Spectrum Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for Poziotinib; Reaffirms Focus on the Commercialization of ROLVEDON injection

— Immediately de-prioritizes poziotinib program, accelerates cost reductions, including 75% reduction in R&D related workforce —

— Spectrum to explore strategic alternatives for the poziotinib program, including partnerships and business development opportunities —

Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI) ("Spectrum" or the "Company"), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding Spectrum's New Drug Application (NDA) for poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer ("NSCLC") harboring HER2 exon 20 insertion mutations. The FDA issued a CRL indicating the poziotinib application cannot be approved in its present form. Based on the CRL, the Company would have to generate additional data including a randomized controlled study prior to approval.

"While we are not surprised by the CRL given the ODAC recommendation in September, we are disappointed. After multiple interactions with the FDA since ODAC, and following careful consideration, we have made the strategic decision to immediately de-prioritize the poziotinib program," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We continue to believe that poziotinib could present a meaningful treatment option for patients with this rare form of lung cancer, for whom other therapies have failed."

Mr. Riga continued, "We are committed to exploring potential strategic alternatives for poziotinib, including partnerships and business development opportunities, and will determine the best path forward in support of patients. We are grateful to the patients, families, and clinicians who participated in the poziotinib program and to the team members who have dedicated their time and efforts."

The Company will de-prioritize poziotinib program activities, effective immediately, and is in the process of reducing its R&D workforce by approximately 75%. Based on the anticipated cost savings from the restructuring, Spectrum believes it will be able to generate the working capital required to support its strategic refocusing through 2024.

The Company will focus efforts on driving growth for its recently launched commercial drug, ROLVEDON. ROLVEDON was approved by the FDA in September 2022. It is for adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Spectrum launched ROLVEDON, which has an estimated market opportunity of approximately $2 billion, shortly following the FDA's approval.

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies. Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals and commercializing in a competitive healthcare marketplace. Spectrum has a pipeline with novel assets that serve areas of unmet need. For additional information on Spectrum please visit www.sppirx.com .

Notice Regarding Forward-looking Statements

Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These forward-looking statements relate to a variety of matters, including, without limitation, statements that relate to Spectrum's business and its future, including the timing and magnitude of its planned reduction in force; the cost savings to be achieved from the planned restructuring and the Company's ability to fund its projected operating expenses and working capital through 2024; the future potential of poziotinib as a meaningful treatment option for patients; the likelihood and timing of potential strategic alternatives for poziotinib; the success of the Company's commercial launch of ROLVEDON, including the potential therapeutic benefits of ROLVEDON and the potential market opportunity for ROLVEDON; the potential of the Company's pipeline to transform the Company in the near future and other statements that are not purely statements of historical fact. These forward- looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Spectrum and are subject to significant risks and uncertainties that could cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. Risks that could cause actual results to differ include, but are not limited to, the possibility that ROLVEDON may not be more effective, safer or more cost efficient than competing drugs; our dependence on third parties for manufacturing, distribution and quality control; the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail and other risks that are described in further detail in the company's reports filed with the SEC. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Spectrum in general, see the risk disclosures in the Annual Report on Form 10-K of Spectrum for the year ended December 31, 2021, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Spectrum.

SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc. and its affiliates. REDEFINING CANCER CARE™ and ROLVEDON™ are the Spectrum Pharmaceuticals' logos and trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.

© 2022 Spectrum Pharmaceuticals, Inc. All Rights Reserved

Tom Riga
Chief Executive Officer
949.788.6700
InvestorRelations@sppirx.com

Lisa Wilson
In-Site Communications, Inc
212.452.2793
lwilson@insitecony.com

News Provided by Business Wire via QuoteMedia

NTR:CA,NTR
The Conversation (0)

Nutrien Announces Release Dates for Third Quarter 2024 Results and Conference Call

Nutrien Ltd. (TSX and NYSE: NTR) announced today plans to release third quarter 2024 results after market close on Wednesday, November 6. Nutrien will host a conference call to discuss its results and outlook at 10:00 a.m. EST on Thursday, November 7.

