On January 16, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a clinical-stage company developing a new class of RNAi-based therapeutics reported its 2018 business strategy during a webcast presentation at the Biotech Showcase conference which brought together over 3,500 life science decision makers and investors from over 50 countries to collaborate and discuss industry trends (Press release, RXi Pharmaceuticals, JAN 16, 2018, View Source [SID1234523145]).

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"After a thorough review of our business operations, development programs and financial resources, a decision was made to focus our efforts on RXi’s expanding and promising immuno-oncology programs to accelerate growth and in turn support a return on investment for our shareholders," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He stated that: "The positive clinical results recently announced from our Phase 2 dermatology study validate the safety and efficacy of our sd-rxRNA therapeutics in humans. These outcomes coupled with robust preclinical results in our immuno-oncology program, further affirm the Company’s focused development path. With a much-improved regulatory landscape for the development of cancer therapeutics, we believe that there is great potential for our sd-rxRNA compounds to provide major advances that could change the paradigm in cancer treatments. Furthermore, the feedback that we have received, through relationships with leading cancer centers, potential business partners as well as institutional investors, in the context of last week’s Biotech Showcase meeting, endorses our sharpened strategy. It is our goal to develop novel immuno-oncology treatments to benefit patients as well as our long-term shareholders and business partners."

2018 Business Strategy

RXi will focus development initiatives on novel immuno-oncology therapeutics using its proprietary sd-rxRNA platform. Focusing the development portfolio on Immuno-oncology, with a near term focus on Adoptive Cell Transfer (ACT), will streamline and reduce our quarterly burn-rate for 2018. The Company is aiming to enter the clinic with at least one of our compounds in the next 18 months, targeting a large multi-billion dollar market. This will be achieved by:

Accelerating the development of RXI-762 and RXI-804, sd-rxRNA compounds targeting PD-1 and TIGIT respectively, for use in the treatment of solid tumors in the context of ACT. Finalize cGMP manufacturing of lead compound.
Expanding internal development efforts and external collaborations with various existing cell-based approaches, evaluating hematopoietic stem cells, NK cells, TILs, CAR T, TCR and engineered NK cells.
Developing immuno-oncology targets beyond checkpoint inhibition, i.e. cell differentiation.
Expanding our research efforts to further demonstrate that our technology is ideally suited to be combined with existing immune effector cell expansion/manufacturing.
Monetize Existing Dermatology and Ophthalmology Franchises:

Relating to the operational review, RXi intends to partner/out-license both its Dermatology and Ophthalmology Franchises. Successfully completing these transactions should provide non-dilutive funding for the Company’s focused development path in Immuno-oncology.

Each of these Franchises is comprised of preclinical and clinical-stage assets broadly covered by a robust intellectual property estate. These assets include:

Dermatology

RXI-109: Phase 2 asset for dermal hypertrophic scarring with positive and statistically significant results addressing a USD 1-3B market.
RXI-231: Topical cosmetic ingredient in a proprietary formulation with positive results reducing a change of skin tone (pigmentation) triggered by UV (p< 0.04) addressing an estimated USD multi-billion dollar market.
RXI-185: Cosmetic ingredient that reduces collagenase in in vitro models. May be developed as a cosmetic to improve the appearance of aging skin.
Samcyprone: Phase 2 small molecule topical immuno-therapy, with proven efficacy in cutaneous warts with an estimated market size USD 2-4B.
Access to the self-delivering platform for human therapeutic and diagnostic use in the field of dermatology, providing access to new compounds targeting proteins of relevance for the treatment of skin diseases.
The intellectual property estate for RXi’s Dermatology Franchise is comprised of 14 patent families covering: RXI-109, RXI-231, RXI-185 and Samcyprone. Importantly, this estate includes 18 granted patents broadly covering the sd-rxRNA platform, including RXI-109 in the US, Europe, Japan and China and Samcyprone in the US.

