Den 26 oktober 2017 rapporterade Xspray Pharma att de har fått godkännande för två sökta patent i USA (Press release, Xspray, OCT 26, 2017, View Source [SID1234523286]). Patentet omfattar komposition avseende produktkandidaterna HyNap-Sora och HyNap-Nilo. Det är Xsprays andra och tredje produktpatent som godkänns på huvudmarknaden i USA på kort tid. Bolaget har tidigare offentliggjort ett patentgodkännande i Japan och USA avseende HyNap-Dasa och har pågående ansökningsärenden för flera motsvarande patent i bland annat Japan och Europa.
"Nu har vi patent beviljade i USA som täcker de tre produkter vi avser att introducera på den amerikanska marknaden efter respektive original-substanspatent har löpt ut (under perioden 2020-2023). Vi har arbetar systematiskt och strategiskt med våra innovationer både för att förverkliga dem till produkter men också genom att säkra värdet med ett fullgott patentskydd. Jag ser det här som en bekräftelse på det arbetet," säger Per Andersson, vd för Xspray Pharma.

Xspray Pharma har erhållit godkännande ("notice of allowance") för två patent i USA avseende produktkandidaterna HyNap-Sora och HyNap-Nilo som är tänkta för behandling av vissa cancerformer. Det är Xsprays andra och tredje produktpatent som godkänns på den viktigaste marknaden, USA. Beskedet kommer i enlighet med bolagets plan att söka och erhålla patent för komposition och metod för samtliga tre produktkandidater under utveckling på de tre viktigaste marknaderna, USA, Europa och Japan.

"Med dessa patent, och de positiva resultaten från vår kliniska studie som vi nyligen offentliggjorde, har vi tagit viktiga steg mot målet att utveckla våra tre första produkter för lansering på den amerikanska marknaden," kommenterar Xsprays vd Per Andersson.

Xspray Pharmas aktier introducerades den 28 september på Nasdaq First North, efter en lyckosamt genomförd nyemission som tillförde bolaget 132 miljoner kronor före emissionskostnader. Planen är nu att använda kapitalet för att utveckla tre produktkandidater och blivande cancerläkemedel baserade på bolagets egenutvecklade teknologi, samt att introducera de första produkterna på den amerikanska marknaden under perioden 2020-2023.

On October 26, 2017 Transgene (Euronext Paris: TNG), a biotech company that designs and develops viral-based immunotherapies, reported that the first patient with recurrent glioblastoma has been treated at La Pitié-Salpêtrière hospital, Greater Paris University Hospitals,AP-HP (Paris), in the first-in-human clinical trial (Oncovirac trial) of TG6002, a novel oncolytic virus (Press release, Transgene, OCT 26, 2017, View Source [SID1234521244]). TG6002 represents the next generation of oncolytic virus(OV), which is administered intravenously and has multiple functions. It has been engineered to combine oncolysis (the breakdown of cancer cells) with the local
production of 5-FU chemotherapy agent in the tumor. It is also expected to induce an immune response
following the antigen spreading that is caused by the cancer cells’ breakdown.

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TG6002: a novel oncolytic virus allowing the targeted production of chemotherapy in the tumor
TG6002 is a next generation oncolytic immunotherapy, which has a double mechanism of action. It has been
designed by Transgene to:
1. induce the breakdown of cancer cells (oncolysis) by tumor-selective viral replication. In preclinical
experiments, TG6002 was able to induce response in the primary tumor and an immune-mediated
regression of distant metastases (immunogenic cell death);
2. allow the local production of chemotherapy (5-FU), a widely used cancer chemotherapy, in the
tumor. TG6002 expresses the proprietary Fcu1 gene in the cancer cells it has infected, leading to
the local conversion of the 5-FC into 5-FU.

First-in-human trial to deliver first readouts in H2 2018
Oncovirac is an open-label Phase 1/2a trial evaluating the safety and tolerability of multiple-ascending doses
of TG6002 administered intravenously in combination with oral 5-FC, a non-cytotoxic pro-drug, flucytosine,
that can be converted in 5-FU. The anti-tumor activity of this novel oncolytic virus will also be monitored.
The study will enroll patients suffering from recurrent glioblastoma, who have failed standard of care
treatment.

Dr. Ahmed Idbaih, M.D., PhD, neuro-oncologist at La Pitié-Salpêtrière Hospital (Paris, France), is the principal
investigator of the study. He is involved in several clinical trials dedicated to primary brain tumor patients. He
also coordinates "GlioTex", a research group focused on glioblastoma and experimental therapeutics at ICM (The
Institut du Cerveau et de la Moelle épinière – Brain & Spine Institute). AP-HP Paris Greater Hospitals, is the
sponsor of Oncovirac, a trial also supported by INCa (French National Cancer Institute). More information on the
trial is available on clinicaltrials.gov (NCT03294486). The first readouts of the study are expected in the second
half of 2018.

