HELSINKI, Oct. 15, 2020 /PRNewswire/ --
THIS STOCK EXCHANGE RELEASE MAY NOT BE RELEASED, PUBLISHED OR OTHERWISE DISTRIBUTED, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, CANADA, HONG KONG SPECIAL ADMINISTRATIVE REGION OF THE PEOPLE'S REPUBLIC OF CHINA, JAPAN, NEW ZEALAND, OR SOUTH AFRICA, OR ANY OTHER JURISDICTION IN WHICH THE TENDER OFFER WOULD BE PROHIBITED BY APPLICABLE LAW. FOR FURTHER INFORMATION, PLEASE SEE SECTION ENTITLED "IMPORTANT INFORMATION" BELOW.
Mehiläinen Yhtiöt Oy, Stock Exchange Release, 15 October 2020 at 5:00 p.m. (EET)
Mehiläinen Yhtiöt Oy ("Mehiläinen" or the "Offeror") and Pihlajalinna Plc ("Pihlajalinna") announced on 5 November 2019 that they had entered into a combination agreement (the "Combination Agreement") pursuant to which Mehiläinen has made a voluntary recommended public cash tender offer for all issued and outstanding shares in Pihlajalinna (the "Tender Offer").
The acceptance period under the Tender Offer (the "Offer Period") commenced on 9 January 2020 at 9:30 a.m. (Finnish time) and was set to expire on 15 October 2020 at 4:00 p.m. (Finnish time). For reasons outlined below, Mehiläinen has decided to extend the Offer Period to expire on 20 November 2020 at 4:00 p.m. (Finnish time), unless extended further or discontinued in accordance with, and subject to, the terms and conditions of the Tender Offer and applicable laws and regulations. The Board of Directors of Pihlajalinna has provided its consent to the extension of the Offer Period until 20 November 2020.
As announced by Mehiläinen on 29 September 2020, the Finnish Competition and Consumer Authority has made a proposal to the Market Court to prohibit the proposed combination of Mehiläinen and Pihlajalinna, and the matter is currently being reviewed by the Market Court. Based on currently available information, Mehiläinen estimates that the Market Court will render its decision in the matter towards the end of the statutory handling period, which expires on 29 December 2020.
The Combination Agreement provides for a mutual termination right of the Combination Agreement in the event that the Tender Offer has not been completed by the agreed long-stop date of 30 November 2020 (the "Long-Stop Date"). For as long as the Combination Agreement remains in force, Mehiläinen has an obligation thereunder to use reasonable best efforts to complete the Tender Offer, including by way of extending the Offer Period to the extent permissible under applicable laws and regulations.
In accordance with its obligations under the Combination Agreement, Mehiläinen has decided to extend the Offer Period until 20 November 2020. While Mehiläinen currently deems it more unlikely than likely that the Market Court would render its decision in time to enable completion of the Tender Offer prior to the Long-Stop Date, Mehiläinen is for reasons outlined below currently not in a position to extend the Offer Period beyond 20 November 2020, such date being the latest date enabling completion of the Tender Offer by the Long-Stop Date, should the Market Court render its decision in time.
An extension of the Offer Period beyond the Long-Stop Date to account for the entire expected duration of the Market Court proceedings would necessarily entail that the Tender Offer could not be completed until the first quarter of 2021 at the earliest, assuming the Market Court's decision will not be appealed. This would in turn necessitate amendments to the existing debt and equity financing arrangements for the Tender Offer. Mehiläinen is therefore currently not in a position to extend the Offer Period beyond the agreed Long-Stop Date to account for the entire expected duration of the Market Court proceedings.
Mehiläinen will continue the Market Court proceedings with the aim of obtaining clearance for the proposed combination. Mehiläinen will also continue its ongoing dialogue with Pihlajalinna with respect to the conduct of the Market Court proceedings.
Due the circumstances referred to above, shareholders of Pihlajalinna are advised of the increased uncertainties related to the completion of the Tender Offer. Firstly, there can be no guarantee that the Offer Period can be extended further, which could result in the lapsing of the Tender Offer after 20 November 2020 provided that the Market Court has not rendered its decision within this time period. Secondly, even if the Offer Period is extended further, there can be no guarantee that the Market Court will approve the proposed combination on terms that are within the limits set out in the terms and conditions of the Tender Offer, or at all. If the Offer Period is extended further and the Market Court decides to approve the proposed combination, Mehiläinen currently estimates that the Tender Offer could be completed during the first quarter of 2021 at the earliest, assuming the Market Court's decision is not appealed.