Ophthalmology

RXI-109: Phase 1/2 asset with proven safety, using intra-ocular injections, for wet AMD with estimated market size USD 3-5B. Readouts expected Q1 2018.
Preclinical data package supporting development of RXI-109 by intraocular injection or topical application to the eye for retinal or corneal scarring indications.
Patented set of sequences against a variety of relevant proteins for targeting ocular disorders. Also, sd-rxRNA compounds against targets which may be involved in retinoblastoma or retinal or corneal scarring.
Preclinical intra-ocular asset (sd-rxRNA targeting VEGF) with dose-dependent effects and tolerability demonstrated in a rodent model.
Access to the self-delivering platform for human therapeutic and diagnostic use in the field of ophthalmology, providing ready access to new compounds targeting proteins of relevance for the treatment of ophthalmic diseases.
RXi’s Ophthalmology intellectual property estate includes 21 patent families. This estate includes 73 patents covering the composition and methods of use the sd-rxRNA platform and targets and sequences from the OPKO assets, including the use of RXI-109 for the treatment of ocular scarring in the US, Japan and China.

The webcast presentation took place on January 8, 2018, and the relating slides and audio may be found on the Company’s website, www.rxipharma.com.

About RXi’s self-delivering RNAi (sd-rxRNA) technology platform

sd-rxRNA, RXi’s proprietary self-delivering RNAi platform, is a single chemically modified compound with delivery and therapeutic properties built directly into the compound itself. The compound is asymmetrical with a phosphorothioate backbone and contains chemical modifications that provide for efficient cellular uptake and gene silencing. These compounds are potent, stable and specific, and demonstrated to be safe and active in a clinical setting.

RXi’s novel sd-rxRNA technology differs from natural and most synthetic RNA interference (RNAi) molecules in that they are chemically modified to allow for efficient internalization of the compounds by cells and silencing of the targeted genes. Importantly, unlike other naked siRNA compounds, delivery of sd-rxRNAs are not limited to a specific cell type. For local delivery and ex vivo cell-based therapeutic applications, our compounds do not require delivery vehicles. This is a significant advantage since delivery vehicles can have related toxicity that affects cell viability. sd-rxRNA has demonstrated nearly 100 percent transfection efficiency with high cell viability in numerous cell types.

On January 16, 2018 MannKind Corporation (Nasdaq:MNKD), focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, reported that its Chief Executive Officer, Michael Castagna, will present at NobleCon14 — Noble Capital Markets’ Fourteenth Annual Investor Conference on Monday, January 29, 2018 at 10:00 Eastern Standard Time at the W Hotel in Fort Lauderdale, Florida (Press release, Mannkind, JAN 16, 2018, View Source [SID1234523147]).

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A high-definition, video webcast of the presentation will be available the following day on the Company’s web site www.mannkindcorp.com, and as part of a complete catalog of presentations available at Noble Capital Markets’ websites: www.noblecapitalmarkets.com, and www.nobleconference.com. You will require a Microsoft SilverLight viewer (a free download from the presentation link) to participate. The webcast and presentation will be archived on the Company’s website and on the Noble websites for 90 days following the event.

On January 16, 2018 Gamida Cell, a leading cellular and immune therapeutics company, reported the initiation of a phase I study evaluating its proprietary NAM-expanded natural killer cells (NAM-NK Cells) in patients with relapsed or refractory CD20+ non-Hodgkin lymphoma (NHL) and multiple myeloma (Press release, Gamida Cell, JAN 16, 2018, View Source [SID1234523184]).

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"There is significant need for novel therapeutic approaches for refractory non-Hodgkin lymphoma and multiple myeloma, which are aggressive malignancies with limited treatment options," said Veronika Bachanova, M.D., Ph.D., hematologist/oncologist at University of Minnesota Health and lead investigator of the clinical study at the Masonic Cancer Center, University of Minnesota. "We initiated this phase I study based on encouraging preclinical data to bring a potential immunotherapeutic treatment approach to patients with these life-threatening cancers."

The phase I study is designed to determine the maximum tolerated dose of NAM-NK Cells; secondary endpoints include overall antitumor response and toxicity. The study is currently recruiting and will enroll approximately 24 patients aged 18 to 70 years old. Participants will undergo a lymphodepleting preparative regimen of cyclophosphamide and fludarabine, and then receive two doses of NAM-NK Cells followed by a short course of interleukin-2 (IL-2). Monoclonal antibodies, rituximab for NHL or elotuzumab for multiple myeloma, are administered prior to and after the NAM-NK Cells infusion to facilitate tumor targeting and antibody dependent cellular cytotoxicity.

