On July 31, 2019 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported it will be featured as a presenting company at the Canaccord Genuity 39th Annual Growth Conference on Wednesday, August 7, 2019 in Boston, MA (Press release, Eleven Biotherapeutics, JUL 31, 2019, View Source [SID1234537938]).

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Event: Canaccord Genuity 39th Annual Growth Conference
Date: August 7, 2019
Time: 10 a.m. EDT
Location: San Francisco room, The InterContinental Boston Hotel in Boston

A live webcast of the company’s presentation will be accessible from the Investors & Media section of Sesen Bio’s website, www.sesenbio.com. An archived replay of the webcast will be available on the company’s website for 90 days after the conference.

On July 31, 2019 Endo International plc (NASDAQ: ENDP) and Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, are reported that Endo International plc’s subsidiary Endo Ventures Limited has entered into definitive agreements with Helsinn to register, commercialize, and distribute Pracinostat on an exclusive basis in Canada upon receipt of the required regulatory approval (Press release, Endo Pharmaceuticals, JUL 31, 2019, View Source [SID1234537971]).

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Under the terms of the agreement, Paladin Labs Inc., an operating company of Endo, will be responsible for the registration, distribution, sales, marketing, medical affairs, pricing and reimbursement activities in connection with Pracinostat in Canada. Helsinn will be responsible for supplying the drug to Paladin and will retain all international development rights, including clinical development activities.

Pracinostat is a novel oral histone deacetylase (HDAC) inhibitor that is in a pivotal Phase 3 study in combination with Azacitidine for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are unfit for intensive chemotherapy. It is also being evaluated in a Phase II study in naïve patients with high or very high-risk myelodysplastic syndrome (MDS). The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Pracinostat in combination with Azacitidine for the treatment of patients with newly diagnosed AML who are ≥75 years of age or unfit for intensive chemotherapy.

AML is a cancer of the blood and bone marrow that is caused by the uncontrolled proliferation of a blood progenitor cell of myeloid lineage. It is the most common type of acute leukemia in adults. Pracinostat is thought to act as an epigenetic cell cycle regulator in cancerous cells. The clinical study combination of Pracinostat and Azacitidine is being evaluated for the effect in reverse gene silencing, leading to cell apoptosis and differentiation.

"Our collaboration with Paladin demonstrates our commitment to advancing the quality of cancer care for patients around the world. Paladin has a very successful 24-year track record of commercializing innovative pharmaceutical products in Canada and our partnership with them will be an invaluable component of our strategy to ensure global access to Pracinostat," said Riccardo Braglia, Helsinn Group Vice Chairman and CEO.

"Pracinostat has shown potential as a possible treatment for AML and MDS in an elderly population with otherwise limited therapeutic options," said Rahul Garella, Senior Vice President, International Pharmaceuticals of Endo. "We are excited to partner with Helsinn and add this important medicine to our leukemia cancer care product offering in Canada."

About Pracinostat:

Pracinostat is an oral HDAC that is in a pivotal Phase III study in combination with Azacitidine for the treatment of adults with newly diagnosed acute myeloid leukemia ("AML") who are unfit for intensive induction chemotherapy. It is also being evaluated in a Phase II study in patients with high risk myelodysplastic syndromes ("MDS"). The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Pracinostat in combination with Azacitidine for the treatment of patients with newly diagnosed AML who are ≥75 years of age or unfit for intensive chemotherapy.

In 2016 Helsinn obtained global rights to Pracinostat from MEI Pharma, Inc. under an exclusive license, development and commercialization agreement, the terms of which are not altered by the sublicense agreement, which also included the right for Helsinn to grant sublicenses to third parties.

Exclusive licensing rights for all territories excluding US, Canada, Japan and South America were granted to Menarini, the Italian biopharmaceutical group, in December 2018.

Pracinostat is an investigational agent and is not approved for commercial use in the U.S. and any other country worldwide.

