-Vertex to develop CTP-656 for potential use in
future combination regimens aimed at treating the underlying cause
of CF-
-Concert to receive $160 million in cash with
potential for $90 million in future regulatory approval milestone
payments-
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today
announced that it has signed a definitive asset purchase agreement
to acquire CTP-656 from Concert Pharmaceuticals (Nasdaq: CNCE).
CTP-656 is an investigational cystic fibrosis transmembrane
conductance regulator (CFTR) potentiator that has the potential to
be used as part of future once-daily combination regimens of CFTR
modulators that treat the underlying cause of cystic fibrosis (CF).
As part of the agreement, Vertex will pay Concert $160 million in
cash for all worldwide development and commercialization rights to
CTP-656. If CTP-656 is approved as part of a combination regimen to
treat CF, Concert could receive up to an additional $90 million in
milestones based on regulatory approval in the U.S. and
reimbursement in the UK, Germany or France. The agreement is
subject to approval by Concert’s shareholders and the expiration of
the waiting period under the Hart-Scott-Rodino Antitrust
Improvements Act. Concert’s Board of Directors unanimously supports
the transaction and recommends that Concert’s shareholders vote in
favor of it.
“Our vision is to develop the most effective and convenient
medicines for people with CF,” said Jeffrey Chodakewitz, M.D.,
Executive Vice President and Chief Medical Officer at Vertex. “We
look forward to exploring once-daily regimens that combine CTP-656
with other potential medicines from our broad CF pipeline that
treat the underlying cause of the disease.”
CTP-656 was developed by Concert through the application of
deuterium chemistry to modify Vertex’s CFTR potentiator, ivacaftor.
Ivacaftor was discovered by Vertex scientists and is approved in
the U.S., Europe, Canada and Australia for people with CF who have
specific mutations in the CFTR gene. CTP-656 has the potential to
play a key role in future once-daily combination regimens to treat
CF. Concert is currently conducting a Phase 2 study of CTP-656 in
people with CF who have gating mutations. As part of the agreement,
Vertex will acquire rights to all of Concert’s other CF research
and preclinical programs.
INDICATION AND IMPORTANT SAFETY
INFORMATION FOR KALYDECO® (ivacaftor)
KALYDECO (ivacaftor) is a prescription medicine used for the
treatment of cystic fibrosis (CF) in patients age 2 years and older
who have one of the following mutations in their CF gene: G551D,
G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or
R117H. KALYDECO is not for use in people with CF due to other
mutations in the CF gene. KALYDECO is not effective in patients
with CF with two copies of the F508del mutation (F508del/F508del)
in the CF gene. It is not known if KALYDECO is safe and effective
in children under 2 years of age.
Patients should not take KALYDECO if they are taking certain
medicines or herbal supplements such as: the antibiotics
rifampin or rifabutin; seizure medications such as phenobarbital,
carbamazepine, or phenytoin; or St. John's wort.
Before taking KALYDECO, patients should tell their doctor if
they: have liver or kidney problems; drink grapefruit juice, or
eat grapefruit or Seville oranges; are pregnant or plan to become
pregnant because it is not known if KALYDECO will harm an unborn
baby; and are breastfeeding or planning to breastfeed because is
not known if KALYDECO passes into breast milk.
KALYDECO may affect the way other medicines work, and other
medicines may affect how KALYDECO works. Therefore the dose of
KALYDECO may need to be adjusted when taken with certain
medications. Patients should especially tell their doctor if they
take antifungal medications such as ketoconazole, itraconazole,
posaconazole, voriconazole, or fluconazole; or antibiotics such as
telithromycin, clarithromycin, or erythromycin.
KALYDECO can cause dizziness in some people who take it.
Patients should not drive a car, use machinery, or do anything that
needs them to be alert until they know how KALYDECO affects them.
Patients should avoid food containing grapefruit or Seville oranges
while taking KALYDECO.
KALYDECO can cause serious side effects including:
High liver enzymes in the blood have been reported in
patients receiving KALYDECO. The patient's doctor will do blood
tests to check their liver before starting KALYDECO, every 3 months
during the first year of taking KALYDECO, and every year while
taking KALYDECO. For patients who have had high liver enzymes in
the past, the doctor may do blood tests to check the liver more
often. Patients should call their doctor right away if they have
any of the following symptoms of liver problems: pain or discomfort
in the upper right stomach (abdominal) area; yellowing of their
skin or the white part of their eyes; loss of appetite; nausea or
vomiting; or dark, amber-colored urine.
