Takeda hikes annual profit outlook by a third after second quarter profit jump

Japan’s Takeda Pharmaceutical Co Ltd boosted its annual operating profit outlook by a third after second-quarter earnings surged on strong global sales of its drugs for bowel disease and multiple myeloma.

It now expects to post 268.9 billion yen(1.87 billion pounds) in operating profit for the year ending in March, beating an average Refinitiv estimate of 222.7 billion yen from eight analysts.

Takeda is working to close a $62 billion acquisition of London-listed Shire. The upgraded forecast includes costs related to the acquisition incurred in the first half of the financial year but not costs from the latter half or projected earnings from Shire post-acquisition.

For the second-quarter, it booked an 86 percent rise in operating profit to 73.1 billion yen.

First-half sales figures showed sales of Entyvio, a treatment for Crohn’s disease and ulcerative colitis that is Takeda’s biggest selling drug, jumped 32.4 percent to 128.4 billion yen. Sales of Ninlaro, which treats multiple myeloma, a cancer of plasma cells, rose 35 percent.

Takeda has gained approval for the Shire deal, potentially the biggest-ever acquisition by a Japanese company, from U.S., Japan and China regulators but is still waiting for the nod from European authorities.

It has proposed selling a Shire Phase 3 inflammatory bowel disease drug to gain European approval for the deal and does not expect its talks with the European Commission will delay closure of the deal.

The Shire deal is aimed at strengthening Takeda’s late-stage pipeline. According to Takeda, the rare disease specialist has seven drug candidates in Phase 3 clinical trials while the Japanese firm has only three.

Takeda, which had a market value of roughly $31 billion, has secured a $30.9 billion bridge loan to help finance the acquisition. But some analysts say they remained concerned about how well the company will cope with its debt repayments – most of which have to be made in a year.

https://www.marketscreener.com/TAKEDA-PHARMACEUTICAL-CO-6491073/news/Takeda-Pharmaceutical-hikes-annual-profit-outlook-by-a-third-after-second-quarter-profit-jump-27516056/

Generex Biotechnology Record & Payment Dates for 20:1 Stock Dividend

Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that the Record Date for the determination of the holders of the Company’s common stock entitled to participate in the Company’s previously announced 20:1 common stock dividend will be Monday, November 5, 2018. The dividend Payment Date will be Tuesday, November 13, 2018.

The stock dividend will result in 20 shares of common stock paid on November 13, 2018 for every one share of common stock owned as of the close of business on November 5, 2018.

About Generex Biotechnology Corporation

Generex is a strategic, diversified healthcare holdings company with offerings in a variety of services, diagnostics, medical devices, and pharmaceutical development.

The Company’s direct-to-patient services support its strategy of all-inclusive access to doctors, diagnostics, therapeutics, and additional health-related services to greatly improve the patient experience in receiving care.

On the provider side, Generex’s management services remove administrative burdens in multiple provider settings, including private practice and hospital, allowing doctors to devote more time to patient care.

Revenue from the Company’s subsidiaries will support clinical advancement of its wholly owned therapeutic products with a focus in immunotherapeutics based on stimulating critical members of the immune response, known as T helper cells, and its proprietary buccal administration of insulin.

https://www.biospace.com/article/releases/generex-biotechnology-announces-record-and-amp-payment-dates-for-20-1-stock-dividend/

Axonics Modulation Technologies Prices 8M Share IPO

Axonics Modulation Technologies, Inc. (“Axonics”), a medical technology company focused on the design, development and commercialization of innovative and minimally invasive sacral neuromodulation (“SNM”) solutions for the treatment of overactive bladder (“OAB”), fecal incontinence (“FI”), and urinary retention (“UR”), today announced the pricing of its initial public offering of 8,000,000 shares of common stock at an initial public offering price of $15.00 per share, before underwriting discounts and commissions. Axonics has also granted the underwriters a 30-day option to purchase an additional 1,200,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions. All of the shares of common stock are being offered by Axonics.

