Pfenex Inc. (NYSE American: PFNX) today announced
that its commercialization partner, Alvogen, has launched
Teriparatide Injection in the United States. Teriparatide
Injection (also referred to as PF708 and Bonsity™) is a
prescription medicine approved for several uses, including in
postmenopausal women with osteoporosis who are at high risk for
having bone fractures.
Teriparatide Injection is the first teriparatide
product since Forteo® (teriparatide injection)1-3 approved for this
use. The Alvogen product is pharmaceutically equivalent to
Forteo (that is, has the same active ingredient in the same
strength, dosage form and route of administration) and has been
shown to have comparable bioavailability. These
characteristics allowed the product to be approved under a
505(b)(2) NDA for which Forteo was the reference drug. It may
provide a lower-cost teriparatide option4 for increasing bone
density in patients at high risk for fracture5, and is FDA-approved
for the same indications as Forteo, which means it can be used for
the same patients as Forteo, including new patients and those
currently responding to treatment1,2.
“We are pleased to announce the availability of
Teriparatide Injection in pharmacies - the first new
FDA-approved teriparatide, which provides an alternative to
Forteo,” said Pfenex CEO Eef Schimmelpennink. “As the
first Pfenex-developed product to reach the market, this marks an
important milestone for the company and delivers on the promise of
the Pfenex Expression Technology platform.”
“Alvogen is excited to bring this critical product to patients
in need of a lower-cost alternative to Forteo,” said Lisa Graver,
President of Alvogen, Inc. “We are happy to partner with Pfenex to
bring this product to market.”
1Teriparatide Injection prescribing information:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b007339-dd0d-f019-5e0a-9b1b0f75011c.
Morristown, NJ: Alvogen, Inc.; 2019. 2Forteo prescribing
information: https://uspl.lilly.com/forteo/forteo.html#pi.
Indianapolis, IN: Eli Lilly and Company; 2012. 3Data on File.4Lower
WAC and AWP compared to Forteo® (teriparatide injection). 5High
risk for fracture is defined as a history of osteoporotic fracture,
multiple risk factors for fracture, or patients who have failed or
are intolerant to other available osteoporosis therapy.
About Teriparatide Injection
Teriparatide
Injection (https://www.alvogenteriparatide.com/) is
a medication designed to assist in building new bone and is
comprised of protein similar to one naturally produced by the body.
It has also been shown to help increase bone strength.1
Teriparatide Injection helps to reinforce bone by
replacing—and replenishing—that which has been lost due to
osteoporosis. Postmenopausal women with osteoporosis, who were at
high risk for fracture, experienced significantly increased bone
mineral density in the spine, after taking Teriparatide Injection
with calcium and vitamin D. These results were demonstrated at
three months, and throughout the treatment period. The risk of new
spine fractures was reduced by approximately two thirds; the risk
of new fractures in other bones—including the ankle/foot, hip,
upper arm, pelvis, ribs and wrist—was cut in half.2
Teriparatide Injection is contraindicated for
those patients with a hypersensitivity to teriparatide or to any of
its excipients. Reactions have included angioedema and anaphylaxis.
(Prescribing Information:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b007339-dd0d-f019-5e0a-9b1b0f75011c)
As part of drug testing, teriparatide, the
active ingredient in Teriparatide Injection, was given to rats for
a significant part of their lifetime. In these studies,
teriparatide caused some rats to develop osteosarcoma, a bone
cancer. Osteosarcoma in humans is a serious but very rare cancer.
Osteosarcoma occurs in about four out of every million older adults
each year. It is not known if humans treated with Teriparatide
Injection also have a higher chance of getting osteosarcoma. Other
side effects may include nausea, dizziness, leg cramps and joint
aches. Injection site reactions include redness, swelling, pain,
itching, a few drops of blood and bruising. (Prescribing
Information:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b007339-dd0d-f019-5e0a-9b1b0f75011c)
1Only proven in postmenopausal women with osteoporosis.2This
clinical study involved 1,637 postmenopausal women with
osteoporosis, of whom 90% had a spine fracture. 541 women took a
daily 20-mcg dose of Teriparatide Injection; 544 took a placebo for
a median time of 19 months, and a maximum of 24 months. All women
took calcium and vitamin D daily.
About Osteoporosis
Osteoporotic fractures create a significant
healthcare burden. An estimated two million osteoporotic fractures
occur annually in the United States, and this number is projected
to grow to three million by 2025. Osteoporosis is a disease of the
bone that makes a person’s bones weak and more likely to break.
Approximately 10 million Americans have osteoporosis and another 44
million have low bone mass placing them at increased risk for
osteoporosis. The annual incidence of osteoporotic fractures in
women is higher than that of stroke, heart attack and breast cancer
combined. A woman’s risk of fracture is equal to her combined risk
of breast, uterine and ovarian cancer.