Maud Brandely, M.D., PhD, Chief Medical Officer of Transgene, added: "TG6002 is a very promising new
generation of oncolytic virus, which has the potential to be administered intravenously. Based on our
compelling preclinical data, we have established that its replication induces immunogenic cell lysis and the
local production of chemotherapy. We are excited to see this novel immunotherapy with multiple modes of
action enter the clinic and look forward to obtaining results that will allow further development of TG6002
in several solid tumors indications."

Dr. Ahmed Idbaih, M.D., PhD, neuro-oncologist at La Pitié-Salpêtrière hospital, AP-HP, and principal
investigator of the trial, added: "Current treatments of recurrent glioblastoma are insufficient. By combining
the immunogenic lysis of cancer cells with the targeted production of chemotherapy in the tumor, TG6002
has the potential to show anti-tumor efficacy and to avoid systemic side effects of chemotherapy. We are
very pleased to be conducting this first in human clinical trial evaluating this novel immunotherapy that we
believe could improve the overall survival of recurrent glioblastoma patients while preserving their quality
of life."

On October 26, 2017 Bayer reported that the third quarter of 2017 marked a period of further strategic and operational progress for the Bayer Group (Press release, Bayer, OCT 26, 2017, View Source [SID1234521222]).

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“Last quarter we took some important strategic steps,” said Werner Baumann, Chairman of the Board of Management, when he presented the interim report for the third quarter on Thursday. Bayer has made very good progress toward its goal of achieving full separation from Covestro in the medium term, he noted. As regards the planned acquisition of Monsanto, Baumann explained how the agreement to sell selected Crop Science businesses to BASF marked another important step. Bayer recorded an increase in sales (currency- and portfolio adjusted – Fx & portfolio adj.) and earnings at Pharmaceuticals in the third quarter. Business at Consumer Health declined, as expected. At Crop Science and Animal Health, sales moved ahead (Fx & portfolio adj.), while EBITDA before special items decreased year on year.

The agreed sale of selected Crop Science businesses to BASF for EUR 5.9 billion is subject to the approval of the antitrust authorities. The transaction is also dependent on the successful closing of Bayer’s acquisition of Monsanto. “With this agreement, we are actively addressing the authorities’ possible concerns regarding the planned acquisition of Monsanto. However, it is not an attempt to preempt any decisions by the regulatory authorities,” Baumann stressed. Bayer continues to work closely with the authorities with the aim of facilitating a successful closing of the transaction by early 2018.

Bayer has reduced its direct interest in Covestro to 24.6 percent, and is declining to exercise certain voting rights at the Covestro Annual General Meeting. “We have thus ceded de facto control over Covestro and deconsolidated it,” Baumann explained. The remaining shares of Covestro are now recognized in the statement of financial position using the equity method. The continuing operations of the Bayer Group are now comprised exclusively of the Life Science businesses. The financial information for the preceding quarters and the prior-year figures have been restated accordingly.

Group sales in the third quarter of 2017 declined by 2.8 percent to EUR 8,025 million (Q3 2016: EUR 8,258 million). Adjusted for currency and portfolio effects, sales advanced 1.2 percent. EBITDA before special items improved by 4.1 percent to EUR 2,204 million (Q3 2016: EUR 2,118 million). Negative currency effects diminished earnings by around EUR 100 million. EBIT came to EUR 1,388 million, matching the prior-year period (Q3 2016: EUR 1,397 million). This figure reflected net special charges of EUR 249 million (Q3 2016: EUR 125 million), consisting primarily of expenses in connection with the agreed acquisition of Monsanto, provisions for legal risks, and efficiency improvement programs. EBIT before special items advanced by 7.6 percent to EUR 1,637 million (Q3 2016: EUR 1,522 million).

Net income came to EUR 3,881 million (Q3 2016: EUR 1,187 million). This figure includes a gain of EUR 2.8 billion resulting from the deconsolidation of Covestro and the presentation of the Covestro Group as an associate for the first time. Earnings per share (total) increased to EUR 4.45 (Q3 2016: EUR 1.43). Core earnings per share from continuing operations fell by 3.9 percent to EUR 1.47 (Q3 2016: EUR 1.53). This is due primarily to the difference in the number of shares, which grew significantly in 2017 as a result of the mandatory convertible notes issued in November 2016. Had the number of shares remained the same, core earnings per share would have improved by 1.4 percent.

