Earlier in his tenure, Mr. Estrem served as
CFO of Baxter Medical Products; CFO and vice president of strategy
in Baxter Medication Delivery, a division that later became Baxter
Medical Products; CFO of Baxter Bioscience, a specialty
therapeutics division; and CFO of Baxter Ltd, a subsidiary based in
Tokyo, Japan. Mr. Estrem is a member of the American Institute of
Certified Public Accountants and the Institute of Internal
Auditors. He received an MBA from Northwestern University’s Kellogg
School of Management and a B.S. in accounting from Illinois State
University.
- John Temperato, Chief Commercial OfficerJohn
Temperato, current president and chief operating officer of
Melinta, has more than 24 years of successful commercial expertise
in pharmaceutical, biotech, and drug delivery/device products and
is leading the team preparing to launch Baxdela in the first
quarter of 2018. Prior to joining Melinta, Mr. Temperato held
multiple leadership positions in sales and managed markets during
his 11-year tenure at Salix Pharmaceuticals, where he most recently
served as the senior vice president of sales and managed
markets. In this role, reporting directly to the CEO and
board of directors, Mr. Temperato played a critical role in the
acquisition and in-licensing of multiple portfolio-expanding
products. He led the successful commercialization and growth of
Xifaxan (a non-systemic antibiotic) for hepatic encephalopathy and
irritable bowel syndrome (IBS-D) and played a principal role in
building, developing, and managing seven specialized sales teams
across multiple channels. Prior to Salix Pharmaceuticals, Mr.
Temperato was a business unit head at Celltech Pharmaceuticals,
where he was responsible for the strategic development and
execution of integrated payer and distribution marketing, which
included contracting and reimbursement. Mr. Temperato earned his
Bachelor of Science degree in Marketing from the University of
Bridgeport in Connecticut, and is a member of several distinguished
healthcare organizations, including the Academy of Managed Care
Pharmacy.
Executive Management
- Lyn Baranowski, Senior Vice President,
Corporate Development and StrategyLyn Baranowski, currently senior
vice president of corporate development and strategy at Melinta,
brings to the company her deep life sciences industry experience
spanning biotech, pharmaceuticals and venture capital. Prior to
joining Melinta, Ms. Baranowski was vice president of commercial
development at Pearl Therapeutics and was instrumental in driving
the company’s corporate development activities including its recent
sale to AstraZeneca. Before her role at Pearl Therapeutics, Ms.
Baranowski served as vice president of Vatera Healthcare Partners,
a healthcare-focused venture capital firm based in New York, where
she was responsible for lead identification, evaluation, and
negotiation as well as working with management teams of portfolio
companies to develop and implement business plans. Ms. Baranowski
previously held public affairs, business development and commercial
executive roles at Novartis, including leading the launch of the
osteoporosis drug Reclast. Ms. Baranowski holds an MBA from Harvard
Business School and a B.A. from American University.
- John Bluth, Executive Vice President, Investor
Relations and Corporate CommunicationsJohn Bluth, currently
executive vice president of investor relations and corporate
communications at Cempra, previously headed investor relations and
corporate communications for two of Silicon Valley’s leading
biotechnology companies, CV Therapeutics, which was acquired in
2009, and Aviron, which was acquired in 2002. Before joining
Aviron, Mr. Bluth led the west coast healthcare practice for
Fleishman-Hillard, an international public relations firm. From
2009-2012, he was senior vice president of investor relations and
group communications at German-based Elster Group, one of the
world’s largest electricity, gas and water measurement and control
providers. Mr. Bluth served as a member of Elster’s group executive
board and built the investor relations and corporate communications
functions for the company through its initial public offering in
2009. Elster was acquired in 2012. From 2012 through mid-2016, Mr.
Bluth was senior vice president of investor relations and corporate
communications and served on the executive committee at PowerSecure
International, Inc., a leading provider of energy technologies and
services to electric utilities and their large industrial,
commercial, institutional and municipal customers. PowerSecure was
acquired in May 2016. Mr. Bluth holds a Bachelor’s degree in
physiology from Cornell University.
