Five Prime Therapeutics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Five Prime Therapeutics, MAR 18, 2015, View Source [SID1234502318]).

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Galectin Therapeutics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Galectin Therapeutics, MAR 18, 2015, View Source [SID1234502320]).

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On March 18, 2015 Nimbus Therapeutics, a biotechnology company focused on designing highly selective and potent medicines to disrupt known drivers of serious diseases, reported the successful completion of an oversubscribed $43 million Series B financing led by Pfizer Venture Investments and Lightstone Ventures (Press release, Nimbus Therapeutics, MAR 18, 2015, View Source [SID1234517064]). All of the company’s Series A investors, including Atlas Venture, SR One, Lilly Ventures and Bill Gates, also participated in the Series B round. Coinciding with this announcement, the company recently changed its name from "Nimbus Discovery" to "Nimbus Therapeutics," to signal its transition to a clinical stage company.

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"Our ability to attract such a high-caliber cadre of new and existing investors reinforces our belief in the boundless potential of our novel computational technology-driven approach to drug discovery and development," said Donald "Don" Nicholson, Ph.D., chief executive officer at Nimbus. "This financing round sets the foundational stage for several key inflection points for Nimbus in 2015 and beyond. Progressing the first of our pipeline of small molecules into the clinic, we hope to make substantial strides this year toward realizing our mission to turn historically difficult targets into medicines that matter for patients."

Nimbus plans to use the funds from the Series B round to advance its lead program, an Acetyl CoA Carboxylase (ACC) inhibitor, into clinical development, representing the first allosteric and liver-targeted inhibitor intended for the treatment of Non-alcoholic Steatohepatitis, or NASH, an increasingly common liver disease which is estimated to affect 16 million Americans.1 Nimbus plans to report Phase 1 data from this program later this year. Additionally, the company will continue to advance its preclinical programs of novel small molecules including those for IRAK4, Tyk2, KRas and other medically-important targets.

"It’s clear that Nimbus not only is employing a breakthrough technological approach for drug discovery and development, but also has the scientific expertise and management acumen to translate the company’s vision into reality," said Chris Christoffersen, Ph.D., General Partner, Lightstone Ventures. "We look forward to supporting Nimbus in the critical years ahead as it advances its promising therapeutics for people impacted by NASH and a broad spectrum of diseases with high unmet needs, and expands its potential reach and impact through new collaborations and partnerships."

Nimbus’ programs address well-validated biological mechanisms implicated in areas of metabolic disease, cancer and immune-inflammatory disorders, which have proven intractable by traditional drug discovery methods. Employing a novel approach to research and development, Nimbus deeply integrates computer-driven drug design, chemistry and pharmacology, working in close coordination with its co-founding partner, Schrödinger, and a highly integrated network of partners and collaborators. The company has demonstrated the ability to accelerate discovery, design and optimization of drug candidates and rapidly move investigational medicines into the clinic.

1Frontline Gastroenterol. 2014 Jul; 5(3): 211-218; Aliment Pharmacol Ther. 2011 Aug; 34(3): 274-85; World J Transplant. 2014 Jun 24; 4(2): 81-92; Hematology. 2014 Dec 29

About ACC and NASH

Acetyl CoA Carboxylase (ACC), a master regulator of fatty acid synthesis and oxidation, has been a sought-after, yet intractable target over the past two decades. Successful inhibition of ACC may enable new strategies to reduce lipids, blood glucose, weight and cardiovascular risk. Nimbus is the first company to successfully design drug-quality allosteric inhibitors targeting ACC for the treatment of metabolic disease as well as cancer.

The company’s first indication for ACC-focused clinical development in metabolic disease is Non-alcoholic Steatohepatitis, or NASH, a serious condition that can lead to liver cirrhosis, often leading to transplant, and other complications including hepatocellular carcinoma, a liver cancer with high mortality rates. Currently there are no therapies specifically approved to treat NASH. Other possible metabolic disease indications for ACC inhibition include type 2 diabetes and hypertriglyceridemia.

Northwest Biotherapeutics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Northwest Biotherapeutics, MAR 17, 2015, View Source [SID1234502354]).

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On March 17, 2015 Actavis plc (NYSE: ACT) reported that it has completed the acquisition of Allergan, Inc. (NYSE: AGN) in a cash and equity transaction valued at approximately $70.5 billion (Press release, Allergan, MAR 17, 2015, View Source [SID:1234512515]). The combination creates one of the world’s top 10 pharmaceutical companies by sales revenue, with combined annual pro forma revenues of more than $23 billion anticipated in 2015.

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"The combination of Actavis and Allergan creates an exceptional global pharmaceutical company and a leader in a new industry model – Growth Pharma," said Brent Saunders, CEO and President of Actavis. "Anchored by world-renowned brand franchises, a leading global generics business, a premier pharmaceutical development pipeline and an experienced management team committed to maintaining highly efficient operations across the organization, we are creating an unrivaled foundation for long-term growth.

"Our combined company will be built around a customer-focused commitment to partnering with physicians, pharmacists and patients to deliver innovative treatments and enhance access to important therapies around the world. We have industry-leading global commercial strength, with sustainable blockbuster brand franchises in key therapeutic categories and broad commercial reach extending across approximately 100 countries. Our experienced field-based representatives will continue to deliver exceptional support on a broad range of products to physicians and specialists around the world. And our powerful global supply chain is broadly recognized as a world leader, with continued excellence in quality and customer service.