The shares of Axonics’ common stock have been approved for listing on The Nasdaq Global Select Market and are expected to begin trading under the ticker symbol “AXNX” on October 31, 2018. The offering is expected to close on November 2, 2018, subject to customary closing conditions.

BofA Merrill Lynch and Morgan Stanley are acting as joint book-running managers for the offering. Wells Fargo Securities is acting as lead manager and SunTrust Robinson Humphrey is acting as co-manager for the offering.

https://www.biospace.com/article/releases/axonics-modulation-technologies-inc-announces-pricing-of-initial-public-offering-of-8000000-shares-of-common-stock/

FDA Works to Improve Plant and Animal Biotechnology Guidelines

Noting advances in genetic manipulation and gene editing, the Food and Drug Administration (FDA) announced a new Plant and Animal Biotechnology Innovation Action Plan.

The plan has three priority areas: advancing public health by promoting innovation; strengthening public outreach and communication; and increasing engagement with domestic and international partners.

The first two steps in implementing the plan include a Public Webinar on Genome Editing in Animals that will focus on the current science and potential risks. The second is a Veterinary Innovation Program (VIP), a new pilot program.

In a statement, FDA Commissioner Scott Gottlieb said, “As a first step, the FDA will adopt a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products, including for intentionally genetically altered animals and the food and drug products derived from them. This modern, flexible framework will advance the agency’s commitment to safety while promoting innovation in this space. Our shared goal is to help usher in new, beneficial and safe products to consumers and animals as quickly and safely as possible.”

The agency plans to publish two guidance documents over the next year, which will clarify what the FDA plans to do and how it plans to apply it oversight processes in evaluating new animal biotechnology products.

The FDA’s Center for Veterinary Medicine (CVM) will hold the public webinar on December 3. In addition to discussing the current technology, the webinar will, according to Gottlieb, “address some of the common misconceptions about the FDA’s regulation of these products. At this webinar, the FDA’s Center for Biologics Evaluation and Research will also provide information about genome editing used in producing human products, including those for use in xenotransplantation, and how these products will be regulated.”

The Veterinary Innovation Program (VIP) is for developers of intentionally genetically altered (IGA) animals and animal cells, tissue and cell- or tissue-based products (ACTPs) that are looking for FDA approval of a new animal drug application. Gottlieb states, “The goal of the VIP is to facilitate advancements in the development of innovative animal products by enhancing certainty in the regulatory process, encouraging development and research, and supporting an efficient and predictable pathway to market for certain, innovative animal products.”

At the same time, the agency will publish guidance on its regulatory approach to plant biotechnology products for human and animal food. This appears to be focused on genetically-modified plants or animals used in food. Gottlieb noted that the agency had evaluated the safety of food from more than 180 varieties of genetically engineered plants already.

Gottlieb points out that the agency is interested in communications and engagement with all stakeholders, not just large corporations, but small and medium companies.

“As the final element of our Action Plan,” Gottlieb stated, “the FDA remains committed to efforts with domestic and international partners to foster efficiency and regulatory cooperation and enhance regulatory science.”

To do so, the agency expects to “engage in a dialogue” about biotechnology techniques such as genome editing and how it might be used to address vector-borne diseases like Zika virus.

And because so much of this new Action Plan will focus on possible food products, cooperation with the United States Department Of Agriculture (USDA) will be involved, as well.

https://www.biospace.com/article/fda-announced-new-plant-and-animal-biotech-innovation-plan/

Will GSK Move Away from Respiratory Treatments for a Focus on Oncology R&D?

Could GlaxoSmithKline, the maker of asthma drugs Advair and Breo Elipta, exit the respiratory business? Alex Hoos, head of oncology at GSK, indicated that could be a real possibility due to increased competition and loss of patent exclusivity.

In an interview with S&P Global Market Intelligence, Hoos said the company could narrow its drug development focus to aim at products that will generate growth. Hoos made the surprising comment during a meeting with reporters at the European Society for Medical Oncology Congress in Munich. Speaking with the reporters, Hoos indicated that there has been a change in focus at GSK under the leadership of Chief Executive Officer Emma Walmsley and Hal Barron, the head of research and development. Barron, Hoos indicated, could be looking to eliminate a number of assets, much like Novartis did this week with a 20 percent cut in research programs, and redirect the resources at big growth areas such as oncology.

