On January 18, 2018 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained approval of its humanized anti-PD-L1 (Programmed Death Ligand-1) monoclonal antibody, "TECENTRIQ Intravenous Infusion 1200mg" (generic name: atezolizumab [recombinant]) from the Ministry of Health, Labour and Welfare (MHLW) for the treatment of "unresectable advanced or recurrent non-small cell lung cancer (NSCLC) (Press release, Chugai, JAN 18, 2018, View Source [SID1234523305])."

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"This is the first approval for TECENTRIQ in Japan, and it also represents the first step for Chugai to provide cancer immunotherapy," said Chugai’s President & COO, Tatsuro Kosaka. "We have been preparing for the new launch to provide TECENTRIQ for all patients as early as possible, and will take every measures to deliver the information needed to promote its appropriate use."

TECENTRIQ is a PD-L1 targeting monoclonal antibody created by Genetench, a member of the Roche Group. PD-L1 is a protein expressed on tumor and tumor-infiltrating immune cells that blocks T cell activity by binding with PD-1 and B7.1 receptors on T cell surface. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells and boost immune response against cancer cells.

TECENTRIQ is already approved in the European Union, United States and more than 50 countries for people with previously treated metastatic NSCLC and for people with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin chemotherapy, or who have had disease progression during or following platinum-containing therapy. In Japan, Chugai has been conducting seven clinical studies in the NSCLC setting to evaluate TECENTRIQ alone or in combination with other drugs. In addition to NSCLC studies, several phase III studies are ongoing for small-cell lung cancer, urotherial carcinoma, breast cancer, renal cell carcinoma, ovarian cancer and prostate cancer.

In Japan, the annual prevalence of lung cancer is estimated to be approximately 134,000 in 2015 (male: 91,000, female: 43,000). The annual mortality of lung cancer, the leading cause of cancer deaths in Japan, is approximately 77,000 (male: 55,000, female: 22,000; predicted figure for 2015).*

As a top pharmaceutical company in the field of oncology in Japan, Chugai is committed to contribute to patients with lung cancers and medical professionals by offering TECENTRIQ as a new treatment option.

About conditions for approval of TECENTRIQ
A drug use surveillance of all patients who receive TECENTRIQ must be conducted until the data on a given number of patients is accumulated.

About the drug use surveillance of TECENTRIQ (All-case registration surveillance)
The all-case registration surveillance is scheduled to collect the data of 1,000 patients who receive TECENTRIQ treatment. Once data for the first 1,000 cases is accumulated, the data will be reviewed to determine whether a new surveillance or further safety measures should be conducted. Results of the surveillance will be reported to the regulatory authorities, and the data shall be announced at future scientific meetings.

Note: The description of INDICATIONS in the Japanese package insert
The following description is noted as in the INDICATIONS:

Efficacy and safety of TECENTRIQ in chemotherapy-naïve patients have not been established.
Efficacy and safety have not been established for postoperative adjuvant chemotherapy with TECENTRIQ.
Eligible patients should be selected after closely reading the CLINICAL STUDIES section, which provides information such as the prior treatment history of patients in the clinical studies, in order to gain a thorough understanding of the efficacy and safety of TECENTRIQ.

On January 18, 2018 Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) reported that the Company will report its financial results for the fourth quarter and full year ended December 31, 2017 on Thursday, February 8, 2018 before the US financial markets open (Press release, Alexion, JAN 18, 2018, View Source [SID1234523288]). Following the release of the financial results, Alexion management will conduct a conference call and audio webcast on Thursday, February 8, 2018, at 10:00 a.m. Eastern Time (ET).

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To participate in this conference call, dial 800-239-9838 (USA) or 323-794-2551 (International), passcode 7453141 shortly before 10:00 a.m. ET. A replay of the call will be available from 1:00 p.m. ET through a limited time thereafter. The replay number is 888-203-1112 (USA) or 719-457-0820 (International), passcode 7453141. The audio webcast can be accessed on the Investor page of View Source

On January 18, 2018 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that it will report its fourth quarter and year 2017 financial results on Tuesday, February 6, 2018 after the close of financial markets. Following the results announcement, company management will host a conference call and webcast discussion of the results and provide a general corporate update (Press release, Seattle Genetics, JAN 18, 2018, View Source;p=RssLanding&cat=news&id=2327230 [SID1234523280]). Access to the event can be obtained as follows:

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LIVE access on Tuesday, February 6, 2018
1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone 888-778-9065 (domestic) or 719-325-2452 (international); conference ID 9278036
Webcast available at www.seattlegenetics.com in the Investors section
REPLAY access

