Abbott Set to Complete Acquisition of St. Jude Medical on January 4, 2017

abbott

Dec. 30, 2016

Abbott Laboratories has announced that it plans to close the acquisition of St. Jude Medical, Inc., on Wednesday, Jan. 4, 2017. The announcement follows receipt of all regulatory clearances required for closing.

After this transaction, Abbott will be able to establish as a leader in the medical device arena and enjoy expanded opportunities for future growth. The company has an ongoing effort to develop a strong, diverse portfolio of devices, diagnostics, nutritionals and branded generic pharmaceuticals, and the addition of St. Jude Medical will be an important part of this effort.

Miles D. White, chairman and chief executive officer, Abbott, said: “We continue to deliberately shape our business for long-term success by securing leadership positions in attractive markets and focusing on customer needs. This philosophy has served as the foundation for significant and sustainable value creation for our shareholders. The addition of St. Jude Medical creates one of the broadest medical device portfolios in the world and provides a steady stream of new technologies and therapies for many years to come.”

 

Advertisements

Biogen and Ionis Receive FDA Approval for spinal muscular atrophy drug Spinraza

biogen-ionis

December 23, 2016

FDA announced that it had provided an accelerated approval for Spinraza (nusinersen), the new drug from Biogen and Ionis, for treating rare cases of spinal muscular atrophy. It is estimated that the total sales of this drug would reach $3 billion by 2026. On this news, shares of Ionis climbed 10% and Biogen saw its stock shot up 2%. After a year of upheavals, both companies badly needed this win.

Billy Dunn, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said: “There has been a long-standing need for a treatment for spinal muscular atrophy, the most common genetic cause of death in infants, and a disease that can affect people at any stage of life. As shown by our suggestion to the sponsor to analyze the results of the study earlier than planned, the FDA is committed to assisting with the development and approval of safe and effective drugs for rare diseases and we worked hard to review this application quickly; we could not be more pleased to have the first approved treatment for this debilitating disease.”

Roche’s emicizumab for the Treatment of haemophilia A meets primary endpoint in phase III study

Roche Igea Luca Dezzani

Roche Igea Luca Dezzani

22 December 2016

Roche has announced that the primary endpoint has been met for the phase III HAVEN 1 study assessing emicizumab prophylaxis in people with haemophilia A and inhibitors to factor VIII. The study revealed a statistically significant reduction in the number of bleeds over time in people treated with emicizumab prophylaxis compared to those receiving no prophylactic treatment. All secondary endpoints were also met, including a statistically significant reduction in the number of bleeds over time with emicizumab prophylaxis treatment in an intra-patient comparison in people who had received prior bypassing agent prophylaxis treatment. Injection site reactions were the most common adverse events with emicizumab, as consistent with prior studies.

Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development, said: “The development of inhibitors that render factor VIII replacement less effective, or ineffective, is one of the greatest challenges in the treatment of haemophilia A today, putting patients at high risk for life-threatening bleeds and repeated bleeds that may cause long-term joint damage. We are pleased to see that, in our first pivotal trial, emicizumab prophylaxis significantly reduced the number of bleeds over time in people in this difficult-to-treat setting. We look forward to working with health authorities to bring this treatment to the haemophilia community as soon as possible.”

“Since the mid-1990’s, there have been incremental improvements in the treatment of haemophilia A with inhibitors. The current burden of treatment is significant. WFH is supportive of research that could yield new therapeutic agents and offer a new treatment option for inhibitor patients. Filling this need would be a significant advance in our quest to achieve Treatment for All including those living with inhibitors,” said Alain Baumann, Chief Executive Officer of the World Federation of Hemophilia.

Allergan Signs $2.9 Billion Breast Cancer Deal

2000px-allergan_plc-svg

Dec 20, 2016

Allergan, a New Jersey based pharmaceutical company, is ending this year on a high note with yet another biotech purchase. It has announced that that it will acquire LifeCell from privately-held Acelity for $2.9 billion in cash. LifeCell focuses on breast reconstruction surgery devices and drugs and is expected to generate $450 million in 2016 revenue.