Net cash provided by operating activities (total) declined by 11.2 percent in the third quarter of 2017, to EUR 2,711 million (Q3 2016: EUR 3,053 million). Net financial debt declined by half to EUR 4.7 billion compared with June 30, 2017, due mainly to cash inflows from operating activities, inflows of EUR 2.2 billion from the sale of Covestro shares, and a reduction of EUR 0.5 billion from the deconsolidation of the Covestro Group.

Pharmaceuticals: Key growth products continue to deliver strong performance

Sales of prescription medicines (Pharmaceuticals) increased by 2.3 percent (Fx & portfolio adj.) to EUR 4,065 million. “Our key growth products again delivered strong performance,” Baumann said. The oral anticoagulant Xarelto, the eye medicine Eylea, the cancer drugs Xofigo and Stivarga, and the pulmonary hypertension treatment Adempas posted total combined sales of EUR 1,522 million, up 13.2 percent (Fx adj.). Xarelto sales increased by 6.6 percent (Fx adj.), with growth driven by gains in Europe and Asia. Sales in the United States, where Xarelto is marketed by a subsidiary of Johnson & Johnson, increased by a double-digit percentage. However, license revenues – recognized as sales at Bayer– were level with the prior-year quarter, in part due to a shift between reporting periods. Sales of Eylea advanced significantly (Fx adj. plus 19.9 percent), due particularly to a substantial expansion of volumes in Japan, Europe and Canada. Xofigo also posted strong gains (Fx adj. plus 24.9 percent), with business continuing to benefit from a successful market launch in Japan and higher demand in Europe. Bayer substantially increased sales of Stivarga (Fx adj. plus 27.7 percent), especially in the United States and Japan. Adempas also showed strong growth (Fx adj. plus 19.3 percent), especially in the United States.

Business with the Kogenate/Kovaltry blood-clotting medicines was down significantly year on year (Fx adj. minus 25.9 percent) due primarily to lower order volumes for the active ingredient placed by a distribution partner. After adjusting for this development, sales were at the prior-year level. In contrast, the hormone-releasing intrauterine devices of the Mirena product family delivered encouraging performance (Fx adj. plus 8.4 percent).

EBITDA before special items of Pharmaceuticals increased by 5.1 percent to EUR 1,493 million. This development was largely the result of higher volumes and a lower cost of goods sold. In addition, the division recorded a positive earnings effect from a receivable in the mid-double-digit millions as one of its distribution partners for Kogenate did not fulfill its purchase obligation. In contrast, negative currency effects diminished earnings by about EUR 60 million.

Weak development at Consumer Health, as expected

Sales of Consumer Health in the third quarter fell by 2.9 percent (Fx & portfolio adj.) to €1,320 million. “As anticipated, we recorded a weak development of business with our self-care products,” Baumann said. The decline in sales in North America was largely due to the market environment remaining challenging in the United States. The negative development in Europe is primarily the result of weaker business in Russia after a strong previous quarter. On a currency-adjusted basis, the division increased sales in Latin America and attained the prior-year level in Asia/Pacific.

The antihistamine Claritin achieved a marked increase in sales (Fx adj. plus 9.3 percent) compared with a weak prior-year quarter, primarily in China and the United States. Sales of the analgesic Aspirin edged higher. Including business with Aspirin Cardio, which is reported under Pharmaceuticals, sales advanced by 7.9 percent (Fx adj.). Business with the Bepanthen/Bepanthol wound and skin care products developed positively (Fx adj. plus 6.1 percent), especially in Europe. Sales of the sunscreen product Coppertone declined substantially (Fx adj. minus 44.6 percent), mainly due to ongoing strong competitive pressure in the United States.

EBITDA before special items of Consumer Health declined by a substantial 16.5 percent to EUR 274 million. The fall in earnings is primarily due to lower volumes and a higher cost of goods sold, which largely resulted from inventory write-offs and the underutilization of production facilities. In addition, currency effects diminished earnings by around EUR 10 million. Earnings also included one-time gains in the amount of around EUR 30 million that mainly related to the sale of non-core brands.

Crop Science posts significant gains in North America and Asia/Pacific

Third-quarter sales of the agricultural business (Crop Science) moved ahead by 2.7 percent (Fx & portfolio adj.) to EUR 2,031 million. Crop Science achieved gratifying business development in North America and Asia/Pacific, where sales rose by 9.8 percent (Fx adj.) and 7.4 percent (Fx adj.), respectively. Sales in Europe/Middle East/Africa and Latin America matched the prior-year level. “On the positive side, we were able to reduce provisions for product returns in Brazil, which shows that the measures we have implemented to normalize the situation in Brazil are taking hold,” Baumann said. In that country, Bayer had to establish provisions in the second quarter due to unexpectedly high inventories of crop protection products.