"Supporting the growth of this innovative industry model is our strategically focused R&D engine, built on novel compounds in specialty and primary care markets where there is significant unmet medical need, and fueled by approximately $1.7 billion in annual investment. With an innovative product development portfolio exceeding 20 near-term projects and a world-class generics pipeline, which continues to hold an industry-leading position in First-to-File opportunities in the U.S. and more than 1,000 marketing authorizations globally, we are uniquely positioned within our industry to ensure our development activities support sustainable long-term organic growth.

"With the acquisition now complete, we will immediately begin implementing our comprehensive integration plans to ensure that we leverage our strengthened global organization to generate sustainable organic earnings growth from our newly expanded base, and continue our ascent into the fastest-growing and most dynamic growth pharmaceutical company in global healthcare."

Financially Compelling Transaction

Actavis continues to expect the transaction to generate double-digit accretion to non-GAAP earnings within the first 12 months, including approximately $1.8 billion in operating and financial synergies to be realized within one year following the close. These synergies exclude any additional revenue or manufacturing synergies, and are in addition to the $475 million of annual savings previously announced by Allergan in connection with Project Endurance. Actavis further expects to generate strong operating cash flow in excess of $8 billion in 2016, which would enable the Company to rapidly de-lever the balance sheet.

Review of the Benefits of the Acquisition

The combination of Actavis and Allergan creates a pharmaceutical business with a growth profile unparalleled within the industry.

Significantly Expanded Brand Pharmaceutical Portfolio Supported by a World-Class Sales and Marketing Organization

The close of the transaction creates an exceptional global brand pharmaceutical business with leading positions in key therapeutic categories. The company has six blockbuster franchises with combined pro forma 2015 revenues of approximately $15 billion expected, including franchises with annual revenues in excess of $3 billion in Eye Care, Neurosciences/CNS and Medical Aesthetics/Dermatology/Plastic Surgery, as well as a portfolio of world-renowned brands including BOTOX, RESTASIS, JUVEDERM, NAMENDA XR, LINZESS and LO LOESTRIN Fe among others.

The combined company will continue to be recognized for its strong commitment as the partner of choice with physicians, specialists, pharmacists, regulators and patients. The combination is committed to creating the best customer experience, based on deeply-held relationships with customers and colleagues in approximately 100 countries around the world. The company’s experienced sales and marketing organization will continue to deliver exceptional support to more than a dozen medical specialists, including primary care physicians, ophthalmologists, optometrists, retinal specialists, neurologists, psychiatrists, dermatologists, aesthetic surgeons, medical aesthetic professionals, plastic surgeons, gastroenterologists, pulmonologists, OB-GYNs, urologists, cardiologists, infectious disease specialists, pain specialists and rehabilitation specialists.

Enhanced Commercial Opportunities across Global Markets

The combination greatly enhances Actavis’ international commercial opportunities. The company has an expanded commercial presence now including approximately 100 countries, with an enhanced presence across Canada, Europe, Southeast Asia and Latin America and a strong footprint in China and India. The combined company will benefit from Allergan’s global brand equity, industry-leading consumer marketing capabilities and strong consumer awareness of key Allergan products in global markets, including BOTOX, RESTASIS, JUVEDERM, LATISSE, NATRELLE and others. On a pro forma basis, the company is expected to have approximately $5 billion in 2015 international revenue, and will have the unique opportunity to drive continued growth in international markets through its enhanced portfolio of brands, generics, branded-generic and over-the-counter products.

Strengthened and Expanded Pharmaceutical R&D Pipeline

The combined company will provide a strong commitment to R&D, with an exceptional level of investment of approximately $1.7 billion expected in 2015, focused on the strategic development of innovative and durable value-enhancing products within brands, generics, biologics and OTC portfolios. The company has more than 20 innovative products in near- or mid-term development, including Cariprazine, Eluxadoline, Esmya, Aczone X and Darpin AMD, among other promising candidates. The company’s pipeline is strategically focused within its core therapeutic areas, with key candidates in Dermatology and Aesthetics, Eye Care, CNS, GI, Anti-infectives, Women’s Health and Urology. The Company’s generics pipeline is also positioned to deliver sustainable growth, with approximately 230 Abbreviated New Drug Applications pending at FDA, including approximately 70 first-to-file applications, as well as nearly 1,000 marketing authorization applications filed outside of the U.S. in 2014.

Commitment to Being the Partner of Choice for Physicians, Patients and the Medical Community

The combined company will retain Allergan’s foundational commitment to being the partner of choice for physicians, patients and the medical community. The Company will continue to foster deep engagement with medical specialists, listening closely to their needs to help advance patient care and deliver treatments that address significant unmet medical needs. In addition, the Company will continue to go above and beyond to provide education and information – with the highest level of integrity – that helps patients fully understand the choices available to them and make well-informed treatment decisions with their doctors. Through these essential partnerships, the Company will continue to bring to bear scientific excellence and rigor to deliver leading products that improve patient outcomes.

Strong Combined Global Leadership Team with Deep Experience across the Business

The combined company’s expanded senior management team is comprised of leaders from both Actavis and Allergan. It is structured to leverage the strong talent from both organizations to ensure that the new company capitalizes on its expanded global commercial footprint and the proven track record of Allergan’s powerful and critically important product franchises, while maintaining Actavis’ continued dominance as a world leader in generics. With this structure in place beginning on Day 1, the company is immediately positioned to maximize growth across all of its global businesses.