SAN DIEGO, Jan. 9, 2012/PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today provided an update on commercial sales of DIFICID® (fidaxomicin) tablets since launching the antibacterial drug in July 2011for the treatment of Clostridium difficile associated-diarrhea (CDAD) in adults 18 years of age or older in the United States.
"Sales of DIFICID in the United Statesover the past five and a half months reflect the strong initial demand for a new antibacterial drug providing a superior sustained clinical response through 25 days after the end of treatment for CDAD. Wholesale level shipments in the fourth quarter of 2011 increased almost 87% compared to the third quarter, drawing down wholesaler inventory levels," said Pedro Lichtinger, President and CEO of Optimer. "We also observed continued strong month over month growth through the fourth quarter of about 11%."
For the three months ended December 31, 2011, Optimer estimates 4,675 DIFICID treatments were shipped from Optimer's wholesalers to hospital pharmacies, retail pharmacies and long-term care facilities, exceeding treatments sold by Optimer to its wholesalers over the same period. This is an increase of 86.6% when compared to the 2,505 treatments shipped from Optimer's wholesalers to hospital pharmacies, retail pharmacies and long-term care facilities for the period of July 19, 2011through September 30, 2011. DIFICID treatments shipped from Optimer's wholesalers to hospital pharmacies, retail pharmacies and long-term care facilities grew at a compounded monthly growth rate of 11.3% for the quarter ended December 31, 2011.
Optimer recognizes product sales of DIFICID upon delivery of product to its wholesalers. For the period of July 19, 2011, the date of DIFICID's first sales, through December 31, 2011 Optimer estimates DIFICID gross sales of $24.4 million. Optimer estimates total DIFICID gross sales for the fourth quarter of 2011 of $12.2 million, compared to gross sales for the third quarter of 2011 of $12.1 million, which included $5.1 millionin inventory stocking by Optimer's wholesalers. DIFICID wholesaler inventory levels at the end of the fourth quarter are estimated to have decreased by $1.1 millionfrom the levels at the end of the third quarter, and remain within Optimer's target range of 14 to 28 days of demand.
"With DIFICID, we bring a new perspective to how CDAD is treated in the United Statesand abroad. To leverage this opportunity and accelerate market penetration we will be focusing our efforts on expanding our label with new indications that we believe hold significant incremental market potential," continued Mr. Lichtinger.
In 2012, Optimer plans to pursue, subject to FDA discussion and review, important new areas where it sees opportunities to expand the DIFICID label, seeking new indications to optimize its commercial potential. The potential for prophylactic use of DIFICID represents an opportunity for significant incremental market expansion. Optimer intends to evaluate prophylactic use of DIFICID in patients undergoing bone marrow transplantation, who are generally at risk for CDAD and where CDAD has a significant impact on the patient and the disease associated cost burden. Additionally, Optimer believes there are a range of patient subpopulations with CDAD, such as other transplant patients and certain sub-populations of cancer patients, where CDAD is associated with a significant impact on the patient and disease associated cost burden.
To focus on these priorities that have the potential to maximize the value of fidaxomicin for patients and shareholders, Optimer has made the strategic decision to discontinue current work in basic research. Optimer will, however, retain its clinical R&D capabilities to develop product candidates.
Hospital Formulary and Patient Access Update
At the end of 2011 DIFICID was on formulary at more than
450 hospitals, a 30% increase in formulary adoption since
mid November. Optimer continues to make progress in
formulary adoption by hospitals.
Patient access to DIFICID has also improved. Currently:
- DIFICID is covered by 89% of Optimer's targeted payor plans, meaning approximately 75% of all covered lives in the United Stateshave access to DIFICID
- 90% of targeted commercial payors and 82% of targeted Medicare Part D payors cover DIFICID
- The top five commercial Pharmacy Benefit Managers (PBMs) and four of the top five Medicare PBMs cover DIFICID
- Commercial and Medicare Part D DIFICID copayment amounts are comparable to Vancocin
Important Safety Information for DIFICID
DIFICID should not be used for systemic infections. Only
use DIFICID for infection proven or strongly suspected to
be caused by C. difficile. Prescribing DIFICID in the
absence of a proven or strongly suspected C. difficile
infection is unlikely to provide benefit to the patient and
increases the risk of the development of drug resistant
bacteria. The most common adverse reactions are nausea
(11%), vomiting (7%), abdominal pain (6%), gastrointestinal
hemorrhage (4%), anemia (2%), and neutropenia (2%)
or call 855-DIFICID (343-4243) for full prescribing information for DIFICID.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a global
biopharmaceutical company focused on discovering,
developing and commercializing innovative hospital
specialty products that have a positive impact on society.
Optimer developed and commercialized DIFICID® (fidaxomicin)
tablets, an FDA-approved antibacterial drug for the
treatment of adult patients with Clostridium
difficile-associated diarrhea (CDAD). Optimer has also
received marketing authorization for fidaxomicin tablets in
the European Union under the trade name DIFICLIR™. The
company is seeking marketing authorization for fidaxomicin
in Canadaand is exploring marketing
authorization in other parts of the world where C.
difficile has emerged as a serious health problem,
including Asia.
Forward-Looking Statements
Statements included in this press release that are not a
description of historical facts are forward-looking
statements, including without limitation statements related
to the perspective for the treatment of CDAD, expansion and
acceleration of DIFICID market penetration, DIFICID sales
or market potential, DIFICID label expansion and new
potential indications for DIFICID, including prophylactic
DIFICID use or use in patient subpopulations, the timing
and nature of activities related to the pursuit of any new
DIFICID indications, the risk, impact and burden of CDAD,
the hospital formulary and patient access status of
DIFICID, and Optimer's clinical development
capabilities. Words such as "believes,"
"would," "anticipates,"
"plans," "expects," "may,"
"intend," "will" and similar
expressions are intended to identify forward-looking
statements. The inclusion of forward-looking statements
should not be regarded as a representation by Optimer that
any of its plans will be achieved. These forward-looking
statements are based on management's expectations on
the date of this release. Actual results may differ
materially from those set forth in this release due to the
risks and uncertainties inherent in Optimer's business
including, without limitation, risks relating to:
Optimer's ability to continue driving adoption and use
of DIFICID, whether healthcare professionals will prescribe
DIFICID, whether DIFICID will receive or continue to
receive reimbursement coverage from healthcare payers and
government agencies, the extent to which DIFICID will be
accepted on hospital formularies and potential delays in
formulary decisions, Optimer's ability to successfully
coordinate commercialization efforts with Cubist
Pharmaceuticals under its co-promotion agreement, whether
Optimer will be able to realize expected benefits under its
co-promotion agreement with Cubist, the fact that past
results may not be predictive of future results of
performance, the possibility of alternative means of
preventing or treating DIFICID impacting adoption and sales
of DIFICID, Optimer's ability, though its third party
manufacturers and logistics providers, to maintain a
sufficient supply of DIFICID to meet demand, Optimer's
ability to pursue new indications for DIFICID, whether any
studies intended to support additional indications for
DIFICID will be successful, whether any new indications for
DIFICID will be approved by the FDA and other risks
detailed in Optimer's filings with the Securities
and Exchange Commission. Forward-looking statements speak
only as of the date of this release, and Optimer undertakes
no obligation to update or revise these statements, except
as may be required by law.
Contacts
Optimer Pharmaceuticals, Inc.
David Walsey, Vice President, Investor
Relations and Corporate Communications
(858) 909-0736
Canale Communications, Inc.
Jason I. Spark, Senior Vice President
(619) 849-6005
SOURCE Optimer Pharmaceuticals, Inc.
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