- Kevin Conway, Vice President, Program
Management and Technical OperationsKevin Conway, current vice
president of program management and technical operations at
Melinta, has more than 30 years of project and operations
management experience in the healthcare industry. Prior to
joining Melinta, he served as vice president program management at
SagePath Medical. Earlier, he led the corporate program management
office for both Takeda Pharmaceuticals North America and, prior to
its merger with Takeda, TAP Pharmaceuticals. In this role, Mr.
Conway led many of the company’s critical corporate level
initiatives. Mr. Conway began his career at Abbott Laboratories and
held positions in operations management, pharmaceutical
manufacturing and packaging. Mr. Conway led cross-functional
project teams responsible for the operational aspects of new
product launches, such as Norvir, Kaletra, Depakote ER and Humira.
Mr. Conway earned a B.E. in mechanical engineering degree from the
University of Dayton. He is certified as a project management
professional by the Project Management Institute.
- Peter DiRoma, Senior Vice President,
Regulatory Affairs and Quality AssurancePeter DiRoma, current
senior vice president, regulatory affairs and quality assurance at
Melinta, brings 19 years of experience in the development, approval
and launch of pharmaceuticals, including the global development and
new drug application registration of Zyvox (linezolid) for
multi-drug resistant pathogens. Prior to joining Melinta, Mr.
DiRoma served as vice president of global regulatory affairs at
Dendreon Corporation, overseeing the European registration of
Provenge (sipuleucel-T), an autologous cellular immunotherapy for
the treatment of asymptomatic or minimally symptomatic metastatic
castration-resistant prostate cancer. Earlier, Mr. DiRoma held
regulatory leadership positions in large pharma including Merck
KGaA/EMD Serono, where he was vice president regulatory affairs,
providing regulatory guidance for the company’s immunology,
oncology, and neurodegenerative disease development portfolio.
Before joining Merck KGaA, he held regulatory positions at
Pharmacia & Upjohn and Pfizer where he was an integral member
of the team that led the Phase 3 and subsequent global regulatory
programs for Zyvox. Mr. DiRoma holds a B.S. in chemistry and
biology from the University of South Florida. He received
undergraduate research grants from the American Cancer Society at
the University of South Florida College of Medicine and from the
National Science Foundation in cancer immunology at the Florida
State University Institute of Molecular Biophysics.
- Suzie Paulson, Vice President, Human
ResourcesSuzie Paulson, current head of human resources at Cempra,
has more than 13 years of human resources experience within the
pharmaceutical industry, has led two companies through multiple
mergers and acquisitions and was responsible for large-scale
salesforce expansions in preparation for new product
launches. Before joining Cempra, Ms. Paulson led human
resource and talent management initiatives at Salix Pharmaceuticals
for eight years. While in these roles, Ms. Paulson managed
all aspects of compensation, workforce planning, talent management
and process improvement. Ms. Paulson earned a B.S. in biological
and life sciences from North Carolina State University and received
her certification as a professional in human resources.
“We are delighted to have the deep experience and
expertise that each of these highly qualified individuals will
bring to the combined organization. They each have proven
track records of success and unwavering commitment to discovering,
developing and commercializing novel treatments for the patients we
serve,” said Thomas Koestler, PhD, chairman of the board of
directors of Melinta.
“These executives bring a breadth of experience
across antibiotic commercialization, development and research that
will lay the foundation for the combined company’s growth for years
to come,” said Garheng Kong, MD, PhD, chairman of the board of
directors of Cempra.
“I am excited to work with these outstanding
leaders to ensure the success of the combined organization and
fulfill our mission of becoming the world’s premier antibiotics
company,” said Mr. Wechsler.
Mr. Wechsler’s appointment as president and CEO and
the executive management team’s appointments are subject to and
effective upon the closing of the merger between Melinta and
Cempra. Mr. Wechsler's appointment as a member of the board of
directors of the combined company is subject to the closing of the
merger and will be effective ten days following the filing of the
supplemental information statement on Schedule 14f-1 relating to
Mr. Wechsler. As previously announced, the Cempra shareholder vote
on the merger is scheduled for November 3, 2017 and the parties
expect to close the merger as promptly as practicable
thereafter.
