On October 26, 2016 AstraZeneca reported positive results from the Phase III SOLO-2 trial designed to determine the efficacy of Lynparza (olaparib) tablets (300mg twice daily) as a monotherapy for the maintenance treatment of platinum-sensitive relapsed, BRCA-mutated ovarian cancer (Press release, AstraZeneca, OCT 26, 2016, View Source [SID1234516002]). Results from the trial demonstrate a clinically-meaningful and statistically-significant improvement of progression-free survival (PFS) among patients treated with Lynparza compared to placebo and provide additional evidence to support the potential use of Lynparza in this patient population.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Importantly, the median PFS in the Lynparza arm of SOLO-2 substantially exceeded that observed in the Phase II maintenance study in patients with platinum-sensitive relapsed ovarian cancer (Study 19).1

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "We are pleased with the robust improvement in progression-free survival demonstrated by Lynparza in the SOLO-2 trial. We will work with regulatory authorities to make Lynparza tablets available as quickly as possible to patients with ovarian cancer. We remain committed to investigating the full potential of Lynparza, both as monotherapy and in combinations, and to identifying all patients who may benefit from this important medicine."

Initial findings demonstrate that safety profile with Lynparza tablets was consistent with previous studies. Full results of SOLO-2 will be presented at a forthcoming medical meeting.

Today’s positive results follow the Fast Track Designation for Lynparza by the US FDA earlier this year, in patients with a BRCA mutation who have platinum-sensitive, relapsed ovarian cancer.

NOTES TO EDITORS

About SOLO-2

SOLO-2 was a Phase III, multicentre trial designed to determine the efficacy of Lynparza tablets as a maintenance monotherapy compared with placebo, in patients with platinum-sensitive relapsed or recurrent BRCA-mutated (BRCAm) ovarian cancer. In SOLO-2, patients with either germline or somatic BRCAm status were eligible for enrolment, although due to the lack of widespread availability of tumour BRCA testing, most patients were enrolled on blood-based germline testing. Those few patients who were enrolled based on a tumour test were also found to have a germline BRCA mutation. Patients were randomised to receive either Lynparza tablets (300mg twice daily) or placebo until disease progression.1

The trial, conducted in collaboration with the European Network for Gynaecological Oncological Trial Groups (ENGOT) and Groupe d’Investigateurs National pour l’Etude des Cancers de l’Ovaire et du sein (GINECO), randomised 295 patients with documented germline BRCA1 or BRCA2 mutations who had received at least 2 prior lines of platinum-based chemotherapy.


About AstraZeneca in ovarian cancer

Worldwide, ovarian cancer is the 7th most commonly diagnosed cancer2 and the 8th most common cause of cancer death in women.3 The risk of developing ovarian cancer is increased in women with specific inherited genetic abnormalities, including BRCA mutations. AstraZeneca is committed to the continued development of our R&D portfolio for ovarian cancer, with a focus on improved care for all patients, including the development of targeted therapies for patients with specific gene mutations such as BRCA.


About Lynparza

Lynparza (olaparib) is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that may exploit tumour DNA damage response (DDR) pathway deficiencies to preferentially kill cancer cells. It is approved by regulatory authorities in the EU and US for the treatment of women with BRCAm ovarian cancer. Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of compounds targeting DNA damage response (DDR) mechanisms in cancer cells.

On October 26, 2016 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven pharmaceutical group, reported its sales for the third quarter and first nine months of 2016 (Press release, Ipsen, OCT 26, 2016, View Source [SID1234516015]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Commenting on the third quarter 2016 performance, David Meek, Chief Executive Officer of Ipsen said: "We are satisfied with the excellent performance achieved in the third quarter. The momentum of the Specialty Care business accelerated in the third quarter, led by the strong global performance of Somatuline as well as a strong performance of Dysport in the US and Decapeptyl in Europe. The Primary Care business is still experiencing challenges in emerging markets and in the third quarter was particularly adversely impacted by a difficult market environment in Russia and Algeria and a slower ramp-up of the new commercial strategy in China."

David Meek added: "We advanced several pipeline programs during the quarter, most notably for our oncology portfolio the Cabometyx program. The recent approval for the second line treatment of advanced Renal Cell Carcinoma (RCC) in Europe and positive clinical results from the CABOSUN study in first line advanced RCC reinforce our conviction in the potential of Cabometyx. We are fully committed to the launch of Cabometyx in the first European countries in the coming weeks."

