Serum Institute of India Private Limited has achieved World Health Organization (WHO) prequalification for PNEUMOSIL®, conta...
January 08 2020 - 8:00AM
Pfenex Inc. (NYSE American: PFNX) today announced that Serum
Institute of India Private Limited (Serum Institute) achieved World
Health Organization (WHO) prequalification for Pneumosil, a
10-valent pneumococcal conjugate vaccine. Pneumosil contains the
recombinant carrier protein CRM197 produced by Serum Institute
under a license to the Pfenex Expression Technology®.
Under the agreement with Serum Institute, Pfenex
is eligible to receive annual fees, milestone payments, and a
tiered low single digit royalty based on net sales for all products
developed by Serum Institute that use the CRM197 carrier protein
produced via the Pfenex Expression Technology.
“Our partnership with Serum Institute continues
to be successful. We are thrilled to have played a part in their
mission to help ensure that children of low- and middle-income
countries have access to lifesaving vaccines at a sustainable
price,” said Eef Schimmelpennink, Chief Executive Officer of
Pfenex.
“I am extremely pleased to see the WHO PQ of
Pneumosil. This could help pave the way for saving lives by using a
highly cost-effective Pneumococcal vaccine. For this vaccine, we
have used Pfenex Expression Technology for the manufacturing of
recombinant CRM197 (rCRM197) co-developed with Pfenex. I am
also pleased to note that our next product in the pipeline which
utilizes rCRM197 is also in late stage clinical development,” said
Adar Poonawalla, Chief Executive Officer of Serum Institute of
India.
Pneumosil covers over 71% invasive pneumococcal
disease (IPD) causing serotypes, and targets the Indian Universal
Immunization Programme and Asian, African and other countries under
the Gavi Advanced Market Commitment (AMC).
A second product being developed by Serum
Institute which also utilizes CRM197 as one of its carrier proteins
and is subject to the Pfenex Expression Technology license is a
thermostable Pentavalent Meningococcal Conjugate Vaccine (A, C, Y,
W-135, X). This product is currently in a Phase 3 clinical study
and is also targeted for developing countries.
About CRM197
Pfenex CRM197 is a non-toxic mutant of
diphtheria toxin having a single amino acid substitution of
glutamic acid to glycine at position 52. CRM197 is a well-defined
protein and functions as a carrier for polysaccharides and haptens,
making them immunogenic. It is utilized as a carrier protein in
several approved conjugate vaccines for diseases such as
Streptococcus pneumoniae, Haemophilus influenzae b and Neisseria
meningitidis. Pfenex CRM197 is a recombinant, soluble form produced
by the Pfenex Expression Technology® platform. CRM197 is currently
being used by vaccine development focused pharmaceutical partners,
including Merck and the Serum Institute of India Private Ltd.,
(SIIPL). In 2018, Merck announced that it had initiated multiple
Phase 3 clinical studies of PCV-15 (V114), an investigational
polyvalent conjugate vaccine for the prevention of pneumococcal
disease. SIIPL who is developing a 10-valent pneumococcal conjugate
vaccine, Pneumosil recently achieved World Health Organization
Prequalification (PQ).
About Pfenex Inc.
Pfenex is a development and licensing
biotechnology company focused on leveraging its Pfenex Expression
Technology® to develop and improve protein therapies for unmet
patient needs. Using the patented Pfenex Expression Technology
platform, Pfenex has created an advanced pipeline of potential
therapeutic equivalents, and vaccines. Pfenex’s lead product
candidate is PF708, a therapeutic equivalent candidate to Forteo®
(teriparatide injection). PF708 has been approved 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
hematology/oncology products in collaboration with Jazz
Pharmaceuticals, including PF743, a recombinant crisantaspase, and
PF745, a recombinant crisantaspase with half-life extension
technology. Pfenex also uses its Pfenex Expression Technology
platform to produce CRM197, a diphtheria toxoid carrier protein
used in prophylactic and therapeutic vaccines.
Cautionary Note Regarding
Forward-Looking Statement –
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 Pfenex's expectation with respect to its
agreement with Serum Institute, including its potential to receive
annual fees, milestone payments and future royalties; and Pfenex’s
expectations with respect to the potential benefits of Pneumosil.
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 the uncertainties inherent in the clinical drug
development process, including, without limitation, the ability to
successfully demonstrate the efficacy and safety of product
candidates; the pre-clinical and clinical results for its product
candidates, which may not support further development of product
candidates or may require additional clinical trials or
modifications to 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; 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; and litigation and other proceedings regarding
intellectual property rights. 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 period ended September 30,
2019 filed with the Securities and Exchange Commission 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
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