About Melinta Therapeutics,
Inc.Melinta Therapeutics, Inc. is dedicated to saving
lives threatened by the global public health crisis of bacterial
infections, through the development and commercialization of novel
antibiotics that provide new and better therapeutic solutions.
Melinta’s lead product is Baxdela, an antibiotic approved for use
in the treatment of acute bacterial skin and skin structure
infections (ABSSSI). Melinta is also committed to developing,
through the application of Nobel Prize-winning science, a new class
of antibiotics designed to overcome the multi- and
extremely-drug-resistant pathogens for which there are few to no
options, known collectively as ESKAPE pathogens (Enterococcus
faecium, Staphylococcus aureus, Klebsiella pneumoniae,
Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter
species and Escherichia coli), which cause the majority of
life-threatening hospital infections. Melinta Therapeutics is
privately held and backed by Vatera Healthcare Partners
(www.vaterahealthcare.com) and Malin Corporation plc
(www.malinplc.com), among other private investors. In August,
Melinta announced its entry into a merger agreement with Cempra,
Inc. (Nasdaq:CEMP). The company is headquartered in New
Haven, CT with offices in Lincolnshire, IL. Visit
www.melinta.com for more information.
About Cempra, Inc.Cempra, Inc. is
a clinical-stage pharmaceutical company focused on developing
differentiated anti-infectives for acute care and community
settings to meet critical medical needs in the treatment of
infectious diseases. Cempra's two lead product candidates are
currently in advanced clinical development. Solithromycin has been
evaluated in two Phase 3 clinical trials for community-acquired
bacterial pneumonia (CABP). Cempra is currently seeking approval
for CABP for both intravenous and oral capsule formulations from
the U.S. Food and Drug Administration. Solithromycin is licensed to
strategic commercial partner Toyama Chemical Co., Ltd., a
subsidiary of FUJIFILM Holdings Corporation, for certain exclusive
rights in Japan. Cempra is contracted with BARDA for the
development of solithromycin for pediatric use and has commenced
enrollment in a global Phase 2/3 trial to evaluate the safety and
efficacy of solithromycin versus standard of care antibiotics in
children and adolescents from two months to 17 years of age.
Solithromycin is also in development for uncomplicated urogenital
urethritis caused by Neisseria gonorrhoeae or chlamydia. Fusidic
acid is Cempra's second product candidate, which has completed a
Phase 3 trial comparing fusidic acid to linezolid in patients with
ABSSSI. Cempra also has an ongoing exploratory study of fusidic
acid for chronic oral treatment of refractory infections in bones
and joints. Both products seek to address the need for new
treatments targeting drug-resistant bacterial infections in the
hospital and in the community. Cempra is also studying
solithromycin for ophthalmic conditions and has synthesized novel
macrolides for non-antibiotic uses such as the treatment of chronic
inflammatory diseases, endocrine diseases and gastric motility
disorders. Cempra was founded in 2006 and is headquartered in
Chapel Hill, N.C. For additional information about Cempra please
visit www.cempra.com.
About the MergerOn August 9, 2017,
Melinta Therapeutics, Inc. and Cempra, Inc. (Nasdaq:CEMP), a
clinical-stage pharmaceutical company focused on developing
differentiated anti-infectives for acute care and community
settings to meet critical medical needs in the treatment of
infectious diseases, announced the companies had entered a
definitive agreement under which Melinta will merge with a
subsidiary of Cempra. The merger is expected to create a
NASDAQ-listed company committed to discovering, developing and
commercializing important anti-infective therapies for patients and
physicians in areas of significant unmet need. The combined
company will have an extensive pipeline, including U.S. Food and
Drug Administration (FDA) approved Baxdela, clinical and
preclinical anti-infectives programs in development across several
indications, and an innovative platform based on Nobel
Prize-winning science. The merger is subject to Cempra
shareholder approval, with a shareholder vote scheduled for
November 3, 2017.