Third quarter 2016 sales highlights

Note: Unless stated otherwise, all variations in sales are stated excluding foreign exchange impacts.

Consolidated Group sales grew 12.2% to €390.6 million.

Sales of Specialty Care products reached €319.7 million, up 17.8% year-on-year. The relative weight of Specialty Care continued to increase to reach 81.8% of Group sales, compared to 77.8% the previous year.

Somatuline sales reached €137.0 million, up 34.1%, year-on-year, driven by the continued strong growth in the United States, and by a good overall performance in Europe, notably in Germany, France, and the UK.
Decapeptyl sales reached €84.2 million, up 6.3% year-on-year, supported by strong volume growth in Europe.
Dysport sales reached €73.9 million, up 9.3% year-on-year, led by a solid performance in the United States, notably in aesthetics through the Galderma partnership. This good performance was negatively impacted by volume declines in Brazil due to importation issues and in Russia due to lower demand.
Primary Care product sales totaled €70.9 million, down 7.5% year-on-year, affected by the decline in sales of Tanakan in Russia, Forlax in Algeria, and also the tail portfolio in France.

Smecta sales reached €25.3 million, down 1.0% year-on-year, affected by the sales decrease in China with a slower ramp-up of the new commercial strategy in China, as well as in France and in Italy despite good performance in Russia.
Forlax sales amounted to €9.0 million, down 8.8% year-on-year, affected by the sales decline in Algeria where import programs have been suspended and despite good volume growth in France.
Tanakan sales comprised €8.9 million, down 31.0% year-on-year, impacted by continued market challenges in Russia.


2016 objectives revised

Based on the performance of the first nine months of 2016, the Group raises its guidance for Specialty Care sales to greater or equal to 15% growth and revises its guidance for Primary Care sales to a range of -3% to -5%. The guidance for Core Operating margin is raised to around 22%.

On October 26, 2016 GSK reported further sales growth, improved cash flow and sustained pipeline progression in Q3 (Press release, GlaxoSmithKline, OCT 26, 2016, View Source [SID1234516014]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Summary

For GlaxoSmithKline’s full Q3 results announcement, visit: View Source to view full Q3 results announcement (PDF)

Group sales £7.5 billion, +8% CER, with continued growth across all three businesses

New product sales £1.21 billion +79% (Q1 2016: £821 million; Q2 2016: £1.05 billion) driven by HIV (Tivicay, Triumeq), Respiratory (Relvar/Breo, Anoro, Incruse, Nucala) and Meningitis vaccines (Bexsero, Menveo)

Improved operating leverage driven by sales growth, delivery of restructuring and integration benefits and continued tight control of costs including targeted reinvestments

Q3 total earnings per share 16.6p, -1% CER, impacted by charges resulting from increases in valuations of Consumer Healthcare and HIV businesses

Q3 core earnings per share 32p, +12% CER

Continue to expect 2016 core EPS percentage growth to be 11-12% CER

Q3 net cash inflow from operations of £1.8 billion (Q3 2015: £0.5 billion)

19p dividend declared for Q3. Continue to expect 80p for FY 2016 and 2017

Sustained delivery in R&D pipeline

On October 26, 2016 The Bayer Group reported that it remained on a path of growth in the third quarter of 2016 and took a major strategic step forward with the agreed acquisition of Monsanto (Press release, Bayer, OCT 26, 2016, View Source [SID1234516003]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The announcement that we had reached agreement to acquire Monsanto is a major strategic milestone for Bayer. We will be creating a global leader in agriculture and, at the same time, reinforcing our leadership position as a Life Science company," said Bayer Management Board Chairman Werner Baumann when he presented the interim report for the third quarter on Wednesday.

The third quarter was very successful in operational terms as well, reported Baumann. In the Life Science businesses, Bayer achieved encouraging sales and earnings growth overall. Pharmaceuticals especially registered a very positive business performance once again. The recently launched products showed continued strong development. Consumer Health increased sales on a currency- and portfolio-adjusted basis (Fx & portfolio adj.) but EBITDA before special items was below the prior-year level. The operating performance of Crop Science held steady year on year in a persistently difficult business environment. Animal Health raised sales and earnings. Covestro registered slight growth in sales (Fx & portfolio adj.) and a substantial increase in EBITDA before special items. The outlook for the full year remains positive. Bayer is raising the forecast for core earnings per share.

