Headcount Expansion Further Bolsters Experienced Commercial Foundation
PDUFA Target Action Date for INVELTYS™ is August 24, 2018
Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the development and commercialization of product candidates using its proprietary mucus-penetrating particle (MPP) technology, today announced the following key commercial hires in preparation for the potential approval and launch of INVELTYSTM, a twice-daily steroid eye drop in development for the treatment of inflammation and pain following ocular surgery:
“We are excited to welcome Kate, Jim, Carl, Pat and Lynette to Kala at such a pivotal time in our Company’s history. We believe that the collective talent, leadership and seasoned industry experience of our new team members will greatly advance Kala’s evolution into a commercial organization,” said Todd Bazemore, Chief Operating Officer of Kala Pharmaceuticals. “As we prepare for the potential approval and launch of INVELTYS, a product candidate that could be the first approved BID steroid eye drop for the treatment of inflammation and pain following ocular surgery, we will also continue to focus on advancing our other pipeline candidates, including KPI-121 0.25% for dry eye disease.”
Kala plans to continue growing its commercial organization in preparation for the launch of INVELTYS, including hiring its own specialty ophthalmology sales force pending the potential approval of the New Drug Application (NDA) for INVELTYS by the U.S. Food and Drug Administration (FDA). Kala’s NDA for INVELTYS was accepted for review by the FDA in January 2018 and given a target action date under the Prescription Drug User Fee Act (PDUFA) of August 24, 2018.
Kathleen McCann Kline, Vice President of Marketing
Ms. Kline
has joined Kala Pharmaceuticals as Vice President of Marketing. Most
recently, she served as Vice President of Marketing for the
Ophthalmology and Women’s Health divisions at Bausch and Lomb where she
was instrumental in leading the strategic initiatives supporting
numerous surgical and pharmaceutical franchises, including intraocular
lenses, surgical equipment and the Loteprednol franchise. Previously,
Ms. Kline held Director and Product Manager positions at Allergan
Pharmaceuticals where her focus was on their ophthalmology brands,
including RESTASIS® and Refresh®.
James Patnoe, Vice President of Commercial Operations and Pricing
Mr.
Patnoe has joined Kala Pharmaceuticals as Vice President of Commercial
Operations and Pricing. Previously, he served as Vice President of Sales
Operations, Contracts and Pricing at Takeda Pharmaceuticals America,
where he spent 10 years in roles of increasing responsibility, including
Vice President of Managed Markets. Formerly, he worked for TAP
Pharmaceuticals and held various sales and leadership positions,
including Vice President of Managed Markets, Director of Sales
Operations and National Account Sales Director.
Carl Rennie, Executive Director of Account Management
Mr.
Rennie has joined Kala Pharmaceuticals as Executive Director of Account
Management. Prior to Kala, he was the Director of National Accounts for
Collegium Pharmaceuticals. Previously, he worked for Sunovion
Pharmaceuticals (Sepracor) as Executive Director of Payer Markets and
National Director of Corporate Accounts. Mr. Rennie served in the United
States Army Medical Service Corps.
Patrick Bedell, Executive Director of Trade and Alternate Channels
Mr.
Bedell has joined Kala Pharmaceuticals as Executive Director of Trade
and Alternate Channels. Most recently, he was Senior Director of Trade
and Alternate Channels for Collegium Pharmaceuticals. Prior to
Collegium, he worked in several commercial roles at Sunovion
Pharmaceuticals (Sepracor), including Executive Director of Trade and
Alternate Channels.
Lynette Zickl, Director of Commercial Analytics and Forecasting
Ms.
Zickl has joined Kala Pharmaceuticals as Director of Commercial
Analytics and Forecasting. Previously, she was Head of Insights and
Analytics for scPharmaceuticals, where she led the Commercial Analytics
and Operations build-out and helped the company transition from Series A
to a publicly-traded company. Prior to scPharmaceuticals, she held
commercial analytics roles at Shire and Cubist Pharmaceuticals.
About Kala Pharmaceuticals, Inc.
Kala is a
biopharmaceutical company focused on the development and
commercialization of therapeutics using its proprietary
mucus-penetrating particle (MPP) technology, with an initial focus on
the treatment of eye diseases. Kala has applied the MPP technology to a
corticosteroid designed for ocular applications, resulting in two lead
product candidates. The product candidates are INVELTYS™ (KPI-121 1%)
for the treatment of inflammation and pain following ocular surgery, for
which an NDA has been accepted for review by the FDA, and KPI-121 0.25%
for the temporary relief of the signs and symptoms of dry eye disease.
Forward Looking Statements
This press release contains
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995, that involve substantial risks and
uncertainties, including statements regarding the collective talent,
leadership and seasoned industry experience of the Company’s new team
greatly supporting the advancement of the Company’s evolution into a
commercial organization, the potential approval and launch of INVELTYS,
INVELTYS potentially being the first approved BID steroid eye drop for
the treatment of inflammation and pain following ocular surgery, the
Company’s continued to focus on advancing our other pipeline candidates,
including KPI-121 0.25% for dry eye disease, and the Company’s plans to
continue growing its commercial organization in preparation for the
launch of INVELTYS, including hiring its own specialty ophthalmology
sales force. All statements, other than statements of historical facts,
contained in this press release, including statements regarding the
Company’s strategy, future operations, future financial position, future
revenue, projected costs, prospects, plans and objectives of management,
are forward-looking statements. The words “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,”
“target,” “potential,” “will,” “would,” “could,” “should,” “continue”
and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain these
identifying words. The Company may not actually achieve the plans,
intentions or expectations disclosed in its forward-looking statements,
and you should not place undue reliance on such forward-looking
statements. Actual results or events could differ materially from the
plans, intentions and expectations disclosed in the forward-looking
statements as a result of various risks and uncertainties including, but
not limited to: whether the data from our Phase 3 clinical trials of
KPI-121 0.25% will warrant submission of an NDA on the timeline
expected, or at all, whether any additional clinical trials will be
required prior to submission of an NDA and whether any such NDA will be
approved; whether our NDA for INVELTYS will be approved by its PDUFA
date or at all; uncertainties inherent in the availability and timing of
data from ongoing clinical trials; expectations for regulatory approvals
to conduct trials or to market products; whether the Company’s cash
resources will be sufficient to fund the Company’s foreseeable and
unforeseeable operating expenses and capital expenditure requirements
for the Company’s expected timeline; other matters that could affect the
availability or commercial potential of the Company’s product
candidates; and other important factors, any of which could cause the
Company’s actual results to differ from those contained in the
forward-looking statements, discussed in the "Risk Factors" section of
the Company’s most recently filed Annual Report on Form 10-K and other
filings the Company makes with the Securities and Exchange Commission.
These forward-looking statements represent the Company’s views as of the
date of this release and should not be relied upon as representing the
Company’s views as of any date subsequent to the date hereof. The
Company does not assume any obligation to update any forward-looking
statements, whether as a result of new information, future events or
otherwise, except as required by law.
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Investor and Media Contact:
MacDougall Biomedical
Communications
Cammy Duong, 781-591-3443
cduong@macbiocom.com