Mehiläinen will supplement the tender offer document concerning the Tender Offer, dated 8 January 2020, to reflect the extension of the Offer Period and other information included in this stock exchange release and will publish such supplement document once it has been approved by the Finnish Financial Supervisory Authority.
Contacts for media and investor inquiries:
Janne-Olli Järvenpää, CEO of Mehiläinen
Requests for contacts through Mehiläinen's communications:Communications Director Laura Martinsuotel. +358 40 196 firstname.lastname@example.org
Joni Aaltonen, CEO of Pihlajalinna Plc
Requests for contacts through Pihlajalinna's communications:Communications manager Taina Lehtomäkitel. +358 50 451 email@example.com
Mehiläinen in brief:
Now 110 years old, Mehiläinen is a rapidly developing and growing private provider of healthcare and social care services, offering comprehensive high-quality services to private, corporate, municipal and insurance customers. Mehiläinen provides help, support and care for approximately 1.3 million customers every year across Finland. In 2019, our revenue was EUR 1064.1 million and our customers were cared for by more than 21,800 employees and private practitioners at over 500 locations. In all of its business areas, Mehiläinen invests in high-quality health care with an impact and develops and exports Finnish digital healthcare know-how across the world as a forerunner in its field.
Pihlajalinna in brief:
Pihlajalinna is one of the leading private providers of social, healthcare and well-being services in Finland. The company provides services for households, companies, insurance companies and public sector entities, such as municipalities, federations of municipalities and hospital districts. Listed on the official list of Nasdaq Helsinki since 2015, Pihlajalinna's reported revenue was EUR 518.6 million in 2019. Pihlajalinna's nearly 6,000 employees and approximately 1,200 private practitioners produce services in over 210 locations across Finland.
THIS STOCK EXCHANGE RELEASE MAY NOT BE RELEASED, PUBLISHED OR OTHERWISE DISTRIBUTED, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, CANADA, HONG KONG SPECIAL ADMINISTRATIVE REGION OF THE PEOPLE'S REPUBLIC OF CHINA, JAPAN, NEW ZEALAND, OR SOUTH AFRICA, OR ANY OTHER JURISDICTION IN WHICH THE TENDER OFFER WOULD BE PROHIBITED BY APPLICABLE LAW.
THIS STOCK EXCHANGE RELEASE IS NOT A TENDER OFFER DOCUMENT AND AS SUCH DOES NOT CONSTITUTE AN OFFER OR INVITATION TO MAKE A SALES OFFER. IN PARTICULAR, THIS STOCK EXCHANGE RELEASE IS NOT AN OFFER TO SELL OR THE SOLICITATION OF AN OFFER TO BUY ANY SECURITIES DESCRIBED HEREIN, AND IS NOT AN EXTENSION OF THE TENDER OFFER, IN, AUSTRALIA, CANADA, HONG KONG SPECIAL ADMINISTRATIVE REGION OF THE PEOPLE'S REPUBLIC OF CHINA, JAPAN, NEW ZEALAND, OR SOUTH AFRICA. INVESTORS SHALL ACCEPT THE TENDER OFFER FOR THE SHARES ONLY ON THE BASIS OF THE INFORMATION PROVIDED IN A TENDER OFFER DOCUMENT. THE TENDER OFFER IS NOT BEING MADE, AND THE SHARES WILL NOT BE ACCEPTED FOR PURCHASE FROM OR ON BEHALF OF PERSONS, DIRECTLY OR INDIRECTLY IN ANY JURISDICTION WHERE EITHER AN OFFER OR ACCEPTANCE THEREOF IS PROHIBITED BY APPLICABLE LAW OR WHERE ANY TENDER OFFER DOCUMENT OR REGISTRATION OR OTHER REQUIREMENTS WOULD APPLY IN ADDITION TO THOSE UNDERTAKEN IN FINLAND.
