Novelos Therapeutics Discontinues Current
`Development Program for NOV-002 in NSCLC
`
`NOV-002 Phase 2 Development Continues in Breast Cancer
`Indication; Seeking to Build Clinical Stage Oncology Pipeline
`
`March 18, 2010 08:30 AM Eastern Daylight Time
`
`NEWTON, Mass.--(BUSINESS WIRE)--Novelos Therapeutics, Inc. (OTCBB: NVLT), a
`biopharmaceutical company focused on the development of therapeutics to treat cancer
`and hepatitis, today announced that primary and secondary endpoints were not met in
`Novelos’ pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) with its lead
`product, NOV-002, in combination with first-line chemotherapy. Adding NOV-002 to
`paclitaxel and carboplatin chemotherapy was not statistically or meaningfully different in
`terms of efficacy-related endpoints or recovery from chemotherapy toxicity versus
`chemotherapy alone. NOV-002 was safe, as it did not add to the overall toxicity of
`chemotherapy. Detailed trial results are expected to be presented at the 2010 annual
`meeting of the American Society of Clinical Oncology (ASCO) taking place June 4-8 in
`Chicago, Illinois.
`
`This randomized, controlled, open-label Phase 3 trial, conducted under a Special Protocol
`Assessment (SPA) and Fast Track designation, enrolled 903 patients with Stage IIIb/IV
`NSCLC and included all histological subtypes. The trial encompassed approximately 100
`clinical sites in 12 countries and evaluated NOV-002 in combination with first-line paclitaxel
`and carboplatin chemotherapy versus paclitaxel and carboplatin alone. The primary
`efficacy endpoint of the trial was improvement in overall survival. Secondary endpoints
`included progression free survival, response rate and duration of response, recovery from
`chemotherapy-induced myelosuppression, determination of immunomodulation, quality of
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`OSI EXHIBIT 2011
`APOTEX V. OSI
`IPR2016-01284
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`life and safety. Based on results from this Phase 3 trial, Novelos will discontinue
`development of NOV-002 for NSCLC in combination with first-line paclitaxel and
`carboplatin chemotherapy.
`
`“We designed and executed a robust Phase 3 NSCLC trial, but disappointingly, NOV-002
`did not work in this very difficult to treat indication in combination with this chemotherapy,”
`said Harry Palmin, President and CEO of Novelos. “Moving forward, our Phase 2 programs
`continue in cancer and hepatitis with our oxidized glutathione-based compounds. We
`expect results from an ongoing NOV-002 Phase 2 breast cancer trial in 3Q 2010, and are
`scheduled to present new NOV-002 nonclinical data at the American Association for
`Cancer Research (AACR) Annual Meeting in April 2010. We also expect to initiate a Phase
`2 hepatitis C trial shortly with our second compound NOV-205. Meanwhile, we intend to
`rebuild our pipeline through licensing or acquiring clinical-stage oncology compounds,
`utilizing our experienced and proven development team.”
`
`About Novelos Therapeutics, Inc.
`
`Novelos Therapeutics, Inc. is a biopharmaceutical company commercializing oxidized
`glutathione-based compounds for the treatment of cancer and hepatitis. Novelos is seeking
`to build a pipeline through licensing or acquiring clinical stage compounds or technologies
`for oncology indications. Our lead compound, NOV-002, has been administered to
`approximately 1,000 cancer patients in clinical trials and is in Phase 2 development for
`solid tumors in combination with chemotherapy. Novelos has a partnership with
`Mundipharma, an independent associated company of Purdue Pharma, to develop and
`commercialize NOV-002 in Europe and Asia (excluding China). Novelos’ second
`compound, NOV-205, which has been administered to approximately 200 hepatitis patients
`in clinical trials, is in Phase 2 development for chronic hepatitis C non-responders. Both
`compounds have been partnered with Lee’s Pharm in China. For additional information
`about Novelos please visit www.novelos.com.
`
`Novelos Therapeutics, Inc.
`One Gateway Center, Suite 504
`Newton, MA 02458
`
`This news release contains forward-looking statements. Such statements are valid only as
`of today, and we disclaim any obligation to update this information. These statements are
`subject to known and unknown risks and uncertainties that may cause actual future
`experience and results to differ materially from the statements made. These statements are
`based on our current beliefs and expectations as to such future outcomes. Drug discovery
`and development involve a high degree of risk. Factors that might cause such a material
`difference include, among others, uncertainties related to the ability to attract and retain
`partners for our technologies, the identification of lead compounds, the successful
`preclinical development thereof, the completion of clinical trials, the FDA review process
`and other government regulation, our pharmaceutical collaborators’ ability to successfully
`develop and commercialize drug candidates, competition from other pharmaceutical
`companies, product pricing and third-party reimbursement.
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`Contacts
`Novelos Therapeutics, Inc.
`COMPANY
`Harry S. Palmin, 617-244-1616 x11
`President and CEO
`hpalmin@novelos.com
`or
`INVESTOR RELATIONS
`Stephen Lichaw, 201-240-3200
`slichaw@novelos.com
`
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