THOUSAND OAKS, Calif.,
Sept. 20, 2021 /PRNewswire/ -- Amgen
today announced that the U.S. District Court for the District of
New Jersey has upheld patents that
protect Amgen's psoriasis therapy Otezla® (apremilast)
in a patent infringement lawsuit against Sandoz Inc. ("Sandoz") and
Zydus Pharmaceuticals (USA), Inc.
("Zydus"). The asserted patents claim apremilast as a composition
of matter ("COM"), methods of treating psoriasis with apremilast,
and crystalline forms of apremilast. The court found infringement
and upheld the validity of four patents – three against each
defendant -- but ruled against Amgen on claims in U.S. Patent No.
10,092,541 covering methods of treating psoriasis with apremilast
according to a specific dosing schedule. Today's decision will
prevent Sandoz and Zydus from making, using, selling, offering to
sell, or importing each of their generic versions of Otezla until
expiration of the COM patent, U.S. Patent No. 7,427,638, in
Feb. 2028.
The decision comes after the New
Jersey court held a bench trial in June 2021. Prior to trial, Sandoz acknowledged
that its generic version of Otezla infringes eight claims in U.S.
Patent Nos. 7,427,638, 7,893,101, 8,455,536, and 10,092,541, and
Zydus acknowledged that its generic version of Otezla infringes
eight claims in U.S. Patent Nos. 7,427,638, 8,093,283, 8,455,536,
and 10,092,541, leaving only the issues of whether Zydus's generic
version of Otezla infringes U.S. Patent No. 7,893,101 and the
validity of the asserted patent claims to be addressed by the
court.
Amgen believes in the value of intellectual property and will
continue to vigorously defend its intellectual property rights.
In the U.S., Otezla is approved for the treatment of adult
patients with moderate-to-severe plaque psoriasis who are
candidates for phototherapy or systemic therapy, adult patients
with active psoriatic arthritis and adult patients with oral ulcers
associated with Behçet's Disease.
About
Otezla® (apremilast)
OTEZLA® (apremilast)
is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4)
specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition
results in increased intracellular cAMP levels, which is thought to
indirectly modulate the production of inflammatory mediators. The
specific mechanism(s) by which Otezla exerts its therapeutic action
in patients is not well defined.
Otezla® (apremilast) U.S. INDICATIONS
Otezla® (apremilast)
is indicated for the treatment of adult patients with moderate to
severe plaque psoriasis who are candidates for phototherapy or
systemic therapy.
Otezla is indicated for the treatment of adult patients with
active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with
oral ulcers associated with Behçet's Disease.
Otezla® (apremilast) U.S. IMPORTANT
SAFETY INFORMATION
Contraindications
- Otezla® (apremilast) is contraindicated in
patients with a known hypersensitivity to apremilast or to any of
the excipients in the formulation
Warnings and Precautions
- Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea,
nausea, and vomiting were associated with the use of Otezla. Most
events occurred within the first few weeks of treatment. In some
cases, patients were hospitalized. Patients 65 years of age or
older and patients taking medications that can lead to volume
depletion or hypotension may be at a higher risk of complications
from severe diarrhea, nausea, or vomiting. Monitor patients who are
more susceptible to complications of diarrhea or vomiting; advise
patients to contact their healthcare provider. Consider Otezla dose
reduction or suspension if patients develop severe diarrhea,
nausea, or vomiting
- Depression: Carefully weigh the risks and benefits of treatment
with Otezla for patients with a history of depression and/or
suicidal thoughts/behavior, or in patients who develop such
symptoms while on Otezla. Patients, caregivers, and families should
be advised of the need to be alert for the emergence or worsening
of depression, suicidal thoughts, or other mood changes, and they
should contact their healthcare provider if such changes occur
-
- Psoriasis: Treatment with Otezla is associated with an
increase in depression. During clinical trials, 1.3% (12/920) of
patients reported depression compared to 0.4% (2/506) on placebo.