THE TENDER OFFER IS NOT BEING MADE DIRECTLY OR INDIRECTLY IN ANY JURISDICTION WHERE PROHIBITED BY APPLICABLE LAW, AND THE TENDER OFFER DOCUMENT AND RELATED ACCEPTANCE FORMS AND SUPPLEMENT DOCUMENTS WILL NOT AND MAY NOT BE DISTRIBUTED, FORWARDED OR TRANSMITTED INTO OR FROM ANY JURISDICTION WHERE PROHIBITED BY APPLICABLE LAWS OR REGULATIONS. IN PARTICULAR, THE TENDER OFFER IS NOT BEING MADE, DIRECTLY OR INDIRECTLY, BY ANY MEANS OR INSTRUMENTALITY (INCLUDING WITHOUT LIMITATION E-MAIL, POST, FACSIMILE TRANSMISSION, TELEX, TELEPHONE OR ELECTRONIC TRANSMISSION BY WAY OF THE INTERNET OR OTHERWISE), IN OR INTO, OR BY USE OF THE POSTAL SERVICE OF, OR THROUGH ANY FACILITIES OF A NATIONAL SECURITIES EXCHANGE OF, AUSTRALIA, CANADA, HONG KONG SPECIAL ADMINISTRATIVE REGION OF THE PEOPLE'S REPUBLIC OF CHINA, JAPAN, NEW ZEALAND, OR SOUTH AFRICA. THE TENDER OFFER CANNOT BE ACCEPTED, DIRECTLY OR INDIRECTLY, BY ANY SUCH USE, MEANS OR INSTRUMENTALITY OR FROM WITHIN, AUSTRALIA, CANADA, HONG KONG SPECIAL ADMINISTRATIVE REGION OF THE PEOPLE'S REPUBLIC OF CHINA, JAPAN, NEW ZEALAND, OR SOUTH AFRICA. ANY PURPOTED ACCEPTANCE OF THE TENDER OFFER RESULTING DIRECTLY OR INDIRECTLY FROM A VIOLATION OF THESE RESTRICTIONS WILL BE INVALID.
THIS STOCK EXCHANGE RELEASE OR ANY OTHER DOCUMENT OR MATERIALS RELATING TO THE TENDER OFFER IS NOT BEING MADE AND HAVE NOT BEEN APPROVED BY AN AUTHORISED PERSON FOR THE PURPOSES OF SECTION 21 OF THE UK FINANCIAL SERVICES AND MARKETS ACT 2000 (THE "FSMA"). ACCORDINGLY, THIS STOCK EXCHANGE RELEASE OR ANY OTHER DOCUMENT OR MATERIALS RELATING TO THE TENDER OFFER ARE NOT BEING DISTRIBUTED TO, AND MUST NOT BE PASSED ON TO, THE GENERAL PUBLIC IN THE UNITED KINGDOM. THE COMMUNICATION OF THIS STOCK EXCHANGE RELEASE OR ANY OTHER DOCUMENT OR MATERIALS RELATING TO THE TENDER OFFER IS EXEMPT FROM THE RESTRICTION ON FINANCIAL PROMOTIONS UNDER SECTION 21 OF THE FSMA ON THE BASIS THAT IT IS A COMMUNICATION BY OR ON BEHALF OF A BODY CORPORATE WHICH RELATES TO A TRANSACTION TO ACQUIRE DAY TO DAY CONTROL OF THE AFFAIRS OF A BODY CORPORATE; OR TO ACQUIRE 50 PER CENT. OR MORE OF THE VOTING SHARES IN A BODY CORPORATE, WITHIN ARTICLE 62 OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005.
Information to shareholders in the United States
Shareholders in the United States are advised that the shares in Pihlajalinna are not listed on a U.S. securities exchange and that Pihlajalinna is not subject to the periodic reporting requirements of the U.S. Securities Exchange Act of 1934, as amended (the "Exchange Act"), and is not required to, and does not, file any reports with the U.S. Securities and Exchange Commission (the "SEC") thereunder.