About AML:

AML is a disorder of the blood and bone marrow caused by the uncontrolled proliferation of an abnormal hematopoietic cell of myeloid lineage. This results in a high circulating number of immature blood cells and replacement of normal bone marrow by malignant cells. AML has eight different subtypes, which are based on the type of cell from which the leukemia developed. It is typically a disease of older patients, with a median age at diagnosis of 67 years. Although the cure rate for AML patients 60 years and younger with intensive chemotherapy is 35 to 40%, it remains poor in older patients, typically not exceeding 15%.

About MDS:

Myelodysplastic Syndrome is a type of blood cancer in which the bone marrow does not make enough healthy blood. MDS is normally a disease of the elderly and sometimes may progress into AML, which is a more rapidly growing cancer.

On July 31, 2019 Takeda Pharmaceutical Company Limited (TOKYO:4502)(NYSE:TAK) (Press release, Takeda, JUL 31, 2019, View Source [SID1234537913]):

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Underlying Revenue declined -0.8% vs FY2018 Q1 pro-forma revenue1

Takeda’s 14 global brands, with an aggregate revenue of 270.2 billion yen posted strong year-over-year growth of +22%. This growth mostly offset the negative impact from intensified competition, phasing, and generic erosion.
Takeda’s 5 key business areas represent ~78% of revenues.
GI grew +8% spearheaded by ENTYVIO continuing to gain market share.
Plasma Derived Therapy (PDT) Immunology grew +2% driven by Albumin growth, with Immunoglobulin (IG) sales impacted by phasing of Intravenous Immunoglobulin (IVIG) shipments.

Rare Diseases declined -10% with rare hematology impacted by competition and price pressure, and strong uptake of TAKHZYRO not fully offsetting the decline of other Hereditary Angioedema (HAE) products due to the switch to TAKHZYRO and stocking in FY2018 Q1.

Oncology grew +8% driven by expansion of NINLARO.

Neuroscience grew +10% driven by the U.S. business under a new commercial structure.

Underlying Core Operating Profit Margin 32.4% for Q1

Reported Operating Profit declined 90.0% to 9.9 billion yen, largely impacted by one-time integration costs as well as non-cash purchase accounting expenses including unwinding of inventory step-up, and increased amortization of intangibles and impairment.
Underlying Core Operating Profit Margin for the current period was 32.4% reflecting synergy savings and continued OPEX discipline.
Achieved several important pipeline milestones in Q1

Currently 19 New Molecular Entity assets in Phase 2 & 3.
Advances in Cell and Gene Therapy platforms where CAR-T Cell Therapy from T-CiRA moves towards clinic and the integration of Adeno-Associated Virus-based (AAV-based) process development and manufacturing center in Austria.
ENTYVIO subcutaneous formulation achieved primary endpoint as maintenance therapy in Crohn’s disease.
Orexin 2 receptor agonist TAK-925 received Sakigake Designation in Japan for treatment of narcolepsy.
Disposing non-core assets to generate cash and focus the business

Net debt / adjusted EBITDA reduced from 4.7x at end of FY2018 to 4.4x as of June 2019, which does not include the $3.4 billion upfront cash payment received July 1, 2019 for the sale of XIIDRA to Novartis.
Sale of TACHOSIL remains on track to close in second half of calendar year.
Negotiations ongoing for further potential divestments.
Costa Saroukos, Chief Financial Officer, commented:

"Takeda had a very strong start to the year, delivering on our strategic priorities while successfully executing the integration of Shire. The combination of solid performance across our 14 global brands, continued OPEX discipline, and realization of cost synergies resulted in strong margins and cash flow. We are also making steady progress against our divestiture plan, with the completion of the XIIDRA sale on July 1st.
For the full year, Takeda has revised management guidance upward to reflect updated VELCADE assumptions and divestitures, and now anticipates delivering an Underlying Core Operating Profit margin in the mid-to-high twenties.
Takeda is relentlessly executing towards our cost synergy, de-leveraging, and margin targets. We remain on track to achieve our previously raised cost synergy target of $2 billion by the end of FY 2021, we are committed to achieving our 2x net debt / adjusted EBITDA target over the next three to five years, and our strong start to fiscal 2019 gives us great confidence towards realizing top-tier margins in the medium-term."