Depression was reported as serious in 0.1% (1/1308) of patients
exposed to Otezla, compared to none in placebo-treated patients
(0/506). Suicidal behavior was observed in 0.1% (1/1308) of
patients on Otezla, compared to 0.2% (1/506) on placebo. One
patient treated with Otezla attempted suicide; one patient on
placebo committed suicide
- Psoriatic Arthritis: Treatment with Otezla is associated
with an increase in depression. During clinical trials, 1.0%
(10/998) reported depression or depressed mood compared to 0.8%
(4/495) treated with placebo. Suicidal ideation and behavior was
observed in 0.2% (3/1441) of patients on Otezla, compared to none
in placebo-treated patients. Depression was reported as serious in
0.2% (3/1441) of patients exposed to Otezla, compared to none in
placebo-treated patients (0/495). Two patients who received placebo
committed suicide compared to none on Otezla
- Behcet's Disease: Treatment with Otezla is associated with
an increase in depression. During the phase 3 clinical trial, 1%
(1/104) reported depression or depressed mood compared to 1%
(1/103) treated with placebo. No instances of suicidal ideation or
behavior were reported in patients treated with Otezla or treated
with placebo
- Weight Decrease: Monitor body weight regularly; evaluate
unexplained or clinically significant weight loss, and consider
discontinuation of Otezla
-
- Psoriasis: During clinical trials, body weight loss of
5-10% occurred in 12% (96/784) of patients treated with Otezla and
in 5% (19/382) of patients treated with placebo. Body weight loss
of ≥10% occurred in 2% (16/784) of patients treated with Otezla
compared to 1% (3/382) of patients treated with placebo
- Psoriatic Arthritis: During clinical trials, body weight
loss of 5-10% was reported in 10% (49/497) of patients taking
Otezla and in 3.3% (16/495) of patients taking placebo
- Behçet's Disease: During the phase 3 clinical trial, body
weight loss of >5% was reported in 4.9% (5/103) of patients
taking Otezla and in 3.9% (4/102) of patients taking placebo
- Drug Interactions: Apremilast exposure was decreased when
Otezla was co-administered with rifampin, a
strong CYP450 enzyme inducer; loss of Otezla efficacy may
occur. Concomitant use of Otezla with CYP450 enzyme
inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin)
is not recommended
Adverse Reactions
- Psoriasis: Adverse reactions reported in ≥5% of patients
were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper
respiratory tract infection (9, 6), tension headache (8, 4), and
headache (6, 4)
- Psoriatic Arthritis: Adverse reactions reported in at
least 2% of patients taking Otezla, that occurred at a frequency at
least 1% higher than that observed in patients taking placebo, for
up to 16 weeks (after the initial 5-day titration), were (Otezla%,
placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9,
2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2,
0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0,
0.2)
- Behçet's Disease: Adverse reactions reported in at least
≥5% of patients taking Otezla, that occurred at a frequency at
least 1% higher than that observed in patients taking placebo, for
up to 12 weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4);
nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract
infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting
(8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract
infection (6.7, 4.9); arthralgia (5.8, 2.9)
Use in Specific Populations
- Pregnancy: Otezla has not been studied in pregnant women.
Advise pregnant women of the potential risk of fetal loss. Consider
pregnancy planning and prevention for females of reproductive
potential. There is a pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to Otezla during pregnancy.
Information about the registry can be obtained by calling
1-877-311-8972 or
visiting https://mothertobaby.org/ongoing-study/otezla/
- Lactation: There are no data on the presence of apremilast or
its metabolites in human milk, the effects of apremilast on the
breastfed infant, or the effects of the drug on milk production.
The developmental and health benefits of breastfeeding should be
considered along with the mother's clinical need for Otezla and any
potential adverse effects on the breastfed child from Otezla or
from the underlying maternal condition
- Renal Impairment: Otezla dosage should be reduced in patients
with severe renal impairment (creatinine clearance less than 30
mL/min) for details, see Dosage and Administration, Section 2, in
the Full Prescribing Information
Please click here for Otezla® Full
Prescribing Information.