The Tender Offer will be made for the issued and outstanding shares in Pihlajalinna, which is domiciled in Finland, and is subject to Finnish disclosure and procedural requirements. The Tender Offer is made in the United States in compliance with Section 14(e) of the Exchange Act and the applicable rules and regulations promulgated thereunder, including Regulation 14E (in each case, subject to any exemptions or relief therefrom, if applicable) and otherwise in accordance with the disclosure and procedural requirements of Finnish law, including with respect to the Tender Offer timetable, settlement procedures, withdrawal, waiver of conditions and timing of payments, which are different from those of the United States. In particular, the financial information included in this stock exchange release has been prepared in accordance with applicable accounting standards in Finland, which may not be comparable to the financial statements or financial information of U.S. companies. The Tender Offer is made to Pihlajalinna's shareholders resident in the United States on the same terms and conditions as those made to all other shareholders of Pihlajalinna to whom an offer is made. Any information documents, including this stock exchange release, are being disseminated to U.S. shareholders on a basis comparable to the method that such documents are provided to Pihlajalinna's other shareholders.
To the extent permissible under applicable law or regulations, including Rule 14e-5 under the Exchange Act, Mehiläinen and its affiliates or its brokers and its brokers' affiliates (acting as agents for Mehiläinen or its affiliates, as applicable) may from time to time and during the pendency of the Tender Offer, and other than pursuant to the Tender Offer and combination, directly or indirectly, purchase or arrange to purchase, the shares in Pihlajalinna or any securities that are convertible into, exchangeable for or exercisable for such shares. These purchases may occur either in the open market at prevailing prices or in private transactions at negotiated prices. To the extent information about such purchases or arrangements to purchase is made public in Finland, such information will be disclosed by means of a press release or other means reasonably calculated to inform U.S. shareholders of Pihlajalinna of such information. In addition, the financial advisers to Mehiläinen may also engage in ordinary course trading activities in securities of Pihlajalinna, which may include purchases or arrangements to purchase such securities. To the extent required in Finland, any information about such purchases will be made public in Finland in the manner required by Finnish law.
Neither the SEC nor any U.S. state securities commission has approved or disapproved the Tender Offer, passed upon the merits or fairness of the Tender Offer, or passed any comment upon the adequacy, accuracy or completeness of the disclosure in this stock exchange release. Any representation to the contrary is a criminal offence in the United States.
The receipt of cash pursuant to the Tender Offer by a U.S. holder of shares in Pihlajalinna may be a taxable transaction for U.S. federal income tax purposes and under applicable U.S. state and local, as well as foreign and other, tax laws. Each holder of shares in Pihlajalinna is urged to consult its independent professional adviser immediately regarding the tax consequences of accepting the Tender Offer.
It may be difficult for Pihlajalinna's shareholders to enforce their rights and any claims they may have arising under the U.S. federal securities laws, since Mehiläinen and Pihlajalinna are located in non-U.S. jurisdictions, and some or all of their respective officers and directors may be residents of non-U.S. jurisdictions. Pihlajalinna's shareholders may not be able to sue Mehiläinen or Pihlajalinna or their respective officers or directors in a non-U.S. court for violations of the U.S. federal securities laws. It may be difficult to compel Mehiläinen and Pihlajalinna and their respective affiliates to subject themselves to a U.S. court's judgment.
This stock exchange release contains statements that, to the extent they are not historical facts, constitute "forward-looking statements". Forward-looking statements include statements concerning plans, expectations, projections, objectives, targets, goals, strategies, future events, future revenues or performance, capital expenditures, financing needs, plans or intentions relating to acquisitions, competitive strengths and weaknesses, plans or goals relating to financial position, future operations and development, business strategy and the trends in the industries and the political and legal environment and other information that is not historical information. In some instances, they can be identified by the use of forward-looking terminology, including the terms "believes", "intends", "may", "will" or "should" or, in each case, their negative or variations on comparable terminology. By their very nature, forward-looking statements involve inherent risks, uncertainties and assumptions, both general and specific, and risks exist that the predictions, forecasts, projections and other forward-looking statements will not be achieved. Given these risks, uncertainties and assumptions, investors are cautioned not to place undue reliance on such forward-looking statements. Any forward-looking statements contained herein speak only as at the date of this stock exchange release.
