– Covers Development of Investigational Plasma Kallikrein
Inhibitors for Treatment of Diabetic Macular Edema–
– $37 Million Upfront Fee Plus Potential Milestone Payments and
Sales Royalties –
– Merck Acquires 9.9% Stake in KalVista in Private Placement –
– Investigational Intravitreal DME Candidate KVD001 Phase 2
Clinical Trial Still Planned to Initiate in 2017 –
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 10, 2017--
KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage
pharmaceutical company focused on the discovery, development, and
commercialization of small molecule protease inhibitors, today announced
that it has entered into a collaboration agreement with Merck, known as
MSD outside the United States and Canada, through a subsidiary, for
KVD001, the Company's investigational intravitreal (IVT) injection
candidate currently in development for potential treatment of diabetic
macular edema (DME), as well as future oral DME compounds based upon
plasma kallikrein inhibition.
"We are pleased to collaborate with Merck for the continuing development
of KVD001 and future oral programs for patients with DME," said Andrew
Crockett, Chief Executive Officer of KalVista. "Plasma kallikrein
inhibition is a novel approach to the treatment of DME that we believe
may offer benefit to a significant number of patients, and an oral
therapy particularly would represent a groundbreaking advance for
treatment of this indication. We have always believed that development
and commercialization of our DME therapies would require the resources
of a large pharmaceutical company, and we believe Merck has the
wherewithal and resources to help us advance development of our DME drug
candidates. Importantly for KalVista, this collaboration also meets our
strategic objectives of maintaining control of our oral HAE portfolio
that we plan to develop independently. We look forward to providing more
details about the Phase 2 trial for KVD001 in DME patients as the trial
Under the terms of the agreement, KalVista has granted to Merck certain
rights including an option to acquire KVD001 through a period following
completion of the Phase 2 proof-of-concept trial that KalVista intends
to commence later this year. KalVista also has granted to Merck a
similar option to acquire investigational orally delivered molecules for
DME that KalVista will continue to develop as part of its ongoing
research and development activities. As consideration for the agreement,
Merck will pay to KalVista a $37 million non-refundable upfront fee.
KalVista is further eligible to receive payments associated with the
exercise of the options by Merck and the achievement of milestones for
each program that potentially total up to $715 million. KalVista also
will receive tiered royalties on net sales for therapeutic candidates
commercialized under this agreement. KalVista will fund and retain
control over the planned Phase 2 clinical trial of KVD001 as well as
development of the investigational oral DME compounds through Phase 2,
unless Merck exercises its options earlier.
In addition to the collaboration, KalVista has entered into a separate
$9.1 million private placement transaction with Merck under which Merck
has acquired 1,070,589 shares of KalVista, representing a 9.9% ownership
stake, at a price of $8.50 per share. This private placement closed
concurrent with execution of the Option Agreement.
"The KalVista team has already made important progress in advancing this
candidate into the clinic. At Merck, we look forward to the opportunity
to apply our expertise and resources upon the achievement of proof of
concept for KVD001," said Ben Thorner, senior vice president and Head of
Business Development & Licensing Merck Research Laboratories. "Merck is
seeking to collaborate on the development of candidates that we believe
have the potential to transform practice in areas where there is a clear
need for new and improved therapeutic options."
The agreement with Merck covers only the investigational IVT and oral
plasma kallikrein inhibitor programs for DME. KalVista retains full
rights to its oral hereditary angioedema (HAE) portfolio, and will have
the opportunity to select and develop future oral HAE compounds.
KalVista intends to continue to aggressively pursue its efforts to
develop a best-in-class oral therapy for HAE, as well as additional
programs focused on other proteases.
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on
the discovery, development, and commercialization of small molecule
protease inhibitors for diseases with significant unmet need. The
initial focus is on inhibitors of plasma kallikrein, which is an
important component of the body's inflammatory response and which, in
excess, can lead to increased vascular permeability, edema and
inflammation. KalVista has developed a proprietary portfolio of novel,
small molecule plasma kallikrein inhibitors initially targeting
hereditary angioedema (HAE) and diabetic macular edema (DME). The
Company has created a structurally diverse portfolio of oral plasma
kallikrein inhibitors from which it plans to select multiple drug
candidates to advance into clinical trials for HAE. The first candidate
of this planned portfolio, KVD818, is currently in a first-in-human
study and additional program candidates are in preclinical development.
KalVista's most advanced program, an intravitreally administered plasma
kallikrein inhibitor known as KVD001, has successfully completed its
first-in-human study in patients with DME and is being prepared for
Phase 2 studies in 2017.
For more information, please visit www.kalvista.com.
This press release contains "forward-looking" statements within the
meaning of the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995. Forward-looking statements can be
identified by words such as: "anticipate," "intend," "plan," "goal,"
"seek," "believe," "project," "estimate," "expect," "strategy,"
"future," "likely," "may," "should," "will" and similar references to
future periods. These statements are subject to numerous risks and
uncertainties that could cause actual results to differ materially from
what we expect. Examples of forward-looking statements include, among
others, available funding and future clinical trial timing and results.
Further information on potential risk factors that could affect our
business and its financial results are detailed in the annual report on
Form 10-K filed on July 27, 2017, our most recent Quarterly Report on
Form 10-Q, and other reports as filed from time to time with
the Securities and Exchange Commission. We undertake no obligation to
publicly update any forward-looking statement, whether written or oral,
that may be made from time to time, whether as a result of new
information, future developments or otherwise.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171010005129/en/
Source: KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc.
Leah Monteiro, 857-999-0808
Corporate Communications & Investor Relations