— Highlights actions resulting from strategic review —
— Conference call and webcast today at
Key elements include:
Strategy. Progenics will focus on oncology, building on its PSMA ADC clinical program and its multiplex kinase inhibitor research program. The Company plans to increase the financial resources and personnel it dedicates to these programs and will seek to in-license complementary opportunities in the oncology space. The Company will discontinue its efforts in virology and infectious diseases and seek to out-license those programs.
Operations. Progenics will close its cGMP manufacturing facility.
Organization. Progenics will reduce headcount by 38, or approximately 26%, of its staff. This reduction arises from the closing of the manufacturing facility, discontinuation of work in virology and infectious diseases, and the completion of development activities by the Company relating to RELISTOR®. Development and commercialization activities and related expenses for RELISTOR have been assumed by Salix Pharmaceuticals, which licensed rights earlier this year. The Company will make changes in its management and governance processes to improve the timeliness and quality of its decision-making and to expedite the implementation of decisions once made.
Finance. Progenics estimates that annual expenses will be reduced by approximately
"We have enhanced our focus. We had been operating across too many therapeutic areas and became spread too thin. As a result, our resources and attention were divided in a way that caused inefficiencies, and blocked us from maximizing the potential of our programs. We have elected to concentrate on oncology, where we can be among the best and bring needed therapies to a growing market. We already have excellent research and clinical capabilities in oncology and expect that our expertise and commitment will allow us to attract new opportunities in that field.
"Progenics will be leaner, more nimble and more decisive. The initiatives announced today will reduce expenses. We made painful decisions as a part of this strategic evaluation. Eliminating jobs is very difficult, as much as I believe it to be necessary for the Company's success. We thank our colleagues who have been affected for their dedication, talent and hard work."
Conference Call and Webcast
Progenics will discuss the outcome of its strategic review initiative in a conference call today at
About Opioids, Constipation and RELISTOR (methylnaltrexone bromide)
Opioid analgesics are frequently prescribed to manage pain in patients with advanced illness. Constipation commonly occurs in palliative-care patients receiving opioid therapy for pain. RELISTOR (methylnaltrexone bromide) Subcutaneous Injection is the first approved medication that specifically targets the underlying cause of OIC in these patients, when response to laxatives has been insufficient. Opioids relieve pain by specifically interacting with mu-opioid receptors within the brain and spinal cord. However, opioids also interact with mu-opioid receptors found outside the central nervous system, such as those within the gastrointestinal tract, resulting in constipation that can be debilitating. RELISTOR is a peripherally acting mu-opioid receptor antagonist that decreases the constipating effects of opioid pain medications without affecting their ability to relieve pain. RELISTOR selectively displaces opioids from the mu-opioid receptors outside the CNS, including those located in the gastrointestinal tract, thereby decreasing their constipating effects. Because of its chemical structure, RELISTOR does not affect opioid-mediated analgesic effects on the CNS.
RELISTOR Subcutaneous Injection is approved in
For more information about RELISTOR, please visit www.RELISTOR.com.
Important Safety Information for RELISTOR
RELISTOR is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond four months has not been studied.
RELISTOR is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician. Use of RELISTOR has not been studied in patients with peritoneal catheters.
Safety and efficacy of RELISTOR have not been established in pediatric patients.
Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie's syndrome). Perforations have involved varying regions of the GI tract: (e.g., stomach, duodenum, colon).
Use RELISTOR with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with RELISTOR and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms.
The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5% vs. 9.8%), flatulence (13.3% vs. 5.7%), nausea (11.5% vs. 4.9%), dizziness (7.3% vs. 2.4%), diarrhea (5.5% vs. 2.4%), and hyperhidrosis (6.7% vs. 6.5%).
RELISTOR full Prescribing Information for the U.S. is available at www.RELISTOR.com.
Note Regarding Forward-Looking Statements
The information in this press release may contain projections and other forward-looking statements regarding future events. Such statements are predictions only, and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others, the cost, timing and results of clinical trials and other development activities; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; and possible safety or efficacy concerns, general business, financial and accounting risks and litigation. More information concerning Progenics and such risks and uncertainties is available on its
website, and in its press releases and reports it files with the
Additional information concerning Progenics and its business may be available in press releases or other public announcements and public filings made after this release.
For more information, please visit www.progenics.com.
For more information about RELISTOR, please visit www.RELISTOR.com.
Amy MartiniCorporate Affairs (914) 789-2816 firstname.lastname@example.org Media: Aline Schimmel Scienta Communications(312) 238-8957 email@example.com
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