"NAM-expanded NK cells have demonstrated increased killing potential and increased in vivo persistence and proliferation in preclinical studies," said Tony Peled, Ph.D., chief scientific officer at Gamida Cell. "We are pleased to see the NAM-NK Cell program enter clinical testing and are committed to collaborating with Dr. Bachanova and her team at the Masonic Cancer Center."

About NAM-NK Cells
Gamida Cell applied the capabilities of its NAM technology to the expansion of highly functional NK cells. In addition to a higher killing potential, NAM-NK Cells secretes higher levels of inflammatory cytokines that facilitate recruitment and activation of other endogenous immune cells to attack tumors. NAM-NK Cells is in phase I development (NCT03019666) in patients with relapsed or refractory CD20+ non-Hodgkin lymphoma and multiple myeloma.

About the Masonic Cancer Center
Masonic Cancer Center, University of Minnesota is a comprehensive cancer center designated by the National Cancer Institute. For more than 25 years, researchers, educators, and care providers have worked to discover the causes, prevention, detection and treatment of cancer and cancer-related disease. Learn more about the Masonic Cancer Center and the phase I clinical trial at cancer.umn.edu.

On January 16, 2018 Innovation Pharmaceuticals, (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, reported shareholders of a productive appearance by Innovation last week at leading health care meetings held in San Francisco, with an audio file of the Biotech Showcase presentation now available on the Company website (Press release, Innovation Pharmaceuticals, JAN 16, 2018, View Source [SID1234523142]).

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Interest in the Brilacidin Franchise—based on the breadth of its treatment potential—was notable. Strong momentum gained as a result of Brilacidin’s recent positive topline findings seen in both Inflammatory Bowel Disease (IBD) and Oral Mucositis (OM), coupled with previously successful results achieved in Acute Bacterial Skin and Skin Structure Infection (ABSSSI), has delivered a complementary cross-indication scientific anchoring for each Brilacidin indication in the Company’s pipeline.

In particular, Brilacidin-OM received an exceptional degree of attention at the San Francisco shows, further adding to an already robust partnering matrix. Innovation is developing Brilacidin-OM under a FDA Fast Track designation as a novel therapeutic and recently met the primary endpoint in a Phase 2 trial for preventing severe OM as well as a key secondary endpoint by delaying the onset of severe OM. Brilacidin has effectively earned a leadership position as an easily-delivered oral rinse drug candidate in OM—what many analysts predict will become a $1 billion market opportunity within the next few years.

"What must be stressed is that Brilacidin is a mature, later-stage drug candidate with platform potential. It took the recent completion of two Phase 2 trials, in IBD and OM, to further validate the exceptional results achieved from our Phase 2b study in ABSSSI. These recent data, taken in aggregate, are what various actively engaged pharmaceutical companies have desired from us for some time—and they are what triggered a newfound flurry of inbound partnership discussions at the San Francisco conferences," commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "Datasets now in hand, reflecting three successfully completed Phase 2 studies across which multiple endpoints were met, have brought the Company to an important inflection point regarding Brilacidin. In coming weeks, we look forward to advancing these discussions with attractive partnership / licensing scenarios, towards determining the best path forward for the Company and its loyal shareholders."

Biotech Showcase Event Recording

An audio file of the Corporate Overview given at 2018 Biotech Showcase, on January 8, in San Francisco, is now available and accessible on the Events and Presentations section of the Company’s website.

Brilacidin-OM (Phase 2 Trial Completed)

As announced earlier, the Company has completed a Phase 2 randomized, double-blind, placebo-controlled trial (see NCT02324335) evaluating Brilacidin’s ability, administered as an oral rinse, to prevent and attenuate OM in patients with Head and Neck Cancer (HNC) receiving chemoradiation with at least 55 Gy across 7 weeks. The study’s primary endpoint was met, with Brilacidin, as a preventative treatment, showing a clear reduction in the incidence of severe OM (SOM) (WHO Grade ≥ 3) compared to placebo. A key secondary endpoint in the trial, delaying the onset of SOM, also was met. The Company has begun exploring patient-friendly improvements to drug delivery (the use of sachets) and will be meeting with the FDA to determine next steps in the clinical development of Brilacidin-OM. Patents for Brilacidin-OM have also been granted globally, most recently in Europe. Worldwide, the potential market for OM, largely untapped, is estimated to be in excess of $1 billion, with the Company considered a top contender in this space.