Cautionary Note Regarding Forward-Looking
StatementsCertain statements in this communication
regarding the proposed merger and other contemplated transactions
(including statements relating to satisfaction of the conditions to
and consummation of the proposed merger) constitute
“forward-looking statements” within the meaning of Section 27A of
the Securities Act and Section 21E of the Securities Exchange Act
and are usually identified by the use of words such as
“anticipates,” “believes,” “estimates,” “expects,” “intends,”
“may,” “plans,” “projects,” “seeks,” “should,” “will,” and
variations of such words or similar expressions. We intend these
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 27A
of the Securities Act and Section 21E of the Securities Exchange
Act and are making this statement for purposes of complying with
those safe harbor provisions. These forward-looking statements
reflect our current views about our plans, intentions,
expectations, strategies and prospects, which are based on the
information currently available to us and on assumptions we have
made. Although we believe that our plans, intentions, expectations,
strategies and prospects as reflected in or suggested by those
forward-looking statements are reasonable, we can give no assurance
that the plans, intentions, expectations or strategies will be
attained or achieved. Furthermore, actual results may differ
materially from those described in the forward-looking statements
and will be affected by a variety of risks and factors that are
beyond our control.
Risks and uncertainties for Cempra and Melinta and
of the combined company include, but are not limited to: inability
to complete the proposed merger and other contemplated
transactions; liquidity and trading market for shares prior to and
following the consummation of the proposed merger; costs and
potential litigation associated with the proposed merger; failure
or delay in obtaining required approvals by the SEC or any other
governmental or quasi-governmental entity necessary to consummate
the proposed merger, which may also result in unexpected additional
transaction expenses and operating cash expenditures on the
parties; failure to obtain the necessary stockholder approvals or
to satisfy other conditions to the closing of the proposed merger
and the other contemplated transactions; a superior proposal being
submitted to either party; failure to issue Cempra common stock in
the proposed merger and other contemplated transactions exempt from
registration or qualification requirements under applicable state
securities laws; risks related to the costs, timing and regulatory
review of the combined company’s studies and clinical trials,
including its ability to address the issues identified by the FDA
in the complete response letter relating to Cempra’s new drug
applications for solithromycin for community acquired bacterial
pneumonia; uncertainties in obtaining successful clinical results
for product candidates and unexpected costs that may result
therefrom; inability or the delay in obtaining required regulatory
approvals for product candidates, which may result in unexpected
cost expenditures; failure to realize any value of certain product
candidates developed and being developed, in light of inherent
risks and difficulties involved in successfully bringing product
candidates to market; inability to develop new product candidates
and support existing products; inability to commercialize and
launch any product candidate that receives regulatory approval,
including Baxdela; the combined company’s anticipated capital
expenditures, its estimates regarding its capital requirements and
its need for future capital; uncertainties of cash flows and
inability to meet working capital needs; cost reductions that may
not result in anticipated level of cost savings or cost reductions
prior to or after the consummation of the proposed merger; the
approval by the FDA and EMA and any other similar foreign
regulatory authorities of other competing or superior products
brought to market; risks resulting from unforeseen side effects;
risk that the market for the combined company’s products may not be
as large as expected; inability to obtain, maintain and enforce
patents and other intellectual property rights or the unexpected
costs associated with such enforcement or litigation; inability to
obtain and maintain commercial manufacturing arrangements with
third party manufacturers or establish commercial scale
manufacturing capabilities; loss of or diminished demand from one
or more key customers or distributors; unexpected cost increases
and pricing pressures; the possibility of economic recession and
its negative impact on customers, vendors or suppliers; and risks
associated with the possible failure to realize certain benefits of
the proposed merger, including future financial, tax, accounting
treatment, and operating results. Many of these factors that
will determine actual results are beyond Cempra’s, Melinta’s, or
the combined company’s ability to control or predict.