Investors can access the call by dialing 1-888-870-4559 or 647-931-1822. A webcast of the call can be accessed by visiting Nutrien's Investor Events and Presentation page.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Nutrien Reports Second Quarter 2024 Results and Announces Chief Financial Officer Transition

  • Second quarter results supported by increased crop input margins, strong global potash demand, higher fertilizer operating rates and lower operating costs.
  • Mark Thompson appointed Executive Vice President and Chief Financial Officer effective August 26, 2024.

All amounts are in US dollars, except as otherwise noted

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Combine harvester harvests ripe wheat.

Top 10 Phosphate Countries by Production (Updated 2024)

Phosphate is mainly used in the form of fertilizer for crops and animal feed supplements. Only 5 percent of world phosphate production is used for other applications, such as corrosion prevention and detergents.

Demand for phosphate fertilizers had created a US$54.6 billion market by 2023, and that figure is expected to grow at a compound annual growth rate of 5.3 percent through 2030 to reach US$78.4 billion.

"One of the primary factors influencing the worldwide market for phosphate fertilizers is the increasing focus on sustainable agriculture," according to Persistence Market Research. "Phosphate fertilizers, which are widely recognized for their ability to augment soil fertility and enhance crop productivity, are crucial for the pursuit of sustainability objectives in the agricultural industry."

Keep reading...Show less
Tractor on farm field.

9 Phosphate Stocks to Watch (Updated 2024)

Demand for both phosphate and potash fertilizers is anticipated to continue growing as the world’s population increases and the amount of arable land decreases.

The phosphate market is expected to witness a compound annual growth rate of 5.3 percent between 2023 and 2030 to reach US$78.4 billion. Driving this growth will be increasing pressure on global food supply brought on by rising populations and climate change, as well as inflation and downstream costs. Phosphate is also increasingly becoming a sought-after battery material for the electric vehicle industry due to its use in lithium-iron-phosphate (LFP) batteries.

Thankfully, phosphate-mining production around the globe is expected to increase, with the largest areas of growth being Africa and the Middle East. Phosphate mining companies with project developments in Brazil, Kazakhstan, Mexico, Peru and Russia are all expected to contribute to increased phosphate rock production as well.

Keep reading...Show less

Nutrien Announces Release Dates for Second Quarter 2024 Results and Conference Call

Nutrien Ltd. (TSX and NYSE: NTR) announced today plans to release second quarter 2024 results after market close on Wednesday, August 7. Nutrien will host a conference call to discuss its results and outlook at 10:00 a.m. EDT on Thursday, August 8.

Investors can access the call by dialing 1-289-514-5100 or 1-800-717-1738. A webcast of the call can be accessed by visiting Nutrien's website at nutrien.com/investors/events .

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Nutrien Prices Offering of an Aggregate of US$1.0 Billion of 3-Year and 10-Year Senior Notes

Nutrien Ltd. (TSX and NYSE: NTR) today announced the pricing of US$400 million aggregate principal amount of 5.200 percent senior notes due June 21, 2027 and US$600 million aggregate principal amount of 5.400 percent senior notes due June 21, 2034 (together, the "senior notes").  The offering is expected to close on or about June 21, 2024, subject to customary closing conditions.  The senior notes, registered under the multi-jurisdictional disclosure system in Canada and the United States, will not be offered in Canada or to any resident of Canada.

Nutrien intends to use the net proceeds from this offering to repay its US$500 million aggregate principal amount of 5.900% senior notes upon their maturity on November 7, 2024, to reduce outstanding indebtedness under its short-term credit facilities, to finance working capital and for general corporate purposes. The senior notes will be unsecured and rank equally with Nutrien's existing senior unsecured debt. The joint book-running managers for the offering are CIBC World Markets Corp., Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC, and RBC Capital Markets, LLC.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×