On January 16, 2018 Novartis reported that its supplemental Biologics License Application (sBLA) for KymriahTM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT) has been accepted by the US Food and Drug Administration (FDA) for Priority Review (Press release, Novartis, JAN 16, 2018, View Source [SID1234523192]). In addition, the European Medicines Agency (EMA) has granted accelerated assessment to the Marketing Authorization Application (MAA) for Kymriah for the treatment of children and young adults with r/r B-cell acute lymphoblastic leukemia (ALL) and for adult patients with r/r DLBCL who are ineligible for ASCT. Priority Review and accelerated assessment are granted to therapies which may provide a significant improvement in the safety and effectiveness of the treatment of a serious disease, and the designations are intended to expedite the standard review time. If approved by the FDA and EMA, Kymriah would represent the first chimeric antigen receptor T cell (CAR-T) therapy available for two distinct indications in non-Hodgkin lymphoma and B-cell ALL.

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Kymriah became the first CAR-T cell therapy to receive regulatory approval when it was approved by the FDA in August 2017 for the treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse.

"The first approval of a CAR-T therapy truly redefined the future of the cancer treatment landscape, and we are only at the beginning of this new era in cancer care," said Samit Hirawat, MD, Head, Novartis Oncology Global Drug Development. "The Priority Review designation and accelerated assessment signal that the FDA and EMA have recognized the potential of Kymriah to provide a much-needed therapeutic option for these patients with relapsed or refractory B-cell ALL and DLBCL. We are now focused on working with these regulatory agencies to bring this potentially transformative therapy to more patients."

Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient’s own T cells to fight cancer. Kymriah uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enhance cellular expansion and persistence. In 2012, Novartis and the University of Pennsylvania (Penn) entered into a global collaboration to further research, develop and commercialize CAR-T cell therapies, including Kymriah, for the investigational treatment of cancers.

The regulatory applications in the US and EU are based on data from the Novartis-sponsored global clinical trial program of Kymriah in children and young adults with r/r B-cell ALL and adult patients with r/r DLBCL demonstrating the efficacy and safety of Kymriah across studies. Results from the pivotal phase II JULIET clinical trial served as the basis of the sBLA and MAA (applications submitted by pharmaceutical companies to health authorities when seeking approval of a new product) for Kymriah in adult patients with r/r DLCBL. Results from the pivotal phase II ELIANA study were submitted as part of the MAA for Kymriah in children and young adults with r/r B-cell ALL.

JULIET is the first multi-center global registration study for Kymriah in adult patients with r/r DLBCL. JULIET is the largest study examining a CAR-T therapy in DLBCL, enrolling patients from 27 sites in 10 countries across the US, Canada, Australia, Japan and Europe, including: Austria, France, Germany, Italy, Norway and the Netherlands. Data from the six-month primary analysis of JULIET were presented at the annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2017.

ELIANA is the first pediatric global CAR-T cell therapy registration trial, examining patients in 25 centers in the US, Canada, Australia, Japan and the EU, including: Austria, Belgium, France, Germany, Italy Norway, and Spain.

Novartis plans additional regulatory submissions for Kymriah in pediatric and young adult patients with r/r B-cell ALL and adult patients with r/r DLBCL beyond the US and EU in 2018.

About CAR-T
CAR-T is different from typical small molecule or biologic therapies because it is manufactured for each individual patient using their own cells. During the treatment process, T cells are drawn from a patient’s blood and reprogrammed in the laboratory to create T cells that are genetically coded to recognize and fight the patient’s cancer cells and other B cells expressing a particular antigen.

About Kymriah Manufacturing
Kymriah is manufactured for each individual patient using their own cells at the Novartis Morris Plains, New Jersey facility. In the US, the target turnaround time for manufacturing Kymriah in the commercial setting is 22 days. The reliable and integrated manufacturing and supply chain platform for Kymriah allows for an individualized treatment approach on a global scale. The process includes cryopreservation of a patient’s harvested (or leukapheresed) cells, giving treating physicians and centers the flexibility to initiate therapy with Kymriah based on the individual patient’s condition. Building on the company’s experience, having manufactured CAR-T cells for over 300 patients from 11 countries across various indications in clinical trials, it has demonstrated a reproducible product. Novartis continues to advance its CAR-T manufacturing expertise in Morris Plains where we have been supplying CAR-T cells for global clinical trials and where we continue to invest in support of the anticipated demand to meet the needs of patients.