About Pfenex Inc.
Pfenex is a development and licensing
biotechnology company focused on leveraging its proprietary protein
production platform, Pfenex Expression Technology®, to develop next
generation and novel protein therapeutics to meaningfully improve
existing therapies and create novel therapies for some of the
biological targets linked to critical diseases still waiting to
successfully be addressed. Using the patented Pfenex Expression
Technology platform, Pfenex has created a broad pipeline that is
diversified across multiple assets, including U.S. Food and Drug
Administration (FDA) approved, next generation and novel
biopharmaceutical products. Pfenex’s lead product is Teriparatide
Injection (previously referred to as PF708 and Bonsity™), a
therapeutic equivalent candidate to Forteo® (teriparatide
injection). Teriparatide Injection has been commercialized in the
U.S. for the treatment of osteoporosis in certain patients at high
risk for fracture, and marketing authorization applications are
pending in other jurisdictions. In addition, Pfenex is developing
hematologic oncology products in collaboration with Jazz
Pharmaceuticals, including PF743, a recombinant Erwinia
asparaginase, and PF745, a half-life extended recombinant Erwinia
asparaginase. Pfenex also uses its Pfenex Expression Technology
platform to produce CRM197, a diphtheria toxoid carrier protein for
use in prophylactic and therapeutic vaccines.
Pfenex investors and others should note that
Pfenex announces material information to the public about Pfenex
through a variety of means, including its website
(http://www.pfenex.com/), its investor relations website
(http://pfenex.investorroom.com/), press releases, SEC filings,
public conference calls, corporate Twitter account
(https://twitter.com/pfenex), Facebook page
(https://www.facebook.com/Pfenex-Inc-105908276167776/timeline/),
and LinkedIn page (https://www.linkedin.com/company/pfenex-inc) in
order to achieve broad, non-exclusionary distribution of
information to the public and to comply with its disclosure
obligations under Regulation FD. Pfenex encourages its investors
and others to monitor and review the information Pfenex makes
public in these locations as such information could be deemed to be
material information. Please note that this list may be updated
from time to time.
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. Forward-looking statements generally relate to
future events or Pfenex's future financial or operating
performance. In some cases, you can identify forward-looking
statements because they contain words such as "may," "will,"
"should," "expects," "plans," "anticipates," "could," "intends,"
"target," "projects," "contemplates," "believes," "estimates,"
"predicts," "potential" or "continue" or the negative of these
words or other similar terms or expressions that concern Pfenex's
future expectations, strategy, plans or intentions. Forward-looking
statements in this press release include, but are not limited to,
statements regarding the future potential of Pfenex’s developed
products, product candidates, and the company in general, including
the potential benefits of Teriparatide Injection, Pfenex
expectations with respect to Teriparatide Injection cost, and
expected market size and growth opportunities for Teriparatide
Injection. Pfenex's expectations and beliefs regarding these
matters may not materialize, and actual results in future periods
are subject to risks and uncertainties that could cause actual
results to differ materially from those projected. Actual results
may differ materially from those indicated by these forward-looking
statements as a result of various factors, including: the FDA may
not grant an “A” therapeutic equivalence designation for PF708;
Pfenex's ability to successfully demonstrate the efficacy and
safety of its product candidates; the pre-clinical and clinical
results for its product candidates, which may not support further
development of product candidates or may require Pfenex to conduct
additional clinical trials or modify ongoing clinical trials or
regulatory pathways; challenges related to commencement, patient
enrollment, completion, and analysis of clinical trials; Pfenex's
ability to manage operating expenses; impacts related to the
COVID-19 pandemic; Pfenex's ability to obtain additional funding to
support its business activities and establish and maintain
strategic business alliances and new business initiatives; Pfenex's
dependence on third parties for development, manufacture,
marketing, sales and distribution of products; unexpected
expenditures; litigation and other proceedings regarding
intellectual property rights; and difficulties in obtaining and
maintaining intellectual property protection for its product
candidates. Information on these and additional risks,
uncertainties, and other information affecting Pfenex's business
and operating results is contained in Pfenex’s Quarterly Report on
Form 10-Q for the quarter ended March 31, 2020 and in its other
filings with the Securities and Exchange Commission. The
forward-looking statements in this press release are based on
information available to Pfenex as of the date hereof, and Pfenex
disclaims any obligation to update any forward-looking statements,
except as required by law.
Company Contact:InvestorRelations@pfenex.com
About Alvogen, Inc.
Alvogen is a global, privately owned
pharmaceutical company focused on developing, manufacturing and
selling generic, brand, over-the counter (OTC) and biosimilar
products for patients around the world. With commercial footprint
in over 20 markets, Alvogen’s key regions include the U.S. and
emerging markets in APAC regions.
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