At Crop Protection, the Insecticides business delivered very positive performance, with sales rising by 13.2 percent (Fx & portfolio adj.). Sales declined at Fungicides (Fx & portfolio adj. minus 6.3 percent), Herbicides (Fx & portfolio adj. minus 1.9 percent) and SeedGrowth (Fx & portfolio adj. minus 1.1 percent). In contrast, Seeds (which also includes the traits business) reported strong gains, with sales rising by 29.6 percent (Fx & portfolio adj.). Environmental Science posted increased sales due to product deliveries to the acquirer of the consumer business divested in the fourth quarter of 2016 (Fx & portfolio adj. plus 6.8 percent).

EBITDA before special items of Crop Science decreased by 3.5 percent to EUR 307 million in the third quarter of 2017. Lower selling prices and a negative currency effect of around EUR 20 million stood against an increase in other operating income, a decline in the cost of goods sold and a decrease in selling expenses. Positive effects in the mid-double-digit millions were recorded in conjunction with the accounting measures taken in the previous quarter in Brazil.

Animal Health: Sales edge higher in challenging market environment

Sales of the Animal Health business rose by 1.4 percent (Fx and portfolio adj.) to EUR 359 million in a weak market environment overall. The business unit achieved considerable gains in the North America region on a currency-adjusted basis, thanks partly to the Cydectin product portfolio acquired in January 2017. Sales of the Advantage family of flea, tick and worm control products were down 3.3 percent (Fx adj.) year on year, mainly as a result of higher competitive pressure in Europe. The Seresto flea and tick collar continued to post double-digit-percentage sales growth, with sales rising by 17.1 percent (Fx adj.). EBITDA before special items of Animal Health declined by 9.0 percent to EUR 81 million, in part due to higher selling expenses and a currency loss of around EUR 5 million.

Nine-month sales edge higher

Group sales in the first nine months of 2017 rose by 1.1 percent (Fx & portfolio adj. plus 1.1 percent) to EUR 26,419 million (9M 2016: EUR 26,120 million). EBITDA before special items came in at EUR 7,505 million, matching the prior-year level (9M 2016: EUR 7,512 million). Net income amounted to EUR 7,188 million (9M 2016: EUR 4,078 million). Earnings per share (total) improved to EUR 8.24 (9M 2016: EUR 4.93), while core earnings per share from continuing operations were down 4.5 percent year on year at EUR 5.33 (9M 2016: EUR 5.58). This is due primarily to the difference in the number of shares, which grew significantly in 2017 as a result of the mandatory convertible notes issued in November 2016. Had the number of shares remained the same, core earnings per share would have improved by 0.7 percent.

Group outlook for 2017 confirmed based on change in structure

Following the deconsolidation of the company, Covestro will be presented as a discontinued operation and is thus, as of the fourth quarter of 2017, treated only as an equity method investment in the forecast. The Bayer Group’s continuing operations thus reflect the values previously referred to under Life Sciences. For the fourth quarter of 2017, the company is now using the exchange rates prevailing on September 30, 2017, including a rate of USD 1.18 (previously: USD 1.14) to the euro.

For the Bayer Group, the company is still planning sales of EUR 35 billion to EUR 36 billion for full year 2017. As before, this corresponds to a low-single-digit percentage increase on a currency- and portfolio-adjusted basis. Bayer continues to expect EBITDA before special items to come in slightly above the level of the previous year. As regards core earnings per share from continuing operations, the company now expects a low-single-digit percentage decrease on the basis of the values that were adjusted for Covestro effects for the current year and previous year. This is due primarily to the difference in the number of shares, which grew significantly in 2017 as a result of the mandatory convertible notes issued in November 2016. Without this effect, core earnings per share would improve by a low-single-digit percentage.

For Pharmaceuticals, Bayer now expects sales of approximately EUR 17 billion (previously: more than EUR 17 billion). This continues to correspond to a mid-single-digit percentage increase on a currency- and portfolio-adjusted basis. As before, the company plans to raise sales of its key growth products to more than EUR 6 billion. Bayer continues to expect a high-single-digit percentage increase in EBITDA before special items and an improvement in the EBITDA margin before special items.

For Consumer Health, Bayer continues to expect sales for the full year of about EUR 6 billion. This still corresponds to the prior-year level on a currency- and portfolio-adjusted basis. As before, the company expects EBITDA before special items to decline by a high-single-digit percentage.