About Amgen
Amgen is committed to unlocking the
potential of biology for patients suffering from serious illnesses
by discovering, developing, manufacturing and delivering innovative
human therapeutics. This approach begins by using tools like
advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its biologics manufacturing expertise to strive for solutions that
improve health outcomes and dramatically improve people's lives. A
biotechnology pioneer since 1980, Amgen has grown to be the world's
largest independent biotechnology company, has reached millions of
patients around the world and is developing a pipeline of medicines
with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
Amgen Forward-Looking Statements
This news release
contains forward-looking statements that are based on the current
expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including any statements on the
outcome, benefits and synergies of collaborations, or potential
collaborations, with any other company (including BeiGene, Ltd.,
Kyowa-Kirin Co., Ltd., or any collaboration to manufacture
therapeutic antibodies against COVID-19), the performance of
Otezla® (apremilast) (including anticipated Otezla sales
growth and the timing of non-GAAP EPS accretion), or the Five Prime
Therapeutics, Inc. acquisition, as well as estimates of revenues,
operating margins, capital expenditures, cash, other financial
metrics, expected legal, arbitration, political, regulatory or
clinical results or practices, customer and prescriber patterns or
practices, reimbursement activities and outcomes, effects of
pandemics or other widespread health problems such as the ongoing
COVID-19 pandemic on our business, outcomes, progress, or effects
relating to studies of Otezla as a potential treatment for
COVID-19, and other such estimates and
results. Forward-looking statements involve significant risks
and uncertainties, including those discussed below and more fully
described in the Securities and Exchange Commission reports filed
by Amgen, including our most recent annual report on Form 10-K and
any subsequent periodic reports on Form 10-Q and current reports on
Form 8-K. Unless otherwise noted, Amgen is providing this
information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future
events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project. Our results
may be affected by our ability to successfully market both new and
existing products domestically and internationally, clinical and
regulatory developments involving current and future products,
sales growth of recently launched products, competition from other
products including biosimilars, difficulties or delays in
manufacturing our products and global economic conditions. In
addition, sales of our products are affected by pricing pressure,
political and public scrutiny and reimbursement policies imposed by
third-party payers, including governments, private insurance plans
and managed care providers and may be affected by regulatory,
clinical and guideline developments and domestic and international
trends toward managed care and healthcare cost containment.
Furthermore, our research, testing, pricing, marketing and other
operations are subject to extensive regulation by domestic and
foreign government regulatory authorities. We or others could
identify safety, side effects or manufacturing problems with our
products, including our devices, after they are on the market. Our
business may be impacted by government investigations, litigation
and product liability claims. In addition, our business may be
impacted by the adoption of new tax legislation or exposure to
additional tax liabilities. If we fail to meet the compliance
obligations in the corporate integrity agreement between us and the
U.S. government, we could become subject to significant sanctions.
Further, while we routinely obtain patents for our products and
technology, the protection offered by our patents and patent
applications may be challenged, invalidated or circumvented by our
competitors, or we may fail to prevail in present and future
intellectual property litigation. We perform a substantial amount
of our commercial manufacturing activities at a few key facilities,
including in Puerto Rico, and also
depend on third parties for a portion of our manufacturing
activities, and limits on supply may constrain sales of certain of
our current products and product candidate development. An outbreak
of disease or similar public health threat, such as COVID-19, and
the public and governmental effort to mitigate against the spread
of such disease, could have a significant adverse effect on the
supply of materials for our manufacturing activities, the
distribution of our products, the commercialization of our product
candidates, and our clinical trial operations, and any such events
may have a material adverse effect on our product development,
product sales, business and results of operations. We rely on
collaborations with third parties for the development of some of
our product candidates and for the commercialization and sales of
some of our commercial products. In addition, we compete with other
companies with respect to many of our marketed products as well as
for the discovery and development of new products. Discovery or
identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, some raw materials, medical
devices and component parts for our products are supplied by sole
third-party suppliers. Certain of our distributors, customers and
payers have substantial purchasing leverage in their dealings with
us. The discovery of significant problems with a product similar to
one of our products that implicate an entire class of products
could have a material adverse effect on sales of the affected
products and on our business and results of operations. Our efforts
to collaborate with or acquire other companies, products or
technology, and to integrate the operations of companies or to
support the products or technology we have acquired, may not be
successful. A breakdown, cyberattack or information security breach
could compromise the confidentiality, integrity and availability of
our systems and our data. Our stock price is volatile and may be
affected by a number of events. Global economic conditions may
magnify certain risks that affect our business. Our business
performance could affect or limit the ability of our Board of
Directors to declare a dividend or our ability to pay a dividend or
repurchase our common stock. We may not be able to access the
capital and credit markets on terms that are favorable to us, or at
all.
CONTACT: Amgen, Thousand
Oaks
Trish Rowland, 805-447-5631
(media)
Michael Strapazon, 805-313-5553
(media)
Arvind Sood, 805-447-1060
(investors)
View original content to download
multimedia:https://www.prnewswire.com/news-releases/amgen-wins-patent-case-on-otezla-apremilast-301380921.html
SOURCE Amgen