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Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, announced that detailed results of the data from the Phase 1b/2 trial combining TG4001, a HPV16 targeted therapeutic vaccine, with avelumab (BAVENCIO®), a human anti-PD-L1 antibody, in HPV16-positive recurrent and/or metastatic malignancies, will be presented in a poster presentation at the upcoming virtual meeting of the Society for Immunotherapy of Cancer (SITC) taking place November 9-14, 2020.
The principal investigator Professor Christophe Le Tourneau will present results from a pooled analysis of the Phase 1b/2 trial, including response rate, median progression-free survival, as well as the impact of patient/disease characteristics on outcome and immunogenicity.
As a reminder, the analysis of the trial data demonstrated clinical activity of the combination regimen and confirmed a manageable safety profile.The purpose of this exploratory Phase 1b/2 trial was to evaluate the safety and efficacy of the combination of TG4001 and an immune checkpoint inhibitor in a heterogeneous group of patients with aggressive, recurrent and/or metastatic HPV16-positive cancer. Clinical activity was observed in the overall study population (34 evaluable patients with oropharyngeal, anal, cervical, or other HPV16-positive cancers).In addition, Transgene has identified patient characteristics associated with promising clinical activity in this trial. For more than 50% of these patients, the disease had not progressed at 12 weeks, compared to an expected median progression-free survival (PFS) of 8 weeks for this population with current treatment regimens*. Consistent with data presented at ESMO 2019 , durable responses have been observed in most of the responder patients.
The trial was being conducted in collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer.
About the trial This multi-center, open-label trial is assessing the safety and efficacy of this immunotherapy combination regimen (TG4001 + avelumab) in patients with HPV16-positive cancers who have disease progression after at least one line of systemic treatment for recurrent/metastatic disease (NCT03260023). Prof. Christophe Le Tourneau, M.D., PhD, Head of the Department of Drug Development and Innovation (D3i) at the Curie Institute, and a world expert in drug development and head and neck cancers, is the Principal Investigator of the study. The trial is being conducted in collaboration with Merck KGaA, Darmstadt, Germany, a leading science and technology company, which in the US and Canada operates its biopharmaceutical business as EMD Serono, and Pfizer Inc. (NYSE: PFE).Patients received TG4001 at the dose of 5x107 pfu, SC, weekly for 6 weeks, every 2 weeks up to six months, and every 12 weeks thereafter, in combination with avelumab at 10 mg/kg, IV every two weeks, until disease progression.The primary endpoint of the Phase 2 part is the overall response rate (ORR, using RECIST 1.1). Secondary endpoints include progression-free survival, overall survival, disease control rate and other immunological parameters.
More information on the trial is available on clinicaltrials.gov.
About HPV-Positive Cancers HPV-positive cancers comprise a variety of malignancies, including head and neck cancers and anogenital cancers . Squamous cell carcinoma of the head and neck (SCCHN) is a heterogeneous group of cancers that can affect sites including the oral cavity, pharynx, and larynx . The incidence of HPV16-related SCCHN has significantly increased in recent years . HPV16 infection is associated with more than 85% of oropharynx squamous cell carcinomas , i.e. approximately 10,000 patients at metastatic stage and receiving a second line of treatment . Other HPV16-positive cancers include cervical , vaginal , vulvar , anal  and penile  cancers, i.e. approximately 15,000 cancers at metastatic stage and eligible for a second line of treatment .
Current treatments include chemoradiotherapy, immune checkpoint inhibitors, or surgical resection with radiotherapy. However, better options are needed for advanced and metastatic HPV+ cancers. It is thought that this immunotherapy combined with other immunotherapeutic agents such as immune checkpoint inhibitors could provide a promising potential treatment option that would address this strong medical need [16,17]. With immune checkpoint inhibitors, median overall survival remains inferior to 11 months [2-6] and median progression-free survival is between 2 and 4 months [2-6]. In this heterogenous group of malignancies, overall response rates are around 10–15% [2-6].