For Crop Science, Bayer is still anticipating sales of below EUR 10 billion. This corresponds to a low-single-digit-percentage decline on a currency- and portfolio-adjusted basis. Meanwhile, the company continues to expect EBITDA before special items to decline by a mid-teens percentage.

For Animal Health, Bayer still anticipates a currency- and portfolio-adjusted increase in sales by a low- to mid-single-digit percentage. As before, it plans to improve EBITDA before special items by a high-single-digit percentage.

In 2017, Bayer now expects to take special charges for continuing operations in EBITDA in the region of EUR 0.6 billion (previously: EUR 0.5 billion). Excluding capital and portfolio measures, net financial debt is targeted to be around EUR 4 billion at the end of 2017 (previously: around EUR 7 billion).

On October 26, 2017 OPKO Health, Inc. (NASDAQ:OPK) reported that its licensee, TESARO, Inc. (Nasdaq:TSRO), received U.S. Food and Drug Administration (FDA) approval for VARUBI (rolapitant) IV in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy (Press release, Opko Health, OCT 26, 2017, View Source [SID1234521224]). Delayed nausea and vomiting can occur anytime between 25 and 120 hours following chemotherapy, and is often extremely debilitating.

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TESARO licensed exclusive rights for the development, manufacture, commercialization, and distribution of VARUBI (rolapitant) from OPKO Health in December 2010. TESARO previously launched an oral version of VARUBI in November 2015. OPKO Health will receive tiered double-digit royalties on sales of VARUBI IV. In addition, OPKO Health is eligible to receive additional commercial milestone payments of up to $85 million upon achievement of certain sales thresholds. TESARO is expected to launch VARUBI IV in November 2017.

“We are especially pleased that our partner, TESARO, has received FDA approval for VARUBI IV. This is particularly important as IV treatments for chemotherapy induced nausea and vomiting account for 90% of the market. We look forward to TESARO’s continued success in commercializing the VARUBI product line,” said Philip Frost, M.D., Chairman and Chief Executive Officer of OPKO Health.

About VARUBI

VARUBI is a highly selective and competitive antagonist of human substance P/neurokinin 1 (NK-1) receptors, which play an important role in the delayed phase of chemotherapy induced nausea and vomiting (CINV). With a long plasma half-life of approximately seven days, a single dose of VARUBI, as part of an antiemetic regimen, significantly improved complete response (CR) rates in the delayed phase of CINV. Results from three Phase 3 trials of VARUBI oral tablets demonstrated a significant reduction in episodes of vomiting or use of rescue medication during the 25- to 120-hour period following administration of highly emetogenic and moderately emetogenic chemotherapy regimens. In addition, patients who received VARUBI reported experiencing less nausea that interfered with normal daily life and fewer episodes of vomiting or retching over multiple cycles of chemotherapy. Results from a bioequivalence trial demonstrated comparability of the IV and oral formulations of VARUBI.

VARUBI is available by prescription only. Please see full prescribing information, including additional important safety information, available at www.varubirx.com.

On October 26, 2017 CohBar, Inc. (OTCQX: CWBR and TSXV: COB.U), an innovative biotechnology company focused on developing mitochondria based therapeutics (MBTs) to treat age-related diseases, reported that the Company will release its third quarter 2017 financial results on Monday, November 13, 2017 and will host a conference call for the shareholders at 2:00 p.m. (Pacific Time) the same day to provide an update on its lead program, emerging pipeline and business (Press release, CohBar, OCT 26, 2017, http://cohbar.com/cohbar-inc-to-announce-third-quarter-2017-financial-results-and-host-conference-call-for-shareholders-on-november-13-2017/ [SID1234521223]).

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Details for the Conference Call and Slide Presentation:
Date: November 13, 2017
Time: 2:00 p.m. (Pacific Time)

Audio, Dial-in U.S. and Canada: 1-888-599-8667
Audio, Dial-in International: 1-719-325-2494
Conference ID# 6432383

Slide Presentation – go to www.webex.com, click on the ‘Join’ button and enter Meeting Number 921656999 and Password Q3Call.

For individuals participating in the Investor Call and Slide Presentation, we request you please call into the audio and log into WebEx approximately 10 minutes before the start of the presentation so that we can begin promptly.

An audio replay of the call will be available beginning at 6:00 p.m. (Pacific Time) on November 13, 2017, through 9:00 p.m. (Pacific Time) on November 27, 2017. To access the recording please dial 1-844-512-2921 in the U.S. and Canada or 1-412-317-6671 internationally and reference Conference ID# 6432383.

The audio replay along with the slide presentation will also be available at www.cohbar.com beginning November 14, 2017 through November 27, 2017.