Brent Saunders, CEO of Allergan, said in a statement: “The acquisition of LifeCell is both strategically and financially compelling to Allergan and serves as our entry point into regenerative medicine as we create a world-class aesthetic and regenerative medicine business in plastic surgery. LifeCell’s regenerative medicine unit is a strong fit with our existing business and can be significantly strengthened with our infrastructure and global reach.”

This fall, Allergan has been on an acquisition spree, buying up several smaller biotech companies to build out its offering. The most recent acquisition of the company was its $125 million deal for Alzheimer’s drug developer Chase Pharmaceutical Corp. This transaction could be worth as much as $1 billion ultimately based on potential milestone payments.

Lilly’s Baricitinib is Recommended by CHMP for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis (RA)

Lilly

Dec. 16, 2016

Eli Lilly and Company and Incyte Corporation have announced that the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency (EMA) has issued a positive opinion recommending the approval of baricitinib – which if approved, would be marketed as Olumiant®. Baricitinib is recommended to be used for treating moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Baricitinib may be used as monotherapy or in combination with methotrexate. This recommendation from CHMP is expected to be followed by the approval from the European Commission, who will make the decision on marketing authorization.

Andrew Hotchkiss, president of Lilly’s European and Canadian operations, said: “Rheumatoid arthritis is a debilitating disease and can have a devastating impact on a person’s quality of life. There is no cure for rheumatoid arthritis and although improvements have been seen in the long-term outcomes for patients, not all people reach low disease activity or remission. Baricitinib is the first JAK inhibitor to receive a positive CHMP opinion for the treatment of RA in the EU. It is an important milestone for people living with rheumatoid arthritis and Lilly is committed to improving outcomes for people living with this chronic condition.”

“The positive opinion for baricitinib paves the way for adults with rheumatoid arthritis to be offered a new treatment option. Incyte is proud to have partnered with Lilly on the research and development of this promising medicine, and we are pleased that the CHMP positive opinion brings us one step closer to providing baricitinib to the many people living with this chronic condition,” said Steven Stein, M.D., chief medical officer, Incyte Corporation.

Pharma 2016: One Year in Review

Lots of new things happened in the pharmaceutical industry in 2016. At Igeahub.com, our mission is to make the pharmaceutical world simple and clear to everyone. We want our readers to have a privileged view on the key player in the healthcare system, and we do our best to keep things simple but highly accurate. The global healthcare environment is changing rapidly, so it is indispensable for life science and healthcare industry executives, researchers, investors, health policymakers and patients to be always updated.

Here is a selection of best pharma perspectives and news published here in this blog in the current year.

Pharmaceutical Products

At igeahub.com, we have covered some important viewpoints regarding pharmaceutical products in 2016, like the following:

Top 25 Pharmaceutical Products in 2015

Immuno-Oncology Upcoming Immunotherapies

World’s Top Ten Cancer Drugs by 2020

Top 10 Orphan Drugs and Their Economic Power

Hi-Tech Medicine: How Google and Apple Will Take Care of Our Health

Pharmaceutical Companies

We have reviewed and ranked the top companies in pharmaceutical and biotech industries:

Top 10 Pharmaceutical Companies 2016

World’s 10 Best Pharma and Biotech Companies of 2015

World’s Top 15 Biotech Companies 2016

The World’s Most Reputable Pharmaceutical Companies 2016

M&A in Pharma: Best 10 Deals in 2015-16

Top 10 Issues in Global Health Pharmaceutical Delivery Supply Chain

Clinical Research

In 2016, we have comprehensively focused on the topic of clinical research involving the efficacy and safety of medications and treatment options, like the following:

Approaches to Boost Clinical Trial Success

Approaches to Conquer Global CRA Shortage

Top 10 Global CROs in 2016

 Career Development in Pharma

Some exciting articles on career development for pharma professionals have been published at igeahub.com, like the following:

Medical Roles in the Industry: Biologist, Pharmacist and Pharmaceutical Physician

Pharmaceutical Sales Representatives – How to Stand Out in the Crowd?