Other risks and uncertainties are more fully
described in Cempra’s Annual Report on Form 10-K for the year ended
December 31, 2016, as amended by Form 10-K/A filed with the SEC on
April 13, 2017, and in other filings that Cempra makes and will
make with the SEC in connection with the proposed transactions,
including the proxy statement described below under “Important
Information and Where to Find It.” Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date
hereof. The statements made in this press release or
presentation speak only as of the date stated herein, and
subsequent events and developments may cause our expectations and
beliefs to change. While we may elect to update these
forward-looking statements publicly at some point in the future, we
specifically disclaim any obligation to do so, whether as a result
of new information, future events or otherwise, except as required
by law. These forward-looking statements should not be relied upon
as representing our views as of any date after the date stated
herein.
Important Information and Where to Find
ItCempra and Melinta and certain of their directors and
executive officers may become participants in solicitation of
proxies from Cempra stockholders in connection with the proposed
transactions. Additional information regarding persons who may,
under the rules of the SEC, be deemed to be participants in the
solicitation of Cempra stockholders in connection with the proposed
merger, and a description of their direct and indirect interest,
whether as security holders, directors or employees of Cempra or
Melinta or otherwise, which may be different from those of Cempra
stockholders generally, is set forth in the definitive proxy
statement filed with the SEC on October 5, 2017 and supplemented as
of October 24, 2017 and October 27, 2017 in connection with
the proposed merger. You can find information about Cempra’s
directors and executive officers in Cempra’s Annual Report on Form
10-K for the year ended December 31, 2016 filed with the SEC on
February 28, 2017, as amended by Form 10-K/A filed with the SEC on
April 13, 2017, and in the definitive proxy statement filed with
the SEC on October 5, 2017 and supplemented as of October 24, 2017
and October 27, 2017 in connection with the proposed merger.
Each of Cempra’s directors, Garheng Kong, David
Zaccardelli, Richard Kent, David Gill, Dov A. Goldstein, John H.
Johnson, P. Sherrill Neff and Michael Dougherty; Cempra’s executive
officers Mark W. Hahn (Executive Vice President and Chief Financial
Officer), David Oldach (Chief Medical Officer) and John Bluth
(Executive Vice President, Investor Relations and Corporate
Communications); Melinta’s directors, Eugene Sun, Thomas Koestler,
Erik Akhund, Kevin Ferro, Cecilia Gonzalo, Christopher Kiritsy,
Pedro Lichtinger, Sean Murphy and John E. Sununu; and Melinta’s
executive officers, John Temperato (President and Chief Operating
Officer) and Paul Estrem (Chief Financial Officer); and Cempra’s
proxy solicitor, Georgeson LLC; may be deemed “participants” in the
solicitation of proxies from the Cempra stockholders in connection
with the proposed transactions.
This communication does not constitute an offer to
sell or the solicitation of an offer to buy any securities or a
solicitation of any vote or approval. A definitive proxy
statement and a proxy card were filed with the SEC on October 5,
2017 and mailed to Cempra’s stockholders on or about the same date,
seeking required stockholder approvals in connection with the
proposed transactions. BEFORE MAKING ANY VOTING OR INVESTMENT
DECISION, INVESTORS AND STOCKHOLDERS ARE URGED TO READ THE PROXY
STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY
OTHER RELEVANT DOCUMENTS THAT CEMPRA HAS FILED OR WILL FILE WITH
THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTIONS.
Stockholders may obtain, free of charge, copies of the proxy
statement and any other documents filed by Cempra with the SEC in
connection with the proposed transactions at the SEC’s website
(http://www.sec.gov), at Cempra’s website
(http://investor.cempra.com/), or by writing to the Secretary,
Cempra, Inc. at 6320 Quadrangle Drive, Suite 360, Chapel Hill,
North Carolina 27517.
For More Information:Lyn
BaranowskiMelinta Therapeutics, Inc.(203)
848-3346news@melinta.com
John BluthCempra, Inc.(984)
209-4534jbluth@cempra.com
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