Major pharma-deals: How anti-cancer drugs are reshaping the pharmaceutical industry

Major pharma-deals: How anti-cancer drugs are reshaping the pharmaceutical industry

Reasons for mega-mergers are not always easy to establish from the outside, but that does not keep people from trying to find them anyway. In the recent $100 billion offer of Pfizer  buy the British firm AstraZeneca, nearly every analyst was unanimous about the primary motives: to exploit the patentlinked lower tax rates in the UK and to access AztraZeneca's anti-cancer pipeline.

Pfizer, in spite of spending $6-7 billion a year on research and development, does not have a good anti-cancer pipeline. AstraZeneca does, and Pfizer wants to grab it quickly. But the story does not end there. This was not the first deal in recent times that had a strong link to cancer drugs.

Two weeks ago, Novartis bought GlaxoSmithKline's cancer division for $16 billion, including a strong early-stage pipeline of potential drugs. Pfizer made a second offer to AstraZeneca last weekend. It was rejected, but industry observers think the last word on this issue has not been heard yet.

Pfizer will pursue its takeover goals relentlessly, and so will several other companies in search of new therapies for cancer. So, cancer is set to drive a major consolidation in the industry, as pharma and biotech companies compete to build good anti-cancer pipelines and develop drug superior combinations.

After a long and uncertain period, cancer therapy suddenly seems to be heating up, holding both promise for patients and business for drug companies. "We are at a very interesting point in cancer R&D," says Debasish Roychowdhury, former head of oncology at Sanofi and now a pharma consultant based near Boston in the US.
"We have an interesting confluence of scientific understanding, drug development technology and flexibility from regulators." In an earlier job, Roychowdhury was heading the development of the GSK anti-cancer pipeline that Novartis has now bought.

 

Merck Announces FDA Acceptance for Review of MK-3475 Biologics License Application for Advanced Melanoma

Merck Announces FDA Acceptance for Review of MK-3475 Biologics License Application for Advanced Melanoma

Priority Review Designation for MK-3475 BLA for Proposed Indication of Unresectable or Metastatic Melanoma in Patients Who Have Been Previously Treated with Ipilimumab

Advancing New Phase 3 Studies with MK-3475 in Adjuvant Melanoma, Previously-Untreated Non-Small Cell Lung Cancer, Advanced Head & Neck and Bladder Cancers

Data from Studies in Three Different Cancer Types to be presented at 2014 ASCO Annual Meeting

Initiating Phase 1 Study with Investigational Anti-GITR Antibody (MK-4166)

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MK-3475, Merck's investigational anti-PD-1 antibody, for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab. The FDA granted Priority Review designation with a PDUFA date of October 28, 2014, and the MK-3475 BLA will be reviewed under the FDA's Accelerated Approval program. The FDA previously granted MK-3475 Breakthrough Therapy designation for advanced melanoma, the most dangerous type of skin cancer. If approved by the FDA, MK-3475 has the potential to be the first anti-PD-1 antibody in a new class of immune checkpoint modulators.

Merck also announced it plans to file a Marketing Authorization Application for MK-3475 in Europe for advanced melanoma by the end of 2014.

"Patients with advanced melanoma have few therapeutic options and often fail to respond to all available treatments," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "We are hopeful that the FDA, through their priority review of our application, will agree to make MK-3475 available to patients with advanced melanoma who have no other therapeutic options."

MK-3475 Development Ongoing in 30 Tumors, as Monotherapy and in Combination

Today, Merck highlighted progress on the advancement of the MK-3475 development program -- currently ongoing in 30 tumor types as monotherapy and in combination. It is anticipated that by the end of 2014, the MK-3475 development program will grow to more than 24 clinical trials across 30 different tumor types, enrolling an estimated 6,000 patients at nearly 300 clinical trial sites worldwide, including four new Phase 3 studies. Ongoing and planned late-stage monotherapy and combination studies include:

   -- Seven Phase 3 registrational trials spanning advanced melanoma (adjuvant,

      ipilimumab-naïve, and ipilimumab-refractory), advanced non-small

      cell lung cancer (NSCLC) (previously-treated and previously-untreated),

      advanced head & neck cancer and advanced bladder cancer; and,

   -- Ten combination studies, including advanced melanoma, advanced NSCLC,

      advanced renal cell carcinoma, HER2+ breast cancer and other solid

      tumors.

Merck also said today that based on encouraging preclinical data, it plans to initiate a Phase 1 dose-ranging study with its investigational anti-GITR agonistic antibody, MK-4166, in patients with advanced malignances. GITR (glucocorticoid-induced TNFR receptor) is an activating immune checkpoint receptor, which is believed to stimulate immune activity against cancer cells. This will be the second investigational immune checkpoint antibody within Merck's immuno-oncology discovery program to enter clinical development.

Dr. Perlmutter added, "Our priority is advancing breakthrough immunomodulatory molecules that reveal the ability of the immune system to eliminate cancer cells. While MK-3475 provides a firm foundation for Merck's research and development strategy in oncology, we are also advancing a broad pipeline of immune checkpoint agonists and antagonists."