Underlying Growth compares two periods (quarters or years) of financial results under a common basis and is used by management to assess the business. These financial results are calculated on a constant currency basis and excluding the impact of divestitures and other amounts that are unusual, non-recurring items or unrelated to our ongoing operations.
Growth versus FY2018 Q1 pro-forma revenue. Pro forma adjustments to reflect amortization of intangible assets as if the acquisition of Shire had occurred at the beginning of FY2018, while removing non-recurring costs related to the acquisition such as transaction costs. The adjustments also include removal of impacts related to Shire’s oncology business which was divested in August 2018.
Core Operating Profit represents net profit adjusted to exclude income tax expenses, our share of profit or loss of investments accounted for using the equity method, finance expenses and income, other operating expenses and income, amortization and impairment losses on intangible assets associated with products and other items that management believes are unrelated to our core operations, such as purchase accounting effects and transaction related costs
Attributable to the owners of the company.
Not Meaningful
FY2019 Management Guidance: Upward revision to reflect changes to assumptions

Takeda no longer assumes any additional U.S. competitor for VELCADE within FY2019
Reflects divestitures of XIIDRA (closed July 1, 2019) and TACHOSIL (expected close CY2019 H2)

vi. Constant Exchange Rate growth (applying FY2018 full year average foreign exchange rate). Compared to baseline of 3,300 billion JPY (rounded pro-forma April 2018 – March 2019 combined revenue of Legacy Takeda and Legacy Shire, converted at April 2018 – March 2019 average exchange rate of 111 JPY/USD; also adjusted to remove the revenue from divested assets such as Techpool, Multilab, and TACHOSIL from Legacy Takeda, and the oncology portfolio and XIIDRA from Legacy Shire)

FY2019 Reported Forecast: Increasing Earnings forecasts with Reported Revenue forecast unchanged

For more details on Takeda’s FY2019 1st quarter results and other financial information, please visit View Source

On July 31, 2019 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it will release its second quarter 2019 financial results on Wednesday, August 7, after the close of the U.S. financial markets (Press release, Syndax, JUL 31, 2019, View Source [SID1234537936]).

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In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET on Wednesday, August 7, to discuss the Company’s financial results and provide a general business update.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 8959885
Domestic Dial-in Number: (855) 251-6663
International Dial-in Number: (281) 542-4259
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.

On July 31, 2019 BioTime, Inc. (NYSE American and TASE: BTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported it is launching a new corporate brand, including a change of its corporate name to Lineage Cell Therapeutics, Inc., effective August 12, 2019 (Press release, BioTime, JUL 31, 2019, View Source [SID1234537955]). In connection with the launch, the Company’s NYSE American ticker symbol will change to "LCTX" and will be effective at the open of the market on August 12, 2019. The Company’s former ticker symbol "BTX" will remain effective through market close as of August 9, 2019. The new website for Lineage Cell Therapeutics will be www.lineagecell.com. The Company’s new identity reflects its commitment to becoming an innovative, leading cell therapy company and highlights its extensive cell therapy platform.

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"BioTime has been a pioneering company in the field of cell therapy, but its assortment of programs and affiliates sometimes detracted from its core business and made it difficult for key audiences to fully appreciate its story. During the past three quarters, a new management team has taken aggressive steps to streamline the corporate structure, selectively convert diverse equity holdings into cash, and focus priorities on our three clinical-stage assets. With a clearer structure and clinical focus now in place, this was the right time to update our name and invite stakeholders to rediscover this exciting business," stated Brian M. Culley, the Company’s Chief Executive Officer. "Our new brand defines us within our field: we control the lineage of pluripotent cells and transplant those differentiated cell types into patients as therapeutics. The descriptive and unique logo is expressive of our core technology and refined focus. We look forward to launching our new brand on August 12th and continuing to build momentum and awareness of the Company’s mission among the investment, medical and patient communities."

The Company also will be relocating its corporate headquarters to Carlsbad, California, effective August 12, 2019. The move to San Diego County will provide the Company with proximity to world-leading academic centers, public and private cell therapy peers, and is expected to offer more centralized decision-making, cost-savings, and access to an extensive network of experienced staff.