Novartis has also successfully established the CTL019 manufacturing process at the Fraunhofer-Institut for cell therapy and immunology (Fraunhofer-Institut für Zelltherapie and Immunologie) facility in Leipzig, Germany, which currently supports the manufacturing of CTL019 for global clinical trials.

Novartis Leadership in Immuno-Oncology
Novartis is at the forefront of investigational immunocellular therapy as the first pharmaceutical company to initiate global CAR-T trials, and has significantly invested in CAR-T research and worked with pioneers in the field. KymriahTM, the first approved CAR-T cell therapy, is the cornerstone of this strategy. Active research programs are underway targeting other hematologic malignancies and solid tumors, and include efforts focused on next generation CAR-Ts that involve simplified manufacturing schemes and gene edited cells.

KymriahTM (tisagenlecleucel) US Important Safety information (for patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse)
The full prescribing information, including Boxed WARNING, for Kymriah can be found at: View Source

Kymriah may cause side effects that are severe or life-threatening, such as Cytokine Release Syndrome (CRS) or Neurological Toxicities. Patients with CRS may experience symptoms including high fever, difficulty breathing, chills/shaking chills, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, or dizziness/lightheadedness. Patients may be admitted to the hospital for CRS and treated with other medications.

Patients with neurological toxicities may experience symptoms such as altered or decreased consciousness, headaches, delirium, confusion, agitation, anxiety, seizures, difficulty speaking and understanding, or loss of balance. Patients should be advised to call their health care provider or get emergency help right away if they experience any of these signs and symptoms of CRS or neurological toxicities.

Because of the risk of CRS and neurological toxicities, Kymriah is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) in the US called Kymriah REMS.

Serious allergic reactions, including anaphylaxis, may occur after Kymriah infusion.
Kymriah can increase the risk of life-threatening infections that may lead to death. Patients should be advised to tell their health care provider right away if they develop fever, chills, or any signs or symptoms of an infection.

Patients may experience prolonged low blood cell counts (cytopenia), where one or more types of blood cells (red blood cells, white blood cells, or platelets) are decreased. The patient’s health care provider will do blood tests to check all of their blood cell counts after treatment with Kymriah. Patients should be advised to tell their health care provider right away if they get a fever, are feeling tired, or have bruising or bleeding.

Patients may experience hypogammaglobulinemia, a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is increased. It is expected that patients may develop hypogammaglobulinemia with Kymriah, and may need to receive immunoglobulin replacement for an indefinite amount of time following treatment with Kymriah. Patients should tell their health care provider about their treatment with Kymriah before receiving a live virus vaccine.

After treatment with Kymriah, patients will be monitored life-long by their health care provider, as they may develop secondary cancers or recurrence of their leukemia.

Patients should not drive, operate heavy machinery, or do other dangerous activities for 8 weeks after receiving Kymriah because the treatment can cause temporary memory and coordination problems, including sleepiness, confusion, weakness, dizziness, and seizures.

Some of the most common side effects of Kymriah are difficulty breathing, fever (100.4°F/38°C or higher), chills/shaking chills, confusion, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, and dizziness/lightheadedness. However, these are not all of the possible side effects of Kymriah. Patients should talk to their health care provider for medical advice about side effects.

Prior to a female patient starting treatment with Kymriah, their health care provider may do a pregnancy test. There is no information available for Kymriah use in pregnant or breast-feeding women. Therefore, Kymriah is not recommended for women who are pregnant or breast feeding. If either sex partner has received Kymriah, patients should talk to their health care provider about birth control and pregnancy.

Patients should tell their health care provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

After receiving Kymriah, patients should be advised that some commercial HIV tests may cause a false positive test result. Patients should also be advised not to donate blood, organs, or tissues and cells for transplantation after receiving Kymriah.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, regarding our ability to implement, scale and sustain commercial manufacturing for the investigational or approved products described in this press release, regarding our ability to build and sustain a network of treatment centers to offer the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that Novartis will successfully implement, scale and sustain commercial manufacturing for the investigational or approved products described in this press release, or successfully build and sustain a network of treatment centers to offer the investigational or approved products described in this press release. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, our ability to successfully implement, scale and sustain commercial manufacturing and build and sustain a network of treatment centers; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; general economic and industry conditions, including the effects of the persistently weak economic and financial environment in many countries; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.