The career section also includes the following two articles from our expert adviser Veronika Nemeth who will continue her collaboration with Igeahub.com throughout 2017:

The Underrated Truth Behind First Impressions

Secret weapon to success

Healthcare sustainability and patient centricity

The other important viewpoints regarding the pharmaceutical industry that have been covered at igeahub.com in 2016 include the following:

Healthcare Sustainability: Here Is How Things Will Change

Top 10 Best Healthcare Systems in the World

Top 5 Causes of Drug Price Hike

Global Aging Pattern in 9 Graphs

Population Health & Personalized Medicine: Can they coexist?

Patients’ Associations and Pharmaceutical Companies: Joint Effort for Health

Patient Engagement: A Key Element in Pharmaceutical Marketing Strategy

Top 10 Medical Tourism Destinations Around the Globe

Global Healthcare Expenditure in 8 Graphs

We also critically reviewed few of the sources for healthcare and pharmaceutical updates:

Top 10 Pharma Blogs 2016

Best Websites for Pharmaceutical and Healthcare Updates

 

Top News 

In 2016, a lot of exciting news have shaken the pharmaceutical and biotech industry. We, at Igeahub.com, have published many of those to quench the thirst of the professionals working in the pharmaceutical industry.

  • Company Business Updates

We have published a good number of news regarding pharma company updates, mergers and acquisitions, etc., like the following:

GSK Returns to War against Cancer

Boehringer Ingelheim Gives Global Development and Commercial Rights to Amgen for Investigational BiTE® Immuno-Oncology Drug for Multiple Myeloma

Quintiles and IMS Health Complete Merger

Novartis Separates its Pharmaceuticals Division into two business units: Novartis Oncology and Novartis Pharmaceuticals

Two Cardiovascular Collaborations Announced by Amgen and Arrowhead Pharmaceuticals

Roche launches a global network of cancer immunotherapy centers of research excellence (imCORE™)

Pfizer Acquires Bamboo Therapeutics and Aims to Become Industry Leader in Gene Therapy

Janssen Collaborates with TESARO, Inc., for Niraparib in Prostate Cancer

CHMP recommends Novartis drug Afinitor® for European Union approval

  • Regulatory Updates

In 2016, regulatory authorities in the pharmaceutical industry, like FDA and EMA, have approved a good number of medications. At Igeahub.com, we have focused on many of those, including the following:

Pfizer Gets Positive CHMP Opinion for IBRANCE® (palbociclib) in Combination with Endocrine Therapy for The Treatment of HR+/HER2- Metastatic Breast Cancer in Europe

BLINCYTO® (blinatumomab) is Approved by FDA for Use in Pediatric Patients with Philadelphia Chromosome-Negative Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia

FDA Accepts Biologics License Application for Romosozumab, Amgen and UCB Announce

EMA and FDA accept Marketing applications of Roche for review of OCREVUS® (ocrelizumab) in two forms of multiple sclerosis

KEYTRUDA® (pembrolizumab) of Merck Receives Positive CHMP Opinion for the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

FDA Approves KEYTRUDA® (pembrolizumab) of Merck for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

FDA Accepts Supplemental Biologics License Application for Merck’s KEYTRUDA® (pembrolizumab) for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer

Lilly And AstraZeneca Receive FDA Fast Track Designation For AZD3293 for Treating Early Alzheimer’s Disease

EMA Validates the Marketing Authorization Application for Avelumab for Treating Metastatic Merkel Cell Carcinoma

European Union Gives Approval to IBRANCE® (palbociclib) for the Treatment of Women with HR+/HER2- Metastatic Breast Cancer

Pfizer’s XALKORI® (Crizotinib) Receives Approval for the Treatment of Patients with ROS1-Positive Advanced Non-Small Cell Lung Cancer in European Union

Takeda Gets Marketing Authorization for NINLARO™ (ixazomib) in Relapsed/Refractory Multiple Myeloma in Canada

Bristol-Myers Squibb and AbbVie Announce the Approval of Empliciti™ (elotuzumab)by European Commission for the Treatment of Multiple Myeloma