Sales of the Bayer Group increased by 2.3 percent (Fx & portfolio adj. 3.5 percent) in the third quarter to EUR 11,262 million (Q3 2015: EUR 11,004 million). EBITDA before special items improved by 6.0 percent to EUR 2,682 million (Q3 2015: EUR 2,530 million). EBIT advanced by 14.2 percent to EUR 1,795 million (Q3 2015: EUR 1,572 million) after special charges of EUR 125 million (Q3 2015: EUR 204 million). These mainly comprised EUR 52 million in connection with the agreed acquisition of Monsanto, EUR 49 million for efficiency improvement measures and EUR 23 million for the integration of acquired businesses. EBIT before special items moved forward by 8.1 percent to EUR 1,920 million (Q3 2015: EUR 1,776 million). Net income increased by 18.8 percent to EUR 1,187 million (Q3 2015: EUR 999 million), and core earnings per share from continuing operations by 2.4 percent to EUR 1.73 (Q3 2015: EUR 1.69).

Gross cash flow from continuing operations climbed by a robust 36.1 percent to EUR 1,951 million (Q3 2015: EUR 1,434 million), due among other things to the increase in EBIT. Owing to a decrease in cash tied up in working capital, net cash flow (total) rose by a substantial 31.0 percent to EUR 3,053 million (Q3 2015: EUR 2,330 million). Net financial debt declined by EUR 2.0 billion, from EUR 17.8 billion on June 30, 2016, to EUR 15.8 billion on September 30, 2016, due mainly to cash inflows from operating activities.

Strong sales and earnings growth at Pharmaceuticals

Sales of prescription medicines (Pharmaceuticals) rose by an encouraging 7.3 percent (Fx & portfolio adj. 7.6 percent) to EUR 4,152 million (Q3 2015: EUR 3,870 million). "Our recently launched products showed continued strong development," said Baumann. 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 1,395 million (Q3 2015: EUR 1,082 million). After adjusting for currency effects, the increase was 28.3 percent. Xarelto again posted strong sales growth (Fx adj. plus 34.4 percent), due mainly to volume increases in Europe and Japan. It also registered encouraging gains in the United States, where it is marketed by a subsidiary of Johnson & Johnson. Sales of Eylea increased considerably (Fx adj. plus 26.5 percent), due particularly to good business performance in Europe and Canada.

Among the established top Pharmaceuticals products, especially the hormone-releasing intrauterine devices of the Mirena product family posted strong sales gains (Fx adj. plus 13.2 percent), due particularly to positive price development in the United States. Continuing to benefit from high demand in China, business with the oral diabetes treatment Glucobay (Fx adj. plus 8.0 percent) and the antibiotic Avalox/Avelox (Fx adj. plus 8.8 percent) registered encouraging growth. Fluctuations in the order volumes placed by Bayer’s distribution partner resulted in slightly lower sales (Fx adj. minus 2.4 percent) of the blood-clotting medicines Kogenate/Kovaltry. Business with the cancer drug Nexavar was noticeably down against the prior-year level (Fx adj. minus 9.3 percent), particularly as a result of increased competitive pressure in the United States. Sales of the multiple sclerosis product Betaferon/Betaseron receded significantly (Fx adj. minus 19.7 percent), mainly because of a weaker business performance in the United States and Europe. Overall, the Pharmaceuticals business expanded in all regions on a currency-adjusted basis.

EBITDA before special items of Pharmaceuticals increased by a substantial 13.4 percent to EUR 1,421 million (Q3 2015: EUR 1,253 million), although investment in research and development remained disproportionately high. One factor in this earnings growth was the very good development of business, particularly for the recently launched products. Another factor was Bayer’s success in keeping selling expenses at around the same level year on year.

Moderate expansion of business at Consumer Health

Sales of self-care products (Consumer Health) were level year on year at EUR 1,425 million (Q3 2015: EUR 1,424 million). After adjusting for currency and portfolio effects, the increase was 3.6 percent. On a currency-adjusted basis, business developed positively in the Latin America/Africa/Middle East, North America and Asia/Pacific regions. In Europe, however, sales declined slightly compared with a strong prior-year quarter. "We achieved double-digit growth with our Aleve, Alka-Seltzer, One A Day and Elevit brands," said Baumann.