Abnormality of the eye lens (cataract) has been noted in some
children and adolescents receiving KALYDECO. The patient's doctor
should perform eye examinations prior to and during treatment with
KALYDECO to look for cataracts. The most common side effects
include headache; upper respiratory tract infection (common cold),
which includes sore throat, nasal or sinus congestion, and runny
nose; stomach (abdominal) pain; diarrhea; rash; nausea; and
dizziness.
These are not all the possible side effects of KALYDECO.
Please click here to see the full Prescribing
Information for KALYDECO (ivacaftor).
About Cystic Fibrosis
Cystic fibrosis is a rare, life-threatening genetic disease
affecting approximately 75,000 people in North
America, Europe and Australia.
CF is caused by a defective or missing CFTR protein resulting
from mutations in the CFTR gene. Children must inherit
two defective CFTR genes — one from each parent — to have
CF. There are approximately 2,000 known mutations in
the CFTR gene. Some of these mutations, which can be
determined by a genetic test, lead to CF by creating defective or
too few CFTR proteins at the cell surface. The defective or missing
CFTR protein results in poor flow of salt and water into or out of
the cell in a number of organs, including the lungs. This leads to
the buildup of abnormally thick, sticky mucus that can cause
chronic lung infections and progressive lung damage in many
patients that eventually leads to death. The median predicted age
of survival for a person born today with CF is 41 years, but the
median age of death is 27 years.
About Vertex
Vertex is a global biotechnology company that aims to discover,
develop and commercialize innovative medicines so people with
serious diseases can lead better lives. In addition to our clinical
development programs focused on cystic fibrosis, Vertex has more
than a dozen ongoing research programs aimed at other serious and
life-threatening diseases.
Founded in 1989 in Cambridge, Mass., Vertex today has research
and development sites and commercial offices in the United States,
Europe, Canada and Australia. For seven years in a row, Science
magazine has named Vertex one of its Top Employers in the life
sciences. For additional information and the latest updates from
the company, please visit www.vrtx.com.
Special Note Regarding Forward-looking
Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995,
including, without limitation, Dr. Chodakewitz’s statements in the
second paragraph of the press release and statements regarding (i)
approval by Concert’s shareholders and the expiration of the
waiting period under the Hart-Scott-Rodino Antitrust Improvements
Act, and (ii) potential milestone payments. While Vertex believes
the forward-looking statements contained in this press release are
accurate, these forward-looking statements represent the company's
beliefs only as of the date of this press release and there are a
number of factors that could cause actual events to differ
materially from those indicated by such forward-looking statements.
These risks and uncertainties include, among other things, the
risks listed under Risk Factors in Vertex's annual report and
quarterly reports filed with the Securities and Exchange Commission
and available through the company's website at www.vrtx.com. Vertex
disclaims any obligation to update the information contained in
this press release as new information becomes available.
Additional Information about the
Transaction and Where to Find It
This press release is being made in respect of the proposed
asset purchase with Concert. The proposed asset purchase and the
asset purchase agreement will be submitted to Concert’s
shareholders for their consideration and approval. In connection
with the proposed asset purchase, Concert will file a proxy
statement with the SEC. This press release does not constitute a
solicitation of any vote or proxy from any shareholder of Concert.
Investors are urged to read the proxy statement carefully and in
its entirety when it becomes available and any other relevant
documents or materials filed or to be filed with the SEC or
incorporated by reference in the proxy statement, because they will
contain important information about the proposed asset sale. The
definitive proxy statement will be mailed to Concert’s
shareholders. In addition, the proxy statement and other documents
will be available free of charge at the SEC’s internet website,
www.sec.gov. When available, the proxy statement and other
pertinent documents may also be obtained free of charge at the
Investors section of Concert’s website, www.concertpharma.com, or
by directing a written request to Concert Pharmaceuticals, Inc.,
Attn: Investor Relations, in writing, at 99 Hayden Ave, #500,
Lexington, MA 02421.
Certain Information Concerning
Participants
Vertex and its directors, executive officers and other members
of management and employees may be deemed to be participants in the
solicitation of proxies in connection with the proposed asset
purchase. Information about Vertex’s directors and executive
officers is included in Vertex’s Annual Report on Form 10-K for the
year ended December 31, 2016 filed with the SEC on February 23,
2017.
(VRTX-GEN)
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version on businesswire.com: http://www.businesswire.com/news/home/20170306005367/en/
Investors:Vertex Pharmaceuticals IncorporatedMichael
Partridge, 617-341-6108orEric Rojas, 617-961-7205orZach Barber,
617-341-6470orMedia:mediainfo@vrtx.comUS: 617-341-6992Europe
& Australia: +44 20 3204 5275
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