FDA Approves Prevnar 13® of Pfizer in Adults Age 18 Through 49

FDA Approves Vermox™ Chewable (Mebendazole) for Treating both Children and Adults with Whipworm and Roundworm Infections

Janssen Submits Marketing Authorisation Application to European Medicines Agency for Darunavir-Based Single Tablet Regimen for the Treatment of HIV-1

European Union Approves Biogen and AbbVie’s Once-Monthly ZINBRYTA™ (daclizumab) for the Treatment of Multiple Sclerosis

European Commission Approves the Immuno-Oncology Combination, Opdivo® (nivolumab) + Yervoy® (ipilimumab) Regimen of Bristol-Myers Squibb, for Treatment of Advanced Melanoma

  • Clinical Trial results

We have reported results of some of the most important clinical trials in this year, including the following:

Merck and Pfizer Announce Investigational Ertugliflozin Met Primary Endpoint of A1C Reduction When Added to Metformin and Sitagliptin for the Treatment of Type 2 Diabetes

Lynparza Phase III SOLO-2 trial reveals substantial progression-free survival benefit

Amgen Announces Top-Line Results from Phase 3 KYPROLIS® (Carfilzomib) CLARION Study in Patients with Newly Diagnosed Multiple Myeloma

Keytruda Shows Promise in Patients with Merkel Cell Carcinoma, A Rare Form of Skin Cancer

Roche’s cancer immunotherapy TECENTRIQ (atezolizumab) assisted people with a particular type of lung cancer live significantly longer compared to chemotherapy, Phase III study showed

Amgen Announces Positive Top-Line Results From XGEVA® (Denosumab) Phase 3 Trial for Patients with Multiple Myeloma

New Data on Opdivo (nivolumab) from Bristol-Myers Squibb Indicate Benefit in Heavily Pre-Treated Classical Hodgkin Lymphoma Patients

New Research Details Published by Merck Scientists About the Early Development of Verubecestat

Merck’s Phase 3 Study Results Evaluating ZEPATIER™ (elbasvir and grazoprevir) in Patients with Chronic Hepatitis C Receiving Treatment for Opioid Dependence Published

New Clinical Results show Novartis’ Entresto™ reduced cardiovascular death or hospitalization for heart failure

Novartis announces positive phase III results showing effectiveness of BAF312 in patients with secondary progressive multiple sclerosis

Data presented by Novartis showing Jakavi® is superior to best available therapy in patients with less advanced polycythemia vera (PV)

We have also covered news from few international congresses, including ASH and ESMO:

Top News from ASH 2016

Top News from ESMO 2016

For all of these news and views published in Igeahub.com, Dr. Luca Dezzani, the editor and chief contributor of Igeahub.com, have been included in the list of 10 top voices 2016 in healthcare by LinkedIn. In 2017, many other exciting and new sections will feature in this blog, including a new series on ‘Pharma companies at a glance’. The important career development section will also continue. Hopefully, you will be with us in 2017 too.

Johnson & Johnson Looks for the Right Deal

jnj

Dec 15, 2016

The auction process to acquire Pharmacyclics was too competitive, and Actelion Pharmaceuticals was too expensive for Johnson & Johnson. Is there any deal that will be just right for J&J?

Officials from Johnson & Johnson announced that it had ended discussions with Actelion on a potential deal. Analysts say that J&J is flush with cash and needs to do a deal soon. Now, the question is, what is J&J looking for?

Analyst Ashtyn Evans of Edward Jones Trust said that the pharma giant could probably handle a deal of any size with $40 billion in cash. He said: “What’s good about JNJ is that because of their size and cash balance, they can do any size of deal.”

However, Analyst Damien Conover of Morningstar cautioned that the company traditionally hasn’t been interested in mega-mergers and says J&J’s cap is somewhere near $20 billion.

Conover recognized the need of an acquisition for J&J. He said: “They need to make an acquisition, especially because their growth is not as fast as it could be. They’re motivated to do it. There’s a huge range of acquisition options out there.”

Conover also added that several of the company’s drug patents are coming up on expiration dates. This means that the company will soon be faced with more generic competition.