The analgesic Aleve registered a currency-adjusted increase of 12.7 percent driven by positive business development in the United States, due in part to a product line extension. The Alka-Seltzer family of products to treat gastric complaints and cold symptoms (Fx adj. plus 15.0 percent) and the One A Day vitamin product (Fx adj. plus 11.8 percent) also achieved substantial sales gains that were mainly attributable to product line extensions in the United States. Business with the Elevit vitamin product grew significantly (Fx adj. plus 17.9 percent), especially in China. By contrast, business with the sunscreen product Coppertone was down (Fx. adj. minus 5.0 percent) against the prior-year quarter due to lower sales in the United States.

EBITDA before special items of Consumer Health declined by 3.5 percent to EUR 328 million (Q3 2015: EUR 340 million). The earnings contributions from the positive business development were not sufficient to offset the higher cost of goods sold and negative currency effects of approximately EUR 20 million.

Crop Science successful in a persistently difficult market environment

Sales of the agricultural business (Crop Science) came in at EUR 2,057 million (Q3 2015: EUR 2,081 million). This amounted to a decline of 1.2 percent on a reported basis. Adjusted for currency and portfolio effects, sales were level year on year. "Crop Science was successful in a persistently difficult market environment," said Baumann. Business at Crop Protection/Seeds was steady overall at the prior-year level despite an ongoing weak business environment, particularly in Latin America. Crop Science sales developed encouragingly in Europe (Fx adj. plus 5.8 percent) and North America (Fx adj. plus 5.7 percent). Sales edged forward year on year (Fx adj. plus 1.1 percent) in the Asia/Pacific region but declined (Fx adj. minus 5.3 percent) in the Latin America/Africa/Middle East region.

At Crop Protection, Fungicides posted an increase of 8.1 percent (Fx. & portfolio adj.), whereas Insecticides saw a considerable decrease (Fx & portfolio adj. minus 16.8 percent). Performance at Herbicides (Fx & portfolio adj. minus 1.0 percent) and Seed-Growth (Fx & portfolio adj. minus 3.7 percent) declined year on year. Development at Seeds was very encouraging, with sales expanding by 21.6 percent (Fx & portfolio adj.). Environmental Science also expanded sales by a robust 17.7 percent (Fx & portfolio adj.).

EBITDA before special items of Crop Science increased by 0.6 percent to EUR 318 million (Q3 2015: EUR 316 million). Higher selling prices and a positive currency effect of around EUR 80 million stood against lower volumes, higher write-downs on receivables and higher research and development expenses, among other things.

Animal Health raises sales and earnings

Bayer grew sales of the Animal Health business by 0.8 percent (Fx & portfolio adj. 2.5 percent) to EUR 360 million (Q3 2015: EUR 357 million). The Asia/Pacific region developed especially positively. Sales also increased in Europe, while business in North America declined slightly. Business with the Seresto flea and tick collar developed positively in all regions, expanding by 19.2 percent (Fx adj.). Sales of the Advantage family of flea, tick and worm control products were level with the prior-year quarter. EBITDA before special items of Animal Health increased by 6.0 percent to EUR 89 million (Q3 2015: EUR 84 million), due especially to volume and price increases and to lower selling expenses. These stood against an increase in the cost of goods sold and in research and development expenses.

Substantial earnings growth at Covestro

Third-quarter sales of Covestro amounted to EUR 3,004 million (Q3 2015: EUR 3,009 million). Business was level year on year on a reported basis (minus 0.2 percent) and edged forward by 1.0 percent after adjusting for currency and portfolio effects. Volumes were up year on year overall, particularly at Polycarbonates and Polyurethanes. Selling prices declined in all business units. EBITDA before special items improved by 19.5 percent to EUR 564 million (Q3 2015: EUR 472 million). This increase resulted mostly from lower raw material prices and higher volumes that more than offset the decline in selling prices. Earnings were diminished by a negative currency effect of around EUR 10 million.