Earlier this summer, Barron unveiled a long-term plan for R&D that is focused on the immune system and genetics. The company said it will focus on the development of medicines that target mechanisms of action with strong human genetic validations. Those targets have a higher probability of success, which means a shift to a genetics-driven portfolio, the company said.

For GlaxoSmithKline, respiratory medications have been a developmental cornerstone. However, as Hoos noted, respiratory sales were a bit underwhelming for the first half of the year. However, the company reported a significant increase in total respiratory sales. For the quarter respiratory drugs brought in £645 million, about $823 million. Will those numbers though stave off a potential divestiture of respiratory drugs?

In his conversation with reporters, Hoos noted the successful past GSK has had with its respiratory franchise. He said it’s been a driver at the company for a long time, but noted sales have been flat of late.

“There is not much growth to be expected. … This was a very successful business and continues to be — it’s just much harder to innovate in respiratory than it is to innovate in oncology,” Hoos said, according to &P Global Market Intelligence.

Hoos further explained that oncology has not been as significant a focus at GSK in the past, but the growth opportunities are immense. As a result, he said the company will be redirecting some resources toward continued development.

A move toward further oncology development will reverse the course the company took three years ago when it divested itself of a significant number of oncology products in a $20 billion deal with Novartis. GSK swapped out some oncology assets for Novartis’ vaccine business and a joint share of an over-the-counter consumer healthcare business – a business that Walmsley acquired in total earlier this year for $13 billion.

As GSK moves forward with the focus on oncology, Hoos noted that the company will need to “clean-up” some of its portfolios. He said there are a few projects not likely to succeed that will need to be stopped. He also said the company will likely divest some assets that are not part of the company’s focus to “liberate resources” that can be used to accelerate development of drug candidates likely to generate significant revenue returns.

“These choices to be made are big choices and they’re not easy — and we’re in that process right now,” Hoos said.

While the company does have some oncology drugs in development, Hoos said GSK could flex its M&A muscle to pick up some late-stage immuno-oncology or cell therapy assets as potential drivers.

https://www.biospace.com/article/will-gsk-move-away-from-respiratory-treatments-for-a-focus-on-oncology-r-and-d-/

Why Veracyte Gained

Shares of Veracyte (NASDAQ: VCYT) closed up 22.5% today after the company reported revenue growth of 34% for the third quarter, giving management the confidence to raise 2018 guidance.

Test volume increased 23% year over year, buoyed by Veracyte’s Afirma Genomic Sequencing Classifier, which tests thyroid nodules to see if they need to be removed.

Adoption of Veracyte’s lung cancer test, the Percepta Bronchial Genomic Classifier that launched almost a year ago, is picking up. Test volume increased 21% compared to the second quarter. The company thinks it’ll perform somewhere between 500 and 1,000 Percepta tests in the fourth quarter.

Veracyte still isn’t cash-flow positive, but it’s headed in the right direction, only burning through $2.4 million in the third quarter, a 58% decrease from the year-ago quarter.

Management increased 2018 revenue guidance to a range of $90 million to $91 million, up from its previous guidance of $87 million to $89 million. The top-line growth will help Veracyte burn less cash; the company now expects to go through $17 million to $18 million, down from previous guidance of $18 million to $21 million. Veracyte ended the third quarter with $77.8 million in the bank thanks to a secondary offering that raised approximately $55 million, so it has a multiyear runway to get to cash-flow positive.

Looking further ahead, Veracyte plans to do a full launch of Envisia Genomic Classifier, which is used to help diagnose a lung disease called idiopathic pulmonary fibrosis, next year, which should help the test-maker keep its momentum going.

https://finance.yahoo.com/news/apos-why-veracyte-jumped-22-212700522.html

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PRA Health sees FY18 EPS $4.22-$4.27, consensus $4.19

Backs FY18 revenue guidance between $2.87B-$2.92B, consensus $2.91B.

https://thefly.com/landingPageNews.php?id=2814897