About TG4001 TG4001 is an investigational therapeutic vaccine based on a non-propagative, highly attenuated Vaccinia vector (MVA), which is engineered to express HPV16 antigens (E6 & E7) and an adjuvant (IL-2). TG4001 is designed to have a two-pronged antiviral approach: to alert the immune system specifically to HPV-16-infected cells that have started to undergo precancerous transformation (cells presenting the HPV16 E6 and E7 antigens) and to further stimulate the infection-clearing activity of the immune system through interleukin 2 (IL-2). TG4001 has been administered to more than 300 individuals, demonstrating good safety, significant HPV clearance rate and promising efficacy results [1; 18]. Its mechanism of action and good safety profile make TG4001 an excellent candidate for combinations with other therapies in HPV-mediated solid tumors.
Avelumab Approved Indications Avelumab (BAVENCIO®) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Avelumab in combination with axitinib is approved in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
Avelumab Important Safety Information from the US FDA-Approved Label The warnings and precautions for avelumab (BAVENCIO®) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis, and other immune-mediated adverse reactions as a single agent or in combination with axitinib [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity in combination with axitinib, major adverse cardiovascular events (MACE) in combination with axitinib [which can be severe and have included fatal cases], and embryo-fetal toxicity.
Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO® monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction peripheral edema, decreased appetite, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO® in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 hematology laboratory value abnormalities reported in at least 10% of patients with Merkel cell carcinoma treated with BAVENCIO® monotherapy include lymphopenia; in patients receiving BAVENCIO® in combination with axitinib, grade 3-4 clinical chemistry abnormalities include blood triglyceride increased and lipase increased.
For full US Prescribing Information and Medication Guide for BAVENCIO®, please see https://www.BAVENCIO.com.
 Le Tourneau et al. "Phase Ib/II trial of TG4001 (Tipapkinogene sovacivec), a therapeutic HPV-vaccine, and Avelumab in patients with recurrent/metastatic HPV16 positive cancers” 2019 ESMO Annual Meeting, 30 September 2019, Poster presentation Cohen et al. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study. Lancet. 2019;393:156–67 Ferris et al. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016;375:1856-1867 Morris et al. Nivolumab for Previously Treated Unresectable Metastatic Anal Cancer (NCI9673): A Multicentre, Single-Arm, Phase 2 Study. Lancet Oncol. 2017;18(4):446-453 Marabelle et al. Pembrolizumab for previously treated advanced anal squamous cell carcinoma: Pooled results from the KEYNOTE-028 and KEYNOTE-158 studies. J Clin Oncol 38: 2020 (suppl; abstr 4020) Chung et al. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol. 2019;10;37(17):1470-1478 ICO/IARC – HPV Information Center > Prevention at a glance – accessed July 2020 Kreimer et al., Human Papillomavirus Types in Head and Neck Squamous Cell Carcinomas Worldwide: A Systematic Review. Cancer Epidemiol Biomarkers Prev. 2005;14(2):467-75 HPV-positive oropharynx cancer: Company estimates based on: Globocan/IARC 2018 Cancer Fact Sheets: oropharynx (C09-10) – accessed July 2020; ICO/IARC – HPV Information Center 2018 Statistics – accessed July 2020; Kreimer et al., Human Papillomavirus Types in Head and Neck Squamous Cell Carcinomas Worldwide: A Systematic Review. Cancer Epidemiol Biomarkers Prev. 2005;14(2):467-75 HPV-positive cervical cancer: Globocan/IARC 2018 Cancer Fact Sheets: cervix uteri (C53) – accessed July 2020; ICO/IARC – HPV Information Center 2018 Statistics – accessed July 2020 HPV-positive vaginal cancer: Globocan/IARC 2018 Cancer Fact Sheets: vagina (C52) – accessed July 2020; ICO/IARC – HPV Information Center 2018 Statistics – accessed July 2020; Kreimer et al., Human Papillomavirus Types in Head and Neck Squamous Cell Carcinomas Worldwide: A Systematic Review. Cancer Epidemiol Biomarkers Prev. 2005;14(2):467-75 HPV-positive vulvar cancer: Globocan/IARC 2018 Cancer Fact Sheets: vulva (C51) – accessed July 2020; ICO/IARC – HPV Information Center 2018 Statistics – accessed July 2020; CDC United States Cancer Statistics: Data Visualizations – accessed July 2020; SEER Cancer