MK-3475 Presentations at 2014 ASCO Annual Meeting

At the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting, Merck will have more than 15 company-sponsored abstracts on MK-3475, including six oral presentations. Clinical data will be presented from studies in advanced melanoma, advanced NSCLC, as well as advanced head & neck cancer, which is the first time data for MK-3475 will be presented in this cancer type.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Merck Forward-Looking Statement

This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation in the United States and internationally; global trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2013 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

 

7 Indian American Scientists Awarded for Cancer Research

7 Indian American Scientists Awarded for Cancer Research

The Society of Asian American Scientists in Cancer Research recently presented awards to seven Indian American doctors for their outstanding contributions to cancer research.

The seven scientists—Dr. Sanjay Gupta, Dr. Addanki Pratap Kumar, Dr. Pinku Mukherjee, Dr. Nihal Ahmad, Dr. Eri S. Srivatsan, Dr. Rajeev Kumar Agarwal and Dr. Anil Kumar Jaiswal—presented their original research work at the meeting of the American Association for Cancer Research at the San Diego Convention Center here from April 5 to 9.

The awards were presented by SAASCR president Dr. Rajvir Dahiya at a ceremony April 6.

Gupta is the Carter Kissell Endowed Chair in Urologic Oncology and research director in the Department of Urology at Case Western Reserve University and The Urology Institute at the University Hospitals Case Medical Center.

In basic research his focus is to understand the risk factors and mechanisms of prostatic and bladder diseases and develop appropriate biomarkers for early detection and prognosis.

Kumar is a tenured professor in the Department of Urology with cross appointment in the Departments of Pharmacology and Molecular Medicine in the School of Medicine at the University of Texas Health Science Center at San Antonio.

A seminal discovery from Kumar’s laboratory regarding the ability of a bark extract to prevent prostate tumor development in pre-clinical animal model led to a clinical trial to test the ability of the extract to potentiate radiation and surgery regimens for prostate cancer patients.

Mukherjee is an Irwin Belk and Oliver Smithies Endowed Professor for Cancer Research at the University of North Carolina at Charlotte. She has a patent issued and 12 others pending for the development of a new antibody that has applications in molecular diagnostics and anti-cancer therapeutics.

Ahmad is a Nelson M. Hagan Endowed Professor at the University of Wisconsin, Madison.

His research is focused on two major lines of investigation: mechanism of cancer development and identification of molecular targets for intervention; and chemoprevention and experimental therapeutics of cancer.

Srivatsan is a professor of surgery at the University of California Los Angeles, David Geffen School of Medicine. He is working on various therapeutic agents for the treatment of cervical and another HPV associated cancer.

With the help of UCLA students, he started a nonprofit organization, Project RISHI, at UCLA in 2005, which now has chapters in all the UC campuses and in Northwestern and Harvard universities. Each of these chapters has adopted a village in India for improving health care.

Agarwal is a program director in the Translational Research Program of the Division of Cancer Treatment and Diagnosis at the National Cancer Institute, National Institutes of Health. Since 2006, Agarwal has been serving the cancer community in various capacities ranging from initial discussion with investigators till the submission of their proposals and from award to completion of the funding cycle.

Jaiswal is a professor of Pharmacology and Experimental Therapeutics, University of Maryland School of Medicine, where he is also the director of the Graduate Program in Molecular and Mechanistic Toxicology.

Jaiswal has made several discoveries that have significantly increased our understanding of cellular responses to environmental and synthetic chemicals and radiations, oxidative stress signaling, cell survival, cell death and molecular carcinogenesis.

Victims of Cancer Now Live Longer with Surgical Oncology in India

Victims of Cancer Now Live Longer with Surgical Oncology in India

Surgical oncology in India has enabled many patients of cancer to live a longer life. Sometimes you may not feel well and also notice some sort of uncommon growths on your body. These growths might make you feel nervous. Now one question arises that what kind of doctor you need to find in getting a proper diagnosis and treatment to live a long and healthy life?

Most cancer surgery hospitals have a division of surgical oncology that does efficient management and treatment of different kinds of cancers. You should understand this well that all tumors are not cancerous, but you will require a proper advice in treating this condition of abnormal growth. When ever you go to a well divided oncology hospital then you should meet an experienced oncologist or cancer surgeon. Such an oncologist can only decide and determine the current status of your condition. He will also device a treatment plan for you which would prove to be the best for you. It is essential to know that if you approach an oncologist then it does not mean that surgery is the only option.

Your oncology surgeon will start your cancer treatment with least invasive treatment options before going to complex treatment procedures. The surgeons who are in the division of the subject of oncology are very experienced in all kinds of treatment and will do all that is essential to keep you happy and fit.

India lags behind in stem cell donors: Expert

India lags behind in stem cell donors: Expert

India is far, far behind in its requirement of stem cell donors to treat life-threatening diseases like cancer, with only 500 transplants taking place annually compared to a requirement of 50,000, an international conference was told today.

Leading experts from the US, Germany and India met here for the International Bone marrow Transplant Summit to talk about the latest advances in stem-cell treatment of diseases.

What became clear during the deliberations of the summit, organised by an NGO Bharat Stem Cell, was lack of awareness about the importance of donating stem cells.

One of India's leading oncologists, Dr Vinod Raina told the conference that the country needed donors for some 50,000 stem cell transplants a year but currently only 500 transplants can be undertaken.

Dr Raina, Director of Medical Oncology and Hematology at Fortis Memorial Research Institute, pointed out that the US had a registry of 22 million donors in a population of 317 million, but in India the figure was a poor 40,000 donors in a population of 1.2 billion.