Net income substantially higher in the first nine months

Group sales in the first nine months of 2016 rose by 0.4 percent (Fx & portfolio adj. 3.0 percent) to EUR 34,949 million (9M 2015: EUR 34,800 million). EBITDA before special items advanced by an encouraging 9.4 percent to EUR 9,123 million (9M 2015: EUR 8,340 million). This was due to the substantial increase in sales volumes and the lower cost of goods sold. Bayer achieved this good business development despite dissynergies resulting from the legal independence of Covestro and the sale of Diabetes Care along with higher research and development spending. Earnings were held back by negative currency effects of around EUR 100 million. Net income improved by 16.6 percent to EUR 4,078 million (9M 2015: EUR 3,497 million), and core earnings per share from continuing operations by 7.1 percent to EUR 6.15 (9M 2015: EUR 5.74).

Confidence for the full year 2016

For the Bayer Group, including Covestro, Bayer is still planning sales of EUR 46 billion to EUR 47 billion in 2016. This continues to correspond to a low-single-digit percentage increase (Fx & portfolio adj.). As before, Bayer plans to increase EBITDA before special items by a high-single-digit percentage. It is now Bayer’s aim to also increase core earnings per share from continuing operations by a high-single-digit percentage (previously: a mid- to high-single-digit percentage). This takes into account Covestro’s inclusion at around 64 percent starting on April 19, 2016 (January 1 to April 18, 2016: around 69 percent).

Bayer continues to plan sales of approximately EUR 35 billion for the Life Science activities, i.e. the Bayer Group excluding Covestro. This still corresponds to a mid-single-digit percentage increase (Fx & portfolio adj.) as previously forecasted. As before, it is planned to raise EBITDA before special items by a mid- to high-single-digit percentage. This planning includes dissynergies of around EUR 130 million from the legal independence of Covestro and from divestments.

For Pharmaceuticals, Bayer continues to expect sales above EUR 16 billion. As before, this corresponds to a high-single-digit percentage increase on a currency- and portfolio-adjusted basis. Bayer continues to plan to raise sales of the recently launched Pharmaceuticals products toward EUR 5.5 billion. The company is still expecting a low-teens percentage increase in EBITDA before special items and aims to improve the EBITDA margin before special items.

In the Consumer Health Division, Bayer continues to expect sales to come in at approximately EUR 6 billion. As before, the company plans to grow sales by a low- to mid-single-digit percentage on a currency- and portfolio-adjusted basis. EBITDA before special items is still expected to come in on the level of the prior year.

In light of the persistently weak market environment, Bayer continues to expect Crop Science sales to be on the prior-year level on a currency- and portfolio-adjusted basis. As before, this is equivalent to reported sales of about EUR 10 billion. Bayer continues to expect a low-single-digit percentage decrease in EBITDA before special items for this division.

At Animal Health, Bayer continues to expect sales to be slightly above the prior-year level and is still planning a currency- and portfolio-adjusted sales increase by a low- to mid-single-digit percentage. The company now expects EBITDA before special items of Animal Health to come in on the level of the prior year (previously: increase by a low- to mid-single-digit percentage).

For 2016, Covestro is still expecting a sales decline. For the full year, EBITDA after adjustment for special items is expected to come in at about EUR 1.9 billion (previously: at least at the prior-year level for the second half of 2016).

"Bayer and Monsanto are a perfect fit"

Bayer reached a major milestone on September 14, 2016, with the signing of a binding agreement to acquire Monsanto for USD 128 per share, representing a transaction value of around USD 66 billion. "This step is entirely logical," said Baumann. "The two companies are a perfect fit and complement each other ideally. We will combine our strengths in seeking solutions to one of the major societal challenges: how to feed a substantially growing global population in an ecologically sustainable way." Bayer’s portfolio will be tailored to the needs of customers throughout the world – from large-scale commercial operations in the United States to smallholder farmers in India. The transaction is subject to customary closing conditions, including approval of the merger agreement by a majority of Monsanto’s stockholders and receipt of required approvals from the relevant antitrust and other authorities. Bayer has initiated the process of obtaining these approvals. It intends to submit the necessary application in the United States before the end of this year and in the European Union probably in the first quarter of 2017. In terms of financing, Bayer successfully closed syndication of the USD 57 billion bank facilities at the beginning of October. Refinancing in the capital markets will depend on respective market conditions and might be executed in part well in advance of closing of the transaction, which Bayer expects by the end of 2017.