Telephone replay will be available beginning at approximately 4:30 p.m. PT on Tuesday, February 6, 2018 through 5:00 p.m. PT on Friday, February 9, 2018 by calling 888-203-1112 (domestic) or 719-457-0820 (international); conference ID 9278036
Webcast replay will be available on the Seattle Genetics website at www.seattlegenetics.com in the Investors section

On January 18, 2018 Cytovation AS, a privately held biotech company developing CyPep-H1 for the treatment of cutaneous warts, reported that it has raised NOK 10m in a private funding round, completing the second stage of fundraising, having raised NOK 20m in June 2017 (Press release, Cytovation, JAN 18, 2018, View Source [SID1234561560]). Both financings were led by a group of private investors in Norway and the Company will now use these funds to advance lead product CyPep-H1 through the final stages of pre-clinical development and into and through a Phase I/IIa clinical trial in patients with warts caused by the human papilloma virus (HPV).

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Cytovation is developing CyPep-H1 as a topical formulation of its proprietary lytic peptide, CyPep. CyPep is a highly-stable, purpose-engineered peptide, consisting of 27 amino acids, that selectively targets transformed or infected cells, destroying the cell membrane and killing the cells. The release of antigens from the lysed cells also triggers an immune response against the diseased cells, providing the possibility of long-term protection against warts.

The mode-of-action of CyPep presents a completely novel strategy to treat this common and potentially debilitating condition. Based on this mechanism, the Company believes that CyPep can have a number of applications in dermatological diseases, with CyPep-H1, for the treatment of cutaneous warts, being the first candidate under development. The Company is also investigating the potential of CyPep-derived peptides for the treatment of certain cancers.

Cytovation’s CEO, Kjell Inge Arnevig, commented on the financing: "The completion of this final tranche of fundraising now enables Cytovation to move through toxicology studies and formulation and into our planned Phase I/IIa clinical trial for CyPep-H1. We expect initial results from this study late 2018 and are confident that they will confirm the potential of this novel treatment approach for the many largely unsatisfied patients globally, who suffer from cutaneous warts."

On January 18, 2018 Sandoz, a Novartis division and the global leader in biosimilars, reported a global partnership with Asia’s premier biopharmaceuticals company, Biocon, to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide (Press release, Novartis, JAN 18, 2018, View Source [SID1234523277]).

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Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of products, and will have a cost and profit share arrangement globally. Worldwide commercialization responsibilities will be divided and each company’s strengths will be leveraged within specific geographies. Sandoz will lead commercialization in North America* and the EU,** while Biocon will lead commercialization in Rest of the World.***

"Today’s announcement bolsters our leadership position in biosimilars and positions us to continue to lead well into the future," said Richard Francis, CEO, Sandoz. "Biocon is a great complement to our proven biosimilar capabilities at Sandoz. Through this collaboration, we are reinforcing our long-term commitment to increase patient access to biologics."

"Together, we will be able to realize benefits at every stage of the value chain, from development, through manufacturing to commercialization," said Carol Lynch, Global Head, Biopharmaceuticals, Sandoz. "This collaboration further strengthens our ability to deliver next-generation biosimilar medicines to patients."

Sandoz is committed to increasing patient access to high-quality biosimilars. We are the global leader in biosimilars, with five biosimilars currently marketed worldwide, as well as a leading global pipeline. Sandoz is well-positioned to continue leading the biosimilars industry based on our experience and capabilities in development, manufacturing and commercialization. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, we benefit strongly from this unique blend of experience and expertise in many different market environments.

As an innovation-led biopharmaceutical company, Biocon has successfully developed and taken a range of novel biologics, biosimilar antibodies, rh-insulin and insulin analogs from ‘lab to market’. The collaboration with Sandoz builds upon Biocon’s successful progress in its existing global biosimilars program. An early mover in the biosimilars space, Biocon has successfully launched its insulin glargine in Japan, trastuzumab and bevacizumab biosimilars in India and rh-insulin, insulin glargine and biosimilar trastuzumab in a few emerging markets; and it was the first Indian company to have a biosimilar approved by the US Food and Drug Administration.

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 "to develop," "to commercialize," "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," "expansion," "portfolio," "collaboration," "partnership," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved biosimilar products described in this press release, or regarding potential future revenues from such products or the collaboration and partnership with Biocon. 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, if approved, such biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. Neither can there be any guarantee that the collaboration and partnership with Biocon will achieve any or all of its intended goals and objectives, or be commercially successful. In particular, our expectations regarding such products, and the collaboration and partnership with Biocon, could be affected by, among other things, 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; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz or Biocon from selling the products developed, manufactured and commercialized under the collaboration and partnership; general economic and industry conditions, including the effects of the persistently weak economic and financial environment in many countries; potential or actual data security and data privacy issues; 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.