stat facts: vulvar cancer – accessed July 2020 HPV-positive anal cancer: Globocan/IARC 2018 Cancer Fact Sheets: anus (C21) – accessed July 2020; ICO/IARC – HPV Information Center 2018 Statistics – accessed July 2020; CDC >Cancer Home >HPV and Cancer >Statistics >Rates by Race and Ethnicity >HPV-Associated Anal Cancer Rates by Race and Ethnicity– accessed July 2020; American Cancer Society: Anal Cancer – accessed July 2020 HPV-positive penile cancer: Globocan/IARC 2018 Cancer Fact Sheets: penis (C60) – accessed July 2020; ICO/IARC – HPV Information Center 2018 Statistics – accessed July 2020; CDC >Cancer Home >HPV and Cancer >Statistics >Rates by Race and Ethnicity >HPV-Associated Cancers Rates by Race and Ethnicity – accessed July 2020; Kreimer et al., Human Papillomavirus Types in Head and Neck Squamous Cell Carcinomas Worldwide: A Systematic Review. Cancer Epidemiol Biomarkers Prev. 2005;14(2):467-75 Company estimates based on notes 10, 11, 12, 13, 14 Melero et al. Evolving synergistic combinations of targeted immunotherapies to combat cancer. Nat Rev Cancer. 2015;15(8): 457-472. Van der Burg et al. Vaccines for established cancer: overcoming the challenges posed by immune evasion Nat Rev Cancer. 2016;16(4):219-233 Harper et al. The Efficacy and Safety of Tipapkinogen Sovacivec Therapeutic HPV Vaccine in Cervical Intraepithelial Neoplasia Grades 2 and 3: Randomized Controlled Phase II Trial With 2.5 Years of Follow-Up. Gynecologic Oncology. 2019; 153(3):521-529
About Transgene Transgene (Euronext: TNG) is a publicly traded French biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.The Company’s clinical-stage programs consist of two therapeutic vaccines (TG4001 for the treatment of HPV-positive cancers, and TG4050, the first individualized therapeutic vaccine based on the myvac® platform) as well as two oncolytic viruses (TG6002 for the treatment of solid tumors, and BT-001, the first oncolytic virus based on the Invir.IO™ platform).With Transgene’s myvac® platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC.With its proprietary platform Invir.IO™, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses. Transgene has an ongoing Invir.IO™ collaboration with AstraZeneca.Additional information about Transgene is available at: www.transgene.fr.Follow us on Twitter: @TransgeneSA
Disclaimer This press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results, regulatory authorities’ agreement with development phases, and development. The Company’s ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical data may not be predictive of human clinical results, the success of clinical studies, the ability to obtain financing and/or partnerships for product manufacturing, development and commercialization, and marketing approval by government regulatory authorities. For a discussion of risks and uncertainties which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque”) section of the Universal Registration Document, available on the AMF website (https://www.amf-france.org) or on Transgene’s website (www.transgene.fr). Forward-looking statements speak only as of the date on which they are made and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.
* Current treatment regimens, including immune checkpoint inhibitors, for patients with metastatic disease receiving a second (or further) line of treatment for their HPV16 associated indications deliver very limited benefit. With immune checkpoint inhibitors, overall response rates are around 10–15% in this heterogenous group of malignancies, while median overall survival is less than 11 months [2-6] and median progression-free survival is around 2 months [2-6].
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(RTTNews) - PPG Industries Inc. (PPG) released a profit for its third quarter that increased from the same period last year.
The company's earnings totaled $442 million, or $1.86 per share. This compares with $366 million, or $1.54 per share, in last year's third quarter.
Excluding items, PPG Industries Inc. reported adjusted earnings of $458 million or $1.93 per share for the period.
Analysts had expected the company to earn $1.92 per share, according to figures compiled by Thomson Reuters. Analysts' estimates typically exclude special items.
The company's revenue for the quarter fell 3.7% to $3.69 billion from $3.83 billion last year.
PPG Industries Inc. earnings at a glance:
-Earnings (Q3): $458 Mln. vs. $396 Mln. last year. -EPS (Q3): $1.93 vs. $1.67 last year. -Analysts Estimate: $1.92 -Revenue (Q3): $3.69 Bln vs. $3.83 Bln last year.