The Plan for Drug Price Cap Nullified by White House

white house.jpg

Dec 16, 2016

The Obama administration has decided to quit on a plan to fight high drug prices that drew strong opposition from both parties and also from apparently all sectors of the healthcare industry. It was confirmed by a spokesperson for the agency regulating Medicare and Medicaid.

The drug pricing plan was proposed in March and would have changed how Medicare pays for drugs. The idea drew opposition immediately from pharmaceutical companies, doctors’ groups and even Democratic lawmakers on Capitol Hill. Companies that had opposed the plan publicly included Eli Lilly, Pfizer, Regeneron, Bristol-Myers Squibb, and Johnson & Johnson.

The intention of the administration was to replace a current Medicare program paying doctors the average price of a drug plus 6%. Under the current system, doctors have an incentive to prescribe higher-cost drugs, as argued by the White House. The proposed plan would have reduced the 6% add-on to 2.5%, and also a flat fee of about $16. However, opponents complained that the new system could have limited patient’s access to certain drugs if doctors’ acquisition costs rose above the Medicare reimbursement level.

Aaron Albright, a spokesman for the Centers for Medicare and Medicaid Services (CMS), said: “After considering comments, CMS will not finalize the Medicare Part B Drug Payment Model during this administration. While there was a great deal of support from some, a number of stakeholders expressed strong concerns about the model. While CMS was working to address these concerns, the complexity of the issues and the limited time available led to the decision not to finalize the rule at this time.”

Lonza Buys Capsugel in $5.5 Billion Health Care Deal

lonza-capsugel

Dec 15, 2016

Lonza has declared that it will buy private-equity backed U.S. capsule maker Capsugel in a $5.5 billion all-cash deal. This will push the Swiss biotech group further into the health care industry.

Lonza will buy Capsugel via a combination of debt and equity financing and will assume around $2 billion in Capsugel debt. Lonza said the acquisition will add $30 million in annual operating synergies by the third year and a further $15 million in tax synergies each year.

Lonza CEO Richard Ridinger said: “The acquisition of Capsugel meets Lonza’s strategic and financial goals. It accelerates our health care continuum strategy by giving us broader exposure to the fast-growing pharma and consumer health care markets. We expect the transaction to be accretive to our core earnings per share in the first full year post closing.”

In recent months, Lonza, of Basel, has been an active deal maker. The company has recently announced the sale of its Braine-L’Alleud, Belgium-based polypeptides business, to PolyPeptide Laboratories Holding, of Malmo, Sweden and Torrance, Calif. for an undisclosed price. Earlier, Lonza acquired Interhealth Nutraceuticals of Benicia Calif., for up to $300 million and liver-cell specialist Triangle Research Labs, of Triangle Park, N.C. for an undisclosed price.

ABOUND Data Explores Safety and Efficacy of ABRAXANE® for the Treatment of Patients with Lung Cancer

Celgene Igea Luca Dezzani

Celgene Igea Luca Dezzani

Dec 6, 2016

Celgene Corporation has announced interim results from the ABOUND clinical trial program evaluating the use of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in patients with advanced non-small cell lung cancer (NSCLC). Interim data presented from the ABOUND trials during the IASLC 17th World Conference on Lung Cancer (WCLC) reinforces the benefit of ABRAXANE/carboplatin doublet therapy in first-line NSCLC.

ABOUND trials also evaluated quality of life utilizing the Lung Cancer Symptom 3-item index Scale (LCSS), Lung Cancer Symptom, Symptom Burden Index, Pulmonary Symptom Scores and the EuroQol five dimensions, five level questionnaire (EQ-5D-5L). According to these interim analyses, quality of life was generally maintained or improved in patient populations.

Michael Pehl, President, Hematology and Oncology for Celgene, said: “These early data from the ABOUND clinical trial program are very encouraging, as they are consistent with the findings related to these hard to treat non-small cell lung cancer patient subgroups seen in the pivotal ABRAXANE Phase III trial. These data, coupled with the ongoing studies of ABRAXANE in combination with novel agents and immunotherapies, provide us with a deeper understanding of how to treat challenging patient populations and will help us continue to develop future treatment options.”