Kala Pharmaceuticals Announces Financing from Athyrium Capital Management Totaling $110 Million
- Financing provides support for NDA filing of KPI-121 0.25%, INVELTYS launch, and topline results for the STRIDE-3 trial of KPI-121 0.25% -
- Initial
“We are pleased to be partnering with Athyrium and to have their support
and confidence in INVELTYS for the treatment of inflammation and pain
following ocular surgery and KPI-121 0.25% for dry eye disease,” said
“We are excited about the commercial potential of both INVELTYS for post-surgical inflammation and pain, and KPI-121 0.25% for dry eye disease,” said Laurent D. Hermouet, Partner at Athyrium. “INVELTYS is the first approved BID ocular corticosteroid for the treatment of inflammation and pain following ocular surgery and has an efficacy, safety and dosing profile which should make it a desirable treatment option in this setting. We are also excited for the potential of KPI-121 0.25% for dry eye disease, and believe, if approved, it could become a standard of care for the treatment of dry eye flares.”
Further information with respect to the credit facility are set forth in
the Form 8-K filed by the Company with the
About INVELTYS™
INVELTYS (loteprednol etabonate ophthalmic suspension) 1% is a
twice-a-day corticosteroid for the treatment of inflammation and pain
following ocular surgery. INVELTYS utilizes Kala’s proprietary
Mucus-Penetrating Particle (MPP) technology to enhance penetration into
target tissues of the eye. In preclinical studies, MPP technology
increased delivery of loteprednol etabonate (LE) into ocular tissues
compared to current LE products. INVELTYS was approved by the
About KPI-121 0.25%
Kala is developing KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease utilizing a two-week course of therapy administered four times a day. Dry eye disease is a chronic, episodic, multifactorial disease affecting the tears and ocular surface and can involve tear film instability, inflammation, discomfort, visual disturbance and ocular surface damage. KPI-121 0.25% utilizes Kala's MPP technology to enhance penetration of LE into target tissue of the eye. Kala has completed one Phase 2 and two Phase 3 clinical trials of KPI-121 0.25%. Kala has initiated a third Phase 3 trial, STRIDE 3, for which topline results are expected in the fourth quarter of 2019. Kala believes that, if approved, KPI-121 0.25%'s broad mechanism of anti-inflammatory activity, rapid onset of relief of both dry eye signs and symptoms, favorable tolerability and safety profile and the potential to complement existing therapies, could result in a favorable profile for the management of dry eye flares and other dry eye associated conditions where short-term treatment is beneficial.
About
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, LE, designed for ocular applications, resulting in the recent approval of INVELTYS for the treatment of inflammation and pain following ocular surgery. Kala plans to submit a New Drug Application for KPI-121 0.25%, for the temporary relief of the signs and symptoms of dry eye disease in the second half of 2018.
About
Athyrium is a specialized asset management company formed in 2008 to
focus on investment opportunities in the global healthcare sector.
Athyrium advises funds with over
Kala’s Cautionary Note Regarding 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 INVELTYS for the treatment of inflammation and pain following
ocular surgery and the Company's lead product candidate KPI-121 0.25%
for the temporary relief of the signs and symptoms of dry eye disease,
the commercial potential for INVELTYS and KPI-121 0.25%, the Company’s
expectations regarding the proceeds from its debt facility, the
Company’s ability to access the second tranche under the debt facility.
All statements, other than statements of historical facts, contained in
this Current Report, 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 Company will be able to successfully
implement its commercialization plans for INVELTYS; whether the market
opportunity for INVELTYS is consistent with the Company’s expectations
and market research; data from the Company’s Phase 3 clinical trials of
KPI-121 0.25% will warrant submission and filing of an NDA on the
timeline expected, or at all; whether any additional clinical trials
will be initiated or required for KPI-121 0.25% prior to submission or
filing of an NDA, or at all, and whether any such NDA will be accepted
for filing and/or approved; the Company’s ability to build a specialty
sales force and prepare for commercial launch of INVELTYS on the
timeline expected, or at all; 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 INVELTYS and 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 Quarterly Report on Form 10-Q and
other filings the Company makes with the
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Source:
Investors
Michael Schaffzin
michael@sternir.com
212-362-1200
or
Media
Kari
Watson
kwatson@macbiocom.com
781-235-3060